Zolpidem Tartrate 5mg Tablets
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• Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist or doctor.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Zolpidem Tartrate tablets are and what they are used for
2. What you need to know before you take Zolpidem Tartrate tablets
3. How to take Zolpidem Tartrate tablets
4. Possible side effects
5. How to store Zolpidem Tartrate tablets
6. Contents of the pack and other information
1. What Zolpidem Tartrate tablets are and what they are used for
Zolpidem Tartrate tablets are sleeping pills (hypnotics) which work by acting on the brain to cause sleepiness.
They may be used for short term treatment of difficulty in sleeping which is severe, disabling or causing great distress.
2 What you need to know before you take Zolpidem Tartrate tablets Do not take Zolpidem Tartrate tablets if you:
• are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue
• have severe liver problems
• suffer from breathing problems whilst sleeping (Sleep Apnoea Syndrome)
• suffer from severe muscle weakness (myasthenia gravis)
• have severe breathing problems
• are under the age of 18 years.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Zolpidem Tartrate tablets if you:
• are elderly or frail. If you get up at night, take care as there is an increased risk of falling and consequently of hip fractures due to the muscle relaxant effect of the tablets
• have any kidney or liver problems.
• have a history of breathing problems. Whilst taking Zolpidem Tartrate tablets your breathing may become less forceful
• have a history of mental illness, anxiety or psychotic illness. Zolpidem Tartrate tablets may unmask or worsen symptoms
• suffer from or have a history of depression
• have or have ever had a history of or tendency to alcohol or drug abuse. The risk of dependence to Zolpidem Tartrate tablets (physical or mental effects produced by a compulsion to keep taking the medicine) increases in these patients, and with dose and length of treatment.
Other considerations
• Habituation - if after a few weeks you notice that the tablets are not working as well as they did when first starting treatment, you should go and see your doctor as an adjustment to your dosage may be required.
• Dependence - when taking this type of medicine there is a risk of dependence, which increases with dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse.
• Withdrawal - treatment should be gradually withdrawn. A transient syndrome whereby the symptoms that led to treatment with Zolpidem Tartrate tablets recur in an enhanced form, may occur on withdrawal. It may be accompanied by other reactions including mood changes, anxiety and restlessness.
• Amnesia - Zolpidem Tartrate tablets can cause memory loss. To reduce this risk you should ensure that you are able to have 7-8 hours uninterrupted sleep.
• Psychiatric and “paradoxical” reactions - Zolpidem Tartrate tablets can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations, psychoses, sleepwalking, inappropriate behaviour, increased insomnia and other adverse behavioural effects.
Other medicines and Zolpidem Tartrate tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zolpidem Tartrate tablets may influence the effect and/or side effects of other medicines. If you see another doctor or go into hospital, particularly if you are having an operation under anaesthesia tell the doctor which medicines you use.
The following medicines may increase the sedating effect of Zolpidem Tartrate tablets:
• medicines to treat mental illness (antipsychotics)
• medicines to treat depression
• other sleeping pills
• medicines to treat anxiety and other tranquillizers
• narcotics (strong pain killers) such as codeine, morphine. Feelings of excitement (euphoria) may increase, which in turn increase the chance on physical or mental dependence
• medicines used to treat epilepsy
• anaesthetics (used during surgery)
• antihistamine medicines which cause sleepiness
• medicines inhibiting liver enzymes. Ask your doctor or pharmacist which medicines have this effect.
The effect of the following medicine may be increased by Zolpidem Tartrate tablets:
• muscle relaxants
The effect of Zolpidem Tartrate tablets may be decreased by the following medicine:
• medicine used to treat tuberculosis (rifampicin).
Zolpidem Tartrate tablets with food, drink and alcohol
Alcohol should not be consumed when taking Zolpidem Tartrate tablets, as the sedating effect may be increased.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Zolpidem Tartrate tablets should not be taken during pregnancy, especially in the first three months. If for urgent medical reasons, Zolpidem Tartrate tablets are taken during late pregnancy or during labour the baby may show withdrawal symptoms after birth because of physical dependence.
If you are planning to become pregnant or suspect you may already be pregnant do not take Zolpidem Tartrate tablets and contact your doctor as soon as possible for advice. If you are taking Zolpidem Tartrate tablets and notice that you are pregnant, contact your doctor as soon as possible for advice.
Zolpidem will appear in breast milk in small amounts, therefore breast-feeding mothers should not take this medicine.
Driving and using machines
Zolpidem Tartrate tablets may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication. If affected do not drive or operate machinery.
Zolpidem Tartrate tablets contain lactose
If you have been told you have an intolerance to some sugars, tell your doctor or pharmacist before taking Zolpidem Tartrate tablets as this medicine contains lactose.
3 How to take Zolpidem Tartrate tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The tablet should be taken together with liquid immediately before going to bed.
The recommended dose is:
Adults
The recommended daily dose for adults is 2 tablets of Zolpidem Tartrate tablets 5mg (corresponding to 10mg zolpidem tartrate/day).
- Elderly and debilitated patients
In elderly or debilitated a dose of 1 tablet of Zolpidem Tartrate tablets 5mg (corresponding to 5mg zolpidem tartrate/day) is recommended. If the effect is insufficient and you tolerate the medicine well, your doctor may decide to increase the dose to 1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem tartrate/day).
