Medication: AsenapineShow answers too
Asenapine (also known as Sycrest® or Saphris®) is mainly used for bipolar mania. In some other countries it is also licensed for schizophrenia and preventing the symptoms coming back.
It has been available in UK and Republic of Ireland since early 2012. It had been available in USA since 2009 and Australia from 2011.
If you want to see all the questions and answers in full, click the "Show answers too" button.
- Where can I print information about asenapine?
There are two options for printing:
- Click "Print this page" at the top to print the whole section
- For a full range of leaflets please click here.
- This includes our range of leaflets, fact sheets, handy charts and links to the manufacturer's leaflets
- WHAT IT IS:
- What is asenapine used for?
Asenapine is licensed and officially approved to help treat the symptoms of:
- Bipolar mania (moderate to severe)
Asenapine can also sometimes be used to help some of the symptoms of:
There are other treatments for the conditions above. The main ones are included in the section on each of the conditions above.
- What is the usual dose of asenapine?
The usual starting dose of asenapine is 10mg twice a day (morning and evening). This can be reduced to 5mg morning and evening if needed. The usual starting dose if given with another antipsychotic is 5mg morning and evening. The top dose is 10mg morning and evening.
Asenapine should not usually be used in people with severe kidney damage. It should be used with care in older people (over 65 years old) and people with moderate kidney damage. This might mean using a slightly lower dose.
- What are the alternatives to asenapine?
This will rather depend on what you are taking it for. To help you choose, click on the links for the main options (self-help and help from others), the main medicines, and a handy chart comparing the main medicines:
- Bipolar mania - main options, main medicines and handy chart
- Schizophrenia - main options, main medicines and handy chart
- Psychosis - main options, main medicines and handy chart
- Schizoaffective disorder - main options and main medicines (you may then need to look at the sections for the mood symptoms and the psychosis symptoms)
There are other treatments for the conditions above. The main ones are included in the section on each of the conditions above.
- How does asenapine work?
There is a naturally occurring chemical messengers ('neurotransmitter') in the brain called dopamine. Dopamine is the chemical messenger in the brain mainly involved with thinking, emotions, behaviour and perception. In some illnesses, this dopamine may be overactive and upsets the normal balance of chemicals in the brain. This excess dopamine helps to produce some of the symptoms of the illness. The main effect that asenapine has is to block some dopamine receptors in the brain, reducing the effect of having too much dopamine and correcting the imbalance. This reduces the symptoms caused by having too much dopamine. Asenapine also has effects on other neurotransmitters in the brain e.g. serotonin (5-HT) receptors, and its beneficial effects may be related to these effects.
- STARTING, TAKING AND STOPPING:
- When should I take asenapine?
Take your asenapine as directed on the medicine label. This is usually twice a day, so take one in the morning and another in the evening. Do not take it at the same time as food or drink (see food or drink question).
Click here for a handy fact sheet on taking medicines during Ramadan.
- How should I take asenapine?
Asenapine tablets are unusual in that they must not be swallowed. They take a bit of skill to take properly. What you should do is:
- Take any other medicines you might need first
- Dry your hands
- Pull back the coloured tab on the blister pack
- Place the tablet under your tongue and allow it to dissolve. This should take a few seconds.
- Do not touch the tablet with wet, damp or moist hands
- Do not push the tablet out, or will probably fall apart
- Do not crush the tablet
- Do not take the tablet out until you are ready to take it
- Do not cut the blister pack
- Do not chew or swallow the tablet
- Do not put the tablet on your tongue - it really doesn't taste that great
- Do not eat or drink for 10 minutes after taking the tablet
The reason for all this is that asenapine is not absorbed or taken into the body if you swallow it, so ordinary tablets don't work.
- How long will asenapine take to work?
This may depend on what you are taking asenapine for. Click the link below for the answer for that condition:
Some of the effects of asenapine appear soon after starting it e.g. drowsiness. The most important action, however, to help the symptoms of your illness may take weeks or even months of regular medication to become fully effective. In the same way if your dose or treatment is changed it may take an equally long period of time before you notice the effects of such a change.
- How long will I need to keep taking asenapine for?
- Is asenapine addictive?
Asenapine is not addictive. If you have taken it for a long time you may get some mild effects if you stop it suddenly. Asenapine is fairly new and nothing has been reported yet. The main problem would be your symptoms coming back.
