Quetiapin Neuropharma

Leaflet accompanying 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.
• 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, depressed. The doctor may recommend continued use of Quetiapin NeuroPharma, even when the patient's condition has already improved.

2. Important information before taking Quetiapin NeuroPharma

When not to take Quetiapin NeuroPharma:

if the patient has been found to be allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
if the patient is taking certain medicines for HIV infection,
azoles (used to treat fungal infections),
erythromycin or clarithromycin (used to treat infections),
nefazodone (used to treat depression).
In case of doubt, the patient should consult a doctor or pharmacist before taking Quetiapin NeuroPharma.

Warnings and precautions

Before starting to take Quetiapin NeuroPharma, the patient should inform the 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 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 if they are elderly
• The patient has liver problems
• The patient has ever 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 reduced white blood cell count in the past (which may have been caused by other medicines)
• The patient is an elderly person with dementia (impairment of brain function). In such a case, 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 medicines that slow down brain activity (depressants).
• The patient has or has had a condition in which they could not completely empty their bladder (urinary retention), has an enlarged prostate, blocked intestines, or increased eye pressure. These symptoms are sometimes caused by medicines (anticholinergics) that affect the functioning of nerve cells, used to treat certain conditions.
• The patient has a history of alcohol and drug abuse.

The patient should immediately inform the doctor if, after taking Quetiapin NeuroPharma, they experience:

• in combination: fever, muscle stiffness, excessive sweating, altered 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
• seizures (epileptic fits)
• prolonged and painful erections (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.
The patient should immediately inform the doctor if they experience:

• fever, flu-like symptoms, sore throat, or any other infections. These may be due to a very low white blood cell count in the blood, in which case it may be necessary to discontinue Quetiapin NeuroPharma and/or initiate appropriate treatment;
• constipation combined with persistent abdominal pain or 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.
They can be asked 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

The patient should tell their doctor about all other medicines they are currently taking or have recently taken and about any medicines they may take.
Quetiapin NeuroPharma should not be taken if the patient is taking any of the following medicines:

• certain medicines for HIV infection,
• azoles (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections),
• nefazodone (used to treat depression).

The patient should tell their doctor if they are taking:

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

Before stopping treatment with any medicine, the patient should consult their doctor.

Taking Quetiapin NeuroPharma with food, drinks, and alcohol

• Quetiapin NeuroPharma can be taken with or without food.
• During treatment with Quetiapin NeuroPharma, the patient should be cautious when drinking alcohol, as Quetiapin NeuroPharma and alcohol can cause drowsiness.
• During treatment with Quetiapin NeuroPharma, the patient should not consume grapefruit juice. It may change the way the medicine works.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Quetiapin NeuroPharma should not be taken during pregnancy without prior discussion with the doctor.
Quetiapin NeuroPharma should not be taken 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: tremors, 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. The patient should not drive or operate machines until they know how the medicine affects them.

Quetiapin NeuroPharma contains lactose

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

Effect on urine tests for the presence of drugs

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

3. How to take Quetiapin NeuroPharma

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist again. The initial dose will be determined by the doctor. The maintenance dose (daily dose) will depend on the disease and the individual patient's needs, but is usually between 150 mg and 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.
• The tablets should be swallowed whole, with water.
• The tablets can be taken with or without food.
• During treatment with Quetiapin NeuroPharma, the patient should not consume grapefruit juice. It may affect the way the medicine works.
• The patient should not stop taking the tablets even if their condition improves, unless the doctor decides otherwise.

Liver function disorders

The doctor may recommend a change in the dosing regimen in patients with liver failure.

Elderly patients

The doctor may recommend a change in 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 prescribed

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

Missing a dose of Quetiapin NeuroPharma

If a dose of Quetiapin NeuroPharma is missed, the patient should take it as soon as possible. If the time to the next dose is short, the patient should wait and take the next dose at the usual time. The patient 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. The doctor may recommend gradual reduction of the dose before stopping treatment.
If the patient has any further doubts about the use of this medicine, they should consult their 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 rhythm
• constipation, upset stomach (indigestion),
• weakness,
• swelling of hands or feet,
• low blood pressure when standing up. This can 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 levels of certain types of blood cells
• increased liver enzyme levels in the blood
• increased levels of the hormone prolactin 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 (prolonged QT interval)
• 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 occurrence of 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 erections (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 fragment of the clot can move with the blood flow to the lungs, causing chest pain and difficulty breathing; if the patient notices any of these symptoms, they should immediately consult their 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 there is a combination of three or more of the following features: increased abdominal fat, reduced "good" cholesterol (HDL-C), increased levels of fatty substances in the blood (triglycerides), high blood pressure, and increased blood sugar levels,

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 blood sugar, changes in thyroid hormone levels, increased liver enzyme levels, decreased levels of certain types of blood cells, decreased red blood cell count, increased levels of the enzyme creatine kinase in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased levels of this hormone may lead to:

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

The 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 levels of the hormone prolactin 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 inflammation
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple bumps

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the
Department of Drug Safety Monitoring
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw,
Phone: +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.
Reporting side effects will help to gather more information on the safety of the 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 expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
• The medicinal product does not require special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 (as quetiapine hemifumarate).
Each Quetiapin NeuroPharma 100 mg tablet contains 100 mg of quetiapine (as quetiapine hemifumarate).
Each Quetiapin NeuroPharma 200 mg tablet contains 200 mg of quetiapine (as quetiapine hemifumarate).
Each Quetiapin NeuroPharma 300 mg tablet contains 300 mg of quetiapine (as quetiapine hemifumarate).
The other ingredients are:
Core:
Hypromellose
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Corn starch
Sodium carboxymethylcellulose (Type A)
Magnesium stearate
Microcrystalline cellulose PH 102
Talc
Silica, colloidal, anhydrous
Coating:
Quetiapin NeuroPharma 25 mg tablets:
Iron oxide red (E 172)
Iron oxide yellow (E 172)
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 400
Orange yellow S (E 110)
Quetiapin NeuroPharma 100 mg tablets:
Iron oxide yellow (E 172)
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 400
Quetiapin NeuroPharma 200 mg and 300 mg tablets:
Hydroxypropylcellulose
Hypromellose 5 cP
Talc
Titanium dioxide (E 171)

What Quetiapin NeuroPharma looks like and what the pack contains

25 mg tablets:
Peach-colored, round, biconvex, film-coated tablets with a diameter of about 5.7 mm.
100 mg tablets:
Yellow, round, biconvex, film-coated tablets with a diameter of about 9.1 mm, with a score line on one side.
200 mg tablets:
White, round, biconvex, film-coated tablets with a diameter of about 12.1 mm, with a score line on one side.
300 mg tablets:
White, oval, biconvex, film-coated tablets with a score line on one side.
The 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
To obtain more detailed information, please contact the representative of the marketing authorization holder in Poland:
Neuraxpharm Polska sp. z o.o.
ul. Domaniewska 37
02-672 Warsaw
[email protected]

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 approval of the leaflet: 06/2021