5 mg and 10 mg resorbable tablets, sublingual
asenapine
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 in adults with bipolar I disorder. Antipsychotic drugs affect chemical signaling substances that enable contact between nerve cells ( neurotransmitters ). Illnesses that affect the brain, such as bipolar I disorder, can be caused by chemical neurotransmitters in the brain, such as dopamine and serotonin, being out of balance and this imbalance can cause some of the symptoms you may experience. It is not known exactly how this drug works, but it is believed to regulate the balance between these chemical neurotransmitters.
Manic episodes associated with bipolar I disorder are a condition with symptoms such as feeling “high”, having an excess of energy, needing much less sleep than usual, speaking very quickly with ramblings, and sometimes being very irritable.
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 with dementia who are treated with other similar types of medicine may have an increased risk of having a stroke or dying. Sycrest is not approved for the treatment of elderly patients with dementia and is not recommended for this group of patients.
Sycrest can cause low blood pressure. During the initial part of the treatment, some people may faint, especially when getting up from a lying to a sitting position. This usually goes away on its own, but if it doesn’t, talk to your doctor. The dose may need to be adjusted.
Asenapine can cause drowsiness, a sudden drop in blood pressure when you stand up, dizziness, and changes in movement and balance. This can lead to falling accidents and thus fractures or other injuries. Patients at risk of falls should be evaluated before prescribing asenapine.
Tell your doctor right away if you get
- involuntary rhythmic movements of the tongue, mouth, and face. It may be necessary to stop treatment with 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 a neuroleptic malignant syndrome).
- if you have ever experienced abnormal movements of the tongue or face ( tardive dyskinesia ). You should know that you can get both of these conditions from this type of medicine.
- if you have a heart condition or are being treated for a heart condition that can cause you to have low blood pressure.
- if you have diabetes or are at risk of developing 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. If you have it, you should not use Sycrest
- if you have difficulty regulating your body temperature
- if you have suicidal thoughts
- if you have abnormally high levels of prolactin in the blood ( hyperprolactinemia )
Be sure to tell your doctor if any of these conditions apply to you because he/she may need to change the dose or monitor you for some time. Also, contact your doctor immediately if any of these conditions appear or worsen while taking Sycrest.
Children and young people
Sycrest is not recommended for use 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 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 antidepressants (especially fluvoxamine, paroxetine, or fluoxetine ) as it may be necessary to change the Sycrest dose or dose of the antidepressant.
You should tell your doctor if you are taking medicines for Parkinson’s disease (such as levodopa ) as this medicine may reduce their effect.
Because Sycrest mainly affects the brain, interference from other drugs (or alcohol) that affect the brain may occur due to an additive effect on brain function.
Because Sycrest can lower blood pressure et al, caution should be taken when taking Sycrest together with other medicines that lower blood pressure et al.
Sycrest with food, drink, and alcohol
Do not eat or drink for 10 minutes after taking this medicine.
You should avoid drinking alcohol while using 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 when you are pregnant unless your doctor has told you to. If you are taking this medicine and become pregnant or are trying to become pregnant, ask your doctor as soon as possible if you can continue to take Sycrest.
In newborn babies whose mothers have taken Sycrest during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, sleepiness, agitation, breathing problems, and difficulty eating. If your child develops any of these symptoms, you may need to contact your doctor.
You should not breastfeed while taking Sycrest.
Driving ability and use of machinery
Sycrest may cause drowsiness or decreased alertness. Therefore, make sure that your concentration and alertness are not affected before driving or using tools or machines.
How to take Sycrest
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one sublingual resorbable tablet, 5 mg or 10 mg, twice daily. One dose is taken in the morning and one in the evening.
User instruction
Sycrest should be placed under the tongue.
Sycrest is not recommended if you cannot take the tablet as described below. If you cannot take this medicine as described below, the effect of the treatment may not be effective.
- Do not remove a sublingual resotriple from the blister until you are ready to take it.
- Your hands must be dry when you take the tablet.
- Do not push the tablet out of the blister. Do not cut or tear the blister.
- Pull back the colored tab (Figure 1).
- Carefully remove the tablet (Figure 2). Do not crush the tablet.
- To ensure optimal absorption, place the tablet under the tongue and wait until it is completely dissolved (Figure 3). The tablet dissolves in the saliva within seconds.
