Quetiapine Orion

Leaflet accompanying the packaging: 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

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

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

Table of contents of the leaflet

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

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

Quetiapine Orion contains the active substance quetiapine. It 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, enthusiastic 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, worried, confused, feels guilty, is tense, depressed.

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

2. Important information before taking Quetiapine Orion

When not to take Quetiapine Orion

• azole medicines (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat infections)
• nefazodone (used to treat depression).

In case of doubts, the patient should consult their doctor or pharmacist before taking Quetiapine Orion.

Warnings and precautions

Before starting to take Quetiapine Orion, the patient should inform their doctor or pharmacist if:

• the patient has 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")
• the patient or a family member has or has had any heart disease, such as arrhythmias, heart muscle weakness 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 the patient is elderly
• the patient has liver problems
• the patient has had seizures (epilepsy)
• 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 Quetiapine Orion
• the patient has had a decreased white blood cell count (which may or may not have been caused by other medicines)
• the patient is 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
• the patient is elderly and has Parkinson's disease/parkinsonism
• the patient or their family members have had blood clots, as the use of medicines like this one may lead to the formation of blood clots
• the patient has or has had breathing difficulties, such as short periods of breathlessness during sleep (sleep apnea syndrome), and is taking medicines that slow down or inhibit normal brain function
• the patient has or has had a condition that makes it difficult to completely empty the bladder (urinary retention), has 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.
• the patient has or has had problems with alcohol or drug abuse.

The patient should immediately inform their doctor if they experience any of the following after taking Quetiapine Orion:

• a combination of symptoms such as fever, muscle stiffness, excessive sweating or altered mental status (a condition called neuroleptic malignant syndrome). Immediate treatment may be necessary
• involuntary muscle movements, 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 immediately.

All these symptoms may occur during treatment with medicines in this therapeutic class.
The patient should immediately inform their doctor if they experience:

• a combination of 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, 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 two 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 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.
It may also be helpful to ask these people to tell the patient if they notice any worsening of depressive symptoms or other worrying changes in behavior.
Severe skin reactions (Severe Cutaneous Adverse Reactions, SCAR)
During treatment with this medicine, very rare severe skin reactions have been reported, which can be life-threatening or fatal. They most often occur in the form of:
Stevens-Johnson syndrome, 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) - skin rash with irregular, itchy, red patches.
If the patient experiences any of these symptoms, they should discontinue Quetiapine Orion and seek medical attention immediately.

Weight gain

Patients taking Quetiapine Orion have been observed to gain weight. The patient and their 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

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Quetiapine Orion should not be taken if the patient is taking any of the following medicines:

• certain medicines used to treat HIV infection
• azole medicines (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 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, the patient should consult their 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 may disrupt the electrolyte balance (decrease potassium or magnesium levels), such as diuretics (which increase urine production) or certain antibiotics (which fight infections)
• medicines that may 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 their doctor.

Quetiapine Orion with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The patient should not take Quetiapine Orion during pregnancy without first discussing it with their 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 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 the patient's child experiences any of these symptoms, they may need to consult their doctor.

Driving and using machines

This medicine may cause drowsiness. The patient should not drive or operate machinery until they know how the medicine affects them.

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 the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Other excipients

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

Effect on urine tests for drug use

In patients taking this medicine, urine tests for drug use performed by some methods may show 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 the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The initial dose will be determined by the 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 the patient is suffering from.
• 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, the patient should not consume grapefruit juice. It may affect the way the medicine works.
• The patient should not stop taking the tablets even when their condition improves, unless their doctor recommends it.

Liver function disorders

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

Elderly patients

The 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.

Taking a higher dose of Quetiapine Orion than recommended

If a higher dose of the medicine 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 Quetiapine Orion tablets with them.

Missing a dose of Quetiapine Orion

If a dose of the medicine is missed, the patient should take it as soon as they remember. If the time until the next dose is short, the patient should wait and take the dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Quetiapine Orion

If treatment with this medicine is stopped suddenly, the patient may experience difficulty sleeping (insomnia) or feel: nausea, headaches, diarrhea, vomiting, dizziness or irritability. The doctor may recommend gradually reducing the dose of the medicine before stopping treatment.
In case of any further doubts about the use of this medicine, the patient should consult their 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 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, fast or irregular heartbeat.
• Constipation, stomach upset (indigestion).
• Weakness.
• Swelling of hands or feet.
• Decrease in blood pressure when standing up. This may cause dizziness or fainting (may lead to falls).
• Increased blood glucose 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.
• Decrease in the number of certain types of blood cells.
• Increased liver enzyme levels in the blood.
• Increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:
• breast enlargement in both men and women, and unexpected production of milk,
• 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 muscle movements, especially of the face and tongue.
• Sexual function disorders.
• Diabetes.
• Change 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.
• Decrease in red blood cell count.
• Decrease in sodium levels in the blood.
• Worsening of existing diabetes.
• Confusion.

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

• Combination of high body temperature (fever), sweating, muscle stiffness, or altered mental status (a condition called neuroleptic malignant syndrome).
• Yellowing of the skin and eyes (jaundice).
• Hepatitis.
• Prolonged, painful erection (priapism).
• Breast enlargement and unexpected production of milk (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 the patient notices any of these symptoms, they should immediately consult their doctor or go to the hospital.
• 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 three or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides, high blood pressure, and increased blood glucose 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 reactions, blisters, or red patches on the skin.
• Severe allergic reactions (anaphylactic reaction), which may cause 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 blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). See section 2.
• Abnormal secretion of a hormone that regulates urine production,
• Muscle breakdown and muscle pain (rhabdomyolysis).

Unknown ( 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 skin with small blisters (small blisters filled with a white-yellowish fluid, called acute generalized exanthematous pustulosis (AGEP)). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever and blistering of 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 and small red or purple spots.
• 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 glucose in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased white blood cell count, decreased red blood cell count, increased creatine 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:

The 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 production of milk 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 the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Quetiapine Orion

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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 Quetiapine Orion contains

The active substance of the medicine 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
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
Date of last revision of the leaflet:01.07.2024