Quetiapine 400 mg film-coated tablets – patient leaflet, side effects, dosage

1 What Quetiapine is and what it is used for

Quetiapine contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Quetiapine 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: where you feel sad. You

  may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.

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

2 What you need to know before you take Quetiapine

Do not take Quetiapine:

• if you are allergic to quetiapine or any of the

  other ingredients of this medicine (listed in section 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 Quetiapine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetiapine if you:

• If you have depression or other conditions that

  are treated with antidepressants. The use of these medicines together with Quetiapine can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapine”).

• or someone in your family have or have had

  any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are taking any medicines that may have an impact on the way your heart beats

• have low blood pressure
• have had a stroke, especially if you are elderly
• have problems with your liver
• have ever had a fit (seizure)

• have diabetes or have a risk of getting diabetes.

  If you do, your doctor may check your blood sugar levels while you are taking Quetiapine

• 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)

• are an elderly person with dementia (loss of

  brain function). If you are, Quetiapine should not be taken because the group of medicines that Quetiapine belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia

  • are an elderly person with Parkinson’s disease/

    parkinsonism

  • or someone else in your family has a history of

    blood clots, as medicines like these have been associated with formation of blood clots

  • have or have had a condition where you stop

    breathing for short periods during your normal nightly sleep (called “sleep apnoea”) and are taking medicines that slow down the normal activity of the brain (“depressants”)

  • have or have had a condition where you

    can’t completely empty your bladder (urinary retention), have an enlarged prostate, a blockage in your intestines, or increased pressure inside your eye. These conditions are sometimes caused by medicines (called “anti-cholinergics”) that affect the way nerve cells function in order to treat certain medical conditions

  • have a history of alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking Quetiapine:

• 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 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)

• Have a fast and irregular heartbeat, even

  when you are at rest, palpitations, breathing problems, chest pain or unexplained tiredness. Your doctor will need to check your heart and if necessary, refer you to a cardiologist immediately.

These conditions can be caused by this type of medicine.

Tell your doctor as soon as possible if you have:

• A fever, flu-like symptoms, sore throat, or any

  other infection, as this could be a result of a very low white blood cell count, which may require Quetiapine to be stopped and/or treatment to be given

• Constipation along with persistent abdominal

  pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.

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.

Severe cutaneous adverse reactions (SCARs)

Severe cutaneous adverse reactions (SCARs) which can be life threatening or fatal have been reported very rarely with treatment of this medicine. These are commonly manifested by:

• Stevens-Johnson syndrome (SJS), a widespread

  rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals

• Toxic Epidermal Necrolysis (TEN), a more severe

  form causing extensive peeling of the skin

• Drug Reaction with Eosinophilia and Systemic

  Symptoms (DRESS) consists of flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)

• Acute Generalised Exanthematous Pustilosis

  (AGEP), small blisters filled with pus

• Erythema Multiforme (EM), skin rash with itchy

  red irregular spots.

Stop taking Quetiapine if you develop these symptoms and contact your doctor or seek medical attention immediately.

Weight gain

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

Children and Adolescents

Quetiapine is not for use in children and adolescents below 18 years of age.

Other medicines and Quetiapine:

Tell your doctor if you are taking, have recently taken or might take any other medicines. Do not take Quetiapine 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 or Lithium (other anti-psychotic

    medicines)

  • Medicines that have an impact on the way

    your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections)

  • Medicines that can cause constipation

  • Medicines (called “anti-cholinergics”) that affect

    the way nerve cells function in order to treat certain medical conditions.

  • anti-depressants. These medicines may interact

    with Quetiapine and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). Contact your doctor when experiencing such symptoms.

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

Quetiapine with food, drink and alcohol

• Quetiapine can be taken with or without food

• Be careful how much alcohol you drink. This

  is because the combined effect of Quetiapine and alcohol can make you sleepy

• Do not drink grapefruit juice while you are

  taking Quetiapine. It can affect the way the medicine works.

Pregnancy and breast-feeding

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

The following symptoms which can represent withdrawal may occur in newborn babies of mothers that have used Quetiapine 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.

Quetiapine contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.

Information on sodium content

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Effect on Urine Drug Screens

If you are having a urine drug screen, taking Quetiapine may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.

3 How to take Quetiapine

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

• 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 Quetiapine. It can affect the way the medicine works
• Do not stop taking your tablets even if you feel better, 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 adolescents

Quetiapine should not be used by children and adolescents aged under 18 years.

If you take more Quetiapine than you should

If you take more Quetiapine than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heartbeats. Contact your doctor or nearest hospital straight away. Keep the Quetiapine with you.

Q uetiapine 50mg, 400mg film-coated tablets

Package leaflet: Information for the patient

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If you forget to take Quetiapine

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 Quetiapine

If you suddenly stop taking Quetiapine, you may be unable to sleep (insomnia), or 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 medicine, ask your doctor or pharmacist.

4 Possible side effects

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, as

  you keep taking Quetiapine) (may lead to falls)

• Discontinuation symptoms (symptoms which

  occur when you stop taking quetiapine) 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

• Abnormal muscle movements. These include

  difficulty 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 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)

• 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 your

  depression

• Shortness of breath

  • Vomiting (mainly in the elderly)
  • Fever

  • Changes in the amount of thyroid hormones in

    your blood

  • Decreases in the number of certain types of

    blood cells

  • Increases in the amount of liver enzymes

    measured in the blood

  • 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 breasts

      and unexpectedly produce breast milk.

