Bonogren

Leaflet accompanying the packaging: patient information

BONOGREN 25 mg coated tablets

BONOGREN 100 mg coated tablets

BONOGREN 200 mg coated tablets

BONOGREN 300 mg coated tablets

Quetiapine

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

• 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 them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Bonogren and what is it used for

Bonogren contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Bonogren can be used to treat diseases such as:

• Depression in bipolar disorder, when the patient feels deep sadness. They may feel depressed, guilty, lack energy and appetite, or have difficulty sleeping.
• Mania: the patient may be very excited, agitated, restless, enthusiastic, or overly active, or have limited critical judgment, including being aggressive or showing destructive behavior.
• Schizophrenia: the patient may hear or feel things that do not actually exist, believe in things that are not true, or be overly suspicious, anxious, confused, guilty, tense, or depressed.

The doctor may continue to prescribe Bonogren even when the patient feels better.

2. Important information before taking Bonogren

When not to take Bonogren:

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

If any of the above situations apply to the patient, they should not take Bonogren. In case of doubt, the patient should consult their doctor or pharmacist before taking Bonogren.

Warnings and precautions

Before starting to take Bonogren, the patient should discuss it with their doctor or pharmacist:

• if the patient has depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Bonogren may lead to the development of serotonin syndrome, which can be life-threatening (see "Bonogren and other medicines").
• if the patient or their family members have or have had any heart diseases, such as arrhythmias, heart muscle weakness, or myocarditis, or if the patient is taking any medicines that may affect heart rhythm,
• if the patient has low blood pressure,
• if the patient has had a stroke, especially if they are elderly,
• if the patient has liver problems,
• if the patient has ever had seizures (convulsions),
• if the patient has diabetes or is at risk of developing diabetes. The doctor may recommend checking the patient's blood sugar levels while taking Bonogren,
• if the patient has ever had a low white blood cell count (which may or may not have been caused by other medicines),
• if the patient is elderly and has dementia (impairment of brain function). Patients with dementia should not take Bonogren, as medicines in the same group as Bonogren may increase the risk of stroke or, in some cases, death in such patients,
• if the patient is elderly and has Parkinson's disease,
• if the patient or their family members have had venous thrombosis, as medicines in this group may increase the risk of venous thrombosis,
• if the patient has or has had short-term cessation of breathing during normal nighttime sleep (a condition called sleep apnea), and is also taking medicines that slow down brain function (i.e., central nervous system depressants),
• if the patient has or has had a condition in which they cannot completely empty their bladder, has an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by taking certain medicines (called anticholinergic medicines) that affect the functioning of nerve cells,
• if the patient has a history of alcohol or drug abuse.

The patient should immediately inform their doctor if they experience any of the following symptoms after starting to take Bonogren:

• simultaneous occurrence of fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate treatment may be necessary,
• uncontrolled movements, mainly of the face or tongue,
• dizziness or severe drowsiness. This may increase the risk of accidental injury (falls) in elderly patients,
• seizures (convulsions),
• prolonged and 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 immediately.

All these symptoms may occur during treatment with medicines in this therapeutic group.
The patient should immediately inform their doctor if:
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• the patient has a fever, flu-like symptoms, sore throat, or any other infection, as this may be caused by a very low white blood cell count, which may require discontinuation of Bonogren and/or taking appropriate measures,
• the patient has constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to serious intestinal obstruction.
• suicidal thoughts and worsening of depression If the patient suffers from depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment, as antidepressant medicines start to work gradually, usually after about 2 weeks, and sometimes later. These thoughts may also worsen in case of sudden discontinuation of treatment. They may occur especially in young adults. Clinical trial results have shown an increased risk of suicidal thoughts and behaviors in young adults under 25 years of age with depression. If the patient ever has thoughts of self-harm or suicide, they should immediately contact their doctor or go to the hospital. It may be helpful to inform a relative or friend about the depression and ask them to read this leaflet. The patient may ask them to monitor them if they notice that their depression has worsened or if there are worrying changes in their behavior.

Severe skin reactions (SCAR)

Very rarely, severe skin reactions (SCAR) have been reported in association with quetiapine treatment. These reactions are characterized by:

• Stevens-Johnson syndrome (SJS), which is a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals;
• toxic epidermal necrolysis (TEN), which is a more severe condition that causes widespread skin peeling;
• drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with a rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes).

If the patient experiences symptoms suggesting a severe skin reaction, they should contact their doctor.

Weight gain

Weight gain has been observed in patients taking quetiapine. The patient and their doctor should regularly monitor the patient's weight.

