Страна: Малайзия
Език: английски
Източник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
28tablet Tablets
Bard Pharmaceuticals Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TARGIN® PROLONGED RELEASE TABLET Oxycodone hydrochloride / Naloxone hydrochloride (5mg/2.5mg, 10mg/5mg, 20mg/10mg, 40mg/20mg) 1 WHAT IS IN THIS LEAFLET 1. What _Targin_ _® _ tablet is used for 2. How _Targin_ _® _ tablet works 3. Before you use _Targin_ _® _ tablet 4. How to use _Targin_ _® _ tablet 5. While you are using it 6. Side effects 7. Storage and Disposal of _Targin_ _® _ tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _TARGIN_ _® _ TABLET IS USED FOR _Targin_ ® tablet is used to relieve moderate to severe chronic pain when other forms of treatment have not been effective and to bring relief from constipation which is a typical side effect of treatment with opioid analgesics. _Targin_ ® tablets are also used to relieve the symptoms of severe to very severe restless legs syndrome in people who can't be treated with dopamine medicines. HOW _TARGIN_ _® _ TABLET WORKS _Targin_ ® tablet contains two different medicines called oxycodone hydrochloride and naloxone hydrochloride. Oxycodone belongs to a group of medicines called opioid analgesics, which are strong pain killers and is responsible for the pain-killing effect of the tablets. Naloxone is intended to bring relief from constipation. Constipation is a typical side effect of treatment with strong painkillers BEFORE YOU USE _TARGIN_ _® _ TABLET _- When you must not use it _ Do not take _Targin® _ tablets if you are allergic to oxycodone, naloxone, opiod painkillers, or any of the ingredients listed at the end of this leaflet. Do not take Targin® tablets if you - have any breathing problems such as severe asthma, respiratory depression (breathing slows or weakens) or other obstructive airways disease. - are severely drowsy or have a reduced level of consciousness - have heart problems due to long term lung disease (Cor pulmonale). - have a condition where your stomach empties more slowly than it should or any condition that obstr Прочетете целия документ
Page 1 of 29 _FOR HOSPITAL USE ONLY _ _THIS PRODUCT MAY BE HABIT-FORMING UPON PROLONGED USE _ PRODUCT INFORMATION - TARGIN _®_ _ _PROLONGED-RELEASE TABLETS 1. NAME OF THE MEDICINE Oxycodone hydrochloride and naloxone hydrochloride dihydrate. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _TARGIN_ ® 5 mg/2.5 mg prolonged-release tablet contains 5 mg of oxycodone hydrochloride equivalent to 4.5 mg oxycodone, and 2.73 mg of naloxone hydrochloride dihydrate equivalent to 2.5 mg naloxone hydrochloride and 2.25 mg naloxone; _TARGIN_ ® 10 mg/5 mg prolonged-release tablet contains 10 mg of oxycodone hydrochloride equivalent to 9.0 mg oxycodone, and 5.45 mg of naloxone hydrochloride dihydrate equivalent to 5.0 mg naloxone hydrochloride and 4.5 mg naloxone; _TARGIN_ ® 20 mg/10 mg prolonged-release tablet contains 20 mg of oxycodone hydrochloride equivalent to 18.0 mg oxycodone, and 10.9 mg of naloxone hydrochloride dihydrate equivalent to 10.0 mg naloxone hydrochloride and 9.0 mg naloxone; _TARGIN_ ® 40 mg/20 mg prolonged-release tablet contains 40 mg of oxycodone hydrochloride equivalent to 36.0 mg oxycodone, and 21.8 mg of naloxone hydrochloride dihydrate equivalent to 20.0 mg naloxone hydrochloride and 18.0 mg naloxone; The inactive ingredients in _TARGIN_ ® 5 mg/2.5 mg tablets are lactose monohydrate, hydroxypropylcellulose, ethylcellulose, stearyl alcohol, talc and magnesium stearate. The inactive ingredients in _TARGIN_ ® 10 mg/5 mg, 20mg/10 mg and 40mg/20 mg tablets are lactose monohydrate, povidone K30, ethylcellulose, stearyl alcohol, talc and magnesium stearate. All tablets are coated with polyvinyl alcohol, titanium dioxide (E171), macrogol 3350 and talc. The tablet coat also contains brilliant blue FCF aluminium lake E133 (5mg/2.5 mg tablets), iron oxide red E172 (20mg/10 mg tablets) and iron oxide yellow E172 (40mg/20 mg tablets) 3. PHARMACEUTICAL FORM _TARGIN_ tablets are available as oblong, unscored film-coated tablets in blister pack sizes of 28 tablets as follows: 5 mg/2.5 mg light blue, marked Прочетете целия документ