Quetiapine Orion

Package Leaflet: Information for the User

Quetiapine Orion, 25 mg, coated tablets

Quetiapine Orion, 100 mg, coated tablets

Quetiapine Orion, 200 mg, coated tablets

Quetiapine Orion, 300 mg, coated tablets

Quetiapine

Read all of this leaflet carefully before taking this medicine.

• 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. 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Quetiapine Orion is and what it is used for

Quetiapine Orion contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics.
Quetiapine Orion is used to treat several diseases such as:

• Depression 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, elated, agitated, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome.
• Schizophrenia, when the patient hears and sees unreal voices and images, believes in non-existent things, is overly suspicious, anxious, confused, feels guilty, is tense, depressed.

The doctor may recommend continuing to take Quetiapine Orion even when the patient's condition has improved.

2. Before you take Quetiapine Orion

When not to take Quetiapine Orion

• certain medicines used to treat HIV infection
• medicines from the azole group (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat infections)
• nefazodone (used to treat depression).

If in doubt, consult your doctor or pharmacist before taking Quetiapine Orion.

Warnings and precautions

Before starting to take Quetiapine Orion, tell your doctor or pharmacist if:

• you have depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Quetiapine Orion may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Quetiapine Orion and other medicines")
• you or a family member have or have had any heart disease, such as arrhythmias, heart failure, or myocarditis, or if you are taking or have taken any medicines 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 seizures (epilepsy)
• you have diabetes or are at risk of developing diabetes. In such cases, your doctor may check your blood sugar levels during treatment with Quetiapine Orion
• you have had a decreased white blood cell count (which may or may not have been caused by other medicines)
• you are an elderly person with dementia (impairment of brain function). In this case, Quetiapine Orion should not be taken, as medicines in the same class as Quetiapine Orion may increase the risk of stroke and sometimes death in elderly people with dementia
• you are an elderly person with Parkinson's disease/parkinsonism
• you or a family member have had blood clots, as the use of medicines like this one may lead to the formation of blood clots
• you have or have had breathing difficulties, such as short periods of breathlessness during sleep (sleep apnea syndrome), and you are taking medicines that slow down or inhibit normal brain function
• you have or have had a condition that makes it difficult to empty the bladder completely (urinary retention), you have an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by medicines (called "anticholinergic medicines") that affect the function of nerve cells, used to treat various diseases.
• you have or have had problems with alcohol or drug abuse.

Tell your doctor immediately if you experience any of the following after taking Quetiapine Orion:

• a combination of symptoms such as fever, stiffness of the muscles, excessive sweating, or changes in mental status (a condition called "neuroleptic malignant syndrome"). Immediate treatment may be necessary
• involuntary movements of the muscles, especially of the face and tongue
• dizziness or severe drowsiness. These symptoms may increase the risk of accidental injury (falls) in elderly patients
• seizures (epilepsy)
• prolonged, 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 to a cardiologist.

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

• a combination of fever, flu-like symptoms, sore throat, or any infection, as this may be a sign of a very low white blood cell count in the blood, which may require discontinuation of Quetiapine Orion and/or appropriate treatment
• constipation combined with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious 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 after some time, usually after 2 weeks, 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 behaviors 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 also ask them to tell you if they notice any worsening of your depression or other worrying changes in your behavior.

Severe skin reactions (SCAR)
During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. These reactions most often occur in the form of:

Stevens-Johnson syndrome, a widespread rash with blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals
Toxic epidermal necrolysis, a more severe form causing widespread peeling of the skin
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including flu-like symptoms with rash, fever, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme levels)
Acute Generalized Exanthematous Pustulosis (AGEP) - small blisters filled with pus
Erythema Multiforme (EM) - a skin rash with irregular, itchy, red patches.
If you experience any of these symptoms, you should discontinue Quetiapine Orion and seek medical attention immediately.

Weight gain

Patients taking Quetiapine Orion have experienced weight gain. The patient and doctor should regularly check the patient's weight.

Children and adolescents

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

Quetiapine Orion and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Do not take Quetiapine Orion if you are taking any of the following medicines:

• certain medicines used to treat HIV infection
• medicines from the azole group (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat infections)
• nefazodone (used to treat depression).

