Serooquel Xl 300 Mg Prolonged-Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEROQUEL® XL 300 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.
• The name of this medicine is Seroquel XL 300 mg prolonged-release tablets but will be referred to as Seroquel XL throughout the remainder of this leaflet.
• 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.
• Seroquel XL is also available in other strengths.
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
1) 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. Seroquel XL can be used to treat several illnesses, such as:
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• Bipolar depression and major depressive episodes in major depressive disorder: where you may feel sad all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can't sleep.
When Seroquel XL is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.
Your doctor may continue to prescribe Seroquel XL even when you are feeling better.
2) 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
Before you take your medicine, tell your doctor if:
• You, or someone in your family, have or have had any heart problems such as a very fast heart beat or prolonged QT on an ECG (heart tracing), or if you are taking any medicines that may have an impact on the way your heart beats.
• You have low blood pressure.
• 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 are an elderly person with dementia. If you are, Seroquel XL should not be taken 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.
• 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.
Tell your doctor immediately if you experience:
• A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This could increase the risk of accidental injury (fall) in elderly patients.
• Fits (seizures).
• A long-lasting and painful erection (Priapism).
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. These thoughts may also be increased if you suddenly stop taking your medication. 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.
Weight gain has been seen in patients taking Seroquel XL. You and your doctor should check your weight regularly.
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 obtained without a prescription and herbal medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Epilepsy medicines (like phenytoin or carbamazepine).
• High blood pressure medicines.
• Rifampicin (for tuberculosis).
• Barbiturates (for difficulty sleeping).
• Thioridazine (another anti-psychotic medicine).
• Medicines that affect the heart, for example, drugs that can cause an imbalance in some of the chemicals in your blood such as diuretics (water pills) or certain antibiotics.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
If you have a urine drug screen, taking Seroquel XL could cause positive results for methadone or drugs for depression called tricyclic antidepressants (TCAs), even though you may not be taking methadone or TCAs. The result will need to be confirmed by a more specific test.
Taking Seroquel XL with food and drink
• Seroquel XL should be taken without food, at least one hour before a meal or at bedtime.
• 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.
The following symptoms may occur in newborn babies of mothers that have used Seroquel XL 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.
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.
3) 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. When you are on your regular dose you will usually be taking between 150 mg and 800 mg each day. It will depend 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 5 different strengths.
• 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, you may feel sleepy, feel faint or dizzy and have palpitations (a pounding heart beat). Contact 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.
POM
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.
4) 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 combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure or heartbeat (a disorder called “neuroleptic malignant syndrome”).
• Jaundice (yellowing of the skin and eyes).
• Hepatitis (inflammation of the liver).
• 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 (called anaphylaxis) that may include difficulty in breathing, dizziness and collapse.
• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
• A severe rash, which may develop quickly. Symptoms may include redness, blistering or peeling of the skin, with possible blisters in the mouth or nose.
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 XL) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
• Putting on weight.
Common (affects less than 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• 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.
• Thoughts of suicide and worsening of your depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
Uncommon (affects less than 1 in 100 people):
• Restless legs.
• Difficulty swallowing.
• Sexual dysfunction.
• Fainting (may lead to falls).
• Stuffy nose.
• Development of diabetes.
• Change in electrical activity of the heart seen on ECG (QT prolongation).
• A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
Rare (affects less than 1 in 1,000 people):
• Swelling of breasts and unexpected production of breast milk (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other activities while you are asleep.
• Body temperature decreased (hypothermia).
• Inflammation of the pancreas, which causes severe pain in the abdomen and back.
Very rare (affects less than 1 in 10,000 people):
• Worsening of pre-existing diabetes.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).
Not known (can not be estimated from the available data):
• Skin rash with irregular red spots (erythema multiforme).
The class of medicines to which Seroquel XL belongs can cause heart rhythm problems, which can be serious and in severe cases fatal.
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, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood cells (including red blood cells), increased blood creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood, 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.
5) 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 the month.
• If your tablets become discoloured or show any sign of deterioration, return them to your pharmacist.
• 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.
6) FURTHER INFORMATION What Seroquel XL contains
• Each prolonged-release film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate).
• The other ingredients are microcrystalline cellulose, sodium citrate, lactose monohydrate, magnesium stearate, hypromellose, macrogol 400, titanium dioxide (E171), ferric oxide yellow (E172).
What Seroquel XL looks like and contents of the pack
Each prolonged-release tablet is pale yellow coloured, bi-convex, capsule shaped and marked with XR300.
Each pack contains 60 prolonged-release tablets.
Product Licence Holder
Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK
Repackaged by xxxxxxxxxxxxxxxxxxxxxxxxxxxxx
Seroquel XL 300 mg, prolonged-released tablets
PL: 33532/0016
Manufacturer: AstraZeneca AB, S-151 85 Sodertalje, Sweden. AstraZeneca UK Ltd., Silk Road Business Park, sK10 2NA Macclesfield, Cheshire, United Kingdom
Seroquel® XL is a registered trademark of the AstraZeneca group of companies.
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
Leaflet dated: 21st March 2013 Leaflet code xxxxx