Kvetaplex

Package Leaflet: Information for the Patient

Kwetaplex, 25 mg, Film-Coated Tablets

Kwetaplex, 100 mg, Film-Coated Tablets

Kwetaplex, 150 mg, Film-Coated Tablets

Kwetaplex, 200 mg, Film-Coated Tablets

Kwetaplex, 300 mg, Film-Coated Tablets

Quetiapine

Read the package leaflet carefully before taking the medicine, as 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Kwetaplex and what is it used for
• 2. Important information before taking Kwetaplex
• 3. How to take Kwetaplex
• 4. Possible side effects
• 5. How to store Kwetaplex
• 6. Contents of the pack and other information

1. What is Kwetaplex and what is it used for

Kwetaplex contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics.
These medicines are used to treat diseases that may cause symptoms such as:
depressive episodes in bipolar disorder, when the patient feels sad, depressed,
lacking energy, loss of appetite, feeling guilty or unable to sleep;
mania: the patient may be very excited, elated, agitated, enthusiastic or overly active, may also have an inappropriate assessment of the situation, including aggressive or destructive behavior;
schizophrenia: the patient may hear or feel things that do not actually exist, have beliefs that contradict reality or be extremely suspicious, frightened, disoriented, guilty, tense or depressed.
The doctor may recommend continued use of Kwetaplex even if the patient feels better.

2. Important information before taking Kwetaplex

When not to take Kwetaplex:

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking any of the following medicines:
• certain medicines used to treat HIV infection;
• azole derivatives (used to treat fungal infections);
• erythromycin or clarithromycin (used to treat infections);
• nefazodone (used to treat depression).

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Do not take Kwetaplex if any of the above situations apply to you. If in doubt, consult your doctor or pharmacist before starting treatment with Kwetaplex.

Warnings and precautions

Before starting treatment with Kwetaplex, discuss with your doctor, pharmacist or nurse

• if the patient or their family members have or have had heart diseases, such as arrhythmias, heart muscle weakness or myocarditis, or if the patient is taking medicines that may affect heart rhythm;
• if the patient has low blood pressure;
• if the patient has had a stroke, especially if they are elderly;
• if the patient has liver problems;
• if the patient has had seizures (convulsions);
• if the patient has diabetes or is at risk of diabetes. If so, the doctor may check blood sugar levels while taking Kwetaplex;
• if the patient has had a low white blood cell count in the past (which may, but does not have to be, caused by other medicines);
• if the patient is an elderly person with dementia (reduced brain function). Such a person should not take Kwetaplex, as medicines in this group may increase the risk of stroke, and sometimes even death, in such patients,
• if the patient is an elderly person with Parkinson's disease/parkinsonism,
• if the patient or their family members have had blood clots, as such medicines may cause blood clots,
• if the patient has or has had a condition where breathing stops for short periods during normal nighttime sleep (so-called sleep apnea) and is taking medicines that slow down normal brain activity (so-called depressants);
• if the patient has or has had a problem with complete emptying of the bladder (urinary retention), has an enlarged prostate, intestinal obstruction or increased eye pressure. These symptoms are sometimes caused by medications (called "anticholinergic agents") used to treat certain diseases that affect nerve cell function;
• if the patient has had problems with alcohol or drug abuse.

You should immediately inform your doctor if you experience symptoms such as:

• a syndrome of symptoms: fever, muscle stiffness, sweating or decreased level of consciousness (a disease called malignant neuroleptic syndrome). Immediate medical attention may be required;
• uncontrolled movements, mainly of the face and tongue;
• dizziness or severe drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients;
• seizures (convulsions);
• prolonged painful erection (priapism);
• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist.

These symptoms may be caused by the use of antipsychotic medicines.
You should inform your doctor as soon as possible if you experience symptoms such as:
fever, flu-like symptoms, sore throat or other infections that may be a sign of a low white blood cell count. This may require discontinuation of Kwetaplex therapy and/or the use of appropriate treatment;
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constipation with persistent abdominal pain or constipation that does not improve with treatment. This may lead to serious bowel obstruction;
suicidal thoughts or worsening depression.
If the patient is depressed, they may experience thoughts of harming themselves or suicide. These thoughts can especially worsen at the beginning of treatment, as the effect of the medicines develops gradually, usually within about 2 weeks, and sometimes longer. These thoughts can also worsen after sudden discontinuation of treatment. These thoughts are more likely to occur in young adults. Clinical trials indicate an increased risk of suicidal thoughts and/or behaviors in young adults, under the age of 25, with depression.
If thoughts of self-harm or suicide occur, you should immediately contact your doctor or go to the hospital. It may be helpful to inform a relative or friend about your depression and ask them to read this leaflet. You can ask these people to tell you if they notice an increase in depressive symptoms or other changes in your behavior.

