Phenergan 25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Promethazine hydrochloride

Available from:

Sanofi Consumer Healthcare

ATC code:

R06AD02

INN (International Name):

Promethazine hydrochloride

Dosage:

25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 0000050938537

Patient Information leaflet

-1-
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PHENERGAN 25 MG
TABLETS
promethazine hydrochloride
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE
Y
OU 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.
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 TAKE THIS MEDICINE IF:
 The person taking the medicine is under
5 years of age
 You are allergic (hypersensitive) to
promethazine hydrochloride or any

Summary of Product characteristics

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