Quetiapin Neuropharma

Leaflet attached to the packaging: patient information

Quetiapin NeuroPharma, 25 mg, coated tablets

Quetiapin NeuroPharma, 100 mg, coated tablets

Quetiapin NeuroPharma, 200 mg, coated tablets

Quetiapin NeuroPharma, 300 mg, coated tablets

Quetiapine

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Quetiapin NeuroPharma and what is it used for

Quetiapin NeuroPharma contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapin NeuroPharma is used to treat several diseases, such as:

• depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, loses appetite, feels guilty, or cannot sleep;
• mania, when the patient is very excited, agitated, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or annoying;
• schizophrenia, when the patient hears and sees unreal voices and images, takes non-existent things for real, is overly suspicious, fearful, confused, feels guilty, is tense, or depressed. The doctor may recommend continued use of Quetiapin NeuroPharma even when the patient's condition has improved.

2. Important information before taking Quetiapin NeuroPharma

When not to take Quetiapin NeuroPharma:

if the patient has been diagnosed with an allergy to quetiapine or any other ingredient of this medicine (listed in section 6); if the patient is taking certain HIV medications, azole antifungals, erythromycin or clarithromycin, or nefazodone (used to treat depression). In case of doubts, consult a doctor or pharmacist before taking Quetiapin NeuroPharma.

Warnings and precautions

Before starting to take Quetiapin NeuroPharma, you should inform your doctor or pharmacist if:

• The patient or someone in their family has or has had any heart problems, such as arrhythmias, heart failure, or myocarditis, or is taking any medications that may affect heart function.
• The patient has low blood pressure.
• The patient has had a stroke, especially if they are elderly.
• The patient has liver problems.
• The patient has had a seizure (epileptic fit).
• The patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may check the patient's blood sugar levels during treatment with Quetiapin NeuroPharma.
• The patient has had a decreased white blood cell count in the past (which may have been caused by other medications).
• The patient is an elderly person with dementia (cognitive impairment). In such cases, Quetiapin NeuroPharma should not be taken, as medicines in the same class as Quetiapin NeuroPharma may increase the risk of stroke and sometimes the risk of death in elderly people with dementia.
• The patient or their family members have had blood clots; the use of such medicines is associated with the formation of blood clots.
• The patient has or has had short-term breathing pauses during normal nighttime sleep (sleep apnea) and is taking medications that slow down brain activity (depressants).
• The patient has or has had difficulty emptying the bladder (urinary retention), has an enlarged prostate, intestinal blockage, or increased eye pressure. These symptoms are sometimes caused by medications (anticholinergics) that affect the functioning of nerve cells, used to treat certain conditions.
• The patient has a history of alcohol or drug abuse.

You should immediately inform your doctor if, after taking Quetiapin NeuroPharma, the patient experiences:

• combined: fever, muscle stiffness, excessive sweating, impaired consciousness (a condition called malignant neuroleptic syndrome); immediate treatment may be necessary.
• involuntary movements, especially of the face or tongue.
• dizziness or severe drowsiness; may increase the risk of accidental injury (fall) in elderly patients.
• seizure (epileptic fit).
• prolonged and 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.

All these symptoms may occur during treatment with medicines in this therapeutic class. You should immediately inform your doctor if the patient experiences:

• fever, flu-like symptoms, sore throat, or any other infection. These may be a consequence of a very low white blood cell count in the blood, and it may be necessary to discontinue Quetiapin NeuroPharma and/or initiate appropriate treatment.
• constipation combined with persistent abdominal pain or persistent constipation that does not respond to treatment, which can lead to a life-threatening bowel obstruction.

Suicidal thoughts or worsening depression

People with depression may sometimes have thoughts of self-harm or suicide. Such symptoms or behaviors may worsen during the initial phase of treatment, as all antidepressant medicines start to work only after some time, usually after two weeks, or sometimes later. These thoughts may worsen after sudden discontinuation of the medicine. Young adults are more likely to have such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behavior in people under 25 years of age with depression. If the patient has ever had suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. You can ask these people to tell the patient if they notice any worsening of depressive symptoms or other worrying changes in behavior.

Rash with eosinophilia and systemic symptoms (DRESS).

Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or hypersensitivity syndrome). If the patient experiences these symptoms, they should discontinue Quetiapin NeuroPharma and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking Quetiapin NeuroPharma have been observed to gain weight. The patient and doctor should regularly check the patient's weight.

Children and adolescents

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

Quetiapin NeuroPharma and other medicines

Tell your doctor about all other medicines you are taking now or have taken recently and about any medicines you may take. Do not take Quetiapin NeuroPharma if you are taking any of the following medicines:

• certain HIV medications.
• azole antifungals.
• erythromycin or clarithromycin.
• nefazodone (used to treat depression).

Tell your doctor if you are taking:

• antiepileptic medications (such as phenytoin or carbamazepine).
• antihypertensive medications.
• barbiturates (medications used for sleep disorders).
• thioridazine or lithium (other antipsychotic medications).
• medications that affect heart rhythm, such as medications that can disrupt electrolyte balance (reduced potassium and magnesium levels), such as diuretics (which increase urine production) or certain antibiotics.
• medications that can cause constipation.
• anticholinergic medications that affect the functioning of nerve cells, used to treat certain conditions.

Before stopping treatment with any medication, consult your doctor.

Using Quetiapin NeuroPharma with food, drinks, and alcohol

• Quetiapin NeuroPharma can be taken with or without food.
• During treatment with Quetiapin NeuroPharma, you should be cautious when drinking alcohol, as the medicine and alcohol can cause drowsiness.
• During treatment with Quetiapin NeuroPharma, you should not consume grapefruit juice. It may change 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 before taking this medicine. You should not take Quetiapin NeuroPharma during pregnancy without discussing it with your doctor first. You should not take Quetiapin NeuroPharma during breastfeeding. In newborns whose mothers took Quetiapin NeuroPharma during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may indicate withdrawal syndrome: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the patient's child experiences any of these symptoms, they may need to contact their doctor.

Driving and using machines

Quetiapin NeuroPharma may cause drowsiness. You should not drive or operate machines until you know how the medicine affects you.

Quetiapin NeuroPharma contains lactose

Quetiapin NeuroPharma contains lactose, a sugar. If your doctor has told you that you do not tolerate some sugars, you should consult your doctor before taking this medicine. One of the ingredients of Quetiapin NeuroPharma 25 mg, namely orange yellow, may cause allergic reactions.

Effect on urine tests for drug detection

In patients taking Quetiapin NeuroPharma, urine tests for drug detection performed by some methods may indicate the presence of methadone or tricyclic antidepressants (TCAs), even if the patient is not taking them. It is recommended to perform tests using other methods to confirm the results.

3. How to take Quetiapin NeuroPharma

This medicine should always be taken as directed by your doctor. If you have any doubts, consult your doctor or pharmacist again. The initial dose will be determined by your doctor. The maintenance dose (daily dose) will depend on the disease and the individual patient's needs, but it usually ranges from 150 mg to 800 mg.

• The medicine should be taken once a day, before bedtime, or twice a day, depending on the disease the patient is suffering from.
• Tablets should be swallowed whole, with water.
• Tablets can be taken with or without food.
• During treatment with Quetiapin NeuroPharma, you should not consume grapefruit juice. It may affect the way the medicine works.
• You should not stop taking the tablets even if your condition improves, unless your doctor decides otherwise.

Liver function disorders

Your doctor may recommend changing the dosing regimen in patients with liver failure.

Elderly patients

Your doctor may recommend changing the dosing regimen in elderly patients.

Use in children and adolescents

Quetiapin NeuroPharma should not be used in patients under 18 years of age.

Taking a higher dose of Quetiapin NeuroPharma than recommended

If a higher dose of Quetiapin NeuroPharma is taken than prescribed by the doctor, the patient may experience drowsiness, dizziness, or irregular heartbeat. You should immediately consult a doctor or go to the nearest hospital. You should take the Quetiapin NeuroPharma tablets with you.

Missing a dose of Quetiapin NeuroPharma

If a dose of Quetiapin NeuroPharma is missed, it should be taken as soon as possible. If the time until the next dose is short, you should wait and take the next dose at the usual time. You should not take a double dose of the medicine to make up for the missed dose.

