País: Malta
Língua: inglês
Origem: Medicines Authority
LEVOMENTHOL
McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom
R06AA52
LEVOMENTHOL 0.55 mg/5ml
SYRUP
LEVOMENTHOL 0.55 mg/5ml
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Withdrawn
2006-08-10
■ _opioid analgesics_ (drugs used to RELIEVE PAIN e.g. codeine, tramadol, morphine). ■ _antipsychotics_ (drugs used to treat MOOD DISORDERS). If you are not sure about any of the medicines your child is taking, show the bottle or pack to your pharmacist. If any of these bullet points 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: ■ Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding. SPECIAL WARNINGS ABOUT THIS MEDICINE ■ This product can make some people feel drowsy, dizzy or have blurred vision. Make sure that your child is not affected if he or she is going to do anything where they need to be alert. Be especially careful if the child is taking another medicine which may also cause drowsiness. ■ If an older child or adult is taking the medicine remember that this product may cause drowsiness, dizziness or blurred vision. Do not drive or operate machinery if you are affected. Avoid alcoholic drink. SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS ■ This medicine contains sorbitol 70% (non crystalline). If you have been told by your doctor that your child has an intolerance to some sugars contact your doctor before taking this medicinal product. ■ This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to 200 mg per 5 ml, equivalent to 5 ml beer, 2 ml wine per 5 ml. This can be harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy. ■ This medicinal product contains 16.47 mg sodium per 5 ml. To be taken in consideration by patients on a controlled sodium diet. 2 BEFORE GIVING YOUR CHILD THIS MEDICINE This medicine is suitable for most children but a few children s Leia o documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT BENYLIN CHILDREN’S NIGHT COUGHS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION BENYLIN CHILDREN’S NIGHT COUGHS contains - ACTIVE INGREDIENT MG/5 ML Diphenhydramine Hydrochloride 7.0 mg Levomenthol 0.55 mg 3. PHARMACEUTICAL FORM A clear colourless syrup with no insoluble matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BENYLIN CHILDREN’S NIGHT COUGHS is indicated for the relief of cough and its congestive symptoms, runny nose and sneezing, and in the treatment of hay fever and other allergic conditions affecting the upper respiratory tract. It is specially formulated for children and contains no artificial dyes or sucrose. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration: Oral CHILDREN UNDER 6 YEARS: BENYLIN CHILDREN’S NIGHT COUGHS is contraindicated in children under the age of 6 years (see section 4.3). CHILDREN 6 TO 12 YEARS: Two 5 ml spoonfuls every 6 hours No more than four doses should be given in any 24 hours. 2 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. Do not exceed the stated dose. Keep out of the reach and sight of children. 4.3 CONTRAINDICATIONS BENYLIN CHILDREN’S NIGHT COUGHS is contraindicated in individuals with known hypersensitivity to the product or any of its constituents. BENYLIN CHILDREN’S NIGHT COUGHS should not be administered to patients currently receiving monoamine oxidase inhibitors (MAOI) or those patients who have received treatmen Leia o documento completo