Anugesic HC Cream

ANUGESIC HC CREAM

Pramocaine hydrochloride, Hydrocortisone acetate, Zinc oxide, Balsam peru, Benzyl benzoate, Bismuth oxide

In this leaflet:

• 1. What Anugesic HC Cream is and what it is used for


• 2. Before you use Anugesic HC Cream


• 3. How to use Anugesic HC Cream


• 4. Possible side effects


• 5. How to store Anugesic HC Cream


• 6. Further information

Important things that you SHOULD know about your medicine:

• Anugesic HC Cream is used to treat severe pain and discomfort associated with haemorrhoids (piles), and pruritus ani (itching around the anus) in adults. Anugesic HC Cream may be used for either of these conditions.



• Anugesic HC Cream is for topical use and should only be used as directed. Do not swallow the cream or use on other areas of the skin. If you accidentally swallow Anugesic HC Cream, tell your doctor immediately.



• Anugesic HC Cream can sometimes cause burning, itching or stinging around the anus (See Section 4 for more details). See your doctor immediately if these symptoms do not go away

Please read the rest of this leaflet. It includes other important information on the safe and effective use of this medicine that might be especially important to you.

What ANUGESIC HC Cream is and what it is used for

• Anugesic HC Cream contains several active ingredients. One of these is Pramocaine hydrochloride which is an anaesthetic which acts on the skin and mucous membranes to relieve pain and itching. Another of the active ingredients is Hydrocortisone acetate which is one of the group of medicines called corticosteroids which help to relieve inflammation. The other active ingredients of Anugesic HC Cream have astringent, protective, soothing and mild antiseptic properties. The cream may also provide lubrication for the insertion of suppositories. (For Other ingredients see Section 6).



• Anugesic HC Cream is used to treat the severe pain and discomfort associated with haemorrhoids (piles), and pruritus ani (itching around the anus). Haemorrhoids (piles) are enlarged or swollen blood vessels around the anus, which can cause varying degrees of discomfort, itching and irritation, particularly after a bowel movement. They may either be internal (inside the anus) or external (outside the anus).



• Anugesic HC Cream is used in adults only and not recommended for children.

Before you use Anugesic HC Cream

Do not use Anugesic HC Cream if you have :

• tubercular, fungal or viral lesions e.g genital warts



• had a reaction to Anugesic HC Cream or any of the individual ingredients



• had a reaction to other similar medicines containing balsam peru

Important information about some of the ingredients of Anugesic HC Cream

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions. Propylene glycol and balsam peru may cause skin irritation.

Take special care with Anugesic HC Cream:

Tell your doctor if any of these apply to you, to help him or her decide if Anugesic HC Cream is suitable for you:

• If you suffer from any rectal bleeding (bleeding from the back passage). Although bleeding, (shown as streaks of blood on toilet paper), is not uncommon in people with piles, it may be a sign of a more serious condition and you should see your doctor to check this.



• If you have any cuts or infection around the anus. Ask your pharmacist or doctor if you are in any doubt about this as it is important not to use Anugesic HC Cream if the area around the anus is infected.



• If you are pregnant, trying to become pregnant now, or likely to want to try to become pregnant in the future.



• If you have chicken pox or shingles



• If you have recently had a smallpox vaccination.

Taking other medicines:

There are no known interactions with other medicines but it is wise to inform your doctor or pharmacist if you are taking, or have recently taken any other medicine –including those bought without a prescription.

Pregnancy and Breast-feeding:

If you are pregnant, trying to become pregnant or breastfeeding, ask your doctor or pharmacist for advice before using Anugesic HC cream as there may be better alternative treatments for you.

How to use Anugesic HC Cream

• Wash the anal area thoroughly and then dry carefully with a soft towel. Apply a small amount of Anugesic HC cream to the affected area at night, again in the morning and after each bowel movement.



• For internal application, use the plastic applicator nozzle provided. After use the nozzle should be washed each time in hot soapy water and then thoroughly rinsed in cold water.



• Do not use the cream for longer than seven days unless your doctor tells you to. If the condition gets worse, or if rectal bleeding starts, consult a doctor immediately.



