Senaxa PR, 2 mg prolonged-release tablets

Land: Malta

Språk: engelska

Källa: Medicines Authority

Tillgänglig från:

Przedsiebiorstwo Farmaceutyczne LEK-AM sp. z o.o 14A Ostrzykowizna Street, 05-170 Zakroczym, , Poland

ATC-kod:

N05CH01

INN (International namn):

MELATONIN 2 mg

Läkemedelsform:

PROLONGED-RELEASE TABLET

Sammansättning:

MELATONIN 2 mg

Receptbelagda typ:

POM

Terapiområde:

PSYCHOLEPTICS

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2023-02-23

Bipacksedel

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B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SENAXA PR 2 MG PROLONGED-RELEASE TABLETS
Melatonin
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 Senaxa PR is and what it is used for
2.
What you need to know before you take Senaxa PR
3.
How to take Senaxa PR
4.
Possible side effects
5.
How to store Senaxa PR
6.
Contents of the pack and other information
1.
WHAT SENAXA PR IS AND WHAT IT IS USED FOR
The active substance of
Senaxa PR, melatonin, belongs to a natural group of hormones
produced by the body.
Senaxa PR is used on its own for the short-term treatment of primary
insomnia (persistent
difficulty in getting to sleep or staying asleep, or poor quality of
sleep) in patients aged 55
years and older.
‘Primary’ means that the insomnia does not have any identified
cause, including any medical,
mental or environmental cause.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SENAXA PR
DO NOT TAKE SENAXA PR
-
if you are allergic to melatonin or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
Senaxa PR:
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If you suffer from liver or kidney problems. No studies on the use of
Senaxa PR in people
with liver or kidney diseases have been performed, you should speak to
your doctor
before taking Senaxa PR as its use is not recommended.
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If you have been told by your doctor that you have an intolerance to
some sugars.
-
If you have been told you suffer from an autoim

Produktens egenskaper

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Senaxa PR, 2 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 2 mg melatonin.
Excipient with known effect: each prolonged-release tablet contains 80
mg lactose
monohydrate. For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, round (8.0 ± 0.3 mm diameter), biconvex tablets
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Senaxa PR is indicated as monotherapy for the short-term treatment of
primary insomnia
characterised by poor quality of sleep in patients who are aged 55 or
over.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 2 mg once daily, 1-2 hours before bedtime and
after food. This
dosage may be continued for up to thirteen weeks.
_Paediatric population _
The safety and efficacy of Senaxa PR in children aged 0 to 18 years
has not yet been
established.
Other pharmaceutical forms/strengths may be more appropriate for
administration to this
population. Currently available data are described in section 5.1.
_Renal impairment _
The effect of any stage of renal impairment on melatonin
pharmacokinetics has not been
studied. Caution should be used when melatonin is administered to such
patients.
_Hepatic impairment _
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There is no experience of the use of Senaxa PR in patients with liver
impairment. Published
data demonstrates markedly elevated endogenous melatonin levels during
daytime hours due
to decreased clearance in patients with hepatic impairment. Therefore,
Senaxa PR is not
recommended for use in patients with hepatic impairment.
Method of Administration
Oral use. Tablets should be swallowed whole to maintain prolonged
release properties.
Crushing or chewing should not be used to facilitate swallowing.
4.3.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4.
SPECIAL WARNINGS AND P