Cinnarizine 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinnarizine

Available from:

Viatris UK Healthcare 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: 5016695291819

Patient Information leaflet

Package leaflet: Information for the patient
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.
• 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.
HOW TO HELP STOP MOTION SICKNESS
The following tips may help you avoid travel
sickness:
At sea:
• Stay on deck and keep your eyes on the horizon
• Keep away from diesel and galley smells
• Do not eat rich and fatty foods while travelling
On the road:
• Keep looking ahead into the distance
• Travel in daylight with a window open
• Make sure children can see out of the windscreen
• Do not read
• Do not eat rich and fatty foods while travelling
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CINNARIZINE
DO NOT TAKE CINNARIZINE IF YOU:
• are allergic to cinnarizine or any of the ot

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
4.1
THERAPEUTIC INDICATIONS
Disorders of balance - maintenance therapy for symptoms of
labyrinthine disorders,
including
vertigo,
tinnitus,
nystagmus,
nausea
and
vomiting
such
as is
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 regime.
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 pri