Zolpidem Tartrate 10mg Tablets
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PATIENT INFORMATION LEAFLET ZOLPIDEM TARTRATE 10 MG TABLETS
What you should know about Zolpidem Tartrate Tablets
Please read this leaflet carefully before you start to take your medicine. This leaflet provides a summary of the information available on your medicine. If you have any question or are not sure about anything, ask your doctor or pharmacist.
The name of your medicine is Zolpidem Tartrate 10mg Tablets.
What is in your medicine
Each tablet contains 10mg of the active ingredient Zolpidem tartrate. The tablets also contain lactose monohydrate, microcrystalline cellulose, sodium starch glycollate, hypromellose, magnesium stearate, titanium dioxide (E171), macrogol 400.
Zolpidem Tartrate 10mg Tablets are available in packs of 10, 28, 100
The active ingredient zolpidem tartrate belongs to a group of drugs called hypnotics. This type of medicine helps people to fall asleep if they are having trouble sleeping (insomnia).
The product licence holder is
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK..
The manufacturer is
Sandoz Limited, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK or Synthon Hispania SL, Poligono las Salinas, 08830 Saint Boi de Llobregat, Barcelona, Spain or Synthon BV, Microweg 22, Nijmegen, NL-6545 CM, Netherlands
Uses
Zolpidem Tartrate tablets are used to help people who are having a lot of difficulty sleeping.
Before taking your tablets
Do not take this medicine before telling your doctor if
• You are sensitive to zolpidem tartrate or any ingredients in these tablets
• You suffer from sleep apnoea (stop breathing for small periods of time while you are sleeping)
• You have myasthenia gravis (muscle weakness)
• You have liver problems
• You have breathing troubles
• You suffer from schizophrenia or other behavioural illnesses
• You have been addicted to drugs or alcohol
• You are, or might be, pregnant or breast-feeding
It is important that you tell your doctor if you are taking any other medicines such as antipsychotics (neuroleptics, which help to correct abnormal behaviour), hypnotics (used to help sleep), anxiolytics (used to prevent anxiety), antidepressants, narcotic analgesics (pain killers), antiepileptics, anaesthetics and some antihistamines (used to treat allergies). You should inform your doctor of any medicines that you are taking that you may have obtained without a prescription.
You should not drink alcohol while taking this medicine.
If you feel drowsy the day after taking Zolpidem Tartrate Tablels you should avoid driving and using machinery. You should not take Zolpidem Tartrate or any other sleeping tablet for longer than your doctor tells you.
Taking this medicine
The recommended doses are given below. Doctors sometimes prescribe different doses to these, if this applies to you discuss it with your doctor, if you have not already done so. If you are elderly or have liver problems you are likely to be prescribed a different dose to that of adults. You should always follow your doctor’s or pharmacist’s instructions on how to take your medicine.
Exactly how many tablets and how often you take them will be written on the label. Please read this carefully. If you have any queries talk to your pharmacist as they may be able to advise you.
Treatment can last from a few days to about 4 weeks. Sleeping problems do not usually last a long time so you should return to your normal sleep routine after you have finished your course of tablets. However if you still have problems at the end of your treatment you should go back and see your doctor.
The tablets start working shortly after taking them therefore you should only take your tablets when you are ready to get into bed and go to sleep. Your tablets should be swallowed with a small glass of water.
Adults: 10mg per day
Elderly: 5mg per day
Children: Not to be given to children
Patients with kidney and liver problems: No adjustment necessary for people with kidney problems. If you have liver problems you are likely to be given 5mg per day.
If you forget to take your dose and fall asleep and then awake a few hours later, you should not take your missed dose. You can take your next dose as normal the next night.
If you accidentally take an extra dose it is unlikely to cause you problems. However if you, or someone else, have taken too many tablets or a large overdose, you may feel drowsy. In very severe cases you may lose consciousness. In cases of overdosage contact your doctor or your hospital accident and emergency department immediately.
If after a few weeks of taking your tablets, it seems that the tablets are not working as well as they did when you first started taking them, you should go back and see your doctor as he may have to adjust the number of tablets you need to take.
There is a risk of dependence when taking this type of medicine, particularly if it is taken for a long time. If you stop taking the tablets abruptly, you may experience some unpleasant effects such as headaches, muscle pain, anxiety, restlessness and irritability.
You may experience mood changes, anxiety, restlessness or a return of the insomnia when you stop taking Zolpidem tablets. Contact your doctor if these symptoms persist.
Sometimes Zolpidem Tartrate Tablets may cause behavioural side-effects, especially in the elderly, such as restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, fears and inappropriate behaviour. If you experience any of these effects that you think may be caused by the tablets, you should contact your doctor.
As with all medicines Zolpidem Tartrate Tablets may cause side-effects in some people. These may include drowsiness in the daytime, dizziness, diarrhoea, headache, nausea, weakness, vomiting and vertigo (sensation of rotation/spinning). Occasionally there are reports of memory loss some hours after taking Zolpidem, nightmares, night restlessness, depression, confusion, tremor, sensations of rotation/spinning, and double vision.
If you have any of these effects and they become worse, unpleasant or inconvenient you should talk to your doctor or pharmacist. If you experience any other unpleasant effects that you think may be caused by Zolpidem Tartrate Tablets you should contact your doctor or pharmacist for advice.
Storing Your Medicine
Do not take Zolpidem Tartrate Tablets after the expiry date shown on the label. Any out of date or unused medicines should be returned to your pharmacist for disposal.
Store these tablets in the original package. Remember keep all medicines out of the reach of children. Your medicine may harm them.
If you notice any defects in your tablets such as chipped or broken tablets, take them to your pharmacist for advice before taking them.
This leaflet was last revised in 03/2013.
REMEMBER this medicine is for you only. Only a doctor can prescribe it for you. Never give it to others, even if they have the same symptoms as you, as it may harm them.
This leaflet applies to Zolpidem Tartrate 10mg Tablets only.