Kwetaplex xr

Package leaflet: Information for the patient

Kwetaplex XR, 150 mg, prolonged-release tablets
Quetiapinum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Kwetaplex XR is and what it is used for

Kwetaplex XR contains a substance called quetiapine. It belongs to a group of medicines
known as antipsychotics. Kwetaplex XR may be used to treat conditions such as:

• Depressive episodes in bipolar affective disorder and major depressive episodes in major depression, when the patient feels intense sadness or despair, guilt, lack of energy and appetite, or has difficulty falling asleep.
• Mania, when the patient may be highly stimulated, excited, overenthusiastic, excessively active, or have impaired critical judgment, including aggressive behavior or destructive actions.
• Schizophrenia, when the patient hears or perceives non-existent voices and sensations, believes in non-existent things, is excessively suspicious, fearful, anxious, confused, or has feelings of guilt, tension, or depression.

In the treatment of major depressive episodes in major depression, Kwetaplex XR
will be used in combination with another medicine.
Your doctor may recommend continuing treatment with Kwetaplex XR even if your condition improves.

2. Important information before taking Kwetaplex XR

When not to take Kwetaplex XR

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine listed in section 6;

• if the patient is currently taking: certain medicines used to treat HIV infection, azole antifungals (used in fungal infections), erythromycin or clarithromycin (used in infections),

  nefazodone (used to treat depression).

  If in doubt, consult a doctor or pharmacist before using Kwetaplex XR.

Warnings and precautions

Before starting treatment with Kwetaplex XR, discuss with your doctor if:

• the patient has or has had heart problems, such as heart rhythm disorders, weakened heart muscle or myocarditis, or if the patient is taking medicines that may cause changes in heart rhythm;
• the patient has low blood pressure;
• the patient has had a stroke, especially if elderly;
• the patient has liver problems;
• the patient has ever had seizures (epilepsy);
• the patient has diabetes or an increased risk of developing diabetes. In this case, the doctor may recommend glucose monitoring during treatment with Kwetaplex XR;
• the patient has ever had a low white blood cell count (regardless of whether it was caused by other medicines or not);
• the patient is an elderly person with dementia (age-related cognitive decline). Such patients should not use Kwetaplex XR, as medicines in this class may increase the risk of stroke and sometimes death in these patients;
• if the patient is an elderly person with Parkinson's disease/parkinsonism;
• the patient or a family member has a history of blood clots, as use of medicines in this class may increase the risk of thrombosis;
• if the patient has or has had conditions involving brief episodes of stopped breathing during normal sleep (so-called sleep apnoea) and is taking medicines that reduce normal brain activity (so-called depressants);
• if the patient has or has had difficulty completely emptying the bladder (urinary retention), enlarged prostate, intestinal obstruction, or increased intraocular pressure. These symptoms may sometimes be caused by medicines (called "anticholinergic agents") used to treat certain disorders affecting nerve cell function;
• if the patient has or has had problems with alcohol or drug abuse;
• if the patient has depression or other conditions treated with antidepressants. Using these medicines together with Kwetaplex XR may lead to serotonin syndrome, a potentially life-threatening condition (see "Kwetaplex XR with other medicines").

The patient should inform the doctor immediately if any of the following symptoms occur:

• fever, marked muscle stiffness, sweating, or decreased level of consciousness (a condition called neuroleptic malignant syndrome). Immediate medical help may be needed;
• involuntary movements, especially of the facial muscles or tongue;
• dizziness, feeling of excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients;
• seizure (convulsion);
• prolonged and painful erection (priapism);
• rapid or 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 immediately to a cardiologist.

All of these symptoms may occur during treatment with medicines in this therapeutic class.

