What is it and how is it used?

Sycrest belongs to a group of medicines called antipsychotics and is used to treat moderate to severe manic episodes associated with bipolar I disorder. Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing. Exactly how Sycrest works is unknown, however, it is believed to adjust the balance of these chemicals.
Manic episodes associated with bipolar I disorder is a condition with symptoms such as feeling ?high?, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not take Sycrest
If you are allergic (hypersensitive) to asenapine or any of the other ingredients (listed in section 6 Further information).

Take special care with Sycrest

Sycrest has not been studied in elderly patients with dementia. However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death. Sycrest is not approved for the treatment of elderly patients with dementia and is not recommended for use in this particular group of patients.

Sycrest may cause low blood pressure. In the early stages of treatment, some people may faint, especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell your doctor. Your dose may need to be adjusted.

Sycrest may cause weight gain.

Tell your doctor immediately if you experience

  • involuntary rhythmic movements of the tongue, mouth and face. Withdrawal of Sycrest may be needed.
  • fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called ?neuroleptic malignant syndrome?). Immediate medical treatment may be needed.

Check with your doctor or pharmacist before taking Sycrest:

  • if you have ever been diagnosed with a condition whose symptoms include high body temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome).
  • if you have ever experienced abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that both of these conditions may be caused by this type of medicine.
  • if you have a heart disease or a treatment for heart disease that makes you prone to low blood pressure
  • if you are diabetic or prone to diabetes
  • you have Parkinson?s disease or dementia
  • if you have epilepsy (seizures)
  • if you experience any difficulty in swallowing (dysphagia)
  • if you have severe liver problems. If you do, you should not take Sycrest
  • if you have difficulty controlling core body temperature
  • if you have thoughts of suicide

Be sure to tell your doctor if you meet any of these conditions as he/she may want to adjust your dose or monitor you for a while. Also contact your doctor immediately if any of these conditions develops or worsens while using Sycrest.

Children and adolescents

Use of Sycrest below the age of 18 years is not recommended due to lack of information on whether it is safe and effective in this age group.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines may reduce the effect of Sycrest.

If you are taking other medicines, Sycrest should be taken last.

You should tell your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine or fluoxetine), as it may be necessary to change your Sycrest or antidepressant medicine dose.

You should tell your doctor if you are taking medicines for Parkinson?s disease (such as levodopa), as Sycrest may make them less effective.

Since Sycrest works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to an additive effect on brain function.

Since Sycrest can lower blood pressure, care should be taken when Sycrest is taken with other medicines that lower blood pressure.

Taking Sycrest with food and drink
Do not eat or drink for 10 minutes after taking the tablet.
You should avoid drinking alcohol when taking Sycrest.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not take Sycrest while you are pregnant, unless your doctor tells you so. If you are taking Sycrest and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Sycrest.

Do not breast-feed when taking Sycrest.

Driving and using machines
Sycrest may affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery.

How is it used?

Always take Sycrest exactly as your doctor or pharmacist has told you. Sycrest is not advised if you are unable to take the tablet as described below.You should check with your doctor or pharmacist if you are not sure. If you are unable to take Sycrest as is described below, the treatment may not be effective for you.
The usual dose is a tablet of 5 mg or 10 mg two times a day. One dose should be taken in the morning and one dose should be taken in the evening.

Instructions for use

  • Do not remove a tablet from the blister until ready to take it.
  • Use dry hands when touching the tablet.
  • Do not push the tablet through the blister. Do not cut or tear the blister.
  • Peel back the colored tab (Figure 1).
  • Gently remove the tablet (Figure 2). Do not crush the tablet.
  • To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure 3). The tablet will dissolve in saliva within seconds.
  • Do not swallow or chew on the tablet.
  • Do not eat or drink for 10 minutes after taking the tablet.

Figure 1 Figure 2 Figure 3

If you take more Sycrest than you should
If you take too much Sycrest, contact a doctor straight away. Take the medicine pack with you. In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems with standing and walking, feel dizzy due to low blood pressure and feel agitated and confused.

If you forget to take Sycrest
Do not take a double dose to make up for a forgotten dose. If you miss one dose, take your next dose as usual. If you miss two or more doses, contact your doctor.

If you stop taking Sycrest

If you stop taking Sycrest, you will lose the effects of this medicine. You should not stop taking this medicine, unless your doctor tells you as your symptoms may return.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are possible side effects?

Like all medicines, Sycrest can cause side effects, although not everybody gets them.