Children and adolescents

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

Bonogren 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. This includes medicines that are available without a prescription and herbal medicines, as they may interfere with the action of other medicines.
The patient should not take Bonogren if they are taking any of the following medicines:

• certain medicines used to treat HIV infection,
• azole antifungal medicines,
• 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 Bonogren and cause symptoms such as involuntary, rhythmic muscle contractions, including contractions of the muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone,

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and elevated 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 difficulty sleeping),
• thioridazine or lithium (other medicines used to treat mental disorders),
• medicines that affect heart rhythm, such as medicines that may cause disturbances in electrolyte balance (decreased potassium or magnesium levels), such as diuretics (water pills) or certain antibiotics (used to treat infections),
• medicines that may cause constipation,
• medicines used to treat certain diseases (called anticholinergic medicines) that affect the functioning of nerve cells.

The patient should not stop taking other medicines without consulting their doctor.

Taking Bonogren with food, drink, and alcohol

• Bonogren can be taken with or without food.
• The patient should be careful with the amount of alcohol they consume. As the combined effect of Bonogren and alcohol may cause drowsiness.
• The patient should not drink grapefruit juice while taking Bonogren. As it may affect the action of the medicine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. Bonogren should not be taken during pregnancy, unless it has been discussed with the doctor. Bonogren should not be used during breastfeeding.
In newborns whose mothers took quetiapine during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may be withdrawal symptoms: tremors, stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If the baby experiences any of these symptoms, the patient should contact their doctor.

Driving and using machines

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

Effect on urine tests

In patients taking quetiapine, urine tests may show the presence of methadone or tricyclic antidepressants, even if the patient is not taking them. Such results must be confirmed using more specific tests.

Bonogren contains lactose

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

Bonogren 25 mg contains orange yellow S (E110)

Bonogren 25 mg tablets contain orange yellow S (E110), which may cause allergic reactions.

Bonogren contains sodium

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

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist. The doctor will determine the initial dose. The maintenance dose (daily dose) will depend on the disease and the patient's needs, but it is usually between 150 mg and 800 mg.

• Depending on the disease, the tablets should be taken once a day, before bedtime, or twice a day.
• The tablets should be swallowed whole with water.
• The tablets can be taken with or without food.
• The patient should not drink grapefruit juice while taking Bonogren. As it may affect the action of the medicine.
• The patient should not stop taking the tablets even if they feel better, unless the doctor decides otherwise.

Liver function disorders

If the patient has liver function disorders, the doctor may change the dose of Bonogren.

Elderly patients

In elderly patients, the doctor may change the dose of Bonogren.

Use in children and adolescents

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

Taking a higher dose of Bonogren than recommended

If the patient takes a higher dose of Bonogren than recommended, they may experience drowsiness, dizziness, and irregular heartbeat. The patient should immediately contact their doctor or go to the nearest hospital. The patient should take the Bonogren tablets with them.

Missing a dose of Bonogren

If the patient misses a dose of Bonogren, they should take the missed tablet as soon as possible. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

Stopping Bonogren treatment

If the patient suddenly stops taking the tablets, they may experience: insomnia, nausea, headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before ending the treatment.
In case of doubt about the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

• dizziness (which may lead to falls), headache, dry mouth,
• drowsiness that may lead to falls (this symptom may disappear as treatment continues),
• withdrawal symptoms (which may occur after treatment is stopped) including difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop the medicine over a period of at least 1 to 2 weeks,
• weight gain,

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• abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain,
• changes in the levels of certain lipids (triglycerides and total cholesterol).

Common side effects(affect up to 1 in 10 people):

• rapid heartbeat,
• palpitations, rapid or irregular heartbeat,
• constipation or upset stomach (indigestion),
• feeling weak,
• swelling of the hands and feet,
• low blood pressure when standing up, which may cause dizziness or fainting (which may lead to falls),
• high blood sugar levels,
• blurred vision,
• abnormal dreams and nightmares,
• increased appetite,
• irritability,
• 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 the blood,
• decreased levels of certain types of blood cells,
• increased liver enzyme levels in the blood,
• increased prolactin levels in the blood, which may rarely lead to:
• breast swelling and unexpected milk production in both men and women,
• absence or irregular menstrual periods in women.

Uncommon side effects(affect up to 1 in 100 people):

• seizures or convulsions,
• allergic reactions, including the appearance of lumps, skin swelling, and swelling around the mouth,
• unpleasant sensation in the legs (restless legs syndrome),
• difficulty swallowing,
• uncontrolled movements, mainly of the face or tongue,
• sexual disorders,
• diabetes,
• changes in the electrical activity of the heart visible on an ECG (QT interval prolongation),
• slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting,
• difficulty urinating,
• fainting (which may lead to falls),
• stuffy nose,
• decreased red blood cell count,
• decreased sodium levels in the blood,
• worsening of existing diabetes.

