Land: Maleisië
Taal: Engels
Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ONDANSETRON HYDROCHLORIDE DIHYDRATE
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
ONDANSETRON HYDROCHLORIDE DIHYDRATE
30Tablet Tablets
Aspen Bad Oldesloe GmbH
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ ZOFRAN ™ TABLET _ _ Ondansetron hydrochloride dihydrate (4mg, 8mg) 1 WHAT IS IN THIS LEAFLET 1. What ZOFRAN is used for 2. How ZOFRAN works 3. Before you use ZOFRAN 4. How to use ZOFRAN 5. While you are using it 6. Side Effects 7. Storage and Disposal of ZOFRAN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ZOFRAN IS USED FOR It is used to prevent and manage nausea (feeling sick) and vomiting (being sick), which can occur: • during treatment for cancer (chemotherapy or radiotherapy) • after an operation HOW ZOFRAN WORKS Zofran belongs to a group of medicines called anti-emetics. Ondansetron is a 5HT 3 receptor antagonist. It works by inhibiting the 5HT 3 receptors on neurons located in peripheral and central nervous system of the body. BEFORE YOU USE ZOFRAN - _When you must not use it _ Do not take Zofran • if you are taking apomorphine (used to treat Parkinson’s disease, a movement disorder) • if you are allergic (hypersensitive) to ondansetron or any other ingredients of Zofran If you think this applies to you, do not use Zofran until you have checked with your doctor. - _Before you start to use it _ Before you use Zofran your doctor needs to know: • if you are allergic to medicines similar to Zofran, such as medicines containing _granisetron_ or _palonosetron_ • if you have ever had heart problems, such as an irregular heartbeat (arrhythmia) • if you have bowel problems • if you have liver disease, your doctor may lower your dose of Zofran • if you are taking other medicines (interactions with other medicinal products including vaccines or biologics) Check with your doctor if you think any of these may apply to you. _Pregnancy and breast-feeding _ Zofran is not recommended for use during pregnancy. • Tell your doctor if you are pregnant or planning to become pregnant. Zofran may harm your unborn baby. • If you do become pregnant during treatment with Zofran, tell your docto Lees het volledige document
Novartis Page 2 Malaysia Package Leaflet 10-Mar-2021 ZOFRAN™ ZOFRAN™ Serotonin (5HT 3 ) antagonist DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM TABLETS: Ondansetron tablets 4 mg: Yellow, oval, film-coated tablet engraved with 'GX ET3’. Each tablet contains ondansetron 4 mg as hydrochloride dihydrate. Ondansetron tablets 8 mg: Yellow, oval, film-coated tablet engraved with 'GX ET5'. Each tablet contains ondansetron 8 mg as hydrochloride dihydrate. ACTIVE SUBSTANCE Ondansetron/Ondansetron hydrochloride dihydrate EXCIPIENTS Lactose Microcrystalline cellulose Pregelatinized maize starch Magnesium stearate Methyl hydroxypropyl cellulose Titanium dioxide (E171) Iron oxide (E172) INDICATIONS ADULTS ZOFRAN oral formulations are indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy. ZOFRAN is also indicated for the prevention of post-operative nausea and vomiting. PAEDIATRIC POPULATION _ORAL FORMULATION: _ ZOFRAN is indicated for the management of nausea and vomiting induced by cytotoxic chemotherapy. No studies have been conducted on the use of orally administered ondansetron in the prevention or treatment of post-operative nausea and vomiting. Novartis Page 3 Malaysia Package Leaflet 10-Mar-2021 ZOFRAN™ DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN CHEMOTHERAPY AND RADIOTHERAPY INDUCED NAUSEA AND VOMITING (CINV AND RINV) The emetogenic potential of cancer treatment varies according to the doses and combinations of chemotherapy and radiotherapy regimens used. The selection of dose regimen should be determined by the severity of the emetogenic challenge. CINV AND RINV IN ADULTS The recommended oral dose is 8 mg taken 1 to 2 hours before chemotherapy or radiation treatment, followed by 8 mg orally every 12 hours for a maximum of 5 days. For highly emetogenic chemotherapy a single oral dose of up to 24 mg ondansetron taken together with 12 mg oral dexamethasone sodium phosphate, 1 to 2 hours before chemotherapy, may be used. After the first 24 hours, oral treatm Lees het volledige document