Tel: 961 4 930252 - Email: info@pheniciagroup.com

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 30.

Composition
Each tablet contains: Letrozole: 2.5 mg.
Excipients: lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (of potato), talc, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose, cotton seed oil, iron oxide yellow, iron oxide red, titanium dioxide.

Properties
Aromatase inhibitors.

Indications
Treatment of postmenopausal women with invasive early breast cancer.
Treatment of hormone-dependent invasive breast cancer in postmenopausal women who have received prior standard adjuvant tamoxifen therapy for 5 years.
First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer.
Treatment of advanced breast cancer after relapse or disease progression, in postmenopausal women.
Letrozole Normon should only be used in case of oestrogen-receptor positive breast cancer and only in postmenopausal women.

Contraindications
Hypersensitivity to letrozole or to any of the excipients. Premenopausal endocrine status. Pregnancy and breast-feeding.

Precautions
Letrozole should only be taken under strict medical control.
Due to the reduction in oestrogens in the body, letrozole can produce osteoporosis. Bone mineral density should be assessed before, during and after treatment.
Caution is advised in women suffering from severe kidney or liver disease and in women with a history of osteoporosis and/or fractures.
Athletes are informed that this drug contains a component that could give positive results in a drugs test.
Letrozole Normon contains lactose. It is not recommended for patients with rare hereditary problems of galactose intolerance, of severe lactase deficiency or of glucose-galactose malabsorption.
Children and adolescents (under 18 years of age): Letrozole Normon is not used in children and adolescents.
Elderly patients (over 65 years of age): Letrozole Normon can be used by people over 65 years of age at the same dose as for other adults.

Ability to drive and use machine
Caution is advised when driving or using machines if fatigue and dizziness is observed.

Pregnancy and lactation
Letrozole Normon is contraindicated during pregnancy and breast-feeding. Letrozole is only recommended in post-menopausal women.

Side effects
Most of the side effects are mild to moderate and will generally disappear after a few days or weeks of treatment. Some side effects, such as hot flushes, hair loss or vaginal bleeding may be due to the lack of oestrogens.
Very common: Hot flushes. Fatigue. Increased sweating. Arthralgia.
Common: Skin Rash. Headache. Dizziness. Malaise. Gastrointestinal disorders (nausea, vomiting, indigestion, constipation, diarrhoea). Increase or decrease in appetite. Muscle pain, osteoporosis. Oedema. Depression. Weight increase. Hair loss.
Uncommon: Anxiety, nervousness, irritability, memory problems, somnolence, insomnia. Dysaesthesia (including paraesthesia, hypoaesthesia). Eye disorders, such as blurred vision, eye irritation. Palpitations, tachycardia, hypertension. Urticaria or dry skin. Vaginal disorders such as bleeding, discharges or dryness. Abdominal pain. Arthritis. Breast pain. Fever. Thirst, taste disorders, dry mouth. Dryness of the mucous membranes. Weight decrease. Urinary tract infection, increased urinary frequency. Cough. Hypercholesterolemia or increased liver enzyme levels.
Rare: Stroke. Angina. Thromboembolic events. Thrombophlebitis. Leukopenia. Severe or continuous blurred vision.

Dosage and administration
The usual dose is one tablet of Letrozole Normon is to be taken once a day, at the same time each day. Take the tablet whole with a glass of water.

Storage conditions
Store below 30°C. Store in its original package to protect from humidity.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Registration Number: 36514/2014