Zerene - Patient leaflet, side effects, dosage

WHAT ZERENE IS AND WHAT IT IS USED FOR

Zerene belongs to a class of substances called benzodiazepi consists of preparations with hypnotic actions.

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 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 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.

Take special care with 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.

3. HOW TO TAKE ZERENE

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.

4. POSSIBLE SIDE EFFECTS

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. rx

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.

5. HOW TO STORE ZERENE Xr

Keep out of the reach and sight of children.

Do not use Zerene after the expiry date, wh

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 30°C.

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.

6. FURTHER INFORMATION

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:

Meda AB

Pipers vag 2A

S-170 09 Solna

Sweden

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

Benzstraße 1

D-61352 Bad Homburg v.d.H.

repMaHuy

Tea.: + 49 6172 888 01

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

Malta

Vivian Corporation Ltd.

Sanitas Building, Tower Street

Msida MSD 1824

Tel: +356 21 320 338

Nederland

MEDA Pharma B.V.

Krijgsman 20

NL-1186 DM Amstelveen

Tel: +31 20 751 65 00

Kùnpoç

MEDA Pharmaceuticals AE

EupuTaviaç 3

GR-15231 XaXavSpi-ATTiKrç

EUaôa

Tql: +30 210 6 77 5690

Latvija

MediNet International Ltd.

Ojära Väciesa iela 13

LV-1004 Rîga

Tälr: +371 67 805 140

Lietuva

MediNet International Ltd.

Laisvés pr. 75

LT 06144 Vilnius

Tel: +370 52 688 490

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 (EMEA) web site:.