Quetiapine Fair-med

Leaflet attached to the packaging: information for the user

Quetiapine Fair-Med, 25 mg, coated tablets

Quetiapine Fair-Med, 100 mg, coated tablets

Quetiapine Fair-Med, 150 mg, coated tablets

Quetiapine Fair-Med, 200 mg, coated tablets

Quetiapine Fair-Med, 300 mg, coated tablets

Quetiapine

You should read the contents of the leaflet before taking 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.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• 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 as yours.
• If the patient experiences any side effects, including any not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Quetiapine Fair-Med and what is it used for

Quetiapine Fair-Med contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics. Quetiapine Fair-Med may be used to treat diseases such as:

• depressive episodes in bipolar disorder, when the patient feels sad, depressed, lacks energy, loses appetite, feels guilty, or cannot sleep;
• mania, when the patient is very excited, agitated, restless, enthusiastic, or overly active, or has impaired critical judgment, is aggressive, or troublesome;
• schizophrenia, when the patient hears or feels non-existent voices and things, has hallucinations, or is overly suspicious, fearful, disoriented, feels guilty, tense, or depressed.

The doctor may recommend continued use of Quetiapine Fair-Med, even if the patient's condition improves.

2. Important information before taking Quetiapine Fair-Med

When not to take Quetiapine Fair-Med:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)

if the patient is taking any of the following medicines: certain HIV medicines, azole antifungals (used to treat fungal infections), erythromycin or clarithromycin (used to treat infections), or nefazodone (used to treat depression).

• if the patient has ever had a condition that affects the blood cells, including a low white blood cell count (which may make them more susceptible to infections)

If any of the above situations apply to the patient, they should not take Quetiapine Fair-Med. If in doubt, the patient should consult their doctor or pharmacist before taking Quetiapine Fair-Med.

Warnings and precautions

Before starting to take Quetiapine Fair-Med, the patient should inform their doctor or pharmacist if:

• they or a family member have or have had any heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart muscle, or if they are taking any medicines that may affect heart rhythm
• they have low blood pressure
• they have had a stroke, especially if they are elderly
• they have liver problems
• they have ever had a seizure (epilepsy)
• they have diabetes or an increased risk of developing diabetes; in this case, the doctor may recommend blood sugar tests while taking Quetiapine Fair-Med
• they have ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not)
• they are elderly with dementia (reduced brain function); such a person should not take Quetiapine Fair-Med, as medicines in the same class as Quetiapine Fair-Med may increase the risk of stroke and, in some cases, the risk of death in elderly people with dementia
• they are elderly with Parkinson's disease/parkinsonism
• they or a family member have ever had blood clots, as taking medicines in this class has been associated with the development of blood clots
• they have or have had a condition where they cannot completely empty their bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms are sometimes caused by medicines (so-called anticholinergic medicines) that affect the functioning of nerve cells, used to treat certain diseases
• they have a history of alcohol or drug abuse

The patient should immediately inform their doctor if they experience any of the following symptoms after taking Quetiapine Fair-Med:

• a combination of fever, severe muscle stiffness, excessive sweating, or decreased level of consciousness (a condition called malignant neuroleptic syndrome). Immediate medical attention may be necessary
• involuntary movements, mainly of the face or tongue
• dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients
• seizure (convulsions)
• prolonged and painful erection (priapism)
• 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, refer the patient to a cardiologist immediately.

All these symptoms may be caused by the action of this type of medicine. The patient should immediately inform their doctor if they experience:

• fever, flu-like symptoms, sore throat, or any other infection, as this may be a consequence of a very low white blood cell count in the blood, in which case it may be necessary to discontinue Quetiapine Fair-Med and/or use appropriate treatment
• constipation along with persistent abdominal pain or constipation that does not improve with treatment, as this may lead to a more serious bowel obstruction

Suicidal thoughts and worsening of depression

Patients with depression may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment, as these medicines usually start to work after 2 weeks, and sometimes later. These thoughts may also worsen if the patient suddenly stops taking the medicine. The occurrence of this type of thought is more likely if the patient is a young adult. Clinical trial data indicate an increased risk of suicidal thoughts and/or behaviors in young adults under 25 years of age with depression.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression and ask them to read this leaflet. The patient may ask their relatives or friends to inform them if they notice that the depression or anxiety has worsened or if there are disturbing changes in the patient's behavior.

DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

Widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (DRESS syndrome, also known as drug hypersensitivity syndrome). If the patient experiences these symptoms, they should discontinue Quetiapine Fair-Med and immediately consult their doctor or seek medical attention.

Weight gain

Weight gain has been observed in patients taking Quetiapine Fair-Med. The patient and their doctor should regularly monitor the patient's weight.

Children and adolescents

Quetiapine Fair-Med is not intended for use in children and adolescents under 18 years of age.

