Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Paracetamol
TriOn Pharma Ltd
N02BE01
Paracetamol
1gram
Effervescent tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04070100; GTIN: 0634154325490
CLIENTE PRODOTTO CODICE DATA RESP. - ALPEX - Atridexamol 1000 mg 50 tab. eff. - XXXX - 23/07/2018 - Damiano Layout FA184 Dimension 105 x 95 x 98 Laetus code XXX Black P 638 P 032 Magenta DISTRIBUTED BY: TriOn Pharma Ltd. 26-30 London Rd. Cowplain P08 8DL, UK info@triopharma.co.uk MA HOLDER: Alpex Pharma (UK) Limited 25a Becher Close Renhold – Bedford MK41 0LP –UK Contact address: PO BOX 849, Bedford, MK45 9EG DO NOT GIVE TO CHILDREN BELOW 16 YEARS OF AGE. This medicinal product is for use only in adults and adolescents aged 16 years. Immediate medical advice should be sought in the event of overdosage even if you feel well. Please read the enclosed leaflet carefully. Prolonged use except on the doctor’s advice may be harmful. This product should be used only when clearly necessary. 50 EFFERVESCENT TABLETS 50 EFFERVESCENT TABLETS WARNINGS ADULTS AND ADOLESCENTS AGED 16 YEARS. Take one tablet (1000 mg) every 6 hours, up to a maximum of 4 tablets (4000 mg) in 24 hours. DO NOT TAKE MORE MEDICINE THAN THE LABEL TELLS YOU TO. IF YOU DO NOT GET BETTER TALK TO YOUR DOCTOR. TALK TO A DOCTOR AT ONCE IF YOU TAKE TOO MUCH OF THIS MEDICINE, EVEN IF YOU FEEL WELL. MAXIMUM DAILY DOSE: The maximum daily dose of paracetamol must not exceed 4000 mg. Maximum single dose is 1000 mg (1 effervescent tablet). If the pain persists for more than 5 days or the fever lasts for more than 3 days, or gets worse or other symptoms appear, you should stop the treatment and consult a doctor. TREATMENT OF MILD TO MODERATE PAIN AND/OR FEVER EACH EFFERVESCENT TABLET CONTAINS 1000 MG PARACETAMOL. Also contains sodium and flavour. Read the package leaflet before use. Dissolve one tablet in a glass of water immediately before use. Allow to dissolve completely before use. See package leaflet for further information. Do not exceed the stated dose. If symptoms persist consult your doctor. Taking higher doses than recommended can cause serious liver damage. Do not use paracetamol unless prescribed by your doctor if you have an addiction to alcohol or Les hele dokumentet
OBJECT 1 ALTRIDEXAMOL 1000 MG EFFERVESCENT TABLETS Summary of Product Characteristics Updated 04-Dec-2020 | Trion Pharma Limited • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Paracetamol 1000 mg Effervescent Tablets. Altridexamol 1000 mg Effervescent Tablets 2. Qualitative and quantitative composition Each effervescent tablet contains 1000mg of Paracetamol. Excipients: Sodium content approximately 438 mg/tablet For a full list of excipient see section 6.1 3. Pharmaceutical form Effervescent Tablet White to almost white round, flat tablets. 4. Clinical particulars 4.1 Therapeutic indications Treatment of mild to moderate pain and/or fever. 4.2 Posology and method of administration This presentation is reserved for use in adults and in adolescents aged 16 years and above. Maximum daily dose: • The maximum daily dose of Paracetamol must not exceed 4000 mg. • Maximum single dose is 1000 mg (1 effervescent tablet). Paracetamol 1000 mg Effervescent Tablets are for oral a Les hele dokumentet