Package leaflet: Information for the user

Etiagen, 25 mg, film-coated tablets
Etiagen, 100 mg, film-coated tablets
Etiagen, 200 mg, film-coated tablets
Quetiapinum
Please read this leaflet carefully before using 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 doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others.
It 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 Etiagen is and what it is used for
Important information before taking Etiagen
How to take Etiagen
Possible side effects
How to store Etiagen
Contents of the pack and other information

1. What Etiagen is and what it is used for

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

Depressive episodes in bipolar affective disorder, during which the patient experiences feelings of deep sadness, intense grief, guilt, lack of energy and appetite, and (or) difficulty sleeping.
Mania, during which the patient is excessively stimulated, excited, has abnormally elevated mood, shows enthusiasm or excessive activity, or exhibits inappropriate behaviour including aggressive or destructive actions.
Schizophrenia, during which the patient sees, hears or feels things that do not exist, believes in things that are not true, becomes extremely suspicious, agitated, disoriented, experiences guilt, or feels tense or depressed.

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

2. Information before using Etiagen

When not to use 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 any of the following medicines:
certain medicines used to treat HIV infections;
azole antifungal medicines;
erythromycin or clarithromycin (used for infections);
nefazodone (an antidepressant medicine).

If any of the above situations apply to the patient, Etiagen must not be taken.
If in doubt, consult a doctor or pharmacist before taking Etiagen.

Warnings and precautions

Before starting treatment with Etiagen, discuss the following with your doctor or pharmacist:

if the patient has or has had heart problems, such as irregular heartbeat, weakened heart muscle, or myocarditis, or if the patient is taking medicines that may affect heart rhythm;
if the patient has low blood pressure;
if the patient has ever had a stroke, especially in elderly patients;
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 developing diabetes; in such cases, the doctor may recommend checking blood glucose levels during treatment with Etiagen;
if the patient has previously had low white blood cell counts (which may or may not have been caused by other medicines);
if the patient is elderly and has dementia (loss of brain function); in such cases, Etiagen must not be used, as it belongs to a group of medicines that may increase the risk of stroke and even death in elderly patients with dementia;
if the patient is an elderly person with Parkinson's disease/parkinsonism;
if the patient or anyone in their family has had blood clots, as use of medicines in this group has been associated with blood clot formation;
if the patient has or has previously had a condition involving temporary breathing pauses during normal nighttime sleep (so-called "sleep apnoea"), especially when taking medicines that slow down brain activity ("central nervous system depressants");
if the patient has or has previously had difficulty completely emptying the bladder (urinary retention), enlarged prostate, intestinal obstruction, or increased eye pressure. These conditions may sometimes be caused or worsened by medicines (so-called "anticholinergic medicines") that affect nerve cell function in treating certain diseases;
if the patient has had problems with alcohol or drug abuse in the past;
if the patient has depression or other conditions treated with antidepressant medicines. Using these medicines together with Etiagen may lead to serotonin syndrome, a potentially life-threatening condition (see "Etiagen with other medicines").

Immediately inform the doctor if any of the following symptoms occur after taking Etiagen:

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;
a group of symptoms including high temperature (fever), severe muscle stiffness, sweating, or confusion (a condition known as neuroleptic malignant syndrome). Immediate medical help may be required;
uncontrolled movements, mainly of the face or tongue;
dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls), especially in elderly patients;
seizures (fits);
prolonged and painful erection (priapism).

All of these symptoms may occur during treatment with this type of medicine.
Immediately inform the doctor if the patient experiences:

fever, flu-like symptoms, sore throat, or any other signs of infection, as this may indicate very low white blood cell count; treatment with quetiapine may need to be stopped and/or appropriate treatment started;
constipation accompanied by persistent abdominal pain or constipation that does not respond to treatment, as this may lead to more serious intestinal blockage.

