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Normon S.A. - Sapin

ANASTROZOLE NORMON
BISOPROLOL NORMON
DESLORATIDINE NORMON
ESCITALOPRAM NORMON
ESOMEPRAZOLE NORMON
ESTECINA Inj.
ESTECINA Tablets
FIXIM
GASTRIMUT
LAMOTRIGINE NORMON
LETROZOLE NORMON
LEVOFLOXACIN NORMON
LIDOCAINE 2% EPINEPHRINE NORMON
NORMOCEF
NORMOPRIL
PARACETAMOL NORMON
SIMVASTATIN NORMON
TOPAGAN

Forms and presentation
Simvastatin Normon 10 mg: Coated tablets: Box of 28.
Simvastatin Normon 20 mg: Coated tablets: Box of 28.
Simvastatin Normon 40 mg: Coated tablets: Box of 28.

Composition
Simvastatin Normon 10 mg: Each tablet contains: Simvastatin: 10 mg. Excipients: pregelatinized corn starch, microcrystalline cellulose, monohydrate lac¬tose, butylhydroxyanisol, magnesium stearate, ascorbic acid, anhydrous citric acid, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide, talc, macrogol 6000.
Simvastatin Normon 20 mg: Each tablet contains: Simvastatin: 20 mg. Excipients: pregelatinized corn starch, microcrystalline cellulose, monohydrate lac¬tose, butylhydroxyanisol, magnesium stearate, ascorbic acid, anhydrous citric acid, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide, talc, macrogol 6000.
Simvastatin Normon 40 mg: Each tablet contains: Simvastatin: 40 mg. Excipients: pregelatinized corn starch, microcrystalline cellulose, monohydrate lac¬tose, butylhydroxyanisol, magnesium stearate, ascorbic acid, anhydrous citric acid, hypromellose, titanium dioxide, yellow iron oxide, red iron oxide, talc, macrogol 6000.

Properties
Simvastatin belongs to the family of drugs called hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors. Simvastatin decreases LDL blood cholesterol level and the level of triglycerides, and it increases the level of HDL cholesterol.

Indications
Simvastatin Normon is indicated in: treating coronary cardiopathy and/or hyperlipidemia.

Contraindications
Hypersensitivity to any of its components, hepatic disease or high transaminases levels, combination with mibefradil, pregnancy or breast-feeding.

Precautions
As Simvastatin Normon contains butylhydroxyanisol as an excipient, it may irritate the eyes, skin and mucosae.
Caution must be exercised in case of significant consumption of alcohol and history of hepatic disease.
Foods and beverages: Grapefruit juice contains a CYP3A4-inhibiting component, therefore the amount of blood Simvastatin increases if taken simultaneously with grapefruit juice. It is not recommended to drink grapefruit juice while undergoing treatment with Simvastatin.

Drug interactions
The following medicines may increase blood Simvastatin levels and favor the occurrence of muscle alterations: cyclosporine, mibefradil, antifungal agents (such as itraconazole or ketoconazole), HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir and saquinavir), fibric acid derivatives (such as bezafibrate, fenofibrate and gemfibrocil), macrolide antibiotics (such as erythromycin and clarithromycin), the nefazodone antidepressant, high doses (more than 1 g/day) of niacin or nicotinic acid.
Simvastatin may cause a slight increase of blood digoxin levels in case of concomitant treatment .
Taking Simvastatin along with oral anticoagulants, such as warfarin, fenprocoumon or acenocumarol, enhances the anticoagulating effect and increases the risk of bleeding. Therefore, the dose of these medicines must be adjusted before and at the start of treatment with Simvastatin.

Ability to drive and use machine
At recommended doses, this medicinal product has no effect on the ability to drive or handle heavy machinery.

Pregnancy and lactation
Pregnancy: Women of child-bearing age must take Simvastatin Normon only when it is very unlikely that they will become pregnant. In case of pregnancy, treatment with Simvastatin Normon must be immediately interrupted.
Lactation: Women taking Simvastatin Normon must not breast-feed.

Side effects
Like all medicinal products, Simvastatin Normon can have side effects.
In the majority of cases, the adverse reactions caused by Simvastatin have been slight and short-lasting. More frequent adverse reactions (occurring in > 1% and < 10% of patients) are digestive disorders, diarrhea, abdominal pain, constipation and flatulence. Weakness and headache are less frequent (occurring in > 0.1% and < 1% of patients). Even less common (occurring in > 0.01% and < 0.1% of patients) are pain, sensitivity to pressure or muscle weakness, hepatic problems and hypersensitivity reactions (allergic reactions which can have different symptoms, joint pain, fever or breathing problems included).
Other adverse reactions can also rarely occur, some of which can be severe. These can be: rhabdomyolysis, hepatitis, jaundice, hypersensitivity reactions, polymyalgia rheumatica, vasculitis, blood-platelet decrease, blood eosinophil increase, sedimentation rate increase, arthritis, isolated joint pains, urticaria, photosensitivity, fever, breathing problem, and general discomfort.

Dosage and administration
To facilitate the ingestion of the tablet, take it with a glass of water.
Adults: It is necessary to support the treatment with a suitable diet. The usual initial dose is 10 mg or 20 mg daily, administered as a single dose in the evening. Some patients with slight to moderate hypercholesterolemia can be treated with an initial dose of 5 mg. The doctor can adjust the dose up to a maximum of 80 mg/day, administered as a single dose in the evening or divided in 3 administrations, 20 mg in the morning, 20 mg in the afternoon, and 40 mg in the evening.
The doctor can prescribe lower doses, especially in combination with cyclosporine, niacin, fibrates, or bile acid sequestering resins or in case of certain renal disorders.
Children: The use in children is not recommended.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Number & Year of Registration 
10 mg: 194917/2005
20 mg: 194916/2005
40 mg: 194915/2005