You are here
- Home
SEROQUEL XR Information for patients
This section contains information on the drug SEROQUEL XR (quetiapine XR). It will provide you with important information but cannot be complete. If you should have any questions or if you are in doubt, please ask your doctor or pharmacist.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seroquel XR 50 mg, 150mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
quetiapine
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:
- What Seroquel XR is and what it is used for
Seroquel XR contains a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. These medicines help with conditions that cause symptoms such as:
- You may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
- You may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive or aggressive behaviours.
- Effects on your mood whereby you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite and/or can’t sleep.
- Before you take Seroquel XR
Do not take Seroquel XR if:
- you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel XR (see section 6: Further information)
- you are taking any of the following medicines:
- some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- nefazodone (for depression).
Do not take Seroquel XR if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seroquel XR.
Take special care with Seroquel XR
Seroquel XR should not be taken by elderly people with dementia (loss of brain function). This is because the group of medicines that Seroquel XR 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, or someone in your family, have any heart problems, for example heart rhythm problems.
- You have low blood pressure.
- You have had a stroke, especially if you are elderly.
- You have problems with your liver.
- You have ever had a fit (seizure).
- 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 XR.
- 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).
Tell your doctor if you experience:
- A high temperature (fever), stiff muscles, feeling confused.
- Uncontrollable movements, mainly of your face or tongue.
- A feeling of severe sleepiness.
These conditions can be caused by this type of medicine.
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 have previously had thoughts about killing or harming yourself.
- 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 major depressive episodes in bipolar disorder.
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 because it may affect the way the medicines work. This includes medicines that you buy without a prescription and herbal medicines.
Do not take Seroquel XR if you are taking any of the following medicines:- Some medicines for HIV.
- Azole medicines (for fungal infections).
- Erythromycin or clarithromycin (for infections).
- Nefazodone (for depression).
Tell your doctor if you are taking any of the following medicines:
- Epilepsy medicines (like phenytoin or carbamazepine).
- High blood pressure medicines.
- Barbiturates (for difficulty sleeping).
- Thioridazine (another anti-psychotic medicine).
Before you stop taking any of your medicines, please talk to your doctor first.
Taking Seroquel XR with food and drink
- Seroquel XR can be affected by food and you should therefore take your tablets at least one hour before a meal.
- Be careful how much alcohol you drink. This is because the combined effect of Seroquel XR and alcohol can make you sleepy.
- Do not drink grapefruit juice while you are taking Seroquel XR. 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 before taking Seroquel XR. You should not take Seroquel XR during pregnancy unless this has been discussed with your doctor. Seroquel XR should not be taken if you are breast-feeding.
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.Important information about some of the ingredients of Seroquel XR
Seroquel XR contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
- How to take Seroquel XR
Always take Seroquel XR 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 on how many Seroquel XR tablets to take each day. This will depend on your illness and needs but will usually be between 300 mg and 800 mg.
Your doctor may start your treatment on a lower dose (50mg) and increase the dose slowly if:
- You are elderly, or
- You have liver problems.- You will take your tablets once a day.
- Do not split, chew or crush the tablets.
- Swallow your tablets whole with a drink of water.
- Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when).
- Do not drink grapefruit juice while you are taking Seroquel XR. It can affect the way the medicine works.
- Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Children and adolescents: Seroquel XR is not recommended for people aged under 18 years.
If you take more Seroquel XR than you should
If you take more Seroquel XR than prescribed by your doctor, you may experience sleepiness, dizziness and abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the Seroquel XR tablets with you.
If you forget to take a dose of Seroquel XR
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 XR
If you suddenly stop taking Seroquel XR, you may be unable to sleep (insomnia), you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. 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 XR can cause side effects, although not everybody gets them. If any of the following side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common (affects more than 1 patient in 10):- Dizziness, headache, dry mouth.
- Feeling sleepy (this may go away with time, as you keep taking Seroquel XR).
- Discontinuation symptoms (symptoms which occur when you stop taking Seroquel XR) 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.
Common (affects 1 to 10 patients in 100):
- Rapid heartbeat.
- Stuffy nose.
- Constipation, upset stomach (indigestion).
- Feeling weak, fainting.
- Swelling of arms or legs.
- Putting on weight, mainly in the first weeks of treatment.
- Low blood pressure when standing up. This may make you feel dizzy or faint.
- Increased levels of sugar in the blood.
- Blurred vision.
- Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
- Abnormal dreams and nightmares.
Uncommon (affects 1 to 10 patients in 1,000):
- Fits or seizures.
- Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
- Unpleasant sensations in the legs (also called restless legs syndrome).
- Difficulty swallowing.
- Disturbance in speech and language.
Rare (affects 1 to 10 patients in 10,000):
- A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very drowsy or faint.
- Yellowing of the skin and eyes (jaundice).
- A long-lasting and painful erection (priapism).
Very rare (affects less than 1 patient in 10,000):
- Worsening of pre-existing diabetes.
- Uncontrollable movements, mainly of your face or tongue.
- Inflammation of the liver (hepatitis).
- Severe rash, blisters, or red patches on the skin.
- A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
- Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
The class of medicines to which Seroquel XR belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
Some side effects are only seen when a blood test is taken. These include increases in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood and decreases in the number of certain types of blood cells. Your doctor may ask you to have blood tests from time to time.
- How to store Seroquel XR
- Keep out of the reach and sight of children.
- Do not use Seroquel XR after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.
- Seroquel XR does not require any special storage conditions.
- 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 XR contains
- The active substance is quetiapine. Seroquel XR tablets contain 50 mg, 150mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
- The other ingredients are:
Tablet core: microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose.
Tablet coating: hypromellose, macrogol, titanium dioxide (E171). The 50 mg, 200 mg and 300 mg tablets also contain iron oxide yellow (E172) and the 50 mg tablets contain iron oxide red (E172).
What Seroquel XR looks like and contents of the pack
All prolonged-release tablets are capsule shaped and marked with XR and the strength. 50 mg tablets are peach coloured; 150mg tablets are white coloured; 200 mg tablets are yellow coloured; 300 mg tablets are pale yellow coloured and 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 available.
Marketing Authorisation Holder and Manufacturer
The marketing authorisation holder in Ireland is: AstraZeneca UK Ltd, 600 Capability Green, Luton, LU1 3LU, UK.
The marketing authorisation holder in Malta is: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
The manufacturer in Ireland and Malta is: AstraZeneca UK Ltd, Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
This medicinal product is authorised in the Member States of the EEA under the following names:COUNTRY TRADE NAME Austria Seroquel XR Belgium Seroquel XR Bulgaria Seroquel XR Cyprus Seroquel XR Czech Republic Seroquel Prolong Denmark Seroquel Prolong Estonia Seroquel XR Finland Seroquel Prolong Germany Seroquel Prolong Greece Seroquel XR Hungary Seroquel XR Iceland Seroquel Prolong Ireland Seroquel XR Italy Seroquel compresse a rilascio prolungato Latvia Seroquel XR Lithuania Seroquel XR Luxembourg Seroquel XR Malta Seroquel XR Netherlands Seroquel XR Norway Seroquel Depot Poland Seroquel XR Portugal Seroquel SR Romania Seroquel XR Slovakia Seroquel XR Slovenia Seroquel SR Spain Seroquel Prolong Sweden Seroquel Depot United Kingdom Seroquel XL This leaflet was last updated in February 2009.
CNS 08 0186a