Quetiapine Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Quetiapine Zentiva

25 mg, 100 mg, 200 mg, 300 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Quetiapine Zentiva is and what it is used for
2. What you need to know before taking Quetiapine Zentiva
3. How to take Quetiapine Zentiva
4. Possible side effects
5. How to store Quetiapine Zentiva
6. Contents of the pack and other information

1. WHAT QUETIAPINA ZENTIVA IS AND WHAT IT IS USED FOR

Quetiapina Zentiva contains a substance called quetiapine. This substance belongs
to a group of medicines known as antipsychotics. Quetiapina Zentiva can be used to
treat several conditions, such as the following:

• Bipolar depression: you may feel sad or depressed, guilty, without energy, without appetite, or have difficulty sleeping.
• Mania: you may feel highly excited, euphoric, restless, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behaviour.
• Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

Your doctor may continue prescribing Quetiapina Zentiva even if you are feeling better.

2. WHAT YOU NEED TO KNOW BEFORE TAKING QUETIAPINE ZENTIVA

Do not take Quetiapine Zentiva if:

• you are allergic to quetiapine or to any of the other ingredients of this medicine (listed in section 6);
• you are taking any of the following medicines:
• certain medicines for HIV infections,
• azole antifungals (for fungal infections),
• erythromycin or clarithromycin (for infections),
• nefazodone (for depression).

Do not take Quetiapine Zentiva if you fall into any of the above categories. If you have any doubts,
consult your doctor or pharmacist before taking Quetiapine Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Zentiva if:

• you or someone in your family has or has had heart problems, such as irregular heartbeat, weakened heart muscle or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
• your blood pressure is low.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have had seizures (epileptic fits).
• you have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetiapine Zentiva.
• you know you have previously had low levels of white blood cells in your blood (whether or not caused by other medicines).
• you are an elderly person with dementia (loss of some brain functions). In this case, Quetiapine Zentiva should not be taken, as this class of medicines to which Quetiapine Zentiva belongs may increase the risk of stroke or, in some cases, the risk of death in elderly patients with dementia.
• you are an elderly person with Parkinson’s disease/parkinsonism.
• you or someone in your family has a history of conditions related to blood clots, as medicines of this type may increase the risk of blood clot formation.
• you have or have had a condition in which you stop breathing for short periods during normal sleep (called "sleep apnea") and you are taking medicines that slow down normal brain activity ("depressants").
• you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect nerve cell function to treat certain medical conditions.
• you have a history of alcohol or drug abuse.

Contact your doctor immediately if you experience any of the following symptoms after taking
Quetiapine Zentiva:

• Fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
• Uncontrollable movements, mainly of the face or tongue.
• Dizziness or a strong feeling of sleepiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (epileptic fits).
• Persistent and painful erection (priapism).

The following conditions may be caused by the type of medicine you are taking.
Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection, as these could be signs of very low white blood cell count, which may require discontinuation of Quetiapine Zentiva and/or additional treatment.
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes feel like harming yourself or committing suicide. These
feelings may be stronger at the beginning of treatment, as these medicines take time to work, usually about two weeks but sometimes longer.
These thoughts may also worsen if you suddenly stop taking the medicine.
You are more likely to have such feelings if you are a young adult.
Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under 25 years of age.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately.
You may find it helpful to inform a relative or close friend that you suffer from depression and encourage them to read this leaflet. You may ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.
Weight gain
Weight gain has been reported in patients treated with Quetiapine Zentiva. It is important that your body weight is monitored regularly by both you and your doctor.
Children and adolescents
Quetiapine Zentiva must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Do not take Quetiapine Zentiva if you are taking any of the following medicines:

• Certain medicines for HIV.
• Azole antifungals (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

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

• Medicines for epilepsy (such as phenytoin or carbamazepine).
• Medicines for high blood pressure.
• Barbiturates (for sleep disorders).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect heart rhythm, for example medicines that may cause electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called "anticholinergics") that affect nerve cell function to treat certain medical conditions.

