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PACKAGE LEAFLET: INFORMATION FOR THE USER_

Zolpidem tartrate 5 mg and 10 mg Film-coated Tablets

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. 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 tablets are and what they are used for

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

3.    How to take Zolpidem tablets

4.    Possible side effects

5.    How to store Zolpidem tablets

6.    Contents of the pack and other information

|    1. What Zolpidem tablets are and what they are used for    ~|

The name of your medicine is Zolpidem tartrate 5mg and 10mg Film-coated Tablets. This contains a medicine called Zolpidem tartrate.

This belongs to a group of medicines called hypnotics. It works by acting on your brain to help you sleep. Zolpidem is used for temporary sleep problems in adults that are causing you severe distress or that are affecting your every day life. This includes sleep problems in adults such as:

•    Difficulty falling asleep

•    Waking in the middle of the night

•    Waking too early

Your doctor will identify your sleep problem wherever possible and the underlying factors before prescribing this medicine for you.The failure of your sleep problems to stop after a 7-14 day course of treatment may indicate you have an underlying disorder, your doctor will assess you at regular intervals.

Zolpidem is not meant to be used everyday for long periods of time. Ask your doctor for advice if you are unsure.

|    2. What you need to know before taking Zolpidem tablets    ~|

Do not take this medicine if:

•    You are allergic (hypersensitive) to zolpidem tartrate or any of the other ingredients of Stilnoct (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    Your lungs do not work properly (respiratory failure)

•    You have severe liver problems

•    You have a problem where you stop breathing for short periods at night (sleep apnoea)

•    You have a problem that causes severe muscle weakness (myasthenia gravis)

•    You have been told by a doctor that you have a mental illness (psychosis)

•    You are under the age of 18

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking zolpidem.

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medicine if

•    You have a history of alcohol or drug abuse

•    You have liver problems

•    You have depression or have had another mental illnesses in the past

•    You have recently taken Zolpidem or other similar medicines for more than four weeks

•    You are elderly

Zolpidem can cause drowsiness and decrease your level of alertness. This could cause you to fall, sometimes leading to severe injuries.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking this medicine. Next-day psychomotor impairment (see also Driving and using machines)

The day after taking Zolpidem Tablets, 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 depressants or another medicines 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 tablets

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

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

Zolpidem tablets may increase the effect of the following medicines:

•    Medicines for some mental health problems (antipsychotics)

•    Medicines for depression such as sertraline

•    Medicines for epilepsy (anticonvulsants)

•    Medicines used in surgery (anaesthetics)

•    Medicines to calm or reduce anxiety or for sleep problems (hypnotics)

•    Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine

•    Some medicines for moderate to severe pain (narcotic analgesics) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol

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 can increase the chance of you getting side effects when taken with zolpidem tablets. To make this less likely, your doctor may decide to lower your dose of Zolpidem Tablets:

•    Some antibiotics such as clarithromycin or erythromycin

•    Some medicines for fungal infections such as ketaconazole and itraconazole

•    Ritonavir (a protease inhibitor)- for HIV infections.

The following medicines can make Zolpidem work less well:

•    Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin

•    Rifampicin (an antibiotic)-for infections

•    St John's Wort (a herbal medicine)- for mood swings and depression Zolpidem tablets with food, drink and alcohol

•    Do not drink alcohol while you are being treated with these tablets. Alcohol can increase the side effects of Zolpidem tablets and make you sleep very deeply so that you do not breathe properly or have difficulty waking.

Pregnancy and breast-feeding

•    Taking Zolpidem during pregnancy may harm your baby.

•    Do not take Zolpidem if breast-feeding as small amounts of Zolpidem may pass into your breast milk.

•    Do not take these tablets if you are pregnant or intend to become pregnant or are breast-feeding.

•    Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving or using machines:

Zolpidem Tablets has major influence on the ability to drive and use machines such as "sleep driving". On the day after taking Zolpidem Tablets (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 Tablets, as it can increase the above listed effects.

Zolpidem Tablets contain Lactose

If you have been previously told by your doctor you have intolerance to some sugars (lactose or milk sugars), contact your doctor before taking this medicine.

|    3. How to take Zolpidem Tablets    ~|

Always take the tablets exactly as your doctor has prescribed.

You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

•    Take this medicine by mouth.

•    Swallow the tablet whole with a drink of water.

•    The usual length of treatment is 2 days to 4 weeks.

