Products information : ATOR 10 mg

ATOR 10 mg 10 mg Atorvastatin
 
Products technical sheet

Pharmaceutical form and presentation

 Pharmaceutical form
Scored and white coated tablet.
Presentation
Box of 28 tablets
M.A number: 923 348 1

Pharmacotherapeutic class

 Atorvastatin is a hypolipemic agent (acting on hypercholesterolemia and hypertriglyceridemia) it acts by inhibition of HMG-CoA reductase.

Composition

Atorvastatin (as calcium trihydrated)..................................10 mg(10,85 mg)
Excipients: Dibasic calcium phosphate anhydrous, microcristallyne cellulose, lactose, sodium croscarmellose, magnesium stearate, Opadry ............................................s.q.f. one tablet.
Active excipients : Lactose

Therapeutic indications

 - Reduction of pure hypercholesterolemia (type IIa) or mixed (type IIb and III) in association with diet therapy.
- Homozygous family hypercholesterolemia, in combination with other hypolipemic drugs.

Contraindications

 ATOR is not indicated in the following cases:
- Allergies to any component of the drug;
- Hepatic diseases;
- Pregnancy and breastfeeding;
- Patients treated with Itraconazole, Ketoconazole (anti-fungal drugs), stiripentol (epilepsy treatment), delaviridine (anti HIV drugs) and telithromycin;
- ATOR should not be combined with fibrates without the doctor’s authorisation.

Warnings and precautions of use

 Warnings
- In the treatment of the hypercholesterolemia, the scrupulous respect of the prescribed diet is essential.
- A hepatic assessment will be carried out before staring treatment and regularly in course of treatment.
- When you experience muscular pains, immediately inform your doctor.
- Because of the presence of lactose, ATOR is contra-indicated in the case of congenital galactosemia, glucose or galactose malabsorption syndrome or lactase deficiency (rare metabolic diseases).
Precautions of use
Ator should be used with precaution in the following cases:
- If you consume important quantities of alcohol or if you had a hepatic disease,
- The consumption of the grapefruit juice must be avoided.
- When wishing being pregnant or breastfeeding.
Pregnancy and breastfeeding Pregnancy 
ATOR is not indicated in pregnancy. If you discover that you are pregnant during the treatment, consult your doctor quickly: he only is able to adapt the treatment according to your condition.
Breastfeeding
ATOR passes in the mother's milk. Consequently, it is advisable not to use it if you wish to breastfeed.

Drugs interactions

 In order to avoid possible interactions between several drugs, it’s necessary to systematically inform your doctor or your pharmacist about any other current treatment. It is particulary important that your doctor knows if you take a fibrate

Undesirable effects

 Like all active products, ATOR can, in certain patients, involve adverse effects:
- The most frequently reported effects were mild and of short duration: digestive disorders (constipation, abdominal distension, abdominal pains, nauseas, and diarrhoea), headaches, fatigue, insomnia and allergic reactions.
- Muscular pains or cramps (with sometimes increase in the muscular enzymes levels) were reported.
If you feel muscular pains, a painful muscular sensitivity or a muscular weakness, contact your doctor immediately because the muscular problems can, in some rare cases, be serious.
- Some biological anomalies were observed: increase in certain liver enzymes levels (ASAT, ALAT); increase in certain muscular enzymes levels (CPK); increase or reduction in glycemia and reduction in the platelets count (thrombocytopenia).
- Were also observed:
•Cutaneous disorders (itchings, wide eruption) and falling hair.
•Neurological signs: swarmings, peripheral neuropathy (distal nerves affection), vertiginous feeling and memory disorders.
•Loss of appetite and vomiting, peripheral oedemas, articular impotence and pains. Inform your doctor or your pharmacist about any undesirable effect non-mentioned in this leaflet.

Dosage and mode of administration

 Dosage
The usual dosage is 10 – 20 mg/day. If necessary, the dose can be increased up to a maximum dose of 80 mg per day.
- In all the cases, to conform strictly to the doctor prescription.
Mode of administration
- ORAL ROUTE. The tablets must be swallowed with a little amount of water.
- To be taken once a day (before, during or after meals).
- In combination with the diet, ATOR constitutes a long term treatment which should be regularly monitored. For correct use of ATOR, it is essential to undergo regular medical examinations, including blood cholesterol and liver enzymes (transaminases) monitoring
In all cases, it is recommended to follow the doctor’s prescriptions.

Storage

 This drug is to be stored at a temperature less than 30° C

Delivery conditions

 List I – Only on medical prescription.