Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Caffeine; Phenylephrine hydrochloride
The Boots Company Plc
N02BE51
Paracetamol; Caffeine; Phenylephrine hydrochloride
300mg ; 25mg ; 5mg
Oral capsule
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 04070100
This medicine is available without prescription, however, you still need to use this product carefully to get the best results from it. Keep this leaflet as you may need to read it again. Ask your pharmacist if you need more information or advice. 1. What is this medicine and what is it used for? This medicine contains: • paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever • phenylephrine which is a decongestant to reduce swelling in the passages of the nose to help you breathe more easily • caffeine which helps to increase the pain relief from paracetamol and makes you more alert. These capsules are used for the relief of the symptoms of colds and flu, including headache, feverishness (high temperature), nasal and sinus congestion and its associated pressure and pain, catarrh, aches and pains. 2. Is this medicine suitable for you? Do not take this medicine if you: • are allergic to paracetamol, phenylephrine, caffeine or any of the other ingredients • are under 12 years of age • have a serious heart condition or cardiovascular disorder(s) • have high blood pressure (hypertension) • have an overactive thyroid • have an enlarged prostate or other prostate problems • are pregnant • are taking antidepressant drugs called monoamine oxidase inhibitors (MAOI’s), or have taken them within the last 14 days – these are medicines such as phenelzine and isocarboxazid • are taking tricyclic antidepressants, such as imipramine, amitriptyline. Please see your doctor or pharmacist before taking this medicine if you: • are breastfeeding • suffer from kidney or liver problems, including alcoholic liver disease or have alcohol dependence • have a blood vessel disease such as Raynaud’s phenomenon • have heart or circulation disease. If you are taking any of the following medicines please see your doctor: • medicines to treat high cholesterol levels which reduce the amount of fat in the blood such as colestyramine • medicines to control fe Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cold Relief Capsules Superdrug Paracetamol Cold Relief with Decongestant Sudafed Blocked Nose & Headache Capsules Non-Drowsy Decongestant with Paracetamol Wilko Non-Drowsy Decongestant with Paracetamol Boots Blocked Nose & Headache Relief Capsules Health Essentials Cold Relief Capsules Boots Cold & Flu Relief Capsules Sainsbury’s Healthcare Sinus Dual Relief Capsules The Local Independent Trading Company Ltd Cold Relief Capsules Spar Cold Relief Capsules Essential Waitrose Cold & Flu Relief Capsules Cold & Flu Relief Capsules Tesco Health Cold & Flu Relief Capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION INGREDIENT QTY UNIT DOSE Paracetamol 300 mg Capsule Caffeine 25 mg Capsule Phenylephrine Hydrochloride 5 mg Capsule 3 PHARMACEUTICAL FORM Capsule, hard [Capsule]. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of the symptoms of colds and flu, including headache, feverishness, nasal and sinus congestion and its associated, pressure and pain, catarrh, aches and pains. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: Oral. ADULTS, THE ELDERLY AND CHILDREN 12 YEARS AND OVER: 2 capsules every 4 to 6 hours as required, up to a maximum of 12 capsules in any 24 hour period. This product is contraindicated in children under the age of 12 years (see section 4.3). 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and/or other constituents. Not to be used in children under the age of 12 years. Patients with prostatic enlargement. Concurrent administration of monoamine oxidase inhibitors and tricyclic antidepressants, severe hypertension, myocardial infarction, hyperthyroidism and pregnancy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Medical advice should be sought before using this product in patients with these conditions: Occlusive vascular disease (e.g. Raynaud's phenomenon) Cardiovascular disease This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppr Прочетете целия документ