Quetiapin Neuropharma

Package Leaflet: Information for the Patient

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 this leaflet carefully before taking Quetiapin NeuroPharma, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Quetiapin NeuroPharma contains a substance called 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 you feel sad, depressed, lack energy, lose your appetite, feel guilty or can't sleep;
• mania, when you are very excited, agitated, enthusiastic, or overly active, or have impaired critical judgment, are aggressive or troublesome;
• schizophrenia, when you hear and see unreal voices and images, take non-existent things for real, are overly suspicious, frightened, confused, feel guilty, are tense, depressed. Your doctor may recommend continued use of Quetiapin NeuroPharma even when your condition has improved.

2. Before you take Quetiapin NeuroPharma

When not to take Quetiapin NeuroPharma:

if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
if you are taking certain medicines for HIV, azole antifungals, erythromycin or clarithromycin, or nefazodone. If in doubt, consult your doctor or pharmacist before taking Quetiapin NeuroPharma.

Warnings and precautions

Before starting Quetiapin NeuroPharma, tell your doctor or pharmacist if:

• You or a family member have or have had heart problems, such as irregular heartbeat, weakness, or inflammation of the heart muscle, or if you are taking or have taken any medications that may affect heart function.
• You have low blood pressure.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have had a seizure (epileptic fit).
• You have diabetes or are at risk of developing diabetes. In such cases, your doctor may check your blood sugar levels during treatment with Quetiapin NeuroPharma.
• You have had a decreased white blood cell count in the past (which may have been caused by other medications).
• You are an elderly person with dementia (impairment of brain function). In this 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.
• You or a family member have had blood clots; the use of such medications is associated with the formation of blood clots.
• You have or have had short-term breathing pauses during normal nighttime sleep (sleep apnea) and are taking medications that slow down brain activity (depressants).
• You have or have had difficulty emptying your bladder completely (urinary retention), have an enlarged prostate, blocked intestines, or increased eye pressure. These symptoms are sometimes caused by medications (anticholinergics) that affect the functioning of nerve cells, used to treat certain conditions.
• You have a history of alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking Quetiapin NeuroPharma:

• 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.
• Seizure (epileptic fit).
• Prolonged and painful erection (priapism).
• Rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately.

All these symptoms can occur during treatment with medications in this therapeutic class.
Tell your doctor immediately if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection. These may be due to 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 along 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 medications start working only after some time, usually after two weeks, and sometimes later. These thoughts may worsen after sudden discontinuation of the medication. 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 you have ever had suicidal thoughts or thoughts of self-harm, you should contact your doctor or go to the hospital immediately. It may be helpful to inform your relatives or friends about your depression and ask them to read this leaflet.
You can ask them to tell you if they notice any worsening of your depression or other worrying changes in your 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 you experience these symptoms, you should discontinue Quetiapin NeuroPharma and contact your doctor or seek medical attention immediately.

Weight gain

Patients taking Quetiapin NeuroPharma have experienced weight gain. You and your doctor should regularly check your 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.

Tell your doctor if you are taking:

• antiepileptic drugs (such as phenytoin or carbamazepine),
• antihypertensive drugs,
• barbiturates (drugs used for sleep disorders),
• thioridazine or lithium (other antipsychotic medications),
• 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 can cause constipation.
• anticholinergic medicines that affect the functioning of nerve cells, used to treat certain conditions.

Before stopping any medication, please consult your doctor.

Taking Quetiapin NeuroPharma with food, drinks, and alcohol

• Quetiapin NeuroPharma can be taken with or without food.
• During treatment with Quetiapin NeuroPharma, be cautious when consuming alcohol, as Quetiapin NeuroPharma with alcohol can cause drowsiness.
• While taking Quetiapin NeuroPharma, do not consume grapefruit juice. It may change the way the medication works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. Do not take Quetiapin NeuroPharma during pregnancy without discussing it with your doctor first.
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: trembling, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your child experiences any of these symptoms, you may need to contact your doctor.

Driving and using machines

Quetiapin NeuroPharma may cause drowsiness. Do not drive or operate machinery until you know how the medication affects you.

Quetiapin NeuroPharma contains lactose

Quetiapin NeuroPharma contains lactose, a sugar. If your doctor has told you that you have an intolerance to some sugars, you should consult your doctor before taking this medication.
One of the ingredients in Quetiapin NeuroPharma 25 mg, namely orange yellow S, 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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Your doctor will determine the initial dose. The maintenance dose (daily dose) will depend on your disease and individual needs, but it is usually between 150 mg and 800 mg.

• The medication should be taken once a day, before bedtime, or twice a day, depending on the disease you are suffering from.
• Swallow the tablets whole with a glass of water.
• The tablets can be taken with or without food.
• While taking Quetiapin NeuroPharma, do not consume grapefruit juice. It may affect the way the medication works.
• Do not stop taking the tablets even if you feel better, 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 more Quetiapin NeuroPharma than prescribed

If you take more Quetiapin NeuroPharma than prescribed by your doctor, you may experience drowsiness, dizziness, irregular heartbeat. Contact your doctor or go to the nearest hospital immediately. Bring the Quetiapin NeuroPharma tablets with you.

Missing a dose of Quetiapin NeuroPharma

If you miss a dose, take it as soon as possible. If the time to the next dose is short, wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Quetiapin NeuroPharma treatment

After sudden discontinuation of Quetiapin NeuroPharma, you may experience difficulty sleeping (insomnia) or feel: nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medication, ask 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 stop the medication 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 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 (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):

• combination of high body temperature, 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 fragment of the clot can break off and travel with the blood to the lungs, causing chest pain and difficulty breathing; if you notice any of these symptoms, you should see a doctor or go to the hospital immediately,
• walking, talking, eating, or performing other activities while asleep (sleepwalking),
• decreased body temperature (hypothermia),
• pancreatitis,
• a condition (known as metabolic syndrome) in which you have a combination of three or more of the following: increased waist circumference, reduced "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels,
• combination of 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 a hormone that regulates the amount of urine excreted,
• muscle breakdown and muscle pain (rhabdomyolysis),

Frequency not known (cannot be estimated from the available data)

• skin rash with irregular red spots (erythema multiforme)
• severe, sudden allergic reaction with symptoms such as fever, blisters, and skin peeling (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 levels of certain types of blood cells, 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 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.

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 levels of the hormone prolactin in the blood. This may rarely lead to:
• breast enlargement and unexpected milk production in boys and girls,
• absence or irregular menstrual periods in girls.
• 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 those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 medication.

5. How to store Quetiapin NeuroPharma

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
• The product does not require any special storage conditions.
• Medicines should 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 Quetiapin NeuroPharma contains

The active substance 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).
Other ingredients are:
Tablet 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
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)
100 mg tablets:
Iron oxide yellow (E 172)
Hypromellose 5 cP
Titanium dioxide (E 171)
Macrogol 400
200 mg and 300 mg tablets:
Hydroxypropylcellulose
Hypromellose 5 cP
Talc
Titanium dioxide (E 171)

What Quetiapin NeuroPharma looks like and contents of the pack

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.
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 Warszawa
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 revision of the leaflet: 06/2021