Medicinal Products

ATORVASTATIN EG 80 mg

Generic drug of Tahor
Therapeutic class: Cardiology and angiology
active ingredients: Atorvastatin
laboratory: EG Labo

Coated tablet
Box of 30
All forms

Indication

hypercholesterolemia

ATORVASTATIN EG is indicated as an adjunct to a diet adapted to lowering high levels of total (C-total) cholesterol, LDL cholesterol (LDL-C), apolipoprotein B and triglycerides in adults, adolescents and children. over 10 years of age with primary hypercholesterolemia including heterozygous familial hypercholesterolaemia or combined (mixed) hyperlipidemia (Fredrickson type IIA, IIb) when the response to diet alone and other non-diet pharmacological is insufficient.

ATORVASTATIN EG is also indicated to decrease levels of C-Total and LDL-C in adults with homozygous familial hypercholesterolemia, in combination with other lipid-lowering drugs (including LDL-C apheresis) or when these treatments are not available.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients considered to be at high risk of occurrence of a first cardiovascular event (see section on Pharmacodynamic properties ), in combination with corrective treatments for other risk factors.

Dosage ATORVASTATIN EG 80 mg Film-coated tablet Box of 30

Dosage

Before starting therapy with ATORVASTATIN EG, the patient should follow a standard cholesterol-lowering diet; this regimen should be continued for the duration of treatment with ATORVASTATIN EG.

The dosage should be adjusted individually based on the initial LDL-C level, the therapeutic goal and the patient's response to treatment.

The usual starting dose is 10 mg once a day. Dosage adjustment should be performed within a minimum interval of 4 weeks. The maximum dosage is 80 mg once a day.

Primary hypercholesterolemia and combined (mixed) hyperlipidemia

A single dose of 10 mg ATORVASTATIN EG is sufficient in the majority of patients. A therapeutic effect is observed after two weeks of treatment, the maximum effect being reached after 4 weeks of treatment. The effect is maintained in case of prolonged treatment.

Heterozygous familial hypercholesterolemia

Treatment will be started with a daily dose of 10 mg ATORVASTATIN EG. The dosage will then be individually adjusted every 4 weeks to 40 mg per day. Thereafter the dose of atorvastatin may be increased up to 80 mg per day. A bile acid chelator may be prescribed in combination with atorvastatin 40 mg daily.

Homozygous familial hypercholesterolemia

The available data are limited (see section on Pharmacodynamic properties )

In patients with homozygous familial hypercholesterolemia, the dose of atorvastatin is between 10 and 80 mg per day (see section 5.1 ). In these patients, atorvastatin should be used in combination with other lipid-lowering drugs (including LDL-C apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dosage used was 10 mg per day. An increase in dosage may be necessary to achieve the LDL-C level set by current guidelines.

Renal failure

No dose adjustment is required in patients with renal impairment (see Warnings and Precautions ).

Hepatic insufficiency

ATORVASTATIN EG should be used with caution in patients with hepatic impairment (see Warnings and Precautions and Pharmacokinetic Properties sections). ATORVASTATIN EG is contraindicated in patients with active liver disease (see section 4.3 ).

Elderly patients

In patients over the age of 70 treated at the recommended doses, the efficacy and safety of use are identical to those observed in the general population.

Pediatric population

hypercholesterolemia

Pediatric use should be reserved for physicians experienced in the treatment of pediatric hyperlipidemia and the efficacy of the treatment should be evaluated regularly.

In children aged 10 years or older, the recommended starting dose is atorvastatin 10 mg daily, and may be increased up to 20 mg daily. This dose increase should be based on the response and tolerance of pediatric patients to treatment. The safety data of pediatric patients treated with a dose greater than 20 mg, ie approximately 0.5 mg / kg, are limited.

The experience is limited in patients aged 6 to 10 years (see section 5.1 ). Atorvastatin is not indicated in children under 10 years of age.

Other dosage forms or dosage may be more appropriate for this population.

Administration mode

ATORVASTATIN EG is for the oral route. Atorvastatin will be taken in a single daily dose, regardless of the time of day, during or after meals.

Against indications

ATORVASTATIN EG is contraindicated in patients with:

Hypersensitivity to the active substance or to any of the excipients of this medicinal product.

· Progressive liver disease or a persistent and unexplained increase in serum transaminases greater than 3 times the upper limit of normal (ULN).

· During pregnancy, during breastfeeding, and in women of childbearing potential who do not use reliable contraceptive methods (see section on Pregnancy and breastfeeding ).

