Diazepam 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Arrow Generics Ltd

ATC code:

N05BA01

INN (International Name):

Diazepam

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Diazepam 5 mg tablets
Diazepam 10 mg tablets
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 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

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam 5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg diazepam.
Excipient:
Each diazepam 5 mg tablet contains 122 mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
5 mg: Pale yellow mottled, round, approximately 8.0 mm in diameter,
flat, bevel
edged tablets, debossed with ‘CY’ 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.
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. Patients who have
taken
benzodiazepines for a prolonged time may require a longer period
during which doses
are reduced.
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