Valoid 50mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Cyclizine hydrochloride

Tilgjengelig fra:

Amdipharm Plc

ATC-kode:

R06AE03

INN (International Name):

Cyclizine hydrochloride

Dosering :

50mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 04060000

Informasjon til brukeren

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, pharmacist or nurse.
•
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,
pharmacist
or
nurse.
This
includes
any
possible
side
effects not listed in this leaflet. See
section 4.
The name of your medicine is Cyclizine
Hydrochloride 50 mg Tablets. It will be
referred
to
as
Cyclizine
Hydrochloride
Tablets for ease hereafter.
WHAT IS IN THIS LEAFLET
1.
What Cyclizine Hydrochloride Tablets
are and what they are used for
2.
What you need to know before you
take Cyclizine Hydrochloride Tablets
3.
How to take Cyclizine Hydrochloride
Tablets
4.
Possible side effects
5.
How to store Cyclizine Hydrochloride
Tablets
6.
Contents
of
the
pack
and
other
information
1.
WHAT CYCLIZINE HYDROCHLORIDE
TABLETS ARE AND WHAT THEY ARE
USED FOR
Cyclizine Hydrochloride Tablets contain
the
active
substance
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 Hydrochloride Tablets may be
used by adults and children aged 6 years
and over. Cyclizine Hydrochloride 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 Hydrochloride 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
HYDROCHLORIDE TABLETS
DO NOT TAKE CYCLIZINE HYDROCHLORIDE
TABLETS:
•
if
you
are
allergic
to
cyclizine
hydrochloride or any of the other
ingredients of this medicine (allergic
reactions

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Valoid 50 mg Tablets
Cyclizine Hydrochloride 50 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of cyclizine hydrochloride.
Excipient with known effect:
Lactose (60mg/tablet).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
White, biconvex, uncoated tablet, scored; coded T4A.
The score line is to facilitate breaking for ease of swallowing and
divide into
equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cyclizine Hydrochloride is 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 Hydrochloride may be of value in relieving vomiting and
attacks of
vertigo
associated
with Menière's
disease and
other
forms
of
vestibular
disturbance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To prevent motion sickness Cyclizine Hydrochloride should be taken
about
one to two hours before departure.
Elderly
There have been no specific studies of Cyclizine Hydrochloride in the
elderly.
Experience has indicated that normal adult dosage is appropriate.
_Paediatric population _
Children less than 6 years of age:
Cyclizine Hydrochloride 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
intoxic