• Anugesic HC Cream is for topical use only. Do not swallow the cream or apply it to any part of the body except for the area around the anus (bottom) or into the rectum (back passage) using the applicator. If you accidentally swallow any cream or use more than your prescribed dose, tell your doctor or pharmacist immediately.

Possible side effects

Like all medicines Anugesic HC Cream can sometimes cause side effects, although not everybody gets them. The following side effects that have been seen with Anugesic HC Cream mostly affect the skin and tissues around the anus. These side effects are usually mild and go away after a short time:

• A burning, itching or stinging is occasionally felt around the anus, especially if the skin is broken.



• Very rarely there are sensitivity reactions, such as a rash.



• Continuous use for long periods of time (longer than seven days) can be harmful, causing the skin to thin, develop a stripy appearance or affect the blood vessels just below the skin. If you use Anugesic HC Cream regularly and are at all worried, speak to your doctor or pharmacist immediately.

If you experience any of the above side effects or notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist at once.

How to store Anugesic HC Cream

• Keep out of the reach and sight of children.



• Anugesic HC Cream should not be used after the expiry date printed on the tube and on the carton.



• Store in the original container.



• Do not store above 25ºC.

Further information

What Anugesic HC Cream contains and the contents of the pack

Each 100 g of cream contains the active ingredients: Pramocaine hydrochloride, Hydrocortisone acetate, Zinc oxide, Balsam peru, Benzyl benzoate, Bismuth oxide.

Anugesic HC Cream also contains the inactive ingredients: liquid paraffin, propylene glycol, polysorbate 60, sorbitan stearate, glyceryl monostearate, titanium dioxide (E171), the preservatives methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and purified water.

Anugesic HC Cream is a buff coloured cream with an antiseptic odour.

Marketing Authorisation Holder:

The Marketing Authorisation Holder in the United Kingdom is

Pfizer Limited

Ramsgate Road

Sandwich

Kent

CT13 9NJ

United Kingdom

The Marketing Authorisation holder in Ireland is

Pfizer Healthcare Ireland

9 Riverwalk

National Digital Park

Citywest Business Campus

Dublin 24

Manufacturer:

McNeil Manufacturing

5 Avenue de Concyr

45071 Orleans Cedex 2

France

Company contact address:

For further information on your medicine, please contact Medical Information at the address below

Pfizer Limited

Walton Oaks

Dorking Road

Tadworth

Surrey

KT20 7NS

Telephone:01304 616161

Leaflet last updated: May 2008

Ref: AU 6_0

Cortomycin

Generic Name: neomycin, polymyxin b, and hydrocortisone (Otic route)

nee-oh-MYE-sin SUL-fate, pol-ee-MIX-in B SUL-fate, hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Antibiotic Otic


• Cort-Biotic


• Cortisporin


• Cortomycin


• Oti-Sone


• Pediotic

Available Dosage Forms:

• Solution


• Suspension

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Neomycin

Uses For Cortomycin

Neomycin, polymyxin B, and hydrocortisone is a combination antibiotic and cortisone-like medicine. It is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems.

Neomycin, polymyxin B, and hydrocortisone preparation is available only with your doctor's prescription.

Before Using Cortomycin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in children with use in other age groups, this preparation is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of otic neomycin, polymyxin B, and hydrocortisone preparation in the elderly with use in other age groups, this preparation is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Any other ear infection or condition (including punctured eardrum)—Use of neomycin, polymyxin B, and hydrocortisone otic preparations may make the condition worse

Proper Use of neomycin, polymyxin b, and hydrocortisone

This section provides information on the proper use of a number of products that contain neomycin, polymyxin b, and hydrocortisone. It may not be specific to Cortomycin. Please read with care.

You may warm the ear drops to body temperature (37 °C or 98.6 °F), but no higher, by holding the bottle in your hand for a few minutes before using the medicine. If the medicine gets too warm, it may break down and not work at all.

To use:

• Lie down or tilt the head so that the infected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.) Your doctor may have inserted a gauze or cotton wick into your ear and may want you to keep the wick moistened with this medicine. Your doctor also may have other directions for you, such as how long you should keep the wick in your ear or when you should return to your doctor to have the wick replaced. If you have any questions about this, check with your doctor.


