Lormetazepam 1mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Lormetazepam

Dostupno od:

Actavis UK Ltd

ATC koda:

N05CD06

INN (International ime):

Lormetazepam

Doziranje:

1mg

Farmaceutski oblik:

Oral tablet

Administracija rute:

Oral

Razred:

Schedule 4 (CD Benz)

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 04010100; GTIN: 5012617018861

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORMETAZEPAM
0.5 MG AND 1 MG TABLETS
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 symptoms 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.
IN THIS LEAFLET:
1) What Lormetazepam is and what it is used for
2) What you need to know before you take Lormetazepam
3) How to take Lormetazepam
4) Possible side effects
5) How to store Lormetazepam
6) Contents of the pack and other information
1) WHAT
LORMETAZEPAM
IS AND WHAT IT IS USED FOR
Lormetazepam is a medicine in the hypnotic group which promotes sleep:
it normalises the time necessary to fall
asleep and its total duration, while reducing sleep disruption.
It is indicated for:
- Short-term treatment of insomnia.
Lormetazepam belongs to a group of hypnotic medicines called
benzodiazepines. Benzodiazepines are only
indicated when the disorder is severe, disabling or subjecting the
individual to extreme distress.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORMETAZEPAM
Do not take Lormetazepam
- if you are allergic (hypersensitive) to the active substance or any
of the other ingredients of
Lormetazepam (listed in section 6).
- if you suffer from myasthenia gravis (a disease characterised by the
appearance of an abnormal
degree of muscle weakness),
- if you have severe respiratory insufficiency (for example, severe
chronic obstructive pulmonary
disease),
- if you suffer from sleep apnoea syndrome (a condition characterised
by short episodes of
stopping breathing which appear during sleep),
- in the case of acute intoxication with alcohol, hypnotics,
analgesics or drugs which act on the
central nervous system (ne

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lormetazepam 1 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1.00 mg of lormetazepam
_Excipients with known effect:_
Each tablet contains 86.40 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Round white tablets, scored on one side.
The tablet can be divided into equal doses.
Round white tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Short-term treatment of insomnia.
Benzodiazepines are only indicated when the disorder is severe,
disabling or
subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dosage and duration of therapy should be individualised. The lowest
effective
dose should be prescribed for the shortest time possible. Generally,
it varies
from a few days to two weeks with a maximum period, including gradual
reduction, of four weeks.
Adults: 0.5mg to 1.5mg before retiring. Subsequently the initial
dosage may be
increased to 2 mg in individual cases if this proves necessary.
Elderly: The lower adult dose is preferable for elderly patients.
_Paediatric population _
Lormetazepam must not be used in children and adolescents under 18
years of age
without a careful assessment of the need for the treatment.
For patients with mild to moderate chronic respiratory insufficiency
or hepatic
insufficiency a dose reduction should be considered.
The tablets should be taken with a small amount of liquid before going
to bed.
4.3
CONTRAINDICATIONS
Lormetazepam is contraindicated in patients with:
•
Hypersensitivity to benzodiazepines or to any of the excipients of
Lormetazepam
tablets
•
Myasthenia gravis
•
Severe respiratory insufficiency (for example, severe chronic
obstructive
pulmonary disease), sleep apnoea syndrome.
•
Acute intoxication with alcohol, hypnotics, analgesics or psychotropic
drugs
(neuroleptics, antidepressants, lithium).
•
Severe liver insufficiency.
Pregnancy and lactation (see also 4.6 “Fertility,