Leaflet: information for the patient

Sycrest 5mg sublingual tablets

Sycrest 10mg sublingual tablets

asenapina

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section4.

1.What Sycrest is and what it is used for

2.What you need to know before you start taking Sycrest

3.How to take Sycrest

4.Possible side effects

5.Storage of Sycrest

6.Contents of the pack and additional information

Sycrest contains the active ingredient asenapine. This medication belongs to a group of medications called antipsychotics. Sycrest is used to treat moderate to severe manic episodes associated with bipolar disorder I in adults.Antipsychotic medications affect the chemicals that allow communication between nerve cells (neurotransmitters). Brain disorders, such as bipolar disorder I, may be due to an imbalance of certain brain chemicals, such as dopamine and serotonin, and these imbalances may cause some of the symptoms you are experiencing. The exact mechanism of action of this medication is not known, however it is believed to adjust the balance of these brain chemicals.

Manic episodes associated with bipolar disorder I are a condition characterized by symptoms such as feeling well, excessive energy, needing less sleep than usual, speaking very quickly with many ideas, and sometimes great irritability.

Do not take Sycrest

If you are allergic to aripiprazole or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Sycrest.

Sycrest has not been studied in elderly patients with dementia. However, these patients who are being treated with other similar types of medications may have a higher risk of stroke (ictus) 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 if they get up after being lying down or sitting. This usually goes away on its own, but if it does not, tell your doctor, as they may need to adjust your dose.

Aripiprazole may cause drowsiness, sudden drops in blood pressure when standing, dizziness, and changes in your ability to move and in balance, which may lead to falls and, consequently, fractures or other traumatic injuries. Patients at risk of falls should be evaluated before prescribing aripiprazole.

Inform your doctor immediately if you experience

-involuntary rhythmic movements of the tongue, mouth, and face. Treatment with Sycrest may need to be suspended.

-fever, intense muscle rigidity, sweating, or decreased level of consciousness (a condition 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 condition whose symptoms are high body temperature and muscle rigidity (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 conditions can be caused by this type of medication.

-if you have a heart disease or are being treated for a heart disease that may make you prone to 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 do, do not take Sycrest

-if you have a problem with body temperature regulation

-if you have thoughts of suicide

• if you have abnormally high levels of prolactin in your blood (hyperprolactinemia)

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

Children and adolescents

Sycrest is not recommended for use in patients under 18years.

Other medications and Sycrest

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Some medications may reduce or increase the effect of Sycrest.

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

You should tell your doctor if you are taking antidepressants (specifically fluvoxamine, paroxetine, or fluoxetine), as your dose of Sycrest or your antidepressant dose may need to be changed.

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

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

Sycrest may lower blood pressure, so you should be careful when taking Sycrest with other medications that lower blood pressure.

Taking Sycrest with food, drinks, and alcohol

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

You should avoid drinking alcohol while taking this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, check with your doctor or pharmacist before using this medication.

Do not take Sycrest while pregnant, unless your doctor tells you to. If you are taking this medication 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): tremor, rigidity, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

Do not breastfeed your baby while taking Sycrest.

Driving and using machines

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is a sublingual tablet of 5or10mg 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 unable to take the tablet as described below. If you are unable to take this medication as described below, the treatment may not be effective for you.

-Do not remove the sublingual tablet from the blister pack until it is time to take it.

-Have dry hands when handling the tablet.

-Do not press the tablet against the blister pack. Do not cut or break the blister pack.

-Peel off the colored tab (Figure1).

-Carefully remove the tablet (Figure2). Do not crush the tablet.

-To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure3). The tablet will dissolve in the saliva in a few seconds.

-Do not swallow or chew the tablet.

-Do not eat or drink for 10minutes after taking the tablet.

Figure1Figure2Figure3

If you take more Sycrest than you should

If you take too much Sycrest, contact a doctor immediately. Bring the medication with you. In case of overdose, you may feel drowsy or tired, have abnormal body movements, experience problems standing or 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 compensate for the missed 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 interrupt treatment with Sycrest

If you interrupt treatment with Sycrest, you will lose the effects of this medication. Do not interrupt treatment with this medication unless your doctor tells you to, as your symptoms may reappear.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Severe side effects have been reported with this medicine.Seek medical attention immediately ifyou have any of the following symptoms:

• allergic reactions (usually involve a combination of symptoms 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 rigidity, confusion, and variable blood pressure, which can lead to coma
• seizures, attacks, or crises
• loss of consciousness
• falls can occur as a result of one or more side effects such as: drowsiness, sudden drops in blood pressure when standing, dizziness, and changes in your ability to move and balance.

Inform your doctor immediately if you have:

• signs of increased blood sugar levels such as thirst, hunger, or excessive urination, weakness, or worsening of diabetes
• involuntary 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(can affect more than 1in 10people)

-anxiety

-drowsiness

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

-weight gain

-increased appetite

-slow or sustained muscle contractions

-restlessness

-involuntary muscle contractions

-slow movements, tremor

-sedation

-dizziness

• nausea

-change in taste

-numbness in the tongue or mouth

• excessive salivation (drooling)

-muscle tension

-fatigue

-increase in liver protein levels

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

-abnormal muscle movements: a group of symptoms known as extrapyramidal symptoms, which can include one or more of the following: abnormal muscle movements, tongue, or jaw, slow or sustained muscle contractions, muscle spasms, tremor (agitation), abnormal eye movements, involuntary muscle contractions, slow movements, or restlessness

• unpleasant sensation in the legs (also known as restless leg syndrome)

-difficulty speaking

-abnormally slow or fast heart rate

-central heart block

-abnormal electrocardiogram (prolongation of the QT interval)

-drop in blood pressure when standing

-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(can affect up to 1in 1,000people)

-alteration of white blood cell levels (leukocytes)

-difficulty focusing the eyes

-blood clots in blood vessels leading to the lungs, which cause chest pain and difficulty breathing

-muscle disease that manifests with unexplained pain

-breast enlargement in men

-excretion of milk or fluid from the breast

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendixV. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack and on the packaging. The expiration date is the last day of the month indicated.

Store this medication in the original packaging to protect it from light and moisture.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of empty packaging and unused medications. By doing so, you will help protect the environment.

Composition of Sycrest

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

Appearance of the product and packaging contents

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

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

The sublingual tablets are supplied in blisters that contain 10 tablets each. The packaging contains 20, 60, or 100 tablets.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

N.V. Organon

Kloosterstraat 6

NL-5349 AB Oss

Netherlands

Responsible for manufacturing

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg, Belgium

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last revision date of this leaflet:{month/year}.

For more detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.