Dalpam 5 mg tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DIAZEPAM 5 mg/stuk

Beschikbaar vanaf:

Neogen Developments N.V. Square Marie Curie 50 1070 ANDERLECHT (BELGIË)

ATC-code:

N05BA01

INN (Algemene Internationale Benaming):

DIAZEPAM 5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

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

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Diazepam

Product samenvatting:

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

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
DALPAM 2 MG TABLETTEN
DALPAM 5 MG TABLETTEN DALPAM 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 Dalpam is and what it is used for
2.
What you need to know before you take Dalpam
3.
How to take Dalpam
4.
Possible side effects
5.
How to store Dalpam
6.
Contents of the pack and further information
1.
WHAT DALPAM IS AND WHAT IT IS USED FOR
Dalpam contain the active substance diazepam which belongs to a group
of medicines called
benzodiazepines. Dalpam has anxiolytic, sedative and muscle relaxant
effect.
Dalpam is used:
-
in the treatment of anxiety.
-
in the treatment of muscle spasms, including those caused by cerebral
spasticity (originates in
the brain).
-
for symptoms of alcohol withdrawal.
-
to provide sedation before operations (premedication).
Your doctor may prescribe Dalpam for other uses. Please follow your
doctor’s instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALPAM
DO NOT TAKE DALPAM
-
if you are
ALLERGIC
to diazepam or any of the other ingredients of this medicine (listed
in
section 6).
-
if you have a condition called
MYASTHENIA GRAVIS
which causes muscles to weaken and tire
easily.
-
if you suffer from
SLEEP APNOEA
(a sleep disorder where you have abnormal pauses in
breathing during sleep).
-
if you have
SEVERE LIVER
disorders.
-
if you have
ACUTE RESPIRATORY DEPRESSION
(slow and/or shallow breathing).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Dalpam
3
-
if you have a

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
Dalpam 2 mg tabletten
Dalpam 5 mg tabletten
Dalpam 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 Dalpam 2 mg tablet contains 168.1 mg lactose monohydrate.
Each Dalpam 5 mg tablet contains 165.1mg lactose monohydrate.
Each Dalpam 10 mg tablet contains 160.1 mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Dalpam 2 mg: white to almost white round, flat, 8 mm in diameter with
“2” on one side and a break
line on the other side.
Dalpam 5 mg: Tablet is white to almost white round, flat, 8 mm in
diameter with “5” on one side and
a break line on the other side.
Dalpam 10 mg: Tablet is white to almost white round, flat, 8 mm in
diameter with “10” on one side
and a break line on the other side.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Anxiety.
- Adjunct in the control of skeletal muscle spasm, including
spasticity caused by upper motor
neuron disorders (such as cerebral palsy).
- Alcohol withdrawal symptoms.
- Premedication before general anaesthesia or for sedation during
minor surgical or investigative
procedures.
Benzodiazepines are only indicated when the disorder is severe,
disabling or subjecting the individual
to extreme distress.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Standard dosage
3
For optimal effect, the dosage should be carefully individualised.
Treatment should begin at the
lowest effective dose appropriate to the particular condition.
Duration of treatment
The duration of treatment should be as short as possible (see section
4.4). The patient should be re-
evaluated after a period of no more than 4 weeks and then regularly
thereafter in order to assess the
need for continued treatment, especially in case the patient is
symptom free. In general, treatment
mu