Suicidal thoughts and worsening depression

Patients with depression may sometimes experience thoughts of self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment, as these medicines take time to work, usually about 2 weeks or sometimes longer. Symptoms may also worsen if the patient suddenly stops taking the medicine. The risk of self-harm or suicidal thoughts is higher in young adult patients. Clinical trial data show an increased risk of suicidal thoughts and/or behaviours in people under 25 years of age with depression.

Contact a doctor immediately or go to hospital if thoughts of self-harm or suicidal thoughts occur. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or concerning changes in behaviour.

Severe skin reactions (SCAR – severe cutaneous adverse reactions)

Very rarely, severe skin reactions (SCAR), which may be life-threatening or fatal, have been reported during treatment with this medicine. These usually present as:

Stevens-Johnson syndrome (SJS) – widespread blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals;
Toxic epidermal necrolysis (TEN) – a more severe form causing extensive skin peeling;
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) – flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes);
Acute Generalized Exanthematous Pustulosis (AGEP) – small pustules filled with pus;
Erythema Multiforme (EM) – skin rash with irregular, itchy, red patches.

If any of these symptoms occur, stop taking Etiagen immediately and contact the treating doctor or seek medical help.

Weight gain

Weight gain has been observed in patients taking quetiapine. Body weight should be monitored regularly.

Children and adolescents

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

Etiagen 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 Etiagen if the patient is taking any of the following medicines:

certain medicines used to treat HIV infections;
azole antifungal medicines;
erythromycin or clarithromycin (used for infections);
nefazodone (an antidepressant medicine).

Inform the treating doctor if the patient is 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, e.g. medicines causing electrolyte imbalance (low potassium or magnesium levels) such as diuretics and certain antibiotics (used to treat infections);
medicines that may cause constipation;
antidepressant medicines. These medicines may interact with Etiagen and cause symptoms such as involuntary, rhythmic muscle contractions (including eye movements), agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, muscle rigidity, and body temperature above 38°C (serotonin syndrome). If such symptoms occur, contact a doctor.

Do not stop taking other medicines without first consulting a doctor.

Etiagen with food, drink, and alcohol

Be cautious when consuming alcoholic beverages. Taking Etiagen with alcohol may increase drowsiness.

Do not drink grapefruit juice during treatment with Etiagen, as it may affect the medicine's action.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine. Etiagen must not be used during pregnancy unless specifically advised by a doctor. Etiagen must not be used during breastfeeding.

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

Driving and operating machinery

This medicine may cause drowsiness. Do not drive or operate machinery until the patient knows how this medicine affects them.

Etiagen contains lactose and sodium

Etiagen contains lactose, a type of sugar. If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before starting treatment.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

Effect of the medicine on urine tests

In patients taking Etiagen, urine tests may show the presence of methadone or antidepressant medicines (tricyclic antidepressants), even if the patient has not taken them. These results must be confirmed with more specific tests.

3. How to use Etiagen

This medicine should always be taken as directed by the physician. If in doubt, consult a doctor or pharmacist.
The physician will decide the initial dose. The maintenance dose (daily dose) of the medicine depends on the disease and the patient's response to treatment, but usually ranges from 150 mg to 800 mg.

This medicine should be taken once daily, in the evening, or twice daily, depending on the patient's condition.
Tablets should be swallowed whole with water. Tablets may be taken with or without food. Etiagen should not be taken at the same time as grapefruit juice, as this could affect the medicine's action.
Do not stop taking the tablets even if you start feeling better, unless otherwise decided by your doctor.

Liver disease:
The physician may recommend a lower dose if the patient has liver disease.
Elderly patients:
The physician may adjust the dose of the medicine.
Use in children and adolescents
Etiagen must not be used in children and adolescents under 18 years of age.
Taking more Etiagen than recommended
Taking more Etiagen than recommended may cause drowsiness, dizziness, sensation of irregular heartbeat, dry mouth, constipation, dilated pupils, and blurred vision. Seek immediate medical advice from a doctor or go to the nearest hospital. Bring the medicine packaging and any remaining tablets with you.
Missed dose of Etiagen
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, wait and take the next dose at the scheduled time.
Do not take a double dose to make up for a missed dose.
Stopping Etiagen
If Etiagen is stopped suddenly, symptoms such as sleep disturbances (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability may occur.
The physician may recommend gradually reducing the dose before stopping treatment completely.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If the patient experiences any of the adverse effects listed below, they should
IMMEDIATELY contact a doctor:

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

abnormal muscle movements, including difficulty initiating intended movement, tremors, restlessness or muscle stiffness without associated pain.

