SYCREST 5 mg Sublingual Tablet

Зміст інструкції

1. Sycrest 5 mg sublingual tablets, 10 mg sublingual tablets
   1. What is Sycrest and what is it used for
   2. What you need to know before you take Sycrest
   3. How to take Sycrest
   4. Possible side effects
   5. How to store Sycrest
   6. Package contents and other information

Sycrest 5 mg sublingual tablets, 10 mg sublingual tablets

asenapine

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Sycrest and what is it used for

Sycrest contains the active substance asenapine. This medicine belongs to a group of medicines
called antipsychotics. Sycrest is used for the treatment of moderate to
severe manic episodes, associated with bipolar I disorder in adults. Antipsychotic medicines affect the
chemicals that allow communication between nerve cells (neurotransmitters). Diseases that affect the
brain, such as bipolar I disorder, may be due to an imbalance of certain chemicals present in the brain, such as dopamine and serotonin, which
can 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 represent a condition with symptoms
such as “feeling up”, having an excessive amount of energy, needing fewer hours of sleep than
usual, talking very quickly with racing thoughts and sometimes severe irritability.

2. What you need to know before you take Sycrest

Do not take Sycrest
If you are allergic to asenapine or 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 suffering from
dementia, who are treated with other types of similar medicines, may be at increased
risk of developing 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 is
an effect that usually goes away on its own, otherwise inform your doctor. A dose
adjustment may be necessary.
Asenapine can cause drowsiness, sudden drop in blood pressure when getting up, dizziness and changes in the ability to move and to maintain balance, which can lead to
falls and, consequently, fractures or other injuries. Patients at risk of falling should be
examined before prescribing asenapine.

Tell your doctor immediately if you experience

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

Check with your doctor or pharmacist before taking Sycrest:

• if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as neuroleptic malignant syndrome).
• if 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.
• if you have heart disease or are being treated for heart disease that predisposes you to low blood pressure
• if you have diabetes or are predisposed to diabetes
• if you have Parkinson's disease or dementia
• if you have epilepsy (seizures)
• if you have difficulty swallowing (dysphagia)
• if you have severe liver problems. In this case, do not take Sycrest
• if you have difficulty controlling your internal body temperature
• if you have suicidal thoughts
• if you have high levels of prolactin in your blood (hyperprolactinemia)

Make sure you tell your doctor if any of these conditions apply to you, as
it may be preferable for them to adjust your dose or monitor you for a certain period. Contact your doctor
immediately if any of these conditions develop or worsen during the use of Sycrest.

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

Other medicines and Sycrest
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Some medicines can reduce or increase 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 and fluoxetine), as it may be necessary to adjust the dose of Sycrest or the
antidepressant medicine.
You should tell your doctor if you are taking medicines for Parkinson's disease (such as levodopa), in
as this medicine may make them less effective.
Because Sycrest acts mainly on the brain, there may be interference from other
medicines (or alcohol) that act on the brain, due to an additive effect on brain
function.
Because Sycrest can lower blood pressure, caution should be exercised when taking
Sycrest with other medicines that lower blood pressure.

Sycrest with food, drinks and alcohol
Do not drink or eat 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, if you suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before using this medicine.
Do not take Sycrest if you are pregnant, unless your doctor tells you to. If you are taking
this medicine and become pregnant or plan to become pregnant, ask your doctor as
soon as possible if you can continue to take Sycrest.
The following symptoms may occur in newborns of mothers who have used Sycrest in the last
trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby presents any of these
symptoms, you may need to contact your doctor.
Do not breastfeed while taking Sycrest.

Driving and using machines
Sycrest can cause drowsiness or sedation. Therefore, make sure that concentration and attention
are not affected before driving vehicles or using machines.

3. How to take Sycrest

Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.
The recommended dose is one sublingual tablet of 5 mg or 10 mg twice a day. One dose
should be taken in the morning and one dose should be taken 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 are not
able to take this medicine as described below, the treatment may not be
effective for you.

• Do not remove the sublingual tablet from the blister until the time of taking it.
• When touching the tablet, your hands must be dry.
• Do not push the tablet through the blister. Do not cut or tear the blister.
• Detach the colored tab (figure 1).
• Gently remove the tablet (figure 2). Do not crush the tablet.
• To ensure optimal absorption, place the tablet under your tongue and wait until it has completely dissolved (figure 3). The tablet will dissolve with saliva in 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. Bring the packaging of the
medicine with you. In case of overdose, you may feel sleepy or tired, or have abnormal movements of the
body, problems 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 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 should not stop taking
this medicine unless your doctor tells you to, as your symptoms may
return.
If you have any further questions on the use of this medicine, ask 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 set 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 can lead to coma
• convulsions, seizures or epileptic fits
• fainting
• falls, which can occur as a result of one or more adverse events such as: drowsiness, sudden drop in blood pressure when getting up, dizziness and changes in the 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 excessive urination, weakness or worsening of diabetes
• worm-like movements of the tongue or other uncontrolled movements of the tongue, mouth, cheeks or jaw that can 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 in the tongue or mouth
• increased salivation (excess saliva)
• muscle stiffness
• fatigue
• increased levels of liver enzymes