Stopping treatment with Quetiapin NeuroPharma

After sudden discontinuation of Quetiapin NeuroPharma, the patient may experience difficulty sleeping (insomnia) or may feel: nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Quetiapin NeuroPharma can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

• dizziness (may lead to falls), headache, dry mouth,
• drowsiness (may resolve during continued treatment with Quetiapin NeuroPharma); may lead to falls,
• withdrawal symptoms (symptoms that occur after stopping Quetiapin NeuroPharma) including: difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually discontinue the medicine over a period of at least 1-2 weeks.
• weight gain.
• abnormal muscle movements, including: difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• changes in blood levels of certain fatty substances (triglycerides and total cholesterol).

Common side effects (may affect up to 1 in 10 people):

• rapid heartbeat.
• feeling that the heart is pounding, rapid heartbeat, or pauses in heart function.
• constipation, upset stomach (indigestion),
• weakness.
• swelling of hands or feet.
• low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls),
• increased blood sugar levels.
• blurred vision.
• unusual dreams and nightmares.
• increased appetite.
• feeling irritable.
• speech and language disorders.
• suicidal thoughts and worsening depression.
• shortness of breath.
• vomiting (mainly in elderly people),
• fever.
• changes in thyroid hormone levels in the blood.
• decreased white blood cell count.
• increased liver enzyme levels in the blood.
• increased prolactin hormone levels in the blood, which may lead to:
• breast enlargement in both men and women, and unexpected milk production.
• absence or irregular menstrual periods in women.

Uncommon side effects (may affect up to 1 in 100 people):

• seizures.
• skin allergic reactions, such as blisters (bubbles), skin swelling, and swelling around the mouth.
• unpleasant sensations in the lower limbs (also known as restless legs syndrome),
• difficulty swallowing.
• involuntary movements, especially of the face or tongue.
• sexual disorders.
• diabetes.
• changes in the electrical activity of the heart visible on an ECG (QT interval prolongation).
• slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• difficulty urinating.
• fainting (which may lead to falls).
• stuffy nose.
• decreased red blood cell count.
• decreased sodium levels in the blood.
• worsening of existing diabetes.

Rare side effects (may affect up to 1 in 1,000 people):

• combined: high body temperature (fever), sweating, muscle stiffness, drowsiness, or fainting (a condition called malignant neuroleptic syndrome).
• yellowing of the skin and eyes (jaundice),
• liver inflammation.
• prolonged and painful erection (priapism),
• breast enlargement and unexpected milk production.
• menstrual disorders.
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg); a blood clot can break loose and travel with the blood to the lungs, causing chest pain and difficulty breathing; if you notice any of these symptoms, you should immediately see a doctor or go to the hospital.
• walking, talking, eating, or performing other activities while asleep (sleepwalking).
• decreased body temperature (hypothermia),
• pancreatitis.
• a condition (known as metabolic syndrome) in which three or more of the following features occur: increased abdominal fat, reduced "good" cholesterol (HDL-C), increased triglyceride levels, high blood pressure, and increased blood sugar levels.
• combined: fever, flu-like symptoms, sore throat, or any other infection, with a very low white blood cell count in the blood (a condition known as agranulocytosis).
• intestinal obstruction.
• increased creatine kinase levels in the blood (a substance derived from muscles),

Very rare side effects (may affect up to 1 in 10,000 people):

• severe rash, blisters, or red spots on the skin.
• severe allergic reactions (anaphylactic reaction) with difficulty breathing or shock.
• rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema),
• severe skin disorder with blistering of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome),
• inappropriate secretion of the hormone that regulates urine production.
• muscle breakdown and muscle pain (rhabdomyolysis),

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

• skin rash with irregular red spots (erythema multiforme).
• severe, sudden allergic reaction with symptoms such as fever, blistering of the skin, and peeling of the skin (toxic epidermal necrolysis).
• in newborns whose mothers took Quetiapin NeuroPharma during pregnancy, withdrawal symptoms may occur.

Medicines in the same class as Quetiapin NeuroPharma may cause heart rhythm disorders, which can be life-threatening and, in severe cases, lead to death. Some side effects can only be detected by blood tests in a laboratory. These include changes in levels of certain fatty substances (triglycerides and total cholesterol) or sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased white blood cell count, decreased red blood cell count, increased creatine kinase levels in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased prolactin hormone levels in the blood. Increased prolactin hormone levels may lead to:

• breast enlargement in both men and women, and unexpected milk production.
• absence or irregular menstrual periods in women.

