Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
ZOLPIDEM TARTRATE
UNIPHARM LTD, ISRAEL
N05CF02
TABLETS
ZOLPIDEM TARTRATE 5 MG
PER OS
Required
TRIMA ISRAEL PHARMACEUTICAL PRODUCTS MAABAROT LTD, ISRAEL
ZOLPIDEM
Treatment of insomnia.
2016-02-28
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. Læs hele dokumentet