País: Reino Unido
Língua: inglês
Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol; Caffeine
Zentiva Pharma UK Ltd
N02BE51
Paracetamol; Caffeine
500mg ; 65mg
Oral tablet
Oral
No Controlled Drug Status
Invalid to prescribe in NHS primary care
BNF: 04070100
Please turn over ➥ Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • You must talk to a doctor if you do not feel better or if you feel worse. What is in this leaflet 1. What this medicine is and what it is used for 2. What you need to know before you take this medicine 3. How to take this medicine 4. Possible side effects 5. How to store this medicine 6. Contents of the pack and other information 1. What this medicine is and what it is used for This medicine contains • paracetamol which is a pain reliever (analgesic) and helps reduce your temperature when you have a fever • caffeine which helps to increase the pain relief from paracetamol and makes you more alert. These tablets are for the relief of mild to moderate pain including headache, migraine, toothache, nerve pain, sore throat and period pains. They are also for symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness, flu, feverishness and feverish colds. 2. What you need to know before you take this medicine Do not take this medicine if you • are allergic to paracetamol, caffeine or any of the other ingredients (as listed in section 6) • have high blood pressure or are taking any medication for high blood pressure, such as beta blockers • your heart beat is too fast, too slow or irregular • are recovering from alcoholism and are taking the medicine disulfiram • are taking any medication to treat anxiety, this includes antidepressants (e.g. lithium carbonate or monoamine oxidase inhibitors), anxiolytics or Leia o documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Max Remedies Paracetamol Plus Caplets Max Remedies Paracetamol and Caffeine Caplets Paracetamol & Caffeine Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Paracetamol 500.0 mg Caffeine 50.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (Tablet) White film coated capsule-shaped tablet with a break line The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the effective treatment of mild to moderate pain such as headache, migraine, neuralgia, backache, rheumatic and muscular pain, period pain and toothache. For the relief of the symptoms of coughs, colds and sore throats. For the reduction of fever in influenza. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Pos olo gy: Ora l. Adults and children of 16 years and over: 1-2 tablets every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. The tablets should be taken with a glass of water. Children 12 to 15 years: 1 tablet every 4-6 hours when necessary to a maximum of 4 doses in 24 hours. The tablets should be taken with a glass of water. Elderly: No special dosage regimen required, but care should be taken to observe the contraindications, precautions and warnings, which may be particularly applicable to elderly persons. Children: Not recommended for children less than 12 years old except under medical supervision. 4.3 CONTRAINDICATIONS Hypersensitivity to paracetamol and/or other constituents. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Precautions: paracetamol should be used with caution in patients with severe renal disease or liver dysfunction. The hazards of overdose are greater in those with non-cirrhotic alcoholic liver disease. Excessive intake of caffeine from coffee and tea should be avoided. Keep out of the reach of children. Warning: Do not exceed the stated dose. If symptoms persist consult your doctor. THE LABEL WILL SAY: Conta Leia o documento completo