Your doctor may recommend regular blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults can also occur in children and adolescents. The following side effect has been observed more frequently or exclusively in children and adolescents:

Very common side effects (may affect more than 1 in 10 people):

• increased prolactin hormone levels in the blood. This may rarely lead to:
• breast enlargement and unexpected milk production in boys and girls.
• in girls, absence or irregular menstrual periods.
• increased appetite.
• vomiting.
• abnormal muscle movements, including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• increased blood pressure.

Common side effects (may affect up to 1 in 10 people):

• feeling weak, fainting (which may lead to falls).
• stuffy nose.
• feeling irritable.
• heart muscle disorders (cardiomyopathy).
• heart muscle inflammation.
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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 Quetiapin NeuroPharma

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiration date stated on the carton after EXP. The expiration date refers to the last day of the month.
• The medicinal product does not require special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Quetiapin NeuroPharma contains

The active substance of the medicine is quetiapine. Each Quetiapin NeuroPharma 25 mg tablet contains 25 mg of quetiapine (in the form of quetiapine hemifumarate). Each Quetiapin NeuroPharma 100 mg tablet contains 100 mg of quetiapine (in the form of quetiapine hemifumarate). Each Quetiapin NeuroPharma 200 mg tablet contains 200 mg of quetiapine (in the form of quetiapine hemifumarate). Each Quetiapin NeuroPharma 300 mg tablet contains 300 mg of quetiapine (in the form of quetiapine hemifumarate). The other ingredients are: tablet core: hypromellose, calcium hydrogen phosphate dihydrate, lactose monohydrate, cornstarch, sodium carboxymethylcellulose (Type A), magnesium stearate, microcrystalline cellulose PH 102, talc, silicon dioxide. tablet coating: Quetiapin NeuroPharma 25 mg: iron oxide red (E 172), iron oxide yellow (E 172), hypromellose 5 cP, titanium dioxide (E 171), macrogol 400, orange yellow lake (E 110). Quetiapin NeuroPharma 100 mg: iron oxide yellow (E 172), hypromellose 5 cP, titanium dioxide (E 171), macrogol 400. Quetiapin NeuroPharma 200 mg and 300 mg: hydroxypropylcellulose, hypromellose 5 cP, talc, titanium dioxide (E 171).

What Quetiapin NeuroPharma looks like and contents of the pack

Quetiapin NeuroPharma 25 mg: peach-colored, round, biconvex film-coated tablets with a diameter of about 5.7 mm. Quetiapin NeuroPharma 100 mg: yellow, round, biconvex film-coated tablets with a diameter of about 9.1 mm, with a dividing line on one side. Quetiapin NeuroPharma 200 mg: white, round, biconvex film-coated tablets with a diameter of about 12.1 mm, with a dividing line on one side. Quetiapin NeuroPharma 300 mg: white, oval, biconvex film-coated tablets with a dividing line on one side. Quetiapin NeuroPharma 100 mg, 200 mg, and 300 mg tablets can be divided into two equal doses. Pack sizes: 10, 20, 30, 50, 60, 100, and 500 tablets in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany. Manufacturers: neuraxpharm Arzneimittel GmbH, Elisabeth-Selbert-Str. 23, 40764 Langenfeld, Germany. Genepharm S.A., 18km Marathon Avenue, 15351 Pallini, Greece. only for Quetiapin NeuroPharma 25 mg: Rontis Hellas Medical and Pharmaceutical Products S.A., P.O. BOX 3012 Larisa Industrial Area Larisa, 41004, Greece. For more information, contact the marketing authorization holder's representative in Poland: Neuraxpharm Polska sp. z o.o., ul. Domaniewska 37, 02-672 Warsaw, info-poland@neuraxpharm.com.

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

Germany: Quetiapin-neuraxpharm 25 / 50 / 100 / 150 / 200 / 300 mg Filmtabletten. Netherlands: Quetiapine Neuraxpharm 25 / 50 / 100 / 150 / 200 / 300 mg filmomhulde tabletten. Poland: Quetiapin NeuroPharma.

Date of leaflet approval: 06/2021