ALIMEMAZINE Film-coated tablets (2019)
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Περιεχόμενα
Name of the medicinal product
Alimemazine tartrate 10mg fim-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains 10mg of alimemazine tartrate. Excipients with Known effect: Lactose 34 mg/tab. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablets. Dark blue, circular, biconvex and film coated tablet. One side of tablet is marked with AL and other side is plain.
Therapeutic indications
Alimemazine has powerful antihistamine and anti-emetic actions and is used in the management of urticaria and pruritus. Alimemazine may be used in pre-medication as a sedative before anaesthesia in children ...
Posology and method of administration
Posology Do NOT exceed the recommended dose (see also section 4.9). Urticaria and pruritus Adults: 10mg two or three times daily. Elderly: Dosage should be reduced to 10mg once or twice daily. Paediatric ...
Contraindications
Hypersensitivity to the active substance, phenothiazines or to any of the excipients listed in section 6.1. Use in patients with hepatic or renal dysfunction, epilepsy, Parkinsons disease, hypothyroidism, ...
Special warnings and precautions for use
Precautions for use Alimemazine should be used with caution in: Elderly or volume depleted patients who are more susceptible to orthostatic hypotension (see section 4.8) Elderly patients presenting chronic ...
Interaction with other medicinal products and other forms of interaction
The sedative effects of phenothiazines may be intensified (additively) by alcohol (see section 4.4), anxiolytics & hypnotics, opiates, barbiturates and other sedatives. There may be increased antimuscarinic ...
Pregnancy and lactation
Pregnancy There is inadequate evidence of the safety of Alimemazine in human pregnancy, but it has been widely used for many years without apparent ill consequence. Some phenothiazines have shown evidence ...
Effects on ability to drive and use machines
Patients should be warned about drowsiness during the early days of treatment, and advised not to drive or operate machinery.
Undesirable effects
The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention: Not known (cannot be estimated from the available data). Blood ...
Overdose
Symptoms Symptoms of phenothiazine overdosage include drowsiness or loss of consciousness, hypotension, tachycardia, ECG changes, ventricular arrhythmias and hypothermia. Severe extra-pyramidal dyskinesias ...
Pharmacodynamic properties
Pharmacotherapeutic group: Phenothiazine derivatives ATC Code: R06AD01 Alimemazine has a central sedative effect, comparable to that of chlorpromazine, but largely devoid of the latters antiadrenaline ...
Pharmacokinetic properties
There is little information about blood levels, distribution and excretion in humans. The rate of metabolism and excretion of phenothiazines decreases in old age.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Cellulose microcrystalline Lactose monohydrate Sodium starch glycolate Silica, colloidal anhydrous Magnesium stearate Hypromellose 2910 Macrogol 400 Opaspray blue liquid M-1-4229
Incompatibilities
Not applicable.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from light.
Nature and contents of container
Tablets are packed in blisters containing 28 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Mercury Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 12762/0534
Date of first authorization / renewal of the authorization
05/01/2015
Date of revision of the text
28/03/2019
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