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

• abnormal muscle movements: a set of symptoms known as extrapyramidal symptoms (EPS) which can include one or more of the following symptoms: abnormal movements of the 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 called restless legs syndrome)
• speech problems
• abnormal heartbeat, slow or fast
• bundle branch block
• abnormal electrocardiogram (prolongation of the QT interval)
• low blood pressure when standing up
• low blood pressure
• tingling in the tongue or mouth
• swollen or painful tongue
• difficulty swallowing
• ulcers, soreness, redness, swelling and blisters inside the mouth
• sexual dysfunction
• irregular 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 the blood vessels to the lungs causing chest pain and difficulty breathing
• muscle disorders that present as continuous unexplained pain and acute pain
• enlargement of male breast
• leakage of milk or fluid from the breast

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly
through 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 that is stated on the blister and the carton. The expiry
date refers to the last day of the month.
Store this medicine in the original packaging to protect the medicine from light and
moisture.
This medicine does not require any particular storage temperature.
Do not dispose of any medicine in waste water 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 ingredient 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 package 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, from white to off-white in colour, with “5” imprinted on
one side.
The 10 mg sublingual tablets are round, from white to off-white in colour, with “10”
imprinted on one side.
The sublingual tablets are supplied in blisters with a detachable film containing each
10 tablets. The packs 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 Heist bv
Industriepark 30
2220 Heist-op-den-Berg, Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Lietuva
Organon Pharma B.V. Lithuania representation
Tel.: +370 52041693
[email protected]

България
Органон (И.А.) Б.В. - клон България
Тел.: +359 2 806 3030
[email protected]

Luxembourg/Luxemburg
Organon Belgium
Tél/Tel: 0080066550123 (+32 2 2418100)
[email protected]

Česká republika
Organon Czech Republic s.r.o.
Tel: +420 233 010 300
[email protected]

Magyarország
Organon Hungary Kft.
Tel.: +36 1 766 1963
[email protected]

Danmark
Organon Denmark ApS
Tlf: +45 4484 6800
[email protected]

Malta
Organon Pharma B.V., Cyprus branch
Tel: +356 2277 8116
[email protected]

Deutschland
Organon Healthcare GmbH
Tel.: 0800 3384 726 (+49 (0) 89 2040022
10)
[email protected]

Nederland
N.V. Organon
Tel: 00800 66550123
(+32 2 2418100)
[email protected]

Eesti
Organon Pharma B.V. Estonian RO
Tel: +372 66 61 300
[email protected]

Norge
Organon Norway AS
Tlf: +47 24 14 56 60
[email protected]

Ελλάδα
BIANEΞ Α.Ε.
Τηλ: +30 210 80091 11
[email protected]

Österreich
Organon Healthcare GmbH
Tel: 0800 3384 726 (+49 (0) 89 2040022 10)
[email protected]

Polska
Organon Polska Sp. z o.o.
Tel.: +48 22 105 50 01
[email protected]

France
Organon France
Tél: +33 (0) 1 57 77 32 00

España
Organon Salud, S.L.
Tel: +34 91 591 12 79
[email protected]

Portugal
Organon Portugal, Sociedade Unipessoal Lda.
Tel: +351 218705500
[email protected]

Hrvatska
Organon Pharma d.o.o.
Tel: +385 1 638 4530
[email protected]

România
Organon Biosciences S.R.L.
Tel: +40 21 527 29 90
[email protected]

Ireland
Organon Pharma (Ireland) Limited
Tel: +353 15828260
[email protected]

Slovenija
Organon Pharma B.V., Oss, branch Ljubljana
Tel: +386 1 300 10 80
[email protected]

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Organon Slovakia s. r. o.
Tel: +421 2 44 88 98 88
[email protected]

Italia
Organon Italia S.r.l.
Tel: +39 06 90259059
[email protected]

Suomi/Finland
Organon Finland Oy
Puh/Tel: +358 (0) 29 170 3520
[email protected]

Κύπρος
Organon Pharma B.V., Cyprus branch
Τηλ: +357 22866730
[email protected]

Sverige
Organon Sweden AB
Tel: +46 8 502 597 00
[email protected]

Latvija
Ārvalsts komersanta “Organon Pharma
B.V.” pārstāvniecība
Tel: +371 66968876
[email protected]

United Kingdom (Northern Ireland)
Organon Pharma (UK) Limited
Tel: +44 (0) 208 159 3593
[email protected]
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu.