Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Naproxen
Bayer Plc
M01AE02
Naproxen
250mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5010605208140
PATIENT INFORMATION LEAFLET Bayer Cross FEMINAX® ULTRA 250 MG GASTRO-RESISTANT TABLETS Naproxen (250 mg) This leaflet contains important information about Feminax® Ultra 250 mg Gastro-resistant tablets (referred to as Feminax® Ultra from now on). Please read it carefully before you take these tablets. WHAT IS FEMINAX® ULTRA FOR? These tablets contain 250 mg of naproxen. This medicine is used to treat period pain (also called menstrual pain or dysmenorrhoea) Naproxen belongs to a group of painkillers called Non-Steroidal Anti-inflammatory Drugs (also called NSAIDs) Other medicines in this group include ibuprofen and aspirin. WHO SHOULD TAKE FEMINAX® ULTRA? Only take this medicine if you are between 15 and 50 years old. Ask your doctor, pharmacist or nurse if you need more information. THINGS TO KNOW BEFORE TAKING FEMINAX® ULTRA DO NOT TAKE THIS MEDICINE IF YOU HAVE, OR HAVE EVER HAD A STOMACH ULCER, OR OTHER SERIOUS STOMACH PROBLEMS This includes any stomach pain that did not go away and any bleeding in the stomach If you have ever had anything like this then you should not take these tablets. DO NOT TAKE THIS MEDICINE IF YOU HAVE SEVERE HEART FAILURE. DO NOT TAKE THIS MEDICINE IF YOU ARE ALREADY TAKING ASPIRIN, LOW DOSE ASPIRIN OR ANY OTHER NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) LIKE IBUPROFEN. THIS INCLUDES CYCLO-OXYGENASE-2 SELECTIVE INHIBITORS (COX2) LIKE CELECOXIB. DO NOT TAKE THIS MEDICINE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO: Naproxen, aspirin, ibuprofen, or another non-steroidal anti-inflammatory drug (NSAID) Anything else in these tablets (look at the list in the ‘What is in these tablets’ section, at the end of the leaflet). Allergic reactions can include wheezing, itchy runny nose, rashes or swelling of the skin. DO NOT TAKE THIS MEDICINE UNLESS YOUR DOCTOR SAID YOU CAN, IF: You are breast feeding, or there is a chance you may be pregnant You started to have period pain more than a year after your first period. DO NOT TAKE THIS MEDICINE, UNLESS YOU Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Feminax ® Ultra 250mg Gastro-Resistant Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of Naproxen. For full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Gastro-Resistant Tablet White, round, biconvex enteric-coated tablets, overprinted in black 3N3. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for the treatment of primary dysmenorrhoea in women aged 15 to 50 years. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. To be taken preferably with or after food swallowed whole with water. Adolescents (post puberty) and adult females between the ages of 15 and 50: On the first day 2 tablets (500 mg) should be taken initially and then one tablet (250 mg) after 6 to 8 hours if needed. On the second and third day, if needed, one tablet (250mg) should be taken every 6 to 8 hours. Not more than 3 tablets to be taken per day. The maximum duration of continuous treatment in any one cycle (period) is 3 days. 4.3 CONTRAINDICATIONS Naproxen is contra-indicated in patients with a history of, or active peptic ulceration and active gastrointestinal bleeding. Naproxen is contra-indicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy. Naproxen is contra-indicated for patients with known hypersensitivity to naproxen, naproxen sodium formulations or any of the excipients. Naproxen should not be given to patients in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis or urticaria. Naproxen should not be given to patients with severe heart failure. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see warnings on GI and cardiovascular risks below). _Cardiovascular and cerebrovascular effects _ Caution (discussion with doctor or pharmacist) is required prior to sta Read the complete document