QUETIAPINE 300 MG FILM-COATED TABLETS

Active substance: QUETIAPINE HEMIFUMARATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
• 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. 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 gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Quetiapine is and what it is used for
2. Before you take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Further information

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. 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.
Your doctor may continue to give you Quetiapine when you are feeling better to prevent your
symptoms from returning.
You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and
ask them to read this leaflet. You might ask them to tell you if they think your symptoms are
getting worse, or if they are worried about any other changes in your behaviour.

2. BEFORE YOU TAKE QUETIAPINE
Do NOT TAKE Quetiapine
• If you are allergic (hypersensitive) to quetiapine or any of the other ingredients of 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).
Do not take Quetiapine if the above applies to you. If you are not sure, talk to your doctor or
pharmacist before taking Quetiapine.
Take special care with Quetiapine
Quetiapine should not be taken by elderly people with dementia (loss of brain function).
This is 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.
Before you take your medicine, tell your doctor if:
• you or someone in your family have any heart problems, for example heart rhythm problems 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, especially if you are elderly;
• you or someone in your family has a history of blood clots, as medicines like these have been
associated with formation of blood clots.
• 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 Quetiapine;
• you know that you have had a low white blood cell count in the past (which may or may not
have been caused by other medicines).
Tell your doctor immediately if you experience:
• A high temperature (fever), severe muscle stiffness, sweating or feeling confused.
• Uncontrollable movements, mainly of your face or tongue.
• A feeling of severe sleepiness or a fall in blood pressure on standing up which causes dizziness
or fainting.
• Unpleasant or distressing restlessness.
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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Do not use Quetiapine if you are already using 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).
• Medicines that can cause an imbalance in electrolytes (such as diuretics) or that have an
impact on the way your heart beats (certain antibiotics)
Before you stop taking any of your medicines, please talk to your doctor first.
Taking Quetiapine with food and drink
• 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 on Quetiapine treatment. 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
Quetiapine. 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 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. Therefore, you should not drive or use machinery until you
know how these tablets affect you.
Important information about some of the ingredients of Quetiapine
Quetiapine contains lactose. If you have been told by your doctor that you have an intolerance to
some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE QUETIAPINE
Always take Quetiapine 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 Quetiapine 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 on Quetiapine treatment. 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:
Quetiapine is not recommended for people aged under 18 years.
Quetiapine tablets come in different strengths. So do not be surprised if the colour or shape of
your tablets changes from time to time.
DO NOT STOP taking your tablets even if you are feeling better, unless your doctor tells you.

