מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
mefenamic acid, Quantity: 250 mg
Pfizer Australia Pty Ltd
Mefenamic acid
Capsule, hard
Excipient Ingredients: Gelatin; carbon black; iron oxide yellow; brilliant blue FCF; lactose monohydrate; titanium dioxide
Oral
50
(S4) Prescription Only Medicine
Treatment of primary dysmenorrhoea and primary menorrhoea. Short-term relief of mild to moderate pain such as dental pain and soft tissue pain.
Visual Identification: An aqua blue/ivory opaque hard gelatin capsule printed 'PARKDAVIS' reverse logo on body and cap in black.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius
Licence status A
2014-07-29
PONSTAN ® CAPSULES _Mefenamic Acid_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PONSTAN. 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 PONSTAN against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PONSTAN IS USED FOR PONSTAN is used to relieve the symptoms of period pain and treat heavy periods. It also provides short term relief of pain in conditions such as: • muscle and joint injuries such as sprains, strains and tendonitis • dental pain. PONSTAN containing mefenamic acid belongs to a group of medicines called Non-Steroidal Anti- Inflammatory Drugs (or NSAIDs). These medicines work by relieving pain and inflammation. Although PONSTAN can relieve the symptoms of pain and inflammation, it will not cure your condition. Your doctor may have prescribed PONSTAN for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY PONSTAN HAS BEEN PRESCRIBED FOR YOU. PONSTAN is not addictive. BEFORE YOU TAKE PONSTAN _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PONSTAN IF: 1. YOU HAVE AN ALLERGY TO: • mefenamic acid or any of the ingredients listed at the end of this leaflet • aspirin • any other NSAID medicine including COX-2 inhibitors. Many medicines used to treat headache, period pain or other aches and pains contain aspirin or NSAID medicines. IF YOU ARE NOT SURE IF YOU ARE TAKING ANY OF THESE MEDICINES, ASK YOUR DOCTOR OR PHARMACIST. Symptoms of an allergic reaction to these medicines may include: • asthma, wheezing or shortness of breath • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing • hives, itching or skin rash • fainting. If you are allergic to aspirin or NSAID medicines and ta קרא את המסמך השלם
Version: pfpponsc10921 Supersedes: pfpponsc10520 Page 1 of 13 AUSTRALIAN PRODUCT INFORMATION – PONSTAN ® (MEFENAMIC ACID) CAPSULES 1. NAME OF THE MEDICINE Mefenamic acid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PONSTAN capsules contain the active ingredient mefenamic acid 250 mg/capsule. EXCIPIENT(S) WITH KNOWN EFFECT • Lactose monohydrate For the full list of excipients, see Section 6.1 - List of excipients. 3. PHARMACEUTICAL FORM Hard capsule. PONSTAN capsules have an opaque aqua blue cap and opaque ivory body with “PARKE DAVIS” printed in black on both the body and cap. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of primary dysmenorrhoea and primary menorrhagia. Short-term relief of mild to moderate pain such as dental pain and soft tissue pain. 4.2 DOSE AND METHOD OF ADMINISTRATION Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. Patients on long term treatment should be reviewed regularly with regards to efficacy, risk factors and ongoing need for treatment. Pregnancy: see Section 4.6 Fertility, pregnancy and lactation. DYSMENORRHOEA 2 capsules (500 mg) three times daily with meals from the onset of pain and continued for the usual duration of pain. Version: pfpponsc10921 Supersedes: pfpponsc10520 Page 2 of 13 MENORRHAGIA 2 capsules (500 mg) three times daily with meals and from the onset of menses and continued according to the judgement of the physician. Therapy should not be continued for more than 7 days except on the advice of a physician. OTHER INDICATIONS 2 capsules (500 mg) three times daily, with meals. 4.3 CONTRAINDICATIONS 1. Patients showing evidence of chronic inflammation and/or active ulceration of either the upper or lower gastrointestinal tract and patients with pre-existing renal disease. 2. Patients in whom aspirin and/or other non-steroidal anti-inflammatory drugs (NSAIDs) have induced symptoms of bronchospasm, allergic rhinitis or urticaria, because the potential exists for cross קרא את המסמך השלם