PRIMALAN Tablet Ref.[7688] Active ingredients: Mequitazine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2011  Publisher: Pierre Fabre Medicament 45, Place Abel Gance, 92100, Boulogne, France

Therapeutic indications

Antihistamine for the treatment of allergic conditions such as hay fever, perennial rhinitis, urticaria, pruritis of allergic origin and allergic reactions associated with insect bites and stings.

Posology and method of administration

Oral use.

Adults

One 5 mg tablet to be taken orally twice a day

Children 12 years of age and over

One 5 mg tablet to be taken twice a day.

Primalan is not recommended in children under 12 years of age.

Elderly population

There is no information on specific dosage recommendation in the elderly. Caution should therefore be exercised in this group of patients: see section 4.4.

Administration

It may be preferable to take this medicine in the evening due to the possible sedative effect of mequitazine in some patient groups (the elderly).

Overdose

Symptoms

Symptoms of severe overdosage have been observed: drowsiness, nausea, vomiting, anticholinergic effects, hypotension, central nervous system depression, convulsions and coma. Overdose may be fatal particularly in infants and children.

Emergency procedure

Treatment is symptomatic and supportive and may include artificial respiration, external cooling for hyperpyrexia, gastric emptying and lavage.

Diazepam may be used to control convulsion, although central nervous system depressants and other phenothiazine derivatives should be avoided.

Activated charcoal could be given. Intravenous fluids and vasopressors except adrenaline may be needed.

Antidote

There is no specific antidote.

Shelf life

3 years.

Special precautions for storage

Do not store above 25°C.

Store in the original container in order to protect from light.

Nature and contents of container

Tablet container: 100 tablets.
Bottles (Polyethylene Injection Blow Moulded HDPE): 100 tablets.
Blister: 100 tablets.
Blister: 60 tablets.
Blister: 56 tablets.
Professional Sample Pack: 6 tablets.

Special precautions for disposal and other handling

None.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.