Sycrest

Patient Information Leaflet

Sycrest 5 mg sublingual tablets, 10 mg sublingual tablets

asenapine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Sycrest is and what it is used for
2. What you need to know before taking Sycrest
3. How to take Sycrest
4. Possible side effects
5. How to store Sycrest
6. Contents of the pack and other information

1. What Sycrest is and what it is used for

Sycrest contains the active substance asenapine. This medicine belongs to a group of medicines called antipsychotics. Sycrest is used to treat moderate to severe manic episodes associated with bipolar I disorder in adults. Antipsychotic medicines affect the chemical substances that enable communication between nerve cells (neurotransmitters). Brain-related disorders, such as bipolar I disorder, may be due to an imbalance of certain chemicals in the brain, such as dopamine and serotonin, which may cause some of the symptoms you are experiencing. The precise mechanism of action of this medicine is unknown; however, it is believed to regulate the balance of these chemicals.
Manic episodes associated with bipolar I disorder are characterized by symptoms such as feeling "high", having an excessive amount of energy, needing fewer hours of sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability.

2. What you need to know before taking Sycrest

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Sycrest.

Sycrest has not been studied in elderly patients with dementia. However, elderly patients with dementia who are treated with other similar types of medicines may be at 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 patient group.

Sycrest may cause low blood pressure. In the early stages of treatment, some people may faint, especially when standing up from lying down or sitting positions. This effect usually resolves on its own; if not, inform your doctor. A dose adjustment may be necessary.

Asenapine may cause drowsiness, sudden drop in blood pressure upon standing, dizziness, and changes in motor function and balance, which may lead to falls and, consequently, fractures or other injuries. Patients at risk of falling should be evaluated before asenapine is prescribed.

Immediately inform your doctor if you experience

• involuntary rhythmic movements of the tongue, mouth, or face. It may be necessary to discontinue Sycrest.
• fever, severe muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.

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).
• you have ever had abnormal movements of the tongue or face (tardive dyskinesia). You should be aware that both of these conditions can be caused by this type of medicine.
• you have heart disease or are being treated for a heart condition that predisposes you to low blood pressure.
• you have diabetes or are predisposed to diabetes.
• you have Parkinson's disease or dementia.
• you have epilepsy (seizures).
• you have difficulty swallowing (dysphagia).
• you have severe liver problems. In this case, do not take Sycrest.
• you have difficulty regulating your internal body temperature.
• you have suicidal thoughts.
• you have high levels of prolactin in your blood (hyperprolactinemia).

Make sure to inform your doctor if any of these conditions apply to you, as they may wish to adjust your dose or monitor you for a period of time. Contact your doctor immediately if any of these conditions develop or worsen while taking Sycrest.

Children and adolescents
Sycrest is not recommended for use in patients under 18 years of age.

Other medicines and Sycrest
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Some medicines may reduce or increase the effect of Sycrest.
If you are taking other medicines, Sycrest should be taken last.

You must inform your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine, and fluoxetine), as it may be necessary to adjust the dose of Sycrest or the antidepressant medicine.

You must inform your doctor if you are taking medicines for Parkinson’s disease (such as levodopa), as this medicine may make them less effective.

Since Sycrest acts mainly on the brain, other medicines (or alcohol) that act on the brain may interfere, due to an additive effect on brain function.

Since Sycrest may lower blood pressure, caution is required when taking Sycrest together with other medicines that lower blood pressure.

Sycrest with food, drinks, and alcohol
Do not eat or drink for 10 minutes after taking this medicine.
You should avoid drinking alcohol while taking this medicine.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Sycrest if you are pregnant, unless your doctor tells you to do so. If you are taking this medicine and become pregnant or plan to become pregnant, ask your doctor as soon as possible whether you can continue taking Sycrest.

The following symptoms may occur in newborns whose mothers have used Sycrest during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.

Do not breastfeed while taking Sycrest.

Driving and using machines
Sycrest may cause drowsiness or sedation. Therefore, make sure your concentration and attention are not affected before driving or operating machinery.

3. How to take Sycrest

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 5 mg or 10 mg sublingual tablet twice daily. One dose should be taken in the morning and one dose in the evening.
Instructions for use

Sycrest is for sublingual use.

Sycrest is not recommended if you are unable to take the tablet as described below. If you
cannot take this medicine as described below, treatment may not be
effective for you.

• Do not remove the sublingual tablet from the blister pack until the time of administration.
• When handling the tablet, your hands must be dry.
• Do not push the tablet through the blister. Do not cut or tear the blister pack.
• Peel off the coloured 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 has completely dissolved (Figure 3). The tablet will dissolve in saliva within a few seconds.
• Do not swallow or chew the tablet.
• Do not drink or eat 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 immediately. Take the medicine package with you.
In case of overdose, you may feel drowsy or tired, experience abnormal body movements, have difficulty standing or walking, feel dizzy due to low blood pressure, and feel agitated or confused.
If you forget to take Sycrest
Do not take a double dose to make up for the missed dose. If you forget a dose, take the next dose as usual. If you forget two or more doses, contact your doctor or pharmacist.
If you stop taking Sycrest
If you stop taking Sycrest, you will lose the effects of this medicine. You must not stop taking
this medicine unless instructed by your doctor, as your symptoms may return.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects have been reported with this medicine. Contact your doctor immediately if you experience any of the following symptoms:

• allergic reactions (these usually include a combination of effects such as difficulty breathing or swallowing, swelling of the face, lips, tongue or throat, skin rash, itching and increased heart rate)
• sudden increase in body temperature, with sweating, rapid heartbeat, severe muscle stiffness, confusion and fluctuations in blood pressure that may lead to coma
• seizures, fits or epileptic attacks
• fainting
• falls, which may occur as a consequence of one or more adverse events such as: drowsiness, sudden drop in blood pressure when standing up, dizziness, and changes in ability to move and maintain balance.