The patient should inform the doctor as soon as possible if any of the following symptoms occur:

• fever, flu-like symptoms, sore throat, or other infections, which may be due to low white blood cell count. This may require discontinuation of Kwetaplex XR therapy and/or appropriate treatment;
• constipation with persistent abdominal pain or constipation that does not resolve despite treatment. This may lead to serious intestinal obstruction.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks or sometimes longer to take effect. Such thoughts may also worsen after abrupt discontinuation of the medicine. Suicidal thoughts, thoughts of self-harm, or suicide attempts are more likely in young adults. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviour in young adults under 25 years of age with depression.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact a doctor immediately or go to a hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask for help from family or friends and ask them to inform them if they notice worsening depression or concerning changes in behaviour.

Severe skin reactions

Very rarely, severe cutaneous adverse reactions (SCAR) have been reported during treatment with this medicine, which may be life-threatening or fatal. These usually present as:

• Stevens-Johnson syndrome (SJS): widespread rash with blistering and skin peeling, especially around the mouth, nose, eyes, and genitals;
• toxic epidermal necrolysis (TEN): a more severe form causing extensive skin detachment;
• drug reaction with eosinophilia and systemic symptoms (DRESS): flu-like symptoms with rash, fever, lymph node swelling, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).

If the patient experiences any of these symptoms, treatment with Kwetaplex XR should be stopped immediately and the patient should contact their doctor or seek medical help without delay.

Weight gain

Patients taking Kwetaplex XR may experience weight gain. Body weight should be monitored regularly by the patient or with the doctor.

Children and adolescents

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

Kwetaplex XR and other medicines

Tell the doctor about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take Kwetaplex XR if the patient is taking:

• certain medicines used to treat HIV;
• azole antifungals (used in fungal infections);
• erythromycin or clarithromycin (used in infections);
• nefazodone (used to treat depression).

Tell the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine);
• antihypertensive medicines;
• barbiturates (medicines used for sleep disorders);
• thioridazine or lithium (or other antipsychotic medicines);
• medicines that affect heart rhythm, for example, medicines that alter electrolyte balance (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used in infections);
• constipating medicines;
• medicines (called "anticholinergic agents") that affect nerve cell function to treat certain disorders;
• antidepressants. These medicines may interact with Kwetaplex XR and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor.

Do not stop taking other medicines without consulting a doctor.

Kwetaplex XR with food, drink, and alcohol

Food may interfere with the action of the medicine; therefore, Kwetaplex XR should be taken at least one hour before a meal or immediately before bedtime.

Exercise caution when consuming alcoholic beverages. Taking Kwetaplex XR together with alcohol may increase drowsiness.

Do not drink grapefruit juice during treatment with Kwetaplex XR, as it may affect how the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine. Kwetaplex XR should not be used during pregnancy unless advised otherwise by a doctor. Kwetaplex XR should not be used during breastfeeding.

Newborns and mothers who took quetiapine during the third trimester of pregnancy (last three months) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, feeding problems. If any of these symptoms occur in the child, medical advice should be sought.

Driving and operating machinery

Kwetaplex XR may cause drowsiness. Do not drive or operate machinery until the patient knows how this medicine affects them.

Effect on urine drug screening tests

If the patient is taking quetiapine and undergoes urine drug screening, certain testing methods may give a false positive result for methadone or tricyclic antidepressants (TCA), even if these substances have not been taken. In such cases, more specific testing should be performed.

Kwetaplex XR contains sodium

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

3. How to take Kwetaplex XR

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist. The initial dose will be determined by the attending physician. The usual daily maintenance dose of Kwetaplex XR generally ranges from 150 mg to 800 mg, depending on the patient's symptoms and individual needs.
Take the medicine once daily.
Do not divide, chew, or crush the tablets.
Swallow the tablets whole with water.
Take the tablets on an empty stomach (at least one hour before a meal or before bedtime, as directed by your doctor).
Do not consume grapefruit juice during treatment with Kwetaplex XR. It may affect the medicine's action.
Even if the patient feels better, do not discontinue the medicine unless instructed by the doctor.