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

• simultaneous occurrence of high fever, sweating, muscle stiffness, or decreased level of consciousness (a condition called malignant neuroleptic syndrome),
• yellowing of the skin and eyes (jaundice),
• hepatitis (inflammation of the liver),
• prolonged and painful erection (priapism),

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• breast swelling and unexpected milk production (galactorrhea),
• menstrual disorders,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, the patient should immediately consult their doctor,
• walking, talking, eating, or performing other activities while asleep,
• decreased body temperature (hypothermia),
• pancreatitis (inflammation of the pancreas),
• a condition (called metabolic syndrome) in which at least three of the following symptoms occur: increased fat around the waist, decreased "good" cholesterol (HDL-C), increased triglyceride levels in the blood, high blood pressure, and increased blood sugar levels,
• agranulocytosis, a condition characterized by the simultaneous occurrence of fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count,
• intestinal obstruction,
• increased levels of creatine kinase in the blood (a substance found in muscles).

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

• severe skin rash, blisters, or red spots on the skin,
• severe allergic reactions (anaphylactic shock), which can cause difficulty breathing or lead to shock,
• sudden swelling of the skin, usually around the eyes, lips, and throat (angioedema),
• blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome). See section 2,
• abnormal secretion of the hormone that regulates urine volume,
• muscle damage and muscle pain (rhabdomyolysis).

Side effects with unknown frequency(cannot be estimated from the available data):

• heart muscle disorders (cardiomyopathy),
• myocarditis (inflammation of the heart muscle),
• vasculitis (inflammation of blood vessels), often with a skin rash with small red or purple bumps,
• a skin rash with irregular red spots (erythema multiforme),
• a severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling skin (toxic epidermal necrolysis). See section 2.
• drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with a rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes). See section 2.
• withdrawal symptoms that may occur in newborns whose mothers took quetiapine during pregnancy.
• stroke.

Medicines in the same group as Bonogren may cause heart rhythm disorders, which can be serious and, in severe cases, life-threatening.
Some side effects can only be detected by blood tests. These include changes in the levels of certain lipids (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzyme levels in the blood, decreased levels of certain types of blood cells, decreased red blood cell count, increased creatine kinase levels in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels may rarely lead to:

• breast swelling and unexpected milk production in both men and women,
• absence or irregular menstrual periods in women.

The doctor may occasionally recommend blood tests.

Additional side effects in children and adolescents

Side effects that occur in adults may also occur in children and adolescents.
The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:
Very common side effects(affect more than 1 in 10 people):

• increased levels of the hormone prolactin in the blood. In rare cases, this may lead to:
• breast swelling and unexpected milk production in both boys and girls,
• absence or irregular menstrual periods in girls,
• increased appetite,
• vomiting,
• abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain,
• increased blood pressure.

Common side effects(affect up to 1 in 10 people):

• feeling weak, fainting (which may lead to falls),
• stuffy nose,
• irritability.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Bonogren

• The medicine should be stored in its original packaging.
• 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 carton. The expiry date refers to the last day of the month.
• 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

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What Bonogren contains

The active substance of Bonogren is quetiapine.
Each 25 mg coated tablet contains 25 mg of quetiapine (as quetiapine fumarate).
Each 100 mg coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).
Each 200 mg coated tablet contains 200 mg of quetiapine (as quetiapine fumarate).
Each 300 mg coated tablet contains 300 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core:
Hypromellose 2910
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Cornstarch
Sodium carboxymethylcellulose (Type A)
Magnesium stearate
Microcrystalline cellulose
Talc
Silica, colloidal anhydrous
Coating:
25 mg:
Iron oxide red (E172)
Iron oxide yellow (E172)
Hypromellose 2910
Titanium dioxide (E171)
Macrogol 400
Orange yellow S (E110)
100 mg:
Iron oxide yellow (E172)
Hypromellose 2910
Titanium dioxide (E171)
Macrogol 400
200 and 300 mg:
Hydroxypropylcellulose
Hypromellose 2910
Talc
Titanium dioxide (E171)

What Bonogren looks like and contents of the pack

Bonogren 25 mg: peach-colored, round, biconvex coated tablets with a diameter of about 5.7 mm.
Bonogren 100 mg: yellow, round, biconvex coated tablets with a score line on one side, with a diameter of about 9.1 mm.
Bonogren 200 mg: white, round, biconvex coated tablets with a score line on one side, with a diameter of about 12.1 mm.
Bonogren 300 mg: white, oval, biconvex coated tablets with a score line on one side.
The 100 mg, 200 mg, and 300 mg tablets can be divided into equal doses.
Packaging:
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Bonogren 25 mg, 100 mg, 200 mg, and 300 mg are packaged in blisters containing 10 coated tablets.
The packaging contains: 10, 20, 30, 50, 60, 90, 100, 120, 180, and 240 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
phone: (+48 22) 679 5135
fax: (+48 22) 678 92 87
e-mail: [email protected]
Manufacturer
Genepharm S.A.
18th klm Marathonos Avenue
153 51 Pallini Attikis
Greece
PharmaPath S.A.
1, 28th Oktovriou St.
Agia Varvara, 123 51
Greece
(only for 25 mg strength)

This medicinal product has been authorized in the EEA Member States under the following names:

Poland:
Bonogren
Czech Republic:
Derin coated tablets

Date of last revision of the leaflet: 06/2024

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