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• leaflet MAH GENERIC_PL 11311-0484
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PATIENT INFORMATION LEAFLET

Zolpidem 10mg Film-Coated Tablets

(Zolpidem Tartrate)

What this medicine is and what it is used for

Zolpidem is a sedative-hypnotic medicine belonging to a group of medicines called benzodiazepine-like agents.

It is used for the short-term treatment of insomnia (difficulty in sleeping) in adults where the condition is debilitating or causing extreme distress.

What you need to know before you take Zolpidem

Do not take Zolpidem if:

•    You are allergic (hypersensitive) to Zolpidem, benzodiazepines or benzodiazepine-like agents or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”)

•    You suffer from severe liver disorders (hepatic insufficiency) because there is a risk of developing a disorder of the brain (encephalopathy)

•    You suffer from a condition where the throat relaxes during sleep and interrupts normal breathing (sleep apnoea syndrome)

•    You suffer from muscle weakness (myasthenia gravis)

•    You suffer from a condition where not enough oxygen passes from the lungs into the blood (severe respiratory insufficiency)

•    You are under 18 years of age

Warnings and precautions

Talk to your doctor before taking Zolpidem:

•    Where possible, the cause of insomnia (difficulty in sleeping) should be identified. Any other factors (such as psychiatric or physical disorders) should be treated before Zolpidem is prescribed. Insomnia should be relieved following a 7-14 day course of treatment

•    As some loss of effectiveness (tolerance) may develop after repeated use of Zolpidem for a few weeks

•    As use of Zolpidem may lead to the development of dependence on this medicine. The risk of dependence increases with dose and duration of treatment and is also greater if you have a history of alcohol or drug abuse. If dependence develops, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms which may consist of headaches or muscle pain, extreme anxiety and tension, restlessness, confusion, irritability and difficulty in sleeping (insomnia). In severe cases the following symptoms may occur; feeling dissociated from your environment (derealisation), feeling of loss of identity/feeling detached from yourself (depersonalisation), over-sensitivity to sound (hyperacusis), numbness and tingling of the arms and/or legs, hypersensitivity to light, noise and touch, seeing or hearing things that are not real (hallucinations) or fits (epileptic seizures)

•    If Zolpidem is withdrawn, a temporary rebound reaction where the symptoms that led to treatment with this medicine may recur in an enhanced form. This may be accompanied by other reactions including mood changes, anxiety and restlessness. It is recommended to decrease the dose of Zolpidem gradually as the risk of withdrawal/rebound symptoms are more likely to develop following abrupt discontinuation of treatment

•    As treatment should be as short as possible. The duration of treatment may vary from a few days to 2 weeks with a maximum (including the tapering-off process) of 4 weeks. See section 3 “How to take Zolpidem”

•    As Zolpidem may induce anterograde amnesia (loss of ability to create new memories after the event that caused the original loss of memory). This usually occurs several hours after taking the medicine. In order to reduce this risk, you should ensure that you will be able to have uninterrupted sleep for 8 hours

•    When using Zolpidem, reactions such as restlessness, agitation, irritability, aggressiveness, mental health disorders (delusion, psychoses), rages, nightmares, seeing or hearing things that are not real (hallucinations), sleepwalking (somnambulism), inappropriate behaviour and increased difficulty in sleeping (insomnia) are known to occur. Should any of these reactions occur, use of this medicine should be discontinued. These reactions are more likely to occur in older people

•    If you are an older person or are weakened/sensitive, as you should take a lower dose of Zolpidem (see section 3 “How to take Zolpidem”). Due to the relaxing effect on muscle by Zolpidem, there is a risk of falls and consequently of hip fractures particularly for older people

•    If you suffer from kidney disorders

•    If you suffer from a severe condition where not enough oxygen passes from the lungs into the blood (chronic respiratory insufficiency) since Zolpidem may impair your control of breathing. Anxiety or agitation have been described as signs of this condition

•    If you suffer from severe mental health disorders that cause abnormal thinking/perceptions (psychotic illness) as Zolpidem is not recommended as the primary treatment

•    If you suffer from depressive symptoms as you should be given the lowest possible dose of Zolpidem. Zolpidem is not intended to be used alone to treat depression or anxiety associated with depression

•    If you have a history of alcohol or drug abuse as Zolpidem should be used with extreme caution as you are at risk of tolerance (loss of effectiveness) and dependence on this medicine

Next-day psychomotor impairment (see also “Driving and using machines”)

The day after taking Zolpidem, 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 increases 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected

by Zolpidem:

•    CNS depressants, medicines used to treat anxiety and sleep disorders such as valium

•    Rifampicin, a medicine used to treat bacterial infections (antibiotic)

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 for depressions

•    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 (sedative 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.

Taking Zolpidem with food and drink and alcohol

During treatment with Zolpidem, it is recommended not to drink alcohol as the sedative effect (of Zolpidem) may be enhanced.

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 for advice before taking this medicine.

Pregnancy

Zolpidem should not be used during pregnancy,

especially in the first 3 months.

If Zolpidem is given during the later stages of pregnancy or during labour, the newborn, may experience such effects as a drop in body temperature (hypothermia), muscle weakness (hypotonia) and breathing more slowly or weakly than usual (moderate respiratory depression).

