QUETIAPINE 300 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - QUETIAPINE 300 MG FILM-COATED TABLETS

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PATIENT INFORMATION LEAFLET

Quetiapine 25 mg

Film-coated Tablets Quetiapine 100 mg Film-coated Tablets Quetiapine 150 mg Film-coated Tablets Quetiapine 200 mg Film-coated Tablets Quetiapine 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 your doctor 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
1. What Quetiapine Tablet is and what it is used for
2. What you need to know before you take

Quetiapine Tablets

3. How to take Quetiapine Tablets
4. Possible side effects
5. How to store Quetiapine Tablets
6. Contents of the pack and other information

1. what quetiapine tablet is and what it is used for

Quetiapine Tablets contains a substance called quetiapine. This belongs to a group of medicines called antipsychotics. Quetiapine Tablets 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 tablets even when you are feeling better.

2. what you need to know before you take quetiapine tablets

Do not take Quetiapine Tablets :

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 tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetiapine if:

if you, 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.
if you have low blood pressure
if you have had a stroke, especially if you are elderly
if you have problems with your liver.
if you have ever had a fit (seizure).
if 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 quetiapine tablets.
if 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).
if you are an elderly person with dementia (loss of brain function). If you are, Quetiapine tablets should not be taken because the group of medicines that Quetiapine tablets belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
if you are an elderly person with Parkinson’s disease/parkinsonism
if 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.
if you 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”).
if you 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.
if you have a history of alcohol or drug abuse.

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

A combination of fever, severe muscle stiffiness, 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).

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)

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 tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines

Do not take quetiapine tablets 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.

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

Quetiapine tablets with food, drink and alcohol

Quetiapine tables can be taken with or without food.
Be careful how much alcohol you drink. This is because the combined effect of quetiapine tables and alcohol can make you sleepy.
Do not drink grapefruit juice while you are taking quetiapine tablets. 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 planning to have a baby ask your doctor for advice before taking this medicine. You should not take Quetiapine tablets during pregnancy unless this has been discussed with your doctor. Quetiapine tablets 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 tablets 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 tablets contains lactose Quetiapine tablets 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.

Quetiapine tablets contains sodium

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 tablets 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 tablets

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 150 mg and 800 mg.

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

If you take more Quetiapine Tablets than you should

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

If you forget to take Quetiapine Tablets

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 Tablets

If you suddenly stop taking Quetiapine tablets, 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 Tablets) (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. Gradually 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 and 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.

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 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).
Inappropriate secretion of a hormone that controls urine volume.
Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).

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

Skin rash with irregular red spots (erythema multiforme)
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) which 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). See section 2.
Symptoms of withdrawal may occur in newborn babies of mothers that have used Quetiapine tablets during their pregnancy
Stroke
The class of medicines to which Quetiapine tablets 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. By reporting side effects you can help provide more information on the safety of this medicine.

For UK: Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. how to store quetiapine tablets

Keep this medicine out of reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use Quetiapine tablets after 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. Content of the package and other information

What Quetiapine Tablets look like and contents of the pack

25mg tablets are pink coloured, round, biconvex, film-coated tablet, plain on both sides.

100mg tablets are Yellow coloured, round, biconvex, film-coated tablet plain on both sides 150mg tablets are pale yellow coloured, round, biconvex, film-coated tablet, plain on both sides. 200mg tablets are white to off white, round, biconvex, film-coated tablet, plain on both sides. 300mg tablets are white to off white, capsule shaped, biconvex, film-coated tablet, with ‘300’ debossed on one side and plain on other side.

PVC/Aluminium foil blisters in pack sizes of 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets per carton.

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

Manufacturer:

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

Laboratori FUNDACIO DAU,

C/ De la letra C, 12–14,

Poligono Industrial de la Zona Franca, 08040 Barcelona, Spain

Accord Healthcare Polska Sp.z o.o., ul. Lutomierska 50,95–200 Pabianice, Poland

ACCORD-UK LTD

WHIDDON VALLEY, BARNSTAPLE, DEVON, EX32 8NS, United Kingdom

Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands

The leaflet was last revised in 02/2021.