Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CHLORPHENIRAMINE MALEATE; PHOLCODINE
Duopharma Marketing Sdn. Bhd.
CHLORPHENIRAMINE MALEATE; PHOLCODINE
90 ml
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_Consumer Medication Information Leaflet (RiMUP)_ _ _ 1 PROMEDYL PLUS LINCTUS Pholcodine / Chlorpheniramine Maleate (10mg/4mg per 5ml) WHAT IS IN THIS LEAFLET 1. What Promedyl Plus Linctus is used for 2. How Promedyl Plus Linctus works 3. Before you use Promedyl Plus Linctus 4. How to use Promedyl Plus Linctus 5. While you are using it 6. Side effects 7. Storage and Disposal of Promedyl Plus Linctus 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PROMEDYL PLUS LINCTUS IS USED FOR Promedyl Plus Linctus is used for the relief of dry and irritating cough. HOW PROMEDYL PLUS LINCTUS WORKS Pholcodine works on the cough centre in the brain to control and stop coughing. It has no analgesic (to relieve pain) properties and in general has little sedative activity. Chlorpheniramine maleate is an antihistamine which works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. It also helps to dry up the nasal mucosa. BEFORE YOU USE PROMEDYL PLUS LINCTUS - _When you must not use it_ _ _ _ _ Do not take Promedyl Plus Linctus if you: • are allergic to any medicine containing pholcodine or chlorpheniramine maleate. • have liver disease. • have a very serious breathing problem (respiratory failure). • are taking or have taken monoamine oxidase inhibitors _Use in children_ _ _ When Promedyl Plus Linctus is used for treatment of cough and cold, it is not to be used in children less than 2 years of age. It is needed to be used with caution and doctor’s or pharmacist’s advice in children 2 to 6 years of age. _Pregnancy and breastfeeding_ _ _ Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breastfeeding. Small amounts of chlorpheniramine are distributed into the breast milk. Use is not recommended in nursing mothers due to risk of adverse effects such as unusual excitement or irritability in infants. Do not take this medicine after the expiry date printed on the pack or if the packaging is to Baca dokumen lengkap
Glue Pg 3 Pg 4 Pg 5 Pg 1 Pg 2 Glue Glue Spine Pg 10 FOR HOLOGRAM : 22MM(W) X12MM(H) Name/Nama : Date/Tarikh : ml ml Take Minum Times Daily Before/After Food Kali Sehari Sebelum/Selepas Makan DOSAGE AND ADMINISTRATION Children 2 to 12 years: 2.5ml three times daily. Adults & Children above 12 years: 5ml three times daily. KEEP CONTAINER TIGHTLY CLOSED. STORE IN A DRY PLACE BELOW 30°C. PROTECT FROM LIGHT. KEEP OUT OF REACH OF CHILDREN. JAUHI DARIPADA KANAK-KANAK. CONTROLLED MEDICINE FOR INKJET PRINTING: LOT MFG EXP 25MM(W) X 15MM(H) SHAKE BEFORE USE. GONCANG SEBELUM DIGUNAKAN PRODUCT REGISTRATION HOLDER: DUOPHARMA MARKETING SDN. BHD. Lot No. 2, 4, 6, 8 & 10, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. MANUFACTURER: DUOPHARMA MANUFACTURING (BANGI) SDN. BHD. Lot No. 2 & 4, Jalan P/7, Section 13, Bangi Industrial Estate, 43650 Bandar Baru Bangi, Selangor, Malaysia. 150000xxxx xx Revision Date: Feb 2021 _Chlorpheniramine maleate:_ Chlorpheniramine maleate is absorbed relatively slowly from the gastro-intesti- nal tract, peak plasma concentrations occurring about 2.5-6 hours after administration by mouth. Bioavailability is low, values of 25% to 50% have been reported. Chlorpheniramine undergoes considerable first-pass metabolism. About 70% of Chlorpheniramine in the circulation is bound to plasma proteins. The half-life values range from 2-43 hours. Chlorpheniramine is widely distributed and extensively metabolized. A duration of action of 4-6 hours has been reported. INDICATIONS For the relief of dry and irritating cough. PHARMACODYNAMICS _Pholcodine: _ Pholcodine is a centrally acting cough suppressant. It has a central action on the cough center in the medulla. It has no analgesic properties and in general has little sedative activity. _Chlorpheniramine maleate:_ Chlorpheniramine maleate is an alkylamine-derivative antihistamine which acts by competing with histamine for H1-receptor sites on effector cells. It thereby prevents, but does not reverse, responses mediate Baca dokumen lengkap