ASSIVAL 2 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

DIAZEPAM

Disponibil de la:

TEVA ISRAEL LTD

Codul ATC:

N05BA01

Forma farmaceutică:

TABLETS

Compoziție:

DIAZEPAM 2 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Zonă Terapeutică:

DIAZEPAM

Indicații terapeutice:

Tension, anxiety, agitation due to acute alcohol withdrawal, adjunct for the relief of skeletal muscle spasm, convulsive disorders.

Data de autorizare:

2021-01-31

Prospect

Assival 2,5,10mg Tablets PIL, NA-SD, 05-2023 Notification
PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
ASSIVAL 2 MG
TABLETS
ASSIVAL 5 MG
TABLETS
ASSIVAL 10 MG
TABLETS
ACTIVE INGREDIENT
ACTIVE INGREDIENT
ACTIVE INGREDIENT
Each tablet contains:
Diazepam 2 mg
Each tablet contains:
Diazepam 5 mg
Each tablet contains:
Diazepam 10 mg
Inactive ingredients and allergens: see section 2 under
‘Important information about
some
of this medicine’s ingredients’, and section 6 ‘Additional
information'.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
INTRODUCTION
This medicine belongs to the group of benzodiazepines, which has
special properties that
require extreme caution when used.
•
Close medical follow-up is very important when taking this medicine.
•
When you take this medicine, be sure to contact your doctor after 2-4
weeks, as the
treatment is only intended for short periods of time.
•
Prolonged use of this medicine may cause it to be less effective.
•
This use may lead to a serious side effect of dependence, where it
will be difficult for
the patient to stop taking the medicine.
•
Uncontrolled discontinuation of treatment is accompanied by withdrawal
symptoms
such as tension, nervousness, confusion, tremors, insomnia, abdominal
pain, nausea,
vomiting, sweating, spasms.
•
At times, prolonged use of this medicine may cause changes in
behavioural patterns
and intrusive thoughts.
•
Particularly in the elderly, be careful when walking, as the medicine
inhibits alertness
and at times coordination of body movements, and therefore there is a
concern of
slips and falls.
TAKING THIS MEDICINE AL

Caracteristicilor produsului

Assival notification NA-SD 05.2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Assival 2mg tablets
Assival 5mg tablets
Assival 10mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Assival 2mg: Each tablet contains 2mg Diazepam.
Assival 5mg: Each tablet contains 5mg Diazepam.
Assival 10mg: Each tablet contains 10mg Diazepam.
Excipients with known effect
Each Assival 2mg tablet contains 74.0mg lactose
Each Assival 5mg tablet contains 72.0mg lactose, 0.03mg FD&C Yellow
No.6 (E110)
Each Assival 10mg tablet contains 48.8mg lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Uncoated tablets.
Assival 2mg: white, round flat tablet with beveled edges, scored in
half on one side, engraved "TEVA" on the other.
Assival 5mg: yellow, round flat tablet with beveled edges, scored in
half on one side, engraved "TEVA" on the other.
Assival 10mg: light blue, round flat tablet with beveled edges, scored
in half on one side, engraved "TEVA" on the other.
All tablets can be divided into 2 equal doses.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
• CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION,
COMA, AND DEATH [SEE SECTION 4.4].
• RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN 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.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Tension, anxiety, agitation due to acute alcohol withdrawal, adjunct
for the relief of skeletal
muscle spasm, convulsive
disorders.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Posology
INFORMATION FOR PATIENTS
Treatment is usually intended for short periods only. Patients should
be instructed to consult their physician after 2-4
weeks of the treatment.
Since benzodiazepines may produce psychologic and physical dependence,
patients should be advised to consult their
physician before in