Seroquel XL 50 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
quetiapine fumarate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Seroquel XL is and what it is used for
- 2. Before you take Seroquel XL
- 3. How to take Seroquel XL
- 4. Possible side effects
- 5. How to store Seroquel XL
- 6. Further information
What Seroquel XL is and what it is used for
Seroquel XL contains a medicine called quetiapine. This belongs to a group of medicines called anti-psychotics. These medicines help with the effects of certain types of mental illness, such as:
- Hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act and feeling alone and confused. This is also known as schizophrenia.
- Effects on your mood and feeling very ‘high’ or excited. You may find that you need to sleep less than usual. You may be more talkative and have racing thoughts or ideas. You may also feel more irritable than usual. This is also known as bipolar mania.
- Effects on your mood whereby you feel sad all the time. You may find that you feel depressed, feel guilty, lack energy, lose your appetite and/or can’t sleep. This is also known as bipolar depression.
Your doctor may continue to give you Seroquel XL when you are feeling better to prevent your symptoms from returning.
You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and ask them to read this leaflet. You might ask them to tell you if they think your symptoms are getting worse, or if they are worried about any other changes in your behaviour.
Before you take Seroquel XL
Do not take Seroquel XL if:
- you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XL (see section 6: Further information)
- you are taking any of the following medicines:
- protease inhibitors, such as nelfinavir (for HIV infection)
- azole medicines (for fungal infections)
- medicines for an infection (like erythromycin or clarithromycin)
- nefazodone (for depression).
Do not take Seroquel XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seroquel XL.
Take special care with Seroquel XL
Seroquel XL should not be taken by elderly people with dementia (loss of brain function).
This is because the group of medicines that Seroquel XL belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
Before you take your medicine, tell your doctor if:
- You have any health problems (like heart problems or low blood pressure) or you have had a stroke.
- You have problems with your liver.
- You have ever had a fit (seizure).
- You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
- You have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Seroquel XL.
- You or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression. If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines.
This includes medicines obtained without a prescription and herbal medicines.
In particular, tell your doctor or pharmacist if you are taking:
- Medicines for anxiety or depression.
- Epilepsy medicines (like phenytoin or carbamazepine).
- High blood pressure medicines.
- Rifampicin (for tuberculosis).
- Barbiturates (for difficulty sleeping).
- Thioridazine (another anti-psychotic medicine).
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Taking Seroquel XL with food and drink
- Seroquel XL should be taken without food, at least one hour before a meal.
- Be careful how much alcohol you drink. This is because the combined effect of Seroquel XL and alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking Seroquel XL. It can affect the way the medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor or pharmacist before taking Seroquel XL.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.
Hospital - If you go into hospital, tell the medical staff that you are taking Seroquel XL.
Important information about some of the ingredients of Seroquel XL
Seroquel XL contains lactose which is a type of sugar. If you have been told by your doctor or pharmacist that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
If you have been on other medication for this condition, and that medication has stopped your periods, changing to Seroquel XL may allow them to return.
How to take Seroquel XL
Always take Seroquel XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose and may gradually increase it. After this the dose will usually be between 200 mg and 800 mg each day. It depends on your illness and needs.
- You will take your tablets once a day.
- Swallow your tablets whole with a drink of water.
- Do not split, chew or crush the tablets.
- Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Seroquel XL tablets are available in 4 different strengths and each strength is a different colour.
- Even though the dose might stay the same, it might be supplied as different strength tablets.
For example one 400 mg tablet (white) or two 200 mg tablets (yellow). - So don’t be surprised if the colour of your tablets changes from time to time.
Liver problems
If you have liver problems your doctor may give you a lower dose.
Elderly people
If you are elderly your doctor may give you a lower dose.
Children and adolescents under 18 years
Seroquel XL should not be used by children and adolescents aged under 18 years.
If you take more Seroquel XL than you should
If you take more Seroquel XL than prescribed by your doctor, go to your doctor or nearest hospital straight away. Take the Seroquel XL tablets with you.
If you forget to take a dose of Seroquel XL
If you forget to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Seroquel XL
If you suddenly stop taking Seroquel XL, you may feel nauseous or vomit, or be unable to sleep or have jerky movements, or your original illness might come back. Your doctor may suggest you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Seroquel XL can cause side effects, although not everybody gets them.
