ZODORM 10

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Kauptu það núna

Opinber matsskýrsla Opinber matsskýrsla (PAR)
02-08-2021

Virkt innihaldsefni:

ZOLPIDEM TARTRATE

Fáanlegur frá:

UNIPHARM LTD, ISRAEL

ATC númer:

N05CF02

Lyfjaform:

COATED TABLETS

Samsetning:

ZOLPIDEM TARTRATE 10 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

UNIPHARM LTD, ISRAEL

Lækningarsvæði:

ZOLPIDEM

Ábendingar:

Treatment of insomnia (Not more than 4 weeks).

Leyfisdagur:

2021-10-31

Upplýsingar fylgiseðill

                                PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS(‬–‬1986
The medicine is dispensed with a doctor’s prescription only
ZODORM 10
TABLETS
The active ingredient and its quantity:
Each ZODORM 10 tablet contains:
Zolpidem Tartrate 10 mg
Inactive and allergenic ingredients in the preparation –
see in section 2 “Important information about some of the
ingredients of the medicine” and section 6 “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor or
pharmacist.
This medicine has been prescribed to treat you. 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 below
the age of 18.
1. WHAT IS THE MEDICINE INTENDED FOR?
For the treatment of insomnia.
THERAPEUTIC GROUP: Hypnotic and sedative substances.
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
• You have ever experienced unconscious behavior during sleep
)e.g., driving a car, preparing and eating food, talking on the
phone or having sex while not being fully awake( after taking
ZODORM 10.
• You are sensitive )allergic( to the active ingredient )zolpidem(
or to any of the other ingredients contained in the medicine
)see section 6 “Further Information”(.
• You have suffered in the past from an allergic reaction to
zolpidem-containing medicines. Symptoms of a severe allergic
reaction to zolpidem can include: swelling of the face, lips and
throat that may cause breathing and swallowing difficulties.
• You suffer from severe liver failure.
• You drank alcohol in the evening or before bedtime.
• You took another medicine intended to help you fall asleep.
• You will not be able to get a full night’s sleep after taking
the
medicine )7-8 hours( before you need to be active again.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE

                                
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Upplýsingar fylgiseðill Upplýsingar fylgiseðill arabíska 04-08-2022
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