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
quetiapinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

Bonogren SR contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Bonogren SR may be used in the treatment of conditions such as:

• Depressive episodes in bipolar affective disorder and major depressive episodes in major depressive disorder, when the patient feels deep sadness. The patient may experience low mood, feelings of guilt, lack of energy and appetite, or difficulties in falling asleep.
• Mania: the patient may be highly excited, elated, overactive, overly enthusiastic, or excessively active, or may have impaired critical judgment, including aggressive behavior or destructive actions.
• Schizophrenia: the patient may hear or sense things that do not exist in reality, believe in things that are not true, or may be excessively suspicious, anxious, confused, have feelings of guilt, be tense or depressed.

In the treatment of major depressive episodes in major depressive disorder, Bonogren SR is used in combination with another medicine.
Your doctor may continue prescribing Bonogren SR even after you start feeling better.

2. Important information before using Bonogren SR

When not to use Bonogren SR

• 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 in doubt, consult a doctor or pharmacist before using Bonogren SR.

Warnings and precautions

Before starting treatment with Bonogren SR, discuss this with your doctor or pharmacist:

• if the patient has depression or other conditions treated with antidepressants. Using these medicines together with Bonogren SR may lead to the development of serotonin syndrome, which can be life-threatening (see "Bonogren SR with other medicines").
• if the patient has or has had any heart conditions, such as irregular heartbeat, weakened heart muscle, 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 elderly,
• if the patient has liver problems,
• if the patient has ever had seizures (fits),
• if the patient has diabetes or is at risk of developing diabetes. In such patients, the doctor may recommend monitoring blood sugar levels during treatment with Bonogren SR,
• if the patient has ever had low white blood cell count (which may or may not have been caused by other medicines),
• if the patient is elderly and has dementia (reduced mental function). Elderly patients with dementia should not take Bonogren SR, as medicines in the class to which Bonogren SR belongs may increase the risk of stroke or, in some cases, risk of death in such patients,
• if the patient is elderly and has Parkinson's disease,
• if the patient has or has had venous thrombosis (blood clots in veins), as medicines in this class may increase the risk of venous thrombosis,
• if the patient has or has had brief episodes of stopped breathing during normal nighttime sleep (a condition called sleep apnoea), especially when taking medicines that slow down brain function (i.e. central nervous system-acting medicines),
• if the patient has or has had an inability to completely empty the bladder (urinary retention), benign prostatic hyperplasia, intestinal obstruction, or increased intraocular pressure. These symptoms may be caused by medicines used in the treatment of certain conditions (called anticholinergic medicines) that affect nerve cell function,
• if the patient has previously abused alcohol or drugs.

Immediately inform the doctor if any of the following symptoms occur after starting Bonogren SR:

• fever, muscle stiffness, sweating, or decreased level of consciousness occurring together (a condition known as neuroleptic malignant syndrome). Immediate treatment may be necessary,
• uncontrolled movements, mainly of the face or tongue,
• dizziness or pronounced drowsiness. This may increase the risk of accidental injury (falls) in elderly patients,
• seizures (fits),
• prolonged and painful erection (priapism),
• rapid or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient immediately to a cardiologist.

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

Immediately inform the doctor if:

• the patient develops fever, flu-like symptoms, sore throat, or any infection, as this may be due to a very low white blood cell count, which may require discontinuation of Bonogren SR and/or initiation of appropriate treatment,
• the patient develops constipation accompanied by persistent abdominal pain or treatment-resistant constipation, as this may lead to serious intestinal obstruction.

Suicidal thoughts and worsening 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 take time to work, usually about 2 weeks or longer. These thoughts may also worsen if treatment is suddenly stopped. They may occur particularly in young adults. Clinical trial data have shown an increased risk of suicidal thoughts and suicidal behaviour in depressed patients under 25 years of age.

If the patient ever experiences thoughts of self-harm or suicide, seek immediate medical help from a doctor or go to 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 inform them if they notice worsening depression or concerning changes in behaviour.

Severe skin adverse reactions (SCAR)

Severe skin adverse reactions (SCAR) have been very rarely reported with quetiapine treatment. These include:

• Stevens-Johnson syndrome (SJS), characterised by widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genital organs;
• toxic epidermal necrolysis (TEN), characterised by more severe symptoms causing extensive skin peeling;
• drug reaction with eosinophilia and systemic symptoms (DRESS), involving flu-like symptoms with rash, fever, lymph node swelling, and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzymes).

If the patient develops symptoms suggestive of a severe skin adverse reaction, contact a doctor immediately.

Weight gain

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

Children and adolescents

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

Bonogren SR with 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 Bonogren SR 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).

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

• antidepressants. These medicines may interact with Bonogren SR and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor immediately,
• antiepileptic medicines (such as phenytoin or carbamazepine),
• medicines used to treat high blood pressure,
• barbiturates (used to treat sleep difficulties),
• thioridazine or lithium (other medicines used to treat psychiatric disorders),
• medicines that affect heart rhythm, for example, medicines that may disturb electrolyte balance (low potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used to treat infections),
• medicines that may cause constipation,
• medicines used to treat certain conditions (called "anticholinergics") that affect nerve cell function.