Severe skin reactions

During treatment with this medicine, very rare severe skin reactions (SCAR, English severe cutaneous adverse reactions) have been reported, which can be life-threatening or fatal. They usually occur as:

• Stevens-Johnson syndrome (English Stevens Johnson syndrome, SJS) widespread rash with blisters and peeling of the skin, especially in the mouth, nose, eyes and genital areas;
• toxic epidermal necrolysis (English toxic epidermal necrolysis, TEN), a more severe form causing widespread peeling of the skin;
• drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with rash, fever, swelling of the glands and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes).

If the patient experiences these symptoms, they should stop taking Kwetaplex and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking Kwetaplex have experienced weight gain. You should regularly check your weight yourself or with your doctor.

Children and adolescents

Kwetaplex is not recommended for children and adolescents under 18 years of age.

Kwetaplex and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Kwetaplex if you are taking any of the following medicines:

• certain medicines used to treat HIV,
• azole derivatives (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

Tell your doctor if you are taking:
antiepileptic medicines (such as phenytoin or carbamazepine),
antihypertensive medicines,
barbiturates (medicines used to treat sleep disorders),
thioridazine or lithium-containing medicines (antipsychotic medicines),
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medicines that affect heart rhythm, such as medicines that disrupt electrolyte balance (decreased potassium or magnesium levels), such as diuretics (diuretics) or certain antibiotics (medicines used to treat infections),
constipating medicines,
medicines (called "anticholinergic agents") that affect the way nerve cells function to treat certain diseases.
Do not stop taking other medicines without consulting your doctor.

Kwetaplex with food, drink, and alcohol

Kwetaplex can be taken with or without food.
While taking Kwetaplex, you should avoid drinking alcoholic beverages. Concurrent use of Kwetaplex and alcohol may cause drowsiness.
Do not take Kwetaplex with grapefruit juice. It may affect the way the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Kwetaplex should not be used during pregnancy, unless your doctor advises otherwise. Quetiapine should not be used during breastfeeding.
In newborns whose mothers took Kwetaplex during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your child, you should contact your doctor.

Driving and using machines

Kwetaplex may cause drowsiness. You should not drive vehicles or operate machines until you know how this medicine affects you.

Effect on urine tests for drug detection

In patients taking Kwetaplex, urine tests for drug detection performed by some methods may show the presence of methadone or other medicines used to treat depression, called tricyclic antidepressants (TCA), even if the patient is not taking these medicines. It is recommended to perform these tests by other methods to confirm the results.

Kwetaplex contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.

Kwetaplex contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

Kwetaplex 25 mg contains orange yellow S (E110)

The medicine may cause allergic reactions.

3. How to take Kwetaplex

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the initial dose.
The maintenance dose (daily dose) depends on the patient's symptoms and needs, but the most commonly used dose of the medicine is between 150 mg and 800 mg.
The medicine should be taken once a day, before bedtime, or twice a day, depending on the patient's disease
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Tablets should be swallowed whole, with a glass of water.
Tablets can be taken with or without food.
Do not take Kwetaplex with grapefruit juice. It may affect the way the medicine works.
Do not stop taking the tablets even if you feel better, unless your doctor decides otherwise.

Patients with liver function disorders

Your doctor may recommend a dose change of Kwetaplex if you have liver function disorders.

Elderly patients

Your doctor may recommend a dose change of Kwetaplex if you are an elderly patient.

Use in children and adolescents

Kwetaplex should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Kwetaplex than recommended

If you take a higher dose of Kwetaplex than recommended, you may experience drowsiness, dizziness, and irregular heartbeat. You should immediately consult your doctor or go to the nearest hospital. You should take Kwetaplex with you.

Missing a dose of Kwetaplex

If you forget to take a dose of Kwetaplex, you should take it as soon as you remember. However, if it is time for your next dose, you should take the medicine at the usual time.
Do not take a double dose to make up for a missed dose of Kwetaplex.