For a drug to be addictive or produce dependence, then it must have a number of characteristics:
- should produce craving for the drug when the last dose "wears off"
- there should be a "reward" (e.g. a good feeling) from taking the drug
- should produce tolerance ie you need more drug to get the same effect
- should produce withdrawal symptoms specific to that drug.
These characteristics come from the World Health Organisation. Asenapine has none of these and so is not addictive. Any discontinuation effects would probably be more of an "adjustment" reaction from sudden removal of a drug rather than "withdrawal".
Click here to read a bit more about this, where you can find our thoughts on this knotty problem.
- What should I do if I forget to take a dose of asenapine?
Start again as soon as you remember unless it is nearly time for your next dose then take the next dose as normal. Do not try to catch up by taking two or more doses at once as you may get more side-effects. You should tell your doctor about this next time you meet. Missing the occasional dose (e.g. once a week) isn't usually a big problem.
If you have problems remembering your doses (as very many people do) ask you pharmacist, doctor or nurse about this. There are some special packs, boxes and devices that can be used to help you remember. You can try leaving the pack somewhere you will see it each morning e.g. in the bedroom, in a car etc, but not anywhere damp.
- Can I stop taking asenapine suddenly?
It is unwise to stop taking asenapine suddenly, even if you feel better. Your symptoms can return if treatment is stopped too early. This may occur some weeks or even many months after the drug has been stopped. You could also experience some mild withdrawal symptoms (as explained above). When the time comes your doctor will usually withdraw asenapine by a gradual reduction in the dose taken over a period of several weeks. You should discuss this fully with your doctor.
If you are thinking of coming off this medicine then you might find our handy fact sheet on stopping medicines useful. It has a list of many of the things you may need to think about before making a decision on this.
- UNWANTED EFFECTS:
- What sort of side-effects might I get if I am taking asenapine?
The table below will show you some of the main side effects you might get from asenapine.
What to do about it
COMMON (more than about 1 in 10 people might get these)
Restlessness or anxiety
Being more on edge. You may sweat a lot more.
Try and relax by taking deep breaths. Wear loose fitting clothes. This often happens early on in treatment and should gradually ease off over several weeks. A lower starting dose may help sometimes.
Somnolence or sleepiness
Feeling sleepy, drowsy or sluggish. This can last for a few hours or longer after taking your dose.
Don't drive or use machinery. Ask your doctor if you can take asenapine at a different time of day. Your doctor may be able to consider changing your dose. It should wear off after a while.
UNCOMMON (less than about 1 in 10 people might get these)
Oral hypothesia or paraesthesia
Some people get a numb tongue or mouth, and perhaps a metal-like taste in the mouth
Asenapine is a weak local anaesthetic. This usually wears off in about 10 to 30 minutes.
Movement disorders (extra-pyramidal side effects or EPSEs)
Having shaky hands. Your eyes and tongue may move on their own. You may feel very restless, or stiff.
It is not usually dangerous but is a well known side effect. If it is distressing or worries you, tell your doctor. He or she may be able to give you something for it e.g. an anticholinergic medicine. Click here for a handy fact sheet on EPSEs.
Feeling tired all the time. This may happen early on in treatment and should go away.
If you feel like this for more than a week after starting asenapine, tell your doctor. It may be possible to adjust your child's dose slightly. It should usually wear off.
Eating more and putting on weight, especially just after you start the drug.
A diet full of vegetables, cereal and fibre may help prevent weight gain. See the separate section below and Click here to see a section on helping you to feel less hungry. Click here for a handy fact sheet on weight gain with antipsychotics.
Feeling restless, agitated or on edge.
Try and relax by taking deep breaths. Contact your doctor if it worries you.
Feeling light-headed and faint.
Don't stand up too quickly. Try and lie or sit down if you feel it coming on. Don't drive.
Where things taste different to usual
This is quite usual for a few minutes after each dose but should wear off after that.
A low blood pressure - this can make you feel dizzy, especially when you stand up.
Try not to stand up too quickly. If you feel dizzy, don't drive. This dizziness is not dangerous. It usually wears off in a few days.
Do not be worried by this list of side effects. Some people get no side effects at all and others may get some effects that are not listed in this table. Side effects tend to be worse with higher doses. Starting with a lower dose sometimes helps. If you think you might have a side effect to your medicine, you should discuss this with your doctor, nurse of pharmacist. You should also see the manufacturer's information leaflet.
A rare side effect of some medicines (including mental health medicines) is hyponatraemia (low sodium in the blood) so click here for a handy fact sheet on hyponatraemia, although not yet reported with asenapine.