- Patients with impaired liver function
In patients with impaired liver function a dose of 1 tablet of Zolpidem Tartrate tablets 5mg (corresponding to 5mg zolpidem tartrate/day) is recommended. If the effect is insufficient and you tolerate the medicine well, your doctor may decide to increase the dose to 1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem tartrate/day).
Maximum dose
A daily dose of 1 tablet of Zolpidem Tartrate tablets 10mg (corresponding to 10mg zolpidem tartrate/day) should not be exceeded.
Children and adolescents
Zolpidem Tartrate tablets must not be used in children and adolescents of less than 18 years of age.
How long should you take Zolpidem Tartrate tablets
The duration of administration should be as short as possible. In general, it could be a few days up to 2 weeks and not exceed 4 weeks the stepwise withdrawal phase included. Your doctor will choose a withdrawal regime based on your individual needs.
Certain situations may require prolongation beyond the maximum time of treatment. Your attending doctor will decide on that after renewed evaluation of your complaints.
If you take more Zolpidem Tartrate tablets than you should
If you, (or someone else) swallow a lot of the tablets at the same time, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately, do not go unaccompanied to seek medical help. If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
If you forget to take Zolpidem Tartrate tablets
If you forget to take a dose immediately before going to bed but remember during the night, only take the missed dose if you are still able to have 7-8 hours of uninterrupted sleep. If this is not possible, take the next dose before bed time the next night. Do not take a double dose to make up for a forgotten tablet. If you are worried ask your pharmacist or doctor for advice.
If you stop taking Zolpidem Tartrate tablets
• Treatment should be gradually withdrawn as the symptoms you are treated for will return more intense than before (rebound insomnia), also anxiety, restlessness and mood changes may occur. These effects will disappear in time.
• If you have become physically dependent to Zolpidem Tartrate tablets, sudden withdrawal of treatment will lead to side effects such as headaches, muscle pain, anxiety, tension, restlessness, confusion, irritability and sleeplessness. In severe cases other effects may appear, such as hypersensitivity to light, noise and physical contact, abnormally acute hearing and painful sensitivity to sound, hallucinations, numbness and tingling of the extremities, derealisation (feeling the world around you is not real), depersonalisation (feeling your mind is becoming separated from your body) or epileptic seizures (violent fitting or shaking). These symptoms may also be experienced between doses, especially if the dose is high.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: frequency cannot be estimated from the available data.
Stop taking Zolpidem Tartrate tablets and see a doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Tell your doctor as soon as possible if you have any of the following side effects:
Common:
• Poor memory while taking Zolpidem Tartrate tablets (amnesia) and strange behaviour during this time. This is more likely to affect you in the few hours after you take this medicine. By having 7-8 hours sleep after taking Zolpidem Tartrate tablets, this is less likely to cause you a problem.
• Sleeping problems that get worse after taking this medicine
• Seeing or hearing things that are not real (hallucinations)
Uncommon:
• Blurred eyesight or 'seeing double'
Frequency unknown:
• Being less aware of your environment
• Falling, especially in the elderly
Sleep-Driving and other strange behaviour
There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine. This includes sleep-driving, sleep walking and having sex. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen.
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
Common:
• Diarrhoea
• Feeling sick (nausea) or being sick (vomiting)
• Abdominal pain
• Respiratory infection
• Headache
• Feeling tired or agitated
• Nightmares
Uncommon:
• Feeling confused or irritable
Frequency unknown:
• Itching skin or skin rash
• Excessive sweating
• Slower breathing (respiratory depression)
• Weak muscles
• Coordination problems (ataxia)
• Abuse
• Feeling restless, aggressive, angry or showing unusual behaviour
• Depression
• Thinking things that are not true (delusions)
• Changes in sex drive (libido)
• Change in the amount of liver enzymes - shown up in the results of blood tests
• Changes in the way you walk
• Zolpidem Tartrate tablets having less effect than normal
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Zolpidem Tartrate tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the product packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information What Zolpidem Tartrate tablets contain
The active substance (the ingredient that makes the medicine work) is zolpidem tartrate. Each tablet contains either 5mg or 10mg of the active ingredient.
The other ingredients are:
• core: lactose monohydrate, microcrystalline cellulose, sodium starch glycollate type A, hydroxypropyl methylcellulose, magnesium stearate
• coating: hydroxypropyl methylcellulose, titanium dioxide (E171), polyethylene glycol 400.
What Zolpidem looks like and contents of the pack
- Zolpidem Tartrate Actavis 5 mg, filmcoated tablets are oval, biconvex, white tablets . One side is imprinted “ZIM”, the other side is imprinted “5”.
- Zolpidem Tartrate Actavis 10 mg, filmcoated tablets are oval, white tablets with a breaking line. One side is imprinted “ZIM”, the other side is imprinted “10”.
The tablets are packed in blisters inserted into a carton and in polyethylene containers with a child- resistant closure.
- Pack size: 28
Marketing authorisation holder
Actavis, Barnstaple, EX32 8NS, UK
Manufacturer
Synthon Hispania S.L., Poligono Las Salinas, 08830 Sant Boi de Llobregat, Spain
Date of last Revision: September 2013