Seroquel 100 Mg Film-Coated Tablets (2024)

PACKAGE LEAFLET: INFORMATION FOR THE USER ^P042806

Seroquel 25 mg, 100 mg, 200 mg and 300 mg film-coated tablets

quetiapine

Read all of this leaflet carefully before you

start taking this medicine because it contains

important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask yourdoctor or pharmacist.

• This medicine has been prescribed for you only.Do not pass it on to others. It may harm them,even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor orpharmacist. This includes any possible side effectsnot listed in this leaflet. See section 4.

What is in this leaflet

• What Seroquel is and what it is used for

• What you need to know before you takeSeroquel

• How to take Seroquel

• Possible side effects

• How to store Seroquel

• Contents of the pack and other information

Seroquel contains a substance called quetiapine. This belongs to a group of medicines calledanti-psychotics. Seroquel can be used to treatseveral illnesses, such as:

• Bipolar depression: where you feel sad. Youmay find that you feel depressed, feel guilty,lack energy, lose your appetite or can’t sleep.

• Mania: where you may feel very excited, elated,agitated, enthusiastic or hyperactive or havepoor judgment including being aggressive ordisruptive.

• Schizophrenia: where you may hear or feelthings that are not there, believe things that arenot true or feel unusually suspicious, anxious,confused, guilty, tense or depressed.

Your doctor may continue to prescribe Seroquel even when you are feeling better.

Do not take Seroquel:

• if you are allergic to quetiapine or any of theother ingredients of this medicine (listed insection 6).

• 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).

If you are not sure, talk to your doctor or pharmacist before taking Seroquel.

Warnings and Precautions

Talk to your doctor or pharmacist before taking

Seroquel:

• if you, or someone in your family, have or havehad any heart problems, for example heartrhythm problems, weakening of the heartmuscle or inflammation of the heart or if youare taking any medicines that may have animpact on the way your heart beats.

• if you have low blood pressure.

• if you have had a stroke, especially if you areelderly.

• if you have problems with your liver.

• if you have ever had a fit (seizure).

• if you have diabetes or have a risk of gettingdiabetes. If you do, your doctor may checkyour blood sugar levels while you are takingSeroquel.

• if you know that you have had low levels of whiteblood cells in the past (which may or may nothave been caused by other medicines).

• if you are an elderly person with dementia (lossof brain function). If you are, Seroquel shouldnot be taken because the group of medicinesthat Seroquel belongs to may increase the riskof stroke, or in some cases the risk of death, inelderly people with dementia.

• if you or someone else in your family has a historyof blood clots, as medicines like these have beenassociated with formation of blood clots.

• if you have or have had a condition where youstop breathing for short periods during yournormal nightly sleep (called “sleep apnoea”)and are taking medicines that slow down thenormal activity of the brain (“depressants”).

• if you have or have had a condition whereyou can’t completely empty your bladder(urinary retention), have an enlarged prostate,a blockage in your intestines, or increasedpressure inside your eye. These conditionsare sometimes caused by medicines (called“anti-cholinergics”) that affect the way nervecells function in order to treat certain medicalconditions.

• if you have a history of alcohol or drug abuse.Tell your doctor immediately if you experience anyof the following after taking Seroquel:

• A combination of fever, severe musclestiffness, sweating or a lowered level ofconsciousness (a disorder called “neurolepticmalignant syndrome”). Immediate medicaltreatment may be needed.

• Uncontrollable movements, mainly of your faceor tongue.

• Dizziness or a severe sense of feeling sleepy.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 ofmedicine.

Tell your doctor as soon as possible if you have:

• A fever, flu-like symptoms, sore throat, orany other infection, as this could be a resultof a very low white blood cell count, whichmay require Seroquel to be stopped and/ortreatment to be given.

• Constipation along with persistent abdominalpain, or constipation which has not respondedto treatment, as this may lead to a moreserious blockage of the bowel.

• Thoughts of suicide and worsening of yourdepression

If you are depressed you may sometimes have thoughts of harming or killing yourself. Thesemay 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 yousuddenly stop taking your medication. Youmay be more likely to think like this if you are ayoung adult. Information from clinical trials hasshown an increased risk of suicidal thoughtsand/or suicidal behaviour in young adults agedless than 25 years with depression.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospitalstraight away. You may find it helpful to tell arelative or close friend that you are depressed,and ask them to read this leaflet. You might askthem to tell you if they think your depressionis getting worse, or if they are worried aboutchanges in your behaviour.