• To keep the medicine as germ-free as possible, do not touch the dropper to any surface (including the ear). Also, keep the container tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic (ear drops) dosage forms:
  
  • For ear canal infection:
    
    • Adults—Use four drops in the ear three or four times a day.
    
    
    • Children—Use three drops in the ear three or four times a day.
    
    
  
  
  • For mastoid cavity infection:
    
    • Adults—Use four to ten drops in the ear every six to eight hours.
    
    
    • Children—Use four or five drops in the ear every six to eight hours.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Cortomycin

If your symptoms do not improve within 1 week, or if they become worse, check with your doctor.

Do not use this medicine for more than 10 days unless otherwise directed by your doctor.

Cortomycin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Itching, skin rash, redness, swelling, or other sign of irritation in or around the ear not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Cortomycin side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Cortomycin resources

• Cortomycin Side Effects (in more detail)
• Cortomycin Use in Pregnancy & Breastfeeding
• Cortomycin Drug Interactions
• Cortomycin Support Group
• 0 Reviews for Cortomycin - Add your own review/rating

• Cortomycin Prescribing Information (FDA)


• Cortomycin Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Cortomycin Concise Consumer Information (Cerner Multum)


• AK-Spore HC Otic Suspension Concise Consumer Information (Cerner Multum)


• Pediotic Prescribing Information (FDA)

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• Otitis Externa
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Topcare Arthritis Pain Relief

acetaminophen

Dosage Form: tablet, film coated, extended release
Topco Arthritis Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:


• arthritis


• the common cold


• headache


• toothache


• muscular aches


• backache


• menstrual cramps


• temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 6 caplets in 24 hours, which is the maximum daily amount


• with other drugs containing acetaminophen


• 3 or more alcoholic drinks every day while using this product

Do not use

• if you are allergic to acetaminophen


• with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

liver disease.

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

• pain gets worse or lasts for more than 10 days


• fever gets worse or lasts more than 3 days


• new symptoms occur


• redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• do not take more than directed (see overdose warning)

adults	take 2 caplets every 8 hours with water swallow whole – do not crush, chew or dissolve do not take more than 6 caplets in 24 hours do not use for more than 10 days unless directed by a doctor
under 18 years of age	ask a doctor

Other information

• store at 20°-25°C (68°-77°F). Avoid excessive heat 40°C (104°F).


• see end panel for lot number and expiration date

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol 400, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

See New Warnings Information

Lasts up to 8 hours

Temporary, Minor

Arthritis Pain Relief

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever/Fever Reducer

Actual Size

Compare to Tylenol® Arthritis Pain active ingredient

†Capsule-Shaped Tablets

Arthritis Pain Relief Carton

Topcare Arthritis Pain Relief  TEMPORARY MINOR acetaminophen  tablet, film coated, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 36800-544 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score no score Shape CAPSULE (caplet) Size 19mm Flavor Imprint Code L544 Contains

Packaging # NDC Package Description Multilevel Packaging 1 36800-544-62 1 BOTTLE In 1 CARTON contains a BOTTLE 1 24 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-544-62) 2 36800-544-71 1 BOTTLE In 1 CARTON contains a BOTTLE 2 50 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-544-71) 3 36800-544-78 1 BOTTLE In 1 CARTON contains a BOTTLE 3 100 TABLET In 1 BOTTLE This package is contained within the CARTON (36800-544-78)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075077	08/04/2005

Labeler - Topco Associates LLC (006935977)

Revised: 08/2009Topco Associates LLC

More Topcare Arthritis Pain Relief resources

• Topcare Arthritis Pain Relief Side Effects (in more detail)
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• Fever
• Muscle Pain
• Pain
• Sciatica

Graceway Pharmaceuticals, LLC

Address Graceway Pharmaceuticals, LLC, 340 Martin Luther King Jr. Blvd., Suite 500 Bristol, TN 37620 Contact Details Phone: 1-800-328-0255 Website: http://www.gracewaypharma.com/ Careers: http://www.gracewaypharma.com/careers Patient Assistance Program: http://www.gracewaypharma.com/assistance

Atropine Ointment

Generic Name: atropine, homatropine, and scopolamine (Ophthalmic route)

Commonly used brand name(s)

In the U.S.