If you take more Quetiapine than you should
If you take more than your normal dose, contact your doctor or the nearest hospital as soon as
possible.
If you take more Quetiapine than prescribed by your doctor, you may experience sleepiness,
dizziness abnormal heart beats, low blood pressure, fits, fainting, muscle damage, confusion,
delirium, excitation, inability to empty bladder or difficulty in breathing.
If you forget to take Quetiapine
Do not take a double dose to make up for a forgotten tablet. If you forget to take a dose, take it as
soon as you remember. Do not take your next dose at the same time. Then go on as before.
If you stop taking Quetiapine
If you suddenly stop taking Quetiapine, 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Quetiapine can cause side effects, although not everybody gets them.
Very common (affects more than 1 patient in 10):
• 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), feeing sick (nausea), headache, diarrhoea, being sick
(vomiting), dizziness, and irritability.
• Putting on weight
• decreased amount of haemoglobin or increased amount of certain fats in blood (triglycerides
and total cholesterol)
Common (affects 1 to 10 patients in 100):
• Rapid heartbeat, abnormal heart beat.
• Stuffy nose, difficulty in breathing.
• Constipation, upset stomach (indigestion), vomiting.
• Feeling weak, fainting (may lead to falls).
• 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, increased level of liver enzymes, increases in the amount
of a hormone called prolactin or alterations of thyroid hormones.
• Blurred vision.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
• Abnormal dreams and nightmares
• Increased appetite
• Feeling irritated
• Disturbance in speech and language.
• Suicidal thoughts.
• Fever.
Uncommon (affects 1 to 10 patients in 1,000):
• Decrease in blood sodium levels
• 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.
• Sexual dysfunction
• Uncontrollable movements, mainly of your face or tongue.
• Worsening of pre-existing diabetes.
• Alteration of the heart rhythm (prologation of QT interval).
• Underactive thyroid gland which can cause tiredness or weight gain (hypothyroidism).
• Platelet count decreased (thrombocytopenia). Decreased number of red blood cells (anaemia).
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).
• 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.
• A long-lasting and painful erection (priapism).
• Swelling of breasts and unexpected production of breast milk (galactorrhoea), menstrual
disorder.
• Talking or eating while sleeping.
• Inflammation of the pancreas.
• Metabolic syndrome.
• Inflammation of the liver (hepatitis).
• Low body temperature.
• Severe reduction in number of white blood cells which makes infections more likely
(agranulcytosis).
• Elevations in blood creatine phosphokinase (a substance in the muscle).
Very rare (affects less than 1 patient in 10,000):
• Excessive water intake (known as SIADH);
• Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson
syndrome).
• 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).
• Muscle disease presenting as unexplained aches, pains and tenderness.
Not known (the frequency can not be estimated from the available data):
• Serious sudden allergic reaction with symptoms such as fever and blisters on the skin and
peeling of the skin (toxic epidermal necrolysis), skin rash with irregular red spots (erythema
multiforme).
• Severe reduction in number of white blood cells (neutropenia).
The class of medicines to which Quetiapine belongs can cause heart rhythm problems, which can
be serious and in severe cases may be fatal.
Your doctor may ask you to have blood tests from time to time.
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 only in children and adolescents:
Very common (affects more than 1 patient in 10):
• Increase in blood pressure
The following side effects have been seen more often in children and adolescents:
Very common (affects more than 1 patient in 10):
• Increase in the amount of a hormone called prolactin, in the blood. This can lead to:
• Swelling of breasts and unexpectedly production of breast milk in boys and girls
• Irregular or no monthly period in girls
• Increased appetite
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking,
feeling restless or muscle stiffness without pain.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. HOW TO STORE QUETIAPINE
Keep out of the reach and sight of children.
Do not use Quetiapine after the expiry date which is stated on the carton, container and blister
after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
HDPE tablet container:
Shelf life after the first opening is 3 months.
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 Quetiapine contains
• The active substance is quetiapine. Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or
300 mg quetiapine (as quetiapine hemifumarate).
• The other ingredients are lactose monohydrate, dihydrate calcium hydrogen phosphate,
microcrystalline cellulose, povidone, sodium starch glycolate (type A), magnesium stearate in
the tablet core and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide
(E172) (only in the 25 mg and 100 mg tablets) and red iron oxide (E172) (only in the 25 mg
tablets) in the film-coating.
What Quetiapine looks like and contents of the pack
The 25 mg tablets are round, pale red film-coated tablets with bevelled edge.
The 100 mg tablets are round, yellow-brown film-coated tablets.
The 150 mg tablets are round, white film-coated tablets with bevelled edge.
The 200 mg tablets are round, white film-coated tablets.
The 300 mg tablets are capsule-shaped, white film-coated tablets.
Quetiapine film-coated tablets are available in boxes of 6 (only the 25 mg tablets), 10, 20, 30,
30 x 1, 50, 60, 90, 98, 100, 100 x 1, 120 (only the 150 mg and 300 mg tablets), 180 (only the
150 mg and 300 mg tablets) or 240 (only the 150 mg and 300 mg tablets) tablets in blister packs
and 250 tablets (only the 100 mg and 200 mg tablets) in a container (HDPE).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by
Consilient Health (UK) Ltd., 500 Chiswick High Road, London. W4 5RG
This leaflet was last revised 03/2012

P0144

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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