Phenergan 25mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Promethazine hydrochloride

MAH:

DE Pharmaceuticals

ATC_code:

R06AD02

INN:

Promethazine hydrochloride

dosage:

25mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 03040100

PIL

PATIENT INFORMATION LEAFLET
PHENERGAN
 25MG TABLETS
(PROMETHAZINE HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Always take this medicine exactly as described in this leaflet or as
your
doctor or pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or advice.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.

You must talk to a doctor if you do not feel better or if you feel
worse
after 7 days.

The name of this medicine is Phenergan

25mg Tablets but will be
referred to as Phenergan Tablets throughout the remainder of this
leaflet.

This medicine is also available in other strengths and pharmaceutical
forms.
WHAT IS IN THIS LEAFLET:
1) What Phenergan Tablets are and what they are used for
2) What you need to know before you take Phenergan Tablets
3) How to take Phenergan Tablets
4) Possible side effects
5) How to store Phenergan Tablets
6) Contents of the pack and other Information
1) WHAT PHENERGAN TABLETS ARE AND WHAT THEY ARE
USED FOR
Phenergan Tablets contain a medicine called promethazine
hydrochloride. This belongs to a group of medicines called
phenothiazines. It works by blocking a natural substance (histamine)
that
your body makes during an allergic reaction. It also works directly on
the
brain to help you feel more relaxed.
WHAT PHENERGAN TABLETS ARE USED FOR
Phenergan Tablets are used to treat the following conditions:

For short term use: to treat adults with difficulty sleeping
(insomnia)

To treat allergic conditions such as hay fever or rashes (like nettle
rash
or hives)

To treat or stop you feeling sick (nausea) or being sick (vomiting)
such
as travel sickness

For short term use: as a sedative for children aged 5 years and above
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHENERGAN TABLETS
DO NOT TA

SPC

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