ZODORM 5

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

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Indlægsseddel Indlægsseddel (PIL)
23-02-2017

Aktiv bestanddel:

ZOLPIDEM TARTRATE

Tilgængelig fra:

UNIPHARM LTD, ISRAEL

ATC-kode:

N05CF02

Lægemiddelform:

TABLETS

Sammensætning:

ZOLPIDEM TARTRATE 5 MG

Indgivelsesvej:

PER OS

Recept type:

Required

Fremstillet af:

TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL

Terapeutisk område:

ZOLPIDEM

Terapeutiske indikationer:

Treatment of insomnia.

Autorisation dato:

2016-02-28

Indlægsseddel

                                119928010
0316H
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
ZODORM 10, ZODORM 5
TABLETS
Active ingredient and its quantity:
Each ZODORM 10 tablet contains:
Zolpidem Tartrate 10 mg
Each ZODORM 5 tablet contains:
Zolpidem Tartrate 5 mg
For a list of inactive ingredients - see section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
Keep this leaflet; you may need to read it again. This leaflet
contains concise information
about the medicine.
This medicine has been prescribed for your treatment. Do not pass it
on to others. It may
harm them even if it seems to you that their medical condition is
similar.
This medicine is not intended for children and adolescents under the
age of 18.
If a side effect worsens or if a side effect not mentioned in this
leaflet occurs, please
refer to a doctor or pharmacist.
If you have further questions, refer to the doctor or pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of insomnia.
THERAPEUTIC GROUP: Hypnotic and tranquilizing substances.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
• You are sensitive to the active ingredient (zolpidem) or to any of
the other ingredients
of the medicine (see section 6), or if you have suffered in the past
from an allergic
reaction to zolpidem-containing medicines.
Signs of an allergic reaction to zolpidem can include: swelling of the
face, lips and
throat that may cause breathing and swallowing difficulties.
• You are suffering from severe liver failure.
• You drank alcohol in the evening or at bedtime.
• You have taken another medicine intended to help you fall asleep.
• You are not able to sleep a full night after taking the medicine
(7-8 hours).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE:
◾
Close medical supervision is very important while taking this
medicine.
◾
Do not use the medicine for more than four consecutive weeks!
Prolonged use may
cause dependence.
                                
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