Bonogren Sr

Package Leaflet: Information for the Patient

BONOGREN SR, 200 mg, prolonged-release tablets

BONOGREN SR, 300 mg, prolonged-release tablets

BONOGREN SR, 400 mg, prolonged-release tablets

Quetiapine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• 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, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

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

1. What is Bonogren SR and what is it used for

Bonogren SR contains the active substance quetiapine, which belongs to a group of medicines called antipsychotics. Bonogren SR is used to treat diseases such as:

• Depression in bipolar disorder and severe depressive episodes in severe depressive 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, overactive, or have limited critical judgment, including being aggressive or showing destructive behavior.
• Schizophrenia: the patient may hear or feel things that do not exist in reality, believe in things that are not true, or be overly suspicious, anxious, confused, lost, guilty, tense, or depressed.

In the treatment of severe depressive episodes in severe depressive disorder, Bonogren SR is used in combination with another medicine.

2. Important information before taking Bonogren SR

When not to take Bonogren SR

• 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),

In case of doubt, consult your doctor or pharmacist before taking Bonogren SR.

Warnings and precautions

Before starting to take Bonogren SR, discuss with your doctor or pharmacist:

• if you have depression or other conditions that are treated with antidepressant medicines. Taking these medicines with Bonogren SR may lead to the development of serotonin syndrome, which can be life-threatening (see "Bonogren SR and other medicines").
• if you or your family members have or have had any heart diseases, such as arrhythmias, heart muscle weakness, 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 SR;
• if you have had a low white blood cell count (which may or may not have been caused by other medicines),
• if you are elderly and have dementia (reduced brain function). Patients with dementia should not take Bonogren SR, as medicines in the same class as Bonogren SR may increase the risk of stroke or, in some cases, death in such patients,
• if you are elderly with Parkinson's disease;
• if you or your family members have had venous thrombosis, as medicines in this class may increase the risk of venous thrombosis,
• if you have or have had short-term cessation of breathing during normal nighttime sleep (sleep apnea), and you are taking medicines that slow down brain function (i.e., central nervous system depressants),
• if you have or have had a condition where you cannot completely empty your bladder (urinary retention), you have an enlarged prostate, intestinal obstruction, or increased eye pressure. Such symptoms may be caused by taking certain medicines (called anticholinergic medicines) that affect the function of nerve cells,
• if you have a history of alcohol or drug abuse.

Inform your doctor immediately if, after starting Bonogren SR, you experience any of the following symptoms:

any of the following symptoms:

• simultaneous occurrence of fever, muscle stiffness, sweating, or decreased level of consciousness (a condition called neuroleptic malignant 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 may occur during treatment with medicines in this therapeutic class.
Inform your doctor immediately if:

• 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 SR and/or initiation of appropriate treatment,
• you have constipation with persistent abdominal pain or constipation that does not respond to treatment, as this may lead to serious intestinal obstruction.

Suicidal thoughts and depression worsening

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. 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 suicidal behavior in depressed young adults under the age of 25.
If you ever have thoughts of self-harm or suicide, 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 disturbing 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 that causes widespread skin peeling;
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which includes flu-like symptoms with a rash, fever, swollen 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, 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 SR should not be used in children and adolescents under the age of 18.

Bonogren SR and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Bonogren SR 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 SR and cause symptoms such as involuntary, rhythmic muscle contractions, including eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, high body temperature (serotonin syndrome). If such symptoms occur, contact 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 disrupt electrolyte balance (decrease 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 the function of nerve cells.

Do not stop taking other medicines without consulting your doctor.

Taking Bonogren SR with food, drink, and alcohol

• Taking Bonogren SR with food may affect the way the medicine works, so Bonogren SR should be taken at least 1 hour before a meal or at bedtime.
• Be careful with the amount of alcohol you drink. The combined effect of Bonogren SR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Bonogren SR, as it may affect the way the medicine works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take Bonogren SR during pregnancy, unless it has been discussed with your doctor. Bonogren SR should not be taken during breastfeeding.
In newborns whose mothers took Bonogren SR during the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may be withdrawal symptoms: shaking, stiffness, and/or muscle weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If your child experiences any of these symptoms, contact your doctor.

Driving and using machines

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

Effects on urine tests

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

Bonogren SR contains lactose

Bonogren SR contains lactose, a type of sugar. If you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Bonogren SR

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Bonogren SR 50 mg prolonged-release tablets or 150 mg prolonged-release tablets are not available on the market. Other quetiapine-containing medicinal products are available in these strengths.
Your doctor will determine your starting dose. The maintenance dose (daily dose) will depend on your disease and needs, but it is usually between 150 mg and 800 mg.

