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 Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication 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 can cause symptoms such as:
depressive episodes in bipolar disorder, when the patient feels sad, depressed,
lacks energy, loses appetite, feels guilty or cannot sleep;
mania: the patient may be very excited, happy, 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, has beliefs that contradict reality or is extremely suspicious, frightened, disoriented, feels guilty, anxious 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;
• medicines that are derivatives of azoles (used to treat fungal infections);
• erythromycin or clarithromycin (used to treat infections);
• nefazodone (used to treat depression).

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 cause changes in 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 the blood sugar level 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 (limited brain function). Such a person should not take Kwetaplex, as medicines from its 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 takes 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 the functioning of nerve cells;
• if the patient has had problems with alcohol or drug abuse.

Inform your doctor immediately 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, refer the patient to a cardiologist immediately.

These symptoms may be caused by the use of antipsychotic medications.
Inform your doctor as soon as possible if you experience symptoms such as:
fever, flu-like symptoms, sore throat or other infections, which may be a result 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 of 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, contact your doctor or go to the hospital immediately. It may be helpful to inform a relative or acquaintance about your depression and ask them to read this leaflet. The patient may ask these people to inform them if they notice an increase in depressive symptoms or other changes in the patient's behavior.

Severe Skin Reactions

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

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, especially in the areas around the mouth, nose, eyes, and genitals;
• 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 a rash, fever, swelling of the glands, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and liver enzymes).

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

Weight Gain

Patients taking Kwetaplex have experienced weight gain. Body weight should be regularly monitored by the patient or their doctor.

Children and Adolescents

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

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,
• medicines from the azole group (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 medicines containing lithium (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 (urine-inducing) 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.
Avoid drinking alcoholic beverages while taking Kwetaplex. 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 child, consult your doctor or pharmacist before taking this medicine.
Kwetaplex should not be used during pregnancy, unless your doctor recommends it. 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, contact your doctor.

Driving and Operating Machines

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

Effect on Urine Tests for Drugs

In patients taking Kwetaplex, urine tests for drugs 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, 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 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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.
Swallow the tablets whole with a glass of water.
The 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 the age of 18.

Overdose of Kwetaplex

If you take more Kwetaplex than you should, you may experience drowsiness, dizziness, and irregular heartbeat. Contact your doctor or the nearest hospital immediately. Take the medicine with you.

Missing a Dose of Kwetaplex

If you forget to take a dose, take it as soon as you remember. However, if it is time for the next dose, take the medicine at the usual time.
Do not take a double dose to make up for a forgotten 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 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 (which can lead to falls), headache, dry mouth;
• feeling of drowsiness (which may resolve during prolonged use of Kwetaplex) (which can lead to falls);
• withdrawal symptoms (symptoms that occur after stopping Kwetaplex), including difficulty sleeping (insomnia), nausea (nausea), headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop the medicine over a period of 1-2 weeks;
• weight gain;
• abnormal muscle movements, including difficulty starting intended movements, tremors, feeling of fatigue or muscle stiffness without pain;
• changes in the levels of certain fats (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 of weakness;
• swelling of the arms or legs;
• low blood pressure when standing up. This may cause dizziness or fainting (which can lead to falls);
• increased blood sugar levels;
• blurred vision;
• unpleasant dreams and nightmares;
• increased appetite;
• feeling of irritation;
• speech disorders;
• suicidal thoughts and worsening of depression;
• shortness of breath;
• vomiting (mainly in elderly people);
• 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 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 (blisters), 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 can 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 granular white blood cells).

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 blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical attention immediately;

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

• severe skin rash, blisters, or red spots on the skin;
• severe allergic reactions (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 with blisters, peeling, and shedding of the skin, especially on the skin of the body, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• inappropriate secretion of a 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) including flu-like symptoms with a rash, fever, swelling of the glands, and abnormal blood test results (including an increased number of white blood cells (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;
• inflammation of blood vessels (vasculitis), often with a skin rash with small red or purple bumps.

Medicines from the group to which Kwetaplex belongs may cause heart rhythm disorders, which can be severe and, in some cases, fatal.
Some side effects can only be recognized by a blood test. This includes:
increased levels of certain lipids (triglycerides and total cholesterol) or sugar in the blood,
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 phosphocreatine kinase levels in the blood (a substance found in muscles), 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 or irregular menstrual cycles.

Occasionally, 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 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 of weakness, fainting (which can lead to falls);
• stuffy nose (runny nose);
• 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 Monitoring of Adverse Reactions to Medicinal Products 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.
By reporting side effects, you can help provide 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).

• 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

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, film-coated tablets, pink, 5.7 mm in diameter.
100 mg: Round, biconvex, film-coated tablets, yellow, 9.1 mm in diameter, with a score line on one side.
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150 mg: Round, biconvex, film-coated tablets, pale yellow, 10.45 mm in diameter.
200 mg: Round, biconvex, film-coated tablets, white, 12.1 mm in diameter, with a score line on one side.
300 mg: Oval, biconvex, film-coated tablets, white, with a score line on one side.
Tablets of 100 mg, 200 mg, and 300 mg can be divided into two equal doses.
A starter pack for 4 days contains 6 tablets of quetiapine (in the form of quetiapine fumarate) 25 mg, 3 tablets of 100 mg, and 1 tablet of 200 mg.
Pack 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 pack 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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