Zolpidem Tartrate 10mg Film-Coated Tablets
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Zolpidem tartrate 5 mg Tablets Zolpidem tartrate 10 mg Tablets
For adults
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
It may harm them, even if pharmacist or nurse. This
• This medicine has been prescribed for you. Do not pass it on to others. their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist/doctor, includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Zolpidem tartrate is and what it is used for
2. Before you take Zolpidem tartrate
3. How to take Zolpidem tartrate
4. Possible side effects
5. How to store Zolpidem tartrate
6. Further information
1. WHAT ZOLPIDEM TARTRATE IS AND WHAT IT IS USED FOR
Zolpidem tartrate is a sleeping tablet belonging to a group of medicines known as benzodiazepine like agents.
It is indicated for short-term treatment of sleep disturbances.
Zolpidem tartrate should only be prescribed for sleep disturbances that are severe, disabling or cause extreme distress and disrupt everyday life.
2. BEFORE YOU TAKE ZOLPIDEM TARTRATE Do not take Zolpidem tartrate:
• if you are allergic (hypersensitive) to zolpidem or any of the other ingredients of Zolpidem tartrate
• if you suffer from severe muscle weakness (myasthenia gravis)
• if your breathing stops for short periods while you are sleeping (sleep apnoea syndrome)
• if you suffer from severe breathing weakness
• if you suffer from severe liver damage
Children and adolescents under 18 years of age must not take Zolpidem tartrate.
Take special care with Zolpidem tartrate General
Before treatment with this medicine
• the cause of the sleep disturbances should be clarified
• underlying diseases should be treated
If treatment of the sleep disturbances is not successful after 7-14 days, this might point to a psychiatric or physical basic disease which should be checked.
General information about effects observed after use of this medicine and similar sleeping tablets:
• Habituation (habit forming)
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 dose may be required.
• Dependence
When taking this type of medicine there is a risk to develop physical or mental effects produced by a habitual compulsion to keep taking the medicine. This risk increases with the dose and length of treatment. There is a greater risk in patients with a history of alcohol or drug abuse. In case of dependence, sudden discontinuation of treatment is accompanied by withdrawal symptoms, (see section 3. “If you stop taking Zolpidem tartrate”).
• Rebound sleeplessness
On abrupt discontinuation of treatment, inability to sleep may return in a more intense form. It may be accompanied by mood changes, anxiety and restlessness. (see section 3. “If you stop taking Zolpidem tartrate”).
• Memory loss (amnesia)
This medicine can cause memory loss several hours after taking it. To reduce this risk you should ensure that you are able to have 7-8 hours uninterrupted sleep.
• Psychiatric and “paradoxical” reactions
This medicine can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (psychoses), rages, nightmares, sensing of things that are not real (hallucinations), sleepwalking, inappropriate behaviour, increased sleep disturbances and other adverse behavioural effects. These reactions occur more commonly in the elderly.
Please tell your doctor if you recognise such symptoms, as treatment should be discontinued.
• Sleep walking and associated 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 walking, sleep driving, preparing and eating food, making phone calls or having sex. If someone in your environment notices such reactions, contact your doctor.
Special patient groups
Like other similar sleeping tablets, Zolpidem tartrate should be administered with care in:
• Elderly and week patients
They should receive a lower dose (see 3. “How to take Zolpidem tartrate”). This medicine has a muscle-relaxant effect. For this reason, especially elderly patients are at risk of falling and consequently of hip joint fractures when getting out of bed at night.
• Patients with impaired kidney function
Please tell your doctor if you suffer from a reduced kidney function. It may take longer for your body to get rid of Zolpidem. Although no dose adjustment is necessary, caution is required.
• Patients with long lasting breathing problems
Some sleeping tablets can impair breathing.
• Patients with alcohol and drug abuse in their medical history
Extreme caution is required. These patients should carefully be supervised during treatment with this medicine, as they are at risk of habituation and psychological dependence.
Zolpidem tartrate and similar sleeping tablets are not indicated:
• for patients with severe liver dysfunctions.
They are at risk of brain damage (encephalopathy)
• for the primary treatment of patients with delusions (psychoses)
• on their own to treat depression or anxiety. Depressive symptoms may get worse. If you have ever felt that you are so useless or worthless that you have thought about taking your life, it is very important that you tell your doctor about this as he may be able to help you
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Other medicines may be affected by Zolpidem tartrate. They, in turn, may affect how well Zolpidem tartrate works. You may feel an increased sleepiness when Zolpidem tartrate is taken along with the medicines listed below:
• medicines to treat mental disorders (neuroleptics, antidepressants [e.g. sertraline], antipsychotics)
• hypnotics (sleeping tablets)
• medicines to treat anxiety disorders
• highly effective pain killers. Increased euphoria may occur which can result in increased psychological dependence.
