NAVIDOXINE 25 mg tablets (Meclozine hydrochloride)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MECLOZINE HYDROCHLORIDE

Available from:

Gen-Orph SAS 185, Les Bureaux de la Coline, 92213, St Cloud Cedex, ACS 539.121.921, France

ATC code:

R06AE05

INN (International Name):

MECLOZINE HYDROCHLORIDE 25 mg

Pharmaceutical form:

TABLET

Composition:

MECLOZINE HYDROCHLORIDE 25 mg

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2005-06-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NAVIDOXINE 25 MG TABLETS
Meclozine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR 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 Navidoxine is and what it is used for
2.
What you need to know before you take Navidoxine
3.
How to take Navidoxine
4.
Possible side effects
5.
How to store Navidoxine
6.
Contents of the pack and other information
1.
WHAT NAVIDOXINE IS AND WHAT IT IS USED FOR
Navidoxine is indicated in adult and adolescent over 12 years old, for
the prevention and symptomatic
treatment of nausea, vomiting and vertigo associated with motion
sickness.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NAVIDOXINE
DO NOT TAKE NAVIDOXINE:
-
if you are allergic to active substance or any of the other
ingredients of this medicine (listed in
section 6).
-
in children under 12 years of age,
-
in patients suffering from prostate or liver insufficiency and those
having angleclosure
glaucoma.
WARNINGS AND PRECAUTIONS
Navidoxine should be used with caution in case of urinary retention,
digestive or urinary obstruction,
in some cases of excessive muscular fatigue (myasthenia), decreased
gastro- intestinal motility, in
case of treatment with some drugs (antidepressants, hypnotics and
tranquillizers) and in case of
alcohol intake. Special precaution is recommended when administering
Navidoxine to elderly
patients (sensitivity to undesirable effects) and to patients driving
a car or operating dangerous
machinery (risk of sedation).
Moreover, in case of prolonged use, there is a risk of dental caries

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NAVIDOXINE® 25 mg tablets (Meclozine hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains: meclozine hydrochloride 25 mg. For excipients,
see 6.1
3.
PHARMACEUTICAL FORM
Tablets.
White, oblong tablet with scored line on both sides, length 9 mm and
width 5 mm. The
tablet can be divided in two equal doses.
4.
CLINICAL PARTICULARS
4.1 Therapeutic indications
Meclozine is indicated in adult and adolescent over 12 years old, for
the prevention
and symptomatic treatment of nausea, vomiting and dizziness associated
with travel
sickness.
4.2 Posology and method of administration
_Dosage adults and children over 12 years: _
For motion sickness, the recommended initial dose is 25 to 50 mg taken
one hour
before departure and repeated every 24 hours during the journey.
_Dosage in elderly subjects: _
Elderly subjects should start the treatment with fractionated
doses (half doses), to be increased gradually according to
tolerability and the clinical
response.
_Patients with renal impairment: _
As elimination is non-renal, the dosage remains the same
and no special precautions are needed.
Dosage reduction may be required if NAVIDOXINE is used simultaneously
with
other central nervous system depressant drugs, with drugs having
anticholinergic
properties, or with MAO inhibitors (see Section 4.5).
4.3 Contraindications
NAVIDOXINE is contraindicated in subjects who have previously
exhibited
hypersensitivity to one of the ingredients of the drug or to
piperazine derivatives. It is
contraindicated in children under 12 years of age, in patients with
prostatism and closed-
angle glaucoma and in patients suffering from hepatic insufficiency.
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4.4 Special warnings and special precautions for use
NAVIDOXINE should be used with caution in cases of urinary retention,
digestive or
urinary obstruction, myasthenia, decreased gastro-intestinal motility,
in the event of
treatment with MAOIs and with the concomitant ingestion of alcohol
Parti