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
Quetiapinum
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Quetiapine Orion is and what it is used for
2. What you need to know before taking 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 known as antipsychotics.
Quetiapine Orion is used to treat conditions such as:

• Depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, has lost appetite, feels guilty, or cannot sleep.
• Mania, when the patient is extremely excited, elated, overactive, enthusiastic, or excessively active, has impaired judgment, is aggressive or troublesome.
• Schizophrenia, when the patient hears and sees unreal voices and images, believes in things that are not real, is excessively suspicious, anxious, confused, feels guilt, is tense, or depressed.

Your doctor may recommend continuing treatment with Quetiapine Orion even after your condition has improved.

2. Information before taking Quetiapine Orion

When not to take Quetiapine Orion

• if the patient is allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking any of the following medicines:
• certain medicines used to treat HIV infection
• medicines in the azole group (used for fungal infections)
• erythromycin or clarithromycin (used for infections)
• nefazodone (used to treat depression).

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

Warnings and precautions

Before starting treatment with Quetiapine Orion, inform your doctor or pharmacist if:

• the patient has depression or other conditions treated with antidepressant medicines. Taking these medicines together 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 diseases, such as heart rhythm disorders, weakened heart muscle, 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, particularly if the patient is elderly
• the patient has liver problems
• the patient has ever had seizures (epilepsy)
• the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Quetiapine Orion
• the patient has previously had a reduced number of white blood cells (which may or may not have been caused by other medicines)
• the patient is an elderly person with dementia (impaired brain function). In such cases, Quetiapine Orion should not be used, as medicines in the class to which Quetiapine Orion belongs may increase the risk of stroke and sometimes also the risk of death in elderly patients with dementia
• the patient is elderly and has Parkinson's disease/parkinsonism
• the patient or a family member has had blood clots, as medicines such as this one may increase the risk of blood clots
• the patient currently has or has previously had breathing problems involving brief periods of stopped breathing during sleep (known as sleep apnoea), and the patient is taking medicines that slow down or suppress normal brain function
• the patient currently has or has previously had difficulty completely emptying 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 nerve cell function, used in the treatment of various diseases
• the patient has or has had problems with alcohol or drug abuse.

Contact the doctor immediately if, after taking Quetiapine Orion, the patient experiences:

• a combination of symptoms such as: fever, severe muscle stiffness, excessive sweating, or altered mental status (this condition is called neuroleptic malignant syndrome). Immediate medical 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, shortness of breath, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient immediately to a cardiologist.

All of these symptoms may occur during treatment with medicines in this therapeutic class.

Contact the doctor immediately if the patient experiences:

• fever together with flu-like symptoms, sore throat, or any infection, as this may be due to a very low number of white blood cells in the blood, which may require discontinuation of Quetiapine Orion and/or appropriate treatment
• constipation together with persistent abdominal pain or persistent constipation despite treatment, as this may lead to a more serious intestinal blockage.

Suicidal thoughts or worsening depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen during the initial phase of treatment, as all antidepressant medicines take time to work, usually at least two weeks, sometimes longer. These thoughts may also worsen after sudden discontinuation of the medicine. Young adults are more likely to experience such thoughts.

Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviour in people under 25 years of age with depression.

If the patient ever experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going to a hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. You may also ask these people to inform the patient if they notice worsening of depressive symptoms or other worrying changes in behaviour.

Severe skin reactions (Severe cutaneous adverse reactions, SCAR)

Very rarely, severe skin reactions that may be life-threatening or lead to death have been reported during treatment with this medicine. These most commonly occur as:

• 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 extensive peeling of the skin
• Drug reaction with eosinophilia and systemic symptoms (DRESS), involving flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme levels)
• Acute Generalized Exanthematous Pustulosis (AGEP) – small pustules filled with pus
• Erythema Multiforme (EM) – skin rash with irregular, itchy, red patches.

If the patient experiences any of these symptoms, stop taking Quetiapine Orion immediately and contact a doctor or seek medical help without delay.

