THERALENE Tablet

This medicine contains Alimemazine, an anti-histamine. It is indicated:

- In occasional insomnia (e.g. travel) and/or temporary insomnia (e.g. emotional events),

- For symptomatic treatment of allergic manifestations such as:

- allergic rhinitis (e.g. seasonal rhinitis, non-seasonal rhinitis,…),

- conjunctivitis (eye inflammation),

- urticaria.

- To relieve dry and irritative cough, particularly cough occurring in the evening or at night.

DOSAGE

In general:

Anti-histamine, cough control:

Repeated doses can be used daily as needed, but do not exceed 4 times per day.

- Adults: 1-2 tablets per dose.

- Children over 6 years of age (i.e. 20kg): 0.125-0.25mg/kg/dose, i.e. 1/2-1 tablet per dose.

Effect on sleep:

A single dose at bedtime.

- Adults: 5-20mg, i.e. 1-4 tablets.

- Children over 6 years of age: 0.25-0.5mg/kg, i.e.:

- Children 20-40kg (6-10 years): 1 tablet.

- Children 40-50kg (10-15 years): 2 tablets.

Method of administration

Oral route.

The tablet should be swallowed with some water.

Time of intake

Given its sedative effect, this medicine should be preferably taken at night-time for treatment of allergic manifestations.

Duration of treatment

The duration of symptomatic treatment must be short (a few days).

In case of cough, the treatment is limited to when cough arises.

- History of hypersensitivity to anti-histamines,

- Children under 6 years of age,

- History of agranulocytosis (marked decreased of white blood cell count) with other phenothiazines,

- Dysuria of prostate origin or of other causes,

- Several forms of glaucoma (increased intraocular pressure).

In general THIS MEDICINE SHOULD NOT BE USED in the following cases unless otherwise indicated by a doctor:

- During the first trimester of pregnancy,

- During breast-feeding,

- In combination with sultopride.

A number of adverse effects may require IMMEDIATE DISCONTINUTION OF THE TREATMENT AND CONSULT YOUR DOCTOR.

- Allergic reactions:

- various types of skin eruptions (erythema, eczema, purpura, urticaria).

- Quincke’s edema (urticarial wales appear in face and neck that may cause dyspnea),

- Anaphylactic shock.

- Skin photosensitivity,

- Severe decrease of white blood cell count that may be manifested as the occurrence or relapse of fever, with or without signs of infection.

- Abnormal decrease of platelets count leading to nose and gum bleedings.

- Convulsions

Other side-effects more commonly seen:

- Drowsiness, decreased vigilance, more pronounced at the beginning of treatment.

- Memory or concentration disorders, dizziness (frequently seen in elderly).

- Loss of motor coordination, tremor.

- Confusion, hallucination.

- Mouth dryness, visual disturbances, urine retention, constipation, palpitation, hypotension.

- Alcohol: the sedative effect of H1-receptor antagonist (antihistamines) is enhanced by alcohol and the resulting disease in alertness may render driving or the use of machinery dangerous. Avoid alcoholic beverages and medications that contain alcohol.

- Sultopride: enhance risk of ventricular arrhythmia, particularly torsades de pointes, by additive electrophysiological effects.

Combinations to be considered with caution:

- Other central nervous system depressants: sedating anti depressants, barbiturates, benzodiazepines, clonidine and related substances, hypnotics, morphine derivatives (analgesics and antitussives), methadone, neuroleptics, anti-anxiety drugs, enhanced central depression. The resulting decrease in alertness may render driving or the use of machinery dangerous.

- Atropine and other atropine-like substances (imipramine antidepressants, anticholinergic antiparkinsonians, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics): addition of atropine-like adverse effects, e.g. urinary retention, constipation, dry mouth.

Pregnancy

- This medicine should not be used in the first trimester of pregnancy.

- It can be used in the second or the third trimester of pregnancy providing that for a short duration (a few days) and with recommended doses.

However, at late pregnancy, the abuse of this medicine may have adverse effects on the newborn. Consequently, always ask your doctor for advice before taking this medicine and never exceed the recommended doses.

Breast-feeding

This medicine is readily excreted into breast milk. The newborn may be adversely affected by its sedative (lethargy, hypotonia) or, conversely, by its excitative effects (insomnia), consequently this medicine should not be used during breast-feeding. As a rule, you should always ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breast-feeding.

In case of occurrence of persistence of fever accompanied with or without signs of infections (sore throat…), pallor or sweating, this must be immediately informed to your attending doctor.

Allergic manifestations;

This medicine is intended for symptomatic treatment of allergy. Consequently, it is preferred to look for possible causes of allergy. If symptoms are persistent or aggravated, PLEASE ASK YOUR DOCTOR FOR ADVICE.

Cough;

- This medicine should not be used for treating productive cough. In this case, cough is a natural defense mechanism necessary to eliminate bronchial secretion. If the condition is a productive cough associated with bronchial obstruction, fever; it is essential to ask your doctor for advice.

- If the condition is a chronic (prolonged) bronchopulmonary disease associated with a productive cough, it is essential to ask your doctor for advice.

- This medicine should not be used in combination with a diluent of bronchial secretion (an expectorant or a mucolytic).

Insomnia;

Doctor’s advice should be consulted in case of sleep disturbances in children.

If possible, cause of insomnia should be looked for. When insomnia persists more than 5 days, ASK YOUR DOCTOR FOR ADVICE.

Precautions for use

- Do not take alcoholic beverages or alcohol-containing drugs during treatment.

- Do not expose to sunlight during treatment.

PLEASE ASK YOUR DOCTOR FOR ADVICE in case of:

- Known chronic liver of kidney disease,

- History of convulsions, or previous or recent onset of epilepsy,

- Presence of severe heart disease, epilepsy,

- In elderly:

- with constipation, dizziness or drowsiness,

- with prostate disorders.

Systemic antihistamine.

Alimemazine

Histamine H1-receptor antagonist, phenothiazine with a lateral aliphatic chain and characterized by:

- A pronounced sedative effect at the usual doses due to central histaminergic and adrenolytic effects,

- An anticholinergic effect that may have hemodynamic repercussions (possible postural hypotension)

By a mechanism of competitive antagonism that shows varying degrees of reversibility, all the antihistamines have in common the capacity to counter the effects exerted by histamine, particularly on the skin, the bronchi, the intestine and the vessels.