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

suicidal thoughts, self-harm ideation, or worsening of depression.

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

diabetes: a condition in which the body does not produce enough insulin or body tissues are unable to use the insulin present in the body. This leads to hyperglycaemia (excess sugar in the blood). Symptoms may include excessive thirst, increased appetite with weight loss, feeling tired, drowsiness, weakness, depression, irritability and general malaise, and passing large amounts of urine;
epileptic seizures, convulsions;
allergic reactions presenting as skin rashes and swelling, including swelling around the mouth;
uncontrolled movements, mainly of the face and tongue;
changes in the heart's electrical activity (prolongation of the QT interval seen on ECG), which may cause very rapid heartbeat and fainting, and may lead to serious heart problems;
difficulty passing urine;
worsening of pre-existing diabetes.

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

a group of symptoms: high body temperature (fever), sweating, muscle stiffness, drowsiness or fainting, marked increase in blood pressure or significantly rapid heartbeat (a condition known as "neuroleptic malignant syndrome");
pancreatitis, causing severe abdominal and back pain;
yellowing of the skin and eyes (jaundice);
hepatitis;
prolonged and painful penile erection (priapism);
formation of blood clots in veins, especially in the lower limbs (symptoms include leg swelling, pain and redness), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties;
agranulocytosis, a condition characterized by the combination of fever, flu-like symptoms, sore throat or other infections, with a very low number of white blood cells;
intestinal obstruction causing severe constipation, bloating, and abdominal swelling or pain.

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

severe allergic reactions (called anaphylaxis), which may include breathing difficulties, dizziness and collapse;
severe rash, which may develop rapidly. Symptoms may include redness, blistering and peeling of the skin, particularly around the mouth, nose, eyes and genital organs (a condition known as Stevens-Johnson syndrome). See section 2;
sudden swelling of the skin, usually around the eyes, mouth and throat;
inappropriate secretion of antidiuretic hormone causing water retention in the body, dilution of blood, and reduced sodium levels. This may lead to lower-than-normal sodium levels in the blood and cause weakness, confusion, and muscle pain;
breakdown of muscle fibres causing muscle pain, tenderness and weakness (rhabdomyolysis).

Adverse effects with unknown frequency (frequency cannot be determined from available data):

widespread redness of the skin with blisters and peeling of the epidermis over most of the body surface (toxic epidermal necrolysis). See section 2;
rash with eosinophilia and systemic symptoms (DRESS). Extensive rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (rash with eosinophilia and systemic symptoms is also known as DRESS or drug hypersensitivity syndrome). See section 2. If the patient develops these symptoms, treatment with Etiagen must be
discontinued immediately and the patient should contact their doctor immediately
or seek medical help;
Stroke.

Other possible adverse effects:
Very common (may affect more than 1 in 10 patients):

dizziness (which may lead to falls), headache, dry mouth;
drowsiness (this symptom may diminish over time during treatment with Etiagen) (may lead to falls);
withdrawal symptoms (symptoms occurring after abrupt discontinuation of Etiagen), including: difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness and irritability. Gradual dose reduction over a period of at least 1 to 2 weeks is recommended;
weight gain;
changes in levels of certain lipids (triglycerides, total cholesterol).

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

rapid heartbeat;
palpitations, fast rhythm;
indigestion or constipation;
feeling of weakness;
swelling of hands or feet;
low blood pressure upon standing, which may cause dizziness or fainting (may lead to falls);
elevated blood sugar levels;
blurred vision;
unusual dreams and nightmares;
increased feeling of hunger;
feeling of irritability;
speech disorders;
shortness of breath;
vomiting (mainly in elderly people);
fever;
changes in blood levels of thyroid hormones;
reduced number of certain types of blood cells;
increased levels of liver enzymes in blood;
increased blood prolactin levels may lead to the following consequences:
breast swelling and unexpected milk production from the breasts in both men and women;
absence of menstruation or irregular menstruation in women.