Weight gain

Weight gain has been observed in patients taking Quetiapine Orion. The patient and doctor should regularly monitor the patient's body 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 the patient is currently taking, has recently taken, or plans to take.

Do not take Quetiapine Orion if the patient is taking any of the following medicines:

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

Tell the doctor if the patient is taking any of the following medicines:

• antidepressants. These medicines may interact with Quetiapine Orion and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movement disorders, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact the doctor
• antiepileptic medicines (such as phenytoin or carbamazepine)
• medicines used to treat high blood pressure
• barbiturates (used for sleep disorders)
• thioridazine or lithium (other antipsychotic medicines)
• medicines affecting heart rhythm, for example, medicines that may disrupt electrolyte balance (reducing potassium or magnesium levels), such as diuretics (causing increased urine output) or certain antibiotics (medicines fighting infections)
• medicines that may cause constipation
• medicines (so-called anticholinergic agents) used in the treatment of various diseases that affect nerve function.

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

Quetiapine Orion with food, drink and alcohol

• Tablets may be taken with or without food.
• During treatment, exercise caution when consuming alcoholic beverages, as the combined effect of this medicine and alcohol may cause drowsiness.
• Do not drink grapefruit juice during treatment with this medicine. It may affect how the medicine works.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. The patient should not take Quetiapine Orion during pregnancy without first discussing it with her 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 third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the patient's baby shows any of these symptoms, medical advice should be sought.

Driving and using machines

This medicine may cause drowsiness. Do not drive or operate machinery until you know how this 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 the patient has been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Other excipients

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

Effect on urine drug screening tests

In patients taking this medicine, urine drug screening tests performed by certain methods may show the presence of methadone or certain antidepressant medicines known as tricyclic antidepressants (TCA), even though the patient has not taken these medicines. It is recommended to confirm the results using alternative testing methods.

3. How to take Quetiapine Orion

This medicine should always be taken exactly as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The initial dose will be determined by the treating physician. The maintenance dose (daily dose) depends
on the severity of the disease and the individual needs of the patient, but usually ranges from 150 mg to 800 mg.

• Quetiapine Orion tablets should be taken once daily, before bedtime, or twice daily, depending on the condition being treated.
• Tablets must be swallowed whole with water.
• Tablets may be taken with or without food.
• Grapefruit juice must not be consumed during treatment with Quetiapine Orion, as it may affect the way the medicine works.
• Do not stop taking the tablets even if you start feeling better, unless otherwise advised by your doctor.

Impaired liver function
The physician may recommend adjusting the dosing regimen in patients with hepatic impairment.
Elderly patients
The physician may recommend adjusting the dosing regimen in elderly patients.
Use in children and adolescents
Quetiapine Orion must not be used in children and adolescents under 18 years of age.
Taking more Quetiapine Orion than prescribed
If you take more tablets than prescribed, you may experience drowsiness, dizziness, or irregular heartbeat.
Seek immediate medical advice from a physician or go to the nearest hospital. Bring the Quetiapine Orion tablets with you.
Missed dose of Quetiapine Orion
If a dose has been missed, take it as soon as you remember. If it is almost time for the next dose,
wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Quetiapine Orion
If treatment with this medicine is stopped abruptly, difficulty sleeping (insomnia) may occur, or you may experience:
nausea, headache, diarrhoea, 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 medicine, consult your physician 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 patients):

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may decrease with continued use of Quetiapine Orion), (may lead to falls).
• Withdrawal symptoms (symptoms occurring after stopping Quetiapine Orion), including: difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, irritability. Gradual discontinuation over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Unusual muscle movements; this may include difficulty initiating movement, tremor, restlessness, or painless muscle stiffness.
• Changes in blood levels of certain fat substances (triglycerides and total cholesterol).

