Stugeron 25 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cinnarizine

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

N07CA; N07CA02

INN (International Name):

Cinnarizine

Dosage:

25 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Antivertigo preparations; cinnarizine

Authorization status:

Marketed

Authorization date:

1979-04-01

Patient Information leaflet

TOP
STUGERON
®
25MG TABLETS
_CINNARIZINE_
PACKAGE LEAFLET: INFORMATION FOR THE USER.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always use 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 doctor or pharmacist if you need more
information or advice.
■
This medicine has been prescribed for you only. Do not
pass it onto 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.
WHAT IS IN THIS LEAFLET:
1. What Stugeron is and what it is used for _see section 1_
2. What you need to know before you take Stugeron
_see section 2_
3. How to take Stugeron _see section 3_
4. Possible side effects _see section 4_
5. How to store Stugeron _see section 5_
6. Contents of the pack and other information _see section 6_
1 WHAT STUGERON IS AND WHAT IT
IS USED FOR
Stugeron is a medicine which is used to treat the symptoms
caused by poor blood flow to the limbs, for example pain in
the legs while walking, pain on resting the limbs, muscular
cramps, cold or numb fingers and toes. It is also used to
treat disorders where there is spasm of blood vessels
e.g. Raynaud’s disease. The tablets contain cinnarizine
which works by preventing the narrowing of blood vessels.
2 BEFORE YOU TAKE STUGERON
This medicine is suitable for most adults and children
12 years and over, but a few people should not use it.
If you are in any doubt, talk to your doctor or pharmacist.
DO NOT USE STUGERON...
■
If you have ever had a BAD REACTION (such as a rash,
itching, swollen face or lips, or shortness of breath)
to any of the ingredients.
■
If it is for a child UNDER 12 YEARS OLD.
■
If you are BREAST-FEEDING.
If any of these apply to you, GET ADVICE FROM A DOCTOR
OR PHARMACIST WITHOUT USING STUGERON.
T

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stugeron 25 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25mg cinnarizine.
Excipients: Contains lactose monohydrate 158.8mg and sucrose 15.0mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White tablets marked ‘JANSSEN’ on one side and ‘S/25’ on the
other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stugeron is
indicated in peripheral
vascular
disease when such symptoms
as
intermittent
claudication and cold
extremities exist and in vasospastic disorders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Stugeron Tablets are for oral administration to adults.
PERIPHERAL VASCULAR DISEASE:
The usual dose is 50 to 75 mg (2-3 tablets) two to three times daily.
Stugeron should preferably be taken after meals.
These doses should not be exceeded.
Peripheral arterial disease is slow to improve with any form of drug
treatment.
Maximum benefits with Stugeron will
not be seen until after several weeks of continuous treatment although
significant improvement in blood flow has
frequently been demonstrated after 1 week.
_Use in elderly:_
as above
_Use in children:_
not recommended
4.3 CONTRAINDICATIONS
Stugeron Tablets are contra-indicated in patients with known
hypersensitivity to cinnarizine or to any excipients listed
in Section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As with other antihistamines, Stugeron may cause epigastric
discomfort; taking it after meals may diminish gastric
irritation.
Stugeron has not been found to reduce blood pressure significantly.
However, the drug should be used with reasonable
caution in hypotensive patients.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___