ALKA-SELTZER Effervescent tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Alka-Seltzer Effervescent Tablets. Acetylsalicylic acid (Aspirin) 324mg Sodium Hydrogen Carbonate 1744mg Citric acid 965mg
2. Qualitative and quantitative composition
Each effervescent tablet contains 324 mg acetylsalicylic acid (Aspirin), 965 mg citric acid and 1744 mg sodium hydrogen carbonate. The active ingredients in water become sodium citrate 1296 mg, sodium ...
3. Pharmaceutical form
Effervescent tablets (Tablet). White circular tablet – one face flat with bevelled edge; reverse embossed with the name Alka-Seltzer, and a rim.
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, ...
4.2. Posology and method of administration
Posology The dose in adults, elderly and children aged 16 years and over, is one or two tablets in water. The dose may be repeated every four hours, as required, with a maximum of eight tablets in 24 hours. ...
4.3. Contraindications
Alka-Seltzer must not be used in the following cases: hypersensitivity to acetylsalicylic acid or other salicylates, or to any of the excipients listed in section 6.1, a history of asthma induced by the ...
4.4. Special warnings and precautions for use
Alka-Seltzer should be used with particular caution in the following cases: hypersensitivity to analgesics/anti inflammatory agents/anti-rheumatics and in the presence of other allergies, history of gastro-intestinal ...
4.5. Interaction with other medicinal products and other forms of interaction
Contra-indicated Interactions Methotrexate used at doses of 15 mg/week or more Increased hematological toxicity of methotrexate (decreased renal clearance of methotrexate by anti-inflammatory agents in ...
4.6. Fertility, pregnancy and lactation
Pregnancy Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/fœtal development. Data from epidemiological studies raise concern about an increased risk of miscarriage ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The listed adverse drug reactions are based on spontaneous reports, thus an organization according to CIOMS III categories of frequency is not possible. <u>Blood and lymphatic system disorders:</u> Haemorrhagic ...
4.9. Overdose
Salicylate toxicity (>100 mg/kg/day over 2 days may produce toxicity) may result from chronic, therapeutically acquired, intoxication, and from, potentially life-threatening, acute intoxications (overdose), ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Nervous system, other analgesics and antipyretics <b>ATC-Code:</b> N02BA01 Acetylsalicylic acid belongs to the group of acidic nonsteroidal anti-inflammatory drugs with ...
5.2. Pharmacokinetic properties
Following oral administration, acetylsalicylic acid is absorbed rapidly and completely from the gastro-intestinal tract. During and after absorption acetylsalicylic acid is converted into its main active ...
5.3. Preclinical safety data
The preclinical safety profile of acetylsalicylic acid is well documented. In animal studies, salicylates caused kidney damage at high dosages but no other organic lesions. Acetylsalicylic acid has been ...
6.1. List of excipients
Povidone Dimeticone Calcium silicate Docusate sodium Sodium benzoate (E211) Sodium saccharin Natural and artificial lemon flavour Natural and artificial lime flavour
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Shelf-life of the product as packaged for sale is 3 years.
6.4. Special precautions for storage
Do not store above 25°C. Store in the original package to protect from moisture.
6.5. Nature and contents of container
Aluminium foil pouches, each containing two tablets. Available in pack sizes of 10 or 20 tablets. Primary packaging material: composite aluminium foil laminate consisting of 40g/m² paper, 14g/m² polyethylene ...
6.6. Special precautions for disposal and other handling
Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product: No special requirements.
7. Marketing authorization holder
Bayer Limited, The Atrium, Blackthorn Road, Dublin 18
8. Marketing authorization number(s)
PA 1410/32/1
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1978 Date of latest renewal: 01 April 2008
10. Date of revision of the text
March 2021
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