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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
Escitalopram Normon 10mg: Film-coated Tablets: Box of 28.
Escitalopram Normon 15mg: Film-coated Tablets: Box of 28.
Escitalopram Normon 20mg: Film-coated Tablets: Box of 28.

Composition
Escitalopram Normon 10mg: Each tablet contains: Escitalopram oxalate: 10 mg. Excipients: microcrystalline cellulose, colloidal silica, sodium croscarmellose, hypromellose, magnesium stearate, titanium dioxide, macrogol 6000 and talc.
Escitalopram Normon 15mg: Each tablet contains: Escitalopram oxalate: 15 mg. Excipients: microcrystalline cellulose, colloidal silica, sodium croscarmellose, hypromellose, magnesium stearate, titanium dioxide, macrogol 6000 and talc.
Escitalopram Normon 20mg: Each tablet contains: Escitalopram oxalate: 20 mg. Excipients: microcrystalline cellulose, colloidal silica, sodium croscarmellose, hypromellose, magnesium stearate, titanium dioxide, macrogol 6000 and talc.

Properties
Escitalopram belongs to the group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medications act on the brain serotonergic system, increasing serotonin levels. Serotonergic system disorders are considered to be a major factor in the development of depression and related diseases.

Indications
Escitalopram Normon is indicated for the treatment of major depressive episodes and anxiety disorders with or without agoraphobia, social anxiety disorder, generalised anxiety disorder and obsessive-compulsive disorder.

Contraindications
Hypersensitivity to escitalopram or any of the other ingredients of Escitalopram Normon.
Concomitant treatment with MAO inhibitors, including selegilin, moclobemide, and linezolid.
Patients with known QT interval prolongation or congenital long QT syndrome. Concomitant treatment with with medicinal products that are known to prolong the QT interval.

Precautions
Escitalopram Normon should be discontinued if a patient develops seizures for the first time, or if there is an increase in seizure frequency (in patients with a previous diagnosis of epilepsy).
Dosage of Escitalopram Normon may need to adjust in patients with liver or renal insufficiency.
In patients with diabetes, treatment with Escitalopram Normon may alter glycaemic control (hypoglycaemia or hyperglycaemia). Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
Escitalopram Normon should be used with caution in patients with hyponatraemia, in patients with known bleeding or bruising tendencies, in patients receiving electroconvulsive treatment, in patients suffering from a coronary heart disease.
Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.
Caution is advised in patients with manic-depressive disease, history of mania/hypomania, with suicidal thoughts and increased depression or anxiety disorder.
The information from clinical trials has shown an increased risk of suicidal behaviours in adults under 25 years of age, with psychiatric diseases that were treated with an antidepressant.
Use in children and adolescents under 18 years of age: Escitalopram Normon should not normally be used to treat children and adolescents under 18 years of age. Furthermore, it is important to know that in patients under 18 years of age there is a higher risk of side events, such as attempted suicide, suicidal thoughts and hostility (mainly aggression, confrontational behaviour and irritation). If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

Drug interactions
Non-selective MAOIs which contain phenelzine, iproniazid, isocarboxazide, nialamide and tranylcypromine. Escitalopram Normon may be started 14 days after discontinuing treatment with an non-selective MAOI. At least 7 days should elapse after discontinuing Escitalopram Normon treatment, before starting a non-selective MAOI.
Reversible selective MAO-A inhibitors, containing moclobemide.
Irreversible MAO-B inhibitors, containing selegiline. These increase the risk of side effects.
The antibiotic linezolid, lithium and tryptophan, imipramine and desipramine.
Sumatriptan and similar medication and tramadol. These drugs increase the risk of side effects.
Cimetidine and omeprazole, fluvoxamine and ticlopidine. These may cause an increase in the blood concentration of Escitalopram Normon.
Saint John’s wort (Hypericum perforatum) herbal medicine.
Acetyl salicylic acid and NSAI drugs.
Warfarin, dipyridamole and phenprocoumon. Patients receiving oral anticoagulant therapy should receive careful coagulation monitoring when escitalopram is started or stopped.
Mefloquine, bupropion and tramadol due to the possible risk of reducing the seizure threshold.
Neuroleptics and antidepressants due to the possible risk of reducing the seizure threshold.
Flecainide, propafenone and metoprolol, clomipramine and nortriptyline and risperidone, thioridazine and haloperidol. The dose of Escitalopram Normon may need to be adjusted.
Escitalopram Normon is contraindicated in combination with medicinal products that prolong the QT interval, such as such as Class IA and III antiarrhythmics, antipsychotics (e.g. pheno-thiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial treatment particularly halofantrine), certain antihistamines (e.g. astemizole, mizolastine).
Taking Escitalopram Normon with food and drink: Escitalopram Normon may be taken with or without food.
The combination of Escitalopram Normon and alcohol is not recommended, though Escitalopram Normon is not likely to react with alcohol.