Patients with hepatic impairment
The physician may recommend an adjusted dose for patients with impaired liver function.

Elderly patients
The physician may recommend an adjusted dose for elderly patients.

Kwetaplex XR is also available in the following strengths: 50 mg, 200 mg, 300 mg, 400 mg.

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

Taking more Kwetaplex XR than recommended
If a higher than recommended dose is taken, the patient may experience drowsiness, dizziness, or irregular heartbeat. Seek immediate medical advice or go to the nearest hospital. Bring the medicine Kwetaplex XR with you.

Missed dose of Kwetaplex XR
If the patient forgets to take a dose, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

Stopping Kwetaplex XR
If treatment with Kwetaplex XR is suddenly discontinued, symptoms such as difficulty falling asleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur. The physician may recommend gradually reducing the dose before stopping treatment.

If you have any further 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 will experience them.
Very common adverse reactions (may affect more than 1 in 10 people):
Dizziness (which may lead to falls), headache, dry mouth.
Somnolence (may diminish during continued use of this medicine) (may lead to falls).
Withdrawal symptoms (symptoms which may occur after discontinuation of this medicine), including
difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness
or irritability. Gradual discontinuation of the medicine over 1–2 weeks is recommended.
Weight gain.
Abnormal muscle movements, including difficulty initiating intended movement, tremors,
restlessness or muscle stiffness without concomitant pain.
Changes in levels of certain lipids (triglycerides, total cholesterol).
Common adverse reactions (may affect up to 1 in 10 people):
Increased heart rate.
Palpitations or irregular heartbeat.
Constipation, indigestion.
Feeling of weakness.
Swelling of hands or feet.
Drop in blood pressure upon standing. These may cause dizziness or fainting (may
lead to falls).
Increased blood glucose levels.
Blurred vision.
Unpleasant dreams and nightmares.
Increased feeling of hunger.
Feeling irritable.
Speech disorders.
Suicidal thoughts and worsening of depression.
Shortness of breath.
Vomiting (mainly in elderly patients).
Fever.
Changes in thyroid hormone levels in blood.
Decreased number of certain types of blood cells.
Increased liver enzyme activity.
Increased blood prolactin levels. Elevated prolactin levels may rarely lead to:
• Breast swelling and unexpected milk production, in both women and men.
• Absence or irregular menstruation in women.
Uncommon adverse reactions (may affect up to 1 in 100 people):
Seizures.
Hypersensitivity reactions, including skin nodules and blisters, skin swelling and swelling around the mouth.
Unpleasant sensations in the lower limbs (so-called restless legs syndrome).
Difficulty swallowing.
Uncontrolled movements, mainly of facial muscles or tongue.
Sexual dysfunction.
Diabetes.
Changes in electrocardiographic activity visible on ECG (prolongation of QT interval).
Reduced heart rate, which may occur at the beginning of treatment and may lead to low
blood pressure and loss of consciousness.
Difficulty in urination.
Fainting (may lead to falls).
Stuffy nose.
Decreased number of red blood cells.
Decreased serum sodium concentration.
Worsening of pre-existing diabetes.
Neutropia (reduced number of granulocytes among white blood cells).
Rare adverse reactions (may affect up to 1 in 1,000 people):
Very high body temperature (fever), excessive sweating, muscle stiffness, somnolence or
fainting (a disorder known as "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Hepatitis.
Prolonged and painful erection (priapism).
Breast swelling and unexpected milk production (galactorrhea).
Menstrual disorders.
Venous thrombosis, particularly in the lower limbs (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 any of these symptoms occur, consult a doctor immediately.
Walking, talking, eating during sleep.
Low body temperature (hypothermia).
Pancreatitis.
"Metabolic syndrome", characterised by a combination of 3 or more of the following:
abdominal obesity, decreased levels of "good cholesterol" (HDL-C), increased triglyceride levels,
increased blood pressure and increased blood glucose.
Fever, flu-like symptoms, sore throat, infections with very low number of white blood cells in
