Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
paracetamol, Quantity: 500 mg; codeine phosphate hemihydrate, Quantity: 30 mg
Arrotex Pharmaceuticals Pty Ltd
codeine phosphate hemihydrate,Paracetamol
Tablet
Excipient Ingredients: magnesium stearate; stearic acid; povidone; pregelatinised maize starch
Oral
50, 20, 4, 2, 10, 12
(S4) Prescription Only Medicine
Short-term management of severe pain for which other treatment options have failed, are contraindicated, not tolerated or are otherwise inappropriate to provide sufficient management of pain.
Visual Identification: White, round tablets, engraved with 'PC' on one side and score line on other side.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-03-13
APO-PARACETAMOL/CODEINE 500/30 TABLETS 1 APO-PARACETAMOL/CODEINE 500/30 TABLETS _Paracetamol and codeine phosphate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about APO- Paracetamol/Codeine 500/30 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 has weighed the risks of you taking APO- Paracetamol/Codeine 500/30 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 IS APO- PARACETAMOL/CODEINE 500/30 USED FOR APO-Paracetamol/Codeine 500/30 is used to relieve moderate to severe pain and fever. APO-Paracetamol/Codeine 500/30 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. Your doctor may have prescribed this medicine for another use. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY THE MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE APO- PARACETAMOL/CODEINE 500/30 _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE APO- PARACETAMOL/CODEINE 500/30 IF YOU ARE ALLERGIC TO PARACETAMOL OR CODEINE 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. DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • Acute breathing difficulties such as bronchitis, unstable asthma or emphysema • Glucose-6-phosphate dehydrogenase deficiency (an enzyme deficiency) • Diarrhoea caused by poisoning or antibiotics • CYP 2D6 ultra-rapid metaboliser DO NOT TAKE APO- PARACETAMOL/CODEINE 500/30 IF YOU HAVE ALCOHOL DEPENDENCE. DO NOT TAKE APO- PARACETAMOL/CODEINE 500/30 DURING THE THIRD TRIMESTER OF PREGNANCY. Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION - APO-PARACETAMOL/CODEINE 500/30 (Paracetamol & Codeine phosphate hemihydrate) tablet 1 NAME OF THE MEDICINE Paracetamol and codeine phosphate hemihydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol 500 mg and Codeine phosphate hemihydrate 30 mg. Excipients of known effect: None. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM APO-Paracetamol/Codeine 500/30 tablet is available as white, round, engraved with “PC” on one side and score line on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Relief of moderate to severe pain, and fever. 4.2 D OSE AND METHOD OF ADMINISTRATION _Adults_ The initial dose is 1 tablet, repeated every 4 to 6 hours if necessary for mild to moderate pain. The initial dose is 2 tablets repeated every 4 to 6 hours if necessary (maximum 8 tablets per day) for severe pain. _ _ APO-Paracetamol/Codeine 500/30 is contraindicated for use in patients who are: • younger than 12 years. • aged between 12-18 years in whom respiratory function might be compromised, including post tonsillectomy and/or adenoidectomy for obstructive sleep apnoea. (See also section 4.3 Contraindications and section 4.4 Special Warnings and Precautions for use, _Paediatric _ _Use_). Tablets to be taken with water. 4.3 C ONTRAINDICATIONS APO-Paracetamol/Codeine 500/30 must not be used in patients with known hypersensitivity to paracetamol, codeine or any of the excipients used in this product. It must not be used in patients with known glucose-6- phosphate-dehydrogenase deficiency or pre-existing respiratory depression, for example acute asthma, acute exacerbations of chronic obstructive pulmonary disease since codeine may exacerbate the condition. Paracetamol should not be used in patients with a history of intolerance to the drug. Paracetamol should not be used in patients with severe hepatocellular insufficiency. Due to codeine’s structural similarity to morphine and oxycodone, patients experien Prečítajte si celý dokument