Etiagen

Leaflet attached to the packaging: information for the user

Etiagen, 25 mg, coated tablets

Etiagen, 100 mg, coated tablets

Etiagen, 200 mg, coated tablets

Quetiapine

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others.
• The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Etiagen and what is it used for

Etiagen contains a substance called quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine may be used to treat a number of diseases, such as:

• Depression in bipolar affective disorder, in which the patient feels states of great depression, intense sadness, has a sense of guilt, lack of energy and appetite, and (or) difficulty sleeping.
• Mania, in which the patient is overexcited, elated, has an overly elevated mood, feels enthusiasm, or exhibits excessive activity, or has impaired judgment along with aggressive or destructive behaviors.
• Schizophrenia, in which the patient sees, hears, or feels non-existent things, believes in things that are not true, or becomes extremely suspicious, excited, disoriented, has a sense of guilt, is tense, or depressed.

The doctor may continue to prescribe Etiagen even when the patient feels an improvement in their well-being.

2. Important information before taking Etiagen

When not to take Etiagen:

• 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 the following medicines:
• certain medicines used to treat HIV infections;
• azole antifungal medicines;
• erythromycin or clarithromycin (used in infections);
• nefazodone (an antidepressant).

If any of the above situations apply to the patient, they should not take Etiagen. In case of doubts, before taking Etiagen, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Etiagen, the patient should discuss it with their doctor or pharmacist:

• if the patient or any of their family members have had heart problems, such as arrhythmias, heart muscle weakness, myocarditis, or if the patient is taking medicines that may affect heart rhythm;
• if the patient has low blood pressure;
• if the patient has had a stroke, especially if the patient is elderly;
• if the patient has liver problems;
• if the patient has ever had epilepsy or seizures;
• if the patient has diabetes or is at risk of diabetes; in this case, the doctor may order a blood glucose test while taking Etiagen;
• if the patient has a history of a low white blood cell count (which may, but does not have to be, caused by taking other medicines);
• if the patient is elderly and has dementia (loss of brain function); in this case, Etiagen should not be taken, as it belongs to a group of medicines that may increase the risk of stroke, and sometimes the risk of death in elderly patients with dementia;
• if the patient is an elderly person with Parkinson's disease/parkinsonism;
• if the patient or any of their family members have had blood clots, as the use of medicines in this group has been associated with the formation of blood clots;
• if the patient has or has had a condition in which they stop breathing for short periods during normal nighttime sleep (so-called "sleep apnea"), and the patient is taking medicines that slow down brain activity ("central nervous system depressants");
• if the patient has or has had a condition in which they cannot completely empty their bladder (urinary retention), has an enlarged prostate, intestinal obstruction, or increased eye pressure. These situations are sometimes caused by taking medicines (so-called "anticholinergic medicines") that affect the functioning of nerve cells to treat certain diseases.
• if the patient has a history of alcohol or drug abuse.
• if the patient has depression or other conditions that are treated with antidepressants. The use of these medicines with Etiagen may lead to the development of serotonin syndrome, a potentially life-threatening condition (see "Etiagen and other medicines").

The patient should immediately inform their doctor if they experience symptoms such as:

• rapid and irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, immediately refer the patient to a cardiologist;
• a syndrome of symptoms: high fever, acute muscle stiffness, sweating, or a feeling of disorientation (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary;
• uncontrolled movements, mainly of the face or tongue;
• dizziness or a feeling of great drowsiness. This may increase the risk of accidental injury (falls) in elderly patients;
• seizures;
• prolonged and painful erections (priapism).

All these symptoms may occur during treatment with this type of medicine.

The patient should immediately inform their doctor if they experience:

• fever, flu-like symptoms, sore throat, or any other infections, as this may be a sign of a very low white blood cell count; discontinuation of quetiapine and (or) appropriate treatment may be necessary;
• constipation with persistent abdominal pain or constipation that is resistant to treatment, as this may lead to more serious bowel obstruction.

Suicidal thoughts and worsening depression

In patients with depression, suicidal thoughts or behaviors may sometimes occur. Such symptoms or behaviors may worsen at the beginning of treatment, as these medicines start to work with a delay, usually after about 2 weeks, sometimes later. Such symptoms may worsen if the patient suddenly stops taking the medicine. The risk of suicidal thoughts or behaviors is more likely in young adult patients. Clinical trial data show an increased risk of suicidal thoughts and (or) behaviors in people under 25 years of age with depression.
The patient should immediately contact their doctor or go to the hospitalif they experience suicidal thoughts or behaviors. It may be helpful to inform relatives
or friendsabout the depression and ask them to read this leaflet. The patient may ask to be informed if they notice that their depression has worsened or if there are worrying changes in their behavior.

