Država: Malezija
Jezik: engleski
Izvor: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NYSTATIN
IMEKS PHARMA SDN. BHD.
NYSTATIN
12ml mL; 30 ml mL; 60 ml mL
T.O. CHEMICALS (1979) LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ 1 TYSTATIN ORAL SUSPENSION ® Nystatin (100,000 units per ml) WHAT IS IN THE LEAFLET 1. What Tystatin is used for 2. How Tystatin works 3. Before you use Tystatin 4. How to use Tystatin 5. While you are using it 6. Side effects 7. Storage and Disposal of Tystatin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT TYSTATIN IS USED FOR Tystatin contains the active ingredient nystatin. Nystatin is available as a 100,000 units/mL oral suspension. It is used to prevent and treat fungal infections of the mouth (thrush) that caused by a fungus called Candida. HOW TYSTATIN WORKS Nystatin belongs to a group of medicines called anti-fungal antibiotics. It works by interfering with their cell membranes and thus kill the fungi and treats the infection. BEFORE YOU USE TYSTATIN - _When you must not use it_ • Have ever had allergic reaction to nystatin, the active ingredient, or to any of the excipients. - _Before you start to use it_ Tell your doctor if you: • Have allergies to any other medicines, food, preservatives or dyes • Have a fungal infection in the lungs or on the skin • Are pregnant, planning to become pregnant, or are breast-feeding. If you are not sure whether you should start taking this medicine, consult your doctor. - _Taking other medicines_ Tell your doctor if you are taking any other medicine, including any that you buy without a prescription. You may need to use different amounts of these medicines, or you may need to take different medicines. - _Pregnancy and lactation_ If you are pregnant or breast-feeding, think that are pregnant or are planning to be pregnant, ask your doctor or pharmacist for advice before taking this medicine. It is not known whether nystatin can cause foetal harm when administered to a pregnant woman. Nystatin should only be prescribed during pregnancy if your doctor thinks it is necessary. It is not known whether nystatin gets into breast milk therefore, ask your doctor for advice Pročitajte cijeli dokument
PLEASE READ CAREFULLY TYSTATIN ORAL SUSPENSION CONTENT Each ml contains 100,000 UNITS OF NYSTATIN, methyl paraben 1.8mg & propyl paraben 0.2mg as preservatives and the following inactive ingredients: polyethylene glycol 1500, microcrystalline cellulose, carboxymethylcellulose sodium, saccharin sodium, glycerin, polysorbate 80, raspberry essence and vanilla flavour. DESCRIPTION A yellow suspension with a raspberry-vanilla flavour. INDICATION _TYSTATIN ORAL SUSPENSION _is indicated for the treatment of candidal infection of the oral_ _ cavity. RECOMMENDED DOSAGE _Infants_:_ _ One ml (equivalent to 100,000 units) four times daily after food. Limited clinical_ _studies in premature and low birth weight infants indicate that 1ml 4 times daily is effective. _Children and Adults_: One to six ml (100,000 to 600,000 units) four times daily after food. MODE OF ADMINISTRATION The suspension should be swished throughout or be retained in the mouth for as long as possible before swallowing. Patients should avoid taking food or drink earlier than one hour after a dose. In infants and young children, apply one half of dose in each side of mouth. The dosage should be continued for 48 hours after lesions have resolved. CONTRAINDICATIONS _TYSTATIN ORAL SUSPENSION _is contraindicated in patients with a history of hypersensitivity to_ _ the drug or any ingredient in the formulation. WARNING AND PRECAUTIONS _TYSTATIN ORAL SUSPENSION _is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, mutagenesis, impairment of fertility- No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. INTERACTIONS WITH OTHER MEDICAMENTS None known PREGNANCY AND LACTATION It is not known whether _TYSTATIN ORAL SUSPENSION_ can cause foetal harm if administered to pregnant women. It is also not known whether Pročitajte cijeli dokument