Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride
Johnson & Johnson (Ireland) Limited
N02BE; N02BE51
Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride
500 mg/12.5 mg/22.5 milligram(s)
Film-coated tablet
Product not subject to medical prescription
Anilides; paracetamol, combinations excl. psycholeptics
Marketed
1998-06-02
Package leaflet: Information for the patient BENYLIN® 4 FLU™ FILM COATED TABLETS Paracetamol 500 mg, Diphenhydramine hydrochloride 12.5 mg, Pseudoephedrine hydrochloride 22.5 mg READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However you still need to take Benylin 4 Flu tablets carefully to get the best results from it. ■ Keep this leaflet. You may need to read it again. ■ Ask your pharmacist if you need more information or advice. ■ You must stop use contact a doctor if your symptoms worsen or do not improve. ■ If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please consult your doctor or pharmacist. WHAT IS IN THIS LEAFLET 1. What Benylin 4 Flu tablets are and what they are used for 2. Before taking Benylin 4 Flu tablets 3. How to take this medicine 4. Possible side effects 5. How to store Benylin 4 Flu tablets 6. Further information 7. Information about treating cough and cold in children 1. WHAT BENYLIN 4 FLU TABLETS ARE AND WHAT THEY ARE USED FOR Benylin 4 Flu Tablets are used to help relieve cold and flu symptoms. The tablets contain paracetamol which helps to relieve aches and pains and fever (high temperature), diphenhydramine, which is an antihistamine that helps relieve coughing, sneezing and runny nose, and pseudoephedrine, which is a decongestant that helps unblock stuffy noses.The medicine is for use in adults and children aged 10 years and over. 2. BEFORE TAKING BENYLIN 4 FLU TABLETS This medicine is suitable for most people, but a few should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT TAKE THIS MEDICINE… ■ If you are taking any other COUGH AND COLD MEDICINES or medicines containing PARACETAMOL. ■ If you have ever had a BAD REACTION to paracetamol, pseudoephedrine or diphenhydramine or any of the other ingredients in this medicine (listed in section 6). ■ If you have HEART DISEASE or HIGH BLOOD PRESSURE. ■ I Lesen Sie das vollständige Dokument
Health Products Regulatory Authority 22 December 2022 CRN00CT21 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Diphenhydramine hydrochloride 12.5 mg Paracetamol 500 mg Pseudoephedrine hydrochloride 22.5 mg Also contains: Sunset yellow E110 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orange, oval, biconvex, film coated tablets (tablets) 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of symptoms associated with colds and flu; including relief of nasal congestion and congestion of mucous membranes of the upper respiratory tract, sneezing, runny nose, coughing, fever, headache, muscular aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER: Two tablets, up to four times daily, as required. Do not take more frequently than every four hours. CHILDREN 10 TO 15 YEARS One tablet, up to four times daily, as required. Do not take more frequently than every four hours. Not to be used for more than five days without the advice of a doctor. Parents or carers should seek medical attention if the child's condition deteriorates during treatment. CHILDREN UNDER 10 YEARS Benylin Four Flu Tablets are contraindicated in children under the age of 10 years (see section 4.3). Do not exceed the stated dose. HEPATIC DYSFUNCTION Caution should be exercised when administrating this medicine to patients with severe hepatic impairment. RENAL DYSFUNCTION Caution should be exercised when administering this medicine to patients with moderate to severe renal impairment. 4.3 CONTRAINDICATIONS Known hypersensitivity to diphenhydramine, paracetamol, pseudoephedrine or to any of the excipients listed in section 6.1. Health Products Regulatory Authority 22 December 2022 CRN00CT21 Page 2 of 9 Concomitant use of o Lesen Sie das vollständige Dokument