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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 tablet. Box of 20.

Composition
Each tablet contains: Desloratadine: 5 mg.
Excipients: anhydrous lactose, microcrystalline cellulose, anhydrous hydrogen phosphate calcium, low- substituted hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica, hypromellose, titanium dioxide, talc,  indigo carmin lake, macrogol 6000.

Indications
Desloratadine Normon relieves symptoms associated with allergic rhinitis.
Desloratadine Normon is also used to relieve the symptoms associated with urticaria. Relief of these symptoms lasts a full day and helps resume a normal daily activities and sleep.
Desloratadine Normon is indicated for adults and adolescents (12 years old and older).

Contraindications
Hypersensitivity to desloratadine, to loratadine or to any of the excipients.

Precautions
Caution is advised in patients with impaired renal function.
Desloratadine 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.

Ability to drive and use machine
At the recommended dose, Desloratadine Normon is not expected to cause impairment of alertness. However, very rarely some people experience drowsiness, which may affect their ability to drive or use machines.

Pregnancy and lactation
Pregnancy: The use of Desloratadine Normon during pregnancy is not recommended.
Lactation: The use of Desloratadine Normon in nursing women is not recommended.

Side effects
In adults, side effects were reported at same frequency as with placebo. However, fatigue, dry mouth and headache were reported more often than with placebo.
In adolescents, headache was the most commonly reported side effect.
During the marketing of Desloratadine Normon, cases of severe allergic reactions (dyspnoea, wheezing, pruritus, urticaria and anaphylaxis) and rash have been reported very rarely. Cases of palpitations, tachycardia, abdominal pain, nausea, vomiting, dyspepsia, diarrhoea, dizziness, somnolence, insomnia, myalgia, hallucinations, seizures, restlessness with psychomotor hyperactivity, hepatitis and abnormal liver function tests have also been reported very rarely.

Dosage and administration
Swallow the tablet whole with water. Desloratadine Normon may be taken with or without a meal.
Adults and adolescents (12 years of age and older): take 1 tablet once a day.

Overdosage
No serious problems are expected with accidental overdose.

Storage conditions
Store in the original package in order to protect from light and moisture. Store below 30°C. Protect from humidity.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Year of submission: 2013
Number & Year of Registration: 187344/2014