Anxicalm 2 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Diazepam

Available from:

Clonmel Healthcare Ltd

ATC code:

N05BA; N05BA01

INN (International Name):

Diazepam

Dosage:

2 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:

1979-04-25

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ANXICALM 2MG TABLETS
ANXICALM 5MG TABLETS
ANXICALM 10MG 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, pharmacist or
nurse.

This medicine has been prescribed for you. 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4..
WHAT IS IN THIS LEAFLET
1.
What Anxicalm is and what it is used for
2.
What you need to know before you take Anxicalm Tablets
3.
How to take Anxicalm Tablets
4.
Possible side effects
5.
How to store Anxicalm Tablets
6.
Contents of the pack and other information.
1. WHAT ANXICALM IS AND WHAT IT IS USE FOR
Anxicalm Tablets contain diazepam. Diazepam belongs to a group of
medicines called
benzodiazepines. It works by depressing activity in the part of the
brain that controls emotion, by
promoting the action of a chemical called gamma-aminobutyric acid
(GABA).
ANXICALM IS USED TO TREAT A NUMBER OF CONDITIONS, INCLUDING:

Severe anxiety, which is an emotional state where you may sweat,
tremble, feel anxious and have
a fast heartbeat

Insomnia (trouble sleeping)

Control of muscle spasm including that associated with tetanus

Epilepsy (when taken with other medicines)

Sedation before minor dental or surgical procedures
Both adults and children can take a small dose of Diazepam before an
operation to help with
relaxation and to cause sleepiness.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ANXICALM TABLETS
DO NOT TAKE ANXICALM

if you are allergic to diazepam or any of the other ingredients of
this medicine (listed in section 6)

if you are breathless or have difficulty breathing

if you suffer from sleep apnoea syndrome

Summary of Product characteristics

Health Products Regulatory Authority
15 January 2019
CRN008MYF
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anxicalm 2 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Diazepam 2mg.
Excipients with known effect
Lactose monohydrate 110.00 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round, white, flat bevel-edged tablet engraved with ‘D2’ on one
face and with a
single scoreline on the reverse.
The scoreline is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(1) Anxiety
(2) Insomnia
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
(3) In the control of muscle spasm including that associated with
tetanus.
(4) In the management of epilepsy.
(5) As pre-operative medication in minor surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Health Products Regulatory Authority
15 January 2019
CRN008MYF
Page 2 of 14
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 short as possible depending on the
indication,
but should not exceed four weeks for insomnia and eight to twelve
weeks in cases of
anxiety, including tapering off process. Extension beyond these
periods should not
take place without re-evaluation of the situation. It may be useful to
inform the
patient when treatment is started that it will be of limited duration
and to explain
precisely how the dosage will be progressively decreased. Moreover it
is important
that the patient should be aware of the possibility of rebound
phenomena, thereby
minimising anxiety over such symptoms should they occur while the
medicinal
product is being discontinued.
There are indications that, in the case of benzodiazepines with a
shor