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

Keep this leaflet, so that you can read it again if necessary.
If you have any 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Leaflet contents

What Bonogren is and what it is used for
Important information before taking Bonogren
How to take Bonogren
Possible side effects
How to store Bonogren
Contents of the pack and other information

1. What Bonogren is and what it is used for

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

Depressive episodes in bipolar affective disorder, when the patient feels profound sadness. The patient may experience depression, feelings of guilt, lack of energy and appetite, or difficulty sleeping.
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, or be tense or depressed.

Your doctor may continue prescribing Bonogren even after the patient starts feeling better.

2. Important information before using Bonogren

When not to use 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 in HIV infection,
- azole antifungal medicines,
- erythromycin or clarithromycin (used to treat infections),
- nefazodone (used to treat depression).

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If any of the above situations apply to the patient, Bonogren must not be taken. If in doubt, consult a doctor or pharmacist before taking Bonogren.
Warnings and precautions
Before starting to take Bonogren, discuss this with your doctor or pharmacist:

if the patient has depression or other conditions treated with antidepressant medicines. Taking these medicines together with Bonogren may lead to the development of serotonin syndrome, which can be life-threatening (see "Bonogren with other medicines").
if the patient has or has had heart problems, either personally or in the family, such as heart rhythm disorders, 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 they are 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 regular blood sugar monitoring during treatment with Bonogren,
if the patient has previously 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 (a decline in brain function). Patients with dementia should not take Bonogren, as medicines in the class to which Bonogren 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 the veins), either personally or in the family, because 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 night sleep (a condition called sleep apnoea), especially if the patient is also taking medicines that slow down brain function (i.e. central nervous system-acting medicines),
if the patient has or has had difficulty completely emptying the bladder (urinary retention), enlarged prostate, intestinal obstruction or increased pressure inside the eye. These symptoms may be caused by taking certain medicines (called anticholinergic medicines) used in the treatment of various diseases, which affect nerve cell function,
if the patient has a history of alcohol or drug abuse.

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

fever, muscle stiffness, sweating or decreased level of consciousness occurring together (a disorder known as 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 (fits),
prolonged and painful erection (priapism),
rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, 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 other infection, as this may be due to a very low white blood cell count, which may require discontinuation of Bonogren treatment and/or appropriate measures,
the patient has constipation accompanied by persistent abdominal pain or treatment-resistant constipation, as this may lead to severe intestinal obstruction.
s uicidal thoughts and worsening of depression. If the patient suffers from depression, they may sometimes have thoughts of self-harm or suicide. These thoughts may increase at the beginning of treatment, as antidepressant medicines take time to work, usually about 2 weeks or sometimes longer. These thoughts may also increase if treatment is suddenly stopped. They may occur especially in young adults. Clinical trial results have shown an increased risk of suicidal thoughts and behaviours in young adult patients with depression under the age of 25. If the patient ever experiences thoughts of self-harm or suicide, they should contact a doctor immediately 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.

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

Stevens-Johnson syndrome (SJS), characterised by widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals;
toxic epidermal necrolysis (TEN), characterised by more severe symptoms leading to extensive skin peeling;
drug reaction with eosinophilia and systemic symptoms (DRESS), including flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).

If the patient develops symptoms suggesting a serious skin adverse reaction, they should contact a doctor immediately.
Weight gain
Weight gain has been observed in patients taking quetiapine. The patient and their doctor should monitor the patient's weight regularly.
Children and adolescents
Bonogren must not be used in children and adolescents under 18 years of age.
Bonogren with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or plans to take. This includes medicines available without a prescription and herbal medicines, as they may interfere with other medicines.
Do not take Bonogren if the patient is taking any of the following medicines:

certain medicines used in HIV infection,
azole antifungal medicines,
erythromycin or clarithromycin (used in infections),
nefazodone (used to treat depression).

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

antidepressant medicines. These medicines may interact with Bonogren and may cause symptoms such as involuntary, rhythmic muscle contractions, including those affecting eye movements, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes,

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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 cause electrolyte imbalance (reduced potassium or magnesium levels), such as diuretics (water tablets) or certain antibiotics (medicines used to treat infections),
medicines that may cause constipation,
medicines used in the treatment of certain diseases (called "anticholinergics") that affect nerve cell function.

Do not stop taking other medicines without consulting a doctor.
Taking Bonogren with food, drink and alcohol

Bonogren may be taken with or without food.
Be cautious about alcohol consumption. The combined effect of Bonogren and alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Bonogren. This may affect the medicine's action.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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 during pregnancy unless discussed with the supervising doctor. Bonogren must not be used during breastfeeding.
Newborns whose mothers took quetiapine 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 the baby develops any of these symptoms, contact a doctor immediately.
Driving and using machines
Quetiapine may cause drowsiness. Do not drive or operate any tools or machinery until it is known how the medicine affects the patient.
Effect of the medicine on urine tests
In patients taking quetiapine, urine tests may show the presence of methadone or antidepressant medicines (tricyclic antidepressants), even if the patient has not taken them. Such test results must be confirmed with more specific tests.
Bonogren contains lactose
If the patient has been previously diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Bonogren 25 mg contains sunset yellow (E110)
Bonogren 25 mg tablets contain sunset yellow (E110), which may cause allergic reactions.
Bonogren contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
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3. How to use Bonogren

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. Your doctor will determine the starting dose. The maintenance
(daily) dose will depend on the condition being treated and the individual needs of the patient, but
usually ranges between 150 mg and 800 mg.

