Phenergan 10mg 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:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 0000050938544

Patient Information leaflet

- 1 -
PACKAGE LEAFLET:
INFORMATION FOR THE USER
PHENERGAN 10 MG
TABLETS
promethazine hydrochloride
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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.
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 an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Phenergan 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of the active substance Promethazine
hydrochloride.
Also contains 69.41mg of lactose monohydrate.
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Film-coated tablet (Tablet)
Pale blue film coated tablets marked PN 10 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
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 Phenergan Elixir 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 Phenergan Elixir is recommended for this age
group.
Children 5-10 years
20 mg as a single night time dose.
Children over 10
years and adults
20 to 50 mg as a single night time dose.
(including elderly)
4.3
CONTRAINDICATIONS
Phenergan should not be used in patients in coma or suffering from CN