INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASPEN GRANISETRON 1 mg (tablet)
ASPEN GRANISETRON 2 mg (tablet)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ASPEN GRANISETRON 1 mg (tablet)
ASPEN GRANISETRON 2 mg (tablet)

COMPOSITION:
ASPEN GRANISETRON 1 mg:
Each tablet contains Granisetron Hydrochloride equivalent to 1,0 mg
Granisetron free base.
ASPEN GRANISETRON 2 mg:
Each tablet contains Granisetron Hydrochloride equivalent to 2,0 mg Granisetron free base.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.2. Anti-emetics and anti-vertigo preparations

PHARMACOLOGICAL ACTION:
Pharmacodynamics:
Granisetron is a selective antagonist of 5-hydroxytryptamine (5-HT)3 receptors with anti-emetic properties. Radioligand binding studies have demonstrated that granisetron has negligible affinity for other receptor types including 5-HT and dopamine D2 binding sites.

Pharmacokinetics:
Granisetron is absorbed after oral administration, with peak plasma concentrations occurring 2 hours after dosing. Due to first-pass metabolism, the oral bioavailability of granisetron is about 60%. Granisetron has an apparent volume of distribution of about 3 L/kg. Plasma protein binding is approximately 65%.
The pharmacokinetics of granisetron exhibit considerable interindividual variation. The elimination half-life is reported to be approximately 3-4 hours in healthy individuals and about 9-12 hours in cancer patients. Granisetron is metabolised primarily by 7-hydroxylation, with less than 20% of a dose recovered unchanged in urine, and the remainder being excreted in faeces and urine as metabolites. Granisetron clearance is not affected by renal impairment, but is lower in the elderly and in patients with hepatic impairment.

INDICATIONS:
ASPEN GRANISETRON is indicated for the prevention of nausea and vomiting induced by moderately emetogenic cytostatic therapy.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients contained in ASPEN GRANISETRON.
children under the age of 2 years.
pregnancy and lactation (see PREGNANCY AND LACTATION).

WARNINGS:
As ASPEN GRANISETRON may reduce lower bowel motility, patients with signs of sub-acute intestinal obstruction should be monitored following administration of ASPEN GRANISETRON. The maximum dose of ASPEN GRANISETRON to be administered over 24 hours should not exceed 9 mg (120 micrograms/kg).

INTERACTIONS:
Hepatic enzyme induction with phenobarbital resulted in an increase in total plasma clearance of intravenous ASPEN GRANISETRON of approximately one quarter.
ASPEN GRANISETRON may be co-administered with benzodiazepines, neuroleptics and anti-ulcer medications commonly prescribed with anti-emetic treatments. Additionally, ASPEN GRANISETRON has shown no apparent interaction with emetogenic cancer chemotherapies. No specific interaction studies have been conducted in anaesthetized patients, but ASPEN GRANISETRON has been safely administered with commonly used anaesthetic and analgesic agents. In addition, in vitro human microsomal studies have shown that the cytochrome P450 subfamily 3A4 (involved in the metabolism of some of the main narcotic analgesic agents) is not modified by ASPEN GRANISETRON.

PREGNANCY AND LACTATION:
The use of ASPEN GRANISETRON during pregnancy and lactation is not recommended as safety and efficacy have not been established (see CONTRA-INDICATIONS).

DOSAGE AND DIRECTIONS FOR USE:
Adults:
The dose of ASPEN GRANISETRON is 1 mg twice a day or 2 mg once a day, for up to one week following cytostatic therapy. The first dose of ASPEN GRANISETRON should be administered within one hour before the start of cytostatic therapy.
Special groups:
Although present experience indicates that no dosage adjustment is required, care should be exercised when administering ASPEN GRANISETRON to elderly patients and patients with renal or hepatic impairment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects:
The following side-effects may occur with use of ASPEN GRANISETRON:
Nervous system disorders:
Frequent: headache
Cardiac disorders:
Less frequent: chest pain, hypotension, tachycardia, bradycardia
Gastrointestinal disorders:
Frequent: constipation
Frequency unknown: hiccups
Metabolism and nutrition disorders:
Frequency unknown: rise in hepatic transaminases
Hypersensitivity reactions:
Minor skin rashes, anaphylaxis

Special Precautions:
Effects on ability to drive and use machines:
There have been reports of somnolence with the use of ASPEN GRANISETRON, and this should be taken into account.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Headache may occur. There is no specific antidote for ASPEN GRANISETRON. In the case of overdosage, symptomatic treatment should be given.

IDENTIFICATION:
ASPEN GRANISETRON 1 mg: triangular, white, biconvex film-coated tablets, with ‘G1’engraved on one side OR triangular, white, biconvex film-coated tablets, with “C”debossed on one side and “45”debossed on the other side.
ASPEN GRANISETRON 2 mg: triangular, white, biconvex film-coated tablets, with ‘G2’ engraved on one side OR triangular, white, biconvex film-coated tablets, with “C”debossed on one side and “46”debossed on the other side.

PRESENTATION:
The tablets are packed into white opaque PVC film/Aluminium foil blisters. The blisters will be placed in a cardboard carton along with a printed package insert.
ASPEN GRANISETRON 1 mg is available in a pack size of 10 film-coated tablets.
ASPEN GRANISETRON 2 mg is available in a pack size of 5 film-coated tablets.

