SOMINEX Tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Sominex.
Qualitative and quantitative composition
Promethazine hydrochloride EP 20mg/tab. Excipient with known effect: Each 20mg tablet contains 276.00mg lactose monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablet.
Therapeutic indications
As a night-time sleep aid, for the correction of temporary disturbances of sleep pattern where there is difficulty in going to sleep or staying asleep, caused for example by specific dislocation of normal ...
Posology and method of administration
Posology For bedtime use only. Adults One tablet at bedtime. May be taken up to one hour after going to bed when sleep is difficult to achieve. Paediatric population Not to be given to children under the ...
Contraindications
Hypersensitivity to the active substance, phenothiazines or to any of the excipients listed in section 6.1. Patients taking MAOIs or within 14 days of taking MAOIs. Patients with any form of CNS depression. ...
Special warnings and precautions for use
Cause drowsiness. Do not drive or operate machinery. Not to be used for more than 7 days without medical advice. In patients with asthma or other respiratory disorders (eg bronchitis or bronchiectasis), ...
Interaction with other medicinal products and other forms of interaction
Promethazine hydrochloride may potentiate the action of alcohol and other centrally acting depressants such as sedatives (barbiturates), opiod analgesics, antipsychotics, anticonvulsants, hypnotics and ...
Pregnancy and lactation
The advice of a doctor should be sought before use. Pregnancy Sominex should not be used in pregnancy unless the physician considers it essential. The use of Sominex is not recommended in the 2 weeks prior ...
Effects on ability to drive and use machines
This product causes drowsiness. Do not drive or operate machinery.
Undesirable effects
<u>Blood and lymphatic system disorders:</u> Agranulocytosis, leucopenia, thrombocytopenia. Blood dycrasias occur rarely. <u>Psychiatric disorders:</u> Sedation, paradoxical reactions such as hyperexcitability ...
Overdose
<u>Common features include:</u> nausea, vomiting, flushing, dilated pupils, dry mouth and tongue, hot dry skin, fever, sinus tachycardia, hypertension, ataxia, nystagmus, drowsiness, delirium, agitation ...
Pharmacodynamic properties
Pharmacotherapeutic group: R06AD02 Promethazine hydrochloride – sedative. The drug is an antihistamine with anticholinergic activity.
Pharmacokinetic properties
Promethazine hydrochloride is readily absorbed from the gastrointestinal tract, but undergoes extensive first pass metabolism in the liver. With only 25% of the oral dose reaching the systemic circulation ...
Preclinical safety data
None stated.
List of excipients
Lactose Maize starch Croscarmellose sodium Magnesium stearate
Incompatibilities
None known.
Shelf life
60 months unopened.
Special precautions for storage
None.
Nature and contents of container
Opaque blister strip of polyvinylchloride/polyvinylidine chloride. Backed with aluminium foil. Each strip contains 8 tablets. One or two strips are packed into each cardboard carton.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Actavis Group PTC ehf, Reykjavíkurvegi 76-78, 220 Hafnarfjordur, Iceland
Marketing authorization number(s)
PL 30306/0080
Date of first authorization / renewal of the authorization
Date of first authorisation: 6<sup>th</sup> September 2002
Date of revision of the text
26/10/2020
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