Quetiapine Orion

Package Leaflet: Information for the User

Quetiapine Orion, 25 mg, Film-Coated Tablets

Quetiapine Orion, 100 mg, Film-Coated Tablets

Quetiapine Orion, 200 mg, Film-Coated Tablets

Quetiapine Orion, 300 mg, Film-Coated Tablets

Quetiapine

Read the package leaflet carefully before taking the medicine, 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 or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents

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

Quetiapine Orion contains the active substance quetiapine, which belongs to a group of medicines called antipsychotics.
Quetiapine Orion is used to treat 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, full of enthusiasm or overly active, or has impaired critical judgment, is aggressive or troublesome.
• Schizophrenia, when the patient hears and sees unreal voices and images, takes non-existent things for real, 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

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6),
• 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).

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 muscle weakness 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 group 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 such medicines is associated with the formation of blood clots
• you have or have had breathing difficulties, such as short periods of breathlessness during sleep (called sleep apnea syndrome) and are taking medicines that slow down or inhibit normal brain function
• you have or have had a condition that makes it difficult to completely empty the bladder (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 disturbances of consciousness (a condition called malignant neuroleptic 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 (fall) in elderly patients
• seizures (epilepsy)
• prolonged, 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.

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

• fever, flu-like symptoms, sore throat or any infection, as this may be a consequence of a very low white blood cell count in the blood, and it may be necessary to discontinue Quetiapine Orion and/or administer 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 symptoms 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 lead to death. These reactions most often occur in the form of:
Stevens-Johnson syndrome, with widespread rash, 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) - skin rash with irregular, itchy, red patches.
If you experience these symptoms, you should discontinue Quetiapine Orion and seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking Quetiapine Orion. 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 might 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, 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 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, you should consult your doctor.

Quetiapine Orion with food, drinks and alcohol

• The tablets can be taken with or without food.
• During treatment, you should be careful when drinking 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Quetiapine Orion during pregnancy without discussing it with your doctor. You should not take Quetiapine Orion during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took quetiapine in 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 (as monohydrate). If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Other excipients

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

Effect on urine tests for drug detection

In patients taking this medicine, urine tests for drug detection performed by some methods may indicate the presence of methadone or certain antidepressant medicines called tricyclic antidepressants (TCA), 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

This medicine should always be taken as directed by your doctor or pharmacist. If you are unsure, you should consult 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 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.
• You should not stop taking the tablets even if your condition improves, unless your doctor advises you to do so.

Liver function disorders

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

Elderly patients

Your doctor may recommend changing the dosage 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 the medicine than prescribed by your doctor, you may experience drowsiness, dizziness, irregular heartbeat. You should contact your doctor or go to the nearest hospital immediately. You should take the Quetiapine Orion tablets with you.

Missed dose of Quetiapine Orion

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

Stopping treatment with Quetiapine Orion

If you suddenly stop taking this medicine, you may experience difficulty sleeping (insomnia) or you may 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, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Quetiapine Orion 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 of drowsiness (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; 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, fast or irregular heartbeat.
• 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. Increased 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 lower limbs (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 (prolonged 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):

• Combination of fever, muscle stiffness, excessive sweating or disturbances of consciousness (a condition called malignant neuroleptic syndrome).
• Yellowing of the skin and whites of the eyes (jaundice).
• Hepatitis.
• Prolonged, painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhoea).
• 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 bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, you should contact your doctor or go to the hospital immediately.
• Sleepwalking, talking, eating or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (called metabolic syndrome) in which there is a combination of 3 or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure and increased blood sugar levels.
• Combination of fever, flu-like symptoms, sore throat or any infection, which may be a consequence of a very low white blood cell count in the blood (a condition called agranulocytosis).
• Bowel obstruction.
• Increased levels of creatine phosphokinase in the blood (a substance derived from muscles).

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

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

Not known ( frequency cannot be estimated from the available data):

• Skin rash with irregular, itchy, red patches (erythema multiforme). See section 2.
• Sudden onset of areas of red, itchy skin with small blisters (acute generalized exanthematous pustulosis (AGEP)). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling (toxic epidermal necrolysis). See section 2.
• 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).
• Myocarditis.
• Vasculitis (inflammation of blood vessels), often with skin rash with small red or purple spots.
• Withdrawal symptoms in newborns of mothers who took quetiapine during pregnancy.
• Stroke.

Medicines in the same group 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 creatine phosphokinase 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 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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 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 that month.
There are no special precautions for storing the 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 film-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 25 mg and 100 mg tablets), red iron oxide (E 172) (only 25 mg tablets).

What Quetiapine Orion looks like and contents of the pack

25 mg: peach-colored, round, film-coated tablets, 6 mm in diameter, with "F71" embossed on one side and smooth on the other side.
100 mg: yellow, round, film-coated tablets, 9 mm in diameter, with "F73" embossed on one side and smooth on the other side.
200 mg: white, round, film-coated tablets, 11 mm in diameter, with "F75" embossed on one side and smooth on the other side.
300 mg: white, capsule-shaped, film-coated tablets, 19 mm long, with "F76" embossed on one side and smooth on the other side.
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
For more information about 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