Asenapine is fairly new so we don't know the full story yet. There have been some very rare reports in USA of what appears to be a sensitivity or allergy to asenapine e.g. swollen tongue, finding it hard to breathe, and skin rash. We don't know yet if this is even caused by the medicine but if this happens to you please seek emergency medical attention.
Side effects: The UK Drug Safety Research Unit (DSRU) was set up 30 years ago in Southampton. DSRU is an independent charity and one of the world leaders at looking at the use and side effects of medicines. Asenapine is a new medicine and they have set up a study called OBSERVA to study it. If you would like to take part please click here and then click the link to "For further information on OBSERVA for study participants (patients) please click here".
- Will asenapine make me sleepy?
Asenapine may make you feel drowsy or sleepy, especially to start with. You should not drive (see below) or operate machinery until you know how it affects you. You should be careful as asenapine may affect your reaction times or reflexes. It is not, however, a sleeping tablet, although if you take it at night it may help you get to sleep.
- Will asenapine cause me to put on weight?
About 1 in 35 people gain some weight with asenapine. Of the people who gain weight, most is gained during the first 6 to 12 months of treatment. It then tends to level out. It is not possible to say what the effect on your own weight may be because each person will be different. If you do start to put on weight or have problems with your weight, you should tell your doctor. He or she may be able to adjust your medicine or the dose to reduce this effect. Your doctor can also arrange for you to see a dietician for advice. If you do gain weight it is possible to lose it while you are still taking this medication, with expert advice about diet. In some people this can be a serious problem. If it causes you distress make sure your doctor knows about this.
Click here for a few tips on how to help you feel less hungry and lose weight.
- Will asenapine affect my sex life?
Drugs can affect desire (libido), arousal (erection) and orgasmic ability. About 1 in 100 people get problems with asenapine. If this happens, however, you should discuss this with your doctor, as a change in dose or medicine may help minimise the problem.
- INTERACTIONS, FOOD AND DRINK:
Please see the separate medicines.
- Are there any foods or drinks that I should avoid if I am taking asenapine?
Do not eat or drink for 10 minutes after taking a tablet, or it won't work as well. You should have no problems with any other foods or drinks (including grapefruit juice), unless you take them with or after the asenapine.
- Can I drink alcohol while I am taking asenapine?
Whether or not it is safe to drink alcohol with any other medicine will depend on:
- How much you have to drink e.g. the amount and over how long
- What you then try to do (e.g. sleep or drive)
- If you have any other conditions e.g. epilepsy, asthma or a chest infection (as alcohol can make it harder to breathe)
- If you are taking any other medicines
Alcohol reaches all parts of the brain and can affect many things e.g. thinking, reactions and breathing. Alcohol can also boost the effect of GABA (the brain's main calming chemical messenger).
If you drink alcohol while taking asenapine it may make you feel more sleepy. If this happens, you must take extra care if you need to drive or operate machinery. You must seek advice on this.
It is not safe to drive after drinking alcohol, with or without asenapine. Some countries allow driving after a small amount of alcohol but others have a zero tolerance. The UK has the highest limit in Europe, France lower, Scandinavia even lower and zero in some Eastern European countries. It is not possible to say what blood level you might have from a drink so it is safest not to drink if you know you may have to drive. It is taken as a very serious offence in most countries. You should see National Guidelines, laws and regulations in the country in which you are driving.
- Will asenapine affect my other medicines?
Asenapine has a few interactions with other medicines:
- If asenapine is taken with benzodiazepines (e.g. diazepam, lorazepam, temazepam), or alcohol, it will cause more drowsiness.
- The effects of asenapine can sometimes be increased by fluvoxamine
- The effect of asenapine can be decreased by eating or drinking for 10 minutes after a dose
- Asenapine can increase the effects of some treatments for high blood pressure and paroxetine (Seroxat®)
- Asenapine can decrease the effects of some treatments for Parkinson's Disease e.g. Madopar® or Sinement®
This does not necessarily mean that this will happen in everyone or that some of these medicines can not be used together. It is just that you may need to follow your doctor's instructions very carefully. There are many other possible drug interactions.
- Are there any problems with smoking with asenapine?
Cigarette smoke contains over 3000 different chemicals. Some of these chemicals can make some of the enzymes in the liver work faster (called "enzyme induction" of e.g. CYP1A2 or P4501A2). This means that any medicine those enzymes break down will be broken down quicker. So, you'll end up with less of that medicine if you smoke. And also you will have more of it in the body if you stop smoking.
