Medicinal Products

ELISOR 40 mg

Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Pravastatin
laboratory: Bristol Myers Squibb

Tablet breackable
Box of 50
All forms

Indication

hypercholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in addition to diet, when the response to diet and other non-pharmacological treatments (eg, exercise, weight loss) is insufficient.

Primary prevention

Reduced cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia who are at high risk of a first cardiovascular event, in addition to diet (see section 5.1 ).

Secondary prevention

Reduced cardiovascular mortality and morbidity in patients with a history of unstable myocardial infarction or angina pectoris and normal or high cholesterol levels, in addition to the correction of other risk factors (see section 5.1 ). .

Posttransplant

Reduction of post-transplantation hyperlipidemia in patients receiving immunosuppressive therapy following organ transplantation (see sections Posology and method of administration, Interaction with other medicinal products and other forms of interaction and Pharmacodynamic properties ).

Dosage ELISOR 40 mg scored tablet Box of 50

Before initiating ELISOR therapy, any secondary cause of hypercholesterolemia should be eliminated and patients should be on a standard cholesterol-lowering diet that should be continued for the duration of the treatment.

ELISOR is administered orally once a day, preferably in the evening, during or after meals.

Hypercholesterolemia : the recommended dose is 10 to 40 mg once a day. The therapeutic response is observed one week after the start of treatment and the maximum effect of a given dose after four weeks. As a result, periodic lipid profiles must be performed and the dosage adjusted accordingly. The maximum daily dose is 40 mg.

Cardiovascular prevention : In all morbidity and mortality prevention studies, the only initial and maintenance dose studied was 40 mg daily.

Posology after transplantation : Following organ transplantation, the recommended starting dose for patients receiving immunosuppressive therapy (see section 5.2 ) is 20 mg daily. Depending on the response on lipid parameters, the dosage may be increased to 40 mg under strict medical supervision (see section Interactions with other medicinal products and other forms of interaction ).

Children and adolescents (8-18 years old) with heterozygous familial hypercholesterolemia : the recommended dose is 10 to 20 mg once daily at 8 to 13 years, doses greater than 20 mg have not been studied in this population; and 10 to 40 mg daily between 14 and 18 years of age (for girls and adolescents of childbearing age, see section Pregnancy and lactation, for the results of the study, see section 5.1 ).

Elderly patients : no dosage adjustment is necessary in these patients unless they have predisposing risk factors (see Warnings and Precautions ) section.

Renal or hepatic impairment : An initial dose of 10 mg daily is recommended in patients with moderate or severe renal impairment or significant hepatic impairment. The dosage should be adjusted under medical supervision according to the response on lipid parameters.

Concomitant Therapies: The lipid-lowering effects of ELISOR on total cholesterol and LDL-cholesterol are increased when combined with a bile acid chelating resin (eg, cholestyramine, colestipol). ELISOR should be administered one hour before or at least four hours after the resin (see section 4.5).

For patients taking ciclosporin, whether or not combined with other immunosuppressants, treatment should be initiated with pravastatin 20 mg once daily and a 40 mg increase should be made with caution (see section Interactions with other medicinal products). drugs and other forms of interaction ).

Against indications

· Hypersensitivity to pravastatin or to any of the constituents of the medication

· Active liver disease, including prolonged and unexplained elevations of serum transaminase levels beyond 3 times the upper limit of normal (> 3 N) (see Warnings and Precautions ) section.

· Pregnancy and lactation (see section Pregnancy and breast-feeding ).

Adverse effects Elisor

The frequencies of adverse events are classified as follows: very common (≥ 1/10); frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000).

Clinical Trials: ELISOR was studied at a dose of 40 mg in seven randomized, double-blind, placebo-controlled studies involving more than 21, 000 patients treated with pravastatin (N = 10, 764) or placebo (N = 10, 719). ), representing more than 47, 000 patient-years of exposure to pravastatin. More than 19, 000 patients were followed for a median of 4.8 to 5.9 years.

The following adverse events have been reported; none were observed at 0.3% higher in the pravastatin group compared to the placebo group.

Nervous system disorders:

Uncommon: dizziness, headache, trouble sleeping, insomnia.

Eye disorders:

Uncommon: impaired vision (including blurred vision and diplopia)

Gastrointestinal disorders:

Uncommon: dyspepsia / heartburn, abdominal pain, nausea / vomiting, constipation, diarrhea, flatulence.

Skin and subcutaneous disorders:

Uncommon: pruritus, rash, urticaria, hair and scalp problems (including alopecia).

Renal and urinary disorders:

Uncommon: abnormal urination (especially dysuria, frequency, nocturia).

Disorders of the reproductive organs and breast:

Uncommon: sexual disorders.

General disorders:

Uncommon: tiredness

Events of particular clinical interest

Skeletal muscles:

Effects on skeletal muscle, for example, musculoskeletal pain, including arthralgia, muscle cramps, myalgia, muscle weakness and elevated CPK levels have been reported in clinical studies. In the CARE, WOSCOPS and LIPID studies, the percentage of myalgia (1.4% with pravastatin versus 1.4% with placebo), muscle weakness (0.1% with pravastatin versus 3 N and> 10 N, 6% with pravastatin versus 1.6% with placebo and 1.0% with pravastatin versus 1.0% with placebo, respectively) was similar to placebo (see Warnings and Precautions ).

Hepatic effects:

Elevations of serum transaminases have been reported. In the three long-term, placebo-controlled studies CARE, WOSCOPS and LIPID, the frequency of marked ALT and ASAT abnormalities (> 3 N) was similar in both treatment groups (= 1.2 %).

Since the placing on the market

In addition to the events listed above, the following adverse events have been reported since the introduction of pravastatin:

Nervous system disorders:

Very rare: peripheral polyneuropathy, especially in case of prolonged use, paresthesia.

Immune system disorders:

Very rare: hypersensitivity reactions: anaphylaxis, angioedema, pseudo-lupus erythematous syndrome.

Gastrointestinal disorders:

Very rare: pancreatitis.

Hepatobiliary disorders:

Very rare: jaundice, hepatitis, fulminant hepatic necrosis.

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis, which may be associated with acute renal failure secondary to myoglobinuria, muscle involvement (see Warnings and Precautions ), myositis, polymyositis.

Isolated cases of tendinous problems, sometimes complicated by rupture.

The following side effects have been reported with the class of statins:

· Nightmare,

· memory loss,

· Depression,

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

· Diabetes: the frequency depends on the presence or absence of risk factors (fasting blood glucose ³ 5.6 mmol / l, BMI> 30 kg / m², increase in triglyceride levels, 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. Healthcare 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

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