Lormetazepam 1mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Lormetazepam

Dostupno od:

Teva 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: 5017007031635

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
LORMETAZEPAM 0.5 MG & 1 MG TABLETS
BENZODIAZEPINE
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, 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 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 one of a group of medicines called benzodiazepines.
Lormetazepam is prescribed as a short-term therapy to help with
sleeping difficulties which are
significantly affecting normal daily life.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE LORMETAZEPAM
DO NOT TAKE LORMETAZEPAM IF YOU:
•
have severe breathing or chest problems
•
are allergic to benzodiazepines or any of the ingredients in this
medicine (listed in section 6). An
allergic reaction can be a rash, itchiness or shortness of breath
•
have myasthenia gravis (very weak or tired muscles)
•
have serious liver problems
•
have sleep apnoea (breathing problems when you are asleep)
•
are breastfeeding
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Lormetazepam if any of
the following applies to you:
•
You are pregnant, or trying to become pregnant (see below).
•
You abuse or have in the past abused drugs or alcohol.
•
You have a personality disorder. If so, you have a greater chance of
becoming dependent on
lormetazepam.
•
You have any kidney or liver problems.
•
You have suffere

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 mg lormetazepam.
Excipient(s) with known effect
Each tablet contains 166.25 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Round, biconvex, white tablets, 8.5 mm in diameter with ‘LMT 1'
embossed on one
side and plain on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lormetazepam is indicated for the short term treatment of insomnia
when it is
disabling or subjecting the individual to extreme distress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Dosage and duration of therapy should be individualised. The lowest
effective dose
should be prescribed for the shortest time possible. Generally, the
duration of
treatment varies from a few days to 2 weeks, with a maximum of 4 weeks
including
the tapering off process. Extension of the treatment period should not
take place
without re-evaluation of the need for continued therapy.
Since insomnia is often transient and intermittent, the prolonged
administration of
lormetazepam is generally unnecessary and is not recommended.
Treatment in all patients should be withdrawn gradually to minimise
possible
withdrawal symptoms (see Special warnings and precautions for use).
_Adults_
0.5mg to 1.5mg before retiring. Subsequently the initial dosage may be
increased in
individual cases if this proves necessary.
For patients with mild to moderate chronic respiratory insufficiency
or hepatic
insufficiency a dose reduction should be considered.
_Elderly_
The lower adult dose is preferable for elderly patients.
_Paediatric population_
Lormetazepam has not been evaluated for the treatment of children.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
•
Severe respiratory insufficiency
•
Sleep apnoea syndrome
•
Myasthenia gravis
•
Severe hepa