However, it seems that there are no extra problems if smoking with asenapine.
- What about illicit drugs such as cannabis, cocaine, ecstasy and opiates with asenapine?
By including this section, we're not saying it's right to take illicit or illegal drugs, because it isn't. We're just trying to answer the questions as best we can under the circumstances. With illicit drugs, the full answer is usually that we don't really know. So, we can only go on a few studies, a few reports and what we know about the drugs themselves.
Cannabis (illegal in most countries):
Smoking cannabis increases the amount of dopamine in the pleasure centres of the brain, which is where the reward or buzz comes from. However, psychosis also comes from having too much dopamine, in another area of the brain. You have to remember that smoking cannabis can also increase dopamine in other areas of the brain, so can make psychosis worse. Please be careful, everything in moderation and if dope makes you worse, keep off the grass. It really won't help you in the long-term. Don't forget that if you're a toker, you're also a smoker, so see the question above. However, there are no extra problems with smoking cannabis with asenapine, other than the smoking itself (see above). Also, don't forget that cannabis can make psychotic symptoms worse.
Cocaine (illegal in most countries)
Cocaine is of course highly addictive and has many adverse or side effects on the body and brain. It can make most mental health symptoms worse in the long-term. However, there are no reports of extra problems with asenapine and cocaine, although this doesn't mean it's safe. All antipsychotics can reduce the stimulant effects of cocaine.
Ecstasy (illegal in most countries)
Ecstasy has many effects on the brain, the main ones producing the high seem to be by boosting serotonin, noradrenaline and dopamine in the brain. While it can cause a high, the effect wears off fairly quickly. It seems that the toxic effects on the brain are cumulative i.e. the more tablets you have over your lifetime, the more chance you have of having damage to the brain e.g. long-term depression and poor memory. However, there are no reports of extra problems with asenapine and ecstasy, but again this doesn't mean it's safe.
The opiates include many chemicals, some of which are used in medical care (e.g. codeine for diarrhoea and stopping coughs, diamorphine and morphine for pain). However, there are no extra problems reported from taking opiates (e.g. heroin, methadone, codeine) with asenapine, although you might feel more drowsy.
- WOMEN'S HEALTH:
- If I am taking a contraceptive pill, will this be affected by taking asenapine?
You should have no problems with "The Pill" and asenapine.
- Will emergency contraception (the "morning-after pill") work if I am taking asenapine?
In the UK, Levonelle one step® is available and is usually known as 'the morning after pill'. It is taken to reduce the chances of becoming pregnant after unprotected sex or failure of a contraceptive method. In fact "Emergency Contraception" is the better term because it can be taken up to 72 hours (3 days) afterwards. It can be bought over-the-counter without a prescription from pharmacies. EllaOne® tablets (which may work up to 5 days afterwards) and a coil (Intra-uterine device) can also be used but must be prescribed by a Doctor.
If you are taking asenapine, the usual dose should work if you follow the instructions carefully.
N.B. We accept that for religious, cultural or ethical reasons some people do not approve of, or agree with, the use of the "Morning After" pill. However, we have answered the question because it is one of the most often asked of NHS Direct in UK, and they suggested we include it.
- Will asenapine affect my periods (menstrual cycle)?
Several female functions such as menstrual cycle (e.g. your periods) are controlled by a hormone called prolactin. Prolactin in the body rises during and after pregnancy and this triggers the body to make breast milk. The amount of prolactin in the body is kept in control by one part of the brain (the tuberoinfundibular system if you want to know). This area of the brain uses dopamine as its chemical messenger. Some medicines (especially antipsychotics) block the effect of dopamine in the brain. This is just what we want to help reduce some of the symptoms caused by too much dopamine e.g. psychosis, paranoia. However, if these medicines also block dopamine in the area of the brain that keeps prolactin under control, prolactin can get out of control and increase. Higher than usual levels of prolactin in the brain and blood will stop your periods (or at least make them irregular or unpredictable). Much higher levels can lead to your breasts leaking milk or lactating (the medical term is galactorrhoea). The name of the hormone (prolactin) might help you guess this anyway i.e. pro- (meaning for) -lactin (as in lactation). High prolactin can make it more difficult to become pregnant, and over many years can have an effect on your sex-life, and maybe even your bones.
Asenapine does not seem to increase prolactin and does not seem to have any effect on fertility. However, if your periods are irregular or late, or you start leaking milk, then you should see your doctor about this to find if there are any other causes.
