Cinnarizine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinnarizine

Available from:

Teva UK Ltd

ATC code:

N07CA02

INN (International Name):

Cinnarizine

Dosage:

15mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04060000; GTIN: 5017007300694

Patient Information leaflet

CINNARIZINE 15 MG TABLETS
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 2-3 days.
1. What Cinnarizine is and what it is used for
2. What you need to know before you take
Cinnarizine
3. How to take Cinnarizine
4. Possible side effects
5. How to store Cinnarizine
6. Contents of the pack and other information
WHAT CINNARIZINE IS AND WHAT IT IS
USED FOR
• Cinnarizine tablets belong to a group of
drugs known as antihistamines.
• Cinnarizine is used to:
•
control travel sickness
•
treat symptoms seen in Ménière’s
disease which include vertigo (a spinning
feeling), tinnitus (a ringing in your ears)
and feeling or being sick.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CINNARIZINE
DO NOT TAKE CINNARIZINE:
• if you are allergic to Cinnarizine or any of
the other ingredients of this medicine
(listed in section 6).
• if you have a hereditary metabolic disorder
called porphyria (a deficiency of specific
enzymes within the body, causing an
increase in substances called porphyrins).
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING CINNARIZINE TABLETS
• if you suffer from Parkinson’s disease.
OTHER MEDICINES AND CINNARIZINE
TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF
THE FOLLOWING:
• tricyclic antidepressant medication, or any
other form of sedative.
If you need to have a skin test for allergies,
tell your doctor that you are taking
Cinnarizine tablets as these may affect the
result. You should stop taking your tablets at
least 4 days before you have the

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cinnarizine15mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cinnarizine 15mg
Excipient(s) with known effect
Each tablet contains 170 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White flat, bevelled-edged tablets, about 9 mm in diameter, coded
‘CNZ 15’ with
breakline on one side, twin triangle logo on reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cinnarizine is used for the control of vestibular disorders such as
vertigo,
tinnitus, nausea and vomiting as seen in Meniere’s disease.
Cinnarizine is also
effective in the control of motion sickness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cinnarizine is for oral administration to both adults and children
according to
the following dosage regimen:
VESTIBULAR SYMPTOMS
ADULTS AND CHILDREN OVER 12 YEARS:
2 tablets three times a day.
CHILDREN 5 – 12 YEARS:
Half the adult dose.
MOTION SICKNESS
ADULTS AND CHILDREN OVER 12 YEARS:
2 tablets 2 hours before travel and 1 tablet every 8 hours during
journey if
necessary.
CHILDREN 5 – 12 YEARS:
Half the adult dose.
Route of Administration
Oral
4.3
CONTRAINDICATIONS
Contra-indicated in porphyria and in patients with known
hypersensitivity to
cinnarizine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other antihistamines, cinnarizine may cause epigastric
discomfort;
taking it after meals may diminish gastric irritation. Cinnarizine
should only
be given to patients with Parkinson’s disease if the advantages
outweigh the
possible risk of aggravating this disease.
4.5
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Concurrent use of alcohol, CNS depressants or tricyclic
antidepressants may
potentiate the sedative effects of these drugs, or cinnarizine.
The antihistamine effect of cinnarizine may prevent an otherwise
positive
reaction to dermal reactivity indicators if used within 4 days prior
to skin
testing.
4.6
PREGNANCY AND LACTATIO