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

• Increased heart rate.
• Sensation of irregular heartbeat, pounding heartbeat, rapid heartbeat, or pauses in heart rhythm.
• Constipation, stomach irritation (dyspepsia).
• Weakness.
• Swelling of hands or feet.
• Low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls).
• Increased blood glucose levels.
• Blurred vision.
• Unusual dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in thyroid hormone levels in blood.
• Decreased number of certain types of blood cells.
• Increased liver enzyme levels in blood.
• Increased blood levels of the hormone prolactin. Elevated prolactin levels may 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 patients):

• Seizures or convulsions.
• Allergic reactions such as skin blisters (vesicles), 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 dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of QT interval).
• Slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Nasal congestion.
• Decreased number of red blood cells in blood.
• Decreased sodium levels in blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• Combination of high body temperature (fever), sweating, muscle stiffness, drowsiness or near-fainting (a condition known as "neuroleptic malignant syndrome").
• Yellowing of the skin and eyes (jaundice).
• Hepatitis (liver inflammation).
• Prolonged, painful erection (priapism).
• Breast enlargement and unexpected milk production (galactorrhea).
• Menstrual cycle disturbances.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the legs); a clot fragment may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the patient should seek immediate medical attention from a doctor or hospital.
• Walking, talking, eating, or performing other activities while asleep.
• Decreased body temperature (hypothermia).
• Pancreatitis.
• A condition (known as "metabolic syndrome") involving a combination of 3 or more of the following: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of certain fats in the blood (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 number of white blood cells in the blood (a condition known as agranulocytosis).
• Intestinal obstruction.
• Increased blood levels of creatine kinase (a substance derived from muscles).

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

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reactions (anaphylactic reaction), causing breathing difficulties or shock.
• Rapid swelling of the skin, usually around the eyes, mouth, and throat (angioedema).
• Severe condition with blister formation on the skin, mouth, eyes, and genital organs (Stevens-Johnson syndrome). See section 2.
• Inappropriate secretion of the hormone regulating urine volume,
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

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

• Skin rash with irregular red patches (erythema multiforme). See section 2.
• Sudden appearance of red skin areas with small blisters (small blisters filled with whitish-yellow fluid, known as "acute generalised exanthematous pustulosis" (AGEP). See section 2.
• Severe, sudden allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme levels). See section 2.
• Heart muscle disorders (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a skin rash consisting of small red or purple nodules.
• Newborns of mothers who took Quetiapine Orion during pregnancy may experience withdrawal symptoms.
• Stroke.

Medicines in the same class as Quetiapine Orion may cause disturbances in heart rhythm, which can be dangerous and, in severe cases, may even lead to death.

Some side effects can only be detected through laboratory blood tests. These include changes in blood levels of certain fat substances (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in blood, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood levels of creatine kinase (a substance derived from muscles), decreased sodium levels in blood, and increased blood levels of the hormone prolactin. Elevated prolactin levels may rarely lead to:

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

Your doctor may recommend periodic blood tests.

Additional side effects in children and adolescents

The same side effects observed in adult patients 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 patients):

• Increased blood levels of the hormone prolactin. In rare cases, this may lead to:
• Breast enlargement and unexpected milk production in boys and girls,
• In girls, absence of menstruation or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle contractions, including difficulty initiating intended movement, tremors, muscle restlessness, or muscle stiffness without associated pain.
• Increased blood pressure.

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

• Feeling weak, fainting (may lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: 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 helps 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 stated on the container. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Quetiapine Orion contains
The active substance is quetiapine.

• Each 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 carboxymethyl starch, povidone, magnesium stearate and colloidal anhydrous silica.
• The tablet coating ingredients are hypromellose, titanium dioxide (E 171), macrogol, iron oxide yellow (E 172) (only for 25 mg and 100 mg tablets), iron oxide red (E 172) (only for 25 mg tablets).

What Quetiapine Orion looks like and contents of the pack
25 mg: Peach-coloured, round coated tablets, 6 mm in diameter, embossed with ‘F71’ on one side and plain on the other side.
100 mg: Yellow, round coated tablets, 9 mm in diameter, embossed with ‘F73’ on one side and plain on the other side.
200 mg: White, round coated tablets, 11 mm in diameter, embossed with ‘F75’ on one side and plain on the other side.
300 mg: White, capsule-shaped coated tablets, 19 mm in length, embossed with ‘F76’ on one side and plain on the other side.
The tablets are available in blister packs containing 10, 30, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]