Diazepam 5mg tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIAZEPAM

Available from:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC code:

N05BA01

INN (International Name):

DIAZEPAM 5 mg

Pharmaceutical form:

TABLET

Composition:

DIAZEPAM 5 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Withdrawn

Authorization date:

2017-11-29

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam 5 mg tablets
Diazepam 10 mg tablets
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 Tablets are and what they are used for
2.
What you need to know before you take Diazepam Tablets
3.
How to take Diazepam Tablets
4.
Possible side effects
5.
How to store Diazepam Tablets
6.
Contents of the pack and other information
1.
WHAT DIAZEPAM TABLETS ARE AND WHAT THEY ARE USED FOR
Diazepam Tablets contain the active substance diazepam which belongs
to a group of medicines called
benzodiazepines. Diazepam has anxiolytic, sedative and muscle relaxant
effect.
Diazepam Tablets are used:
In adults
-
short-term (2-4 weeks) symptomatic treatment of anxiety that is
severe, disabling or subjecting
the individual to extreme distress
-
Symptomatic treatment of acute alcohol withdrawal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM TABLETS
DO NOT TAKE DIAZEPAM TABLETS IF YOU:
-
are
ALLERGIC
(hypersensitive) to diazepam or to other benzodiazepine medicines or
to any of the
other ingredients of this medicine (see section 6).
-
have a condition called
MYASTHENIA GRAVIS
which causes muscles to weaken and tire easily.
-
suffer from
SLEEP APNOEA
(a sleep disorder where you have abnormal pauses in breathing during
sleep).
-
have
SEVERE LIVER
disorders.
-
have
ACUTE RESPIRATORY DEPRESSION
(slow and/or shallow breathing).
-
have
ACUTE INTOXICATION WITH OTHER CNS ACTIVE SUBSTANCES
(e.g. hypnotics, analgesics,
antidepressants, antipsychotics).
WARNINGS AND

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Diazepam 5 mg tablets
Diazepam 10 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg diazepam.
Each tablet contains 10 mg diazepam.
Excipient:
Each diazepam 5 mg tablet contains 122 mg lactose.
Each diazepam 10 mg tablet contains 117 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
5 mg: White to off white, round, approximately 8.0 mm in diameter,
flat, bevel edged tablets,
debossed with ‘CY’ on one side and plain on other side.
10 mg: White to off white, round, approximately 8.5 mm in diameter,
flat, bevel edged tablets,
debossed with ‘CZ’ on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Adult
-
Short-term (2-4 weeks) symptomatic treatment of anxiety that is
severe, disabling or
subjecting the individual to extreme distress
-
Symptomatic treatment of acute alcohol withdrawal.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Standard dosage
For optimal effect, the dosage should be carefully individualised.
Treatment should begin at the
lowest effective dose appropriate to the particular condition.
In order to obtain suitable doses of less than 5mg diazepam
alternative products have to be used.
Duration of treatment
The duration of treatment should be as short as possible. In general,
treatment should not last longer
than 4 weeks including tapering off process. Extension beyond this
period should not take place
without re-evaluation of the patient’s status.
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The patient must 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.
-
Long-term chronic use is not recommended. In certain cases, extension
beyond the
maximum treatment period may be necessary; if so, it should not take
place without re-
evaluation of the patient’s status with special expertise.
_Tapering off _
Treatment should always be tapered off gradually. Patie