Cinnarizine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinnarizine

Available from:

Mawdsley-Brooks & Company 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

Patient Information leaflet

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Cinnarizine 15 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg of cinnarizine.
Excipient with known effect:
Each tablet contains 162.5 mg lactose anhydrous
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
White, flat bevel edged tablets marked “G” on both sides
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cinnarizine is used for the control of vestibular disorders such as
vertigo, tinnitus,
nausea and vomiting such as that seen in Meniere's disease.
Cinnarizine is also effective in the control of motion sickness.
4.3
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Vestibular symptoms:
_Adults, elderly and children over 12 years: _
Two tablets three times a day.
_Children 5-12 years: _
One tablet three times a day.
The stated doses should not be exceeded.
Motion sickness:
_Adults, elderly and children over 12 years: _
Two tablets two hours before travel and one tablet every eight hours
during journey if
necessary.
_Children 5-12 years: _
One tablet two hours before travel and half a tablet every eight hours
during journey if
necessary.
Method of administration
For oral use.
Cinnarizine should preferably be taken after meals. The tablets may be
sucked,
chewed or swallowed whole with water.
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 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.
Because of its antihistamine effect, cinnarizine may prevent an
otherwise positive reaction to
dermal reactivity indicators if used within 4 days prior to testing.
Use of cinnarizine should be avoided in porphyria.
There have been no specific studies in hepatic or rena