PRIMALAN Tablet (2011)
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Περιεχόμενα
Name of the medicinal product
Primalan 5 mg Tablets.
Qualitative and quantitative composition
Mequitazine 5 mg. For a full list of excipients, see section 6.1.
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.
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. ...
Contraindications
Hypersensitivity to mequitazine or to any of the excipients or sensitivity to phenothiazines. In patients with a history of agranulocytosis linked to the use of phenothiazines.: see section 4.8. In patients ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
The combination of Mequitazine with other drugs is likely to exacerbate the known induced side effects of these drugs. <u>Contraindicated: MAOIs:</u> see section 4.3 contra-indications. Precautions Mequitazine ...
Pregnancy and lactation
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 ...
Effects on ability to drive and use machines
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 ...
Undesirable effects
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 ...
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antihistamines for systemic use ATC code: R06AD07 Mequitazine is a phenothiazine derivative with the actions and uses of antihistamines. Antihistamines diminish or abolish the ...
Pharmacokinetic properties
Absorption Mequitazine is readily absorbed from the gastrointestinal tract. Distribution The apparent volume of distribution is high, indicating that mequitazine is extensively distributed outside the ...
Preclinical safety data
No teratogenic effects were observed in animal studies with mequitazine. Other preclinical effects were observed only at exposure considered sufficiently in excess of the maximum human exposure indicating ...
List of excipients
Lactose Maize starch Colloidal silicon dioxide E551 Magnesium stearate Microcrystalline cellulose E460
Incompatibilities
Not applicable.
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.
Marketing authorization holder
Pierre Fabre Medicament 45, Place Abel Gance, 92100, Boulogne, France
Marketing authorization number(s)
PL 05630/0028
Date of first authorization / renewal of the authorization
21/06/2011
Date of revision of the text
21/06/2011
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