Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
Carbocisteine
McNeil Healthcare (Ireland) Ltd
R05CB; R05CB03
Carbocisteine
250 mg/5ml
Syrup
Product not subject to medical prescription
Mucolytics; carbocisteine
Not marketed
2001-07-27
■ This medicine is used to help treat conditions where the lungs produce too much mucus (phlegm) or the mucus is too thick. ■ This medicine is for use by adults and children aged 2 years and over. ■ DO NOT USE THIS MEDICINE: ■ There are some people who should not use this medicine. _To find out if you are one of them see section 2 _ ■ If you have ever had a BAD REACTION to any of the ingredients. _For the list of ingredients see section 6 _ ■ SPEAK TO YOUR DOCTOR: ■ If you suffer from any of the conditions mentioned in section 2. _See section 2 _ ■ If you are taking any other medicines. _See section 2 _ ■ FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See section 3 _ NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE THIS MEDICINE. Keep the leaflet: you might need it again. 1 WHAT THE MEDICINE IS FOR Benylin Mucus Relief is a medicine which is used to help treat conditions where the lungs produce too much mucus (phlegm) or the mucus is too thick. It contains Carbocisteine (a mucolytic) to help thin the mucus when it has become too thick or sticky to cough up. The medicine is for use in adults and children aged 2 years and over. 2 BEFORE TAKING THIS MEDICINE This medicine is suitable for most people but a few people should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… ■ If you have ever had a BAD REACTION to any of the ingredients. ■ For a child under 4 years of age. If any of these apply to you, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING BENYLIN MUCUS RELIEF. TALK TO YOUR DOCTOR OR PHARMACIST… ■ If you suffer from LIVER or KIDNEY PROBLEMS. ■ If you have, or have ever had a stomach ulcer. ■ If you are taking other medicines including pholcodine linctus. If you are not sure about any of the medicines you are taking, show the bottle or pack to your pharmacist. If any of these bullet points apply to you now or in the past, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING ■ Ask your doctor or pharmacist f Przeczytaj cały dokument
Health Products Regulatory Authority 26 October 2021 CRN00CGYW Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benylin Mucus Relief 250mg/5ml Syrup 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5 ml contains 250 mg carbocisteine (50mg/ml). Excipients: Each 5ml also contains 7.5 mg methyl parahydroxybenzoate, 47.1 mg sodium and 0.03 mg sunset yellow (E110). For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Syrup Clear, light yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mucolytic agent for use in disorders of the lower respiratory tract in which an increase in the amount and viscosity of mucus is a prominent feature. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oral administration: ADULTS AND CHILDREN OVER 12 YEARS Three 5 ml spoonfuls three times a day initially; after a satisfactory response, this may be reduced to two 5 ml spoonfuls three times daily. CHILDREN OVER 4 YEARS (6-12 years): One 5 ml spoonful three times a day (4-5 years): Half to one 5 ml spoonful twice a day (5-10ml). Not recommended for children under 4 years. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients. Carbocisteine is contra-indicated in cases of active peptic ulcer. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product should be used with caution in patients with a history of peptic ulceration, because of the possible effect on the mucous glands of the stomach. If symptoms persist or get worse, or if new symptoms occur, patients should stop use and consult a physician. Health Products Regulatory Authority 26 October 2021 CRN00CGYW Page 2 of 4 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known, but see Section 6.2 below. 4.6 FERTILITY, PREGNANCY AND LACTATION There are insufficient adequate and well controlled studies in pregnant women. Therefore, Benylin Mucus Relief action should not be used during pregnancy or by nursing mothers. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not r Przeczytaj cały dokument