• muscle relaxants
• medicines to treat epilepsy
• anaesthetics
• medicines to treat allergies or common colds with concurrent sedative effect (sedative antihistamines)
• medicines to treat a variety of fungal infections such as itraconazole and ketoconazole.
Medicines enhancing the activity of certain liver enzymes can reduce the effect of this medicine: e.g. Rifampicin (for the treatment of tuberculosis).
Taking Zolpidem tartrate with food and drink
You should not drink any alcohol during treatment, as this will change and intensify the effect of zolpidem in an unforeseeable way. The ability to perform tasks that demands an increased concentration is additionally impaired by this combination.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Zolpidem tartrate should not be taken during pregnancy, especially not in the first three months because no sufficient data is available to evaluate safe administration of this medicine during pregnancy and breast feeding. Although Zolpidem tartrate did not show any malformations or any effect damaging the embryo in animal studies, the safety during human pregnancy has not been verified.
Please inform your doctor if you want to become pregnant during treatment with Zolpidem tartrate or if you suspect to be pregnant, so that he/she can decide whether treatment is to be continued or i.e. converted.
If this medicine is taken for compelling medicinal reasons during the last months of pregnancy or during delivery, your baby might suffer from low body temperature, floppy muscle, and breathing difficulties, and may show withdrawal symptoms after birth because of physical dependence.
Since zolpidem passes into mother’s milk in low quantities, this medicine should not be taken during breast feeding.
Driving and using machines
Do not drive or use any tools or machines.
Sleepiness, memory defects, impaired concentration and impaired muscular function may have an adverse effect on the ability to drive or the ability to operate machinery (See section 2 “Taking Zolpidem tartrate with food and drink”).
This applies to a higher degree after insufficient duration of sleep.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine until you know how it affects you.
• It is an offence to drive if this medicine affects your ability to drive.
However, you would not be committing an offence if:
• The medicine has been prescribed to treat a medical or dental problem and
• You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
• It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
Important information about some of the ingredients of Zolpidem tartrate
Zolpidem tartrate contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE ZOLPIDEM TARTRATE
Always take Zolpidem tartrate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The film-coated tablet should be taken together with liquid immediately before going to bed. Make sure that you are able to have an uninterrupted sleep of 7-8 hours.
The usual dose is:
Adults
The recommended daily dose for adults is 2 film-coated tablets of Zolpidem tartrate 5 mg or 1 film-coated tablet of Zolpidem tartrate 10 mg (corresponding to 10 mg zolpidem tartrate/day).
• Elderly and weak patients
The recommended daily dose in elderly or weak patients is 1 film-coated tablet of Zolpidem tartrate 5 mg or 1/2 film-coated tablet of Zolpidem tartrate 10 mg (corresponding to 5 mg zolpidem tartrate/day). The doctor will decide whether the daily dose may need to be increased.
• Patients with impaired liver function
The recommended daily dose in patients with impaired liver function is 1 film-coated tablet of Zolpidem tartrate 5 mg or 1/2 film-coated tablet of Zolpidem tartrate 10 mg (corresponding to 5 mg zolpidem tartrate/day). The doctor will decide whether the daily dose may need to be increased.
Maximum dose
A daily dose of 2 film-coated tablets of Zolpidem tartrate 5 mg or 1 film-coated tablet of Zolpidem tartrate 10 mg (corresponding to 10 mg zolpidem tartrate/day) should not be exceeded.
Children and adolescents
Zolpidem tartrate must not be used in children and adolescents under 18 years of age.
How long should you take Zolpidem tartrate
The duration of treatment should be as short as possible. This it could be a few days up to 2 weeks and should not be longer than four weeks. Your doctor will tell you when and how to stop treatment.
If you take more Zolpidem tartrate than you should
Contact your doctor immediately. Take this leaflet and any leftover tablets with you to show your doctor.
In case of overdosage of Zolpidem tartrate alone, depression of consciousness has been reported which was in the range from extreme sleepiness up to light coma.
If you forget to take Zolpidem tartrate
If you forget to take a dose immediately before bed but remember during the night, only take the missed dose, if you are still able to have 7-8 hours of uninterrupted sleep before you need to get up.
