How does it work?
Sycrest sublingual tablets contain the active ingredient asenapine maleate, which is a type of medicine known as an atypical antipsychotic.
The way in which asenapine works is not fully understood, however it is known to act on various receptors in the brain, particularly dopamine receptors and serotonin (5HT) receptors.
Dopamine and serotonin are natural compounds called neurotransmitters, and are involved in transmitting messages between brain cells. Psychotic illness, such as bipolar disorder, is considered to be caused by disturbances in the activity of neurotransmitters (mainly dopamine) in the brain.
Asenapine is thought to work mainly by stabilising the dopamine and serotonin activity in the brain, without interfering with the activity of other neurotransmitters. It does this by blocking the receptors in the brain that dopamine and 5HT act on. This prevents the excessive activity of dopamine and serotonin and helps to control episodes of mania in bipolar disorders.
What is it used for?
- Moderate to severe manic episodes in adults with bipolar I disorder.
How do I take it?
- Each Sycrest sublingual tablet should only be removed from the packaging when you are ready to take it. The tablet should be removed gently, by peeling back the coloured tab. This will avoid the tablet being crushed. Don’t push the tablet through the pack. The tablet must be handled with dry hands only, as any moisture will make the tablet dissolve.
- Sycrest sublingual tablets should be placed under the tongue and allowed to dissolve completely. The tablets dissolve quickly (within a few seconds) in saliva. The tablets should not be chewed, crushed or swallowed. You should not eat or drink for at least ten minutes after taking each tablet.
- If you need to take another medicine at the same time of day as Sycrest tablets, you should take your Sycrest after you have taken the other medicine(s).
- You may experience a slight numbness of the tongue and/or a bitter aftertaste after taking Sycrest; this is usual and will subside quickly.
- The dose prescribed and how often the medicine needs to be taken may vary. Sycrest tablets are usually taken twice a day, once in the morning and once in the evening. It is important to follow the instructions given by your doctor. These will be printed on the dispensing label your pharmacist has put on the packet of medicine.
- If you forget to take a dose at your normal time you should just take your next dose as normal. Do not take a double dose to make up for a missed dose.
- Unless your doctor tells you otherwise, you should not suddenly stop taking this medicine, even if you feel better and think you don't need it any more. This is because the medicine controls the symptoms of the illness but doesn't actually cure it. This means that if you suddenly stop treatment your symptoms could come back. When it is time to stop treatment this should usually be done gradually, following the instructions given by your doctor.
- This medicine may cause drowsiness and dizziness and so may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.
- You should avoid drinking alcohol while taking this medicine, because if you feel sleepy or lightheaded while taking this medicine, these side effects are likely to be made worse by drinking alcohol.
- This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing, especially when you first start taking the medicine. This may make you feel dizzy or unsteady and could make you faint. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass.
- This medicine can cause some people to put on weight. Talk to your doctor about this before you start treatment so that you can discuss strategies, such as diet and exercise, for minimising any weight gain.
- Consult your doctor immediately if you experience abnormal movements, particularly of the face, lips, jaw and tongue, while taking this medicine. These symptoms may be indicative of a rare side effect known as tardive dyskinesia, and your doctor may ask you to stop taking this medicine, or decrease your dose.
- Consult your doctor immediately if you experience the following symptoms while taking this medicine: high fever, sweating, muscle stiffness, faster breathing and drowsiness or sleepiness. These symptoms may be due to a rare side effect known as the neuroleptic malignant syndrome, and your treatment may need to be stopped.
Use with caution in
- Elderly people.
- Moderately decreased liver function.
- Severely decreased kidney function.
- People with any conditions involving the heart and blood vessels (cardiovascular disease), eg history of heart attack, angina, heart failure, heart block or abnormal heart beats.
- People with a family history of a type of abnormal heart beat seen on a heart monitoring trace (ECG) as a 'prolonged QT interval'.
- People with any conditions involving the blood vessels in the brain (cerebrovascular disease), eg history of stroke.
- People with low blood pressure (hypotension), eg due to dehydration, blood loss, severe vomiting or diarrhoea, or treatment with diuretics or medicines for high blood pressure.
- People with a history of fits (seizures), eg epilepsy.
- People with conditions that increase the risk of epilepsy or convulsions, eg brain damage or withdrawal from alcohol.
- Diabetes or family history of diabetes. (If you have diabetes your blood sugar levels should be monitored closely while you are having treatment with this medicine, because it may increase your blood sugar.)
- Parkinson's disease.
- Dementia with lewy bodies.
Not to be used in
- Severely decreased liver function.
- This medicine has not been studied in children and adolescents under the age of 18 and it is not recommended for this age group.
- This medicine is not licensed or recommended for treating psychosis in elderly people with dementia, eg Alzheimer's disease, as antipsychotic medicines may increase the risk of stroke or death in this group of people.
