Document: Zolpidem Mylan film-coated tablet ENG PL change

• Zolpidem Mylan film-coated tablet PL
• Zolpidem Mylan film-coated tablet ENG PL

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Package leaflet: Information for the patient

Zolpidem Mylan 10 mg Film-coated Tablets

(zolpidem tartrate)

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 doctor or pharmacist.

- 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.

In this leaflet:

1. What Zolpidem Mylan is and what it is used for

2. What you need to know before you take Zolpidem Mylan

3. How to take Zolpidem Mylan

4. Possible side effects

5. How to store Zolpidem Mylan

6. Contents of the pack and other information.

1. What Zolpidem Mylanis and what it is used for

Zolpidem Mylan contains zolpidem, which belongs to a group of medicines called hypnotics. Zolpidem Mylan Tablets are sleeping pills, which work by acting on the brain to cause sleepiness.

This medicine may be used in adults for short-term treatment of insomnia which is severe, disabling or causing great distress. Insomnia is a difficulty in falling asleep or sleeping properly.

2. What you need to know before you take Zolpidem Mylan

Do not take Zolpidem Mylanif 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 sleep apnoea (a condition where you stop breathing for very short periods whilst sleeping)

• suffer from severe muscle weakness (myasthenia gravis)

• have acute and/or severe breathing problems

• are under 18 years of age.

Warnings and precautions

Talk to your doctor before taking this medicine if you:

• are elderly or frail. If you get up at night, take care. Zolpidem Mylan may relax your muscles. This increases your risk of falling and consequently of hip fractures.

• have any kidney or liver problems.

• have a history of breathing problems. Whilst taking Zolpidem Mylan your breathing may become less forceful

• have a history of mental illness, anxiety or psychotic illness. Zolpidem Mylan may unmask or worsen symptoms

• suffer from or have a history of depression (feeling sad)

• have, or have ever had a history of, or tendency towards alcohol or drug abuse. The risk of dependence on Zolpidem Mylan (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

• Tolerance – if, after a few weeks, you notice that your tablets are not working as well as they did when you first started treatment, you should see your doctor. Adjustment of 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. The risk is greater if you have a history of alcohol or drug abuse.

• Withdrawal - treatment should be withdrawn gradually. A short-lived syndrome may occur on withdrawal, where the symptoms that led to your treatment with Zolpidem Mylan recur in an enhanced form. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

• Amnesia - Zolpidem Mylan can cause memory loss. To reduce this risk you should ensure that you are able to have 8 hours of uninterrupted sleep.

• Psychiatric and "paradoxical" reactions - Zolpidem Mylan can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations (seeing, hearing or feeling things that are not there), psychoses (losing contact with reality, unable to think and judge clearly), inappropriate behaviour and increased insomnia.

• Sleep walking and other associated behaviours – Zolpidem Mylan can cause people to do things whilst asleep that they do not remember when they wake up. This includes sleep walking, sleep driving, preparing and eating food, making phone calls or having sex. Alcohol and some medicines used to treat depression or anxiety or the use of Zolpidem Mylan at doses larger than the maximum recommended dose can increase the risk of these side effects.

• Falls and injury – zolpidem can cause you to feel drowsy or have lower levels of awareness, which may lead to falling and possible injury.

• Next-day psychomotor impairment (see also “Driving and using machines”) - The day after taking Zolpidem Mylan, the risk of psychomotor impairment, including impaired driving ability, may be increased if:

• You take this medicine less than 8 hours before performing activities that require your alertness

• You take a higher dose than the recommended dose

• You take zolpidem while you are already taking another central nervous system depressant or another medicine that increase zolpidem in your blood, or while drinking alcohol, or while taking illicit substances.

Take the single intake immediately at bedtime. Do not take another dose during the same night.

Other medicines and Zolpidem Mylan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Zolpidem Mylan may influence the effect and/or side effects of other medicines. If you are to have an operation under general anaesthetic, tell the doctor which medicines you use.

While taking zolpidem with the following medicines, drowsiness and next-day psychomotor impairment effects, including impaired driving ability, may be increased.