Ability to drive and use machine
Patients should be cautioned not to drive or handle machinery until it is known how they react to Escitalopram Normon.

Pregnancy and lactation
Pregnancy: Escitalopram Normon should not be used during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit. The following symptoms may occur in the neonate after maternal Escitalopram Normon use during the last 3 months of pregnancy: respiratory distress, cyanosis, seizures, temperature instability, feeding difficulty, vomiting, hypoglycaemia, muscle rigidity or lethargy, intense reflexes, tremor, restlessness, irritability, constant crying, drowsiness and difficulty sleeping. If Escitalopram Normon is used during pregnancy, it should never be discontinued abruptly.
Lactation: Breast-feeding is not recommended during treatment.

Side effects
Adverse events usually disappear after a few weeks of treatment.
Uncommon: Unusual bleeding, including gastrointestinal bleeding.
Rare: Angioedemas, serotonergic syndrome, urinary problems, seizures, liver dysfunction/hepatitis, ventricular arrhythmia including torsade de pointes.
In addition to the above, the following adverse events have been reported:
Very common: nausea.
Common: Sinusitis, increased or reduced appetite, anxiety, agitation, abnormal dreaming, difficulties in falling asleep, drowsiness, dizziness, yawning, shaking, skin itching, diarrhoea, constipation, vomiting, dry mouth, increased sweating, arthralgia and myalgia, sexual disorders (delayed ejaculation, impotence, reduced sexual behaviour and women may experience difficulties in reaching orgasm), fatigue, fever, weight gain.
Uncommon: Hives, skin rash, pruritus, teeth grinding, agitation, nervousness, panic attacks, state of confusion, sleep disruption, problems tasting, syncope, midriasis, visual disturbances, tinnitus, hair loss, vaginal bleeding, weight loss, fast heart rate, swelling of the arms and legs, nose bleeding.
Rare: Aggression, depersonalisation, hallucinations, low heart rate.
Unknown frequency: suicidal ideation, suicidal behaviour, hyponatraemia, orthostatic hypotension, impaired liver function tests, involuntary muscle movements, priapism, clotting disorders, including skin and ecchymosis and thrombocytopenia, angioedema, inadequate ADH secretion, galactorrhoea, mania, akathisia, anorexia, alteration of the heart rhythm (prolongation of QT interval).

Dosage and administration
Escitalopram Normon may be taken with or without food. Swallow the tablets with water. Do not chew.
Adults:
- Depression: The recommended standard dose of Escitalopram Normon is 10 mg taken as single daily dose, the dose may be increased up to 20 mg a day.
- Panic disorder: The starting dose of Escitalopram Normon is 5 mg and is taken as a single daily dose during the first week after which it is increased to 10 mg a day. The dose may be increased up to 20 mg a day.
- Social anxiety disorder: The recommended standard dose of Escitalopram Normon is 10 mg taken as single daily dose. The dose may be reduced to 5 mg a day or increased up to 20 mg a day, dependent on individual patient response.
- Generalised anxiety disorder: The recommended standard dose of Escitalopram Normon is 10 mg taken as one daily dose. The dose may be increased to a maximum of 20 mg per day.
- Obsessive-compulsive disorder: The recommended standard dose of Escitalopram Normon is 10 mg taken as single daily dose. The dose may be gradually increased to a maximum of 20 mg/day.
Elderly (over the age of 65): The recommended standard dose of Escitalopram Normon is 5 mg taken as single daily dose.
Children and adolescents (< 18 years): Escitalopram Normon should not be normally administered to children or adolescents.
Discontinuation symptoms seen when stopping treatment: With abrupt discontinuation of Escitalopram Normon, withdrawal symptoms may be experiencesd. The risk is higher when Escitalopram Normon has been used for a long time, at high doses or when the dose is reduced too fast. Symptoms are mild and disappear spontaneously in 2 weeks. However, in some patients they may be severe or prolonged (2-3 months or longer).
The withdrawal symptoms include: dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disruption (very intense dreams, nightmares, insomnia ), restlessness, headache, light-headedness, nausea, sweating (including nocturnal sweating), restlessness, instability, confusion or disorientation, agitation or irritation, diarrhoea, visual impairment, fast pulse and palpitations.

Storage conditions
Store below 30ºC and protect form humidity.

Origin: Spain
Laboratories: Normon
Distributor: Droguerie Phenicia
Year of submission: 2012
Number & Year of Registration
10mg: 97246/2013
15mg: 97247/2013
20mg: 97248/2013