Kventiax 100 mg coated tablets

Package leaflet: Information for the patient

Kventiax 25 mg coated tablets
Kventiax 100 mg coated tablets
Kventiax 200 mg coated tablets
Kventiax 300 mg coated tablets
quetiapine
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

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

1. What Kventiax is and what it is used for

Kventiax contains an active substance called quetiapine. It belongs to a group of medicines known as antipsychotics.
Kventiax is used to treat several conditions, such as:

• depressive episodes in bipolar affective disorder: a condition in which the patient feels sadness, profound low mood, lack of energy, loss of appetite, feelings of guilt, or inability to sleep;
• mania: a condition in which the patient is highly excited, stimulated, agitated, enthusiastic, or excessively active, or has impaired judgment, is aggressive or troublesome;
• schizophrenia: a condition in which the patient hears and sees unreal voices and images, believes in non-existent things, is excessively suspicious, anxious, confused, feels guilt, or is tense or depressed.

Even if you start to feel better, your doctor may advise you to continue treatment with Kventiax.

2. Important information before using Kventiax

When NOT TO USE Kventiax

• 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 infections,
• azole antifungals (used in fungal infections),
• erythromycin or clarithromycin (antibiotics used in infections),
• nefazodone (a medicine used to treat depression).

If in doubt, consult a doctor or pharmacist before taking Kventiax.

Warnings and precautions

Before starting treatment with Kventiax, inform your doctor or pharmacist if:

• the patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart muscle, or myocarditis, or if the patient is taking or has taken any medicines that may affect heart function;
• the patient has low blood pressure;
• the patient has had a stroke, especially elderly patients;
• the patient has liver problems;
• the patient has ever had a seizure;
• the patient has diabetes or is at risk of diabetes; in this case, the doctor may monitor blood sugar levels during treatment with Kventiax;
• the patient has previously had a low white blood cell count (regardless of whether it was caused by other medicines or not);
• the patient is elderly and has dementia (loss of brain function). Kventiax should not be used in these patients, as medicines in the class to which Kventiax belongs may increase the risk of stroke and, in some cases, risk of death;
• the patient is elderly and suffers from Parkinson's disease/parkinsonism;
• the patient or a family member has had or has blood clots, as medicines in this class may increase the risk of their formation;
• the patient has had or has a condition in which breathing stops for a short time during sleep at night (a condition called "sleep apnea") and is taking medicines that depress normal brain activity (antidepressants);
• the patient has had or has a condition in which they were unable to empty the bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These conditions are often caused by medicines (so-called anticholinergic medicines) affecting nerve cell function, used in the treatment of certain diseases;
• the patient has previously been addicted to alcohol or drugs;
• the patient has depression or other conditions treated with antidepressants. Taking these medicines together with Kventiax may lead to serotonin syndrome, a potentially life-threatening condition (see "Kventiax and other medicines").

Contact your doctor immediately if any of the following symptoms occur after taking Kventiax:

• high temperature (fever), muscle stiffness, excessive sweating, and/or reduced consciousness occurring together (a condition called neuroleptic malignant syndrome). Immediate medical help may be required;
• uncontrolled movements, mainly affecting facial muscles or the tongue;
• dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients;
• seizures (epileptic fits);
• 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.

Contact your doctor immediately if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any other infection, as this may be due to a very low white blood cell count; treatment with Kventiax may need to be discontinued and/or appropriate treatment initiated;
• constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to severe intestinal obstruction.

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment, as medicines usually start working only after about 2 weeks, or sometimes later. Symptoms may also worsen if the patient suddenly stops taking the medicine. These symptoms are more likely in young adult patients. Clinical trial data show an increased risk of suicidal thoughts and/or suicidal behaviour in people under 25 years of age with depression.

Contact a doctor immediately or go to hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or concerning changes in behaviour.

Severe skin adverse reactions (SCAR)

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

• Stevens-Johnson syndrome (SJS), widespread blistering and peeling of the skin, particularly around the mouth, nose, eyes, and genitals;
• toxic epidermal necrolysis (TEN), a more severe form causing extensive skin peeling;
• drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme activity);
• acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus;
• erythema multiforme (EM), skin rash with red, itchy, irregular patches.

If any of these symptoms occur, stop taking Kventiax immediately and contact a doctor or seek medical help without delay.

Weight gain

Patients taking Kventiax may experience weight gain. The doctor will monitor the patient's weight regularly.

Children and adolescents

Kventiax is not intended for use in children and adolescents under 18 years of age.

Kventiax and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Do not take Kventiax if the patient is taking any of the following medicines:

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

Inform your doctor if the patient is taking any of the following medicines:

• antiepileptic medicines (such as phenytoin or carbamazepine),
• antihypertensive medicines,
• barbiturates (medicines used to treat sleep disorders),
• thioridazine or lithium (other antipsychotic medicines),
• medicines affecting heart rhythm, e.g. medicines that may cause electrolyte imbalances (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• medicines (so-called anticholinergic medicines) affecting nerve cell function, used in the treatment of certain diseases,
• antidepressants. These medicines may interact with Kventiax and symptoms such as involuntary rhythmic muscle contractions, including eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C (serotonin syndrome) may occur. If such symptoms occur, contact your doctor.

Do not stop taking other medicines without consulting your doctor.

Taking Kventiax with food, drink and alcohol

• Kventiax may be taken with or without food.
• Exercise caution when consuming alcoholic beverages. Taking Kventiax with alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Kventiax, as it may affect the medicine's action.