Weight gain

Weight gain has been seen in patients taking Seroquel. You and your doctor should check yourweight regularly.

Children and adolescents Seroquel is not for use in children andadolescents below 18 years of age.

Other medicines and Seroquel

Tell your doctor if you are taking, have recently

taken or might take any other 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 orcarbamazepine).

• High blood pressure medicines.

• Barbiturates (for difficulty sleeping).

• Thioridazine or Lithium (other anti-psychoticmedicines).

• Medicines that have an impact on the way yourheart beats, for example, drugs that can cause animbalance in electrolytes (low levels of potassiumor magnesium) such as diuretics (water pills) orcertain antibiotics (drugs to treat infections).

• Medicines that can cause constipation.

• Medicines (called “anti-cholinergics”) that affectthe way nerve cells function in order to treatcertain medical conditions.

Before you stop taking any of your medicines, please talk to your doctor first.

Seroquel with food, drink and alcohol

• Seroquel can be taken with or without food.

• Be careful how much alcohol you drink. This isbecause the combined effect of Seroquel andalcohol can make you sleepy.

• Do not drink grapefruit juice while you aretaking Seroquel. It can affect the way themedicine works.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby ask yourdoctor for advice before taking this medicine. Youshould not take Seroquel during pregnancy unlessthis has been discussed with your doctor. Seroquelshould not be taken if you are breast-feeding.

The following symptoms which can represent withdrawal may occur in newborn babies of mothersthat have used Seroquel in the last trimester (lastthree months of their pregnancy): shaking, musclestiffness and/or weakness, sleepiness, agitation,breathing problems, and difficulty in feeding. If yourbaby develops any of these symptoms you mayneed to contact your doctor.

Driving and using machines Your tablets may make you feel sleepy. Do notdrive or use any tools or machines until you knowhow the tablets affect you.

Seroquel contains lactose Seroquel contains lactose which is a type ofsugar. If you have been told by your doctor thatyou have an intolerance to some sugars, talk toyour doctor before taking this medicine.

Effect on Urine Drug Screens If you are having a urine drug screen, takingSeroquel may cause positive results formethadone or certain drugs for depression calledtricyclic antidepressants (TCAs) when some testmethods are used, even though you may not betaking methadone or TCAs. If this happens, amore specific test can be performed.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacistif you are not sure. Your doctor will decide on yourstarting dose. The maintenance dose (daily dose)will depend on your illness and needs but will usuallybe between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtimeor 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 aretaking Seroquel. It can affect the way themedicine works.

• Do not stop taking your tablets even if you feelbetter, unless your doctor tells you.

Liver problems

If you have liver problems your doctor may change your dose.

Elderly people

If you are elderly your doctor may change your dose. Use in children and adolescentsSeroquel should not be used by children andadolescents aged under 18 years.

If you take more Seroquel than you should If you take more Seroquel than prescribed byyour doctor, you may feel sleepy, feel dizzy andexperience abnormal heart beats. Contact yourdoctor or nearest hospital straight away. Keep theSeroquel tablets with you.

If you forget to take Seroquel If you forget to take a dose, take it as soon asyou remember. If it is almost time to take the nextdose, wait until then. Do not take a double dose tomake up for a forgotten tablet.

If you stop taking Seroquel If you suddenly stop taking Seroquel, you maybe unable to sleep (insomnia), or you may feelsick (nausea), or you may experience headache,diarrhoea, being sick (vomiting), dizziness orirritability. Your doctor may suggest you reducethe dose gradually before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

Very common: may affect more than

1 in 10 people

• Dizziness (may lead to falls), headache,dry mouth.

• Feeling sleepy (this may go away with time, asyou keep taking Seroquel) (may lead to falls).

• Discontinuation symptoms (symptoms whichoccur when you stop taking Seroquel) includenot being able to sleep (insomnia), feelingsick (nausea), headache, diarrhoea, beingsick (vomiting), dizziness and irritability.

Gradual withdrawal over a period of at least

1 to 2 weeks is advisable.

• Putting on weight.

• Abnormal muscle movements. These includedifficulty starting muscle movements, shaking,feeling restless or muscle stiffness without pain.

• Changes in the amount of certain fats(triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Rapid heartbeat.

• Feeling like your heart is pounding, racing orhas skipped beats.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• Swelling of arms or legs.

• Low blood pressure when standing up. This maymake you feel dizzy or faint (may lead to falls).