If this is not the case, restart immediately before the next night. Do not take a double dose to make up for a forgotten dose.
If you stop taking Zolpidem tartrate
Do not stop taking this medicine suddenly. Otherwise, the inability to sleep may return in a more intense form, maybe accompanied by mood changes, anxiety and restlessness.
In case of dependence, withdrawal symptoms such as headache, muscle pain, severe anxiety and tension, sleep disorders, restlessness, confusion, and irritability may occur. In severe cases other effects can include derealisation or depersonalisation (feeling ‘divorced’ from one’s own identity and sense of reality), pins and needles in the limbs, hypersensitivity to light, sound and touch, hallucinations or epileptic seizures.
As the risk of withdrawal symptoms and rebound sleeplessness is higher after abrupt discontinuation of treatment, your doctor will advise you to terminate treatment by gradual reduction in the dose.
See section 2. “Dependence” and “Rebound sleeplessness”.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zolpidem tartrate can cause side effects, although not everybody gets them.
These effects seem to be related to individual sensitivity and seem to appear more often within the
hour after taking the tablet if you do not go to bed or you do not sleep immediately.
These side effects occur most frequently in elderly patients.
The side effects are:
Common (affects 1 to 10 users in 100):
Mental: Sensing things that are not real (hallucinations), agitation, nightmares
Nerves: Sleepiness during the following day, numbed emotions, reduced alertness, tiredness,
headache, dizziness, difficultly remembering things, which may be associated with inappropriate behaviour, ataxia (loss of co-ordination of the muscles), worsening insomnia
Ears: Sensation of spinning with loss of balance (vertigo)
Stomach and intestine: diarrhoea, feeling sick, vomiting stomach pain General disorders and administration site illnesses: fatigue Uncommon (affects 1 to 10 users in 1,000):
Mental: State of confusion, irritability
Eyes: Double vision
Not known(frequency cannot be estimated from the available data)
Mental: Restlessness, aggression, delusions, anger, mental disturbances (psychosis),
sleepwalking, inappropriate behaviour and other adverse behavioural effects , memory loss (amnesia), which may be associated with inappropriate behaviour (see section 2, Take special care with Zolpidem tartrate). Such reactions are more likely to occur in the elderly.
Pre-existing depression may be unmasked during use of Zolpidem tartrate or other sleeping tablets (hypnotics).
Taking Zolpidem tartrate for a long period of time may lead to physical or psychological dependence. If you suddenly stop taking Zolpidem tartrate, you may suffer from withdrawal symptoms (see section 2, Take special care with Zolpidem tartrate).
Misuse of Zolpidem tartrate by drug abusers has been reported.
Decrease in sexual need (libido)
Skin: Rash, nettle rash, itching, excessive sweating
Muscles: Muscle weakness
General disorders and administration site illnesses: abnormal posture when walking (abnormal gait), drug tolerance, falls (mainly in eldery patients and when Zolpidem tartrate was not taken as prescribed).
Liver: Increased liver enzymes
Immune system: Sudden swelling of the lips, cheeks, eyelids, tongue or throat.
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 Keep out of the reach and sight of children.
Do not use Zolpidem tartrate after the expiry date which is stated on the carton and the blister after Exp. The expiry date refers to the last day of that month.
Store in the original package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Zolpidem tartrate contains
The active substance is zolpidem tartrate.
The other ingredients are
Tablet core: Lactose monohydrate, microcrystalline cellulose, sodium starch glycollate (Type A), magnesium stearate, hypromellose
Tablet coating: Hypromellose, macrogol 400, titanium dioxide (colouring agent E 171)
What Zolpidem tartrate 5 mg and 10 mg looks like and contents of the pack
Zolpidem tartrate 5 mg film-coated tablets are white, oval, biconvex and embossed with “ZIM” and “5” on one side.
Zolpidem tartrate 10 mg film-coated tablets are white, oval, biconvex and embossed with “ZIM” and “10” on one side. The tablet can be divided into equal halves.
The film-coated tablets are packed in blisters in a carton containing 4, 5, 7, 10, 14, 15, 20, 28, 30, 50, 100, 500 film-coated tablets.
Zolpidem tartrate tablets are also available in tablet containers with 30, 100 or 500 tablets, sealed with a child proof closure.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
ratiopharm GmbH, Graf-Arco-Strasse 3, D-89079 Ulm, Germany.
Manufacturers:
Merckle GmbH, Ludwig-Merckle-Strasse 3, D-89143 Blaubeuren, Germany.
This leaflet was last revised in: June 2014.