PRIMALAN Tablet Ref.[7688] Active ingredients: Mequitazine

Cases of agranulocyctosis have been described with phenothiazines. Patients should be warned that in the event of fever or an infection whilst under treatment, they should obtain medical consultation as soon as possible. In the event of marked changes to the blood count, treatment should be discontinued.

As with all antihistamines, mequitazine should be used with caution in epilepsy, asthma, prostatic hypertrophy, glaucoma, and cardiovascular or hepatic diseases.

Epileptic patients should be closely monitored because of a possible lowering of the epileptogenic threshold, known to occur with phenothiazines.

In patients with severe liver impairment there is a risk of reduced clearance and an accumulation of mequitazine.

Elderly patients are more susceptible to the side-effects of antihistamines, particularly the central nervous system depressant activity and the hypotensive effects even at therapeutic doses. Caution should therefore be exercised in this group of patients.

Avoid the consumption of alcoholic drinks and medicines containing alcohol.

Impaired alertness may render driving or machine use dangerous

Caution should be exercised with sympathomimetic amines, their adrenergic effect on cardiovascular system is exacerbated.

The association with other central nervous system depressive drugs may major the central depression. Therefore, due to a possible reduced level of alertness, driving or operating machinery may be dangerous.

An enhancement of atropine undesirable effects (e.g: urinary retention, constipation, dryness of the mouth) could be observed in association with atropine and related drugs.

Because of the presence of Lactose, patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose – galactose malabsorption should not take this medicine.

The combination of Mequitazine with other drugs is likely to exacerbate the known induced side effects of these drugs.

Contraindicated: MAOIs: see section 4.3 contra-indications.

Precautions

Mequitazine may potentiate sympathomimetic amines, other antimuscarinic drugs such as atropine and tricyclic antidepressants (enhancement of antimuscarinic and sedative effects), and central nervous system depressants, including hypnotics and anxiolytics (enhancement of the sedative effect).

Alcohol. Enhancement of the sedative effects of HI antihistamines with the use of alcohol may occur in individual patients.

Pregnancy

Animal studies have not demonstrated any teratogenic effect of mequitazine. Insufficient relevant clinical data are available at present to assess any malformative or foetotoxic effects of mequitazine when it is administered during pregnancy.

In neonates bom to mothers who have received long-term treatment with high doses of anticholinergic medicines, rare cases of digestive signs related to their atropine properties (abdominal distension, meconium ileus, delayed meconium passage, difficulties in starting feeding, tachycardia, neurological disorders, etc) have been reported.

Taking into account these data, caution should be exercised when prescribing to pregnant women. It is recommended not to use Mequitazine during the first trimester of pregnancy. It should only be prescribed if necessary thereafter, for occasional limited use during the third trimester of pregnancy.

If this medicinal product is administered towards the end of pregnancy, it is justified to ensure a period of monitoring of the neurological and digestive functions of the neonate.

Lactation

It is unknown whether mequitazine is excreted in human breast milk.

The excretion of mequitazine in milk has not been studied in animals.

A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Primalan 5 mg Tablets should be made taking into account the benefit of breast-feeding to the child and the benefit of Primalan 5 mg tablets therapy to the mother. In the event of lactation, use of this medicinal product may only be envisaged for brief periods (a few days).

In objective tests mequitazine has been shown to have no significant effect on alertness, performance and reaction time. As drowsiness can occur in some patients it is advisable to check individual responses prior to driving or operating machinery.

The most common undesirable effect with antihistamines is drowsiness/sedation. The severity varies with each patient (particularly in the elderly population).

The following anticholinergic/antimuscarinic effects may also occasionally occur: dryness of the mouth, constipation, disturbance of accommodation, mydriasis, tightness in the chest, urinary retention, dysuria.

Adverse reactions reported are listed below, by organ system.

Immune system disorders: Allergic reaction related to any of the ingredients, Anaphylactic shock

Blood and lymphatic system disorders: Blood dyscrasias (rare cases of agranulocytosis were described with phenothiazines)

Psychiatric disorders: Hallucinations particularly in the elderly population, Nervousness

Nervous system disorders: Drowsiness, Sedation: severity varies with each patient (particularly in the elderly population), Mental confusion particularly in the elderly population, Agitation, Excitement, Insomnia, Headache, Psychomotor impairment Acute dyskinesia, Extrapyramidal effects (reported with phenothiazine drugs)

Eyes disorders: Focusing disturbances, Disturbance of accommodation, Mydriasis (anticholinergic/antimuscarinic effects)

Cardiac disorders: Cardiac palpitations

Vascular disorders: Hypotension

Gastrointestinal disorders: Dryness of the mouth, Constipation (anticholinergic/antimuscarinic effects)

Skin and subcutaneous tissue disorders: Photosensitivity, Erythema, Eczema, Pruritus, Purpura, Urticaria, Quincke’s Oedema

Renal and Urinary disorders: Urinary retention, Dysuria (anticholinergic/antimuscarinic effects)

General disorders and administration site conditions: Tightness in the chest

Not applicable.