Granisetron Actavis

Granisetron Actavis

granisetron

Manufacturer:

Teva

Distributor:

Zuellig
Full Prescribing Info
Contents
Granisetron.
Description
Each 1 mg film-coated tablet contains 1 mg granisetron (as the hydrochloride).
Excipients/Inactive Ingredients: Lactose (anhydrous), Microcrystalline cellulose, Sodium starch glycolate (type A), Hypromellose, Magnesium stearate. Tablet film-coating with Opadry II 85F 18378: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc.
Indications/Uses
Granisetron Actavis contains a medicine called granisetron. This belongs to a group of medicines called '5-HT3 receptor antagonists' or 'antiemetics'. These tablets are only for use in adults. Granisetron Actavis is used to prevent or treat nausea and vomiting (feeling and being sick) caused by other medical treatments, such as chemotherapy or radiotherapy for cancer.
Dosage/Direction for Use
Always take Granisetron Actavis exactly as the doctor has prescribed. The patient should check with the doctor, nurse or pharmacist if not sure.
The dose of Granisetron Actavis varies from one patient to another. It depends on age, weight, and whether the patient is being given the medicine to prevent, or treat, nausea and vomiting. The doctor will work out how much to give the patient.
Prevention of feeling or being sick: The first dose of Granisetron Actavis will usually be given an hour before the radio- or chemotherapy. The dose will be either one or two 1 mg tablets or one 2 mg tablet once a day for up to a week after the radio- or chemotherapy.
Treatment of feeling or being sick: The dose will usually be either one or two 1 mg tablets or one 2 mg tablet once a day, but the doctor may decide to increase the dose up to nine 1 mg tablets a day.
If the patient forgets to take Granisetron Actavis: If the patient forgets to take the medicine speak to the doctor or nurse.
Do not take a double dose to make up for a forgotten tablet.
If the patient stops taking Granisetron Actavis: Do not stop taking the medicine before the treatment is finished. If the patient does stop taking the medicine, symptoms may return.
If the patient has any further questions on the use of this medicine, ask the doctor, nurse or pharmacist.
Overdosage
If the patient takes more Granisetron Actavis than prescribed: If the patient has taken too many of the tablets talk to the doctor or nurse. These symptoms of overdose include mild headaches. The patient will be treated depending on the symptoms.
Contraindications
Do not take Granisetron Actavis tablets if the patient is allergic (hypersensitive) to granisetron or any of the other ingredients of Granisetron Actavis (see Description).
If not sure, talk to the doctor, nurse or pharmacist before taking these tablets.
Special Precautions
Check with the doctor, nurse or pharmacist before using these tablets, if the patient: is having problems with bowel movements because of a blockage of the gut (intestines); has heart problems, is being treated for cancer with a medicine that is known to damage the heart or has problems with levels of salts, such as potassium, sodium or calcium, in the body (electrolyte abnormalities); is taking other '5-HT3 receptor antagonist' medicines. These include dolasetron, ondansetron used like Granisetron Actavis in the treatment and prevention of nausea and vomiting.
Cases of life-threatening serotonin syndrome have been reported with 5-HT3 receptor antagonist antiemetics, particularly when given in combination with other serotonergic and/or neuroleptic drugs. Treatment should be discontinued if such events occur and supportive symptomatic treatment should be initiated. If concomitant treatment of Granisetron Actavis with a drug affecting the serotonergic neurotransmitter system is clinically warranted, careful observations of the patient is advised, particularly during treatment initiation and dose increases.
Important information about some of the ingredients of Granisetron Actavis: Granisetron Actavis contains lactose (a type of sugar). If the patient has been told by the doctor to have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Effects on the Ability to Drive or Operate Machinery: Granisetron Actavis has no or negligible effect on the ability to drive or use any tools or machines
Children: Children should not take these tablets.
Use In Pregnancy & Lactation
The patient should not take these tablets if pregnant, trying to get pregnant or is breast-feeding, unless the doctor has prescribed.
Ask the doctor, nurse or pharmacist for advice before taking any medicine.
Side Effects
Like all medicines, Granisetron tablets can cause side effects, although not everybody gets them. In case of the following problem the patient must see a doctor straight away: allergic reactions (anaphylaxis). The signs may include swelling of the throat, face, lips and mouth, difficulty in breathing or swallowing.
Other side effects that may be experienced while taking this medicine are: Very Common: affects more than 1 user in 10: headache; constipation. The doctor will monitor the patient's condition.
Common: affects 1 to 10 users in 100: problems sleeping (insomnia); changes in how the liver is working shown by blood tests; diarrhoea.
Uncommon: affects 1 to 10 users in 1,000: skin rashes or an allergic skin reaction or "nettle-rash" or "hives" (urticaria). The signs may include red, raised itchy bumps; changes in the heartbeat (rhythm) and changes seen on ECG readings (electrical recordings of the heart); abnormal involuntary movements, such as shaking, muscle rigidity and muscle contractions.
If any of the side effects gets serious, or if the patient notices any side effects not listed in the monograph, tell the doctor, nurse or pharmacist.
Drug Interactions
Please tell the doctor, nurse or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription. This is because Granisetron Actavis can affect the way some medicines work. Also some other medicines can affect the way these tablets work.
In particular, tell the doctor, nurse or pharmacist if the patient is taking the following medicines: medicines used to treat an irregular hearbeart, other '5-HT3 receptor antagonist' medicines such as dolasetron or ondansetron (see Precautions); phenobarbital, a medicine used to treat epilepsy; a medicine called ketoconazole used in the treatment of fungal infections; the antibiotic erythromycin used to treat bacterial infections.
Caution For Usage
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Store below 25°C.
MIMS Class
ATC Classification
A04AA02 - granisetron ; Belongs to the class of serotonin (5HT3) antagonists. Used for the prevention of nausea and vomiting.
Presentation/Packing
FC tab 1 mg (triangular, white, biconvex, embossed with "G1" on one side) x 10's.
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