Severe skin reactions (SCAR, severe cutaneous adverse reactions)

During treatment with this medicine, very rare severe skin reactions (SCAR) have been reported, which can be life-threatening or lead to death. They usually occur in the form of:

• Stevens-Johnson syndrome (SJS) - a widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals
• Toxic epidermal necrolysis (TEN) - a more severe form causing widespread peeling of the skin
• Drug reaction with eosinophilia and systemic symptoms (DRESS) involving flu-like symptoms with a rash, fever, lymph node enlargement, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and liver enzymes)
• Acute generalized exanthematous pustulosis (AGEP) - small pus-filled blisters
• Erythema multiforme (EM) - a skin rash with irregular, itchy, red patches

If the patient experiences these symptoms, they should stop taking Etiagen and immediately contact their doctor or seek medical attention.

Weight gain

Patients taking quetiapine have been observed to gain weight. The patient's weight should be checked regularly.

Children and adolescents

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

Etiagen and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Etiagen should not be taken if the patient is taking any of the following medicines:

• certain medicines used to treat HIV infections
• azole antifungal medicines
• erythromycin or clarithromycin (used in infections)
• nefazodone (an antidepressant)

The patient should inform their doctor if they are taking any of the following medicines:

• medicines used to treat epilepsy (such as phenytoin or carbamazepine)
• medicines used to treat high blood pressure
• barbiturates (used for difficulty sleeping)
• thioridazine or lithium (other medicines used to treat mental illnesses)
• medicines that may affect heart rhythm, such as medicines that may cause electrolyte imbalance (low potassium or magnesium) in the blood, such as diuretics and certain antibiotics (used to treat infections)
• medicines that may cause constipation
• antidepressants. These medicines may interact with Etiagen and may cause symptoms such as involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, the patient should consult their doctor.

The patient should not stop taking other medicines without first consulting their doctor.

Etiagen with food, drink, and alcohol

The patient should be cautious when drinking alcoholic beverages. Taking Etiagen with alcohol may cause drowsiness.
The patient should not drink grapefruit juice while taking Etiagen, as it may affect the action of Etiagen.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Etiagen should not be taken during pregnancy, unless the doctor recommends otherwise. Etiagen should not be taken during breastfeeding.
In newborns of mothers who took quetiapine in the last trimester of pregnancy (the last three months of pregnancy), the following symptoms may occur, which may be withdrawal symptoms: trembling, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing problems, and difficulty feeding.
If the newborn experiences any of these symptoms, they should contact their doctor.

Driving and using machines

The medicine may cause drowsiness. The patient should not drive vehicles or operate machinery until they know how the medicine affects them.

Etiagen contains lactose and sodium

Etiagen contains lactose, which is a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free.”

Effect on urine tests

In patients taking Etiagen, urine tests may show the presence of methadone or antidepressants (from the tricyclic antidepressant group), even if the patient is not taking them. Such results must be confirmed using more specific tests.

3. How to take Etiagen

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will decide on the initial dose. The maintenance dose (daily dose) of the medicine depends on the disease and the patient's response to the medicine, but it is usually between 150 mg and 800 mg.

• The medicine should be taken once a day, in the evening, or twice a day, depending on the patient's disease.
• The tablets should be swallowed whole, with a glass of water. The tablets can be taken with or without food. Etiagen should not be taken with grapefruit juice, as it may affect the action of the medicine.
• The patient should not stop taking the tablets even when they feel an improvement in their well-being, unless the doctor decides otherwise.

Liver disease:

The doctor may recommend taking the medicine in a lower dose if the patient has liver disease.

Elderly patients:

The doctor may change the dose of the medicine.

Use in children and adolescents

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

Taking a higher dose of Etiagen than recommended

Taking a higher dose of Etiagen than recommended may cause drowsiness, dizziness, irregular heartbeat, dry mouth, constipation, dilated pupils, and blurred vision. The patient should immediately consult their doctor or go to the nearest hospital. The patient should take the packaging and any remaining Etiagen tablets with them.

Missing a dose of Etiagen

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, they should wait until then.
The patient should not take a double dose to make up for the missed dose.