• AK-Dilate


• AK-Pentolate


• Altafrin


• Atropine Care


• Cyclogyl


• Cyclomydril


• Eye Cool


• Homatropaire


• Isopto Atropine


• Isopto Homatropine


• Isopto Hyoscine


• Mydfrin


• Mydral


• Mydriacyl


• Neofrin


• Neo-Synephrine


• Paremyd

In Canada

• Ak-Dilate


• Ak-Pentolate


• Atropine


• Atropine-Ak


• Atropine Eye Ointment


• Atropine Ointment


• Atropisol


• Minims Phenylephrine Hydrochloride

Available Dosage Forms:

• Ointment


• Solution

Uses For Atropine Ointment

Ophthalmic atropine, homatropine, and scopolamine are used to dilate (enlarge) the pupil of the eye. They are used before eye examinations, before and after eye surgery, and to treat certain eye conditions, such as uveitis or posterior synechiae.

These medicines are available only with your doctor's prescription.

Before Using Atropine Ointment

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Infants and young children and children with blond hair or blue eyes may be especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment . Children should use a lower strength of this medicine.

Geriatric

Elderly people are especially sensitive to the effects of atropine, homatropine, or scopolamine. This may increase the chance of side effects during treatment.

Pregnancy

Studies on effects in pregnancy have not been done in either humans or animals. However, these medicines may be absorbed into the body.

Breast Feeding

These medicines may be absorbed into the body. Atropine passes into the breast milk in very small amounts and may cause side effects, such as fast pulse, fever, or dry skin, in babies of nursing mothers using ophthalmic atropine. It is not known whether homatropine or scopolamine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using one of these medicines and who wish to breast-feed should discuss this with their doctor.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain damage (in children) or


• Down's syndrome (mongolism) (in children and adults) or


• Glaucoma or


• Other eye diseases or problems or


• Spastic paralysis (in children)—Use of ophthalmic atropine, homatropine, or scopolamine may make the condition worse.

Proper Use of atropine, homatropine, and scopolamine

This section provides information on the proper use of a number of products that contain atropine, homatropine, and scopolamine. It may not be specific to Atropine Ointment. Please read with care.

To use the ophthalmic solution (eye drops) form of this medicine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them. If you are using the eye drops for an infant or child, be sure to wash his or her hands immediately afterwards also, and do not let any of the medicine get in his or her mouth. In addition, wipe off any medicine that may have accidentally gotten on the infant or child, including his or her face or eyelids.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To use the ointment form of this medicine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1/3- to ½;-cm (approximately ⅛-inch in infants and young children and ¼-inch in older children and adults) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye ointment, wash your hands to remove any medicine that may be on them. If you are using the eye ointment for an infant or child, be sure to wash his or her hands immediately afterwards also, and do not let any of the medicine get in his or her mouth. In addition, wipe off any medicine that may have accidentally gotten on the infant or child, including his or her face or eyelids.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in infants and children, since overdose is very dangerous in infants and children.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For atropine


• For ophthalmic ointment dosage form:
  
  • For uveitis:
    
    • Adults—Use a thin strip of the ointment in the eye one or two times a day.
    
    
    • Children—Use a thin strip of the ointment in the eye one to three times a day.
    
    
  
  
  • For eye examinations:
    
    • Adults—Use and dose must be determined by your doctor.
    
    
    • Children—Use a thin strip of the ointment in the eye three times a day for one to three days before the examination.
    
    
  
  


• For ophthalmic solution (eye drops) dosage form:
  
  • For uveitis:
    
    • Adults—Use one drop in the eye one or two times a day.
    
    
    • Children—Use one drop in the eye one to three times a day.
    
    
  
  
  • For eye examinations:
    
    • Adults—Use and dose must be determined by your doctor.
    
    
    • Children—Use one drop in the eye two times a day for one to three days before the examination.
    