- What if I want to start a family or find I'm pregnant while taking asenapine?
It is important to consider that there will be a risk to you and your child from taking a medicine during pregnancy but also a possible risk from stopping the medicine e.g. getting ill again. Unfortunately, no decision is risk-free. It will be for you to decide which is the least risk. All we can do here is to help you understand some of the issues, so you can make an informed decision. For your information, major malformations occur "spontaneously" in about 2-4% of all pregnancies, even if no drugs are taken. The main problem with medicines is termed "teratogenicity" i.e. a medicine causing a malformation in the unborn child. A medicine causing teratogenicity is called a "teratogen". Since a baby has completed it's main development between days 17 and 60 of the pregnancy (the so-called "first trimester") these first 2-16 weeks are the main concern. After that, there may be other problems e.g. some medicines may cause slower growth. The infant may also be affected after birth e.g. withdrawal effects are possible with some drugs.
If possible, the best option is to plan in advance. If you think you could become pregnant, discuss this with your doctor and it may be possible to switch to medicines thought to carry least risk, and take other risk-reducing steps e.g. adjusting doses, taking vitamin supplements etc. If you have just discovered you are pregnant, don't panic, but seek advice from your GP within the next few days if possible. He or she may also want to refer you on to someone with more specialist knowledge of your medicine.
Very few medicines have been shown to be completely safe in pregnancy and so no manufacturer or advisor can ever say any medicine is safe. They will usually advise not to take a medicine during pregnancy, unless the benefit is much greater than the risk. In the UK, there is the NTIS (National Teratology Information Service) who offer individual risk assessments. However, their advice should always be used to help you and your doctor decide what is the risk to you and your baby. There is a risk from taking the medicine and a risk should you stop a medicine e.g. you might become ill again and need to go back on the medication again. The advice offered here is just that i.e. advice, but may give you some idea about the possible risks and what (at the time of writing) is known through the medical press
It may be helpful to know that in the USA, the FDA (Food and Drug Administration) classifies medicines in pregnancy in five groups:
A = Studies show no risk, so harm to the unborn child appears only a remote possibility
B = Animal and human studies indicate a lack of risk but are not fully conclusive
C = Animal studies indicate a risk but there is no safety data in humans
D = a definite risk exists but the benefit may outweigh the risk in some people
X = the risk outweighs any possible benefit
Asenapine is classified as "C". There is no human information available yet so you should only take it if you really need to if you are pregnant. You should seek personal advice from your GP, who may then if necessary seek further specialist advice.
- Can I breast feed if I am taking asenapine?
Almost every medicine passes into breast-milk. The main questions are how much and if this is likely to have an effect on your baby. But also remember that being ill (e.g. depressed, manic, psychotic) may have more harmful and lasting effects on you and your child (such as bonding and behaviour e.g. Field, 2010) than a small amount of an effective medicine. If you have been taking a medicine while you are pregnant, you should usually be able to carry on as the amount in breast-milk is much less than the baby would have got while you were pregnant. It is usually thought to be fairly safe if the baby gets less than 10% of the mum's dose. But there may be times when although a medicine gets into breast milk the benefit may be worth the risk, so you should seek personal advice on this.
If you stop any medicine suddenly, some people can get discontinuation or withdrawal symptoms (see question above). If you have been taking a medicine during pregnancy, the same can sometimes happen to the baby when born. If the drug gets into breast milk, this can reduce the effect of suddenly not having the medicine (as well as coping with being in the big wide world too).
If you want to breast-feed there are some things you can do to reduce any risk:
- Nearly all medicines can be taken once a day. So, taking your daily dose just before the baby's longest sleep (often this will be at night) will reduce the amount the baby gets from the milk.
- Any side effects in the baby will be higher if the mum is taking a higher dose. So, try to take the lowest dose possible to still get an effect.
- Try not to take any medicines you don't really need. This includes any medicines you might buy over-the-counter
- Make sure your nurse, health visitor or doctor checks your baby for any side effects e.g. being extra sleepy, having colic, feeding problems, being floppy or poor weight gain. If there are any problems you might need to switch medicines or drop your dose a bit
- Hind milk (the second half of the feed) is likely to contain slightly more of any medicine than the first half
- Avoid new medicines if possible as there is less information about them and breast-feeding.
You must be extra careful of any medicines if your baby was pre-mature, or has kidney, liver, heart or brain problems.
