Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
CLONAZEPAM
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
N03AE01
TABLETS
CLONAZEPAM 0.5 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
CLONAZEPAM
CLONAZEPAM
Typical or atypical petit mal, Lennox - Gastaut syndrome (petit mal variant), generalized primary or secondary tonic-clonic seizures including grand mal and focal seizures. Panic disorder.
2012-12-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only CLONEX ® 0.5 MG Tablets COMPOSITION Each tablet contains: Clonazepam 0.5 mg CLONEX ® 2 MG Tablets COMPOSITION Each tablet contains: Clonazepam 2 mg For information regarding inactive ingredients and allergens, see section 2 under “Important information about some of the ingredients of the medicine” and section 6 – “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for your treatment. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. INTRODUCTION TO THE CONSUMER LEAFLET FOR BENZODIAZEPINES This medicine belongs to the benzodiazepines group, which has special characteristics that require extra care during use. It is highly important to be under close medical supervision when taking this medicine. The following paragraph refers only to a short-term treatment with the medicine: • When taking this medicine, be sure to refer to the doctor after 2-4 weeks, since the treatment is only intended for short time periods. • Prolonged use of this medicine may cause the effect of the medicine to decrease. • Prolonged use may cause severe dependency, which will make it difficult for the patient to stop taking the medicine. • Uncontrolled discontinuation of the treatment may be accompanied by withdrawal effects such as: stress, agitation, confusion, tremor, insomnia, abdominal pain, vomiting, nausea, sweating, spasms, cramps and muscle pain. • Prolonged use of this medicine may sometimes cause changes in behavioral patterns and obsessive thoughts. • Care should be taken when walking, especially in the elderly, since the medicine impairs alertness and sometimes the coordination of body movements, wh Citiți documentul complet
Clonex 0.5mg, 2mg KL 04/2022 Notification SUMMARY OF PRODUCT CHARACTERISTICS CLONEX ® 1. NAME OF THE MEDICINAL PRODUCT CLONEX ® 0.5 MG CLONEX ® 2 MG Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clonex 0.5 mg - each tablet contains clonazepam 0.5 mg Excipient with known effect: 75 mg of lactose monohydrate and 0.188 mg of color FD&C Yellow No. 6. Clonex 2 mg - each tablet contains clonazepam 2 mg Excipient with known effect: 120 mg of lactose monohydrate. For the full list of excipients, see "DESCRIPTION" 3. THERAPEUTIC INDICATIONS Typical or atypical petit mal, Lennox - Gastaut syndrome (petit mal variant), generalized primary or secondary tonic-clonic seizures including grand mal and focal seizures. Panic disorder. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL REACTIONS CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH . RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE WARNING AND PRECAUTIONS). THE USE OF BENZODIAZEPINES , INCLUDING CLONAZEPAM TABLETS, EXPOSES USERS TO RISKS OF ABUSE, MISUSE , AND ADDICTION, WHICH CAN LEAD TO OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING CLONAZEPAM TABLETS AND THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE, AND ADDICTION (SEE WARNINGS). THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING CLONAZEPAM TABLETS, MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE REDUCTION Citiți documentul complet