This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. When antipsychotic medicines have been used during the third trimester of pregnancy some side effects and withdrawal effects have been seen in the baby after birth and the baby may need extra monitoring because of this. Seek further medical advice from your doctor.
- If you get pregnant, think you could be pregnant, or want to plan a pregnancy while taking this medicine it is important to consult your doctor straight away for advice. You should not suddenly stop taking this medicine unless your doctor tells you to, as this could cause your symptoms to come back.
- It is not known if this medicine passes into breast milk. The manufacturer states that mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Very common (affect more than 1 in 10 people)
Common (affect between 1 in 10 and 1 in 100 people)
- Feeling restless, agitated and unable to sit still (akathisia).
- Difficulty performing voluntary movements, resulting in jerky or involuntary movements or muscle twitches (dyskinesia).
- Abnormal muscle tension (dystonia).
- Increased appetite and weight.
- Change in taste.
- Numbness of the mouth.
Uncommon (affect between 1 in 100 and 1 in 1000 people)
- Raised blood sugar levels (hyperglycaemia).
- Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects).
- Abnormal heart rhythm seen as a 'prolonged QT interval' on a heart monitoring trace or ECG.
- Slow heart rate.
- Low blood pressure.
- A drop in blood pressure that occurs when moving from a lying or sitting position to sitting or standing, causing dizziness and lightheadedness (postural hypotension).
- Swollen or painful tongue.
- Difficulty swallowing.
- Sensation of pins and needles in the mouth.
- Stopping or absence of menstrual periods (amenorrhoea).
- Sexual problems.
- Problems with speech.
Rare (affect between 1 in 1000 and 1 in 10,000 people)
- Blurred vision.
- Neuroleptic malignant syndrome (see warning section above).
- Abnormal production of breast milk or fluid from the nipples (galactorrhoea).
- Abnormal enlargement of the breasts in men (gynaecomastia).
- Muscle breakdown (rhabdomyolysis) causing aches and pain.
- Decrease in the numbers of a type of white blood cell (neutrophil) in the blood (neutropenia).
- Blood clot in the lungs (pulmonary embolism). Tell your doctor immediately if you experience chest pain, shortness of breath, pain on breathing or coughing, or coughing up blood while taking this medicine.
- Severe allergic reaction with symptoms such as swelling of the tongue and throat, difficulty breathing, skin rash, itching and increased heart rate. Tell your doctor straight away if you experience this.
The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.
If you need to take another medicine at the same time of day as Sycrest tablets, you should take your Sycrest after you have taken the other medicine(s).
There may be an increased chance of feeling sleepy if this medicine is taken in combination with alcohol or medicines that can make you drowsy, such as the following:
- barbiturates, eg amobarbital, phenobarbital
- benzodiazepines, eg diazepam, temazepam
- MAOI antidepressants, eg phenelzine
- sedating antihistamines, eg chlorphenamine, hydroxyzine
- sleeping tablets, eg zopiclone
- strong opioid painkillers, eg morphine, codeine, dihydrocodeine
- tricyclic antidepressants, eg amitriptyline.
This medicine may enhance the blood pressure-lowering effects of certain medicines used to treat high blood pressure (antihypertensives). If you are taking medicines for high blood pressure you should tell your doctor if you feel dizzy or faint after starting treatment with this medicine, as your blood pressure medicines may need adjusting.
The antidepressant fluvoxamine may increase the amount of asenapine in the blood if used in combination with Sycrest tablets. Your doctor may need to change your dose of Sycrest tablets if you are taking both these medicines.
If asenapine is used in combination with the antidepressant paroxetine, it may increase the amount of paroxetine in the blood. Your dose of paroxetine may need to be reduced by your doctor if you are taking both these medicines
There may be an increased risk of abnormal heart rhythms (prolonged QT interval on a heart monitoring trace or ECG) if the following medicines are taken in combination with asenapine:
- antiarrhythmics (medicines to treat abnormal heart beats), eg amiodarone, procainamide, disopyramide, sotalol
- the antihistamines astemizole, mizolastine or terfenadine
- certain antidepressants, eg amitriptyline, imipramine, maprotiline
- certain antimalarials, eg halofantrine, chloroquine, quinine, mefloquine
- certain other antipsychotics, eg thioridazine, chlorpromazine, sertindole, haloperidol
- intravenous erythromycin or pentamidine
- medicines that can alter the levels of salts such as potassium or magnesium in your blood, eg diuretics such as furosemide.
Asenapine may oppose the effect of medicines for Parkinson's disease that work by stimulating dopamine receptors in the brain, for example levodopa, ropinirole, pergolide, bromocriptine.
Asenapine may oppose the effect of anticonvulsant medicines used to treat epilepsy.
Asenapine may increase blood sugar levels and disturb the control of diabetes. People with diabetes may need an adjustment in the dose of their antidiabetic medication.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain asenapine maleate as the active ingredient.