Cyclizine hydrochloride Cipla 50mg tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

CYCLIZINE HYDROCHLORIDE

Disponibil de la:

Cipla (EU) Limited Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom

Codul ATC:

R06AE03

INN (nume internaţional):

CYCLIZINE HYDROCHLORIDE 50 mg

Forma farmaceutică:

TABLET

Compoziție:

CYCLIZINE HYDROCHLORIDE 50 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIHISTAMINES FOR SYSTEMIC USE

Statutul autorizaţiei:

Withdrawn

Data de autorizare:

2015-01-02

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Cyclizine hydrochloride Cipla 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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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 IT IS USED FOR
Cyclizine hydrochloride 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 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 or any other ingredients of this
medicine (listed in
section 6). 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
diffic

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Cyclizine hydrochloride Cipla 50 mg tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of cyclizine hydrochloride.
Excipients with known effect:
Each tablet contains 37 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off white, circular shaped, flat bevelled uncoated tablet
with central break line on one side
and plain on other.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Cyclizine hydrochloride is indicated 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 Meniere's disease and other forms of vestibular
disturbance.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Route of administration_
: oral
_Adults and Children over 12 Years_
:
50 mg orally, which may be repeated up to three times a day.
_Children 6 – 12 Years_
:
25 mg orally, which may be repeated up to three times a day.
_Children less than 6 years of age_
:
Cyclizine Hydrochloride tablets are not recommended for children less
than 6 years of age.
_Use in the Elderly_
:
There have been no specific studies of Cyclizine hydrochloride in the
elderly. Experience has
indicated that normal adult dosage is appropriate.
To prevent motion sickness Cyclizine hydrochloride should be taken
about one to two hours
before departure.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other anticholinergic agents, Cyclizine hydrochloride may
precipitate incipient
gl