Ketipinor: detailed information

Package leaflet: Information for the user

Ketipinor, 25 mg, film-coated tablets
Ketipinor, 100 mg, film-coated tablets
Ketipinor, 200 mg, film-coated tablets
Ketipinor, 300 mg, film-coated tablets
Quetiapinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

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. The medicine may harm someone else, 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

What Ketipinor is and what it is used for
What you need to know before taking Ketipinor
How to take Ketipinor
Possible side effects
How to store Ketipinor
Contents of the pack and other information

1. What Ketipinor is and what it is used for

Ketipinor contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Ketipinor is used in the treatment of several conditions, such as:

depressive episodes in bipolar disorder, when the patient feels sadness, depression, lack of energy, loss of appetite, guilt, or has difficulty sleeping;
mania, when the patient is extremely excited, elated, overactive, enthusiastic, or excessively active, has impaired critical judgment, or is aggressive or troublesome;
schizophrenia, when the patient hears or sees unreal voices and images, believes in things that are not real, is excessively suspicious, anxious, confused, feels guilt, or is tense and depressed.

Your doctor may recommend continuing treatment with Ketipinor even after your condition has improved.

2. Important information before taking Ketipinor

When not to take Ketipinor

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 antifungals (used to treat fungal infections),
erythromycin or clarithromycin (used to treat infections),
nefazodone (used to treat depression).
If in doubt, consult a doctor or pharmacist before taking Ketipinor.

Warnings and precautions
Before starting to take Ketipinor, inform your doctor or pharmacist if:

the patient has depression or other conditions treated with antidepressant medicines. Taking these medicines together with Ketipinor may lead to serotonin syndrome, a potentially life-threatening condition (see "Ketipinor and other medicines").
the patient or a family member has or has had any heart problems, such as irregular heartbeat, weakened heart muscle, or myocarditis, or if the patient is taking or has taken any medicines that may affect heart function,
the patient has low blood pressure,
the patient has had a stroke, particularly if the patient is elderly,
the patient has liver problems,
the patient has ever had seizures (epilepsy),
the patient has diabetes or is at risk of developing diabetes. In such cases, the doctor may monitor the patient's blood sugar levels during treatment with Ketipinor,
the patient has previously had a low white blood cell count (which may or may not have been caused by other medicines),
the patient is elderly and has Parkinson’s disease/parkinsonism,
the patient is an elderly person with dementia (impaired brain function); in such cases, Ketipinor should not be used, as medicines of the class to which Ketipinor belongs may increase the risk of stroke and, in some cases, also the risk of death in elderly patients with dementia,
the patient or a family member has a history of blood clots, as use of medicines such as this has been associated with clot formation,
the patient has or has previously had breathing problems involving brief periods of stopped breathing during sleep (known as sleep apnoea), and the patient is taking medicines that slow down or suppress normal brain function,
the patient has or has previously had difficulty completely emptying the bladder (urinary retention), an enlarged prostate, intestinal obstruction, or increased eye pressure. These problems may sometimes be caused by medicines (so-called anticholinergic agents) that affect nerve function to treat certain conditions,
the patient has previously abused alcohol or drugs.

Immediately inform the doctor if the patient experiences any of the following after taking Ketipinor:

a combination of symptoms such as: fever, severe muscle stiffness, excessive sweating, or altered mental status (this condition is known as neuroleptic malignant syndrome); immediate treatment may be required,
involuntary muscle movements, particularly of the face and tongue,
dizziness or severe drowsiness: these effects may increase the risk of accidental injury (falls) in elderly patients,
seizures (epilepsy),
prolonged, 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 of this therapeutic class.
Immediately inform the doctor if the patient experiences:

a combination of fever, flu-like symptoms, sore throat, or any other infections, as this may be due to a very low number of white blood cells in the blood, which may require discontinuation of Ketipinor and/or appropriate treatment.
constipation accompanied by persistent abdominal pain or persistent constipation despite treatment, as this may lead to more serious intestinal obstruction.
Suicidal thoughts or worsening depression
Patients with depression may sometimes have thoughts of self-harm or suicide. These symptoms or behaviours may worsen during the initial phase of treatment, as all antidepressant medicines take time to work, usually about two weeks or sometimes longer. These thoughts may also worsen after abrupt discontinuation of the medicine. Young adults are more likely to experience such thoughts. Clinical trial data indicate an increased risk of suicidal thoughts and/or suicidal behaviour in people under 25 years of age with depression.

