Stugeron 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cinnarizine

Available from:

Janssen-Cilag 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: 5012674061022

Patient Information leaflet

FACE 1
© J-C 2019
GB - AW_165626
– 1 –
PACKAGE LEAFL ET: INFORMATION FOR THE PATIENT 15 MG TABLETS
Cinnarizine
Stugeron is a registered trademark
READ ALL OF THIS LEAFL ET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
• Keep this leafl et. 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. 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 eff ects, talk to your
doctor or pharmacist. This includes any
possible side eff ects not listed in this
leafl et. See section 4.
WHAT IS IN THIS LEAFL ET
1 WHAT STUGERON TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU
TAKE STUGERON TABLETS
3 HOW TO TAKE STUGERON TABLETS
4 POSSIBLE SIDE EFF ECTS
5 HOW TO STORE STUGERON TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT STUGERON TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Stugeron
15 mg tablets. It is called Stugeron
tablets in this leafl et.
The tablets contain a medicine called
cinnarizine that helps symptoms caused
by balance or movement problems.
Stugeron tablets are used:
• to control motion sickness
• for problems with balance (such as
Ménières disease) to treat symptoms of:
- feeling dizzy or lightheaded
- ringing in the ears
- feeling sick (nausea) and being sick
(vomiting)
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
AW_165626.pdf - Page 1 of 5 - November 19, 201

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Stugeron
15 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 15 mg cinnarizine.
Excipients with known effect:
Each tablet contains 160 mg lactose monohydrate and 15 mg sucrose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White circular tablet with S/15 on one side and JANSSEN on the other
side.
4
CLINICAL PARTICULARS
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.
Prophylaxis of motion sickness
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Oral. The tablets may be chewed, sucked or swallowed whole.
Posology
Stugeron should preferably be taken after meals.
Vestibular symptoms
Adults, elderly and children over 12 years: 2 tablets three times a
day.
Children 5 to 12 years: One half the adult dose.
These doses should not be exceeded.
Motion sickness
Adults, elderly and children over 12 years: 2 tablets 2 hours before
you travel
and 1 tablet every 8 hours during your journey.
Children 5 to 12 years: One half the adult dose.
4.3.
CONTRA-INDICATIONS
Stugeron should not be given to patients with known hypersensitivity
to
cinnarizine.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other antihistamines, Stugeron may cause epigastric
discomfort;
taking it after meals may diminish the gastric irritation.
In patients with Parkinson’s Disease, Stugeron should only be given
if the
advantages outweigh the possible risk of aggravating this disease.
Because of its antihistamine effect, Stugeron 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 renal dysfunction.
Stugeron
should be used with care in patients with hepatic or renal
insufficiency.
Patients with rare hereditary problems of fructose