Medicinal Products

ATORVASTATIN RANBAXY 10 mg

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

Coated tablet
box of 30
All forms

Indication

hypercholesterolemia

ATORVASTATIN RANBAXY is indicated as a supplement to reduce high levels of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults, adolescents, and children 10 years of age and older with primary hypercholesterolemia. Familial hypercholesterolemia (heterozygote) or mixed hyperlipidemias (corresponding to Fredrickson's Types IIa and IIb), when response to a diet or other non-pharmacological treatments is not sufficient.

ATORVASTATIN RANBAXY is also indicated for the reduction of total cholesterol and LDL-C in adults with homozygous familial hypercholesterolemia, in addition to other lipid-lowering treatments (eg LDL apheresis) or if such treatments are unavailable. .

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients with a high risk of having a first cardiovascular event (see section on Pharmacodynamic properties ), in addition to the correction of other risk factors.

Dosage ATORVASTATIN RANBAXY 10 mg film-coated tablet box of 30

hypercholesterolemia

ATORVASTATIN RANBAXY is indicated as a supplement to reduce high levels of total cholesterol, LDL-cholesterol, apolipoprotein B and triglycerides in adults, adolescents, and children 10 years of age and older with primary hypercholesterolemia. Familial hypercholesterolemia (heterozygote) or mixed hyperlipidemias (corresponding to Fredrickson's Types IIa and IIb), when response to a diet or other non-pharmacological treatments is not sufficient.

ATORVASTATIN RANBAXY is also indicated for the reduction of total cholesterol and LDL-C in adults with homozygous familial hypercholesterolemia, in addition to other lipid-lowering treatments (eg LDL apheresis) or if such treatments are unavailable. .

Prevention of cardiovascular diseases

Prevention of cardiovascular events in patients with a high risk of having a first cardiovascular event (see section on Pharmacodynamic properties ), in addition to the correction of other risk factors.

Against indications

ATORVASTATIN RANBAXY is contraindicated in patients:

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

· Have active liver disease or have persistent and unexplained increases in serum transaminases greater than 3 times the upper limit of normal,

Pregnant, breastfeeding or child-bearing women who do not use a reliable method of contraception (see section Pregnancy and breast-feeding ).

Atorvastatin Ranbaxy side effects

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

The following adverse reactions observed with atorvastatin are based on clinical studies and the significant experience gained since the commercialization of the molecule.

The estimated frequency of these effects is established according to the following convention: very frequent (≥ 1/10), frequent (≥ 1/100, <1/10); uncommon (≥ 1 / 1, 000, <1/100); rare (≥ 1 / 10, 000, <1 / 1, 000); very rare (≤ 1 / 10, 000).

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: hypoglycaemia, 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.

Hearing and auditory canal disorders:

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.

Dermatological and subcutaneous disorders:

Uncommon: urticaria, rash, pruritus, alopecia.

Rare: angioneurotic edema, dermatitis herpetiformis including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders:

Common: myalgia, arthralgia, extremity pain, muscle spasm, swelling of the joints, back pain.

Uncommon: neck pain, muscle fatigue.

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

Reproductive system and breast disorders:

Very rare: gynecomastia.

General disorders and administration site:

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 generally mild, 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. 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 atorvastatin patients, a proportion similar to that seen with other HMG-2 inhibitors. CoA reductase in 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 ).

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 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:

Common: Increased alanine aminotransferase, increased blood creatine 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 ).

· Non-insulin dependent diabetes: The frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol / l, BMI> 30kg / m2, increased triglycerides, history of hypertension).

Reporting of suspected adverse reactions

The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

ANSM alert of 12/05/2015:

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

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