    • Women to have no monthly periods

      or irregular periods.

Uncommon (may affect up to 1 in 100 people):

• Fits or seizures

• Allergic reactions that may include raised

  lumps (weals), swelling of the skin and swelling around the mouth

• Fainting (may lead to falls)

• Unpleasant sensations in the legs (also called

  restless legs syndrome)

• Difficulty swallowing

• Uncontrollable movements, mainly of your face

  or tongue

• Sexual dysfunction
• Stuffy nose
• 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

• Difficulty in passing urine
• Decrease in the amount of red blood cells
• Decrease in the amount of sodium in the blood
• Worsening of pre-existing diabetes
• Confusion.

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

• A combination of high temperature (fever),

  sweating, stiff muscles, feeling very drowsy or faint (a disorder called “neuroleptic malignant syndrome”)

• Yellowing of the skin and eyes (jaundice)
• Inflammation of the liver (hepatitis)
• A long-lasting and painful erection (priapism)
• Menstrual disorder

• 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. If you notice any of these symptoms seek medical advice immediately

• Walking, talking, eating or other activities while

  you are asleep

  • Body temperature decreased (hypothermia)

  • Swelling of breasts and unexpected production

    of breast milk (galactorrhoea)

  • Inflammation of the pancreas

  • A condition (called “metabolic syndrome”)

    where you may have a combination of 3 or more of the following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar

  • Combination of fever, flu-like symptoms, sore

    throat, or any other infection with very low white blood cell count, a condition called agranulocytosis

  • Bowel obstruction

  • Increased blood creatine phosphokinase (a

    substance 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 the

  eyes, lips and throat (angioedema)

• A serious blistering condition of the skin,

  mouth, eyes and genitals (Stevens-Johnson syndrome). See section 2

• Inappropriate secretion of a hormone that

  controls urine volume

• Breakdown of muscle fibres and pain in

  muscles (rhabdomyolysis).

Not known (frequency cannot be estimated from the available data):

• Skin rash with irregular red spots (erythema

  multiforme). See section 2

• Rapid appearance of areas of red skin studded

  with small pustules (small blisters filled with white/yellow fluid called as Acute Generalised Exanthematous Pustulosis (AGEP). See section 2

• Serious, sudden allergic reaction with

  symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis). See section 2

• Drug Reaction with Eosinophilia and Systemic

  Symptoms (DRESS), often associated with flu-like symptoms with skin rash, fever, swollen glands, and blood abnormalities (increase in white blood cells (eosinophilia) and liver enzymes). See section 2

• Symptoms of withdrawal may occur in

  newborn babies of mothers that have used Quetiapine during their pregnancy

• Stroke
• Disease of the heart muscle (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)

• Inflammation of blood vessels (vasculitis),

  often with a skin rash with small red or purple bumps.

  The class of medicines to which Quetiapine 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 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, decrease in the amount of 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 the

    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.

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 not been seen in adults:

Very common (may affect 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 the breasts

    and unexpectedly produce breast milk

  • Girls to have no monthly period or irregular

    periods.

• Increased appetite
• Vomiting

• Abnormal muscle movement. These include

  difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card

Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Quetiapine

• Keep this medicine out of sight and reach of children
• This medicinal product does not require any special storage conditions
• Do not take Quetiapine after the expiry date, which is stated on carton box and blister after EXP. The expiry date refers to the last day of that month
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6 Contents of the pack and other information

What Quetiapine contains

The active substance is quetiapine fumarate.

Each film-coated tablet contains 50mg or 400mg of quetiapine (as quetiapine fumarate).

The other ingredients are:

Tablet core: lactose monohydrate, cellulose microcrystalline, povidone, magnesium stearate, sodium starch glycolate, calcium hydrogen phosphate dihydrate.

Film-coating contains:

50mg

Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521)

400mg

Hypromellose (E464), Titanium dioxide (E171), Macrogol (E1521), Iron oxide yellow (E172)

What Quetiapine looks like and contents of the pack

50mg: White to off white, round, biconvex, film-coated tablet debossed ‘50’ on one side, plain on other side. The diameter of the tablet is approximately 6.0 mm. PVC/Aluminium foil blisters in pack sizes of 10, 20, 30, 50, 60 and 100 tablets.

400mg: Yellow coloured, capsule shaped, biconvex, film-coated tablet, with ‘400’ debossed on one side and plain on other sides. The tablets are approximately 19.1 x 8.9 mm in size. PVC/ Aluminium foil blisters in pack sizes of 10, 20, 50, 60 and 100 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Accord Healthcare Limited

Sage House, 319 Pinner Road North Harrow, Middlesex

HA1 4HF

United Kingdom

Manufacturers

Accord Healthcare Limited

Sage House, 319 Pinner Road North Harrow, Middlesex

HA1 4HF

United Kingdom

Accord-UK Ltd,

Whiddon Valley

Barnstaple, EX32 8NS

United Kingdom

This leaflet was last revised in July 2024.

If you would like a leaflet with larger text, please contact

01271 385257

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