Document: Zolpidem Vitabalans film-coated tablet ENG PL change

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

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Package leaflet: Information for the user

Zolpidem Vitabalans 10 mg film-coated tablets

zolpidem tartrate

Read all of this leaflet carefully before you start using 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.

What is in this leaflet

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

2. What you need to know before you use Zolpidem Vitabalans

3. How to use Zolpidem Vitabalans

4. Possible side effects

6. Contents of the pack and other information

Zolpidem Vitabalans is a sleeping medicine for adults for short term treatment only.

Do not use Zolpidem Vitabalans

• if you are allergic to zolpidem tartrate or any of the other ingredients of this medicine (listed in section 6)

• if you have sleep apnoea syndrome (stopping breathing for short period while asleep)

• if you have severe liver insufficiency

• if you suffer from severe muscular weakness (Myastenia gravis)

• if you have severe breathing or chest problems (severe respiratory problems).

Warnings and precautions

Talk to your doctor before taking Zolpidem Vitabalans:

• if you are elderly

• if you have liver insufficiency

• if you have chronic respiratory problems

• if you have or have had any psychiatric disease. Zolpidem may unmask or worsen symptoms.

• if you have depression

• if you have a history of medicine or alcohol abuse. The risk of dependence on Zolpidem Vitabalans (physical or mental effects produced by a compulsion to keep the taking medicine) increases in these patients, and with dose and length of treatment.

Next-daypsychomotor impairment (seealso Driving and using machines)

The dayaftertaking Zolpidem Vitabalans,the riskofpsychomotorimpairment,including impaired driving abilitymaybe 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 immediatelyat bedtime.

Do not take anotherdoseduring the same night.

Other considerations

• Habituation – 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, whereby the symptoms that led to your treatment with Zolpidem Vitabalans recur in an enhanced form. It may be accompanied by other reactions including mood changes, anxiety and restlessness.

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

• Psychiatric and "paradoxical" reactions – Zolpidem Vitabalans can cause behavioural side effects such as restlessness, agitation, irritability, aggressiveness, delusions (false beliefs), rages, nightmares, hallucinations, psychoses (hallucinations; when you see, hear or feel things that are not there), inappropriate behaviour and increased insomnia.

• Sleep walking and other associated behaviours – Zolpidem Vitabalans 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 Vitabalans at doses exceeding the maximum recommended dose can increase the risk of these side effects.

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

If any of the above applies to you please tell your doctor or pharmacist without delay.

Children and adolescents

Zolpidem Vitabalans is not intended for use in children and adolescents under 18 years of age.

Other medicines and Zolpidem Vitabalans

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

While taking zolpidemwiththe following medicines,drowsinessand next-daypsychomotorimpairment effects,including impaireddriving ability,maybe 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 anesthesia

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

While taking zolpidemwithantidepressantsincluding bupropion,desipramine,fluoxetine,sertraline and venlafaxine,youmaysee thingsthat are not real (hallucinations).

It isnot recommended to take zolpidemwithfluvoxamine orciprofloxacin.

Care should be taken when used in combination with muscle relaxants.

Strong pain killers (narcotic pain killers) can increase anxiety which may intensify dependence on Zolpidem Vitabalans.

Drugs that inhibit certain hepatic enzymes (such as ketoconazole, used as antifungal) may enhance the effect of Zolpidem Vitabalans.

The effect of Zolpidem Vitabalans is reduced when used with rifampicine (used for infectious disease).

Zolpidem Vitabalans with food, drink and alcohol

You can use Zolpidem Vitabalans together with food and drink. Although, avoid taking alcohol while using Zolpidem Vitabalans as this may increase the sedative effect and affect your ability to drive and use machines.

Pregnancy, breast-feeding and fertility

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 Vitabalans should not be taken during pregnancy, especially in the first three months. If you are planning to become pregnant, or suspect you may already be pregnant, do not take Zolpidem Vitabalans and contact your doctor as soon as possible for advice.

If for urgent medical reasons, you take Zolpidem Vitabalans 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.

Small amount of zolpidem passes into breast milk. Zolpidem Vitabalans should not be used during breast-feeding.

Driving and using machines

Zolpidem Vitabalanshasmajorinfluence ontheabilitytodrive and use machinessuchas“sleep driving”. Onthe dayaftertaking Zolpidem Vitabalans(asotherhypnoticmedicines),youshould 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

Aperiod ofat least 8 hoursisrecommended betweentaking zolpidemand driving,using machinery and working atheightstominimize the above listedeffects.

Do not drinkalcohol ortake otherpsychoactive substanceswhile youare taking Zolpidem Vitabalans,asit canincrease the above listed effects.

Always use this medicineexactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The tablet should be taken with fluid.

The tablet can be divided into equal doses.

Adults

The recommended dose per24 hoursis10 mg ofZolpidem Vitabalans.Alowerdose maybe prescribed to some patients.Zolpidem Vitabalansshould be taken:

• as a single intake,

• just before bedtime

Make sureyou have aperiod ofat least 8 hoursaftertaking thismedicine before performing activities that require youralertness.

Do not exceed 10 mg per24 hours.

Elderly (over 65 years) or debilitated patients

The recommended dose is 5 mg (half a tablet).

Patients with liver problems

The usual 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.

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 Vitabalans for longer than 4 weeks.

If you use more Zolpidem Vitabalans than you should

If you have used more Zolpidem Vitabalans than the recommended dose you should contact your doctor or hospital.

If you forget to use Zolpidem Vitabalans

Do not take a double dose to make up for a forgotten dose.

If you forgot to take Zolpidem Vitabalans before bedtime, take it while you are in bed only if you are sure that you will be able to get a full night sleep (8 hours).

If you stop using Zolpidem Vitabalans

Psychological dependence can occur. Sudden discontinuation of treatment may increase the risk of reactions (like headache, muscle pain and mood changes), it is recommended to decrease the dosages gradually.

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 medicinecan cause side effects, although not everybody gets them.

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

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

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

• hallucinations, agitation, nightmares

• drowsiness, headache, dizziness, increased insomnia, amnesia (which may be associated with inappropriate behaviours)

• 'spinning' sensation

• drowsiness the following day, numbed emotions, reduced alertness, double vision

• diarrhoea, nausea, vomiting

• fatigue

• abdominal pain

• back pain

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

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

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

• serious allergic reactions which causes swelling of the face or the throat

• restlessness, aggression, delusion (false beliefs), rages, psychosis (hallucinations; when you see, hear or feel things that are not there), inappropriate behaviour

• changes in sex drive (libido disorder)

• depression (feeling sad)

• 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 Vitabalans

• 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

• 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 the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Zolpidem Vitabalans

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 label and carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of deterioration.

This medicinal product 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 Vitabalans contains

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

The other ingredients are:

Tablet core:microcrystalline cellulose, calcium hydrogen phosphate dihydrate, silica colloidal anhydrous, magnesium stearate and sodium starch glycolate (Type A)

Tablet coating: polydextrose, hypromellose, titanium dioxide (E171) and macrogol.

What Zolpidem Vitabalans looks like and contents of the pack

Tablets are white, capsule shaped convex tablet with score, and length is 10 mm and width 5 mm.

The tablet can be divided into equal doses.

Pack sizes:10, 20, 30, 60, 100 film-coated tablets in blister

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Vitabalans Oy

Varastokatu 7-9

13500 Hämeenlinna

FINLAND

Tel: +358 3 615 600

Fax: +358 3 618 3130

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

<[To be completed nationally] >

This leaflet was last revisedin 2016-03-16