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• SEROQUEL Information for patients

• SEROQUEL Information for patients

This section contains information on the drug SEROQUEL (quetiapine). 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.

• • What Seroquel is and what it is used for
  • Before you take Seroquel
  • How to take Seroquel
  • Possible side effects
  • How to store Seroquel
  • Further information

• • What Seroquel is and what it is used for

    Seroquel contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. 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
    

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  • Before you take Seroquel

    Do not take Seroquel if:

    • you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Seroquel (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 if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seroquel.

    Take special care with Seroquel

    Seroquel should not be taken by elderly people with dementia (loss of brain function). This is because the group of medicines that Seroquel 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.
    • 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 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 with food and drink

    • Seroquel can be taken with or without food.
    • Be careful how much alcohol you drink. This is because the combined effect of Seroquel and alcohol can make you sleepy.
    • Do not drink grapefruit juice while you are taking Seroquel. 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. You should not take Seroquel during pregnancy unless this has been discussed with your doctor. Seroquel 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
    Seroquel 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.

     

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  • How to take Seroquel

    Always take Seroquel 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 tablets to take each day. This will depend on your illness and needs but will usually be between 150 mg and 800 mg.

    Your doctor may start your treatment on a lower dose and increase the dose slowly if:
    - You are elderly, or
    - You have liver problems.

    • You will take your tablets once a day, at bedtime or twice a day, depending on your illness.
    • Swallow your tablets whole with a drink of water.
    • You can take your tablets with or without food.
    • Do not drink grapefruit juice while you are taking Seroquel. 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 is not recommended for people aged under 18 years.

    If you take more Seroquel than you should
    If you take more Seroquel 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 tablets with you.

    If you forget to take a dose of Seroquel
    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
    If you suddenly stop taking Seroquel, 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.

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  • Possible side effects

    Like all medicines, Seroquel 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).
    • Discontinuation symptoms (symptoms which occur when you stop taking Seroquel) include not being able to sleep (insomnia), feeing 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 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.

     

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  • How to store Seroquel

    • Keep out of the reach and sight of children.
    • Do not use Seroquel after the expiry date which is stated on the container after EXP. The expiry date refers to the last day of that month.
    • Do not store above 30°C.
    • 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.
      

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  • Further information

    What Seroquel contains

    • The active substance is quetiapine. Seroquel tablets contain 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).

    The other ingredients are:
    Tablet core: povidone, calcium hydrogen phosphate, microcrystalline cellulose, sodium starch glycollate Type A, lactose monohydrate, magnesium stearate.
    Tablet coating: hypromellose, macrogol, titanium dioxide (E171). The 25 mg, 100 mg and 150 mg tablet also contain iron oxide yellow (E172) and the 25 mg contain iron oxide red (E172).

    
    What Seroquel looks like and contents of the pack

    Seroquel 25 mg film-coated tablets are peach coloured, Seroquel 100 mg film-coated tablets are yellow, Seroquel 150 mg film-coated tablets are pale yellow, Seroquel 200 mg film-coated tablets are white, Seroquel 300 mg film-coated tablets are white.

    Pack sizes of 20, 30, 50, 60 and 100 tablets are registered for all strengths. In addition, for 25 mg tablets pack size of 6 tablets is registered. For 100 mg, 150 mg, 200 mg and 300 mg tablets pack sizes of 10, 90, 120, 180 and 240 tablets are registered. For 3-Day Starterpack pack size of 8 tablets is registered and for 4-Day Starterpack pack size of 10 tablets is registered. 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
    Belgium	Seroquel
    Bulgaria	Seroquel
    Czech Republic	Seroquel
    Cyprus	Seroquel
    Denmark	Seroquel
    Estonia	Seroquel
    Finland	Seroquel
    Germany	Seroquel
    Greece	Seroquel
    Hungary	Seroquel
    Iceland	Seroquel
    Ireland	Seroquel
    Italy	Seroquel
    Latvia	Seroquel
    Lithuania	Seroquel
    Luxembourg	Seroquel
    Malta	Seroquel
    Netherlands	Seroquel, Quetiapine Zeneca
    Norway	Seroquel
    Poland	Seroquel
    Portugal	Seroquel
    Romania	Seroquel
    Slovakia	Seroquel
    Slovenia	Seroquel
    Spain	Seroquel
    Sweden	Seroquel
    United Kingdom	Seroquel

    
    
    This leaflet was last updated in February 2009.

    CNS 08 0200a

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