Sonata
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-10-2015
Charakterystyka produktu
(SPC)
21-10-2015
Sprawozdanie z oceny publicznego
(PAR)
21-10-2015
Składnik aktywny:
zaleplon
Dostępny od:
Meda AB
Kod ATC:
N05CF03
INN (International Nazwa):
zaleplon
Grupa terapeutyczna:
Psycholeptics
Dziedzina terapeutyczna:
Sleep Initiation and Maintenance Disorders
Wskazania:
Sonata 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.
Podsumowanie produktu:
Revision: 19
Status autoryzacji:
Withdrawn
Data autoryzacji:
1999-03-12
Ulotka dla pacjenta
34
B. PACKAGE LEAFLET
Medicinal product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sonata 5 mg hard capsules
zaleplon
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. 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 Sonata is and what it is used for
2.
What you need to know before you take Sonata
3.
How to take Sonata
4.
Possible side effects
5.
How to store Sonata
6.
Contents of the pack and other information
1.
WHAT SONATA IS AND WHAT IT IS USED FOR
Sonata belongs to a class of substances called benzodiazepine-related
medicinal products, which
consists of preparations with hypnotic actions.
Sonata 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SONATA
DO NOT TAKE SONATA
if you are allergic to zaleplon or any of the other ingredients of
this medicine (listed in
section 6).
if you have sleep apnoea syndrome (stopping breathing for short
periods
while asleep).
if you have severe kidney or liver problems.
if you have myasthenia gravis (very weak or tired muscles).
if you have severe breathing or chest problems.
If you are in any doubt about whether you have any of these
conditions, do ask your doctor.
Children and adolescents under 18 years of age must not take Sonata.
WARNINGS AND PRECAUTIONS
Talk to your doctor
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Sonata 5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg of zaleplon.
Excipient with known effect: Lactose monohydrate 54 mg.
For the 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
the strength “5 mg”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sonata 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
.
Sonata 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
Sonata.
The total daily dose of Sonata 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 Sonata.
Paediatric patients
Sonata is contraindicated in children and adolescents under 18 years
of age (see section 4.3).
Hepatic impairment
As clearance is reduced, patients with mild to moderate hepatic
impairment should be treated with
Sonata 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 Sonata
pharmacokinetics is not altered in such patients. Severe renal
impairment is contraindicated (see
section 4.3.).
4.3
CONTRAINDICA
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