Insomniger 10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Temazepam

Available from:

Generics (UK) Limited

ATC code:

N05CD; N05CD07

INN (International Name):

Temazepam

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

Benzodiazepine derivatives; temazepam

Authorization status:

Not marketed

Authorization date:

1997-07-25

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
INSOMNIGER 10 MG AND 20 MG TABLETS
temazepam
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 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 Insomniger is and what it is used for
2. What you need to know before you take Insomniger
3. How to take Insomniger
4. Possible side effects
5. How to store Insomniger
6. Contents of the pack and other information.
1.
WHAT INSOMNIGER IS AND WHAT IT IS USED FOR
Insomniger belongs to a group of medicines called benzodiazepines or
hypnotics.
Benzodiazepines are used to make you feel less anxious, they can also
be used to make you feel
sleepy, relax your muscles and stop or prevent fits. Insomniger can be
used for the following:

difficulty sleeping (insomnia), when your lack of sleep is causing you
a lot of distress

to be given before minor surgery and other similar procedures
(pre-medication) to make you
feel more relaxed (or less anxious).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INSOMNIGER
DO NOT TAKE INSOMNIGER:

if you are allergic to temazepam, or any other benzodiazepine medicine
(such as diazepam or
nitrazepam), or any of the other ingredients in this medicine (listed
in section 6)

if you suffer from long term fatigue and muscle weakness (myasthenia
gravis)

if you suffer from irregular breathing whilst asleep (sleep apnoea
syndrome)

if you have severe lung or liver problems

if you have a genetic disease called spinocerebellar ataxia (SCA)

if you have a dependence on alcohol or drugs (including sedatives and

Summary of Product characteristics

Health Products Regulatory Authority
10 December 2018
CRN008LNH
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Insomniger 10 mg tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10mg of temazepam.
Excipients with known effect:
Each Tablet contains 68.69 mg of lactose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to pale yellow, round, flat bevelled-edged scored tablets with 7
mm diameter,
marked ‘T/10’ on the scored side, and ‘G’ on the other.
The score line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term management of insomnia. Benzodiazepines are only indicated
when the
disorder is severe, disabling or subjecting the individual to extreme
distress.
For premedication prior to minor surgery or other related procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults including the elderly_
Treatment should be started with the lowest recommended dose. The
maximum
dose should not be exceeded.
_Insomnia _
Dosage should be checked regularly at the start of treatment in order
to decrease, if
necessary, the dose or frequency of administration to prevent overdose
due to
Health Products Regulatory Authority
10 December 2018
CRN008LNH
Page 2 of 14
accumulation. Treatment should be as short as possible. Generally the
duration of
treatment varies from a few days to two weeks with a maximum,
including
tapering-off, of four weeks. The tapering-off process should be
tailored to the
individual. 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.
The product should be taken on retiring or up to 30 minutes before
going to bed.
Adults: 10-20mg. In exceptional circumstances the dose may be
increased to
30-40mg.
Elderly: 10mg. In exceptional circumstances the dose may be increased
to 20mg.
_Premedication_
Adults: