Modification(s) apportée(s) à cette version / …

1 PATIENT INFORMATION LEAFLETZOLPIDEM 5MG OR 10MG TABLETSRead all of this leaflet carefully before youstart taking this medicine because it containsimportant information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask yourdoctor or pharmacist. This medicine has been prescribed for youonly. Do not pass it on to others. It mayharm them, even if their signs of illness arethe same as yours. If you get any side effects, talk to your doctoror pharmacist. This includes any possible sideeffects not listed in this leaflet. See section 4. Your doctor may have given you thismedicine before from another company. Itmay have looked slightly different. However,either brand will have the same is in this leaflet: 1. What zolpidem is and what it is used for2. What you need to know before you takezolpidem3. How to take zolpidem4. Possible side effects5. How to store zolpidem6.

2 Contents of the pack and other information1. What zolpidem is and what it is used forThe name of your medicine is Zolpidem 5mgor 10mg Tablets (called zolpidem throughoutthis leaflet). Zolpidem contains a medicinecalled zolpidem tartrate. This belongs to agroup of medicines called hypnotics. It worksby acting on your brain to help you is used to treat sleep problems inadultssuch as: Difficulty falling asleep Waking in the middle of the nightZolpidem is used for temporary sleepproblems. Zolpidem is not meant to be usedevery day for long periods of time. Ask yourdoctor for advice if you are What you need to know before you takezolpidemDo not take zolpidem if:X You are allergic (hypersensitive) to zolpidemtartrate or any of the other ingredients ofthis medicine (listed in section 6).Signs of an allergic reaction include: a rash,swallowing or breathing problems, swellingof your lips, face, throat or You have a problem where you stopbreathing for short periods at night (sleepapnoea).

3 X You have a problem that causes severemuscle weakness (myasthenia gravis).X You have breathing difficulties (hypoventilate).X You have severe liver You are under the age of 18. X You have a severe mental not take this medicine if any of the aboveapplies to you. If you are not sure, talk to yourdoctor or pharmacist before taking and precautionsTalk to your doctor or pharmacist beforetaking zolpidem if: Your lungs do not work properly. You have any liver problems. You have a history of drug or alcohol abuse. You are or have been depressed. You do not feel you will ever be able to stoptaking zolpidem or other medicines used totreat sleep can cause drowsiness and decreaseyour level of alertness. This could cause you tofall, sometimes leading to severe you are not sure if any of the above appliesto you, talk to your doctor or pharmacistbefore taking day psychomotor impairment (see also'Driving and using machines')The day after taking zolpidem, the risk ofpsychomotor impairment, including impaireddriving ability may be increased if: You take this medicine less than 8 hoursbefore performing activities that requireyour alertness.

4 You take a higher dose than recommended. You take zolpidem while you are alreadytaking other central nervous systemdepressants or other medicines that increasezolpidem in your blood, or while drinkingalcohol, or while taking illicit the single intake immediately at not take another dose during the same medicines and zolpidemTell your doctor or pharmacist if you are taking,have recently taken or might take any othermedicines. This includes medicines you buywithout a prescription, including herbal is because zolpidem can affect the way someother medicines work. Also some medicines canaffect the way zolpidem may increase the effect of thefollowing medicines:While taking zolpidem with the followingmedicines, drowsiness and next-daypsycho-motor impairment effects, includingimpaired driving ability, may be increased: Medicines for mental problems (antipsychotics).

5 Medicines for depression such as sertraline. Some medicines for moderate to severe pain(narcotic analgesics). Medicines for epilepsy (anticonvulsants) Medicines used in surgery (anaesthetics). Medicines to calm or reduce anxiety or forsleep problems (hypnotics). Medicines for hay fever, rashes or otherallergies that can make you sleepy (sedativeantihistamines) such as chlorphenamine AC / Item :702303 Description AC :Notice Zolpidem cprDestination :Grande BretagneDate / version :16-03-18 V8 Dimension :210x148 mmType :Roul. DoubleAccord Sp cificationAccord CQLD elpharm Site de DijonModification(s) apport e(s) cette version / Modification(s) brought to this version :Polices / Fonts :OceanTexte corps mini / Text size mini : 10 ptCode actuel / Current code : 701817 Couleur (s) / Color(s) :1 Noir UPlan N :N 84*702303* SENS DE DEROULEMENTRECTO(Int rieur bobine)While taking zolpidem with antidepressantsincluding bupropion, desipramine, fluoxetine,sertraline and venlafaxine, you may see thingsthat are not real (hallucinations).