Tell your doctor if you are taking any of the following medicines:

• antidepressant medicines. These medicines may interact with Quetiapine Orion and may cause symptoms such as involuntary, rhythmic muscle contractions, including contractions of the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, you should consult your doctor
• antiepileptic medicines (such as phenytoin or carbamazepine)
• medicines used to treat high blood pressure
• barbiturates (used to treat sleep disorders)
• thioridazine or lithium (other antipsychotic medicines)
• medicines that affect heart rhythm, such as medicines that can disrupt the electrolyte balance (decrease potassium or magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which fight infections)
• medicines that can cause constipation
• medicines (so-called anticholinergic preparations) used to treat various diseases, which affect the functioning of nerves.

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

Quetiapine Orion with food, drinks, and alcohol

• The tablets can be taken with or without food.
• During treatment, you should be cautious when consuming alcoholic beverages, as the combined effect of this medicine and alcohol may cause drowsiness.
• During treatment with this medicine, you should not consume grapefruit juice. It may affect the way the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. You should not take Quetiapine Orion during pregnancy without first discussing it with your doctor. Quetiapine Orion should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took quetiapine during the last trimester of pregnancy (in the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your child experiences any of these symptoms, you may need to contact your doctor.

Driving and using machines

This medicine may cause drowsiness. You should not drive or operate machinery until you know how the medicine affects you.

Quetiapine Orion contains lactose

This medicine contains 4.9 mg (in 25 mg tablets), 19.7 mg (in 100 mg tablets), 39.3 mg (in 200 mg tablets), and 59 mg (in 300 mg tablets) of lactose (in the form of monohydrate). If you have been told that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

Other excipients

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Effect on urine tests for drugs

In patients taking this medicine, urine tests for drugs performed by some methods may indicate the presence of methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs), even if the patient is not taking these medicines. It is recommended to perform these tests by other methods to confirm the results.

3. How to take Quetiapine Orion

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The initial dose will be determined by your doctor. The maintenance dose (daily dose) will depend on the severity of the disease and the individual patient's needs, but it is usually between 150 mg and 800 mg.

• The tablets should be taken once a day, before bedtime, or twice a day, depending on the disease being treated.
• The tablets should be swallowed whole, with a glass of water.
• The tablets can be taken with or without food.
• During treatment with Quetiapine Orion, you should not consume grapefruit juice. It may affect the way the medicine works.
• Do not stop taking the tablets even if your condition improves, unless your doctor tells you to.

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

Quetiapine Orion should not be used in children and adolescents under 18 years of age.

Overdose of Quetiapine Orion

If you take more of this medicine than you should, you may feel drowsy, dizzy, or have an irregular heartbeat. You should contact your doctor or go to the nearest hospital immediately. Take the Quetiapine Orion tablets with you.

Missing a dose of Quetiapine Orion

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

Stopping treatment with Quetiapine Orion

If you suddenly stop taking this medicine, you may experience difficulty sleeping (insomnia) or feel: nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose of the medicine before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):

• Dizziness (may lead to falls), headache, dry mouth.
• Feeling drowsy (which may resolve during continued treatment with Quetiapine Orion), (may lead to falls).
• Withdrawal symptoms (symptoms that occur after stopping Quetiapine Orion), including: difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, irritability. It is recommended to gradually discontinue the medicine over a period of at least 1 to 2 weeks.
• Weight gain.
• Abnormal muscle movements; this may be difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Changes in blood levels of certain fats (triglycerides and total cholesterol).

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

• Increased heart rate.
• Feeling of irregular heartbeat, that the heart is pounding, rapid heartbeat, or pauses in heart rhythm.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Decreased blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal 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 levels of liver enzymes in the blood.
• Increased levels of the hormone prolactin in the blood. Elevated prolactin levels may rarely lead to:
• breast enlargement and unexpected milk production in both men and women,
• absence or irregular menstrual periods in women.