Depending on the condition, tablets should be taken once daily, before bedtime, or twice daily.
Tablets should be swallowed whole with water.
Tablets may be taken with or without food.
You should not drink grapefruit juice while taking Bonogren. 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 should not be used in children and adolescents under 18 years of age.
Taking more Bonogren than recommended
If a patient takes more Bonogren than recommended, they may experience drowsiness, dizziness,
and irregular heartbeat. Seek immediate medical advice from a doctor or go to the nearest hospital.
Bring the Bonogren tablets with you.
Missed dose of Bonogren
If a dose of Bonogren 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 tablet at the usual time. Do not take a double
dose to make up for a missed tablet.
Stopping Bonogren treatment
If treatment with Bonogren is stopped suddenly, symptoms such as insomnia, nausea, headache,
diarrhea, vomiting, dizziness, or irritability may occur. Your doctor may recommend gradually
reducing the dose before stopping treatment completely.
If in doubt about how to use the medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.

Very common adverse reactions (affect more than 1 in 10 patients):

dizziness (which may lead to falls), headache, dry mouth,
drowsiness which may lead to falls (this symptom may diminish with continued treatment),
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,
abnormal muscle movements, including difficulty initiating intended movement, tremor, restlessness or muscle rigidity without concomitant pain,
changes in levels of certain lipids (triglycerides and total cholesterol).

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

rapid heartbeat,
palpitations, accelerated or irregular heartbeat,
constipation or indigestion,
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 appetite,
irritability,
speech and language disorders,
suicidal thoughts and worsening of depression,
shortness of breath,
vomiting (mainly in elderly people),
fever,
changes in blood levels of thyroid hormones,
decreased number of certain types of blood cells,
increased levels of liver enzymes in blood,
increased blood prolactin levels, which in rare cases may lead to:
- breast enlargement and unexpected milk production from the breasts in both men and women,
- absence of menstruation or irregular menstruation in women.

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

seizures or epileptic fits,
hypersensitivity reactions, including raised skin lumps, 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 on ECG (prolongation of QT interval),
slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting,
difficulty passing urine,
fainting (which may lead to falls),
stuffy nose,
decreased number of red blood cells,
decreased sodium levels in blood,
worsening of pre-existing diabetes.

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

occurrence of high fever, sweating, muscle stiffness, drowsiness or fainting (a disorder called neuroleptic malignant syndrome),
yellowing of the skin and eyes (jaundice),
liver inflammation (hepatitis),
prolonged and painful erection (priapism),
breast enlargement and unexpected milk production (galactorrhea),
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 breathing difficulties. If any of these symptoms occur, seek medical advice immediately,
walking, talking, eating or performing other activities while asleep,
decreased body temperature (hypothermia),
pancreatitis,
a medical condition (called metabolic syndrome) involving 3 or more of the following: increased abdominal fat tissue, decreased levels of "good cholesterol" (HDL-C), 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 blood creatine kinase levels (a substance found in muscles).

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

severe rash, blisters or red spots on the skin,
severe allergic reactions (so-called anaphylactic shock), which may cause breathing difficulties 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,
damage to muscle fibres and muscle pain (rhabdomyolysis).

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

heart muscle disorders (cardiomyopathy),
inflammation of the heart muscle,
blood vessel inflammation (vasculitis), often with a skin rash consisting of small red or purple nodules,
rash with irregular red patches (erythema multiforme),
severe, sudden allergic reaction with symptoms such as fever, skin blisters 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 white blood cell count (eosinophilia) and liver enzymes). See section 2.
withdrawal symptoms that may occur in newborns whose mothers used quetiapine during pregnancy.
stroke.

Medicines in the class to which Bonogren belongs may cause disturbances in heart rhythm, 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 lipids (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzyme activity, decreased number of certain types of blood cells, decreased number of red blood cells, increased blood creatine kinase levels (a substance found in muscles), decreased blood sodium levels and increased blood prolactin levels. Increased prolactin levels may, in rare cases, lead to:

breast enlargement and unexpected milk production in both women and men,
absence or irregular menstruation in women.

Your doctor may occasionally recommend 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 (affect more than 1 in 10 patients):

increased levels of a hormone called prolactin in blood. In rare cases this may lead to:
- breast enlargement 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 rigidity without concomitant pain,
increased blood pressure.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Bonogren

Keep the medicine in the original packaging.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box. The expiry date refers to the last day of the specified 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 is quetiapine.
Each 25 mg film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate).
Each 100 mg film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).
Each 200 mg film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate).
Each 300 mg film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate).

The other ingredients are:
Tablet core:
Hypromellose 2910
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Corn starch
Sodium carboxymethyl starch (Type A)
Magnesium stearate
Microcrystalline cellulose
Talc
Colloidal anhydrous silica

Tablet coating:
25 mg:
Iron oxide red (E172)
Iron oxide yellow (E172)
Hypromellose 2910
Titanium dioxide (E171)
Macrogol 400
Orange yellow (E110)

100 mg:
Iron oxide yellow (E172)
Hypromellose 2910
Titanium dioxide (E171)
Macrogol 400

200 mg and 300 mg:
Hydroxypropyl cellulose
Hypromellose 2910
Talc
Titanium dioxide (E171)

What Bonogren looks like and contents of the pack
Bonogren 25 mg: peach-coloured, round, biconvex film-coated tablets with a diameter of approx. 5.7 mm.
Bonogren 100 mg: yellow, round, biconvex film-coated tablets with a score line on one side, with a diameter of approx. 9.1 mm.
Bonogren 200 mg: white, round, biconvex film-coated tablets with a score line on one side, with a diameter of approx. 12.1 mm.
Bonogren 300 mg: white, oblong, biconvex film-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 film-coated tablets are packed in blisters containing 10 film-coated tablets.
Pack sizes: 10, 20, 30, 50, 60, 90, 100, 120, 180 and 240 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
Genepharm S.A.
18th km 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 is authorised in the EEA Member States under the following names:
Poland: Bonogren
Czech Republic: Derin potahovane tablety
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