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.

2 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. 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).

3 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).

4 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).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.

5 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.

6 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.

7 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). 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).

8 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).

9 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.

10 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. 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.