Sonata
zaleplon
Sonata 5 mg hard capsules zaleplon
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 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
Medicinal product no longer authorised
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.
if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
if you have sleep apnoea syndrome (stopping breathing for short periods while asleep).
if you have severe kidney or liver problems.
if you have myasthenia gravis (very weak or tired muscles).
if you have severe breathing or chest problems.
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.
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.
Do not give this medicine to children and adolescents under 18 years of age.
Medicinal product no longer authorised
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).
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”).
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.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Medicinal product no longer authorised
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.
There are different doses for people who are 65 or older, and those who have mild to moderate liver problems:
65 or older: Take one 5 mg capsule
Mild to moderate liver problems: Take one 5 mg capsule
Sonata has been designed, so that if the contents of the capsule are dissolved in liquid, the liquid will change colour and become cloudy.
Contact a doctor immediately and say how many capsules you have taken. Do not go unaccompanied to seek medical help.
If an overdose has been taken you may become increasingly drowsy very quickly, with high doses probably leading to a coma.
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.
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.
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.
Medicinal product no longer authorised
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.
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.
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.
The 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), yellow iron oxide (E172), black iron oxide (E172) and sodium lauryl sulphate. Printing inks on the shell contain the following (gold ink SB-3002): shellac, ammonium hydroxide, yellow iron oxide (E172).
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.
Medicinal product no longer authorised
Marketing Authorisation holder: Meda AB
Pipers väg 2A
S-170 73 Solna Sweden
Manufacturer:
MEDA Manufacturing GmbH Neurather Ring 1
51063 Cologne
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166
B-1170 Brussels
Tél/Tel: +32 2 5 04 08 11
Lietuva
Meda Pharma SIA Veiverių 134
LT – 46352 Kaunas Tel.: +370 37 330 509
България
ТП Меда Фармасойтикалс Ул. Одрин 71-75, ет.2, ап 7
1303 София
Тел.: +359 2 4177977
Luxembourg/Luxemburg MEDA Pharma S.A./N.V. Chaussée de la Hulpe 166/ Terhulpsesteenweg 166
B-1170 Brussels Belgique/Belgien Tél/Tel: +32 2 5 04 08 11
Česká republika MEDA Pharma s.r.o. Kodaňská 1441/46 CZ 100 10 Praha 10
Tel: +420 234 064 203
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 Allerød Tlf: +45 44 52 88 88
Malta
Alfred Gera & Sons Ltd. 10, Triq il-Masġar
Qormi QRM 3217
Tel: +356 2092 4000
Deutschland
MEDA Pharma GmbH & Co. KG Benzstraße 1
D-61352 Bad Homburg v.d.H. Tel: + 49 6172 888 01
Nederland
MEDA Pharma B.V. Krijgsman 20
NL-1186 DM Amstelveen Tel: +31 20 751 65 00
Eesti
Meda Pharma SIA Narva mnt 11D
EE - 10151 Tallinn, Eesti Tel. + 372 6261 025
Norge Meda A/S
Askerveien 61 N-1384 Asker
Tlf: +47 66 75 33 00
Ελλάδα
MEDA Pharmaceuticals AE
Ευρυτανίας 3
Medicinal product no longer authorised
GR-15231 Χαλάνδρι-Αττική Τηλ: +30 210 6 77 5690
Österreich
MEDA Pharma GmbH Guglgasse 15
A-1110 Wien
Tel: + 43 1 86 390 0
España
MEDA Pharma S.A.U. Avenida de Castilla, 2
Parque Empresarial San Fernando Edificio Berlin
E-28830 San Fernando de Henares (Madrid) Tel: +34 91 669 93 00
Polska
Meda Pharmaceuticals Sp. z o.o. Al. Jana Pawła II nr 15
PL-00-828 Warszawa Tel: +48 22 697 7100
France
MEDA PHARMA SAS
25 Bd. de l´Amiral Bruix F-75016 Paris
Tél : +33 156 64 10 70
Portugal
MEDA Pharma Produtos Farmacêuticos SA Rua do Centro Cultural 13
P-1749-066 Lisboa Tel: +351 21 842 0300
Hrvatska
Medical Intertrade d.o.o. Dr. Franje Tudmana 3 10431 Sveta Nedelja
Tel: +385 1 3374 010
România
MEDA Pharmaceuticals Switzerland GmbH Reprezentanta Romania
Calea Floreasca 141-143, et.4 014467 Bucuresti
Tel.: +40 21 230 90 30
Ireland
Meda Health Sales Ireland Limited, Unit 34/35, Block A,
Dunboyne Business Park, Dunboyne
Co. Meath
Tel: +353 1 802 66 24
Ísland Meda AB Box 906
S-170 09 Solna Svíþjóð.
Sími: +46 8 630 1900
Slovenija
MEDA Pharmaceuticals Switzerland GmbH, Podružnica Ljubljana
Cesta 24. junija 23 Ljubljana
Tel: +386 59 096 951
Slovenská republika MEDA Pharma spol. s r.o.. Trnavská cesta 50
SK-821 02 Bratislava
Tel: +421 2 4914 0171
Italia
Meda Pharma S.p.A. Viale Brenta, 18
I-20139 Milano
Tel: +39 02 57 416 1
Suomi/Finland Meda Oy
Vaisalantie 4/ Vaisalavägen 4 FI-02130 Espoo/ Esbo Puh/Tel: +358 20 720 9550
Κύπρος
MEDA Pharmaceuticals AE
Ευρυτανίας 3
GR-15231 Χαλάνδρι-Αττική Ελλάδα
Τηλ: +30 210 6 77 5690
Sverige Meda AB Box 906
S-170 09 Solna
Tel: +46 8 630 1900
Medicinal product no longer authorised
Latvija
Meda Pharma SIA Vienības gatve 109 LV-1058 Riga, Latvia Tel.: +371 67616137
United Kingdom
Meda Pharmaceuticals Ltd. Skyway House
Parsonage Road Takeley
Bishop's Stortford CM22 6PU - UK
Tel: +44 845 460 0000