• Depending on the disease, the tablets should be taken once a day.
• The tablets should not be divided, chewed, or crushed.
• The tablets should be swallowed whole with water.
• The tablets should be taken without food (at least 1 hour before a meal or at bedtime; your doctor will determine the time of intake).
• Do not drink grapefruit juice while taking Bonogren SR, as it may affect the way the medicine works.
• Do 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 SR.

Elderly patients

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

Use in children and adolescents

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

Overdose of Bonogren SR

If you take more Bonogren SR than you should, you may experience drowsiness, dizziness, and abnormal heart rhythm. Contact your doctor or go to the nearest hospital immediately. Take the Bonogren SR tablets with you.

Missed dose of Bonogren SR

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

Stopping Bonogren SR treatment

If you stop taking Bonogren SR suddenly, 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 SR, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Bonogren SR can cause side effects, although not everybody gets them.
Very common side effects(may 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 resolve 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,

Common side effects(may 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,
• feeling irritable,
• speech disorders and difficulty speaking,
• suicidal thoughts and depression worsening,
• shortness of breath,
• fever,
• changes in thyroid hormone levels in the blood,
• decrease in the number of certain types of blood cells,
• increase in liver enzyme levels in the blood,
• increase in 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(may affect up to 1 in 100 people):

• seizures or convulsions,
• allergic reactions, including blistering of the skin, swelling of the skin, and swelling around the mouth,
• unpleasant feeling 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 normal 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,
• decrease in red blood cell count,
• decrease in sodium levels in the blood,
• worsening of existing diabetes.

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

• simultaneous occurrence of high fever, sweating, muscle stiffness, or decreased level of consciousness (a condition called neuroleptic malignant syndrome),
• yellowing of the skin and eyes (jaundice),
• liver inflammation,
• prolonged and painful erection (priapism),
• breast swelling and unexpected milk production in both men and women,

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

• severe skin rash, blisters, or red spots on the skin,
• severe reactions (anaphylactic shock), which may 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 fiber damage and muscle pain (rhabdomyolysis).

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

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

Medicines in the same class as Bonogren SR 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 fat levels (triglycerides and total cholesterol) or blood sugar levels, 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 found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. Increased prolactin levels in the blood 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 recommend regular 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(may affect more than 1 in 10 people):

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

Common side effects(may 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, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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 this medicine.

5. How to store Bonogren SR

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after EXP.
• The expiry date refers to the last day of that month.
• There are no special storage instructions for this medicine.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bonogren SR contains

The active substance of Bonogren SR is quetiapine.
Each 200 mg prolonged-release tablet contains 200 mg quetiapine (as quetiapine fumarate).
Each 300 mg prolonged-release tablet contains 300 mg quetiapine (as quetiapine fumarate).
Each 400 mg prolonged-release tablet contains 400 mg quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core:
Methacrylic acid - ethyl acrylate copolymer (1:1) type A
Lactose
Magnesium stearate
Crystalline maltose
Talc
Tablet coating:
Methacrylic acid - ethyl acrylate copolymer (1:1) type A
Triethyl citrate

What Bonogren SR looks like and contents of the pack

Bonogren SR 200 mg: white or almost white, elongated, biconvex prolonged-release tablets with a length of 15.2 mm, width of 7.7 mm, and thickness of 4.8 mm, with "200" embossed on one side.
Bonogren SR 300 mg: white or almost white, elongated, biconvex prolonged-release tablets with a length of 18.2 mm, width of 8.2 mm, and thickness of 5.4 mm, with "300" embossed on one side.
Bonogren SR 400 mg: white or almost white, oval, biconvex prolonged-release tablets with a length of 20.7 mm, width of 10.2 mm, and thickness of 6.3 mm, with "400" embossed on one side.
Bonogren SR is available in PVC/PCTFE/Aluminum blisters packaged in cartons.
Pack sizes:
Bonogren SR 200 mg prolonged-release tablets: 10, 30, 50, 60, 100, and 180 tablets
Bonogren SR 300 mg prolonged-release tablets: 10, 30, 50, 60, 100, and 180 tablets
Bonogren SR 400 mg prolonged-release tablets: 10, 30, 50, 60, 100, and 180 tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Vipharm S.A.
A. and F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
Phone: (+48 22) 679 5135
Fax: (+48 22) 678 92 87
Email: [email protected]
Manufacturer:
Pharmathen International S.A.
Sapes Industrial Park Block 5
69300 Rodopi
Greece
Pharmathen S.A.
6, Dervenakion str.
15351 Pallini, Attiki
Greece

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

Poland:
Bonogren SR
Czech Republic:
Derin Prolong
Slovakia:
Derin Prolong 200 mg
Derin Prolong 300 mg
Derin Prolong 400 mg

Date of last revision of the package leaflet: 20.09.2024