Active ingredient
- asenapine maleate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00025/0658.
Sycrest 5mg and 10mg Sublingual Tablets
Package leaflet: Information for the patient
Sycrest® 5 mg sublingual tablets
Sycrest® 10 mg sublingual tablets
asenapine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in 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 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 associated with bipolar I disorder in adults. Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters). Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing. Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals.
Manic episodes associated with bipolar I disorder is a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas 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 with dementia, who are treated with other similar types of medicine, may have an increased risk of 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 will usually pass on its own but if it does not, tell your doctor. Your dose may need to be adjusted.
Asenapine may cause sleepiness, sudden drops in blood pressure when you stand up, dizziness and changes in your ability to move and balance, which may lead to falls and, consequently, fractures or other injuries. Patients at risk for fall should be evaluated prior to prescribing asenapine.
Tell your doctor immediately if you experience
Check with your doctor or pharmacist before taking Sycrest:
Be sure to tell your doctor if you meet any of these conditions as he/she may want to adjust your dose or monitor you for a while. Also contact your doctor immediately if any of these conditions develops or worsens while using Sycrest.
Children and adolescents
Sycrest is not recommended for use in patients below 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 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 Sycrest or antidepressant medicine dose.
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.
Since Sycrest works primarily in the brain, interference from other medicines (or alcohol) that work in the brain could occur due to an additive effect on brain function.
Since Sycrest can lower blood pressure, care should be taken when Sycrest is taken with other medicines that lower blood pressure.
Sycrest with food, drink 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 breast-feeding
If you are pregnant or breast-feeding, 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 so. If you are taking this medicine and you become pregnant or you plan to get pregnant, ask your doctor as soon as possible whether you may continue taking Sycrest.
The following symptoms may occur in newborn babies, of mothers that have used Sycrest in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Do not breast-feed when taking Sycrest.
Driving and using machines
Sycrest may cause sleepiness or sedation. Therefore, make sure your concentration and alertness are not affected before you drive or operate machinery.
3. How to take Sycrest
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is a sublingual tablet of 5 mg or 10 mg two times 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 advised if you are unable to take the tablet as described below. If you are unable to take this medicine as is described below, the treatment may not be effective for you.
If you take more Sycrest than you should
If you take too much Sycrest, contact a doctor straight away. Take the medicine pack with you. In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems with 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 forgotten dose. If you miss one dose, take your next dose as usual. If you miss 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 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. Seek medical attention immediately if you have any of the following symptoms:
Tell your doctor right away if you have:
Other side effects reported with this medicine include:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 which is stated on the blister and on the carton. The expiry date refers to the last day of that month.
Store this medicine in the original package in order to protect from light and moisture.
This medicinal product does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sycrest contains
What Sycrest looks like and contents of the pack
The 5 mg sublingual tablets are round white to off-white tablets marked with “5” on one side.
The 10 mg sublingual tablets are round white to off-white tablets marked with “10” on one side.
The sublingual tablets are provided in peelable blisters containing 10 tablets each. Packs may contain 20, 60 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holders
Marketing Authorisation Holder in Great Britain:
Marketing Authorisation Holder in UK (Northern Ireland):
Manufacturer
For any information about this medicine, please contact:
This leaflet was last revised in March 2021.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© Organon Pharma (UK) Limited, 2021. All rights reserved.
PIL.SYC.21.GB-NI.7644.Art 61.3
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
+44 (0) 208 159 3593
+44 (0) 208 159 3500