Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
GUAIFENESIN
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
R05CA03
GUAIFENESIN 50 mg/5ml
SYRUP
GUAIFENESIN 50 mg/5ml
OTC
COUGH AND COLD PREPARATIONS
Withdrawn
2006-08-10
3 HOW TO USE THIS MEDICINE CHECK THE TABLE BELOW TO SEE HOW MUCH MEDICINE TO TAKE. ■ For oral use only. ■ Do not give more than the stated dose shown below. CHILDREN UNDER 6 YEARS OLD This medicine is not recommended for children under 6 years old. CHILDREN 6 - 12 YEARS IF ANYONE HAS TOO MUCH If anyone has taken too much, contact a doctor or your nearest Accident and Emergency department (Casualty), taking this leaflet and pack with you. IF YOU FORGET TO GIVE THE MEDICINE You should only give this medicine as required following the dosage instructions above carefully. If you forget to give a dose, give the next dose when needed. DO NOT give a double dose. 2 BEFORE GIVING THIS MEDICINE TO YOUR CHILD This medicine is suitable for most children but a few children should not use it. If you are in any doubt, talk to your doctor or pharmacist. DO NOT USE THIS MEDICINE… ■ If your child has ever had a BAD REACTION to this product or any of the ingredients. See section 6 for full list of ingredients. ■ If your child is taking ANY OTHER COUGH AND COLD MEDICINE. ■ If your child is aged under 6 years. If any of these apply, GET ADVICE FROM A DOCTOR OR PHARMACIST WITHOUT USING BENYLIN CHILDREN’S CHESTY COUGHS. TALK TO YOUR DOCTOR OR PHARMACIST… ■ If your child suffers from LIVER or KIDNEY PROBLEMS. ■ If your child has A PERSISTENT COUGH such as occurs with asthma, has ASTHMA, is suffering from an ASTHMA ATTACK or a COUGH THAT PRODUCES A LOT OF MUCUS (PHLEGM). If any of these apply now or in the past, TALK TO A DOCTOR OR PHARMACIST. IF YOU ARE PREGNANT OR BREAST-FEEDING The following advice is included in case an older child or adult is taking the medicine. ■ If you are pregnant or breast-feeding, only use this medicine on the advice of your doctor. SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS ■ This medicine contains sorbitol liquid. This should be taken into account in patients with diabetes mellitus. ■ This medicinal product contains 14.88 mg sodium per 5 ml. To be taken into consideration by patient Citiți documentul complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT BENYLIN Children's Chesty Coughs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BENYLIN Children's Chesty Coughs contains 50 mg guaifenesin in each 5 ml. Each 5ml also contains: Sorbitol liquid (non-crystallising) Sodium Citrate Sodium Saccharin Sodium Benzoate Carmellose Sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS BENYLIN Children's Chesty Coughs is an expectorant for the symptomatic relief of acute productive (chesty) coughs. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY ADULTS AND CHILDREN AGED 12 YEARS AND OVER: Not applicable. CHILDREN AGED 6 TO 12 YEARS: 10 ml syrup four times daily. Page 2 of 7 Maximum daily dose: 40 ml syrup (400 mg guaifenesin) Not to be used for more than 5 days without the advice of a doctor. Parents and carers should seek medical attention if the child’s condition deteriorates during treatment. CHILDREN UNDER 6 YEARS: Benylin Children’s Chesty Coughs is contraindicated in children under the age of 6 years (see section 4.3). METHOD OF ADMINISTRATION For oral use Do not exceed the stated dose. Keep out of the sight and reach of children. 4.3. CONTRAINDICATIONS BENYLIN Children's Chesty Coughs is contraindicated in individuals with known hypersensitivity to the product, or any of its components. Not to be used in children under the age of 6 years. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Ask a doctor before use if your child suffers from chronic cough, if he/she has asthma or is suffering from an acute asthma attack. Stop use and ask a healthcare professional if your child’s cough lasts for more than 5 days, comes back, or is accompanied by a fever, rash or persistent headache. Do not give with a cough suppressant. Caution should be exercised in the presence of severe renal or severe hepatic impairment. Not more than 4 doses should be given in any 24 hours. Do not exceed the stated dose Citiți documentul complet