País: Malásia
Língua: inglês
Origem: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Methadone HCl
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
Methadone HCl
60 ml
DUOPHARMA MANUFACTURING (BANGI) SDN BHD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 ASEPTONE SYRUP Methadone hydrochloride (5mg/ml) WHAT IS IN THE LEAFLET 1. What ASEPTONE SYRUP is used for 2. How ASEPTONE SYRUP works 3. Before you use ASEPTONE SYRUP 4. How to use ASEPTONE SYRUP 5. While you are using it 6. Side effects 7. Storage and disposal of ASEPTONE SYRUP 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT ASEPTONE SYRUP IS USED FOR This medicine is for treatment of addiction in opioid drugs. ASEPTONE SYRUP is only available with a doctor’s prescription. HOW ASEPTONE SYRUP WORKS ASEPTONE SYRUP contains methadone hydrochloride as the active ingredient. It belongs to a group of medicines called opioid. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason. BEFORE YOU USE ASEPTONE SYRUP - _When you must not use it_ Do not take this medicine if you have an allergy to: methadone any other opioid drugs any of the other ingredients listed at the end of this leaflet Symptoms of an allergic reaction may include shortness of breath wheezing difficulty in breathing swelling of the face, lips, tongue or any other parts of the body rash, itching or hives on the skin. Do not take ASEPTONE SYRUP if you suffer from a lung disorder such as asthma or any illness causing difficulty in breathing have a recent head injury or increased pressure in the head have a bowel condition known as ulcerative colitis have severe liver problem alcoholism are taking, or have taken in the last two weeks, drugs for depression known as Monoamine Oxidase Inhibitors (MAOIs), paralytic ileus (paralysis of the intestinal muscle) If any of these apply to you, get advice from a doctor or pharmacist. Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist Leia o documento completo
*All text and graphic must be 2mm away from diecut outline and glue area. 40 BASE 40mm x 112mm 38 5 2 5 4 2 56 Spine Glue Glue 40 LEAFLET FRONT 40mm x 569mm 61 5 2 2 56 55 56 56 55 56 56 55 54 Glue Glue Pg 2 Pg 3 Pg 4 Pg 5 Pg 6 Pg 7 Pg 8 Pg 9 Pg 10 Pg 11 40 LEAFLET INSIDE 40mm x 569mm 54 7 2 56 55 55 56 55 56 56 51 5 61 Pg 12 Pg 13 Pg 14 Pg 15 Pg 16 Pg 17 Pg 18 Pg 19 Pg 20 Pg 1 DESCRIPTION A red coloured syrup. COMPOSITION Each ml contains Methadone Hydrochloride 5mg. PHARMACODYNAMICS Methadone HCl is a primarily μ opioid agonist. It binds with stereospecific receptors at many sites within the central nervous system (CNS). The most prominent involve the CNS and organs composed of smooth muscle. PHARMACOKINETICS Protein binding : High Half life : 15 – 25 hours; increases with repeated administration. Onset of action : Oral: 30 – 60 minutes Time to peak effect : Oral: 1.5 – 2 hours 1500012091 N.2 Each 1 ml contains _METHADONE HCI 5MG_ Preservatives: Methyl Paraben 1mg Propyl Paraben 0.10mg PRODUCT REGISTRATION HOLDER: DUOPHARMA MANUFACTURING (BANGI) 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. Reg. No. : MAL05041880AZ Store below 30ºC. Protect from light. Keep out of reach of children. JAUHKAN DARIPADA KANAK-KANAK _PLEASE REFER PACKAGE INSERT FOR_ _FULL INFORMATION._ ROUTE OF ADMINISTRATION : ORAL This preparation may be habit forming on prolonged use. Avoid alcoholic beverages. Aseptone Syrup is available with sodium saccharin as a sweetening agent. Phenylketonurics are warned that this product, in some form, contains phenylalanine. STORAGE CONDITIONS Store below 30 o C. Keep out of reach of children. Jauhkan daripada kanak-kanak. PACK SIZE : 60ml SHELF LIFE: Please refer to outer package. THE PHYSICIAN MUST REMEMBER, HOWEVER, THAT METHADONE IS A LONG-ACTING DEPRE Leia o documento completo