Medicinal Products

ATORVASTATIN ARROW 40 mg film-coated tablet box of 30 film-coated tablets

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

Film-coated tablet
All forms

Indication

© Hypercholestà Rola © mie

Atorvastatin is indicated in addition to a diet adapted to decrease high levels of total cholesterol (C-total), LDL cholesterol (LDL-C)., apolipoprotein B and triglycerides, in adults, adolescents, and children over 10 years of age who have a primary heterozygous familial hypercholesterolemia or a combination hyperlipidemia ( mixed) (type IIA, IIb according to Fredrickson's classification), when the response to diet alone and other non-pharmacological measures is inadequate.

Atorvastatin is also indicated to decrease total cholesterol and LDL-C levels in adults with homozygous familial hypercholesterolemia, in combination with other lipid-lowering therapies ( including LDL pathway) or when these treatments are not available.

Prevention of cardiovascular disease

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 of other risk factors.

Dosage ATORVASTATIN ARROW 40 mg film-coated box of 30 film-coated tablets

© Hypercholestà Rola © mie

Atorvastatin is indicated in addition to a diet adapted to decrease high levels of total cholesterol (C-total), LDL cholesterol (LDL-C)., apolipoprotein B and triglycerides, in adults, adolescents, and children over 10 years of age who have a primary heterozygous familial hypercholesterolemia or a combination hyperlipidemia ( mixed) (type IIA, IIb according to Fredrickson's classification), when the response to diet alone and other non-pharmacological measures is inadequate.

Atorvastatin is also indicated to decrease total cholesterol and LDL-C levels in adults with homozygous familial hypercholesterolemia, in combination with other lipid-lowering therapies ( including LDL pathway) or when these treatments are not available.

Prevention of cardiovascular disease

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 of other risk factors.

Against indications

Atorvastatin is contraindicated in patients with:

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

 · an invasive hepatic condition or a persistent and unexplained increase in serum transaminases greater than 3 times the upper limit of normal.

· During pregnancy, during breastfeeding and in women of reproductive age who do not use reliable contraceptive methods (see section Pregnancy and breast-feeding ).

Side effects Atorvastatin Arrow

In controlled clinical trials comparing the effect of atorvastatin to placebo in 16, 066 patients (8755 patients treated with atorvastatin versus 7311 patients receiving placebo) treated for an average duration At 53 weeks, 5.2% of patients treated with atorvastatin discontinued treatment due to adverse effects, compared with 4.0% of patients receiving placebo.

The following adverse effects observed with atorvastatin are the result of clinical studies and the significant post-marketing experience with the molecule.

The estimated frequencies of the events are classified according to the following convention: Frequent (³ 1 / 100, <1/10); not very frequent (³ 1 / 1, 000, <1/100); rare (³ 1 / 10, 000, <1/1000); very rare (£ 1 / 10, 000).

Infections and infestations

Frequent: nasopharyngitis.

Hematologic and lymphatic system disorders

Rare: thrombocytopenia.

Immune system disorders

Frequent: allergic reactions.

Very rare: anaphylaxis.

Metabolism and nutrition disorders

Frequent: hyperglycemia.

Uncommon: hypoglycaemia, weight gain, anorexia.

Psychiatric disorders

Not very common: insomnia, nightmares.

Nervous system disorders

Frequent: cephalated.

Not very frequent: vertigo, paresthesia, hypoesthesia, amnesia, dysgeusia.

Rare: Peripheral neuropathy.

Eye disorders

Not very frequent: blurred vision.

Rare: visual disturbances.

Affections of the ear and labyrinth

Not very common: tinnitus.

Very rare: hearing loss.

Respiratory, thoracic and mediastinal disorders

Frequent: pharyngolaryngeal pain, epistaxis.

Gastrointestinal disorders

Frequent: constipation, flatulence, dyspepsia, nausea, diarrhea.

Not very common: high and low abdominal pain, eruption, vomiting, pancreatitis.

Hereditary conditions

Not very frequent: hepatitis.

Rare: cholestasis.

Very rare: hepatic insufficiency.

Skin and subcutaneous tissue disorders

Uncommon: hives, skin rash, pruritus, alopecia.

Rare: angioneurotic edema, bullous dermatitis including polymorphic rheumatism, Stevens-Johnson syndrome, and Lyell's syndrome.

Musculoskeletal and connective tissue disorders

Frequent: myalgia, arthralgia, extremity pain, muscle spasms, joint swelling, back pain.

Not very common: neck pain, muscle fatigue.

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

Disorders of reproductive organs and breast

Very rare: gynecomasty.

General disorders and administration site abnormalities

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

investigations

Frequent: abnormalities of functional explorations hepatic, increased blood levels of creatine phosphokinase.

Not very common: leucocyturia.

As with other HMG-CoA reductase inhibitors, increases in serum transaminase levels have been reported in patients receiving atorvastatin. These changes have generally been mild and transient and do not require treatment interruption. Clinically significant increases (> 3 times the upper limit of normal) in serum transaminase levels occurred in 0.8% of patients receiving atorvastatin. These increases were dose-dependent and reversible in all patients.

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

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. years, 14 patients were in an age range of 6 to 9 years, and 228 patients were in a age range of 10 to 17 years.

Nervous system disorders

Frequent: cephalated.

Gastrointestinal disorders

Frequent: abdominal pain.

investigations

Frequent: increased alanine aminotransferase levels, increased blood levels of blood phosphokinase creatine.

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

The following undesirable effects have been reported with some statins:

· Sexual disorders.

 · Depression.

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

ANSM alert of 12/05/2015:

Musculoskeletal disorders: Not known: necrotizing myopathy, autoimmune mediated (see section 4.4)

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