Phenergan 25mg tablets

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Promethazine hydrochloride

Доступно од:

Pilsco Ltd

АТЦ код:

R06AD02

INN (Међународно име):

Promethazine hydrochloride

Дозирање:

25mg

Фармацеутски облик:

Oral tablet

Пут администрације:

Oral

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 03040100; GTIN: 05060669871095

Информативни летак

•
Liver problems that may cause the eyes
or skin to go yellow (jaundice)
•
Muscle stiffness or shaking
•
Being unable to control some muscles in
your head or face
•
You notice unusual movements of the
tongue, facial muscle spasms, rolling
eyes and trembling
•
Very fast, uneven or forceful heartbeat
(palpitations)
•
Irregular heartbeat
•
Tiredness which lasts for a long time.
This may be due to a blood problem
called anaemia
•
Over-active behaviour in children
TELL YOUR DOCTOR OR PHARMACIST IF ANY
OF THE FOLLOWING SIDE EFFECTS GET
SERIOUS OR LASTS LONGER THAN A FEW
DAYS. ALSO TELL THEM IF YOU NOTICE ANY
SIDE EFFECTS NOT LISTED IN THIS LEAFLET.
•
Dry mouth, blurred vision or you cannot
pass water (urine)
•
Feeling drowsy or sleepy, tiredness,
disorientation, having nightmares,
headaches, feeling restless
•
Loss of appetite (anorexia), indigestion
•
Feeling dizzy, lightheaded, faint
(hypotension)
•
Feeling confused, especially in elderly
people
•
Being more sensitive to the sun than
usual. If this happens keep out of direct
sunlight and do not use sun lamps
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety
of this medicine.
5. HOW TO STORE PHENERGAN TABLETS
•
Keep out of the sight and reach of
children
•
Do not take Phenergan Tablets after the
expiry date which is stated on the carton
and blister pack after EXP. The expiry
date refers to the last day of that month
•
Do not store above 30°C
•
Store in the original package in order to
protect from light
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help protect the environment.
6.
CONTENTS OF THE PACK AND OTHER
INFORMATION
WHAT PHENER

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenergan 25 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg of the active substance Promethazine
hydrochloride.
Also contains 173.52mg of lactose monohydrate.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Pale blue film coated tablets marked PN 25 on one side.
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 Phenergan Elixir is recommended for this age
group.
Children 5-10 years
25 mg as a single dose*.
Maximum daily dose 25 mg.
Children over 10
years and adults
(including elderly)
25 mg as a single dose*.
Increasing to a maximum of 25 mg bd as required.
*Single doses are best taken at night.
_AS AN ANTIEMETIC: _
Children 2-5 years
The use of Phenergan Elixir is recommended for this age
group.
Children 5-10 years
The use of Phenergan Elixir or Phenergan 10 mg Tablets is
recommended.
Children over 10
years and adults
(including elderly)
25 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 Phenergan Elixir is recommended for this age
group.
Children 5-10 years
25 mg as a single night time dose.
Children over 10
years and adults
(including elderly)
25 or 50 mg as a single night time dose.
4.3
CONTRAINDICATIONS
Phenergan should not be used in patients in coma or suffering from CNS
depression
of any cause.
Phenergan should not be given to p