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

• Seizures or convulsions.
• Allergic reactions, such as blisters on the skin, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also known as "restless legs syndrome").
• Difficulty swallowing.
• Involuntary movements of the muscles, especially of the face and tongue.
• Sexual function disorders.
• Diabetes.
• Changes in the electrical activity of the heart visible on an ECG (prolongation of the QT interval).
• Slower than normal heart rate, which may occur when starting treatment and may be associated with decreased blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decreased red blood cell count.
• Decreased sodium levels in the blood.
• Worsening of existing diabetes.
• Confusion.

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

• A combination of high body temperature (fever), muscle stiffness, excessive sweating, or changes in mental status (a condition called "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Liver inflammation.
• Prolonged, 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 legs), a fragment of the clot may 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 immediately.
• Sleepwalking, talking, or eating during sleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called "metabolic syndrome") in which there is a combination of three or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood sugar levels.
• A combination of fever, flu-like symptoms, sore throat, or any infection, which may be a sign of a very low white blood cell count in the blood (a condition called "agranulocytosis").
• Bowel obstruction.
• Increased levels of the enzyme creatine phosphokinase in the blood (a substance derived from muscles).

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

• Severe skin reactions, blisters, or red patches on the skin.
• Severe allergic reactions (anaphylactic reaction), with symptoms such as difficulty breathing or shock.
• Rapidly developing swelling of the skin, usually around the eyes and mouth, as well as the throat (angioedema).
• Severe skin reaction with blisters, peeling, and rash (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone that regulates urine volume,
• Muscle breakdown and muscle pain (rhabdomyolysis).

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

• A skin rash with irregular, itchy, red patches (erythema multiforme). See section 2.
• Sudden onset of areas of red, blistering skin (acute generalized exanthematous pustulosis (AGEP)). See section 2.
• A severe, sudden allergic reaction with symptoms such as fever, blisters, and peeling of the skin (toxic epidermal necrolysis). See section 2.
• A drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, lymph node enlargement, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme levels). See section 2.
• Heart muscle disorders (cardiomyopathy).
• Heart muscle inflammation.
• Blood vessel inflammation (vasculitis), often with a skin rash with small red or purple bumps.
• Withdrawal symptoms in newborns of mothers who took quetiapine during pregnancy.
• Stroke.

Medicines in the same class as Quetiapine Orion may cause heart rhythm disorders, which can be dangerous and even life-threatening in severe cases.
Some side effects can only be detected by blood tests in the laboratory. These include changes in levels of certain fats (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 levels of the enzyme creatine phosphokinase in the blood (a substance derived from muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Elevated prolactin levels may rarely lead to:

• breast enlargement and unexpected milk production in both men and women,
• 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 may also occur in children and adolescents.
The following side effects have been observed more frequently or exclusively in children and adolescents:

• Very common (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 contractions, including difficulty starting movement, tremors, restlessness, or muscle stiffness without pain.
• Increased blood pressure. Common (may affect up to 1 in 10 people):
• Feeling weak, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw
phone: 22 49 21 301
fax: 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects 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 Quetiapine Orion

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 packaging. The expiry date refers to the last day of the month.
There are no special storage instructions for this medicine.
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 Quetiapine Orion contains

The active substance is quetiapine.

• One coated tablet contains quetiapine fumarate equivalent to 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine.
• The other ingredients are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, lactose monohydrate, sodium carboxymethylcellulose, povidone, magnesium stearate, and anhydrous colloidal silica.
• The tablet coating contains hypromellose, titanium dioxide (E 171), macrogol, yellow iron oxide (E 172) (only in 25 mg and 100 mg tablets), red iron oxide (E 172) (only in 25 mg tablets).

What Quetiapine Orion looks like and contents of the pack

25 mg: Peach-colored, round, coated tablets, 6 mm in diameter, with "F71" embossed on one side and smooth on the other.
100 mg: Yellow, round, coated tablets, 9 mm in diameter, with "F73" embossed on one side and smooth on the other.
200 mg: White, round, coated tablets, 11 mm in diameter, with "F75" embossed on one side and smooth on the other.
300 mg: White, capsule-shaped, coated tablets, 19 mm in length, with "F76" embossed on one side and smooth on the other.
The tablets are available in blisters, in packs of 10, 30, 60, 90, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
kontakt@orionpharma.info.pl
Date of last revision of the leaflet:01.07.2024