Inform your doctor immediately if you have:

• signs of increased blood sugar levels such as excessive thirst, hunger or urination, weakness or worsening of diabetes
• worm-like movements of the tongue or other uncontrolled movements of the tongue, mouth, cheeks or jaw that may spread to arms and legs.

Other side effects reported with this medicine include:
Very common side effects (may affect more than 1 in 10 people)

• anxiety
• numbness

Common side effects (may affect up to 1 in 10 people)

• weight gain
• increased appetite
• slow or sustained muscle contractions
• restlessness
• involuntary muscle contractions
• slow movements, tremor
• sedation
• dizziness
• nausea
• change in taste
• sensation of numbness of the tongue or mouth
• increased salivation (drooling)
• muscle stiffness
• fatigue
• increased levels of liver enzymes

Uncommon side effects (may affect up to 1 in 100 people)

• abnormal muscle movements: a group 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 eye movements, involuntary muscle contractions, slow movements, or restlessness
• unpleasant sensations in the legs (also known as restless legs syndrome)
• speech problems
• abnormal, slow or fast heartbeat
• cardiac bundle branch block
• abnormal electrocardiogram (prolonged QT interval)
• low blood pressure when standing
• low blood pressure
• tingling of the tongue or in the mouth
• swollen or painful tongue
• difficulty swallowing
• ulcers, soreness, redness, swelling and blisters inside the mouth
• sexual dysfunction
• absence of regular menstrual cycles

Rare side effects (may affect up to 1 in 1,000 people)

• changes in white blood cell levels
• difficulty focusing vision
• blood clots in blood vessels to the lungs causing chest pain and difficulty breathing
• muscle disorders presenting as unexplained continuous pain and acute pain
• enlargement of male breast
• milk or fluid discharge from the breast

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sycrest

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Store this medicine in its original packaging to protect it from light and moisture.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sycrest contains

• The active substance is asenapine.
• Each 5 mg sublingual tablet of Sycrest contains 5 mg of asenapine.
• Each 10 mg sublingual tablet of Sycrest contains 10 mg of asenapine.
• The exact content is indicated on the packaging of Sycrest tablets.
• The excipients are gelatin and mannitol (E421).

Description of the appearance of Sycrest and contents of the pack
The 5 mg sublingual tablets are round, white to off-white, with "5" engraved on one side.
The 10 mg sublingual tablets are round, white to off-white, with "10" engraved on one side.
The sublingual tablets are supplied in blisters with a peelable film, each containing 10 tablets. Packs contain 20, 60 or 100 tablets.
Not all pack sizes may be marketed.

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

Manufacturer
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg, Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Organon Belgium Organon Pharma B.V. Lithuania atstovybė
Tél/Tel: 0080066550123 (+32 2 2418100) Tel.: +370 52041693
[email protected] [email protected]

България Luxembourg/Luxemburg
Органон (И.А.) Б.В. - клон България Organon Belgium
Тел.: +359 2 806 3030 Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected] [email protected]

Česká republika Magyarország
Organon Czech Republic s.r.o. Organon Hungary Kft.
Tel: +420 233 010 300 Tel.: +36 1 766 1963
[email protected] [email protected]

Danmark Malta
Organon Denmark ApS Organon Pharma B.V., Cyprus branch
Tlf: +45 4484 6800 Tel: +356 2277 8116
[email protected] [email protected]

Deutschland Nederland
Organon Healthcare GmbH N.V. Organon
Tel.: 0800 3384 726 (+49 (0) 89 2040022 10) Tel: 00800 66550123 (+32 2 2418100)
[email protected] [email protected]

Eesti Norge
Organon Pharma B.V. Estonian RO Organon Norway AS
Tel: +372 66 61 300 Tlf: +47 24 14 56 60
[email protected] [email protected]

Ελλάδα Österreich
BIANEΞ Α.Ε. Organon Healthcare GmbH
Τηλ: +30 210 80091 11 Tel: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected] [email protected]

España Polska
Organon Salud, S.L. Organon Polska Sp. z o.o.
Tel: +34 91 591 12 79 Tel.: +48 22 105 50 01
[email protected] [email protected]

France Portugal
Organon France Organon Portugal, Sociedade Unipessoal Lda.
Tél: +33 (0) 1 57 77 32 00 Tel: +351 218705500
[email protected]

Hrvatska România
Organon Pharma d.o.o. Organon Biosciences S.R.L.
Tel: +385 1 638 4530 Tel: +40 21 527 29 90
[email protected] [email protected]

Ireland Slovenija
Organon Pharma (Ireland) Limited Organon Pharma B.V., Oss, podružnica Ljubljana
Tel: +353 15828260 Tel: +386 1 300 10 80
[email protected] [email protected]

Ísland Slovenská republika
Vistor hf. Organon Slovakia s. r. o.
Sími: +354 535 7000 Tel: +421 2 44 88 98 88
[email protected]

Italia Suomi/Finland
Organon Italia S.r.l. Organon Finland Oy
Tel: +39 06 90259059 Puh/Tel: +358 (0) 29 170 3520
[email protected] [email protected]

Κύπρος Sverige
Organon Pharma B.V., Cyprus branch Organon Sweden AB
Τηλ: +357 22866730 Tel: +46 8 502 597 00
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Ārvalsts komersanta “Organon Pharma Organon Pharma (UK) Limited
B.V.” pārstāvniecība Tel: +44 (0) 208 159 3593
Tel: +371 66968876 [email protected]
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.