Very common side effects (affects more than 1 user in 10)

  • anxiety
  • sleepiness

Common side effects (affects 1 to 10 users in 100)

  • weight gain
  • increased appetite
  • slow or sustained muscle contractions
  • restlessness
  • involuntary muscle contractions
  • slow movements, tremor
  • sedation
  • dizziness
  • change in taste
  • numb feeling of the tongue or in the mouth
  • muscle tightness
  • fatigue
  • increase in the level of liver proteins

Uncommon side effects (affects 1 to 10 users in 1,000)

  • high blood sugar
  • fainting episode
  • convulsion
  • abnormal muscle movements: a collection of symptoms known as extrapyramidal symptoms (EPS) which may include one or more of the following: abnormal movements of muscles, tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (shaking), abnormal movements of the eyes, involuntary muscle contractions, slow movements, or restlessness
  • speech problems
  • abnormal slow heartbeat
  • middle heart block
  • abnormal electrocardiogram (prolongation of the QT interval)
  • low blood pressure upon standing
  • low blood pressure
  • tingling of the tongue or in the mouth
  • swollen or painful tongue
  • difficulty in swallowing
  • sexual dysfunction
  • lack of regular menstrual periods

Rare side effects (affects 1 to 10 users in 10,000)

  • changes in the levels of white blood cells
  • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
  • difficulties in focusing with the eyes
  • blood clots in blood vessels to the lungs causing chest pain and difficulty in breathing
  • muscle disease presenting as unexplained aches and pains
  • male breast enlargement
  • leakage of milk or fluid from the breast

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.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Sycrest after the expiry date which is stated on the blister and on the carton. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

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

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.

Further information

What Sycrest contains

? The active substance is asenapine. Each Sycrest tablet contains either 5 mg or 10 mg of the active substance. The exact amount is shown on your Sycrest tablet pack.
? The other ingredients are gelatin and mannitol (E421).

What Sycrest looks like and contents of the pack

The 5 mg sublingual tablets are round white to off-white tablets marked with ?5? on one side. The 10 mg sublingual tablets are round white to off-white tablets marked with ?10? on one side.

The sublingual tablets are provided in peelable blisters containing 10 tablets each. Packs may contain 20, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder

N.V. Organon
Kloosterstraat 6
NL-5349 AB Oss
The Netherlands

Manufacturer
Organon (Ireland) Ltd.
Drynam Road, Swords
Co. Dublin, Ireland

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

BelgiëBelgiqueBelgien Lundbeck S.A. Avenue Molière 225Molierelaan 225 B-1050 BruxellesBrussel TélTel 32 2 340 2828 LuxembourgLuxemburg Lundbeck S.A. Avenue Molière 225Molierelaan 225 B-1050 BruxellesBrussel TélTel 32 2 340 2828

Magyarország Lundbeck Hungária Kft. Montevideo utca 3b H-1037 Budapest Tel. 36 1 436 9980 Lundbeck Export AS Representative Office EXPO 2000 Vaptzarov Blvd. 55 Sofia 1407 Te. 359 2962 4696

eská republika Lundbeck eská republika s.r.o. Bozdchova 7 CZ-150 00 Praha 5 Tel 420 225 275 600 Malta Charles di Girogio Ltd Triq il-Kanonku Kamenu Pirrota MT-1114 BKara BKR Tel 356 25600500

Danmark Lundbeck Pharma AS Dalbergstrøget 5 DL-2630 Taastrup Tel 45 4371 4270 Nederland Lundbeck B.V. Plaza Arena, Jupiter Gebouw Herikerbergweg 100 NL-1101 CM Amsterdam Tel 31 20 697 1901

Deutschland Lundbeck GmbH Karnapp 25 D-21079 Hamburg Tel 49 40 23649 0 Norge H. Lundbeck AS Strandveien 15 B N-1366 Lysaker Tlf 47 91 300 800

Österreich Dresdner Strasse 82 A-1200 Vienna Tel 43 1 331 070 Eesti Lundbeck Eesti AS Weizenbergi 29 EE-10150 Tallinn Tel 372 605 9350

Lundbeck Hellas S.A. 64, Kifisias Avenue GR-151 25 Marousi, Athens 30 210 610 5036 Polska Lundbeck Poland Sp. z o. o. ul. Krzywickiego 34 PL-02-078 Warszawa Tel. 48 22 626 9300

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Slovenija Lundbeck Pharma d.o.o. Titova cesta 8 SI-2000 Maribor Tel. 386 2 229 4500 Ireland Lundbeck Ireland Ltd 7 Riverwalk Citywest Business Campus IRL - Dublin 24 Tel 353 1 468 9800

Ísland Lundbeck Export útibú á Íslandi Ármúla 1 IS-270 Reykjavík Sími 354 414 7070 Slovenská republika Lundbeck Slovensko s.r.o. Zvolenská 19 SK-821 09 Bratislava 2 Tel 421 2 5341 4218

Italia Lundbeck Italia S.p.A. Via G. Fara 35 I-20124 Milan Tel 39 02 677 4171 SuomiFinland Oy H. Lundbeck Ab Itäinen Pitkäkatu 4 Österlånggatan 4 FIN-20520 TurkuÅbo PuhTel 358 2 276 5000

Sverige H. Lundbeck AB Box 23 S-250 53 Helsingborg Tel 46 42 25 43 00 Lundbeck Hellas A.E . - STADYL BUILDING CY-1066 . 357 22490305

Latvija SIA Lundbeck Latvia Kleistu iela 24 Rga, LV 1067 Tel 371 6 7 067 884 United Kingdom Lundbeck Limited Lundbeck House Caldecotte Lake Business Park Caldecotte Milton Keynes MK7 8LG - UK Tel 44 1908 649 966

Lietuva
UAB Lundbeck Lietuva
L. Stuokos-Guceviciaus 9-3
LT 01122 Vilnius
Tel: + 370 5 231 4188

This leaflet was last approved in {MM/YYYY}.

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