Navidoxine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

meclozine hydrochloride 25 mg

Available from:

UCB Pharma SA

ATC code:

R06AE05

INN (International Name):

meclozine hydrochloride

Pharmaceutical form:

tablet

Authorization status:

Authorised

Authorization date:

2005-06-01

Patient Information leaflet

R1294884-A 
Navidoxine
® 
Meclozine hydrochloride  
tablets 25mg 

NAME OF THE MEDICINAL PRODUCT 
NAVIDOXINE (Meclozine hydrochloride) 

COMPOSITION 
Meclozine hydrochloride 25 mg − Colloidal anhydrous
silica − Maize starch − Calcium stearate − Polyvidone 
K30 − Lactose monohydrate −Talc : q.s. for one tablet 

PHARMACEUTICAL FORM 
Boxes of 10 tablets 

PHARMACOTHERAPEUTIC GROUP 
Medicinal product for the treatment of
nausea, vomiting and vertigo. 

MARKETING AUTHORISATION HOLDER 
UCB Pharma SA 
Allee de la Recherche 60, B-1070 Brussels · Belgium 

MANUFACTURER 
UCB Pharma SA 
Chemin du Foriest, B-1420 Braine-l’ Alleud · Belgium 

INDICATED IN 
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. 

CASES WHERE THE USE OF THE DRUG SHOULD BE AVOIDED 
NAVIDOXINE is contra-indicated in patients with a
known hypersensitivity to the drug, in children under 12 
years of age, in patients suffering from prostate or
liver insufficiency and those having angle-closure 
glaucoma. 

SPECIAL 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 and, in elderly and mentally ill patients, a 
risk of confusion. Elderly patients will start
treatment at reduced dose for
a limited ti

Summary of Product characteristics

5 
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 

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. 

4.4 Special warnings and special precautions for use 

NAVIDOXINE should be used with caution in cases of urinary
retention, digestive or urinary 
obstr