Diazepam 2mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Diazepam

Available from:

Teva UK Ltd

ATC code:

N05BA01

INN (International Name):

Diazepam

Dosage:

2mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 4 (CD Benz)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010200; GTIN: 5017007110941

Patient Information leaflet

However, you would not be committing an offence if:
•
The medicine has been prescribed to treat a
medical or dental problem and
•
You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
•
It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.
DIAZEPAM CONTAINS LACTOSE AND E110 (SUNSET YELLOW)
•
Patients who are intolerant to LACTOSE should note
that Diazepam Tablets contain a small amount of
lactose. If your doctor has told you that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.
•
The 5 mg tablet contains E110 (SUNSET YELLOW), which
may cause allergic reactions.
HOW TO TAKE DIAZEPAM
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. You should continue to
take these tablets for as long as your doctor tells you to.
The tablets should be swallowed with a drink of water.
Your doctor will decide on the correct dosage; the
recommended dose is:
ANXIETY:
•
ADULTS: 2 mg three times daily. If your symptoms
are severe you may be given 15 – 30 mg daily
taken in divided doses.
MUSCLE SPASM:
•
ADULTS: 2 - 60 mg daily taken in divided doses.
•
CHILDREN: 2 - 40 mg daily taken in divided doses.
For both adults and children the dose is dependent
on the symptoms, your doctor will decide on the
correct dosage.
TROUBLE IN SLEEPING ASSOCIATED WITH ANXIETY:
•
ADULTS: 5 - 15 mg before going to bed. Do not take
more than the maximum dose.
PRE-MEDICATION:
•
ADULTS: 5 - 20 mg
•
CHILDREN: 2 - 10 mg
USE IN CHILDREN:
Your doctor will want to carefully assess children who
are given Diazepam and keep the length of treatment
as short as possible.
ELDERLY AND DEBILITATED (VERY FRAIL) PATIENTS:
Normally the starting dose is half of the ordinary adult
dose. If you are elderly or frail you are likely to be more
sensitive t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Diazepam 2 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg of diazepam. For excipients see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
White, flat, bevel edged tablets, engraved "Berk 2" with a breakline
on reverse
or "2" with a breakline on reverse.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Diazepam is indicated for the short-term relief only (2-4 weeks) of
anxiety that
is severe, disabling or subjecting the individual to unacceptable
distress,
occurring alone or in association with insomnia or short-term
psychosomatic,
organic or psychotic illness. The use of benzodiazepines to treat
short-term
"mild" anxiety is considered to be inappropriate and unsuitable.
Diazepam may be used for the short-term treatment of insomnia only
when it
is severe, disabling or subjecting the individual to extreme distress.
Diazepam is also indicated for muscle spasm and premedication.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
As an anxiolytic, the lowest effective dose which can control the
symptoms should be
employed; dosage regimes should not exceed beyond 4 weeks and
treatment with
benzodiazepines should always be gradually withdrawn. Patients who
have received
benzodiazepines for a long time may require an extended withdrawal
period during
which the doses are reduced. Long-term chronic use is not recommended.
Long-term
chronic use is not recommended; treatment should be as short as
possible. The
patient should be reassessed regularly and the need for continued
treatment evaluated,
especially if the patient is symptom free. It should not exceed 2-3
months for anxiety
and 4 weeks for insomnia, including the tapering off period. Extension
beyond these
periods should not take place without re-evaluation of the situation.
Anxiety States: Adults
Usual dose of 2 mg three times daily.
Severe anxiety states: 15-30 mg daily in divided doses.
Insomnia associated with anxiety: Adults
5 - 15 mg before retiring. The maximum dose should not b