Before stopping any medicine, discuss it with your doctor.
Quetiapine Zentiva with food, drinks and alcohol

• Quetiapine Zentiva can be taken regardless of meals.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quetiapine Zentiva and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Quetiapine Zentiva, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You must not take Quetiapine Zentiva during pregnancy without first discussing it with your doctor. Quetiapine Zentiva must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who took Quetiapine Zentiva during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate machinery until you know how this medicine affects you.
Quetiapine Zentiva contains lactose
This medicine contains lactose, a type of sugar. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
Quetiapine Zentiva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".
Effect on urine drug screening tests
If you need to undergo a urine drug screening test, taking Quetiapine Zentiva may lead to false positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. In such cases, more specific tests should be performed.

3. HOW TO TAKE QUETIAPINE ZENTIVA

Take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.
Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

• Take the tablets once daily, in the evening before going to bed, or twice daily, depending on the type of condition.
• Swallow the tablets whole with a glass of water.
• You may take the tablets regardless of meals.
• Do not drink grapefruit juice while taking Quetiapine Zentiva, as it may affect the medicine's action.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you that you can.

Liver problems
If you have liver problems, your doctor may adjust your dose.
Elderly
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents under 18 years of age
Quetiapine Zentiva must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Zentiva than you should
If you take more Quetiapine Zentiva than prescribed, you may feel drowsy, dizzy, or experience an irregular heartbeat. Contact your doctor or the nearest hospital immediately, and take the medicine pack with you.
If you forget to take Quetiapine Zentiva
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Quetiapine Zentiva
If you stop treatment with Quetiapine Zentiva suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions (may affect more than 1 in 10 people):

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which diminishes over time with continued treatment with Quetiapine Zentiva) (which may lead to falls).
• Withdrawal symptoms (symptoms occurring when you stop taking Quetiapine Zentiva), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. A gradual discontinuation of the medication is recommended over a period of at least 1 to 2 weeks.
• Increase in body weight.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle rigidity without pain.
• Changes in levels of certain blood lipids (triglycerides and total cholesterol).

Common adverse reactions (may affect up to 1 in 10 people):

• Fast heartbeat.
• Sensation of rapid or forceful heartbeat or awareness of missed beats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure upon standing (orthostatic hypotension). This may cause dizziness or fainting (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decreased numbers of certain types of blood cells.
• Increased levels of liver enzymes in the blood.
• Increased levels of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
• Breast enlargement and unexpected milk production in both men and women.
• Absence or irregularity of menstrual cycles in women.

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

• Seizures or epileptic fits.
• Allergic reactions including swelling (wheals), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity observed on ECG (prolongation of QT interval).
• Slowing of the normal heart rate may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Nasal congestion.
• Decreased number of red blood cells in the blood.
• Reduced sodium levels in the blood.
• Worsening of pre-existing diabetes.

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

• High body temperature (fever) associated with sweating, muscle rigidity, pronounced drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production from the mammary gland (galactorrhea).
• Menstrual disorders.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.
• Sleepwalking and other related events (such as talking during sleep and sleep-related eating disorders).
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
• Combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count, a condition known as agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• Severe skin rash, blisters, or red patches on the skin.
• Severe allergic reaction (called anaphylaxis) which may cause breathing difficulties or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• Severe condition characterized by blister formation on the skin, in the mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fiber damage and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated from available data):

• Skin rash associated with appearance of irregular red patches (erythema multiforme).
• Severe sudden allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis).
• Drug rash with eosinophilia and systemic symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs (Drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). Stop using Quetiapine Zentiva and contact your doctor or seek immediate medical help if you develop these symptoms.
• Withdrawal symptoms may occur in newborns of mothers who used Quetiapine Zentiva during pregnancy.
• Stroke

The class of medicines to which Quetiapine Zentiva belongs may cause problems with heart rhythm, which can be serious and, in some cases, fatal.