•    The recommended dose per 24 hours is 10 mg 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.

Patients with liver problems

The usual starting dose is one tablet (5mg) just before bedtime. Your doctor may decide to increase this to two 8 tablets (10mg) if it is safe to do so.    5

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Children and Adolescents

Zolpidem should not be used in people under 18 years old.

If you take more tablets than you should:

If you or someone else swallows a lot of the tablets or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty (A&E) or your doctor immediately. Take your medicine in its original packaging with you in order to enable the doctor to identify your medication easily.

Taking too much of this medicine can be very dangerous. The following effects may happen:

•    Feeling drowsy, confused, sleeping deeply and possibly falling into a fatal coma.

If you forget to take your tablets

Zolpidem must only be taken at bedtime. If you forget to take your tablet at bedtime, then you should not take it at any other time, otherwise you may feel drowsy, dizzy and confused during the day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking these tablets

Keep taking Zolpidem Tablets until your doctor tells you to stop. Do not stop taking Zolpidem suddenly, but tell your doctor if you want to stop. Your doctor will need to lower your dose and stop your tablets over a period of time.

If you stop taking Zolpidem Tablets suddenly, your sleep problems may come back and you may get a 'withdrawal effect'. If this happens you may get some of the effects listed below.

See a doctor straight away if you get any of the following effects:

•    Feeling anxious, restless, irritable or confused

•    Headache

•    Faster heartbeat or uneven heartbeat (palpitations)

•    Nightmares, seeing or hearing things that are not real (hallucinations)

•    Being more sensitive to light, noise and touch than normal

•    Relaxed grip on reality

•    Feeling distant from your body or feeling 'puppet-like'

•    Numbness and tingling in your hands and feet

•    Aching muscles

•    Stomach problems

•    Sleep problems come back worse than before In rare cases fits (seizures) may also occur.

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.

Stop taking Zolpidem tablets and see a doctor or go to 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 (may affect up to 1 in 10 people)

•    Poor memory while taking Zolpidem (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, 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 (may affect up to 1 in 100 people)

•    Blurred eyesight or 'seeing double'

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

•    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 (may affect up to 1 in 10 people)

•    Diarrhoea

•    Feeling sick (nausea) or being sick (vomiting)

•    Abdominal pain

•    Respiratory infection

•    Headache

•    Feeling tired or agitated

•    Nightmares

•    A feeling of being out of touch with reality and being unable to think or judge clearly (psychosis)

•    Feeling dizzy, Feeling drowsy or sleepy

•    Back pain

Uncommon (may affect up to 1 in 100 people)

•    Feeling confused or irritable

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

•    Itching skin or skin rash

•    Excessive sweating

•    Slower breathing (respiratory depression)

•    Weak muscles

•    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 tablets having less effect than normal.

•    Becoming dependent on Zolpidem

Reporting 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 Yellow Card Scheme website: www.mhra.gov.uk/yellow card . By reporting side effects you can help provide more information on the safety of this medicine.

|    5. How to store Zolpidem tablets    ~|

•    Keep this medicine out of sight and reach of children.

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

•    Do not store above 25⁰C. Store 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 protect the environment.

|    6. Contents of the pack and other information    ~|

What Zolpidem 5 mg and 10 mg tablets contains:

•    The active ingredient is Zolpidem tartrate

•    The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, sodium starch glycollate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide (E171), purified talc, macrogol 6000.

What the tablets look like and contents of the pack

•    There are two strengths of Zolpidem tartrate tablets, 5mg and 10mg

•    Zolpidem 5mg tablets are white to almost white, round, biconvex, film-coated tablets '5' embossing on one side and plain on the other side.

•    Zolpidem 10mg tablets are white to almost white, caplet shaped, biconvex, film-coated tablets with break line on one side and 'BL 10' embossing on other side.

•    This medicine is available in packs of 7,14, 28, 56 or 84 tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Name and address:    Bristol Laboratories Limited,

Unit 3, Canalside, Northbridge Road, Berkhamsted,

Hertfordshire, HP4 1EG.

Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

Email:    info@bristol-labs.co.uk

Zolpidem tartrate 5mg film-coated Tablets; PL 17907/0123 Zolpidem tartrate 10mg film-coated Tablets; PL 17907/0124 This leaflet was last revised in April 2015

To request a copy of this leaflet in Braille, large print or audio format, please contact the license holder at the address (or telephone, fax, email) above.

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