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. Do not take Kventiax during pregnancy unless advised by a doctor. Kventiax should not be used during breastfeeding.

Newborns whose mothers took Kventiax during the third trimester of pregnancy (last three months) may experience the following symptoms, which may indicate withdrawal syndrome: tremor, muscle stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the child, contact a doctor.

Driving and using machines

Kventiax may cause drowsiness. Do not drive or operate machinery until the patient knows how the medicine affects him/her.

Kventiax contains lactose and sodium

Kventiax contains lactose, which is a type of sugar. If the patient has been previously diagnosed with intolerance to certain sugars, he/she should consult a doctor before taking this medicine.

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

Effect on drug screening tests

Taking Kventiax may cause false positive results in certain drug screening tests for methadone or certain tricyclic antidepressants. If this occurs, a more specific testing method should be used.

3. How to take Kventiax

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist. Your doctor will determine the initial dose. The maintenance dose of the medicine (daily dose) depends on the condition being treated and the individual needs of the patient, but usually ranges from 150 mg to 800 mg.

• The tablets should be taken once daily before going to bed or twice daily, depending on the condition being treated.
• Tablets should be swallowed whole with water.
• This medicine may be taken with food or independently of meals.
• You should not drink grapefruit juice during treatment with Kventiax. It may affect the medicine's action.
• Even if you feel better, do not stop taking this medicine unless your doctor advises otherwise.

Liver function disorders
If the patient has liver problems, the doctor may decide to adjust the dose of the medicine.
Elderly patients
If the patient is elderly, the doctor may decide to adjust the dose of the medicine.
Use in children and adolescents
Kventiax must not be used in patients under 18 years of age.
Taking more Kventiax than prescribed
If you take more Kventiax than prescribed by your doctor, you may experience drowsiness, dizziness, or irregular heartbeat. Seek immediate medical advice from your doctor or go to the nearest hospital. Take the medicine packaging with you.
Missed dose of Kventiax
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Kventiax
If Kventiax is stopped abruptly, difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability may occur. Your doctor may recommend gradually reducing the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

Very common: may affect more than 1 in 10 people

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (usually diminishes over time during treatment with Kventiax) (may lead to falls).
• Withdrawal symptoms (symptoms occurring after stopping the medicine), including insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of Kventiax is recommended over at least 1–2 weeks.
• Weight gain.
• Involuntary muscle contractions; these may include difficulty initiating movement, tremor, restlessness, or painless muscle stiffness.
• Changes in blood levels of certain lipids (triglycerides and total cholesterol).

Common: may affect up to 1 in 10 people

• Fast heartbeat.
• Irregular heartbeat – sensation of rapid or irregular heart rhythm.
• Constipation, stomach discomfort (dyspepsia).
• Weakness.
• Swelling of hands or feet.
• Low blood pressure upon standing, which may cause dizziness or fainting (may lead to falls).
• Increased blood glucose levels.
• Blurred vision.
• Unusual dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and articulation disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in blood levels of thyroid hormones.
• Decreased number of certain types of blood cells.
• Increased levels of liver enzymes in blood.
• Increased blood levels of the hormone prolactin; elevated prolactin levels may lead to:
  • breast enlargement in both men and women and unexpected milk production,
  • absence or irregular menstruation in women.

Uncommon: may affect up to 1 in 100 people

• Seizures.
• Allergic reactions, including skin blisters (rash), skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly affecting facial muscles or the tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in heart electrical activity seen on ECG (prolongation of QT interval).
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty in urination.
• Fainting (may lead to falls).
• Nasal congestion.
• Decreased number of red blood cells in blood.
• Decreased sodium levels in blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• Combination of symptoms: high temperature (fever), excessive sweating, muscle stiffness, severe drowsiness or fainting (a condition known as neuroleptic malignant syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• Prolonged and painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• Menstrual cycle disturbances.
• Blood clots in veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, contact your doctor immediately.
• Walking, eating, or performing other activities while asleep.
• Low body temperature (hypothermia).
• Pancreatitis (inflammation of the pancreas).
• A condition (referred to as "metabolic syndrome") involving a combination of 3 or more of the following: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased blood lipid levels (triglycerides), high blood pressure, and increased blood sugar levels.
• Simultaneous occurrence of fever, flu-like symptoms, sore throat or any other infection, and very low white blood cell count (a condition known as agranulocyt游戏副本

5. How to store Kventiax tablets

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after the abbreviation "Lot".
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Kventiax contains

• The active substance is quetiapine. Each coated tablet contains 25 mg, 100 mg, 200 mg or 300 mg of quetiapine (as quetiapine hemifumarate).
• The other ingredients are: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 4000, yellow iron oxide (E 172) (only in 25 mg and 100 mg tablets), and red iron oxide (E 172) (only in 25 mg tablets) in the tablet coating. See section 2 "Kventiax contains lactose and sodium".

What Kventiax looks like and contents of the pack
25 mg: round, light red coated tablets with bevelled edges
100 mg: round, yellow-brown coated tablets
200 mg: round, white coated tablets
300 mg: white coated tablets, capsule-shaped
Pack sizes: 30, 60 or 90 coated tablets in blister packs contained in a cardboard box

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer/Importer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA - FARMA d.o.o., V. Holjevca 20/E, 10450 Jastrebarsko, Croatia

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

For more detailed information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. 22 57 37 500