Cyclizine 50mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Cyclizine hydrochloride

Διαθέσιμο από:

Advanz Pharma

Φαρμακολογική κατηγορία (ATC):

R06AE03

INN (Διεθνής Όνομα):

Cyclizine hydrochloride

Δοσολογία:

50mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04060000; GTIN: 5060064172032

Φύλλο οδηγιών χρήσης

28053233
CYCLIZINE HYDROCHLORIDE 50 MG TABLETS
CYCLIZINE HYDROCHLORIDE
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
hydrochlori

Αρχείο Π.Χ.Π.

OBJECT 1
CYCLIZINE 50MG TABLETS
Summary of Product Characteristics Updated 16-Oct-2018 | ADVANZ Pharma
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
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
ca