Stopping Etiagen

If the patient suddenly stops taking Etiagen, they may experience symptoms such as:
sleep problems (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. The doctor may recommend gradually reducing the dose of the medicine over a period of at least 1 to 2 weeks.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should

IMMEDIATELY contact their doctor:

Very common(may affect more than 1 in 10 people):

• abnormal muscle movements, including difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain.

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

• suicidal thoughts, self-harm, or worsening depression.

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

• diabetes: a condition in which the body does not produce enough insulin or other body tissues are unable to use the insulin present in the body. This leads to hyperglycemia (too much sugar in the blood). Symptoms may include excessive thirst, increased appetite, weight loss, feeling tired, drowsy, weak, depressed, irritable, and generally unwell, frequent urination;
• seizures;
• allergic reactions in the form of skin lumps and swelling, as well as swelling around the mouth;
• uncontrolled movements, mainly of the face and tongue;
• changes in the electrical activity of the heart (visible in the ECG as QT interval prolongation), which may cause very rapid heartbeat and fainting, and may cause serious heart problems;
• difficulty urinating;
• worsening of pre-existing diabetes.

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

• a syndrome of symptoms: high body temperature (fever), sweating, muscle stiffness, feeling drowsy or fainting, high blood pressure, and rapid heartbeat (a condition called malignant neuroleptic syndrome);
• pancreatitis, which causes severe abdominal and back pain;
• jaundice (yellowing of the skin and eyes);
• hepatitis;
• prolonged and painful erections (priapism);
• formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing;
• agranulocytosis, a condition characterized by the simultaneous occurrence of fever, flu-like symptoms, sore throat, or other infections with a very low white blood cell count;
• intestinal obstruction, causing severe constipation, bloating, and abdominal swelling or pain.

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

• severe allergic reactions (anaphylaxis), which may include difficulty breathing, dizziness, and fainting;
• severe skin rash, which may develop rapidly. Symptoms may include redness, blistering, and peeling of the skin, especially around the mouth, nose, eyes, and genitals (a condition known as Stevens-Johnson syndrome). See section 2;
• sudden swelling of the skin, usually around the eyes, mouth, and throat;
• abnormal secretion of antidiuretic hormone, leading to water retention in the body, dilution of the blood, and decreased sodium levels. This may lead to weakness, disorientation, and muscle pain;
• breakdown of muscle fibers, causing pain, tenderness, and weakness of the muscles (rhabdomyolysis).

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

• generalized redness of the skin with blisters and peeling of the skin on most of the body surface (toxic epidermal necrolysis). See section 2;
• drug reaction with eosinophilia and systemic symptoms (DRESS). Widespread rash, high fever, enlarged lymph nodes, and abnormal blood test results (including an increased number of white blood cells (eosinophilia) and liver enzymes)

(eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms is also known as DRESS or hypersensitivity syndrome). See section 2. If the patient experiences these symptoms, they should
stop taking Etiagen and immediately contact their doctor
or seek medical attention;

• stroke.

Other possible side effects:

Very common(may affect more than 1 in 10 people):

• dizziness (which may lead to falls), headache, dry mouth;
• feeling drowsy (this symptom may disappear over time while taking Etiagen) (may lead to falls);
• withdrawal symptoms (symptoms that occur after suddenly stopping Etiagen), including: difficulty sleeping (insomnia), nausea, headache, diarrhea, vomiting, dizziness, and irritability. It is recommended to gradually reduce the dose of the medicine over a period of at least 1 to 2 weeks;
• weight gain;
• changes in the levels of certain sugars (triglycerides and total cholesterol) in the blood.

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

• rapid heartbeat;
• feeling of palpitations, rapid rhythm;
• indigestion or constipation;
• feeling weak;
• swelling of the hands or feet;
• low blood pressure when standing up, which may cause dizziness or fainting (may lead to falls);
• high blood sugar levels;
• blurred vision;
• unusual dreams and nightmares;
• increased appetite;
• feeling irritable;
• speech disorders;
• shortness of breath;
• vomiting (mainly in elderly people);
• fever;
• changes in thyroid hormone levels in the blood;
• decreased number of certain types of blood cells;
• increased liver enzyme levels in the blood;
• increased prolactin levels in the blood may have the following consequences:
• breast swelling and unexpected milk production in men and women;
• absence of menstruation or irregular menstruation in women.

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

• unpleasant feeling in the legs (restless legs syndrome);
• difficulty swallowing;
• sexual disorders;
• slower than usual heartbeat, which may occur at the beginning of treatment, may be associated with low blood pressure and fainting;
• fainting (which may lead to falls);
• stuffy nose;
• decreased red blood cell count;
• decreased sodium levels in the blood;
• confusion.

