Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide
Haleon UK Ltd
N02BE51
Paracetamol; Promethazine hydrochloride; Dextromethorphan hydrobromide
50mg/1ml ; 1mg/1ml ; 750microgram/1ml
Oral solution
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 04070100; GTIN: 5000347062193
PACKAGE LEAFLET: INFORMATION FOR THE USER NIGHT NURSE HOT LEMON MENTHOL Powder for Oral Solution _PARACETAMOL, DEXTROMETHORPHAN, PROMETHAZINE_ _ _ PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use this medicine 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 does this medicine do 2. Check before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Further information 1. WHAT DOES THIS MEDICINE DO NIGHT NURSE HOT LEMON MENTHOL POWDER FOR ORAL SOLUTION IS USED FOR THE NIGHT-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. Promethazine hydrochloride is an antihistamine which dries up a runny nose and aids restful sleep. Dextromethorphan hydrobromide is a cough suppressant that helps relieve dry or tickly coughs. This medicine also helps to relieve a sore throat. 2. CHECK BEFORE YOU TAKE THIS MEDICINE CONTAINS PARACETAMOL. TAKING TOO MUCH PARACETAMOL CAN CAUSE SERIOUS HARM TO YOUR LIVER. DO NOT TAKE ANYTHING ELSE CONTAINING PARACETAMOL WITHIN FOUR HOURS OF TAKING THIS PRODUCT. DO NOT TAKE WITH OTHER ANTIHISTAMINE-CONTAINING PREPARATIONS, INCLUDING TOPICAL ANTIHISTAMINES AND COUGH AND COLD MEDICINES. <_X SYMBOL_> DO NOT TAKE THIS MEDICINE: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, promethazine hydrochloride, dextromethorphan hydrobromide or to any of the other ingredients (listed in Section 6). • if you have a CHEST INFECTION, WORSENING ASTHMA or SEVERE RESPIRATORY PROBLEMS. • if you are taking or have taken MONOAMINE OXIDASE INHIBITORS (MAOIs) prescribed for DEPRESSION in the LAST TWO WEEKS. <_! SYMBOL> _ TAKE SPECIAL CARE WITH THIS MEDICINE This medicine can lead to Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Night Nurse Hot Lemon Menthol Powder for Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active constituents mg/sachet Paracetamol 1000.0 Promethazine hydrochloride 20.0 Dextromethorphan hydrobromide Excipients Aspartame 15.0 mg/sachet 35.0 Sodium (as sodium citrate dihydrate) 117.3 For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for oral solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the symptomatic relief of colds, chills and influenza at night. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of Administration Oral Adults and children 16 years and over: Empty contents of one sachet into a mug. Half fill with very hot water. Stir well. Add cold water as necessary. One sachet to be taken just before going to bed. Not to be given to children under 16 years except on medical advice. Maximum daily dose: Only one sachet should be taken per night. Do not exceed the stated dose Maximum duration of continued use without medical advice: 3 days. Other products containing paracetamol may be taken during the day but the total daily dose of paracetamol must not exceed 4000mg (including this product) in any 24 hour period. Allow at least four hours between taking any paracetamol-containing product and this product. Should not be used with other cough or cold medicines, or any other antihistamine-containing products, including those used on the skin. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, dextromethorphan, promethazine or any of the other constituents. With, or at risk of developing, respiratory failure (e.g. those with chronic obstructive airways disease or pneumonia, or during an asthma attack or an exacerbation of asthma). Patients taking or have taken monoamine oxidase inhibitors (MAOIs) in the last two weeks. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Contains paracetamol. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Avoid use of othe Прочитать полный документ