Diazepam 10 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diazepam

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

N05BA; N05BA01

INN (International Name):

Diazepam

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Benzodiazepine derivatives; diazepam

Authorization status:

Marketed

Authorization date:

2012-02-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAZEPAM 2 MG TABLETS
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, tell 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 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM
3.
HOW TO TAKE DIAZEPAM
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DIAZEPAM
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DIAZEPAM IS AND WHAT IT IS USED FOR
Diazepam contains the active substance diazepam which belongs to a
group of medicines called
benzodiazepines. Diazepam has anxiolytic, sedative and muscle relaxant
effect.
Diazepam 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 Diazepam for other uses. Please follow your
doctor’s instructions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAZEPAM
DO NOT TAKE Diazepam:

if you are allergic to diazepam or any of the other ingredients of
this medicine (listed in section 6)
or to other benzodiazepine medicines.

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 PRECAUTI

Summary of Product characteristics

Health Products Regulatory Authority
30 October 2019
CRN009CDQ
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diazepam Actavis 10 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg diazepam.
Excipient(s) with known effect:
Each Diazepam 10 mg tablet contains 320.50 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round, flat and bevelled tablets, 11.0 mm in diameter, with a
scoreline on one side and ‘D10’ engraved on the other. 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
Posology
Standard dosage
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 must not last longer
than 8 to 12 weeks, including tapering off process.
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