Cyclizine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cyclizine hydrochloride

Available from:

Morningside Healthcare Ltd

ATC code:

R06AE03

INN (International Name):

Cyclizine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5055132713453 5055132717802

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
!
Keep this leaflet. You may need to read it again.
!
If you have any further questions, ask your doctor or
pharmacist.
!
This medicine has been prescribed for you only. Do not
pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
!
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.
WHAT IS IN THIS LEAFLET:
1.
What Cyclizine Tablets are and what they are used for
2.
What you need to know before you take Cyclizine Tablets
3.
How to take Cyclizine Tablets
4.
Possible side effects
5.
How to store Cyclizine Tablets
6.
Contents of the pack and other information
1. WHAT CYCLIZINE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Cyclizine Hydrochloride 50mg
Tablets.
Cyclizine
Tablets
contains
the
active
ingredient
cyclizine hydrochloride, which belongs to a group of medicines
called antihistamines which can be used to help stop you
feeling sick (nausea) or being sick (vomiting).
Cyclizine Tablets may be used by adults and children aged 6
years and over. Cyclizine Tablets may be used if you suffer from
travel or motion sickness; nausea caused by cancer treatment
(radiography) or other medicines; or if you have had an
operation, as general anaesthetics can sometimes cause
sickness.
Cyclizine Tablets can also be used to treat sickness caused by
some inner ear problems such as Meniere's disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYCLIZINE
TABLETS
DO NOT TAKE CYCLIZINE TABLETS IF:
!
you have ever had an allergic reaction to cyclizine or any of
the other ingredients of this medicine (allergic reactions
include mild symptoms such as itching and/or rash. More
severe symptoms include swelling of the face, lips, tongue
and/or throat with difficulty in swallowing or breathing).
!
you
have
been
drinking
alcohol.
The
anti-vomiting
properties of cyclizi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cyclizine Hydrochloride 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of cyclizine hydrochloride.
Excipients with known effect: Each tablet contains 37.00mg of Lactose
monohydrate.
For a full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
White to off white, circular shaped, flat bevelled uncoated tablets
with central break line
on one side and plain on other.
The tablet can be divided into two halves.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cyclizine Tablets are indicated in adults and in children aged 6 years
and over for the
prevention and treatment of nausea and vomiting including:-
•
Motion sickness.
•
Nausea and vomiting caused by narcotic analgesics and by general
anaesthetics in
the post-operative period.
•
Vomiting associated with radiotherapy, especially for breast cancer
since cyclizine
does not elevate prolactin levels.
Cyclizine Tablets may be of value in relieving vomiting and attacks of
vertigo associated
with Meniere's disease and other forms of vestibular disturbance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To prevent motion sickness Cyclizine Tablets should be taken about one
to two
hours before departure.
ELDERLY
There
have
been
no
specific
studies
of
Cyclizine
Tablets
in
the
elderly.
Experience has indicated that normal adult dosage is appropriate.
PAEDIATRIC POPULATION
Children less than 6 years of age:
Cyclizine Tablets are not recommended for children less than 6 years
of age.
Children 6 to 12 years of age:
25 mg orally, which may be repeated up to three times a day.
Children over 12 years of age:
50 mg orally, which may be repeated up to three times a day.
Adults
50 mg orally, which may be repeated up to three times a day.
Method of administration:
Oral.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Cyclizine is contraindicated in the presence of acute alcohol
intoxication. T