STUNARONE TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CINNARIZINE

Available from:

J-C HEALTH CARE LTD

ATC code:

N07CA02

Pharmaceutical form:

TABLETS

Composition:

CINNARIZINE 25 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

JANSSEN CILAG S.P.A., ITALY

Therapeutic group:

CINNARIZINE

Therapeutic area:

CINNARIZINE

Therapeutic indications:

Symptomatic treatment of nausea and vertigo due to meniere's disease and other labyrinthine disturbances and for travel sickness.

Authorization date:

2022-09-30

Patient Information leaflet

The tablet can be halved to ease administration, but not for
taking a partial dose. Please use a tablet splitter to halve
the tablet.
There is no information about crushing/chewing.
IF YOU ACCIDENTALLY TOOK A HIGHER DOSAGE, or if a child has
accidentally swallowed the medicine, refer immediately to a
doctor or proceed to a hospital emergency room and bring
the package of the medicine with you.
Too high a dose of Stunarone Tablets may be manifested
by the following signs and symptoms: alterations in
consciousness, ranging from sleepiness to loss of
consciousness and coma, vomiting, muscle weakness
or lack of coordination and seizures, low blood pressure.
Death has been reported in association with cinnarizine
overdose. IF YOU SUSPECT THAT YOU TOOK AN OVERDOSE,
REFER IMMEDIATELY TO THE DOCTOR.
IF YOU FORGOT TO TAKE THE MEDICINE at the required time, do
not take a double dose. Take the next dose at the scheduled
time and consult a doctor.
Adhere to the treatment regimen as recommended by the
doctor.
Even if there is an improvement in your health, do not stop
treatment with the medicine without consulting the doctor.
DO NOT TAKE MEDICINES IN THE DARK! CHECK THE LABEL AND
THE DOSE EACH TIME YOU TAKE MEDICINE. WEAR GLASSES
IF YOU NEED THEM.
IF YOU HAVE FURTHER QUESTIONS REGARDING USE OF THE
MEDICINE, CONSULT THE DOCTOR OR PHARMACIST.
4. SIDE EFFECTS
As with any medicine, use of Stunarone may cause side
effects in some users. Do not be alarmed by the list of side
effects. You may not suffer from any of them.
Side effects which require special attention:
An allergic reaction, manifested by swelling of the face or
throat. Hives, irritation, redness or blistering of the skin. Refer
to a doctor as soon as possible.
Common side effects – effects occurring in 1-10 in 100 users
• Sleepiness
• Weight gain
• Nausea
Uncommon side effects – effects occurring in 1-10 in 1,000
users
• Longer than usual nocturnal sleep
• Vomiting
• Excessive sweating
• Tiredness
• Appearance of red and itchy round lesions or itchy

Summary of Product characteristics

1
Stunarone SPC 11.2020
STUNARONE TABLETS
COMPOSITION
_Active substances _
Cinnarizine.
_Excipients:_
_ _lactose monohydrate, maize starch, sucrose, talc, cottonseed oil
hydrogenated, polyvidone K 90.
PHARMACEUTICAL FORM AND ACTIVE SUBSTANCE QUANTITY PER UNIT
Stunarone tablets 25 mg.
White, circular, biconvex, halfscored tablet with the inscription
“JANSSEN” on one side and “S/25”
on the other side.
_Therapeutic indications _
Symptomatic treatment of nausea and vertigo due to Meniere's disease
and other labyrinthine
disturbances and for travel sickness.
DOSAGE/ADMINISTRATION
_Disorders of balance: _
In adults: 1 tablet of 25 mg t.i.d.
_Motion sickness: _
in adults: 1 tablet of 25 mg half an hour before traveling; to be
repeated every 6 hours.
in children (5-12): half of the adult dose is recommended.
Stunarone tablets should preferably be taken after meals with some
liquid.
Stunarone tablet may be divided at the score line only for easier
administration, but not for
administering a partial dose. Please use a tablet divider to achieve
half a dosage. CONTRAINDICATIONS
Stunarone tablets is contraindicated in patients with a history of
extrapyramidal symptoms,
Parkinsonism or depression.
Insufficient clinical data are as yet available for use of Stunarone
tablets in children aged under 5
years.
Stunarone tablets should not be used in cases of recent myocardial
infarction or hypersensitivity
to the active substance or any other ingredient listed in the
excipient section.
WARNINGS AND PRECAUTIONS
Elderly patients in particular must be investigated during treatment
for the occurrence of
extrapyramidal symptoms and depression. If these occur,, the product
must be discontinued.
Caution is required in cases of pronounced arterial hypertension.
Stunarone tablets can cause
somnolence, especially at the start of treatment. Therefore, special
caution is required when
alcohol, CNS depressants or Tricyclic antidepressants are used
concomitantly with Stunarone
tablets.
Like other antihistamines, Stunarone tablets can caus