Promethazine hydrochloride 10mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Promethazine hydrochloride

Disponible depuis:

Genesis Pharmaceuticals Ltd

Code ATC:

R06AD02

DCI (Dénomination commune internationale):

Promethazine hydrochloride

Dosage:

10mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 03040100; GTIN: 5060014442451

Notice patient

_CHILDREN 5-10 YEARS: _A single dose of either one or two
tablets (10 mg or 20 mg) given at night or one tablet (10
mg) given twice a day. DO NOT give more than two
tablets (20 mg) each day.
_CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _
_ELDERLY): _Start with one tablet (10 mg) twice a day. This
may be increased to a maximum of two tablets (20 mg)
three times a day.
FOR TREATMENT AND PREVENTION OF FEELING SICK OR BEING
SICK (SUCH AS IN TRAVEL SICKNESS)
_CHILDREN 2-5 YEARS: _A liquid form of this medicine should
be used in this age group.
_CHILDREN 5-10 YEARS: _A single tablet to be taken the night
before the journey. This may be repeated after 6-8 hours
if necessary.
_CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _
_ELDERLY): _Two tablets (20 mg) to be taken the night before
the journey. This may be repeated after 6-8 hours if
necessary.
AS A SHORT TERM PAEDIATRIC SEDATIVE AND FOR SHORT TERM
TREATMENT OF INSOMNIA IN ADULTS.
_CHILDREN 2-5 YEARS: _A liquid form of this medicine should
be used in this age group.
_CHILDREN 5-10 YEARS: _ Two tablets (20 mg) given as a
single dose at night time.
_CHILDREN OVER 10 YEARS AND ADULTS (INCLUDING THE _
_ELDERLY): _Two to five tablets (20 mg to 50 mg) as a single
dose at night time.
CHILDREN UNDER 2 YEARS
DO NOT give this medicine to children under 2 years of
age.
Use this medicine only as recommended. Do not exceed
the recommended dose.
EXPOSURE TO SUNLIGHT
Promethazine Tablets can make your skin more sensitive
to sunlight. Keep out of direct sunlight while taking this
medicine.
IF YOU TAKE MORE PROMETHAZINE THAN YOU SHOULD
If you or your child takes more Promethazine Tablets than
you should, tell a doctor or go to a hospital casualty
department straight away. Take the medicine pack with
you. This is so the doctor knows what you or your child
has taken.
The following effects may occur:

IN CHILDREN: excitation, moving unsteadily or
stumbling, uncontrolled writhing movements
especially of the hands or feet, hearing or seeing
things that are not there (hallucinatio

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Promethazine Hydrochloride 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of the active substance Promethazine
Hydrochloride BP
Also contains 23.6 mg of lactose and 33.7 mg of Sucrose
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sugar-coated tablet
Blue sugar coated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As symptomatic treatment for allergic conditions of the upper
respiratory tract and
skin including allergic rhinitis, urticaria and anaphylactic reactions
to drugs and
foreign proteins
As an antiemetic
For short term use:
-
Treatment of insomnia in adults
-
As a paediatric sedative
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
Not for use in children under the age of 2 years (see section 4.3).
_AS AN ANTIHISTAMINE IN ALLERGY: _
Children 2-5 years
The use of Promethazine liquid is
recommended for this age group.
Children 5-10 years
Either 10 or 20 mg as a single dose*.
Or 10 mg bd.
Maximum daily dose 20 mg.
Children over 10 years and adults
(including elderly)
Initially 10 mg bd.
Increasing to a maximum of 20 mg tds as
required.
*Single doses are best taken at night.
_AS AN ANTIEMETIC: _
Children 2-5 years
The use of Promethazine liquid is
recommended for this age group.
Children 5-10 years
10 mg to be taken the night before the
journey.
To be repeated after 6–8 hours as
required.
Children over 10 years and adults
(including elderly)
20 mg to be taken the night before the
journey.
To be repeated after 6–8 hours as
required.
_AS A PAEDIATRIC SEDATIVE FOR SHORT TERM USE AND FOR SHORT TERM
TREATMENT OF INSOMNIA _
_IN ADULTS: _
Children 2-5 years
The use of Promethazine liquid is
recommended for this age group.
Children 5-10 years
20 mg as a single night time dose.
Children over 10 years and adults
(including elderly)
20 to 50 mg as a single night time dose
4.3
CONTRAINDICATIONS
Promethazine should not be used in patients in coma or suffering fr