If the patient ever experiences suicidal thoughts or thoughts of self-harm,
seek immediate medical advice from a doctor or go to hospital.
It may be helpful to inform family members or friends about the depression and ask them to read this leaflet.
You may also ask these individuals to inform the patient if they notice worsening of depressive symptoms or other concerning behavioural changes.
Severe skin reactions (SCARs – Severe Cutaneous Adverse Reactions)
Very rarely, severe skin reactions that may be life-threatening or fatal have been reported during treatment with this medicine. These most commonly include:
Stevens-Johnson syndrome, widespread rash with blistering and peeling of the skin, particularly around the mouth, nose, eyes, and genitals;
Toxic epidermal necrolysis, a more severe form causing extensive peeling of the skin;
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), including flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzyme levels);
Acute Generalized Exanthematous Pustulosis (AGEP) – small pustules filled with pus;
Erythema Multiforme (EM) – skin rash with irregular, itchy, red patches.
If the patient experiences any of these symptoms, stop taking Ketipinor immediately and contact a doctor or seek medical help without delay.
Weight gain
Weight gain has been observed in patients taking Ketipinor. The patient and doctor should regularly monitor the patient’s body weight.
Children and adolescents
Ketipinor is not intended for use in children and adolescents under 18 years of age.
Ketipinor and 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 Ketipinor if the patient is taking any of the following medicines:

certain medicines used to treat HIV infection,
azole antifungals (used to treat fungal infections),
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 Ketipinor and cause symptoms such as involuntary, rhythmic muscle contractions, including those of the eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, and body temperature above 38°C. If such symptoms occur, contact the doctor immediately.
antiepileptic medicines (such as phenytoin or carbamazepine),
medicines used to treat high blood pressure,
barbiturates (used for sleep disorders),
thioridazine or lithium (other antipsychotic medicines),
medicines affecting heart rhythm, for example, medicines that may disturb electrolyte balance (reduced potassium or magnesium levels), such as diuretics (causing increased urine production) or certain antibiotics (used to treat infections),
medicines that may cause constipation,
medicines (so-called anticholinergic agents) that affect nerve function to treat certain conditions.

The patient should consult a doctor before stopping any medicine.
Ketipinor with food, drink and alcohol

Ketipinor can be taken with or without food.
During treatment with Ketipinor, caution should be exercised when consuming alcoholic beverages, as the combined effect of Ketipinor and alcohol may cause drowsiness.
Grapefruit juice should not be consumed during treatment with Ketipinor, as it may affect how the medicine works.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
The patient should not take Ketipinor during pregnancy unless discussed with her doctor. Ketipinor should not be taken during breastfeeding.
The following symptoms, which may indicate withdrawal syndrome, may occur in newborns of mothers who took Ketipinor during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the patient’s child develops any of these symptoms, medical advice should be sought.
Driving and operating machinery
This medicine may cause drowsiness. Do not drive or operate machinery until you know how the medicine affects you.
Effect on urine drug screening tests
In patients taking Ketipinor, urine drug screening tests performed by certain methods may show positive results for methadone or certain antidepressants known as tricyclic antidepressants (TCA), even though the patient has not taken these medicines. It is recommended that these tests be confirmed using alternative methods.
Ketipinor contains lactose
Ketipinor contains 19.7 mg, 39.3 mg, or 59 mg of lactose (as monohydrate), in 100 mg, 200 mg, and 300 mg tablets, respectively. If the patient has been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.
Other excipients
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Ketipinor

This medicine should always be taken as directed by the physician or pharmacist. If in doubt,
consult the physician or pharmacist.
The initial dose will be determined by the treating physician. The maintenance dose (daily dose)
depends on the severity of the disease and the individual needs of the patient, but usually ranges
from 150 mg to 800 mg.

Ketipinor tablets should be taken once daily, before bedtime, or twice daily, depending on the condition being treated.
Tablets should be swallowed whole with water.
Tablets may be taken with or without food.
Grapefruit juice should not be consumed during treatment with Ketipinor. It may affect how the medicine works.
Do not stop taking the tablets even if you start to feel better, until your doctor decides otherwise.

