Bonogren

Package Leaflet: Information for the Patient

BONOGREN 25 mg coated tablets

BONOGREN 100 mg coated tablets

BONOGREN 200 mg coated tablets

BONOGREN 300 mg 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Bonogren and what is it used for

Bonogren contains the active substance quetiapine, which 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 are not real, believe in things that are not true, or be overly suspicious, anxious, confused, guilty, tense, or depressed.

Your doctor may continue to prescribe Bonogren even when you feel better.

2. Important information before taking Bonogren

When not to take Bonogren:

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

If any of the above situations apply to you, do not take Bonogren. If in doubt, consult your doctor or pharmacist before taking Bonogren.

Warnings and precautions

Before starting Bonogren, discuss with your doctor or pharmacist:

• if you have 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 you or your family have a history of heart disease, such as arrhythmias, heart failure, or myocarditis, or if you are taking any medicines that may affect heart rhythm,
• if you have low blood pressure,
• if you have had a stroke, especially if you are elderly,
• if you have liver problems,
• if you have had seizures (convulsions),
• if you have diabetes or are at risk of developing diabetes. Your doctor may recommend checking your blood sugar levels while taking Bonogren,
• if you have a history of low white blood cell count (which may or may not have been caused by other medicines),
• if you are elderly and have dementia (disorder of brain function). Patients with dementia should not take Bonogren, as medicines in the same class as Bonogren may increase the risk of stroke or, in some cases, death in such patients,
• if you are elderly and have Parkinson's disease,
• if you or your family have a history of venous thrombosis, as medicines in this class may increase the risk of venous thrombosis,
• if you have or have had a condition where you cannot fully empty your bladder (urinary retention), you have an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms may be caused by taking certain medicines (called anticholinergic medicines) that affect nerve cell function,
• if you have a history of alcohol or drug abuse.

You should immediately inform your doctor if you experience any of the following symptoms after starting 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. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist immediately.

All these symptoms can occur during treatment with medicines in this therapeutic class.
You should immediately inform your doctor if:
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• you have 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,
• you have constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to serious bowel obstruction.
• suicidal thoughts and worsening of depression If you are suffering from depression, you 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. They may also worsen if treatment is suddenly stopped. They can occur especially in young adults. Clinical trial results have shown an increased risk of suicidal thoughts and suicidal behavior in young adults under 25 years of age with depression. If you ever have thoughts of self-harm or suicide, you should contact your doctor or go to the hospital immediately. It may be helpful to inform a relative or friend about your depression and ask them to read this leaflet. You may ask them to tell you if they notice that your depression has worsened or if you have any worrying changes in your behavior.

Severe skin reactions (SCAR)

Very rarely, severe skin reactions have been reported 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 causing widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with a rash, fever, swelling of glands, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes).

If you experience symptoms of a severe skin reaction, you should contact your doctor.

Weight gain

Weight gain has been observed in patients taking quetiapine. You and your doctor should regularly monitor your weight.

Children and adolescents

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

Bonogren and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, and about any medicines you plan to take. This includes medicines obtained without a prescription and herbal medicines, as they may interfere with the action of other medicines.
You should not take Bonogren if you 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).

Tell your doctor if you 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 those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone,

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and elevated body temperature (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 medicines used to treat mental disorders),
• medicines that affect heart rhythm, such as those that can cause electrolyte disturbances (decreased potassium or magnesium levels), such as diuretics or certain antibiotics (used to treat infections),
• medicines that can cause constipation,
• medicines used to treat certain diseases (called anticholinergic medicines) that affect nerve cell function.

You should not stop taking other medicines without consulting your doctor.

Taking Bonogren with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medicine. You should not take Bonogren during pregnancy, unless you have discussed it with your 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: trembling, stiffness and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your child experiences any of these symptoms, you should contact your doctor.

Driving and using machines

Quetiapine may cause drowsiness. You should not drive or operate machinery until you know how Bonogren affects you.

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 by more specific tests.

Bonogren contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking Bonogren.

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 it is essentially 'sodium-free'.
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3. How to take Bonogren

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. Your 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.
• You should not drink grapefruit juice while taking Bonogren, as it may affect the action of the medicine.
• You should not stop taking the tablets even if you feel better, unless your doctor decides otherwise.

Liver function disorders

If you have liver function disorders, your 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.

Overdose of Bonogren

If you take more Bonogren than you should, you may experience drowsiness, dizziness, and irregular heartbeat. You should immediately contact your doctor or go to the nearest hospital. You should take the Bonogren tablets with you.

Missing a dose of Bonogren

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

Stopping Bonogren treatment

If you suddenly stop taking the tablets, you may experience insomnia, nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any doubts about taking Bonogren, you should consult your 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 stopping treatment) including difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually stop taking 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) in the blood.

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 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 levels of liver enzymes in the blood,
• increased levels of prolactin in the blood, which in rare cases may 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 (prolonged QT interval),
• slower than usual heartbeat, 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),
• liver inflammation (hepatitis),
• prolonged and painful erection (priapism),

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• breast swelling and unexpected milk production (galactorrhoea),
• menstrual disorders,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, you should immediately consult your doctor,
• walking, talking, eating, or performing other activities while asleep,
• decreased body temperature (hypothermia),
• pancreatitis,
• 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 triglycerides in the blood, high blood pressure, and increased blood sugar levels,
• a condition characterized by the simultaneous occurrence of fever, flu-like symptoms, sore throat, and a very low white blood cell count (agranulocytosis),
• 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),
• heart muscle inflammation (myocarditis),
• blood vessel inflammation (vasculitis), 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 glands, 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 class 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 sugar in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity, 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.

Your doctor may occasionally recommend blood tests.

Additional side effects in children and adolescents

Side effects that occur in adults can 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 you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety 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
You can also report side effects to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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.
• Do not use this medicine 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. 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

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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
Maize starch
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 packs contain: 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: vipharm@vipharm.com.pl
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 package leaflet: 06/2024

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