Stopping treatment with Kwetaplex

If you suddenly stop taking Kwetaplex, you may experience symptoms such as: insomnia, nausea, headache, diarrhea, vomiting, dizziness, and irritability. Your doctor may recommend gradually reducing the dose before completely stopping treatment.
If you have any further questions about taking this medicine, consult 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 (which may lead to falls), headache, dry mouth;
• feeling drowsy (which may resolve with continued use of Kwetaplex) (which may lead to falls);
• withdrawal symptoms (symptoms that occur when stopping Kwetaplex) including difficulty sleeping (insomnia), nausea (nausea), headaches, diarrhea, vomiting, dizziness or irritability. It is recommended to gradually stop taking the medicine over 1-2 weeks;
• weight gain;
• abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness or muscle stiffness without pain;
• changes in lipid levels (triglycerides, total cholesterol).

Common:may affect up to 1 in 10 people

• rapid heartbeat;
• feeling of palpitations or irregular heartbeat;
• constipation, upset stomach (indigestion);

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• feeling weak;
• swelling of the arms or legs;
• low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls);
• increased blood sugar levels;
• blurred vision;
• unpleasant dreams and nightmares;
• increased appetite;
• feeling irritable;
• speech disorders;
• suicidal thoughts and worsening depression;
• shortness of breath;
• vomiting (mainly in elderly patients);
• fever;
• changes in thyroid hormone levels in the blood;
• decrease in the number of different types of blood cells, including red blood cells;
• increase in liver enzyme activity;
• increase in prolactin levels in the blood. Elevated prolactin levels may rarely cause:
• in men and women - breast enlargement and unexpected milk production,
• in women - cessation of menstruation or irregular menstrual cycles.

Uncommon:may affect up to 1 in 100 people

• seizures or convulsions;
• allergic reactions, including the appearance of blisters on the skin (hives), skin swelling and swelling in the mouth;
• unpleasant sensations in the legs (also called restless legs syndrome);
• difficulty swallowing;
• involuntary movements, especially of the face or tongue;
• sexual disorders;
• diabetes;
• change in the electrical activity of the heart visible on the ECG (QT interval prolongation);
• slower than usual heartbeat, which occurs more frequently at the beginning of treatment and may be associated with low blood pressure and fainting;
• difficulty urinating;
• fainting (which may lead to falls);
• stuffy nose;
• decrease in red blood cell count;
• decrease in sodium levels in the blood;
• worsening of existing diabetes;
• neutropenia (decreased number of granulocytes).

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

• a syndrome of symptoms: increased temperature (fever), sweating, muscle stiffness, feeling of extreme drowsiness or fainting (a disease called "malignant neuroleptic syndrome");
• yellowing of the skin and eyes (jaundice);
• hepatitis;
• prolonged and painful erection (priapism);
• breast enlargement and unexpected milk production;
• menstrual disorders;
• blood clots, especially in the legs (which may cause symptoms such as swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, you should immediately consult your doctor;

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• walking, talking, eating, or performing other activities while asleep;
• decreased body temperature (hypothermia);
• pancreatitis;
• a condition called metabolic syndrome, which includes a combination of 3 or more symptoms (increased fat around the waist, decreased "good" cholesterol (HDL), increased triglycerides, high blood pressure, increased blood sugar levels);
• fever, flu-like symptoms, sore throat, infections with a very low white blood cell count (so-called agranulocytosis);
• intestinal obstruction;
• increase in creatine phosphokinase activity in the blood.

Very rare:may affect up to 1 in 10,000 people

• severe rash, blisters, or red spots on the skin;
• severe allergic reactions (so-called anaphylactic shock), which can cause difficulty breathing or shock;
• sudden severe swelling of the skin, usually around the eyes, lips, and throat (angioedema);
• severe skin reactions, including widespread rash with blisters and peeling of the skin, especially in the mouth, nose, eyes, and genital areas (Stevens-Johnson syndrome); See section 2.
• inappropriate secretion of the hormone that controls the amount of urine excreted;
• muscle damage and muscle pain (rhabdomyolysis).

Frequency not known:cannot be estimated from the available data

• severe disease causing red spots on the skin (erythema multiforme);
• severe, sudden allergic reaction with symptoms such as fever, blisters on the skin, peeling of the skin (toxic epidermal necrolysis) See section 2.
• drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with rash, fever, swelling of the glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes) See section 2.
• in newborns of mothers who took quetiapine during pregnancy, withdrawal symptoms may occur;
• stroke;
• heart muscle disorders (cardiomyopathy);
• myocarditis;
• vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple spots.

