Χώρα: Ηνωμένο Βασίλειο
Γλώσσα: Αγγλικά
Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ibuprofen
McNeil Products Ltd
M01AE01
Ibuprofen
20mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010100; GTIN: 5010123728328 5010123728311
Babies under 3 months Do not give to babies under 3 months. Consult your doctor. Children from 3 months to 12 years For Pain and Fever Relief: Age Dose 3 months - 6 months 2.5 ml 3 times a day. ■ weighing over 5 kg Do not use for more than 24 hours 6 months - 1 year 2.5 ml 3 times a day 1 year - 2 years 2.5 ml 3 or 4 times a day 3 years - 7 years 5 ml 3 or 4 times a day 8 years - 12 years 10 ml (5 ml + 5 ml) 3 or 4 times a day ■ Doses should usually be given every 6 - 8 hours. Leave at least 4 hours between doses. ■ Short term use only: - Do not give to babies aged from 3 months to under 6 months for more than 24 hours. - Do not give to children aged 6 months or over for more than 3 days. ■ If symptoms persist or worsen consult your doctor. For Post-Immunisation Fever: Age Dose Babies and children 2.5 ml up to twice a day 3 months and over ■ weighing over 5 kg If necessary, the second dose should be given 6 hours after the first one. ■ Do not give more than 2 doses in 24 hours. ■ Do not give to a child under 3 months unless recommended by your doctor. ■ If the fever is not reduced you should consult your doctor. Speak to your doctor ■ If your baby needs more than the dose shown in the table, or if the fever doesn't go away, speak to your doctor as soon as possible. ■ If you are not sure of your child's illness or it is accompanied by a rash, breathing difficulties, diarrhoea or excessive tiredness or lethargy, speak to your doctor straight away. Do not give CALPROFEN ® until you get medical advice. If anyone has taken too much If anyone has taken too much of this product, contact a doctor or your nearest Accident and Emergency Department (Casualty), taking this leaflet and pack with you. The symptoms can include nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feel Διαβάστε το πλήρες έγγραφο
OBJECT 1 CALPROFEN 100MG/5ML ORAL SUSPENSION IBUPROFEN Summary of Product Characteristics Updated 04-May-2018 | McNeil Products Ltd 1. Name of the medicinal product Calprofen 100mg/5ml Oral Suspension Ibuprofen 2. Qualitative and quantitative composition Ibuprofen 100 mg/5 ml Also contains maltitol syrup (E965), sodium methylhydroxybenzoate (E219), sodium propylhydroxybenzoate (E217), propylene glycol (E1520) and ethanol. For excipients – see section 6.1 3. Pharmaceutical form Oral Suspension Sugar Free, Colour Free and Strawberry Flavour 4. Clinical particulars 4.1 Therapeutic indications Children aged 3 months to 12 years: Mild to moderate pain, post-immunisation pyrexia, rheumatic or muscular pain, headache, reduction of fever, sore throat, teething pain, toothache, minor aches and pains, symptoms of cold and influenza. 4.2 Posology and method of administration To be taken orally. For short term use only. Children aged 3 months to 12 years: Not recommended for children weighing less than 5 kg. For pain and fever – 20mg/kg/day in divided doses. Infants 3-6 months: 2.5 ml three times a day. Do not use for more than 24 hours. Infants 6-12 months: 2.5 ml three times a day. Children 1-2 years: 2.5 ml three to four times a day Children 3-7 years: 5 ml three to four times a day Children 8-12 years: 10 ml three to four times a day Doses should be taken every 6 – 8 hours when required, and at least 4 hours should be left between doses. Post-immunisation fever: 2.5 ml (50 mg) followed by one further dose of 2.5 ml (50mg) six hours later if necessary. No more than 2 doses in 24 hours. If fever is not reduced, consult a doctor. Do not give to children under 3 months of age. For children aged ≥3 months to ≤5 months: if the child's symptoms worsen or if the symptoms persist for more than 24 hours, consult a doctor For children aged 6 months and over: if symptoms worsen or if the symptoms persist for more than 3 days, consult a doctor 4.3 Contraindications Hypersensitivity to Ibuprofen or any of the excipients in t Διαβάστε το πλήρες έγγραφο