- Do not swallow or chew the tablet.
- Do not eat or drink for 10 minutes after taking the tablet.
If you have taken too much Sycrest
If you have taken too much Sycrest, contact your doctor immediately. Take the medicine package with you. In case of overdose, you may feel sleepy or tired, have abnormal body movements, have trouble 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 make up for a missed dose. If you have forgotten a dose, take the next dose as usual. If you have forgotten two doses or more, contact your doctor or pharmacist.
If you stop taking Sycrest
If you stop taking Sycrest, the effect of this medicine will cease. You should not stop taking the medicine unless your doctor tells you to because your symptoms may return.
If you have further questions about this medicine, contact your doctor or pharmacist.
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 (Often there is a combination of different symptoms such as difficulty breathing or difficulty swallowing, swelling of the face, lips, tongue, or throat, rash, itching, and a faster heartbeat.)
- sudden rise in body temperature with sweating, rapid heartbeat, severe muscle stiffness, confusion, and fluctuating blood pressure which may lead to coma
- convulsions
- fainting
- falls, which may occur as a result of one or more of the following side effects: sleepiness, sudden drop in blood pressure when standing up, dizziness, and altered ability to move and balance.
Tell your doctor immediately if you have:
- signs of elevated blood sugar levels such as excessive thirst, hunger or urination, weakness or worsening diabetes
- involuntary movements of the tongue or other uncontrolled movements of the tongue, mouth, cheeks, or jaw, which can also be felt in the arms and legs
Other side effects reported with this drug include:
Very common side effects ( may affect more than 1 in 10 users)
- anxiety
- somnolence
Common side effects ( may affect up to 1 in 10 users)
- weight gain
- increased appetite
- slow or persistent muscle contractions
- restlessness
- involuntary muscle contractions
- slow movements, tremors
- drowsiness
- dizziness
- nausea
- altered taste
- numbness in the tongue or the mouth
- increased saliva (drooling)
- muscle tension
- fatigue
- increase in liver protein levels
Uncommon side effects ( may affect up to 1 in 100 users)
- abnormal body movements: a collection of symptoms called extrapyramidal symptoms (EPS) which may include one or more of the following: abnormal movements of muscles, tongue or jaw, slow or persistent muscle contractions, muscle spasms, tremors (shaking), abnormal eye movements, involuntary muscle contractions, slow movements or restlessness.
- unpleasant feeling in the legs also called “restless legs syndrome”
- speech difficulties
- abnormally slow or fast heartbeats
- heart block (disorders in the conduction system of the heart)
- abnormal electrocardiogram ( ECG ), (prolongation of the QT interval et)
- low blood pressure when standing
- low blood pressure
- tingling in the tongue or the mouth
- swelling or pain in the tongue
- swallowing difficulties
- sores, soreness, redness, swelling, and blisters in the mouth
- sexual dysfunction
- irregular menstrual periods
Rare side effects ( may affect up to 1 in 1,000 users)
- changes in values of white blood cells
- difficulty focusing with the eyes
- blood clots in the blood vessels to the lungs causing chest pain and difficulty breathing
- muscle disease that manifests itself as unexplained aches and pains
- breast enlargement in men
- leakage of milk or fluid from the breasts
How to store Sycrest
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the blister and carton after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Light sensitive. Moisture sensitive.
No special temperature instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is asenapine.
- Each Sycrest 5 mg sublingual resorbable tablet contains 5 mg asenapine.
- Each Sycrest 10 mg sublingual resorbable tablet contains 10 mg of asenapine.
- The exact amount is indicated on your Sycrest packaging.
- Other ingredients are gelatin and mannitol (E421).
Appearance and package sizes of the medicine
5 mg resorbable tablets, sublingual, are round white to off-white, marked with “5” on one side.
10 mg resorbable tablets, sublingual, are round white to off-white, marked with “10” on one side.
The responsible tablets are available in peel-off blisters containing 10 tablets each. Packages may contain 20, 60, or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
NL-5349 AB Us
Netherlands
Manufacturer
Schering-Plough Labo NV
Industriepark 30
B-2220 Heist-op-den-Berg, Belgium
Contact the representative of the marketing authorization holder if you want to know more about this medicine:
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