blood (so-called agranulocytosis).
Intestinal obstruction.
Increased blood creatine kinase activity.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Severe rash, blisters, red spots on the skin.
Severe allergic reactions (anaphylactic), which may cause breathing difficulties or
shock.
Rapidly developing swelling of the skin, usually around the eyes, mouth or throat (angioedema).
Blisters appearing on the skin, in the mouth, eyes and genital areas (Stevens-Johnson syndrome). See section 2.
Abnormal secretion of the hormone regulating urine volume.
Rhabdomyolysis (breakdown of striated muscle) and muscle pain.
Unknown frequency: frequency cannot be estimated from the available data
Rash with irregular red patches (erythema multiforme).
Severe, sudden allergic reaction with symptoms such as fever and skin blisters,
skin peeling (toxic epidermal necrolysis). See section 2.
Drug reaction with eosinophilia and systemic symptoms (DRESS) includes flu-like symptoms with
rash, high body temperature, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and liver enzymes). See
section 2.
In newborns of mothers who used quetiapine during pregnancy, withdrawal symptoms may occur.
Stroke.
Heart muscle disorders (cardiomyopathy).
Inflammation of the heart muscle (myocarditis).
Inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple lumps.
The group of medicines to which Kwetaplex XR, extended-release tablets, belongs, may
cause disturbances in heart rhythm, which may be severe and, in severe cases, may
lead to death.
Some adverse reactions are detected during laboratory blood tests. These include
changes in levels of certain lipids (triglycerides and total cholesterol) or blood glucose,
changes in thyroid hormone levels in blood, increased liver enzyme activity,
decreased number of certain types of blood cells, decreased number of red blood cells,
increased blood creatine kinase activity (a substance in muscles), decreased
serum sodium concentration, and increased blood prolactin levels.
Increased prolactin levels may rarely lead to:
• Breast swelling and unexpected milk production, in both women and men.
• Absence or irregular menstruation in women.
Your doctor may recommend periodic monitoring tests.
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 occurred more frequently in children and adolescents than in adult
patients or were observed only in children and adolescents:
Very common adverse reactions (may affect more than 1 in 10 patients):
Increased prolactin levels, which may rarely lead to:
• breast swelling and unexpected milk production, in both girls and boys;
• absence or irregular menstruation in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements, including difficulty initiating intended movement, tremors,
restlessness or muscle stiffness without concomitant pain.
Increased blood pressure.
Common adverse reactions (may affect up to 1 in 10 patients):
Feeling of weakness, fainting (may lead to falls).
Stuffy nose.
Feeling of irritability.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions
not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Kwetaplex XR

Keep the medicine out of the sight and reach of children.
There are no special storage temperature requirements for this medicine.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
The term "Lot" on the packaging and blister means "Batch number".
The term "EXP" on the packaging and blister means "Expiry date".
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Kwetaplex XR contains

• The active substance is quetiapine. Each prolonged-release coated tablet contains 150 mg of quetiapine (as quetiapine fumarate).
• Other ingredients are:

Core: hypromellose 2910, hypromellose 2208, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate
Coating: titanium dioxide (E 171), hypromellose 2910, macrogol, polysorbate 80.

What Kwetaplex XR looks like and contents of the pack:
Kwetaplex XR 150 mg are prolonged-release, biconvex, elongated coated tablets.
Kwetaplex XR 150 mg are white tablets with the imprint "Q 150" on one side.
Packs contain 60 tablets in PVC/Aclar/Aluminium blisters or PVC/PVDC blisters, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Manufacturers:

1. Adamed Pharma S.A., Pieńków, ul. M. Adamkiewicza 6A, 05-152 Czosnów, Poland
2. Teva Pharma S.L.U., C/C, nº4, Poligono Industrial Malpica, 50016 Zaragoza, Spain
3. Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany