Promethazine hydrochloride 25mg tablets

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Promethazine hydrochloride

Fáanlegur frá:

A A H Pharmaceuticals Ltd

ATC númer:

R06AD02

INN (Alþjóðlegt nafn):

Promethazine hydrochloride

Skammtar:

25mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 03040100; GTIN: 5025903084679

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENERGAN® 25MG TABLETS / PROMETHAZINE HYDROCHLORIDE 25MG TABLETS
(promethazine hydrochloride)
This medicine is available as any of the above names but will be
referred to as Phenergan Tablets throughout the
following leaflet.
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

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Promethazine Hydrochloride 25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of the active substance promethazine
hydrochloride.
Also contains 35.4 mg of lactose and 51.5 mg of sucrose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sugar coated tablet
Blue sugar-coated circular tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
As symptomatic treatment of allergic conditions of the upper
respiratory tract and
skin including allergic rhinitis, urticaria and anaphylactic reactions
to drug or 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 2 years of age (see section 4.3).
_AS AN ANTIHISTAMINE IN ALLERGY: _
Children 2-5 years
The use of Promethazine liquid 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 twice a day as
required.
*Single doses are best taken at night.
_AS AN ANTIEMETIC: _
Children 2-5 years
The use of Promethazine liquid is recommended
for this age group.
Children 5-10 years
The use of Promethazine liquid or Promethazine
10mg tablet 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 Promethazine liquid 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
Promethazine should not be used in patients in coma or suffering from
CNS
depression of any