• Increased levels of sugar in the blood.

• Blurred vision.

• Abnormal dreams and nightmares.

• Feeling more hungry.

• Feeling irritated.

• Disturbance in speech and language.

• Thoughts of suicide and worsening of yourdepression.

• Shortness of breath.

• Vomiting (mainly in the elderly).

• Fever.

• Changes in the amount of thyroid hormones inyour blood.

• Decreases in the number of certain types ofblood cells.

• Increases in the amount of liver enzymesmeasured in the blood.

• Increases in the amount of the hormoneprolactin in the blood. Increases in thehormone prolactin could in rare cases lead tothe following:

- Men and women to have swelling breasts andunexpectedly produce breast milk.

- Women to have no monthly periods orirregular periods.

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Uncommon: may affect up to 1 in 100 people

• Fits or seizures.

• Allergic reactions that may include raisedlumps (weals), swelling of the skin and swellingaround the mouth.

• Unpleasant sensations in the legs (also calledrestless legs syndrome).

• Difficulty swallowing.

• Uncontrollable movements, mainly of your faceand tongue.

• Sexual dysfunction.

• Diabetes.

• Change in electrical activity of the heart seenon ECG (QT prolongation).

• A slower than normal heart rate which mayoccur when starting treatment and which maybe associated with low blood pressure andfainting.

• Difficulty in passing urine.

• Fainting (may lead to falls).

• Stuffy nose.

• Decrease in the amount of red blood cells.

• Decrease in the amount of sodium in the blood.

• Worsening of pre-existing diabetes.

Rare: may affect up to 1 in 1,000 people

• A combination of high temperature (fever),sweating, stiff muscles, feeling very drowsy orfaint (a disorder called “neuroleptic malignantsyndrome”).

• Yellowing of the skin and eyes (jaundice).

• Inflammation of the liver (hepatitis).

• A long-lasting and painful erection (priapism).

• Swelling of breasts and unexpected productionof breast milk (galactorrhoea).

• Menstrual disorder.

• Blood clots in the veins especially in the legs(symptoms include swelling, pain and rednessin the leg), which may travel through bloodvessels to the lungs causing chest pain anddifficulty in breathing. If you notice any of thesesymptoms seek medical advice immediately.

• Walking, talking, eating or other activities whileyou are asleep.

• Body temperature decreased (hypothermia).

• Inflammation of the pancreas.

• A condition (called “metabolic syndrome”)where you have a combination of 3 or more ofthe following: an increase in fat around yourabdomen, a decrease in “good cholesterol”(HDL-C), an increase in a type of fat in yourblood called triglycerides, high blood pressureand an increase in your blood sugar.

• Combination of fever, flu-like symptoms, sorethroat, or any other infection with very lowwhite blood cell count, a condition calledagranulocytosis.

• Bowel obstruction.

• Increased blood creatine phosphokinase (asubstance from the muscles).

Very rare: may affect up to 1 in 10,000 people

• 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 theeyes, lips and throat (angioedema).

• A serious blistering condition of the skin,mouth, eyes and genitals (Stevens-Johnsonsyndrome).

• Inappropriate secretion of a hormone thatcontrols urine volume.

• Breakdown of muscle fibers and pain inmuscles (rhabdomyolysis).

Not known: frequency cannot be estimated from the available data

• Skin rash with irregular red spots (erythemamultiforme).

• Serious, sudden allergic reaction with symptomssuch as fever and blisters on the skin andpeeling of the skin (toxic epidermal necrolysis).

• Symptoms of withdrawal may occur in newbornbabies of mothers that have used Seroquelduring their pregnancy.

The class of medicines to which Seroquel belongs can cause heart rhythm problems, which can beserious and in severe cases may be fatal.

Some side effects are only seen when a blood test is taken. These include changes in the amountof certain fats (triglycerides and total cholesterol)or sugar in the blood, changes in the amount ofthyroid hormones in your blood, increased liverenzymes, decreases in the number of certaintypes of blood cells, decrease in the amountof red blood cells, increased blood creatinephosphokinase (a substance in the muscles),decrease in the amount of sodium in the blood andincreases in the amount of the hormone prolactinin the blood. Increases in the hormone prolactincould in rare cases lead to the following:

• Men and women to have swelling of thebreasts and unexpectedly produce breast milk.

• Women to have no monthly period or irregularperiods.

Your doctor may ask you to have blood tests from time to time.