Do not stop taking other medicines without consulting a doctor.

Taking Bonogren SR with food, drink and alcohol

• Taking Bonogren SR with food may interfere with its effectiveness. Therefore, Bonogren SR should be taken at least one hour before a meal or immediately before bedtime.
• Be cautious with alcohol consumption. The combined effect of Bonogren SR and alcohol may cause drowsiness.
• Do not drink grapefruit juice while taking Bonogren SR. This 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 a doctor before using this medicine. Do not take Bonogren SR during pregnancy unless discussed with the treating doctor. Bonogren SR must not be used during breastfeeding.

Newborns whose mothers took Bonogren SR during the third trimester of pregnancy (last three months) may experience the following symptoms, which may be withdrawal symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the baby, contact a doctor.

Driving and using machines

Quetiapine may cause drowsiness. Do not drive or operate any tools or machinery until you know how this medicine affects you.

Effect of the medicine on urine tests

In patients taking Bonogren SR, urine tests may show the presence of methadone or antidepressants (tricyclic antidepressants), even if the patient has not taken these medicines. Such results should be confirmed with more specific tests.

Bonogren SR contains lactose

Bonogren SR contains lactose, which is a type of sugar. If the patient has been diagnosed with intolerance to certain sugars, such as lactose, consult a doctor before taking this medicine.

3. How to take Bonogren SR

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
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Bonogren SR 50 mg prolonged-release tablets or 150 mg prolonged-release tablets are not available on the market. At these doses, other medicinal products containing quetiapine are available.
The doctor will determine the starting dose for the patient. The maintenance dose (daily dose) will depend on the disease and the patient's needs, but usually ranges between 150 mg and 800 mg.

• Depending on the condition, the tablets should be taken once daily.
• Do not divide, chew, or crush the tablets.
• Swallow the tablets whole with water.
• Take the tablets without food (at least one hour before a meal or immediately before bedtime; the doctor will determine the appropriate time for dosing).
• Do not consume grapefruit juice while taking Bonogren SR. It may affect how the medicine works.
• Do not stop taking the tablets even if the patient feels better, unless otherwise decided by the doctor.

Liver function disorders
If the patient has impaired liver function, the doctor may adjust the dose of the medicine.
Elderly patients
In elderly patients, the doctor may adjust the dose of the medicine.
Use in children and adolescents
Bonogren SR should not be used in children and adolescents under 18 years of age.
Taking more Bonogren SR than prescribed
If a patient takes more Bonogren SR than prescribed, they may experience drowsiness, dizziness, and irregular heartbeat. Seek immediate medical attention by contacting a doctor or going to the nearest hospital. Bring the Bonogren SR tablets with you.
Missed dose of Bonogren SR
If a dose of Bonogren SR is missed, take the missed tablet as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.
Stopping Bonogren SR
If the tablets are stopped abruptly, symptoms such as insomnia, nausea, headache, diarrhea, vomiting, dizziness, or irritability may occur.
The doctor may recommend gradually reducing the dose before stopping treatment.
If in doubt about the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
Very common adverse reactions (may affect more than 1 in 10 people):

• dizziness (which may lead to falls), headache, dry mouth,
• drowsiness which may lead to falls (this symptom may subside as treatment continues),
• withdrawal symptoms (which may occur after stopping treatment) including difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness and irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended,
• weight gain,

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

Common adverse reactions (may affect up to 1 in 10 people):

• fast heartbeat,
• palpitations, accelerated or irregular heartbeat,
• constipation or stomach upset (dyspepsia),
• feeling of weakness,
• swelling of hands and feet,
• low blood pressure upon standing which may cause dizziness or fainting (which may lead to falls),
• increased blood sugar levels,
• blurred vision,
• unusual dreams and nightmares,
• increased feeling of hunger,
• feeling irritable,
• speech disorders and difficulty speaking,
• suicidal thoughts and worsening of depression,
• shortness of breath,
• vomiting (mainly in elderly people),
• fever,
• changes in levels of thyroid hormones in blood,
• decreased number of certain types of blood cells,
• increased levels of liver enzymes in blood,
• increased levels of prolactin in blood, which in rare cases may lead to: breast swelling and unexpected milk production from the breasts in both men and women, absence of menstruation or irregular menstruation in women.

Uncommon adverse reactions (may affect up to 1 in 100 people):

• seizures or epileptic fits,
• allergic reactions, including skin blisters, skin swelling and swelling around the mouth,
• unpleasant sensations in the legs (so-called restless legs syndrome),
• difficulty swallowing,
• uncontrolled movements, mainly of facial muscles or tongue,
• sexual dysfunction,
• diabetes,
• changes in the electrical activity of the heart seen in ECG examination (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 passing urine,
• fainting (which may lead to falls),
• stuffy nose,
• decreased number of red blood cells,
• decreased sodium levels in blood,
• worsening of existing diabetes.

