Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, HYOSCINE HYDROBROMIDE
Bayer Limited
N02AA59
PARACETAMOL, CAFFEINE, CODEINE PHOSPHATE, HYOSCINE HYDROBROMIDE
500 8 100 50 Milligram
Tablets
Product not subject to medical prescription
Natural opium alkaloids
Authorised
2009-12-04
Package Leaflet: Information for the patient Feminax Tablets Paracetamol 500 mg, Codeine Phosphate 8 mg, Hyoscine Hydrobromide 100 micrograms, Caffeine (as monohydrate) 50 mg READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Always take this medicine exactly as described in this leaflet or as your pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 3 days. WHAT IS IN THIS LEAFLET: 1. What Feminax Tablets are and what they are used for 2. What you need to know before you take Feminax Tablets 3. How to take Feminax Tablets 4. Possible side effects 5. How to store Feminax Tablets 6. Contents of the pack and other information 1. WHAT FEMINAX TABLETS ARE AND WHAT THEY ARE USED FOR Feminax Tablets rapidly relieve period pain. They relieve the cramping pain and backache you experience with period pain. This product contains codeine. Codeine belongs to a group of medicines called opioid analgesics which act to relieve pain. It can be used on its own or in combination with other pain killers such as paracetamol. Hyoscine hydrobromide is a drug that relaxes smooth muscle and may relieve spasms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FEMINAX TABLETS DO NOT TAKE FEMINAX TABLETS: • if you are allergic to paracetamol, codeine, hyoscine or caffeine Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Feminax Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A white oval, biconvex tablet with bevelled edges, with a score line on one side. The other side is embossed with ‘Feminax’. The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of pain and discomfort associated with menstrual periods. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults:_ Adults and girls over 12 years: Up to 2 tablets every 4 hours. Not more than 6 tablets in 24 hours. The duration of treatment should be limited to 3 days and if no effective pain relief is achieved the patients/carers should be advised to seek the views of a physician. _Elderly persons:_ Not applicable. _Children aged less than 12 years:_ Not applicable. Codeine should not be used in children below the age of 12 years because of the risk of opioid toxicity due to the variable and unpredictable metabolism of codeine to morphine (see sections 4.3 and 4.4). Method of administration Oral. Paracetamol 500.0 mg Codeine Phosphate 8.0 mg Hyoscine Hydrobromide 100.0 micrograms Caffeine Monohydrate equivalent to anhydrous caffeine 50.0 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _0_ _/_ _1_ _0_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _8_ _6 Read the complete document