STUGERON 15 Milligram Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CINNARIZINE

Available from:

McNeil Healthcare (Ireland) Ltd

ATC code:

N07CA02

INN (International Name):

CINNARIZINE

Dosage:

15 Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Antivertigo preparations

Authorization status:

Authorised

Authorization date:

2009-01-16

Patient Information leaflet

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The combined effect of Stugeron and ALCOHOL may
make you feel drowsy, therefore avoid ALCOHOL
while taking this medicine.
■
The combined effect of Stugeron and _tricyclic _
_antidepressants_ and _hypnotics_ (drugs used to treat
MOOD OR SLEEP DISORDERS) may make you drowsy.
■
Some people may experience stomach discomfort
after taking Stugeron. Taking Stugeron after a meal
may help reduce the possibility of stomach
discomfort.
DRIVING AND USING MACHINES
■
Some people may feel drowsy after taking
Stugeron 15. If you are affected in this way, do
not drive or operate machinery.
SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS
■
If you have been told you have an intolerance to
some sugars, contact your doctor before taking
this medicine.
3 HOW TO TAKE THIS MEDICINE
ALWAYS TAKE THIS MEDICINE EXACTLY AS YOUR
DOCTOR OR PHARMACIST HAS TOLD YOU.
■
Do not use more than the stated dose shown in the
table.
■
Stugeron should preferably be taken after meals.
■
For oral use only.
■
The tablets may be sucked, chewed or swallowed
whole with water.
CHILDREN UNDER 5 YEARS
Stugeron is not recommended for children under
5 years old.
DO NOT USE THIS MEDICINE…
■
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 5 YEARS OLD.
■
If you are BREAST-FEEDING.
If any of these apply to you, GET ADVICE FROM
A DOCTOR OR PHARMACIST WITHOUT USING STUGERON.
TALK TO YOUR DOCTOR OR PHARMACIST BEFORE
TAKING THIS MEDICINE…
■
If you have PARKINSON’S DISEASE.
■
If you have low blood pressure.
■
If you have PORPHYRIA (a hereditary BLOOD DISORDER).
■
If you have LIVER or KIDNEY PROBLEMS.
■
If you are FRUCTOSE AND GALACTOSE INTOLERANT.
■
If you are taking ALCOHOL.
■
If you are taking any OTHER MEDICINES, including:
■
_Tranquilisers _(drugs used to RELAX MUSCLES or
DECREASE ANXIETY).
■
_Tricyclic antidepressants _or_ hypnotics _(drugs
used to treat MOOD OR SLEEP DISORDERS).
If you are not sure about an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stugeron 15 mg Tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cinnarizine 15 mg.
Excipients: Each tablet contains 160 mg lactose monohydrate and 15 mg
sucrose.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
A biconvex, circular, white tablet engraved “S|15” on one side and
“Janssen” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the prevention and control of motion sickness.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use. Stugeron should preferably be taken after meals.
Adults:
2 tablets 2 hours before travelling, then 1 tablet every 8 hours
during the journey.
Children 5 - 12 years:
Half the adult dose.
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 upset,
which may be diminished if taken after meals.
Cinnarizine is a vasodilator.
While it has not been found to reduce blood pressure significantly, it
should be used with
caution in those with coronary artery disease or in patients with
hypotension.
In patients with Parkinson's disease, Stugeron should only be given if
the advantages outweigh the possible risk of
aggravating this disease.
Stugeron may cause somnolence, especially at the start of treatment.
Therefore, caution should be taken when alcohol
or CNS depressants or tricyclic antidepressants are used
concomitantly. (See Section 4.5)
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