Some adverse reactions can only be detected through blood tests. These include changes in levels of certain blood lipids (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, decreased numbers of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance from muscles), reduced sodium levels in blood, and increased levels of prolactin hormone in blood. Elevated levels of prolactin hormone may, in rare cases, lead to the following consequences:

• Breast enlargement and unexpected milk production from the mammary gland in both men and women.
• Absence or irregularity of menstrual cycles in women.

Therefore, your doctor may periodically prescribe blood tests for you.

Additional adverse reactions in children and adolescents

The same adverse reactions observed in adults may also occur in children and adolescents.

The following adverse reactions have been reported more frequently in children and adolescents, or were not reported in adults:

Very common adverse reactions (may affect more than 1 in 10 people):

• Increased blood levels of a hormone called prolactin. In rare cases, these increases in prolactin levels may cause the following conditions:
• Breast enlargement and unexpected milk production from the mammary gland in boys and girls.
• Absence or irregularity of menstrual cycles in girls.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness, or muscle rigidity without pain.
• Increased blood pressure.

Common adverse reactions (may affect up to 1 in 10 people):

• Weakness, fainting (may lead to falls).
• Nasal congestion.
• Irritability.

Reporting of adverse reactions

If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE QUETIAPINE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the packaging.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Quetiapina Zentiva contains:
Quetiapina Zentiva 25 mg film-coated tablets
The active substance is quetiapine.
One film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K 27-32, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400, red iron oxide (E-172) and yellow iron oxide (E-172).

Quetiapina Zentiva 100 mg film-coated tablets
The active substance is quetiapine.
One film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K 27-32, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400, yellow iron oxide (E-172).

Quetiapina Zentiva 200 mg film-coated tablets
The active substance is quetiapine.
One film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K 27-32, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400.

Quetiapina Zentiva 300 mg film-coated tablets
The active substance is quetiapine.
One film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: anhydrous calcium hydrogen phosphate, monohydrate lactose, microcrystalline cellulose, sodium starch glycolate (Type A), povidone K 27-32, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 400.

Description of the appearance of Quetiapina Zentiva and pack contents
Quetiapina Zentiva 25 mg film-coated tablets: peach-colored, round, biconvex film-coated tablets.
Quetiapina Zentiva 100 mg film-coated tablets: yellow, round, biconvex film-coated tablets with a score line on one side*.
Quetiapina Zentiva 200 mg film-coated tablets: white, round, biconvex film-coated tablets.
Quetiapina Zentiva 300 mg film-coated tablets: white, capsule-shaped film-coated tablets with a score line on one side*.
* The tablets can be divided into two equal doses.

Quetiapina Zentiva 25 mg film-coated tablets
PVC/PE/PVdC/Aluminum blisters:
Unit dose blister packs: 100x1.
HDPE bottles:
60, 100 tablets.

Quetiapina Zentiva 100 mg film-coated tablets
PVC/PE/PVdC/Aluminum blisters:
Blister packs containing: 10, 20, 50, 60, 100 and 240 tablets.
Unit dose blister packs: 100x1.
HDPE bottles:
60, 100 tablets.

Quetiapina Zentiva 200 mg film-coated tablets
PVC/PE/PVdC/Aluminum blisters:
Blister packs containing: 10, 20, 50, 60, 100 tablets.
Unit dose blister packs: 50x1, 100x1.
HDPE bottles:
60, 100 tablets.

Quetiapina Zentiva 300 mg film-coated tablets
PVC/PE/PVdC/Aluminum blisters:
Blister packs containing: 10, 20, 50, 60, 100 tablets.
Unit dose blister packs: 50x1, 100x1.
HDPE bottles:
60, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Viale L. Bodio 37/b
20158 Milan, Italy

Manufacturer
Takeda Pharma Sp. Z.o.o.
ul. Ksiestwa Lowickiego 12
99-420 Lyszkowice (Poland)
HBM Pharma s.r.o.
Sklabinská 30
03680 Martin (Slovak Republic)

This medicinal product is authorized in the European Economic Area Member States under the following names:
Germany: Quetiapin Zentiva 25/100/200/300 mg Filmtabletten
Italy: Quetiapina Zentiva