PACKAGE LEAFLET: INFORMATION FOR THE USER

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Quetiapine 25 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. See section 4.

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.    Contents of the pack and other information

A SANDOZ

What Quetiapine is and what it is used for

Quetiapine belongs to a group of medicines called

antipsychotics.

Quetiapine is used to treat:

•    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 give you Quetiapine when

you are feeling better.

2

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 used to treat HIV infections -azole medicines (medicines used to treat fungal

infections)

-erythromycin or clarithromycin (medicines used to treat bacterial infections)

-nefazodone (medicine used to treat 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

Before you take your medicine inform your doctor or pharmacist 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.

•    You have low blood pressure.

•    You have had a stroke, especially if you are older.

•    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 low levels of white blood cells in the past (which may or may not have been caused by other medicines).

•    You are an older 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 older people with dementia.

•    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.

Tell your doctor or pharmacist immediately if you

experience

•    A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a dis order 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 older people.

•    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.

magnesium) such as diuretics (water pills) or certain antibiotics (medicines used to treat bacterial infections).

•    Medicines that can cause constipation.

Taking Quetiapine with food and drink

•    Food: see section 3 under „Method of administration”

•    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

•    Pregnancy

Inform your doctor immediately if you are pregnant or think you may be. You should not take Quetiapine during pregnancy unless this has been discussed with your doctor.

The following symptoms which can represent withdrawal may occur in newborn babies, of mothers who 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.

•    Quetiapine should not be taken if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking

any medicine.

Driving and using machines

Your tablets may make you feel sleepy and dizzy. 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 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 Quetiapine.

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 Quetiapine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Medicinal products containing higher strengths of quetiapine are available for doses not practicable with this medicine.

The usual dose is:

Adults

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.

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

Older people

If you are older your doctor may change your dose. Patients with liver problems If you have liver problems your doctor may change your dose.

Method of administration

For oral use.

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.

Weight gain

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

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 take Quetiapine if you are taking any of the following medicines

•    Some medicines used to treat HIV infections.

•    Azole medicines (medicines used to treat fungal infections).

•    Erythromycin or clarithromycin (medicines used to treat bacterial infections).

•    Nefazodone (medicine used to treat depression).

Tell your doctor if you are taking any of the following medicines:

•    Epilepsy medicines (like phenytoin or carbamazepine).

•    High blood pressure medicines.

•    Barbiturates (medicines used to treat 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

•    Swallow your tablets 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.

Duration of treatment:

This will be decided by your doctor. Do not stop taking your tablets even if you feel better, unless your doctor tells you.

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 heart beats. Contact your doctor or nearest hospital straight away. Keep the tablets with you.

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 product, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, Quetiapine can cause side effects,

although not everybody gets them.

Stop taking Quetiapine immediately and contact

your doctor at once or go to the nearest hospital if

any of the following events happen to you:

•    a combination of high temperature (fever), sweating, stiff muscle, feeling very drowsy or faint (a disorder called “neuroleptic malignant syndrome”)

•    a severe allergic reaction, which involves difficulty breathing, low blood pressure, swelling in the mouth or throat, skin rash and itching

•    symptoms of “angioedema” such as swollen face, tongue or pharynx, difficulties to swallow and to breath and hives

•    fits or seizures

•    long-lasting and painful erection

•    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

• serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the

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skin (toxic epidermal necrolysis).

•    combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition called agranulocytosis)

Reported side effects listed according to the frequencies are:

Very common, affects more than 1 user 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 [invented name]) 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, affects 1 to 10 users in 100:

•    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 older people)

•    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 of breasts and unexpectedly produce breast milk

-    women to have no monthly period or irregular periods

Uncommon, affects 1 to 10 users in 1,000:

•    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

•    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

•    fainting (may lead to falls)

•    stuffy nose

•    decrease in the amount of red blood cells

•    decrease in the amount of sodium in the blood

Rare, affects 1 to 10 users in 10,000:

•    yellowing of the skin and eyes (jaundice)

•    inflammation of the liver (hepatitis)

•    swelling of breasts and unexpected production of breast milk (galactorrhoea)

•    menstrual disorder

•    walking, talking, eating or other activities while you are asleep

•    body temperature decreased (hypothermia)

•    inflammation of the pancreas

•    a condition called “metabolic syndrome” where you may have a combination of three 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

•    bowel obstruction

•    increased blood creatine phosphokinase (a substance from the muscles)

Very rare, affects less than 1 user in 10,000:

•    so called “angioedema”, see also first paragraph in this chapter

•    a serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)

•    severe allergic reaction, see also first paragraph in this chapter

•    inappropriate secretion of a hormone that controls urine volume

•    breakdown of muscle fibers and pain in muscles (rhabdomyolysis)

•    worsening of pre-existing diabetes

Not known, frequency cannot be estimated from the available data

•    symptoms of withdrawal may occur in newborn babies of mothers who have used Quetiapine during their pregnancy

•    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)

Also reported are:

•    heart arrest

•    specific heart rhythm disorders

•    sudden unexplained death

These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.

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 breasts and un expectedly 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.

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, affects more than 1 user in 10:

•    increase in the amount of a hormone called prolactin in the blood

This could in rare cases lead to the following:

-    boys and girls to have swelling of breasts and un expectedly produce breast milk

-    girls to have no monthly period or irregular periods

•    increased appetite

•    vomiting

•    abnormal muscle movements. 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 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.

You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

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 and on the blister/bottle label. The expiry date refers to the last day of that month.

Plastic bottles: Do not use after 6 months have elapsed from first opening.

This medicinal product does not require any special storage conditions.

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.

Contents of the pack and other information

What Quetiapine contains

The active substance is quetiapine. Each film-coated

tablet contains 25 mg quetiapine (as quetiapine fumarate).

The other ingredients are:

•    Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K29/32), silica colloidal hydrated, sodium starch glycolate (type A)

•    Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172)

What Quetiapine looks like and contents of the pack

Quetiapine 25 mg film-coated tablets are salmon-pink

coloured and round (6.0 mm diameter).

Quetiapine 25 mg film-coated tablets are available in

•    blister packs with 6, 10, 14, 20, 30, 50, 60, 90, 100 or 120 film-coated tablets

•    perforated unit dose blister packs with 100 x 1 film-coated tablets

•    plastic bottles with screw caps with 50, 60, 100, 250 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley,

Camberley, Surrey, GU16 7SR, UK.

Manufacturer Salutas Pharma GmbH,

Otto-von-Guericke-Allee 1,39179 Barleben or

Salutas Pharma GmbH,

Dieselstrasse 5, 70839 Gerlingen or

Lek Pharmaceuticals d.d.,

Verovskova 57, 1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d.,

Trimlini 2D, 9220 Lendava, Slovenia or

LEK S.A.,

Ul. Podlipie 16 C, 95 010 Strykow, Poland or LEK S.A.,

Ul. Domaniewska 50 C, 02-672 Warszawa, Poland or S.C. Sandoz S.R.L.,

7A Livezeni Street, 540472 Targu Mures, Jud. Mures, Romania.

This leaflet was last revised in 06/2015.

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