Adverse effects Atorvastatin EG

In controlled clinical studies comparing the effect of atorvastatin with placebo in 16066 patients (8755 patients treated with ATORVASTATIN EG, 7311 patients receiving placebo) treated for an average duration of 53 weeks, 5.2% of patients treated by atorvastatin discontinued treatment due to adverse events, compared to 4.0% of patients receiving placebo.

The following adverse reactions observed with atorvastatin are from clinical studies and significant experience gained since product marketing.

The estimated frequencies of adverse reactions are classified according to the following convention: frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10000, <1/1000); very rare (≤ 1/10000).

Infections and infestations

Common: nasopharyngitis

Blood and lymphatic system disorders

Rare: thrombocytopenia.

Immune system disorders

Common: allergic reactions

Very rare: anaphylaxis.

Metabolism and nutrition disorders

Frequent: hyperglycemia.

Uncommon: hypoglycemia, weight gain, anorexia.

Psychiatric disorders

Uncommon: nightmares, insomnia.

Nervous system disorders

Frequent: headache.

Uncommon: dizziness, paresthesia, hypoesthesia, dysgeusia, amnesia.

Rare: peripheral neuropathy.

Eye disorders

Uncommon: blurred vision.

Rare: visual disturbances.

Affections of the ear and labyrinth

Uncommon: tinnitus.

Very rare: hearing loss.

Respiratory, thoracic and mediastinal disorders

Common: pharyngolaryngeal pain, epistaxis.

Gastrointestinal disorders

Common: constipation, flatulence, dyspepsia, nausea, diarrhea

Uncommon: vomiting, upper and lower abdominal pain, belching, pancreatitis.

Hepatobiliary disorders

Uncommon: Hepatitis

Rare: cholestasis.

Very rare: liver failure.

Skin and subcutaneous tissue disorders

Uncommon: urticaria, rash, pruritus, alopecia.

Rare: angioneurotic edema, bullous dermatosis including erythema multiforme, Stevens-Johnson syndrome and Lyell syndrome.

Musculoskeletal and connective tissue disorders

Common: myalgia, arthralgia, extremity pain, muscle spasm, joint swelling, back pain.

Uncommon: cervical pain, muscle fatigue.

Rare: myopathy, myositis, rhabdomyolysis, tendinopathy, sometimes complicated by rupture.

Disorders of reproductive organs and breast

Very rare: gynecomastia.

General disorders and administration site conditions

Uncommon: malaise, asthenia, chest pain, peripheral edema, fatigue, pyrexia.

investigations

Frequent: abnormal liver function tests, increased blood levels of creatine phosphokinase.

Uncommon: leukocyturia.

As with other HMG-CoA reductase inhibitors, increases in serum transaminase levels have been reported in patients receiving ATORVASTATIN EG. These changes were usually mild and transient and did not necessitate discontinuation of treatment.

Clinically significant increases (> 3 times the upper limit of normal) in serum transaminase levels were observed in 0.8% of patients treated with ATORVASTATIN EG. These increases were dose-dependent and reversible in all patients.

An increase in serum creatine phosphokinase (CPK) by more than three times the upper limit of normal was observed in 2.5% of patients receiving ATORVASTATIN EG, a proportion similar to that seen with other HMG inhibitors -CoA reductase in clinical studies.

Serum levels greater than 10 times the upper limit of normal were observed in 0.4% of patients treated with ATORVASTATIN EG (see Warnings and Precautions ).

Pediatric population

The clinical pharmacovigilance database includes safety data for 249 pediatric patients who received atorvastatin, of which 7 patients were under 6 years of age, 14 patients were in the 6 to 9 year age group, and 228 patients were in an age range of 10 to 17 years.

Nervous system disorders

Frequent: headache.

Gastrointestinal disorders

Common: abdominal pain

investigations

Frequent: increased alanine aminotransferase, increased creatine blood phosphokinase.

On the basis of available data, the frequency, type and severity of adverse reactions in children are expected to be identical to those in adults. Experience with long-term safety in the pediatric population is currently limited.

The following adverse events have been reported with some statins:

· Sexual disorders.

· Depression.

· Exceptional cases of interstitial lung disease, especially during long-term treatment (see Warnings and Precautions section ).

Diabetes: The frequency depends on the presence or absence of risk factors (fasting glucose ³ 5.6 mmol / l, BMI> 30 kg / m², increased triglyceride levels, history of hypertension).

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