Zerene 5 mg hard capsules

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

Zerene will help you to sleep. Sleeping problems donot 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 Zerene if you have

• hypersensitivity (an allergy) to zaleplon or to any other ingredients of Zerene
• sleep apnoea syndrome (stopping breathing for short periodswhile 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.

Take special care with Zerene

• Never drink alcoholwhile you are being treated with Zerene. Alcoholcan increase the undesirable effectsof 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. 33
• 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.

Taking other medicines

Do not take anyother 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.

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).

Taking Zerene with food and drink

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 alcoholwhile you are being treated with Zerene (see ?Take Special care with Zerene?).

Pregnancy and breast-feeding

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.

Driving and using machines

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.

Important information about some of the ingredients of Zerene

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

Zerene 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 Zerene than you should

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.

If you forget to take Zerene

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 Zerene

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.

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.

What Zerene contains

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).

What Zerene looks like and contents of the pack

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 and Manufacturer

Marketing Authorisation holder Manufacturer MEDA Manufacturing GmbH Neurather Ring 1 51063 Cologne Germany Meda AB Pipers väg 2A S-170 09 Solna Sweden

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien MEDA Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 B-1170 Brussels TélTel 32 2 5 04 08 11 LuxembourgLuxemburg MEDA Pharma S.A.N.V. Chaussée de la Hulpe 166 Terhulpsesteenweg 166 B-1170 Brussels BelgiqueBelgien TélTel 32 2 5 04 08 11

Magyarország MEDA PHARMA Hungary Kereskedelmi Kft. H-1139 Budapest Váci ut 91 Tel. 36 1 236 3410 MEDA Pharma GmbH Co. KG Benzstraße 1 D-61352 Bad Homburg v.d.H. . 49 6172 888 01

eská republika MEDA Pharma s.r.o. Kodaská 144146 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 AS 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 AS 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

MEDA Pharmaceuticals AE 3 GR-15231 - 30 210 6 77 5690 Polska Meda Pharmaceuticals Sp.z.o.o. Al. Jana Pawla II15 PL-00-828 Warszawa Tel 48 22 697 7100

Portugal MEDA Pharma Produtos Farmaeuticos SA Rua do Centro Cultural 13 P-1749-066 Lisboa Tel 351 21 842 0300 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

France MEDA PHARMA SAS 25 Bd. de lAmiral 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

Slovenija MEDA Pharma GmbH Guglgasse 15 A-1110 Wien Avstrija Tel 43 1 86 390 0 Ireland Meda Health Sales Ireland Ltd. Office 10 Dunboyne Business Park Dunboyne IRL - Co Meath Tel 353 1 802 66 24

Slovenská republika MEDA Pharma spol. s r.o.. Trnavská cesta 50 SK-821 02 Bratislava Tel 421 2 4914 0172 Ísland Meda AB Box 906 S-170 09 Solna Svíjóð. Sími 46 8 630 1900

Italia Meda Pharma S.p.A. Viale Brenta, 18 I-20139 Milano Tel 39 02 57 416 1 SuomiFinland Meda Oy Vaisalantie 4 FIN-02130 Espoo PuhTel 358 20 720 9550

Sverige Meda AB Box 906 S-170 09 Solna Tel 46 8 630 1900 MEDA Pharmaceuticals AE 3 GR-15231 - 30 210 6 77 5690

Latvija MediNet International Ltd. Ojra Vciea iela 13 LV-1004 Rga Tlr 371 67 805 140 United Kingdom Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU - UK Tel 44 845 460 0000

Lietuva
MediNet International Ltd.
Laisv-s pr. 75
LT 06144 Vilnius
Tel: +370 52 688 490

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