6 It is not recommended to take zolpidem withfluvoxamine, ciprofloxacin or St. John's Wort (aherbal medicine) used for mood swings from concomitant use with opioidsConcomitant use of zolpidem and opioids(strong pain killers, medicines for substitutiontherapy and some cough medicines) increasesthe risk of drowsiness, difficulties in breathing(respiratory depression), coma and may belife-threatening. Because of this, concomitantuse should only be considered when othertreatment options are not if your doctor does prescribezolpidem together with opioids the dosage andduration of concomitant treatment should belimited by your tell your doctor about all opioidmedicines you are taking, and follow yourdoctor s dosage recommendation closely. Itcould be helpful to inform friends or relativesto be aware of sign and symptoms statedabove. Contact your doctor when experiencingsuch following medicines can increase thechance of you getting side effects when takenwith zolpidem.

7 To make this less likely, yourdoctor may decide to lower your dose ofzolpidem: Some medicines for fungal infections suchas following medicines can make zolpidemwork less well: Rifampicin (an antibiotic) for with alcoholDo not drink alcoholwhile you are takingzolpidem. Alcohol can increase the effects ofzolpidem and make you sleep very deeply sothat you do not breathe properly or havedifficulty and breast-feeding Talk to your doctor before taking thismedicine if you are pregnant, might becomepregnant, or think you may be pregnant. Do not take zolpidem if you are in the last3 months of pregnancy or during labourbecause it may be harmful to your baby. Ifyour doctor feels it is necessary for you tokeep using this medicine your baby may beborn with breathing difficulties, limp orweak muscles, a low body temperature(hypothermia) and may have withdrawalsymptoms.

8 Do not take zolpidem if you are breast-feeding or planning to breast-feed. This isbecause small amounts may pass intomother s your doctor or pharmacist for advice beforetaking any medicine if you are pregnant and using machinesOn the day after taking zolpidem, do not driveor use machinery or tools if you feel sleepy,dizzy or confused. Zolpidem has a majorinfluence on the ability to drive and usemachines such as sleep-driving . On the dayafter taking zolpidem (as with other hypnoticmedicines), you should be aware that: You may feel drowsy, sleepy, dizzy orconfused. You may take longer to make quickdecisions. You may have double or blurred vision. You may be less period of at least 8 hours is recommendedbetween taking zolpidem and driving, usingmachinery and working at heights tominimize the above listed not drink alcohol or take other psychoactivesubstances while you are taking zolpidem as itcan increase the above listed contains lactoseIf you have been told by your doctor that youcannot tolerate some sugars, talk to yourdoctor before having this How to take zolpidemAlways take zolpidem exactly as your doctor hastold you.

9 You should check with your doctor orpharmacist if you are not this medicine The recommended dose per 24 hours is 10mgof zolpidem. A lower dose may be prescribedto some patients . Zolpidem should be taken: as a single intake, just before bedtime. Swallow the tablet whole with a drink ofwater. Treatment should not normally continuebeyond 4 sure you have a period of at least 8 hoursafter taking this medicine before performingactivities that require your not exceed 10mg per 24 much to takeAdults The recommended dose is one 10mg tablet(or two 5mg tablets) just before bedtime. Alower dose may be prescribed to The usual dose is one 5mg tablet justbefore bedtime. 7023032 Code AC / Item :702303 Description AC :Notice Zolpidem cprDestination :Grande BretagneDate / version :16-03-18 V8 Dimension :210x148 mmType :Roul. DoubleAccord Sp cificationAccord CQLD elpharm Site de DijonModification(s) apport e(s) cette version / Modification(s) brought to this version :Polices / Fonts :OceanTexte corps mini / Text size mini : 10 ptCode actuel / Current code : 701817 Couleur (s) / Color(s) :1 Noir UPlan N :N 84 patients with liver problems The usual starting dose is one 5mg tabletjust before bedtime.

10 This may beincreased to two 5mg tablets (or one 10mgtablet) by your doctor if and adolescentsDo not give this medicine to children under 18years Tests Zolpidem can change the levels of liverenzymes shown up in blood tests. This canmean that your liver is not working properly. If you are going to have a blood test, it isimportant to tell your doctor that you aretaking you take more zolpidem than you shouldIf you take more zolpidem than you should,tell a doctor or go to a hospital casualtydepartment straight away. Take the medicinepack with you. This is so the doctor knowswhat you have too much zolpidem can be verydangerous. The following effects may happen: Feeling drowsy, confused, sleeping deeplyand possibly falling into a comaIf you forget to take Zolpidem Zolpidem must only be taken at bedtime. Ifyou forget to take your tablet at bedtime, thenyou should not take it at any other time,otherwise you may feel drowsy, dizzy andconfused during the nottake a doubledose to make up for a forgotten you stop taking zolpidemKeep taking zolpidem until your doctor tellsyou to stop.