País: Malta
Idioma: inglés
Fuente: Malta Medicines Authority
MECLOZINE HYDROCHLORIDE
Gen-Orph SAS 185, Les Bureaux de la Coline, 92213, St Cloud Cedex, ACS 539.121.921, France
R06AE05
MECLOZINE HYDROCHLORIDE 25 mg
TABLET
MECLOZINE HYDROCHLORIDE 25 mg
OTC
ANTIHISTAMINES FOR SYSTEMIC USE
Authorised
2005-06-01
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 Leer el documento completo
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. Page 1 of 5 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 Leer el documento completo