CLONEX 0.5 MG

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

CLONAZEPAM

Tilgængelig fra:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC-kode:

N03AE01

Lægemiddelform:

TABLETS

Sammensætning:

CLONAZEPAM 0.5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Terapeutisk gruppe:

CLONAZEPAM

Terapeutisk område:

CLONAZEPAM

Terapeutiske indikationer:

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.

Autorisation dato:

2012-12-31

Indlægsseddel

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

Produktets egenskaber

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