Sonata - patient leaflet, side effects, dosage

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

What Sonata is and what it is used for

What you need to know before you take Sonata

How to take Sonata

Possible side effects

How to store Sonata

Contents of the pack and other information

What Sonata is and what it is used for

Sonata belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.

Sonata will help you to sleep. Sleeping problems do not usually last long, and most people only need a short course of treatment. The duration of treatment should usually vary from a few days to two weeks. If you still have problems sleeping after you have finished your capsules, contact your doctor again.

Do not take Sonata

If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children and adolescents under 18 years of age must not take Sonata.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sonata.

• Never drink alcohol while you are being treated with Sonata. Alcohol can increase the undesirable effects of any medicine taken to help you sleep.
• Use with extreme caution if you have ever been addicted to medicines or alcohol.
• If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them. Once physical dependence has developed, abrupt termination of treatment may be accompanied by withdrawal symptoms.

These may consist of headaches, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability.

• Do not use Sonata or any other sleeping medicine for longer than your doctor tells you to.
• Do not use a second dose of Sonata within a single night.
• If your sleeplessness persists or worsens after a short course of Sonata treatment contact your doctor.
• There is a chance that you may experience a certain type of temporary memory loss (amnesia) and lack of coordination when taking sleep medicines. This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
• There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event. If you experience these events, contact your doctor immediately.
• Reactions like restlessness, agitation, irritability, aggressiveness, abnormal thinking, delusion, rages, nightmares, depersonalisation, hallucinations, psychoses, inappropriate behaviour, extroversion that seems out of character and other behavioural effects have been reported following use of any medicines belonging to the sleep inducing group, including Sonata. These reactions may be active substance-induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. They are more likely to occur in the elderly. If you experience these events, contact your doctor immediately.
• Rare cases of severe allergic reactions have been reported. An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue, or nausea and vomiting. If you experience any of these events, contact your doctor immediately.

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Sonata

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take any other medicines without asking your doctor or pharmacist first. This includes medicines that can be bought without a prescription. Some can cause drowsiness and should not be taken while taking Sonata.

When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should. Be aware that such combinations may cause you to feel drowsy the next day. These medicines include: substances used in the treatment of mental conditions (antipsychotics, hypnotics, anxiolytics/se­datives, antidepressants), medicines used for strong pain relief (narcotic analgesics), medicines used for the treatment of seizures/convul­sions (antiepileptic medicines), medicines used for loss of feeling/ insensibility (anaesthetics), and medicines used in the treatment of allergies (sedative antihistamines). Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

You should tell your doctor or pharmacist if you are taking cimetidine (a stomach medicine) or erythromycin (an antibiotic).

Sonata with food, drink and alcohol

It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly. Swallow the capsule(s) with a small glass of water. Never drink alcohol while you are being treated with Sonata (see “Warnings and precautions”).

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 or pharmacist for advice before taking this medicine. Sonata should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy and breast-feeding.

Driving and using machines

Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness. This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata’). If affected do not drive or operate machinery.

Sonata contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, c before taking this medicinal product.

3. How to take Sonata

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

The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep. You should not take a second dose within a single night.

Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.

If you take more Sonata than you should

iately and say how many capsules you have taken. Do not go medical help.

s been taken you may become increasingly drowsy very quickly, with high doses to a coma.

If you forget to take Sonata

Just take your next capsule at the usual time, then go on as before. Do not try and catch up on the doses you have missed.

If you stop taking Sonata

On stopping treatment, your original sleeplessness may return and you may experience symptoms such as mood changes, anxiety, and restlessness. If you suffer from these symptoms, ask your doctor for advice.

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 you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.

The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)

Side effects that may occur commonly: drowsiness; memory difficulties; sensations like tingling, e.g. in the extremities (paraesthesia); painful menstruation.

Uncommon side effects include: dizziness; weakness; reduced coordination of movements; unsteadiness and/or falls (ataxia); decreased concentration; apathy; restlessness; depression; agitation; irritability; confusion; abnormal thinking and behaviour (extroversion that seems out of character, decreased inhibition, aggressiveness, rages, delusion, depersonalisation, psychosis); nightmares; hallucinations; double vision or other sight problems; increased sensitivity to noise (hyperacusis); smell disorder (parosmia); speech disorders, including slurred speech; numbness, e.g. in the extremities (hypoaesthesia); nausea; decreased appetite; increased sensitivity to light (sunlight, UV light); feeling vaguely ill (malaise).

In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care. An allergic reaction may also include a rash, itching, or swelling of the face, lips, throat or tongue.

Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Sonata

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

This medicinal product does not require any special temperature storage conditions.

If you have any further questions, please consult your doctor or pharmacist.

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 informationThe active substance in each Sonata hard capsule is zaleplon 5 mg.

The other ingredients are microcrystalline cellulose, pregelatinised starch, silicon dioxide, sodium lauryl sulphate, magnesium stearate, lactose monohydrate, indigo carmine (E132), titanium dioxide (E171).

Ingredients of the capsule shell: gelatin, titanium dioxide (E171), red iron oxide (E172), oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. Printing inks on th the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxid

What Sonata looks like and contents of the pack

Sonata 5 mg hard capsules, which contain a light blue powder, have a light brown cap and white body, with gold imprint “5 mg”. They are packed in blisters. Each pack contains 7, 10 or 14 hard capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Magyarország

MEDA PHARMA Hungary Kereskedelmi Kft.

H-1139 Budapest

Váci ut 91

Tel.: +36 1 236 3410

Danmark Meda A/S Solvang 8 DK-3450 Allerod Tlf: +45 44 52 88 88

Malta Alfred Gera & Sons Ltd. 10, Triq il-Masgar Qormi QRM 3217 Tel: +356 2092 4000

United Kingdom

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU – UK

Tel: +44 845 460 0000

Detailed information on this medicine is available on the European Medicines Agency web site:.