Pays: Malte
Langue: anglais
Source: Medicines Authority
CITRIC ACID; ACETYLSALICYLIC ACID; SODIUM HYDROGEN CARBONATE
Bayer PLC
N02BA01
CITRIC ACID; ACETYLSALICYLIC ACID; SODIUM HYDROGEN CARBONATE
EFFERVESCENT TABLET
CITRIC ACID 965 mg; ACETYLSALICYLIC ACID 324 mg; SODIUM HYDROGEN CARBONATE 1744 mg
OTC
ANALGESICS ANALGESICS
Authorised
2007-01-05
CH-10281 BAYER RP-BEIL ALKA-SELTZER ORIGINAL Great Britain PCKO016268 85876740 Leaflet 85876740 - Bitterfeld 445 (Laetus Code) - 7163 Illustrator CS6 PIL-PCKO016268-85876740 4 315 x 148 mm April 20th 2017 8 pt (x-height: 1,23 mm) Minion Pro - - 1 - - - - - - version version 12 mm 7,7 mm Stéphane Romano romano@packpool.ch +41 61 201 10 23 triptyque code barcode Dieline Black Ink Coverage _ % 1 _ORIGINAL_ _ASPIRIN_ READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. This medicine is available without prescription. However, you still need to use Alka-Seltzer Original carefully to get the best results from it. • Keep this leaflet. You may need to read it again. • Ask your pharmacist if you need more information or advice. • You must contact a doctor if your symptoms worsen or do not improve after 3 days. • If you have any unusual effects after using this product, tell your doctor or pharmacist. IN THIS LEAFLET: 1. What is Alka-Seltzer Original and what is it used for? 2. Before you take Alka-Seltzer Original 3. How to take Alka-Seltzer Original 4. Possible side effects 5. How to store Alka-Seltzer Original 6. Further information 1. WHAT IS ALKA-SELTZER ® ORIGINAL AND WHAT IS IT USED FOR? Alka-Seltzer Original are effervescent tablets which dissolve in water to give a sparkling solution. The active substance is aspirin (acetylsalicylic acid). Aspirin belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDS). It is used for the treatment of pain and reduction of fever and also has anti-inflammatory properties. Alka-Seltzer Original can be used for the: • Treatment of mild to moderate pain including headache, migraine, backache (including lumbago), nerve pain (neuralgia and sciatica), period pain, toothache and sore throat. • Symptomatic relief of colds and influenza. • Relief of rheumatic pain (arthritis), muscle tenderness and stiffness (including fibrositis), muscular aches and pains, the pain of joint swelling and stiffness, strains and Lire le document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alka-Seltzer Original 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Acetylsalicylic acid 324 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Effervescent tablets for oral administration. White, round tablet, embossed ‘Alka Seltzer’ on one side. 4 CLINICAL PARTICULARS ` 4.1 THERAPEUTIC INDICATIONS For fast and effective symptomatic relief of mild to moderate pain including headache, migraine, neuralgia, toothache, sore throat, period pains, aches and pains. Symptomatic relief of sprains, strains, rheumatic pain, sciatica, lumbago, fibrositis, muscular aches and pains, joint swelling and stiffness. Symptomatic relief of influenza, feverishness, feverish colds. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Alka-Seltzer Original tablets must always be dissolved in a glass of water prior to oral administration. The tablets dissolve more quickly in warm water. The dose in adults, elderly and children aged 16 years and over, is two tablets in water. The dose may be repeated every four hours, as required, with a maximum of four dosages in 24 hours. These dosages should not be continued for more than three days without consulting a physician. The stated dose must not be exceeded. Do not give to children under 16 years, unless specifically indicated (e.g. for Kawasaki’s disease). 4.3 CONTRAINDICATIONS Acetylsalicylic acid must not be used in the following cases: hypersensitivity to acetylsalicylic acid or other salicylates, or to any other compo- nents of the product, a history of hypersensitivity reactions (e.g. asthma, rhinitis, urticaria) induced by the administration of salicylates or substances with a similar action, notably non- steroidal anti-inflammatory drugs, active or a history of peptic ulcers, haemorrhagic diathesis, severe renal failure, severe hepatic failure, severe cardiac failure, in combination with methotrexate at doses of 15 mg/week or more (see interac- tions with other medicinal Lire le document complet