CALPOL SIX PLUS Orodispersible tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
Calpol Six Plus Fastmelts (250 mg Orodispersible Tablets).
2. Qualitative and quantitative composition
Paracetamol 250 mg. <u>Excipients:</u> also contains mannitol (E421), aspartame ((E951)) contains 8mg aspartame per tablet), benzyl alcohol and glucose. For the full list of excipients, see section 6.1. ...
3. Pharmaceutical form
Orodispersible tablet. Round, white, bi-convex tablets with central concave depression.
4.1. Therapeutic indications
Calpol Six Plus Fastmelts is indicated for the treatment of mild to moderate pain and as an antipyretic. It can be used in many conditions including headache, toothache, earache, sore throat, colds and ...
4.2. Posology and method of administration
Oral. Tablets should be placed in the mouth where they melt on the tongue. The tablet will rapidly disperse to a pleasant tasting paste that can be easily ingested. Alternatively the tablet can be dispersed ...
4.3. Contraindications
Hypersensitivity to paracetamol or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Do not exceed the recommended dose. Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help straight away. Quick medical attention is critical for ...
4.5. Interaction with other medicinal products and other forms of interaction
Drugs which induce hepatic microsomal enzymes Metabolism of paracetamol possibly accelerated by carbamazepine, fosphenytoin, phenytoin, phenobarbital, primidone (also isolated reports of hepatotoxicity). ...
4.6. Fertility, pregnancy and lactation
Pregnancy A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity. Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show ...
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
Adverse drug reactions (ADRs) identified during clinical trials and post-marketing experience with paracetamol are listed below by System Organ Class (SOC). The frequencies are defined according to the ...
4.9. Overdose
Liver damage is possible in adults and adolescents (≥12 years of age) who have taken 7.5g or more of paracetamol. It is considered that excess quantities of a toxic metabolite (usually adequately detoxified ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other Analgesics and Antipyretics (Anilides) <b>ATC Code:</b> N02BE01 Paracetamol has analgesic and antipyretic effects similar to those of aspirin and is useful in the ...
5.2. Pharmacokinetic properties
Paracetamol is rapidly and almost completely absorbed from the gastro-intestinal tract. Peak plasma concentrations are reached 30-90 minutes post dose. Paracetamol is distributed rapidly throughout all ...
5.3. Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity, genotoxicity, and carcinogenicity. Conventional studies using the currently accepted ...
6.1. List of excipients
Mannitol (E421) Crospovidone Aspartame (E951) Strawberry flavouring E. 9620941 (containing benzyl alcohol and glucose) Magnesium stearate Basic butylated methacrylate copolymer Polyacrylate dispersion ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
Strip containing 24 tablets. The blister consists of a blister complex (Polyamide/PVC/Aluminium) and either: an aluminium sealing sheet or a paper/aluminium child resistant sealing sheet.
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
McNeil Products Limited, 50–100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
8. Marketing authorization number(s)
PL 15513/0082
9. Date of first authorization / renewal of the authorization
19<sup>th</sup> March 2001/03 March 2009
10. Date of revision of the text
25 August 2021
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