Phenergan 5mg/5ml elixir

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:

1mg/1ml

Pharmaceutical form:

Oral solution

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03040100; GTIN: 5013011002487

Patient Information leaflet

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
PHENERGAN ELIXIR
5MG/5ML ORAL
SOLUTION
promethazine hydrochloride
Is this leafl et hard to
see or read?
Phone [phone]
for help
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in
this leafl et or as your doctor or pharmacist has told
you.
• Keep this leafl et. You may need to read it again.
• Ask your pharmacist if you need more
information or advice.
• If you get any side eff ects, talk to your doctor
or pharmacist. This included any possible side
eff ects not listed in this leafl et. 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 LEAFL ET :
1. What Phenergan Elixir is and what it is used for
2. What you need to know before you take
Phenergan Elixir
3. How to take Phenergan Elixir
4. Possible side eff ects
5. How to store Phenergan Elixir
6. Contents of the pack and other information
1. WHAT PHENERGAN ELIXIR IS AND WHAT IT IS
USED FOR
Phenergan Elixir contains 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 ELIXIR IS USED FOR
Phenergan Elixir is used to treat the following
conditions:
• For short term use: to treat adults with diffi culty
sleeping (insomnia)
• To treat allergic conditions such as hay fever or
rashes (like nettle rash or hives)
• To stop you feeling sick (nausea) or being sick
(vomiting) such as travel sickness
• For short term use: as a sedative for children aged
2 years and above
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PHENERGAN ELIXIR
DO NOT TAKE THIS MEDICINE IF:
Х
The person taking the medicine is under 2 years
of age
Х
You

Summary of Product characteristics

OBJECT 1
PHENERGAN ELIXIR
Summary of Product Characteristics Updated 27-Sep-2016 | SANOFI
1. Name of the medicinal product
Phenergan Elixir 5mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of solution contains 5mg of the active substance promethazine
hydrochloride.
Also contains 37mg sodium and 1.457mg potassium per 5ml dose.
Contains Maltitol, sodium sulphinte anhydrous (E221) and sodium
metabisulphite (E223).
For full list of excipients see section 6.1.
3. Pharmaceutical form
Oral Solution
Clear, golden, syrupy liquid.
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.
For short term use 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
Either 5–15 mg as a single dose.
Or 5 mg bd.
Maximum daily dose 15 mg.
Children 5-10 years
Either 10–25 mg as a single dose.
Or 5-10 mg bd.
Maximum daily dose 25 mg.
Children over 10 years and
adults (including elderly)
Initially 10 mg bd.
Increasing to a maximum of 20 mg tds as required.
_AS AN ANTIEMETIC:_
Children 2-5 years
5 mg to be taken the night before the journey.
To be repeated after 6–8 hours as required.
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)
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
15 or 20 mg as a single night time dose.
Children 5-10 years
20 or 25 mg as a single night time dose.
Children over 10 years and
adults (including e