Liver function disorders
The physician may recommend adjusting the dosing regimen in patients with hepatic impairment.
Elderly patients
The physician may recommend adjusting the dosing regimen in elderly patients.
Use in children and adolescents
Ketipinor should not be used in children and adolescents under 18 years of age.
Taking more Ketipinor than recommended
If more Ketipinor has been taken than prescribed, symptoms such as drowsiness, dizziness, or irregular heartbeat may occur. Seek immediate medical advice from a physician or go to the nearest hospital. Bring the Ketipinor tablets with you.
Missed dose of Ketipinor
If a dose has been missed, take it as soon as remembered. If it is almost time for the next dose, wait and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Ketipinor
If treatment with Ketipinor is stopped abruptly, difficulty sleeping (insomnia) may occur, or the patient may experience nausea, headache, diarrhea, vomiting, dizziness, or irritability. The physician may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

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

Very common (may occur in more than 1 in 10 patients):

dizziness (which may lead to falls), headache, dry mouth,
drowsiness (which may diminish during continued treatment with Ketipinor) (may lead to falls),
withdrawal symptoms (symptoms occurring after discontinuation of Ketipinor), including: difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended.
weight gain,
abnormal muscle contractions; this may include difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness,
changes in blood levels of certain lipid substances (triglycerides and total cholesterol).

Common (may occur in 1 in 10 patients):

increased heart rate,
sensation of irregular heartbeat, palpitations, rapid heartbeat or pauses in heart rhythm,
constipation, stomach irritation (dyspepsia),
weakness,
swelling of hands or feet,
low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls),
increased blood glucose levels,
blurred vision,
unusual dreams and nightmares,
increased appetite,
feeling irritable,
speech and language disturbances,
suicidal thoughts and worsening of depression,
shortness of breath,
vomiting (mainly in elderly patients),
fever,
changes in thyroid hormone levels in blood,
decreased number of certain types of blood cells,
increased levels of liver enzymes in blood,
increased concentration of the hormone prolactin in blood. Elevated prolactin levels may rarely lead to:
breast enlargement in both men and women, and unexpected milk production,
absence or irregular menstruation in women.

Uncommon (may occur in 1 in 100 patients):

seizures or seizure attacks,
allergic reactions such as skin blisters (vesicles), skin swelling and swelling around the mouth,
unpleasant sensations in the lower limbs (also known as restless legs syndrome),
difficulty swallowing,
involuntary muscle movements, particularly of the face and tongue,
sexual dysfunction,
diabetes,
changes in the electrical activity of the heart visible on ECG (prolongation of QT interval),
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 (may lead to falls),
nasal congestion,
decreased number of red blood cells in blood,
decreased sodium levels in blood,
worsening of pre-existing diabetes,
disorientation.

Rare (may occur in 1 in 1,000 patients):

combination of high body temperature (fever), sweating, muscle rigidity, drowsiness or near-fainting (a condition known as "neuroleptic malignant syndrome"),
yellowing of the skin and eyes (jaundice),
hepatitis (liver inflammation),
prolonged, painful erection (priapism),
breast enlargement and unexpected milk discharge (galactorrhea),
menstrual cycle disturbances,
formation of blood clots in veins, especially in the legs (symptoms include swelling, pain and redness of the legs); a fragment of the clot may travel through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, patients should seek immediate medical attention at a doctor’s office or hospital.
sleepwalking, talking, eating or performing other activities while asleep,
decreased body temperature (hypothermia),
pancreatitis,
a condition (known as "metabolic syndrome") involving a combination of 3 or more of the following: increased abdominal fat, reduced "good cholesterol" (HDL-C), increased levels of blood lipids (triglycerides), high blood pressure, and elevated blood glucose,
combination of fever, flu-like symptoms, sore throat or any other infection with a very low number of white blood cells in blood (a condition known as agranulocytosis),
intestinal obstruction,
increased creatine phosphokinase levels in blood (a substance derived from muscles).

Very rare (may occur in 1 in 10,000 patients):

severe rash, blisters or red spots on the skin,
severe hypersensitivity reactions (anaphylactic reaction), manifesting as difficulty breathing or shock,
rapidly developing swelling of the skin, usually around the eyes, mouth and throat (angioedema),
severe condition with blister formation on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome). See section 2.
inappropriate secretion of the hormone regulating urine volume,
muscle fiber breakdown and muscle pain (rhabdomyolysis).

