Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Caffeine
Haleon UK Ltd
N02BE51
Paracetamol; Caffeine
500mg ; 65mg
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 5000347063282
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE YOU START USING THIS MEDICINE. This medicine is available without prescription, but you still need to use Panadol Extra Soluble Tablets carefully to get the best results from them. • Keep this leaflet, you may need to read it again. • If you have any questions, or if there is anything you do not understand, ask your pharmacist. • Contains Paracetamol. IN THIS LEAFLET: 1. What Panadol Extra Soluble Tablets do 2. Check before you take Panadol Extra Soluble Tablets 3. How to take Panadol Extra Soluble Tablets 4. Possible side effects 5. How to store Panadol Extra Soluble Tablets 6. Further information 1. What Panadol Extra Soluble Tablets do PANADOL EXTRA SOLUBLE TABLETS ARE USED FOR THE RELIEF OF HEADACHE, MIGRAINE, BACKACHE, RHEUMATIC PAIN, TOOTHACHE AND PERIOD PAIN. They also relieve sore throat and the fever, aches and pains of colds and flu. The tablets contain two active ingredients. Paracetamol is a painkiller and also reduces your temperature when you have a fever. Caffeine acts to further help the effectiveness of paracetamol. 2. Check before you take Panadol Extra Soluble Tablets DO NOT TAKE PANADOL EXTRA SOLUBLE TABLETS: • IF YOU HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, caffeine or to any of the other ingredients (listed in Section 6) • if you are taking ANY OTHER PRESCRIPTION OR NON PRESCRIPTION MEDICINES CONTAINING PARACETAMOL to treat pain, fever, symptoms of cold and flu, or to aid sleep. ASK YOUR DOCTOR BEFORE YOU TAKE THIS MEDICINE: • if you have LIVER or KIDNEY DISEASE, including ALCOHOLIC LIVER DISEASE • if you have been told by your doctor that you have an INTOLERANCE TO SOME SUGARS • if you need 1 or more tablets daily for a prolonged period, especially if you have been advised to follow a LOW SALT (SODIUM) DIET . • if you are UNDERWEIGHT or MALNOURISHED • if you regularly DRINK ALCOHOL • if you have a SEVERE INFECTION as this may increase the risk of METABOLIC ACIDOSIS. • Signs of metabolic acidosis include: - deep, Přečtěte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Panadol Extra Soluble Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Paracetamol Ph.Eur. 500.0 mg and Caffeine Ph.Eur. 65.0 mg. 3 PHARMACEUTICAL FORM Effervescent tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Panadol Extra is a mild analgesic and antipyretic formulated to give extra pain relief. The soluble tablets are recommended for the treatment of most painful and febrile conditions, for example, headache including migraine, backache, toothache, colds and influenza, sore throat, rheumatic pain and dysmenorrhoea. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Panadol Extra should be dissolved in at least half a tumblerful of water. Adults (including the elderly) and children aged 16 years and over: Two tablets up to four times daily. Do not exceed 8 tablets in 24 hours. Children aged 12-15 years: One tablet up to four times daily. Do not exceed 4 tablets in 24 hours. Not recommended for children under 12 years. Do not take more frequently than every 4 hours. Do not take for longer than three days without consulting your doctor. Method of Administration Panadol Extra Soluble Tablets are for oral administration only. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol, caffeine or any of the other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Do not exceed the stated dose. Contains paracetamol. Do not use with any other paracetamol containing products. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which may require liver transplant or lead to death. Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease. Caution should be exercised in patients with glutathione depleted states as the use of paracetamol may increase the risk of metabolic acidosis (see section 4.9). Excessive intake of ca Přečtěte si celý dokument