If any of the following happens, stop taking Seroquel XL and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:
Uncommon (affects less than 1 in 100 people):
- Fits or seizures
- Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
- Uncontrollable movements, mainly of your face or tongue (Tardive dyskinesia).
Rare (affects less than 1 in 1,000 people):
- A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure or heartbeat.
- Jaundice (yellowing of the skin and eyes).
- Priapism (a long-lasting and painful erection).
- Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Very rare (affects less than 1 in 10,000 people):
- Severe allergic reaction that may include difficulty in breathing, dizziness and collapse.
- Hepatitis (inflammation of the liver).
- Rapid swelling of the skin, usually around the eyes, lips and throat.
Other possible side effects:
Very common (affects more than 1 in 10 people):
- Dizziness (may lead to falls), headache, dry mouth.
- Feeling sleepy (this may go away with time, as you keep taking Seroquel XL) (may lead to falls).
- Discontinuation symptoms (symptoms which occur when you stop taking Seroquel) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness and irritability. They usually go away after 1 week from your last dose.
- Putting on weight.
Common (affects less than 1 in 10 people):
- Rapid heartbeat.
- Stuffy nose.
- Constipation, upset stomach (indigestion).
- Feeling weak, fainting (may lead to falls).
- Swelling of arms or legs.
- Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
- High blood sugar.
- Blurred vision.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
- Abnormal dreams and nightmares.
- Feeling more hungry.
- Feeling irritated.
- Disturbance in speech or language.
Uncommon (affects less than 1 in 100 people):
- Restless legs.
- Difficulty swallowing.
Rare (affects less than 1 in 1,000 people):
- Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Very rare (affects less than 1 in 10,000 people):
- Worsening of pre-existing diabetes.
- A severe rash, blisters or red patches on the skin.
Some side effects are only seen when a blood test is taken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, decreases in the number of certain types of blood cells and increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
- Men and women to have swelling of breasts and unexpectedly produce breast milk.
- Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
If any of the side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
Children and adolescents
The same side effects that may occur in adults may also occur in children and adolescents.
The following side effect has been seen only in children and adolescents:
Very Common (affects more than 1 in 10 people):
- Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (affects more than 1 in 10 people):
- Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
- boys and girls to have swelling of breasts and unexpectedly produce breast milk
- girls to have no monthly period or irregular periods.
- Increased appetite.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
How to store Seroquel XL
- Do not store above 30°C. Store in the original package.
- Keep your Seroquel XL tablets in a safe place, where children cannot see or reach them.
- Do not use Seroquel XL after the expiry date which is stated on the container. The expiry date refers to the last day of that month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further information
What Seroquel XL contains
- Each tablet contains either 50 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
- The other ingredients are microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171). The 50 mg, 200 mg and 300 mg tablets also contain ferric oxide (E172).
What Seroquel XL looks like and contents of the pack
All tablet strengths are capsule shaped and marked with XR and the strength. 50 mg tablets are peach coloured; 200 mg tablets are yellow coloured; 300 mg tablets are pale yellow coloured; 400 mg tablets are white coloured.
Pack sizes of 10, 30, 50, 60 and 100 tablets are registered for all strengths. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
- The marketing authorisations for Seroquel XL are held by
- The tablets are made by
and
This leaflet was last updated in January 2010
Seroquel XL is a trade mark of the AstraZeneca group of companies.
© AstraZeneca 2010
You can also get information on mental health from the following national organisations:
- MIND (National Association for Mental Health): Mindinfoline: 0845 7660163
- RETHINK (Formerly the National Schizophrenia Fellowship) Advice Service: 0208 9746814
- National Schizophrenia Fellowship (Scotland): 0131 662 4359
- SANELINE Helpline: 0845 7678000
To listen to, or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information:
Product name : Reference number
Seroquel XL prolonged release tablets 50 mg : PL 17901/0249
Seroquel XL prolonged release tablets 200 mg : PL 17901/0250
Seroquel XL prolonged release tablets 300 mg : PL 17901/0251
Seroquel XL prolonged release tablets 400 mg : PL 17901/0252
This is a service provided by the Royal National Institute of Blind People.
CNS 10 0004c
P027233
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