Xyrem
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
12-10-2022
Valmisteyhteenveto
(SPC)
12-10-2022
Julkisesta arviointikertomuksesta
(PAR)
23-04-2021
Aktiivinen ainesosa:
sodium oxybate
Saatavilla:
UCB Pharma Ltd
ATC-koodi:
N07XX04
INN (Kansainvälinen yleisnimi):
sodium oxybate
Terapeuttinen ryhmä:
Other nervous system drugs
Terapeuttinen alue:
Cataplexy; Narcolepsy
Käyttöaiheet:
Treatment of narcolepsy with cataplexy in adult patients.
Tuoteyhteenveto:
Revision: 36
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2005-10-13
Pakkausseloste
27
B. PACKAGE LEAFLET
28
PACKAGE LEAFLET: INFORMATION FOR THE USER
XYREM 500 MG/ML ORAL SOLUTION
Sodium oxybate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 your 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 Xyrem is and what it is used for
2.
What you need to know before you take Xyrem
3.
How to take Xyrem
4.
Possible side effects
5
How to store Xyrem
6.
Contents of the pack and other information
1.
WHAT XYREM IS AND WHAT IT IS USED FOR
Xyrem contains the active substance sodium oxybate. Xyrem works by
consolidating night-time sleep,
though its exact mechanism of action is unknown.
Xyrem is used to treat narcolepsy with cataplexy in adults,
adolescents and children from 7 years of
age.
Narcolepsy is a sleep disorder that may include attacks of sleep
during normal waking hours, as well
as cataplexy, sleep paralysis, hallucinations and poor sleep.
Cataplexy is the onset of sudden muscle
weakness or paralysis without losing consciousness, in response to a
sudden emotional reaction such
as anger, fear, joy, laughter or surprise.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE XYREM
DO NOT TAKE XYREM
-
if you are allergic to sodium oxybate or any of the other ingredients
of this medicine (listed in
section 6);
-
if you have succinic semialdehyde dehydrogenase deficiency (a rare
metabolic disorder);
-
if you suffer from major depression;
-
if you are being treated with opioid or barbiturate medicines.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Xyrem:
-
if you have breathing or lung problems (and especially if you are
ob
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Valmisteyhteenveto
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Xyrem 500 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution
contains 500 mg of sodium oxybate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
The oral solution is clear to slightly opalescent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of narcolepsy with cataplexy in adult patients, adolescents
and children from the age of 7
years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the guidance of a
physician experienced in the
treatment of narcolepsy. Physicians should strictly adhere to the
contraindications, warnings and
precautions.
Posology
Adult
The recommended starting dose is 4.5 g/day sodium oxybate divided into
two equal doses of
2.25 g/dose. The dose should be titrated to effect based on efficacy
and tolerability (see section 4.4) up
to a maximum of 9 g/day divided into two equal doses of 4.5 g/dose by
adjusting up or down in dose
increments of 1.5 g/day (i.e. 0.75 g/dose). A minimum of one to two
weeks is recommended between
dose increments. The dose of 9 g/day should not be exceeded due to the
possible occurrence of severe
symptoms at doses of 18 g/day or above (see section 4.4).
_ _
Single doses of 4.5 g should not be given unless the patient has been
titrated previously to that dose
level.
If sodium oxybate and valproate are used concomitantly (see section
4.5), a decrease in sodium
oxybate dose by 20% is recommended. The recommended starting dose for
sodium oxybate, when
used concomitantly with valproate, is 3.6 g per day administered
orally in two equal divided doses of
approximately 1.8 g. If concomitant use is warranted, patient response
and tolerability should be
monitored and dose should be adapted accordingly (see section 4.4).
Discontinuation of Xyrem
The discontinuation effects of sodium oxybate have not been
systematically evaluated in controlled
clinical trials (see sectio
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