Frequency not known (frequency cannot be estimated from available data):

sudden appearance of red skin areas with small blisters (small blisters filled with whitish-yellow fluid, known as "acute generalized exanthematous pustulosis" (AGEP)). See section 2.
skin rash with irregular red patches (erythema multiforme),
severe, sudden allergic reaction with symptoms such as fever, blistering of 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 lymph nodes and abnormal blood test results (including increased white blood cell count (eosinophilia) and liver enzyme levels). See section 2.
heart muscle disorders (cardiomyopathy),
inflammation of the heart muscle (myocarditis),
inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules,
withdrawal symptoms may occur in newborns of mothers who took Ketipinor during pregnancy,
stroke.

Medicines of the class to which Ketipinor belongs may cause disturbances in heart rhythm, which may be dangerous and, in severe cases, may lead to death.

Some adverse reactions can only be detected by laboratory blood tests. These include changes in blood levels of certain lipid substances (triglycerides and total cholesterol) or blood glucose, changes in thyroid hormone levels in blood, increased liver enzyme levels in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase levels in blood (a substance derived from muscles), decreased sodium levels in blood, and increased blood concentration of the hormone prolactin. Elevated prolactin levels may rarely lead to:

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

Your doctor may recommend periodic blood monitoring tests.

Additional adverse reactions in children and adolescents

The same adverse reactions observed in adult patients may occur in children and adolescents.

The following adverse reactions have been observed more frequently or exclusively in children and adolescents:

Very common (may occur in more than 1 in 10 patients):

increased blood levels of the hormone prolactin. In rare cases, this may lead to:
breast enlargement and unexpected milk discharge in boys and girls,
in girls, cessation or irregular menstruation,
increased appetite,
vomiting,
abnormal muscle contractions, including difficulty initiating intended movement, tremors, muscle restlessness or muscle stiffness without pain,
increased blood pressure.

Common (may occur in up to 1 in 10 patients):

feeling of weakness, fainting (may lead to falls),
nasal congestion,
feeling irritable.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can 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,
Phone: 22 49 21 301,
Fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ketipinor

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special precautions regarding storage of the medicinal product are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ketipinor contains

The active substance is quetiapine. Each coated tablet contains 25 mg, 100 mg, 200 mg, or 300 mg of quetiapine (as fumarate).
Other ingredients in the core of the 25 mg tablet are microcrystalline cellulose, sodium croscarmellose, povidone K 30, and magnesium stearate.
Other ingredients in the core of the 100 mg, 200 mg, and 300 mg tablets are microcrystalline cellulose, calcium hydrogen phosphate dihydrate, lactose monohydrate, sodium carboxymethyl starch (type A), povidone K 30, and magnesium stearate.
Ingredients of the coating of the 25 mg and 100 mg tablets: Opadry II (containing polyvinyl alcohol (partially hydrolysed), polyethylene glycol 3350, talc, titanium dioxide (E171), iron oxides (E172)).
Ingredients of the coating of the 200 mg and 300 mg tablets: Opadry II White (containing polyvinyl alcohol (partially hydrolysed), polyethylene glycol 3350, talc, titanium dioxide (E171)).

What Ketipinor looks like and contents of the pack
Ketipinor 25 mg: brown or dark pink, round, convex coated tablets with a diameter of 6 mm,
embossed with ‘OR41’ on one side and smooth on the other.
Ketipinor 100 mg: light yellow, round, convex coated tablets with a diameter of 8 mm,
embossed with ‘OR411’ on one side and smooth on the other.
Ketipinor 200 mg: white, round, convex coated tablets with a diameter of 11 mm,
embossed with ‘OR412’ on one side and smooth on the other.
Ketipinor 300 mg: white, capsule-shaped coated tablets, 19 mm in length,
embossed with ‘OR413’ on one side and smooth on the other.
The tablets are available in blister packs contained in cardboard boxes and in HDPE bottles.
Blister packs:
25 mg: 6, 10, 30, 60, and 100 tablets.
100 mg, 200 mg, and 300 mg: 30, 60, 90, and 100 tablets.
Plastic bottles:
25 mg, 100 mg, 200 mg, and 300 mg: 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer
Orion Corporation, Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Finland, Estonia, Latvia, Lithuania, Poland: Ketipinor
Hungary: Quetiapine Orion