    
  
  

• For homatropine


• For ophthalmic solution (eye drops) dosage form:
  
  • For uveitis:
    
    • Adults and children—Use 1 or 2 drops in the eye two or three times a day.
    
    
  
  
  • For eye examinations:
    
    • Adults—Use 1 or 2 drops in the eye. May be repeated every five to ten minutes for two or three doses.
    
    
    • Children—Use 1 or 2 drops in the eye every ten minutes for two or three doses.
    
    
  
  

• For scopolamine


• For ophthalmic solution (eye drops) dosage form:
  
  • For uveitis:
    
    • Adults and children—Use one drop in the eye up to four times a day.
    
    
  
  
  • For eye examinations:
    
    • Adults—Use one drop in the eye one hour before the examination.
    
    
    • Children—Use one drop in the eye two times a day for two days before the examination.
    
    
  
  
  • For posterior synechiae:
    
    • Adults—Use one drop in the eye every ten minutes for three doses.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For use before and after surgery:
    
    • Adults and children—Use one drop in the eye one to four times a day.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine and your dosing schedule is:

• One dose a day—Apply the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


• More than one dose a day—Apply the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Atropine Ointment

After you apply this medicine to your eyes:

• Your pupils will become unusually large and you will have blurring of vision, especially for close objects. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.


• Your eyes will become more sensitive to light than they are normally. Wear sunglasses to protect your eyes from sunlight and other bright lights.

These effects may continue for several days after you stop using this medicine. However, check with your doctor if they continue longer than:

• 14 days if you are using atropine.


• 3 days if you are using homatropine.


• 7 days if you are using scopolamine.

Atropine Ointment Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Symptoms of too much medicine being absorbed into the body

• Clumsiness or unsteadiness


• confusion or unusual behavior


• dryness of skin


• fast or irregular heartbeat


• fever


• flushing or redness of face


• seeing, hearing, or feeling things that are not there


• skin rash


• slurred speech


• swollen stomach in infants


• thirst or unusual dryness of mouth


• unusual drowsiness, tiredness, or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision


• brief burning or stinging of the eyes


• eye irritation not present before use of this medicine


• increased sensitivity of eyes to light


• swelling of the eyelids

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Erythrocin

Pronunciation: e-RITH-roe-MYE-sin BASE STEER-ate
Generic Name: Erythromycin Base and Stearate
Brand Name: Examples include Erythromycin Filmtabs and Erythrocin

Erythrocin is used for:

Treating infections caused by certain bacteria. It is also used to prevent attacks of rheumatic fever. It may also be used for other conditions as determined by your doctor.

Erythrocin is a macrolide antibiotic. It works by killing or slowing the growth of sensitive bacteria.

Do NOT use Erythrocin if:

• you are allergic to any ingredient in Erythrocin


• you are taking astemizole, cisapride, diltiazem, dofetilide, dronedarone, eletriptan, an ergot alkaloid (eg, dihydroergotamine, ergotamine), halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide, propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, tolvaptan, toremifene, vandetanib, or verapamil

Contact your doctor or health care provider right away if any of these apply to you.

Before using Erythrocin:

Some medical conditions may interact with Erythrocin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have diarrhea


• if you have a history of kidney or liver disease, heart problems, a fast or irregular heartbeat, myasthenia gravis, or the blood disease porphyria


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Erythrocin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Astemizole, cisapride, diltiazem, dofetilide, dronedarone, halofantrine, an HIV protease inhibitor (eg, ritonavir), an imidazole (eg, ketoconazole), nilotinib, pimozide , propafenone, a streptogramin (eg, quinupristin/dalfopristin), terfenadine, tetrabenazine, toremifene, vandetanib, or verapamil because side effects, such as heart toxicity or irregular heartbeat, may occur. Check with your doctor if you have questions about which medicines may affect your heartbeat


• Eletriptan, ergot alkaloids (eg, dihydroergotamine, ergotamine), or tolvaptan because the risk of their side effects may be increased by Erythrocin


• Many prescription and nonprescription medicines (eg, used for aches and pains, allergies, blood thinning, breathing problems, cancer, diabetes, erection problems, gout, irregular heartbeat or other heart problems, high blood calcium levels, high blood pressure, high cholesterol, HIV infection, inflammation, infections, low blood sodium levels, migraine, mood or mental problems, nausea and vomiting, overactive bladder, Parkinson disease, prevention of organ transplant rejection, seizures, stomach problems, trouble sleeping), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may also interact with Erythrocin. Ask your doctor or pharmacist if you are unsure if any of your medicines might interfere with Erythrocin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Erythrocin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Erythrocin:

Use Erythrocin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Erythrocin by mouth on an empty stomach at least 1 hour before or 2 hours after eating. If stomach upset occurs, take with food to reduce stomach irritation.


