SYCREST 10 mg SUBLINGUAL TABLETS

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 you start taking Sycrest.

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

Sycrest may cause a drop in blood pressure. In the early stages of treatment, some people may faint, especially when standing up after lying down or sitting. It usually goes away on its own, but if it does not, tell your doctor, as you may need a dose adjustment.

Asenapine may cause drowsiness, sudden drops in blood pressure when standing up, dizziness, and changes in your ability to move and balance, which can lead to falls and, consequently, fractures or other traumatic injuries. Patients at risk of falls should be assessed before asenapine is prescribed.

Tell your doctor immediately if you experience

• rhythmic involuntary movements of the tongue, mouth, and face. It may be necessary to stop treatment with Sycrest.
• fever, intense muscle stiffness, sweating, or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.

Before taking Sycrest, check with your doctor or pharmacist:

• if you have ever been diagnosed with a disease whose symptoms are 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 diseases can be caused by this type of medicine.

• if you have a heart disease or are being treated for a heart disease that may make you prone to having low blood pressure
• if you have diabetes or are prone to diabetes
• if you have Parkinson's disease or dementia
• if you have epilepsy (seizures)
• if you experience difficulty swallowing (dysphagia)
• if you have severe liver problems. If you have them, you should not take Sycrest
• if you have a problem controlling body temperature
• if you have thoughts of suicide
  • if you have abnormally high levels of prolactin in the blood (hyperprolactinemia)

Make sure to tell your doctor if you are in any of these circumstances so that he/she can adjust your dose or monitor you for some time. Also, consult your doctor immediately if you develop any of these conditions or if they worsen while you are using Sycrest.

Children and adolescents

The use of Sycrest is not recommended in patients under 18 years of age.

Other medicines and Sycrest

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

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

Sycrest acts mainly in the brain, so there may be interference with other medicines (or with alcohol) that also act in the brain due to a sum of effects on brain function.

Sycrest may decrease blood pressure, so caution should be exercised when Sycrest is taken with other medicines that decrease blood pressure.

Taking Sycrest with food, drinks, and alcohol

Do not eat or drink for 10 minutes after taking this medicine.

You should avoid drinking alcohol when taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Sycrest while you are pregnant, unless your doctor tells you to. If you are taking this medicine and become pregnant or plan to become pregnant, consult your doctor as soon as possible to find out if you can continue taking Sycrest.

The following symptoms may occur in newborn babies of mothers who have been treated with Sycrest in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

Do not breastfeed while you are taking Sycrest.

Driving and using machines

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

3. How to take Sycrest

Follow exactly the instructions of administration of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is one 5 or 10 mg sublingual tablet twice a day. One dose should be taken in the morning and another dose should be taken at night.

Instructions for use

Sycrest is for sublingual use.

Sycrest is not recommended if you are not able 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 moment of taking it.
• Have dry hands when touching the tablet.
• Do not press the tablet against the blister. Do not cut or break the blister.
• Peel off the colored tab (Figure 1).
• Remove the tablet carefully (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 in a few seconds.
• Do not swallow or chew 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 immediately. Bring the medicine with you. In case of overdose, you may feel drowsy or tired, have abnormal body movements, problems standing or walking, feel dizzy due to a drop in blood pressure, and feel agitated and confused.

If you forget to take Sycrest

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take your next dose as usual. If you forget to take two or more doses, consult 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 come back.

If you have any further questions on the use of this product, 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. Seek medical attention immediately if you have any of the following symptoms:

• allergic reactions (usually involving 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 pulse, severe muscle stiffness, confusion, and variable blood pressure, which can lead to coma
• seizures, attacks, or crises
• fainting
• falls can occur as a result of one or more side effects such as: drowsiness, sudden drops in blood pressure when standing up, dizziness, and changes in your ability to move and balance.

Tell your doctor immediately if you have:

• signs of high blood sugar levels such as thirst, hunger, or excessive urination, weakness, or worsening of diabetes
• snaking movements of the tongue, or other uncontrolled movements of the tongue, mouth, cheeks, jaw that can progress to the arms and legs

Other side effects reported with this medicine are:

Very common side effects(may affect more than 1 in 10 people)

• anxiety
• drowsiness

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, tremors
• sedation
• dizziness
  • nausea

• change in taste
• feeling of numbness in the tongue or mouth
  • increased saliva (drooling)

• muscle stiffness
• fatigue
• increase in liver protein levels

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

• abnormal movements of the muscles: a set of symptoms known as extrapyramidal symptoms, which may include one or more of the following: abnormal movements of the muscles, tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremors (agitation), abnormal eye movements, involuntary muscle contractions, slow movements, or restlessness
  • unpleasant feeling in the legs (also known as restless legs syndrome)

• difficulty speaking
• abnormally slow or fast heartbeat
• heart block
• abnormal electrocardiogram (prolonged QT interval)
• drop in blood pressure when standing up
• low blood pressure
• tingling in the tongue or mouth
• swollen or painful tongue
• difficulty swallowing
  • ulcers, pain, redness, swelling, and blisters inside the mouth

• sexual dysfunction
• absence of regular menstrual periods

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

• alteration of white blood cell levels (leukocytes)
• difficulty focusing
• blood clots in blood vessels to the lungs, causing chest pain and difficulty breathing
• muscle disease that manifests with unexplained pain
• breast enlargement in men
• spontaneous milk or fluid secretion from the breast

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Sycrest

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry date is the last day of the month stated.

Store this medicine in the original package to protect it from light and moisture.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Sycrest Composition

• The active ingredient is asenapine.
• Each 5 mg Sycrest sublingual tablet contains 5 mg of asenapine.
• Each 10 mg Sycrest sublingual tablet contains 10 mg of asenapine.
• The exact amount is shown on your Sycrest packaging.
• The other ingredients are gelatin and mannitol (E-421).

Product Appearance and Package Contents

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

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

The sublingual tablets are supplied in peelable blisters, each containing 10 tablets. The packs contain 20, 60 or 100 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

N.V. Organon

Kloosterstraat 6

NL-5349 AB Oss

Netherlands

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg, Belgium

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:{month/YYYY}.

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