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

• breast swelling and unexpected milk production in women (galactorrhea);
• menstrual disorders;
• walking, talking, and eating during sleep;
• low body temperature (hypothermia);
• a condition called metabolic syndrome, in which there is a combination of three or more symptoms: fat accumulation in the abdominal area, decreased "good" cholesterol (HDL-C), increased triglyceride levels in the blood, high blood pressure, and increased blood sugar levels;
• increased creatine kinase activity in the blood (a substance found in muscles).

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

• skin rash with irregular, itchy, red patches (erythema multiforme);
• withdrawal symptoms, which may occur in newborns whose mothers took Etiagen during pregnancy;
• heart muscle disorders (cardiomyopathy);
• heart muscle inflammation;
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple bumps.

The group of medicines to which quetiapine belongs may cause heart rhythm disorders, which can sometimes be serious and, in severe cases, lead to death.
Some side effects have only been observed in blood tests. These include changes in the levels of certain sugars (triglycerides and total cholesterol) or glucose (sugar) in the blood, changes in thyroid hormone levels in the blood, increased liver enzyme activity, decreased number of certain types of blood cells, decreased red blood cell count, increased creatine kinase activity in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased prolactin levels in the blood. The doctor may recommend that the patient have blood tests from time to time.

Side effects in children and adolescents:

Children and adolescents may experience the same side effects as adults.
The following side effects have been observed more frequently in children and adolescents or have not been observed in adults:
Very common(may affect more than 1 in 10 people):

• increased prolactin levels in the blood. Increased prolactin levels may rarely lead to the following symptoms:
• breast swelling and unexpected milk production in boys and girls;
• absence of menstruation or irregular menstruation in girls.
• increased appetite;
• vomiting;
• abnormal muscle movements. These include difficulty starting intended movements, tremors, restlessness, or muscle stiffness without pain;
• high blood pressure.

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

• feeling weak, fainting (which may lead to falls);
• stuffy nose;
• feeling irritable.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 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 Etiagen

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Etiagen contains

• The active substance of the medicine is quetiapine fumarate. One 25 mg Etiagen coated tablet contains 25 mg of quetiapine (in the form of quetiapine fumarate) and 4.50 mg of lactose monohydrate. One 100 mg Etiagen coated tablet contains 100 mg of quetiapine (in the form of quetiapine fumarate) and 18 mg of lactose monohydrate. One 200 mg Etiagen coated tablet contains 200 mg of quetiapine (in the form of quetiapine fumarate) and 36 mg of lactose monohydrate.
• The other ingredients of the medicine are: lactose monohydrate (see section 2 "Etiagen contains lactose and sodium"), microcrystalline cellulose, povidone 30, magnesium stearate, sodium carboxymethylcellulose (type A) (see section 2 "Etiagen contains lactose and sodium"), calcium hydrogen phosphate dihydrate. The tablet coating contains: 25 mg tablets: titanium dioxide (E 171), hypromellose, macrogol 400, iron oxide red (E 172) 100 mg tablets: titanium dioxide (E 171), hypromellose, macrogol 6000, iron oxide yellow (E 172), talc 200 mg tablets: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80

What Etiagen looks like and contents of the pack

Etiagen is available as coated tablets.
Etiagen, 25 mg, coated tablets:
round, biconvex, pink tablets with "Q" engraved on one side.
Etiagen, 25 mg, coated tablets are available in:
blister packs of 10 and 30 tablets, in a cardboard box, and
perforated unit dose blister packs of 6 x 1 tablet and 60 x 1 tablet
Etiagen, 100 mg, coated tablets:
round, yellow tablets with "Q" engraved above "100" on one side.
Etiagen, 100 mg, coated tablets are available in:
blister packs of 60 and 90 tablets, in a cardboard box, and
perforated unit dose blister packs of 60 x 1 tablet
Etiagen, 200 mg, coated tablets:
round, white tablets with "Q" engraved above "200" on one side.
Etiagen, 200 mg, coated tablets are available in:
blister packs of 60 and 90 tablets, in a cardboard box, and
perforated unit dose blister packs of 60 x 1 tablet
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland
Manufacturer
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Generics [UK] Limited
Potters Bar, Hertfordshire, EN6 1TL
United Kingdom
Mylan Hungary Kft.
Mylan utca 1.
Komárom 2900
Hungary
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 54 66 400
Date of last revision of the leaflet:June 2024