Zerene
zaleplon
Zerene 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 symptoms are the same as yours.
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.
In this leaflet:
What Zerene is and what it is used for
Before you take Zerene
How to take Zerene
Possible side effects
How to store Zerene
Further information
Zerene belongs to a class of substances called benzodiazepine-related medicinal products, which consists of preparations with hypnotic actions.
Medicinal product no longer authorised
Zerene 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.
hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene
sleep apnoea syndrome (stopping breathing for short periods while asleep)
severe kidney or liver problems
myasthenia gravis (very weak or tired muscles)
severe breathing or chest problems
If you are in any doubt about whether you have any of these conditions, do ask your doctor. Children under 18 years of age must not take Zerene.
Never drink alcohol while you are being treated with Zerene. 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 Zerene, 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 Zerene or any other sleeping medicine for longer than your doctor tells you to.
Do not use a second dose of Zerene within a single night.
If your sleeplessness persists or worsens after a short course of Zerene 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 Zerene.
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 Zerene. 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 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 Zerene.
Medicinal product no longer authorised
When Zerene 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).
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 Zerene 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 Zerene (see “Take Special care with Zerene”).
Tell your doctor if you are or intend to become pregnant. Zerene should not be taken at these times because there are not enough clinical data available to assess its safety during pregnancy.
Tell your doctor if you are breast-feeding. Zerene should not be taken at this time because there is not enough clinical data available to assess its safety during breast-feeding.
Zerene 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. 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 Zerene exactly as your doctor has told you. You should check with your doctor 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.
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
Medicinal product no longer authorised
Zerene 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 product, ask your doctor or pharmacist.
Like all medicines, Zerene 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 convertion:
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)
Like all medicines, Zerene 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.
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.
Medicinal product no longer authorised
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.
Keep out of the reach and sight of children.
Do not use Zerene after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30ºC.
If you have any further questions, please consult your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substance in each Zerene 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), sodium lauryl sulphate and silicon dioxide. Printing inks on the shell contain the following (gold ink S-13050): shellac, lecithin, simethicone, yellow iron oxide (E172).
Zerene 5 mg hard capsules, which contain an intensely dark blue powder, have a light brown cap, with gold imprint “W”, 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: Meda AB
Pipers väg 2A
S-170 09 Solna Sweden
Manufacturer:
MEDA Manufacturing GmbH Neurather Ring 1
51063 Cologne Germany
Medicinal product no longer authorised
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
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
България
MEDA Pharma GmbH & Co. KG Benzstraße 1
D-61352 Bad Homburg v.d.H.
Германия
Тел.: + 49 6172 888 01
Magyarország
MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest
Váci ut 91
Tel.: +36 1 236 3410
Česká republika MEDA Pharma s.r.o. Kodaňská 1441/46 CZ 100 10 Praha 10
Tel: +420 234 064 203
Malta
Vivian Corporation Ltd. Sanitas Building, Tower Street Msida MSD 1824
Tel: +356 21 320 338
Danmark Meda A/S Solvang 8
DK-3450 Allerød Tlf: +45 44 52 88 88
Nederland
MEDA Pharma B.V. Krijgsman 20
NL-1186 DM Amstelveen Tel: +31 20 751 65 00
Deutschland
MEDA Pharma GmbH & Co. KG Benzstraße 1
D-61352 Bad Homburg v.d.H. Tel: + 49 6172 888 01
Norge Meda A/S
Askerveien 61 N-1384 Asker
Tlf: +47 66 75 33 00
Eesti
MediNet International Ltd. Narva mnt. 11D
EE - 10151 Tallinn Tel: +372 62 61 025
Österreich
MEDA Pharma GmbH Guglgasse 15
A-1110 Wien
Tel: + 43 1 86 390 0
Ελλάδα
MEDA Pharmaceuticals AE
Ευρυτανίας 3
GR-15231 Χαλάνδρι-Αττική Τηλ: +30 210 6 77 5690
Polska
Meda Pharmaceuticals Sp.z.o.o. Al. Jana Pawla II/15
PL-00-828 Warszawa Tel: +48 22 697 7100
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
Portugal
MEDA Pharma Produtos Farmaĉeuticos SA Rua do Centro Cultural 13
P-1749-066 Lisboa Tel: +351 21 842 0300
France
Medicinal product no longer authorised
MEDA PHARMA SAS
25 Bd. de l´Amiral Bruix F-75016 Paris
Tél : +33 156 64 10 70
România
MEDA Pharma GmbH & Co. KG Benzstraße 1
D-61352 Bad Homburg v.d.H. Germania
Tel: + 49 6172 888 01
Ireland
Meda Health Sales Ireland Ltd. Office 10
Dunboyne Business Park Dunboyne
IRL - Co Meath
Tel: +353 1 802 66 24
Slovenija
MEDA Pharma GmbH Guglgasse 15
A-1110 Wien Avstrija
Tel: + 43 1 86 390 0
Ísland Meda AB Box 906
S-170 09 Solna Svíþjóð.
Sími: +46 8 630 1900
Slovenská republika MEDA Pharma spol. s r.o.. Trnavská cesta 50
SK-821 02 Bratislava
Tel: +421 2 4914 0172
Italia
Meda Pharma S.p.A. Viale Brenta, 18
I-20139 Milano
Tel: +39 02 57 416 1
Suomi/Finland Meda Oy Vaisalantie 4
FIN-02130 Espoo
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
Latvija
MediNet International Ltd. Ojāra Vācieša iela 13
LV-1004 Rīga
Tālr: +371 67 805 140
United Kingdom
Meda Pharmaceuticals Ltd. Skyway House
Parsonage Road Takeley
Bishop's Stortford CM22 6PU - UK
Tel: +44 845 460 0000
Lietuva
MediNet International Ltd. Laisvės pr. 75
LT 06144 Vilnius
Tel: +370 52 688 490
Medicinal product no longer authorised