Medicines in the same group as Kwetaplex may cause heart rhythm disorders, which can be severe and, in some cases, fatal.
Some side effects can only be detected by a blood test. These include:
increased levels of certain lipids (triglycerides and total cholesterol) or blood sugar,
changes in thyroid hormone levels in the blood, increased liver enzyme activity,
decrease in the number of different types of blood cells, including red blood cells, increased creatine phosphokinase activity in the blood, decreased sodium levels in the blood, and increased prolactin levels in the blood. Elevated prolactin levels may rarely cause:

• in men and women - breast enlargement and unexpected milk production,
• in women - cessation of menstruation or irregular menstrual cycles.

From time to time, your doctor may order a blood test.

Additional side effects in children and adolescents

Side effects that occur in adults may also occur in children and adolescents.
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The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:
Very common:may affect more than 1 in 10 people

• increased prolactin levels in the blood. This may rarely cause: ‐ in boys and girls, breast enlargement and unexpected milk production, ‐ in girls, cessation of menstruation or irregular menstrual cycles;
• increased appetite;
• vomiting;
• abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain;
• increased blood pressure.

Common:may affect up to 1 in 10 people

• feeling weak, fainting (which may lead to falls);
• stuffy nose (cold);
• irritability.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Kwetaplex

Keep the medicine out of the sight and reach of children.
Store the medicine in its original packaging.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Kwetaplex contains

• The active substance of the medicine is quetiapine. Each 25 mg tablet contains 25 mg of quetiapine (in the form of quetiapine fumarate). Each 100 mg tablet contains 100 mg of quetiapine (in the form of quetiapine fumarate). Each 150 mg tablet contains 150 mg of quetiapine (in the form of quetiapine fumarate). Each 200 mg tablet contains 200 mg of quetiapine (in the form of quetiapine fumarate).

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Each 300 mg tablet contains 300 mg of quetiapine (in the form of quetiapine fumarate).

• The other ingredients are: Tablet core: Hypromellose 2910 Calcium hydrogen phosphate dihydrate Lactose monohydrate Cornstarch Sodium carboxymethylcellulose (type A) Magnesium stearate Microcrystalline cellulose pH 102 Talc Silica, colloidal anhydrous

Tablet coating:
25 mg:
Opadry Pink 02B34304:
Iron oxide red (E172)
Iron oxide yellow (E 172)
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Orange yellow S (E 110)
100 mg:
Opadry Yellow 02B32696:
Iron oxide yellow (E 172)
Hypromellose 2910
Titanium dioxide (E 171)
Macrogol 400
150 mg:
Opadry Yellow 02B32696:
Iron oxide yellow (E 172)
Hypromellose
Titanium dioxide (E 171)
Macrogol 400
Opadry White 20A28735:
Hydroxypropylcellulose
Hypromellose
Titanium dioxide (E 171)
Talc
200 mg and 300 mg:
Opadry White 20A28735:
Hydroxypropylcellulose
Hypromellose
Titanium dioxide (E 171)
Talc

What Kwetaplex looks like and contents of the pack

25 mg: Round, biconvex, pink film-coated tablets, 5.7 mm in diameter.
100 mg: Round, biconvex, yellow film-coated tablets, 9.1 mm in diameter with a dividing line on one side.
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150 mg: Round, biconvex, pale yellow film-coated tablets, 10.45 mm in diameter.
200 mg: Round, biconvex, white film-coated tablets, 12.1 mm in diameter with a dividing line on one side.
300 mg: Oval, biconvex, white film-coated tablets, with a dividing line on one side.
100 mg, 200 mg, and 300 mg tablets can be divided into two equal parts.
A starter pack for 4 days contains 6 quetiapine tablets (in the form of quetiapine fumarate) 25 mg, 3 tablets 100 mg, and 1 tablet 200 mg.
Package sizes: 25 mg - 30, 60, 90, 120 tablets; 100 mg, 150 mg, 200 mg, and 300 mg - 60 tablets; starter pack for 4 days.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Genepharm S.A.
18 Km. Marathon Ave.
153 51 Pallini
Greece
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. BOX 3012 Larisa Industrial Area Larisa, 41004
Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PL: Kwetaplex

Date of last revision of the leaflet: 10.2021

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