• Medicines for some mental health problems (antipsychotics)

• Medicines for sleep problems (hypnotics)

• Medicines to calm or reduce anxiety

• Medicines used to relax muscles

• Medicines for depression

• Medicines for moderate to severe pain (narcotic analgesics)

• Medicines for epilepsy

• Medicines used for anaesthesia

• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedatives antihistamines).

While taking zolpidem with antidepressants including bupropion, desipramine, fluoxetine, sertraline and venlafaxine, you may see things that are not real (hallucinations).

It is not recommended to take zolpidem with fluvoxamine or ciprofloxacin.

The following medicines may increase the sedating effect of Zolpidem Mylan:

Rifampicin, a medicine used to treat tuberculosis, may cause a decrease in the effect of Zolpidem Mylan.

Zolpidem Mylanwith alcohol

Alcohol should not be consumed when taking Zolpidem Mylan, as the sedating effect may be increased.

Pregnancy and breast-feeding

Zolpidem Mylan should not be taken during pregnancy, especially in the first three months. If for urgent medical reasons, you take Zolpidem Mylan during late pregnancy or during labour, your baby might suffer from low body temperature, floppy muscle, and breathing difficulties, and may show withdrawal symptoms after birth because of physical dependence.

Do not breast-feed your baby, as small amounts of zolpidem can pass into breast milk.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Zolpidem Mylan has major influence on the ability to drive and use machines such as “sleep driving”. On the day after taking Zolpidem Mylan (as other hypnotic medicines), you should be aware that:

• You may feel drowsy, sleepy, dizzy or confused

• Your quick decision-making may be longer

• Your vision may be blurred or double

• You may be less alert.

A period of at least 8 hours is recommended between taking zolpidem and driving, using machinery and working at heights to minimise the above listed effects.

Do not drink alcohol or take other psychoactive substances while you are taking Zolpidem Mylan, as it can increase the above listed effects.

Zolpidem Mylancontains lactose

If your doctor has told you that you have an intolerance to some sugars, such as lactose, contact your doctor before taking this medicine.

3. Howto take Zolpidem Mylan

Always take Zolpidem Mylan exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablets act rapidly and should be swallowed whole with liquid immediately before going to bed, or in bed. Make sure you have at least 8 hours of sleep after taking this medicine.

The tablets can be divided into equal doses.

Adults: The recommended dose per 24 hours is 10 mg of Zolpidem Mylan. A lower dose may be prescribed to some patients. Zolpidem Mylan should be taken:

• as a single intake

• just before bedtime.

Make sure you have a period of at least 8 hours after taking this medicine before performing activities that require your alertness.

Do not exceed 10 mg per 24 hours.

Elderly (over 65 years) or debilitated patients: The recommended dose is 5 mg.

Patients with liver problems: The recommended starting dose is 5 mg. Your doctor may decide to increase this to 10 mg if it is safe to do so.

The maximum dose of 10 mg must not be exceeded in any patients.

Use in children and adolescents: Zolpidem Mylan should not be taken by patients under 18 years of age.

If 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.

Duration of treatment

The duration of administration should be as short as possible. This usually varies from a few days to two weeks. The maximum treatment period, including the stepwise withdrawal process, is four weeks.

Your doctor will choose a stepwise withdrawal regime for you based on your individual needs. In certainsituations you may be required to take Zolpidem Mylanfor longer than 4 weeks.

If you take more Zolpidem Mylanthan 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 doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Do not go unaccompanied to seek medical help. If an overdose has been taken you may become increasingly drowsy very quickly, with high doses possibly leading to a coma or even death.

If you forget to take Zolpidem Mylan

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 8 hours of uninterrupted sleep. If this is not possible, take the next dose before bed time the next night. You should not take this medicine at another time of the day because it may make you feel drowsy, dizzy or confused. Do not take a double dose to make up for a forgotten dose. If you are worried ask your pharmacist or doctor for advice.

