Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 15 mg
Arrotex Pharmaceuticals Pty Ltd
codeine phosphate hemihydrate,Paracetamol
Tablet, uncoated
Excipient Ingredients: stearic acid; sodium lauryl sulfate; maize starch; colloidal anhydrous silica; pregelatinised maize starch; purified talc; hyprolose; magnesium stearate; povidone
Oral
24, 40, 10, 12
(S4) Prescription Only Medicine
For the temporary relief of acute moderate pain
Visual Identification: Paracetamol & codeine tablets are white to off white, capsule shaped biconvex, uncoated tablets with central breakline on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2013-04-17
Chemists’ Own Strong Pain Extra CMI 1 CHEMISTS’ OWN STRONG PAIN EXTRA_ _ CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Chemists’ Own ® Strong Pain Extra tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you taking Chemists’ Own Strong Pain Extra against the benefits this medicine is expected to have for you. KEEP THIS INFORMATION WITH THE TABLETS. You may need to read it again. WHAT CHEMISTS’ OWN STRONG PAIN EXTRA USED FOR Chemists’ Own Strong Pain Extra is used to relieve moderate to severe pain. Chemists’ Own Strong Pain Extra contains paracetamol and codeine. Paracetamol and codeine work together to stop the pain messages from getting through to the brain. Paracetamol also acts in the brain to reduce fever. Codeine phosphate is an opioid pain reliever. ASK YOUR PHARMACIST OR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT THIS MEDICINE. This medicine may be addictive if taken for more than a few days at a time. IT IS ONLY AVAILABLE FROM YOUR PHARMACIST. BEFORE YOU TAKE/GIVE CHEMISTS’ OWN STRONG PAIN EXTRA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE _CHEMISTS’ OWN _ _STRONG PAIN EXTRA _IF: 1. YOU HAVE AN ALLERGY TO: • Paracetamol or Codeine Phosphate hemihydrate, or any of the ingredients listed under “Product Description” at the end of this leaflet. The Symptoms of an allergic reaction may include a rash, asthma attack or hay fever. _2. _ _DO NOT TAKE THIS _ _MEDICINE IF_ _ _ _YOU HAVE _ _ANY OF THE FOLLOWING_ _ _ _CONDITIONS: _ • Acute breathing difficulties such as bronchitis, unstable asthma or emphysema • Glucose-6-phosphate- dehydrogenase deficiency (an enzyme deficiency) • Ultra-rapid metaboliser of CYP 2D6 • Liver failure • chronic constipation • Diarrhoea caused by antibiotics or poisoning _DO NOT TAKE THIS _ _MEDICINE IF YOU_ _ HAVE _ _A HISTORY OF Les hele dokumentet
Page 1 of 14 CHEMISTS’ OWN STRONG PAIN EXTRA PRODUCT INFORMATION (PI) NAME OF THE MEDICINE : CHEMISTS’ OWN STRONG PAIN EXTRA AUSTRALIAN APPROVED NAME Paracetamol and Codeine phosphate hemihydrate CHEMICAL STRUCTURE _Paracetamol. _Chemical name: N-( 4-hydroxyphenyl)acetamide. Molecular formula: C 8 H 9 NO 2 MW: 151.2. _Codeine _ _phosphate _ _hemihydrate_. Chemical name: (5R,6S)-7, 8-didehydro-4,5- epoxy-3-methoxy-N- methylmorphinan-6-ol dihydrogen orthophospate hemihydrate. Molecular formula: C 18 H 21 NO 3 .H 3 PO 4 .½H 2 O. MW: 406.4 DESCRIPTION: COMPOSITION _ACTIVE_. Each capsule-shaped tablet contains Paracetamol 500 mg and codeine phosphate hemihydrate 15 mg._ _ _INACTIVE_.Starch – maize, Hydroxypropylcellulose, Starch-Pregelantinised maize, Sodium lauryl sulphate, Talc-purified, Silica colloidal anhydrous, Magnesium sterate Page 2 of 14 Paracetamol is a white or almost white, crystalline powder. It is sparingly soluble in water, freely soluble in alcohol and very slightly soluble in methylene chloride. It has a melting point between 168°C and 172°C. Codeine phosphate hemihydrate is a white or almost white, crystalline powder or small, colourless crystals. It is freely soluble in water and slightly soluble or vey slightly soluble in ethanol (96 percent). ACTIONS Analgesic and antipyretic. PHARMACOLOGY: PARACETAMOL: Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis. CODEINE: Codeine acts centrally. It has an analgesic effect, which is thought to be due mainly to its partial metabolic conversion to morphine. Codeine has about one-sixth the analgesic activity of morphine. There is evidence to suggest that a combination of paracetamol with codeine is superior in analgesic action to either drug administered alone. PHARMACOKINETICS: PARACETAMOL: Paracetamol is readily absorbed from the gastrointestinal tract with peak Les hele dokumentet