Diazepam STADA 5 mg tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

DIAZEPAM 5 mg/stuk

INN (Algemene Internationale Benaming):

DIAZEPAM 5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL, GEPREGELATINEERD

Toedieningsweg:

Oraal gebruik

Autorisatie datum:

1900-01-01

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam STADA 2 mg tabletten
Diazepam STADA 5 mg tabletten
Diazepam STADA 10 mg tabletten
diazepam
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 Diazepam STADA is and what it is used for
2. What you need to know before you take Diazepam STADA
3. How to take Diazepam STADA
4. Possible side effects
5. How to store Diazepam STADA
6. Contents of the pack and further information
1. WHAT DIAZEPAM STADA IS AND WHAT IT IS USED FOR
Diazepam STADA contains the active substance diazepam, which belongs
to a group of
medicines called benzodiazepines.
Diazepam STADA is used for the treatment of the following conditions:
In adults:
•
symptoms of anxiety
•
symptoms that occur during alcohol withdrawal
In adults and children over 6 years old:
•
muscle spasms or pain caused by inflammation of muscles and joints or
trauma, including
spasms caused by conditions such as cerebral palsy (group of disorders
that affect the
ability to move, maintain balance and posture) and paraplegia
(paralysis of the lower half of
the body, affecting both legs) as well as athetosis (continuous,
involuntary, slow movements
and unusual fingers and hands) and stiff-person syndrome
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM STADA
DO NOT TAKE DIAZEPAM STADA IF YOU
•
are allergic to diazepam or any of the other ingredients of this
medicine (listed in section 6)
•
have a condition called myasthenia gravis which causes muscles to
weaken and tire easily
•
have acute respir

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Diazepam STADA 2 mg tabletten
Diazepam STADA 5 mg tabletten
Diazepam STADA 10 mg tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg diazepam.
Each tablet contains 5 mg diazepam.
Each tablet contains 10 mg diazepam.
Excipient(s) with known effect
Each tablet contains 159.70 mg lactose.
Each tablet contains 156.85 mg lactose.
Each tablet contains 152.10 mg lactose.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Tablet is white to almost white round, flat, 8.0 mm in diameter, with
“2” on one side and break
line on the other side.
Tablet is white to almost white round, flat, 8.0 mm in diameter, with
“5” on one side and break
line on the other side.
Tablet is white to almost white round, flat, 8.0 mm in diameter, with
“10” on one side and break
line on the other side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Adults _
•
symptomatic treatment of anxiety
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the
individual to extreme distress.
•
symptomatic treatment of Alcohol Withdrawal syndrome
_Adults and children over 6 years old _
•
symptomatic treatment of skeletal muscle spasm (inflammation of
muscles or joints,
trauma), including spasticity caused by upper motor neuron disorders
(such as cerebral
palsy, paraplegia as well as athetosis and stiff-person syndrome)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dosage should be adapted to each particular condition. Treatment
should begin at the
lowest effective dose and then gradually increased until optimal
effect is reached.
ADULTS
_Anxiety _
•
Usual dose: 2 mg to 5 mg diazepam two to three times daily.
•
Maximum dose: In severe cases the dose may be incrementally increased
up to 30 mg
diazepam daily in 2 to 4 divided doses. Adjusted on an individual
basis.
•
The lowest dose which can control symptoms should be used.
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