• Erythrocin works best if it is taken at the same time(s) each day.


• To clear up your infection completely, take Erythrocin for the full course of treatment. Keep taking it even if you feel better in a few days.


• Do not eat grapefruit or drink grapefruit juice while you use Erythrocin.


• If you miss a dose of Erythrocin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Erythrocin.

Important safety information:

• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Erythrocin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Erythrocin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Erythrocin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor or dentist that you take Erythrocin before you receive any medical or dental care, emergency care, or surgery.


• Rarely, patients taking Erythrocin have developed reversible hearing loss. The risk is greater if you have kidney problems or you take high doses of Erythrocin. Contact your doctor if you develop decreased hearing or hearing loss.


• Erythrocin may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Erythrocin.


• Lab tests, including liver function, kidney function, and complete blood cell counts, may be performed while you use Erythrocin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Erythrocin with caution in the ELDERLY; they may be more sensitive to its effects, especially irregular heartbeat (prolonged QT interval).


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Erythrocin while you are pregnant. Erythrocin is found in breast milk. If you are or will be breast-feeding while you use Erythrocin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Erythrocin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Loss of appetite; mild diarrhea; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; changes in the amount of urine produced; decreased hearing or hearing loss; irregular heartbeat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain; stomach cramps; symptoms of liver problems (eg, yellowing of the skin or eyes; pale stools; severe or persistent nausea, vomiting, or loss of appetite; dark urine).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Erythrocin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org ), or emergency room immediately.

Proper storage of Erythrocin:

Store Erythrocin at room temperature, below 86 degrees F (30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Keep Erythrocin out of the reach of children and away from pets.

General information:

• If you have any questions about Erythrocin, please talk with your doctor, pharmacist, or other health care provider.


• Erythrocin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Erythrocin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Erythrocin resources

• Erythrocin Side Effects (in more detail)
• Erythrocin Use in Pregnancy & Breastfeeding
• Erythrocin Drug Interactions
• Erythrocin Support Group
• 2 Reviews for Erythrocin - Add your own review/rating

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Nabilone 1mg Capsules

1. Name Of The Medicinal Product

Nabilone Capsules

2. Qualitative And Quantitative Composition

Nabilone Capsules contain 1.0mg Nabilone per capsule.

3. Pharmaceutical Form

Blue and white capsules imprinted "CL 3101”.

4. Clinical Particulars

4.1 Therapeutic Indications

Nabilone is indicated for the control of nausea and vomiting, caused by chemotherapeutic agents used in the treatment of cancer, in patients who have failed to respond adequately to conventional antiemetic treatments.

4.2 Posology And Method Of Administration

Nabilone is for administration to adults only. It is not recommended for use in children younger than 18 years of age as safety and efficacy have not been established.

The usual adult dosage is 1mg or 2mg twice a day. To minimise side-effects, it is recommended that the lower starting dose is used and that the dose is increased as necessary. The first dose should be administered the night before initiation of chemotherapy, and the second dose should be given one to three hours before the first dose of the oncolytic agent is administered.

The maximum daily dose should not exceed 6mg, given in three divided doses.

Nabilone may be administered throughout each cycle of chemotherapy and, if necessary, for 48 hours after the last dose of each cycle. Data on the chronic use of nabilone are not available.

The elderly: as for adults (see 'precautions').

4.3 Contraindications

Nabilone is contra-indicated in patients with a known allergy to cannabinoid agents and when the nausea and vomiting arises from any cause other than cancer chemotherapy.

