ATORSTAN Film-coated tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Atorstan 10 mg film-coated tablets. Atorstan 20 mg film-coated tablets. Atorstan 40 mg film-coated tablets. Atorstan 80 mg film-coated tablets.
2. Qualitative and quantitative composition
<u>Atorstan 10 mg film-coated tablets:</u> Each film-coated tablet contains atorvastatin calcium equivalent to 10 mg atorvastatin. <u>Atorstan 20 mg film-coated tablets:</u> Each film-coated tablet contains ...
3. Pharmaceutical form
Film-coated tablet. White, oval-shaped, film-coated tablets, blank on both sides.
4.1. Therapeutic indications
Hypercholesterolemia Atorstan is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents ...
4.2. Posology and method of administration
Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Atorstan. This diet should continue during treatment with Atorstan. The dose should be individualised according ...
4.3. Contraindications
Atorstan is contraindicated in patients: with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. with active liver disease or unexplained persistent elevations ...
4.4. Special warnings and precautions for use
Liver effects Liver function tests should be performed before the initiation of treatment and periodically thereafter. Patients who develop any signs or symptoms suggestive of liver injury should have ...
4.5. Interaction with other medicinal products and other forms of interaction
Effect of co-administered medicinal products on atorvastatin Atorvastatin is metabolised by cytochrome P450 3A4 (CYP3A4) and is a substrate of the hepatic transporters, organic anion-transporting polypeptide ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential Women of child-bearing potential should use appropriate contraceptive measures during treatment (see section 4.3). Pregnancy Atorvastatin is contraindicated during pregnancy ...
4.7. Effects on ability to drive and use machines
Atorstan has negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
In the atorvastatin placebo-controlled clinical trial database of 16,066 (8755 atorvastatin vs. 7311 placebo) patients treated for a mean period of 53 weeks, 5.2% of patients on atorvastatin discontinued ...
4.9. Overdose
Specific treatment is not available for atorvastatin overdosage. Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required. Liver function ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Lipid modifying agents, Lipid modifying agents plain <b>ATC code:</b> C10AA05 Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting ...
5.2. Pharmacokinetic properties
Absorption Atorvastatin is rapidly absorbed after oral administration; maximum plasma concentrations (C<sub>max</sub>) occur within 1 to 2 hours. Extent of absorption increases in proportion to atorvastatin ...
5.3. Preclinical safety data
Atorvastatin was negative for mutagenic and clastogenic potential in a battery of 4 <em>in vitro</em> tests and 1 <em>in vivo</em> assay. Atorvastatin was not found to be carcinogenic in rats, but high ...
6.1. List of excipients
<u>Core:</u> Cellulose, microcrystalline Croscarmellose sodium Lactose monohydrate Polysorbate 80 Hydroxypropylcellulose Calcium carbonate Magnesium stearate <u>Coating:</u> Hypromellose Titanium dioxide ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
Aluminium/Aluminium blisters. Pack-sizes of 14, 28, 30, 100 and 1000 film-coated tablets. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Atorstan 10 mg film-coated tablet: 20937 Atorstan 20 mg film-coated tablet: 20938 Atorstan 40 mg film-coated tablet: 20939 Atorstan 80 mg film-coated tablet: 20940
9. Date of first authorization / renewal of the authorization
Date of first authorization: 16 May 2011 Date of latest renewal: 16 September 2015
10. Date of revision of the text
10/03/2022
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