Babies born to mothers who took Zolpidem chronically during the latter stages of pregnancy may develop withdrawal symptoms in the postnatal period (the first 6 weeks after birth) as a result of dependence.

Breast-feeding

If you are breast-feeding, Zolpidem should not be taken as Zolpidem is passed into breast milk.

Driving and using machines

This 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:

o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the

instructions given by the prescriber or in the information provided with the medicine and o 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.

continued....

Zolpidem has major influence on the ability to drive and use machines such as “sleep driving”. On the day after taking Zolpidem (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 minimize the above listed effects.

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

Zolpidem contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

31 How to take Zolpidem

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

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

The tablets can be divided into equal doses.

Treatment should be as short as possible. The duration of treatment may vary from a few days to 2 weeks with a maximum (including the tapering-off process) of 4 weeks.

Adults

•    The treatment should be taken in a single intake (see above) and not be re-administered during the same night.

•    The recommended daily dose for adults is 10mg to be taken with sufficient fluid just before bedtime.

•    The lowest effective daily dose of Zolpidem should be used and must not exceed 10mg.

Older people, weakened/sensitive patients and patients with impaired liver function The recommended dose is 5mg. This dose should only be increased to 10mg if the response is inadequate and the medicine is well tolerated.

Use in children

Zolpidem is not recommended for use in children and adolescents below 18 years of age.

If you take more Zolpidem than you should:

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose include: impaired consciousness ranging from sleepiness or drowsiness (somnolence) to light coma.

If you forget to take Zolpidem

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Zolpidem Tablets

It is important that you keep taking Zolpidem for as long as your doctor has told you to.

Treatment should be as short as possible. The duration of treatment may vary from a few days to 2 weeks with a maximum (including the tapering-off process) of 4 weeks.

See “Warnings and precautions” section for further information with regards to dependence, withdrawal and rebound effects.

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

4 Possible side effects

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

These effects are usually related to personal sensitivity and appear more often within the hour following the medicine intake if you do not go to bed or do not sleep immediately.

expected) - see “Other side effects” section below

Other side effects (frequency not known)

These effects occur usually at the start of treatment and usually disappear over time

•    Loss of ability to create new memories after the event that caused the original loss of memory (anterograde amnesia). The risk increases with higher doses. These effects may be associated with inappropriate behaviour (see “Warnings and precautions” section)

•    Pre-existing depressive symptoms may occur

•    Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, mental health disorders (delusion, psychoses), rages, nightmares, seeing or hearing things that are not real (hallucinations) and inappropriate behaviour may occur. These reactions are more likely to occur in older people (see “Warnings and precautions” section)

•    The risk of dependence on this medicine increases with dose and duration of treatment and is also greater if you have a history of alcohol or drug abuse. If dependence develops, abrupt discontinuation of treatment will be accompanied by withdrawal symptoms. If Zolpidem is withdrawn, a temporary rebound reaction where the symptoms that led to treatment with this medicine may recur in an enhanced form (see “Warnings and precautions” section)

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 the internet at (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

How to store Zolpidem

•    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 carton/blister after EXP. The expiry date refers to the last day of that month.

•    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.

Contents of the pack and other Information

What Zolpidem contains:

Each film-coated tablet contains 10mg of zolpidem tartrate equivalent to 8.03mg of Zolpidem.

The other ingredients are:

Tablet core: succinic acid, sodium carboxymethyl starch (type A), microcrystalline cellulose, lactose monohydrate, magnesium stearate, colloidal silicon dioxide

Tablet coating: lactose monohydrate, macrogol 4000, hypromellose, colouring agent titanium dioxide (E 171)

What Zolpidem looks like and contents of the pack:

Zolpidem are white, oblong, biconvex film-coated tablets with length of 10mm-10.4mm and height of 2.6mm- 3.0mm, with a break score.

Zolpidem is available in:

Zolpidem tablets are available in packs of 10, 20, 28, 30, 50, 98 or 100 tablets.

Not all pack sizes may be marketed.

Product Licence Number:

PL 11311/0484

Marketing Authorisation Holder

Tillomed Laboratories Ltd 3 Howard Road,

Eaton Socon, St. Neots,

Cambridgeshire,

PE19 8ET,

UK

Manufacturer:

Salutas Pharma GMBH Otto-von-Guericke-Allee 1,

D-39179 Barleben,

Germany

This leaflet was last revised in October 2014

Seek medical advice immediately if you develop the following symptoms:

• Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

Common side effects (may affect up to 1 in 10 people)

•    Drowsiness the following day (after taking Zolpidem)

•    Headache

•    Dizziness

•    Numbed emotions

•    Reduced alertness

•    Confusion

•    A sensation of whirling and loss of balance, feeling dizzy or giddy (vertigo)

•    Diarrhoea

•    Feeling and/or being sick (nausea, vomiting)

•    Double vision

•    Skin reactions

•    Loss of memory (amnesia)

Uncommon side effects (may affect up to 1 in 100 people)

•    Tiredness, weakness or lack energy (fatigue)

•    Muscle weakness

•    Lack of voluntary co-ordination of muscle movements [unsteadiness or clumsiness] (ataxia)

Rare side effects (may affect up to 1 in 1000 people)

•    Decreased sexual drive (libido)

•    Paradoxical reactions (an effect of medicine, opposite to the effect which would normally be

Rog-Ver.7s