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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
Film-coated tablets: Box of 28.

Composition
Each tablet contains: Anastrozole: 1 mg.
Excipients: lactose monohydrate, povidone, sodium starch glycolate (of potato gluten-free) and magnesium stearate.

Properties
Aromatase inhibitors.

Indications
Anastrozole Normon is used to treat breast cancer in post-menopausal women.

Contraindications
Hypersensitivity to anastrozole or any other component. Pre-menopausal women. Pregnant or breast-feeding women. Severe liver or kidneys disorders. Current use or tamoxifen or hormone replacement therapy.

Precautions
Anastrozole is not indicated for women before menopause or for children.
Anastrozole lowers circulating estrogen levels, and this can produce a reduction in bone mineral density with a possible consequent increased risk of fracture.
No specific studies have been carried out on the combination of LHRH analogues and anastrozole. Therefore, anastrozole and LHRH analogues should not be used in combination.
Anastrozole tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Athletes are informed that this drug contains a component that could give positive results in a drug test.

Drug interactions
Anastrozole may interact with tamoxifen, drugs that contain oestrogens (hormone replacement therapy). These drugs may reduce the effect of anastrozole. These drugs should not be used in combination.
Food and drink do not affect anastrozole.

Ability to drive and use machine
Anastrozole is unlikely to sidely affect the capacity to drive a car or handle machinery. However, weakness or tiredness may occasionally occur, in this case, patients should not drive or handle tools or machines.

Pregnancy and lactation
Anastrozole should not be used during pregnancy and breastfeeding. Anastrozole is used only to treat breast cancer in post-menopausal women.

Side effects

Immune system disorders:

Very rare: severe anaphylactic reactions, angioedema, Stevens-Johnson syndrome, urticaria.

Metabolic and nutritional disorders:

Infrequent: loss of appetite, high cholesterol levels.

Nervous system disorders:

Frequent: headache and carpal tunnel syndrome.

Infrequent: somnolence.

Vascular disorders:

Very frequent: hot flushes.

Very rare: Venous thromboembolic events, deep vein thrombosis (DVT) or pulmonary embolism.

Gastrointestinal disorders:

Frequent: nausea, diarrhoea.

Infrequent: vomiting.

Skin and subcutaneous tissue disorders:

Frequent: weakened hair, rash.

Very rare: erythema multiforme.

Musculoskeletal and connective tissue disorders:

Frequent: joint pain or rigidity, bone fractures.

Disorders of the reproductive system and the breast:

Frequent: dryness of the vagina.

Infrequent: vaginal bleeding (normally in the 1st weeks of treatment).

General disorders and alterations at the administration site:

Frequent: weakness, mood alterations.

 
Dosage and administration
The normal dose is one tablet (1 mg of anastrozole once a day).
 
Storage conditions
Store below 30°C and protect from humidity.