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

Product name and form

Primalan 5 mg Tablets.

Pharmaceutical Form

Round white or almost white tablet, 9mm diameter, flat faced bevel-edged with two score-lines on one face. The score-lines can be used to divide the tablet into equal halves.

Qualitative and quantitative composition

Mequitazine 5 mg.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Mequitazine

Mequitazine is a phenothiazine derivative with the actions and uses of antihistamines. Antihistamines diminish or abolish the main actions of histamine in the body by competitive, reversible blaockade of histamine receptor site on tissues; they do not inactivate histamine or prevent its synthesis or release. Antihistamines are used for palliative treatment of allergic reactions.

List of Excipients

Lactose
Maize starch
Colloidal silicon dioxide E551
Magnesium stearate
Microcrystalline cellulose E460

Pack sizes and marketing

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.

Marketing authorization holder

Pierre Fabre Medicament 45, Place Abel Gance, 92100, Boulogne, France

Marketing authorization dates and numbers

PL 05630/0028

21/06/2011

Drugs

Drug Countries
PRIMALAN France, Tunisia

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