Additional side effects in children and adolescents

The same side effects that may occur in adults may also occur in children and adolescents.

The following side effects have been seen more often in children and adolescents or have notbeen seen in adults:

Very common: may affect more than 1 in 10 people

• Increase in the amount of a hormone calledprolactin, in the blood. Increases in thehormone prolactin could in rare cases lead tothe following:

- Boys and girls to have swelling of breastsand unexpectedly produce breast milk

- Girls to have no monthly period or irregularperiods.

• Increased appetite.

• Vomiting.

• Abnormal muscle movements. Theseinclude difficulty starting muscle movements,shaking, feeling restless or muscle stiffnesswithout pain.

• Increase in blood pressure.

Common: may affect up to 1 in 10 people

• Feeling weak, fainting (may lead to falls).

• Stuffy nose.

• Feeling irritated.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible sideeffects not listed in this leaflet. You can alsoreport side effects directly via the Yellow CardScheme (Website: www.mhra.gov.uk/yellowcard).By reporting side effects you can help providemore information on the safety of this medicine.

What Seroquel contains

• The active substance is quetiapine. Seroqueltablets contain 25 mg, 100 mg, 200 mg

or 300 mg of quetiapine (as quetiapine fumarate). The other ingredients are:

Tablet core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose,sodium starch glycollate Type A, lactosemonohydrate, magnesium stearate.

Tablet coating: hypromellose, macrogol, titanium dioxide (E171). The 25 mg and 100 mg tablet alsocontain iron oxide yellow (E172) and the 25 mgcontain iron oxide red (E172).

What Seroquel looks like and contents of the pack

Seroquel 25 mg film-coated tablets are peach coloured, round biconvex and engraved withSEROQUEL 25 on one sideSeroquel 100 mg film-coated tablets areyellow, round biconvex and engraved withSEROQUEL 100 on one sideSeroquel 200 mg film-coated tablets arewhite, round biconvex and engraved withSEROQUEL 200 on one sideSeroquel 300 mg film-coated tablets are white,capsule-shaped and engraved with SEROQUELon one side and 300 on the other sidePack sizes of 20, 30, 50, 60 and 100 tablets areregistered for all strengths. In addition, for 25 mgtablets pack size of 6 tablets is registered. For100 mg, 200 mg and 300 mg tablets pack sizes of10, 90 are registered. For 300 mg tablets pack sizesof 120, 180 and 240 tablets are registered. For3-Day Starterpack pack size of 8 tablets is registeredand for 4-Day Starterpack pack size of 10 tablets isregistered. Not all pack sizes may be available.Marketing Authorisation Holder and Manufacturer

• The Marketing Authorisations for Seroquelare held by AstraZeneca UK Limited,

600 Capability Green, Luton, LU1 3LU,

United Kingdom.

• The tablets are made by AstraZeneca UK Limited,Silk Road Business Park, Macclesfield,

Cheshire, SK10 2NA, United Kingdom, or AstraZeneca Pharmaceuticals LP, 587 OldBaltimore Pike, Newark, Delaware 19702, USA.

This medicinal product is authorised in the Member states of the EEA under the followingnames:

To listen to, or request a copy of this leaflet inBraille, large print or audioplease call, free of charge:0800 198 5000 (UK only).Please be ready to give thefollowing information:Product name Reference

Seroquel 25 mg PL film-coated 17901/0038tablets

Seroquel 100 mg PL film-coated 17901/0039tablets

Seroquel 200 mg PL film-coated 17901/0040tablets

Seroquel 300 mg PL film-coated 17901/0088tablets

This leaflet was last revised in May 2016.

CNS 16 0003

Seroquel is a trade mark of the AstraZeneca group of companies.

© AstraZeneca 2016

You can also get information on mental health from the following national organisations:

• MIND (National Association for Mental Health).MindinfoLine: 0845 766 0163.

• RETHINK (Formerly the NationalSchizophrenia Fellowship). Advice Service:020 8974 6814.

• National Schizophrenia Fellowship (Scotland):0131 662 4359.

• SANELINE Helpline: 0845 767 8000.

• Keep this medicine out of the sight and reachof children.

• Do not use this medicine after the expiry datewhich is stated on the container after EXP. Theexpiry date refers to the last day of that month.

• Do not store above 30°C.

• Do not throw away any medicines viawastewater or household waste. Ask yourpharmacist how to throw away medicines youno longer use. These measures will help toprotect the environment.