We know that some asenapine gets into breast milk in animals but we don't know if the same happens in humans. So you ought to avoid breast-feeding when taking asenapine. If you do, you should talk about this to your doctor, nurse or health visitor because they will need to be able to do regular checks on your baby to make sure there are no problems.
- OTHER QUESTIONS AND ANSWERS:
- Can I drive while I am taking asenapine?
Asenapine can affect your driving e.g. sometimes a few people can feel drowsy with asenapine. Until this wears off, or you know how asenapine affects you, do not drive or operate machinery. You should be careful as it may affect your reaction times or reflexes even though you feel well.
If you are taking any medicines, the rules about driving will depend on the country you're driving in. Click on the links below for advice:
- Medicines and driving in the UK (England, Scotland, Northern Ireland and Wales)
- Medicines and driving in the Republic of Ireland
Click here for a handy fact sheet on driving and medication.
General advice on driving safely
If you want to drive, you should take sensible steps to reduce any risk. These could include:
- Avoid driving when you are tired or ill
- Do not drive after having any alcohol as this can make any drowsiness worse (a third of all fatal road traffic incidents involve alcohol-dependent drivers)
- Avoid driving at night, dusk or in bad weather
- Avoid motorways, dual carriageways and the rush hour
- Give yourself plenty of time. Don't rush
- Be extra careful if you have not slept well the previous night
As some medicines can affect your driving, be extra careful:
- If starting a new medicine
- After a change in dose (especially an increase)
- If you are on a high dose or seem very sensitive to side effects
- If you are taking any medicines for other symptoms e.g. antihistamines for hay fever or allergies
- If your medicine causes you blurred vision, drowsiness, poor co-ordination, poor attention
If you are driving less than 2000 miles a year, once you consider insurance, tax, MoT, repairs, maintenance, parking and petrol, you may actually find it is cheaper to get taxis and busses, and walk the short journeys.
- Will I need any blood or other tests while I am taking asenapine?
Some of the side effects of some antipsychotics can include weight gain, high blood pressure, and diabetes. These are sometimes called the "metabolic syndrome". This can happen to anyone but is more common in bipolar disorder and schizophrenia. And some medicines can also make it more likely but asenapine seems to be less likely to cause these problems. However, before you start asenapine you might want to have your blood glucose, blood lipids (fats), blood prolactin, weight, waist and blood pressure checked. These can then be checked again every 6-12 months to make sure you are not getting any of these type of side effects. If you are, these can usually be treated.
- Where can I find more information about asenapine?
In 2012 the UK Medicines and Healthcare products Regulatory Agency set up a Medicines Safety Information part of their website. You will have to search for the medicine or medicines you want to look for, although there isn't much here about the tricyclics because they've been around too long. The parts you might find of interest are as follows:
DAPs contain a complete list of all possible side effects that have been reported by healthcare professionals and patients to the MHRA, via the Yellow Card Scheme. Each DAP lists all of the reactions reported by health professionals and patients for a particular medicine.
- C&M note: Please be careful reading this section. It includes all possible side effects listed against every medicine someone was taking. So, if all your hair fell out while you were taking 5 medicines, this event would be listed against all five medicines, even though only one or even none might have been the cause. The idea is to try to get all information and perhaps find some rare side effects. The numbers of reported cases also depend on how often the medicine is prescribed e.g. 50 reports based on 500 prescriptions is worth looking at, but 5 cases based on 5,000,000 prescriptions could well just be chance.
The MHRA's assessment of a medicine can be found in the Public Assessment Reports (PARs), although commercial and personal confidential information has been taken out. PARs are usually available for medicines licensed in the UK after 30 October 2005.
A Risk Management Plan (RMP) is a document that describes all the available knowledge about the safety and effectiveness of a medicine.
Drug Safety Update is the MHRAs monthly newsletter for healthcare professionals. It has information and clinical advice on the safe use of medicines.
This page contains the official product information. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. PILs are based on the Summaries of Product Characteristics - a description of a medicinal product's properties and the conditions for its use. These are also linked from the leaflets question above.
The European Medicines Agency (EMA) is the body that approves medicines for use in the EU. Their website has a summary of the European Public Assessment Report (EPAR) for asenapine (Sycrest®). The EPAR is all the scientific stuff put in a readable way. It explains how and why the Committee for Medicinal Products for Human Use (CHMP) looked at the information on asenapine (Sycrest) and decided to allow it to be marketed ("granting a marketing authorisation" as the call it). Click here to see their readable report.