Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
PHOLCODINE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE
GlaxoSmithKline Consumer Health-care UK Trading Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom
N02BE51
PHOLCODINE 10/30 mg/ml PARACETAMOL 1000 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60/30 mg/ml
ORAL SOLUTION
PHOLCODINE 10/30 mg/ml PARACETAMOL 1000 mg PSEUDOEPHEDRINE HYDROCHLORIDE 60/30 mg/ml
OTC
ANALGESICS
Withdrawn
2006-05-29
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Day Nurse carefully to get the best results from it. • Keep this leaflet you may need to read it again. • If you have any further questions, ask your pharmacist. IN THIS LEAFLET: 1. What Day Nurse does 2. Check before you take Day Nurse 3. How to take Day Nurse 4. Possible side effects 5. How to store Day Nurse 6. Further information 1. What Day Nurse does DAY NURSE IS USED FOR THE DAY-TIME RELIEF OF THE MAJOR SYMPTOMS OF COLDS, CHILLS AND FLU. The medicine contains three active ingredients. Paracetamol is a painkiller and reduces your temperature when you have a fever. Pseudoephedrine hydrochloride is a decongestant which unblocks your nose and sinuses helping you breathe more easily. Pholcodine is a cough suppressant that helps relieve dry or tickly coughs. Day Nurse also helps relieve a sore throat. 2. Check before you take Day Nurse DO NOT TAKE DAY NURSE: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, pseudoephedrine hydrochloride, pholcodine or any of the other ingredients (listed in Section 6) • if you have high BLOOD PRESSURE or HEART DISEASE • if you have KIDNEY DISEASE or HYPEREXCITABILITY • if you have DIFFICULTY BREATHING or LUNG PROBLEMS • if you are taking APPETITE SUPPRESSANTS or STIMULANT DRUGS called amphetamines (sometimes used to treat ADHD) • if you have taken monoamine oxidase inhibitors (MAOIs) prescribed for DEPRESSION in the LAST TWO WEEKS. DO NOT TAKE WITH ANY OTHER PARACETAMOL-CONTAINING PRODUCTS. DO NOT TAKE WITH ANY OTHER FLU, COLD OR DECONGESTANT PRODUCT. TAKE SPECIAL CARE WITH DAY NURSE: • Do not drive if the medicine makes you dizzy • Avoid drinking alcohol whilst taking this medicine • Day Nurse contains 5% v/v ethanol (ALCOHOL). i.e. up to 1.2g per dose, equivalent to 30 ml beer, 12.5 ml wine. This could be harmful if you suffer from ALCOHOLISM. This should also be considered if you are PREGNANT or Baca dokumen lengkap
P age 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Day Nurse 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredient Paracetamol Pseudoephedrine Hydrochloride Pholcodine per 30 ml 1000 mg 60 mg 10 mg For excipients, see 6.1 3. PHARMACEUTICAL FORM Oral Solution Clear orange liquid 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For the relief of the symptoms of colds and influenza. For oral administration. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Take during the day. It is important to SHAKE THE BOTTLE for at least 10 seconds before use Should not used with other paracetamol-containing products, decongestants or cough and cold medicines. Adults and children 16 years and over 30 ml every four hours Up to a maximum of 4 doses in 24 hours if needed, or up to a maximum of three doses within any 24 hour period if a night-time paracetamol-containing product is taken before bedtime. Minimum dosing interval: 4 hours. Do not exceed the stated dose Children under 16 years Not to be given to children under sixteen years of age. P age 2 of 10 Elderly There is no specific requirement for dosage reduction in the elderly. 4.3. CONTRAINDICATIONS This product is contraindicated in patients with: • Hypersensitivity to any of the ingredients or excipients. • Severe hypertension or severe coronary artery disease., • Severe renal impairment. • Hyperexcitability • With or at risk of developing, respiratory failure (e.g. those with chronic obstructive airways disease or pneumonia) or those with bronchiolitis or bronchiectasis due to sputum retention. • Who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants). • Who are receiving Monoamine Oxidase Inhibitors (MAOIs) or for two weeks after stopping a MAOI drug. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE For oral use only. Always use the measuring cup supplied with the pack. Should be given with caution to patients with mild to moderate kidney impairment and in Baca dokumen lengkap