Zerene
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
15-10-2012
Produktets egenskaber
(SPC)
15-10-2012
Offentlige vurderingsrapport
(PAR)
16-10-2012
Aktiv bestanddel:
zaleplon
Tilgængelig fra:
Meda AB
ATC-kode:
N05CF03
INN (International Name):
zaleplon
Terapeutisk gruppe:
Psycholeptics
Terapeutisk område:
Sleep Initiation and Maintenance Disorders
Terapeutiske indikationer:
Zerene is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
Produkt oversigt:
Revision: 13
Autorisation status:
Withdrawn
Autorisation dato:
1999-03-12
Indlægsseddel
32
B. PACKAGE LEAFLET
Medicinal product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
Zerene 5 mg hard capsules
zaleplon
Read all of this leaflet carefully before you start taking this
medicine.
−
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
−
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.
What Zerene is and what it is used for
2.
Before you take Zerene
3.
How to take Zerene
4.
Possible side effects
5.
How to store Zerene
6.
Further information
1.
WHAT ZERENE IS AND WHAT IT IS USED FOR
Zerene belongs to a class of substances called benzodiazepine-related
medicinal products, which
consists of preparations with hypnotic actions.
Zerene will help you to sleep. Sleeping problems do not usually last
long, and most people only need a
short course of treatment. The duration of treatment should usually
vary from a few days to two
weeks. If you still have problems sleeping after you have finished
your capsules, contact your doctor
again.
2.
BEFORE YOU TAKE ZERENE
Do not take Zerene if you have
•
hypersensitivity (an allergy) to zaleplon or to any other ingredients
of Zerene
•
sleep apnoea syndrome (stopping breathing for short periods while
asleep)
•
severe kidney or liver problems
•
myasthenia gravis (very weak or tired muscles)
•
severe breathing or chest problems
If you are in any doubt about whether you have any of these
conditions, do ask your doctor.
Children under 18 years of age must not take Zerene.
Take special care with Zerene
•
Never drink alcohol while you are being treated with Zerene. Alcohol
can increase the
undesirable effects of any medicine taken to help you sleep.
•
Use with extreme caution if you have ever been addicted to medicines
or alco
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Zerene 5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg of zaleplon.
Excipient: Lactose monohydrate 54 mg.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Capsules have an opaque white and opaque light brown hard shell with
gold band, “W” and the
strength “5 mg”.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Zerene is indicated for the treatment of patients with insomnia who
have difficulty falling asleep. It is
indicated only when the disorder is severe, disabling or subjecting
the individual to extreme distress.
4.2
Posology and method of administration
For adults, the recommended dose is 10 mg.
Treatment should be as short as possible with a maximum duration of
two weeks.
Zerene can be taken immediately before going to bed or after the
patient has gone to bed and is
experiencing difficulty falling asleep. As administration after food
delays the time to maximal plasma
concentration by approximately 2 hours no food should be eaten with or
shortly before intake of
Zerene.
The total daily dose of Zerene should not exceed 10 mg in any patient.
Patients should be advised not
to take a second dose within a single night.
Elderly
Elderly patients may be sensitive to the effects of hypnotics;
therefore, 5 mg is the recommended dose
of Zerene.
Paediatric patients
Zerene is contraindicated in children (see section 4.3).
Hepatic impairment
As clearance is reduced, patients with mild to moderate hepatic
impairment should be treated with
Zerene 5 mg. For severe hepatic impairment see section 4.3.
Medicinal product no longer authorised
3
Renal impairment
No dosage adjustment is required in patients with mild to moderate
renal insufficiency, because
Zerene pharmacokinetics is not altered in such patients. Severe renal
impairment is contraindicated
(see section 4.3.).
4.3
Contraindications
Hypersensitivity to the active
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