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

unpleasant sensation in the legs (so-called restless legs syndrome);
difficulty swallowing;
sexual disorders;
slower-than-normal heartbeat, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting;
fainting (which may lead to falls);
nasal congestion;
reduced number of red blood cells;
reduced sodium levels in blood;
confusion.

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

breast swelling and unexpected production of breast milk (galactorrhoea);
menstrual disorders;
sleepwalking, talking or eating during sleep;
drop in body temperature (hypothermia);
a condition called metabolic syndrome, in which three or more of the following occur: increased abdominal fat tissue, decreased levels of "good cholesterol" (HDL-C), increased levels of one type of blood fat – triglycerides, hypertension, and increased blood sugar levels;
increased blood creatine kinase activity (a substance from muscles).

Adverse effects with unknown frequency (frequency cannot be determined from available data):

rash with irregular red patches (erythema multiforme);
withdrawal symptoms which may occur in newborns whose mothers took Etiagen during pregnancy;
disorders of the heart muscle (cardiomyopathy);
inflammation of the heart muscle (myocarditis);
inflammation of blood vessels (vasculitis), often with skin rash presenting as small red or purple nodules.

The group of medicines to which quetiapine belongs may cause disturbances in heart rhythm, which may sometimes be serious and, in severe cases, may lead to death.
Some adverse effects have only been observed in blood tests. These include changes in levels of certain lipids (triglycerides and total cholesterol) or glucose (sugar) in blood, changes in blood levels of thyroid hormones, increased liver enzyme activity, reduced number of certain types of blood cells, reduced number of red blood cells, increased blood creatine kinase activity (a substance contained in muscles), reduced sodium levels in blood, and increased blood levels of a hormone called prolactin.
Your doctor may recommend periodic blood tests for you.

Adverse effects in children and adolescents:
Children and adolescents may experience the same adverse effects as adults.
The following adverse effects have been observed more frequently in children and adolescents, or were not observed in adults:

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

increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to the following symptoms:
breast swelling and unexpected milk production from the breasts in boys and girls;
absence of menstruation or irregular menstruation in girls.
increased appetite;
vomiting;
abnormal muscle movements. These include difficulty initiating movements, tremors, restlessness or muscle stiffness without pain;
elevated blood pressure.

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

feeling of weakness, fainting (which may lead to falls);
nasal congestion;
feeling of irritability.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store Etiagen

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package,
following the abbreviation EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Etiagen contains

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

What Etiagen looks like and contents of the pack
Etiagen is available as film-coated tablets.
Etiagen 25 mg film-coated tablets:
Round, biconvex, peach-coloured film-coated tablets with the imprint "Q" on one side.
Etiagen 25 mg film-coated tablets are available in the following pack sizes:
Packs of 10 and 30 film-coated tablets in PVC/PVDC/Aluminium blisters, in a cardboard carton, and
perforated blister strips divided into single doses: 6 x 1 tablet and 60 x 1 tablet
Etiagen 100 mg film-coated tablets:
Round, yellow film-coated tablets with the imprint "Q" above "100" on one side.
Etiagen 100 mg film-coated tablets are available in the following pack sizes:
Packs of 60 and 90 film-coated tablets in PVC/PVDC/Aluminium blisters, in a cardboard carton, and
perforated blister strips divided into single doses: 60 x 1 tablet
Etiagen 200 mg film-coated tablets:
Round, white film-coated tablets with the imprint "Q" above "200" on one side.
Etiagen 200 mg film-coated tablets are available in the following pack sizes:
Packs of 60 and 90 film-coated tablets in PVC/PVDC/Aluminium blisters, in a cardboard carton, and
perforated blister strips divided into single doses: 60 x 1 tablet
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400