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

• occurrence of fever, sweating, muscle stiffness, drowsiness or fainting at the same time (a disorder called neuroleptic malignant syndrome),
• yellowing of the skin and eyes (jaundice),
• liver inflammation,
• prolonged and painful erection (priapism),
• breast swelling and unexpected milk production (galactorrhoea),

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• menstrual disorders,
• blood clots in veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, consult a doctor immediately,
• walking, talking, eating or performing other activities during sleep,
• decreased body temperature (hypothermia),
• pancreatitis,
• medical condition (called metabolic syndrome), in which 3 or more of the following symptoms may occur simultaneously: increased abdominal fat tissue, decreased levels of "good cholesterol" (HDL), increased blood triglyceride levels, high blood pressure and increased blood sugar levels,
• agranulocytosis, a condition characterised by the combination of fever, flu-like symptoms, sore throat, or other infections with a very low number of white blood cells,
• intestinal obstruction,
• increased levels of creatine phosphokinase in blood (a substance found in muscles).

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• severe rash, blisters or red spots on the skin,
• severe reactions (so-called 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, in the mouth, eyes and genital organs (Stevens-Johnson syndrome). See section 2,
• abnormal secretion of the hormone regulating urine volume,
• muscle fibre damage and muscle pain (rhabdomyolysis).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• skin rash with irregular red patches (erythema multiforme),
• severe, sudden allergic reaction with symptoms such as fever and blisters on 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 glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and liver enzymes). See section 2,
• withdrawal symptoms which may occur in newborns whose mothers took quetiapine during pregnancy,
• stroke,
• disorders of the heart muscle (cardiomyopathy),
• inflammation of the heart muscle,
• inflammation of blood vessels (vasculitis), often with skin rash with small red or purple nodules.

Medicines from the group to which Bonogren SR belongs may cause heart rhythm disorders, which
may be serious and in severe cases even fatal.
Some adverse reactions can only be detected by blood tests. These include
changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar,
changes in levels of thyroid hormones in blood, increased activity of liver enzymes,
decreased number of certain types of blood cells, decreased number of red blood cells, increased
levels of creatine phosphokinase in blood (a substance found in muscles), decreased
sodium levels in blood and increased levels of prolactin in blood. Increased levels of prolactin
in blood may in rare cases lead to:

• breast swelling and unexpected milk production in both women and men;
• absence or irregular menstruation in women. pl_PIL_sk332_IB07G 7

Your doctor may recommend periodic blood tests.
Additional adverse reactions in children and adolescents
Adverse reactions occurring in adults may also occur in children and adolescents.
The following adverse reactions have been observed more frequently in children and adolescents or were not observed in adults:
Very common adverse reactions (may affect more than 1 in 10 people):

• increased levels of a hormone called prolactin in blood. In rare cases this may lead to:
  • breast swelling and unexpected milk production in both girls and boys,
  • absence or irregular menstruation in girls,
• increased appetite,
• vomiting,
• abnormal muscle movements, including difficulty initiating intended movement, tremor, restlessness or muscle stiffness without pain,
• increased blood pressure.

Common adverse reactions (may affect up to 1 in 10 people):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Bonogren SR

• Keep this medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the cardboard box after EXP.
• The expiry date refers to the last day of the stated month.
• No special storage conditions apply for this medicine.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Bonogren SR contains
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The active substance is quetiapine.
Each 200 mg prolonged-release tablet contains 200 mg of quetiapine (as quetiapine fumarate).
Each 300 mg prolonged-release tablet contains 300 mg of quetiapine (as quetiapine fumarate).
Each 400 mg prolonged-release tablet contains 400 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:
Tablet core:
Methacrylic acid and ethyl acrylate copolymer (1:1), type A
Lactose
Magnesium stearate
Crystalline maltose
Talc

Tablet coating:
Methacrylic acid and 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, 15.2 mm long, 7.7 mm wide and 4.8 mm thick, with "200" embossed on one side.
Bonogren SR 300 mg: white or almost white, elongated, biconvex prolonged-release tablets, 18.2 mm long, 8.2 mm wide and 5.4 mm thick, with "300" embossed on one side.
Bonogren SR 400 mg: white or almost white, oval, biconvex prolonged-release tablets, 20.7 mm long, 10.2 mm wide and 6.3 mm thick, with "400" embossed on one side.

Bonogren SR is available in PVC/PCTFE/Aluminium blister packs contained in cardboard boxes.
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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: (+4822) 679 5135
fax: (+4822) 678 92 87
e-mail: [email protected]

Manufacturer:
Pharmathen International S.A
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Sapes Industrial Park Block 5
69300 Rodopi
Greece
Pharmathen S.A
6, Dervenakion str.
15351 Pallini, Attiki
Greece

This medicinal product has been authorised in the EEA Member States under the following names:
Poland: Bonogren SR
Czech Republic: Derin Prolong
Slovakia: Derin Prolong 200 mg
Derin Prolong 300 mg
Derin Prolong 400 mg
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