Cinnarizine 15mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Cinnarizine

Saadav alates:

A A H Pharmaceuticals Ltd

ATC kood:

N07CA02

INN (Rahvusvaheline Nimetus):

Cinnarizine

Annus:

15mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04060000; GTIN: 5025903003830

Infovoldik

Package leaflet: Information for the patient
CINNARIZINE 15 MG
TABLETS
cinnarizine
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.
• 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 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.
1. WHAT CINNARIZINE IS AND WHAT IT IS USED FOR
Cinnarizine belongs to a group of medicines
called antihistamines. Cinnarizine is used
to control problems with balance (such as
Meniere's disease) which can cause vertigo (a
spinning sensation or dizziness), ringing in the
ears, nausea (feeling sick), vomiting (being sick)
and loss of hearing. Cinnarizine can also help to
control travel sickness.
This medicine is for use in adults and children
aged over 5 years.
2. 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).
WARNINGS AND PRECAUTIONS - TALK TO YOUR
DOCTOR OR PHARMACIST BEFORE TAKING
CINNARIZINE IF YOU:
• suffer from Parkinson's disease (Cinnarizine
may make your symptoms worse).
• need a skin allergy test, as Cinnarizine can
affect the results. You will need to STOP taking
Cinnarizine 4 days before the test.
• have a blood problem called porphyria.
• have problems with your liver or kidne

Toote omadused

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