4.4 Special Warnings And Precautions For Use

As nabilone is excreted primarily by the biliary route, the drug is not recommended for use in patients with severe liver dysfunction.

Patients receiving Nabilone should be closely observed, if possible, within an inpatient setting. This is especially important during the treatment of naive patients. However, even patients experienced with cannabinoid agents may have serious untoward responses not predicted by prior uneventful exposures. Patients should be made aware of possible changes of mood and other adverse behavioural effects of the drug.

Since Nabilone can elevate supine and standing heart rates and cause postural hypotension, it should be used with caution in the elderly and in patients with hypertension and heart disease.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Nabilone should be administered with caution to patients who are taking other psychoactive drugs or CNS depressants, including alcohol, barbiturates and narcotic analgesics, or to those with a history of psychiatric disorder (including manic-depressive illness and schizophrenia). Nabilone has been shown to have an additive CNS depressant effect when given with either diazepam, secobarbitone sodium, alcohol or codeine.

4.6 Pregnancy And Lactation

Usage in pregnancy: Laboratory studies have so far shown no evidence of teratogenicity. There are no adequate and well controlled studies in pregnant women. Nabilone should be used during pregnancy only if clearly needed.

Reproduction studies performed in rats at 150 times the human dose and rabbits at 40 times the human dose revealed a dose-related reduction in litter size, an increase in the incidence of foetal resorptions, and an increase in the incidence of stillborn pups. The number of implantations was unaffected by treatment. These effects appear related to the dose-dependent reduction in maternal food intake and gain in body weight induced by Nabilone. At 150 times the maximum recommended human dose, Nabilone produced a reduction in neonatal survival that may be related to reduced milk production by mothers. Nabilone is known to have an inhibitory effect on prolactin release, which could contribute to the observed reduction in milk production. Hypothermia was also reported in the offspring of high-dose groups of female rats, which may have also contributed to reduced neonatal survival.

Nursing mothers: It is not known whether this drug is excreted in breast milk. It is not recommended that Nabilone be given to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

Nabilone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as operating machinery or driving a car; therefore the patient should be advised accordingly. The effects of Nabilone may persist for a variable and unpredictable period of time following its oral administration. Adverse psychiatric reactions can persist for 48 to 72 hours following cessation of treatment.

4.8 Undesirable Effects

During controlled clinical trials of nabilone, virtually all patients experienced at least one adverse reaction. These included pyschotomimetic reactions.

In these trials, the commonest statistically significant adverse events (in decreasing order of incidence) were: drowsiness, vertigo/dizziness, euphoria (high), dry mouth, ataxia, visual disturbance, concentration difficulties, sleep disturbance, dysphoria, hypotension, headache and nausea.

Other reported events include confusion, disorientation, hallucinations, psychosis, depression, decreased co-ordination, tremors, tachycardia, decreased appetite and abdominal pain.

Tolerance to such CNS effects as relaxation, drowsiness and euphoria develops rapidly and is readily reversible.

Drug abuse and dependence: Nabilone is an abusable substance, capable of producing subjective side-effects, such as euphoria or "high", at therapeutic doses. Prescriptions should be limited to the amount necessary for a single cycle of chemotherapy (i.e., a few days). The physical dependence capability of Nabilone is unknown. Patients who participated in clinical trials, up to 5 days duration, showed no withdrawal symptoms on cessation of dosing.

4.9 Overdose

Signs and symptoms are an extension of the psychotomimetic and physiological effects of nabilone. Overdosage may be considered to have occurred, even at prescribed dosages, if disturbing psychiatric symptoms are present. Subsequent doses should be withheld until patients have returned to their baseline mental status; routine dosing, possibly at a lower dose, may then be resumed if clinically indicated. In controlled clinical trials, alterations in mental status, related to the use of nabilone, resolved within 72 hours without specific medical therapy. Vital signs should be monitored, since hypertension, hypotension and tachycardia have occurred.

No cases of overdosage with more than 10mg/day of Nabilone have been reported during clinical trials. Signs and symptoms to be anticipated in large overdose situations are psychotic episodes, including hallucinations and anxiety reactions, respiratory depression and coma.

