Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
HYDROXYCHLOROQUINE SULPHATE
IMEKS PHARMA SDN. BHD.
HYDROXYCHLOROQUINE SULPHATE
100 Tablets
Sriprasit Pharma Co. Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ QUINNEL 200 MG FILM-COATED TABLET Hydroxychloroquine Sulfate (200 mg) _ _ 1 WHAT IS IN THIS LEAFLET 1. What _QUINNEL_ is used for 2. How _QUINNEL_ works 3. Before you use _QUINNEL_ 4. How to use _QUINNEL_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _QUINNEL_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT _QUINNEL_ IS USED FOR _QUINNEL_ is used in the treatment of: • Rheumatoid arthritis (inflammation of the joints characterized by stiffness, swelling and pain) in adult and children. • Discoid and systemic lupus erythematosus (where the immune system attacks the body causing tissue damage and inflammation). • Skin problems that are triggered or worsened by sunlight. HOW _QUINNEL_ WORKS _QUINNEL_ contains the active ingredient _hydroxychloroquine _ _sulfate._ It works by reducing inflammation and thus can reduce pain, swelling and joint stiffness. BEFORE YOU USE _QUINNEL _ - _When you must not use it_ Do not take _QUINNEL_ if: • You are allergic (hypersensitive) to: - _hydroxychloroquine sulfate_ or 4-amino- quinoline compounds (e.g. _chloroquine_ , _amodiaquine_ ) or any of the other ingredients in the formulation. Signs of allergic reaction include: a rash, swallowing or breathing problems, swelling of lips, face, throat or tongue. • You have an eye problem which affects the retina, the inside of the eye (maculopathy) or you get a change in eye colour or any other eye problem. _ _ _Do not take this medicine if any of the above _ _apply to you. If you are not sure, talk to your _ _doctor _ _or _ _pharmacist _ _before _ _taking _ _QUINNEL. _ _ _ - _Before you start to use it _ Talk to your doctor or pharmacist before taking _QUINNEL_ if: • You have liver or kidney problems. • You have serious stomach or gut problems. • You have heart problems. • You have any problems with your blood. You may have blood tests to check this. • You have any problems with your nervous system o Baca dokumen lengkap
COMPOSITION Each film-coated tablet contains Hydroxychloroquine sulfate 200 mg. DESCRIPTION White round biconvex film-coated tablet debossed with “H, 200” on one side and plain on the other. PHARMACODYNAMICS Antimalarial agents like chloroquine and hydroxychloroquine have several pharmacological actions which may be involved in their therapeutic effect in the treatment of rheumatic disease, but the role of each is not known. These include interaction with sulphydryl groups, interference with enzyme activity (including phospholipase, NADH-cytochrome C reductase, cholinesterase, proteases and hydrolases), DNA binding, stabilisation of lysosomal membranes, inhibition of prostaglandin formation, inhibition of polymorphonuclear cell chemotaxis and phagocytosis, possible interference with interleukin 1 production from monocytes and inhibition of neutrophil superoxide release. PHARMACOKINETICS Hydroxychloroquine has actions, pharmacokinetics and metabolism similar to those of chloroquine. Absorption: Following oral administration, peak blood concentrations is achieved in approximately 4 hours. Oral absolute bioavailability is 79%. Distribution: Hydroxychloroquine has a large volume of distribution due to extensive tissue accumulation (5500 L in blood, 44000 L in plasma), and has been shown to accumulate in blood cells, with a blood to plasma ratio of 7.2. Approximately 50% of hydroxychloroquine is bound to plasma proteins. Metabolism: Hydroxychloroquine is mainly metabolized to N-desethyl- hydroxychloroquine, and two other metabolites in common with chloroquine, desethylchloroquine and bidesethylchloroquine. It can be extrapolated from chloroquine, that hydroxychloroquine could be metabolized_ in vitro_ by the same CYPs as for chloroquine, i.e. CYP2C8 and CYP3A, and to a lesser extent by CYP2D6. Elimination: Hydroxychloroquine presents a multi-phasic elimination profile with a long terminal half-life ranging from 30 to 60 days. Approximately 20- 25% of the hydroxychloroquine dose is eliminated as unchanged drug in t Baca dokumen lengkap