STORAGE INSTRUCTIONS:
Store below 25ºC protected from light and moisture.
Do not remove the blister from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
ASPEN GRANISETRON 1 mg: 42/5.7.2/1007
ASPEN GRANISETRON 2 mg: 42/5.7.2/1008

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 February 2009

===============================================

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking ASPEN GRANISETRON
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or your pharmacist.
•        ASPEN GRANISETRON has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS: S4
ASPEN GRANISETRON 1 mg (tablet)
ASPEN GRANISETRON 2 mg (tablet)

1. WHAT ASPEN GRANISETRON CONTAINS:
The active substance is:
ASPEN GRANISETRON 1 mg: Each tablet contains granisetron hydrochloride equivalent to 1,0 mg granisetron free base.
ASPEN GRANISETRON 2 mg: Each tablet contains granisetron hydrochloride equivalent to 2,0 mg granisetron free base.
The other ingredients are:
Lactose Anhydrous, Microcrystalline Cellulose Type 101, Sodium Starch Glycolate (Type A), Hypromellose 2910 / 5cP, Magnesium Stearate, Opadry II 85F18378 White.

2. WHAT ASPEN GRANISETRON IS USED FOR:
ASPEN GRANISETRON belongs to a group of medicines called 5-HT3 receptor antagonists which act as anti-emetics. ASPEN GRANISETRON is used to prevent nausea and vomiting.
ASPEN GRANISETRON is used to stop you from feeling or being sick, and is especially useful when you need to have medical treatment that may cause you to feel or be sick, for example, chemotherapy or radiotherapy.

3. BEFORE YOU TAKE ASPEN GRANISETRON:
Do not take ASPEN GRANISETRON if:
You are allergic to granisetron, or any other component of the medicine.
You are pregnant or breast-feeding.
Take special care with ASPEN GRANISETRON:
If you answer YES to any of the following questions, tell your doctor or nurse BEFORE you are given your medicine. You may need to be given another medicine instead.
Are you allergic to ASPEN GRANISETRON or any related drugs (other 5-HT3receptor antagonists, such as ondansetron)?
Have you been told by a doctor that your bowels don’t work properly?
Do you have any pain in your abdomen (tummy) or does your abdomen feel distended or swollen?
Do you have severe constipation?

Pregnancy and Breast-feeding:
If you are pregnant or breast-feeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.
ASPEN GRANISETRON may not be used at any time during pregnancy or whilst breast-feeding.

Driving and using machinery:
You may experience side-effects that can affect your concentration. If you are unable to concentrate or remain alert after taking your medicine, then do not drive or operate machinery or perform any activity for which you need to be attentive.

Taking other medicines with ASPEN GRANISETRON:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN GRANISETRON with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.
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.

4. HOW TO TAKE ASPEN GRANISETRON:
The dose of ASPEN GRANISETRON is 1 mg twice a day or 2 mg once a day for up to one week following chemotherapy or radiotherapy treatment. The first dose of ASPEN GRANISETRON should be administered within one hour before the start of chemotherapy or radiotherapy treatment.
If you take more ASPEN GRANISETRON than you should:
Headache may occur. In the case of overdosage, symptomatic treatment should be given.
If you forget to take ASPEN GRANISETRON:
Do not take a double dose to make up for forgotten individual doses.

5. POSSIBLE SIDE-EFFECTS:
ASPEN GRANISETRON can have side-effects.
Some patients may experience headache or constipation.
Occasionally, allergic reactions also occur. Tell your doctor if you get a rash or start to itch. You should tell your doctor straight away if you become short of breath or get a swollen face. These reactions are rare but need urgent medical treatment. If you are having blood tests, tell your doctor you have been given ASPEN GRANISETRON because it sometimes causes changes in tests of liver function.
Not all side-effects reported for ASPEN GRANISETRON are included in this leaflet. Should your general health worsen while taking ASPEN GRANISETRON, please consult your doctor, pharmacist or other health care professional for advice.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

STORAGE AND DISPOSING OF ASPEN GRANISETRON:
Store below 25ºC protected from light and moisture.
Do not remove the blister from the carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
Do not use after the expiry date stated on the label.
Return all unused medicine to your pharmacist.
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets)

7. PRESENTATION OF ASPEN GRANISETRON:
The tablets are packed into white opaque PVC film /Aluminium foil blisters. The blisters will be placed in a cardboard carton along with a printed package insert.
ASPEN GRANISETRON 1 mg is available in a pack size of 10 film-coated tablets.
ASPEN GRANISETRON 2 mg is available in a pack size of 5 film-coated tablets.

8. IDENTIFICATION OF ASPEN GRANISETRON:
ASPEN GRANISETRON 1 mg: triangular, white, biconvex film-coated tablets, with ‘G1’ engraved on one side OR triangular, white, biconvex film-coated tablets, with “C”debossed on one side and “45”debossed on the other side.

ASPEN GRANISETRON 2 mg: triangular, white, biconvex film-coated tablets, with ‘G2’engraved on one side OR triangular, white, biconvex film-coated tablets, with “C”debossed on one side and “46” debossed on the other side.

9. REGISTRATION NUMBER
ASPEN GRANISETRON 1 mg: 42/5.7.2/1007
ASPEN GRANISETRON 2 mg: 42/5.7.2/1008

10. NAME AND ADDRESS OF REGISTRATION HOLDER:
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

11. DATE OF PUBLICATION
12 February 2009

New addition to this site: February 2010
Source: Pharmaceutical Industry

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