Treatment: Conservative management, if possible (i.e. verbal support and comfort). In more severe cases, antipsychotic drugs may be useful, although they have not been systematically evaluated. Such patients should be closely monitored because of the potential for drug interactions (eg., additive CNS depressant effects due to Nabilone and chlorpromazine).

General supportive care is recommended. Consider giving activated charcoal to decrease absorption from the gastrointestinal tract. The use of forced diuresis, peritoneal dialysis, haemodialysis, charcoal haemoperfusion, or cholestyramine, has not been reported. Most of a dose of Nabilone is eliminated through the biliary system.

Treatment for respiratory depression and comatose state consists of symptomatic and supportive therapy. Attention should be paid to the occurrence of hypothermia. Consider fluids, inotropes and/or vasopressors for hypotension.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Nabilone is a synthetic cannabinoid which has been shown to have significant anti-emetic activity in patients undergoing chemotherapy for malignant neoplasms. The mode of action of Nabilone has been studied in cats and dogs. Although its anti-emetic action is not yet fully understood, it is apparent that there are a number of points in the control systems of the body at which Nabilone could block the emetic mechanism.

5.2 Pharmacokinetic Properties

Absorption

Two fasted subjects were given an oral dose of 2mg ¹⁴C-nabilone. Nabilone was readily absorbed from the gastrointestinal tract. Pharmacokinetic comparison between the oral and intravenous routes of administration suggested that most of the drug was available after oral dosage. Similarly, the percentages of radioactivity in the faeces and urine were approximately sixty per cent and twenty-four per cent respectively whichever route was employed, supporting the view that most of the oral dose was absorbed.

Half-life

The plasma half-life of unchanged Nabilone in these volunteers was approximately two hours. The estimated half-life of the carbinol metabolite was somewhat longer at between five and ten hours. Total radioactivity had a half-life of approximately thirty-five hours.

Transport

The rapid disappearance of absorbed drug from the plasma has been related to extensive tissue distribution and to rapid metabolism and excretion.

Metabolism

Two metabolic pathways have been suggested. The major pathway probably involves the direct oxidation of Nabilone to produce hydroxylic and carboxylic analogues. These compounds are thought to account for the remaining plasma radioactivity when carbinol metabolites have been extracted.

Excretion

When 2mg of ¹⁴C-nabilone was administered orally, over sixty per cent of the total radioactivity was eliminated in the faeces and about twenty five per cent in the urine. The discrepancy is probably due to additive analytical errors, since respiratory ¹⁴C CO2 did not account for the remaining fifteen per cent. Comparison with intravenous administration indicated no significant differences in the excretion pattern suggesting the biliary system to be the major excretory pathway.

5.3 Preclinical Safety Data

Monkeys treated with Nabilone at doses as high as 2mg/kg/day for a year experienced no significant adverse events. This result contrasts with the finding in a planned 1-year dog study that was prematurely terminated because of deaths associated with convulsions in dogs receiving as little as 0.5mg/kg/day. The earliest deaths, however, occurred at 56 days in dogs receiving 2mg/kg/day. The unusual vulnerability of the dog is not understood; it is hypothesised, however, that the explanation lies in the fact that the dog differs markedly from other species (including humans) in its metabolism of Nabilone.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies have not been performed with Nabilone. The influence on fertility and reproduction at doses of 150 and 40 times the maximum recommended human dose was evaluated in rats and rabbits, respectively. In these studies there was no evidence of teratogenicity due to Nabilone. In high dose groups, however, Nabilone produced a slight decrease in mean litter size, although the number of implantations was unaffected by treatment.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Povidone

Starch flowable

Indigo carmine

Red iron oxide

Titanium dioxide

Gelatin

Edible black ink

6.2 Incompatibilities

None known.

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

Bottles: Keep tightly closed. Store at 15 - 25 ºC.

Blisters: Store at 15 - 25 ºC.

6.5 Nature And Contents Of Container

High density polyethylene bottles with screw caps or blister packs, each containing 20 capsules.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

UK

8. Marketing Authorisation Number(S)

PL 15142/0028

9. Date Of First Authorisation/Renewal Of The Authorisation

27 March 2009

10. Date Of Revision Of The Text

June 2009