If you stop taking Zolpidem Mylan

Keep taking your medicine until your doctor tells you to stop. Do not stop taking your medicine suddenly, but tell your doctor if you want to stop. Treatment should be withdrawn gradually, otherwise the sleep problems you are treated for may return more intensely 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 Mylan, 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.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Zolpidem Mylan and tell your doctor immediately or go to yournearest hospital emergency department:

Common (may affect up to 1 in 10 people):

Not known(frequency cannot be estimated from the available data):

• physical dependence: use (even at therapeutic dosages) may lead to physical dependence; sudden discontinuation of treatment may result in withdrawal effects and recurrence of problems

• psychological dependence: this is when you think that you cannot ever sleep without taking Zolpidem Mylan

• feeling very sleepy or tired, unable to concentrate or carry out normal activities

• difficulty breathing

• psychosis (losing contact with reality, unable to think and judge clearly)

• itchy skin with yellowing of the skin or eyes, abdominal pain, dark urine, fever or chills. These may be signs of a problem with your liver

These side effects are serious. You may need medical attention.

The risk of amnesia is higher at higher doses. If you make sure that you can have 8 hours of uninterrupted sleep the risk of amnesia is reduced.

Tell your doctor or pharmacist if any of the following side effects occur or worsen:

Common (may affect up to 1 in 10 people):

• hallucinations, agitation, nightmares

• drowsiness, headache, dizziness, increased insomnia

• 'spinning' sensation

• drowsiness the following day, numbed emotions, reduced alertness

• diarrhoea, nausea, vomiting

• skin reactions

• back pain

• fatigue

• abdominal pain

• infections in the nose or throat.

Uncommon (may affect up to 1 in 100 people):

• co-ordination disturbances

• double vision.

Rare (may affect up to 1 in 1,000 people):

Not known (frequency cannot be estimated from the available data):

• restlessness, aggression, delusion (false beliefs), rages, inappropriate behaviour.

• depression (feeling sad)

• decreased libido

• sleep walking

• increased levels of some liver enzymes (which would be detected by your doctor during a blood test)

• skin rash, itching, hives

• excessive sweating

• muscle weakness

• changes in the way you walk

• the need to take increasingly higher doses of a medicine to gain the same effect

• falls, particularly in the elderly.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via [to be completed nationally].

5. How to store Zolpidem Mylan

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Keep your medicine in the original package.

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 to protect the environment.

6. Contents of the pack and other information

What Zolpidem Mylancontains

The active substance is zolpidem tartrate. Each tablet contains 10 mg of zolpidem tartrate.

The other ingredients are lactose monohydrate (see section 2, ‘Zolpidem Mylan contains lactose’), microcrystalline cellulose, pregelatinised maize starch, magnesium stearate. The coating includes hypromellose, titanium dioxide (E171), polysorbate 80 (E433), macrogol 400.

What Zolpidem Mylanlooks like and contents of the pack

Your medicine comes as a white to off-white capsule shaped film-coated tablet, marked “ZM breakline 10” on one side and “G” on the other. The tablets can be divided into equal doses.

Zolpidem Mylan Tablets are available in blister packs or in plastic containers containing 4, 7, 10, 14, 20, 28, 30, 50, 100 or 250 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

[To be completed Nationally]

Manufacturer

[To be completed Nationally]

Generics [UK] Limited, Station Close, Potters Bar, Herts EN6 1TL, United Kingdom

Gerard Laboratories, 35/36 Baldoyle Industrial Estate Grange Road Dublin 13, Ireland

Orifice Medical AB, Aktergatan 2, 271 53 Ystad, Sverige

Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Netherlands

Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium-Zolpidem Mylan 10 mg filmomhulde tabletten

Denmark – Zolpidem “Mylan” filmovertrukne tabletter 10 mg

Germany –Zolpidem dura 10 mg filmtabletten

Ireland – Zoldem 10 mg Film-coated Tablets

Luxembourg – Dodorest 10 mg filmomhulde tabletten

Netherlands – Zolpidemtartraat Mylan 10 mg, filmomhulde tabletten

Sweden – Zolpidem Mylan 10 mg filmdragerade tabletter

United Kingdom – Zolpidem 10 mg Film-coated Tablets

This leaflet was last revised in [to be completed nationally].

2016-10-18