Medicinal Products

ATORVASTATIN BGR 40 mg

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

Divisible coated tablet
Box of 90
All forms

Indication

hypercholesterolemia

ATORVASTATIN BGR is indicated as an adjunct to a diet adapted to lowering the levels of total (C-total), LDL-cholesterol (LDL-C), apolipoprotein B and triglyceride levels in adults, adolescents and children 10 years of age or older with primary hypercholesterolemia, including heterozygous familial hypercholesterolemia or mixed hyperlipidemia (corresponding to Fredrikson Type IIa and IIb), when response to diet and other non-pharmacologic measures is inadequate.

ATORVASTATIN BGR is also indicated for the reduction of total cholesterol and LDL-C in adults with homozygous familial hypercholesterolemia in addition to other lipid-lowering drugs (including LDL apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients considered to be at high risk of occurrence of the first cardiovascular event (see section on Pharmacodynamic properties ), in addition to the correction of other risk factors.

Dosage ATORVASTATIN BGR 40 mg scored film tablet Box of 90

Dosage

Before starting treatment with ATORVASTATIN BGR, the patient should follow a standard cholesterol-lowering diet. This regimen will then be continued for the duration of treatment with ATORVASTATIN BGR.

The dosage should be adjusted individually based on the initial LDL-C levels, 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

Atorvastatin 10 mg once is sufficient in most 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 with ATORVASTATIN BGR should begin at a dose of 10 mg daily. The dose will then be individually adjusted every four weeks to 40 mg daily. Thereafter, the dosage may be increased up to 80 mg per day maximum. A bile acid chelator may also be prescribed in combination with a dose of 40 mg of atorvastatin per day.

Homozygous familial hypercholesterolemia

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

In patients with homozygous familial hypercholesterolemia, the dose of atorvastatin ranges from 10 to 80 mg per day (see section 5.1 ). In these patients, atorvastatin should be administered in addition to other lipid-lowering drugs (including LDL-cholesterol apheresis) or when such treatments are not available.

Prevention of cardiovascular diseases

In primary prevention studies, the dosage used was 10 mg / day. A higher dosage may be required to achieve the LDL-C targets set by the current recommendations.

Renal failure

No dose adjustment is required (see Warnings and Precautions ).

Hepatic insufficiency

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

Use in the elderly

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

Pediatric use

Hypercholesterolemia:

Pediatric use should only be performed by physicians experienced in the treatment of pediatric hyperlipidemia and patients should be monitored regularly to assess progress.

For patients aged 10 years or older, the recommended starting dose of atorvastatin is 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 children aged 6 to 10 years (see section 5.1 ). Atorvastatin is not indicated for the treatment of patients under 10 years of age. Other dosage forms / dosages may be more appropriate for this population.

Administration mode

ATORVASTATIN BGR is intended for oral use. Atorvastatin will be taken as a single daily dose regardless of the time of day, during or after meals.

Against indications

ATORVASTATIN BGR is contraindicated in patients:

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

· Have active liver disease or persistent and unexplained elevations of serum transaminases greater than three times the upper limit of normal.

· In pregnant, lactating or child-bearing women who are not using reliable contraceptive methods (see section Pregnancy and breast-feeding ).

Atorvastatin Bgr side effects

Controlled clinical studies comparing the effect of atorvastatin to placebo in 16, 066 patients (8755 atorvastatin-treated patients, 7311 placebo-treated patients) treated for an average of 53 weeks, 5.2% of patients atorvastatin were discontinued 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. These changes were usually mild and transient and did not necessitate discontinuation of treatment. Clinically significant increases (> 3 times the ULN) of serum transaminase levels were observed in 0.8% of patients treated with atorvastatin. These increases were dose-dependent and reversible in all patients.

Increased serum creatine phosphokinase (CPK) levels by more than three times the ULN was observed in 2.5% of atorvastatin patients, a proportion similar to that seen with other HMG-CoA reductase inhibitors. clinical studies. Serum levels greater than 10 times the upper limit of normal were observed in 0.4% of atorvastatin-treated patients (see Warnings and Precautions section ).

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 ).

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.

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