Quetiapine Fair-Med and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should not take Quetiapine Fair-Med if they are taking any of the following medicines:

• certain HIV medicines
• azole antifungals (used to treat fungal infections)
• erythromycin or clarithromycin (used to treat infections)
• nefazodone (used to treat depression)

The patient should tell their doctor if they are taking:

• antiepileptic medicines (such as phenytoin or carbamazepine)
• antihypertensive medicines
• barbiturates (medicines used to treat sleep disorders)
• thioridazine or lithium (other antipsychotic medicines)
• medicines that affect heart rhythm, such as medicines that disrupt electrolyte levels (decreased potassium or magnesium levels), such as diuretics (urine-inducing medicines) or certain antibiotics (medicines used to treat infections)
• medicines that can cause constipation
• so-called anticholinergic medicines, which affect the functioning of nerve cells, used to treat certain diseases

Before stopping any medicine, the patient should first consult their doctor.

Quetiapine Fair-Med with food, drink, and alcohol

• Quetiapine Fair-Med can be taken with or without food
• the patient should be careful with the amount of alcohol they drink. Taking Quetiapine Fair-Med and alcohol at the same time may cause drowsiness
• the patient should not drink grapefruit juice while taking Quetiapine Fair-Med, as it may affect the way the medicine works

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 before taking this medicine. Quetiapine Fair-Med should not be taken during pregnancy, unless advised by a doctor. Quetiapine Fair-Med should not be taken during breastfeeding. The following symptoms, which may indicate withdrawal syndrome, may occur in newborns whose mothers took quetiapine in the last 3 months of pregnancy: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the child experiences any of these symptoms, medical attention may be necessary.

Driving and using machines

The tablets may cause drowsiness. The patient should not drive, use tools, or operate machinery until they are sure how the tablets affect them.

Effect on urine tests for drug use

In patients taking Quetiapine Fair-Med, urine tests for drug use performed by some methods may show the presence of methadone or certain antidepressants (tricyclic antidepressants), even if the patient is not taking these medicines. It is recommended to confirm the results using tests performed by other methods. Quetiapine Fair-Med 25 mg contains orange yellow S (E110), which may cause allergic reactions.

Quetiapine Fair-Med contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

3. How to take Quetiapine Fair-Med

Quetiapine Fair-Med should always be taken as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist. The initial dose will be determined by the doctor. The maintenance dose (daily dose) of Quetiapine Fair-Med will depend on the disease and the patient's needs, but it is usually between 150 mg and 800 mg.

• the tablets should be taken once a day at bedtime or twice a day, depending on the disease the patient is suffering from.
• the tablets should be swallowed whole, with a glass of water.
• the tablets can be taken with or without food.
• the patient should not drink grapefruit juice while taking Quetiapine Fair-Med, as it may affect the way the medicine works.
• the patient should not stop taking Quetiapine Fair-Med, even if they feel better, unless advised by their doctor.

Patients with liver function disorders

The doctor may recommend a dose change for patients with liver function disorders.

Elderly patients

The doctor may recommend a dose change for elderly patients.

Use in children and adolescents

Quetiapine Fair-Med should not be used in children and adolescents under 18 years of age.

Taking a higher dose of Quetiapine Fair-Med than recommended

If the patient takes a higher dose of Quetiapine Fair-Med than recommended by their doctor, they may experience drowsiness, dizziness, and heart rhythm disturbances. The patient should immediately consult their doctor or go to the nearest hospital. The patient should take the Quetiapine Fair-Med packaging with them.

Missing a dose of Quetiapine Fair-Med

If the patient forgets to take a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should take the next dose, skipping the missed one. The patient should not take a double dose to make up for the missed dose.

Stopping Quetiapine Fair-Med

If the patient suddenly stops taking Quetiapine Fair-Med, they may experience difficulty sleeping (insomnia), nausea (nausea), headaches, diarrhea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment. 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, Quetiapine Fair-Med can cause side effects, although not everybody gets them. Very commonside effects (may affect more than 1 in 10 people):

• dizziness (which may cause falls), headache, dry mouth
• drowsiness (which may cause falls; this side effect often disappears during continued treatment with Quetiapine Fair-Med)
• withdrawal symptoms (symptoms that may occur after stopping Quetiapine Fair-Med), including: difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. It is recommended to gradually stop taking the medicine over at least 1 to 2 weeks
• weight gain
• abnormal muscle movements; this may be difficulty starting movement, tremors, restlessness, or muscle stiffness without pain
• changes in blood levels of certain fats (triglycerides and total cholesterol)

Commonside effects (may affect up to 1 in 10 people):

• rapid heartbeat
• feeling of strong, fast heartbeat or missing heartbeats
• constipation, indigestion
• weakness
• swelling of hands or feet
• low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls)
• increased blood sugar levels
• blurred vision
• unusual dreams and nightmares
• increased appetite
• feeling irritable
• speech and language disorders
• suicidal thoughts and worsening of depression
• shortness of breath
• vomiting (mainly in elderly patients)
• fever
• changes in thyroid hormone levels in the blood
• decrease in the number of certain types of blood cells
• increase in liver enzyme levels in the blood
• increase in prolactin hormone levels in the blood; increased prolactin levels may rarely lead to:
• breast swelling and unexpected milk production in both men and women
• absence or irregular menstrual periods in women

Uncommonside effects (may affect up to 1 in 100 people):

• seizures
• allergic reactions, which may include blisters and bubbles on the skin, skin swelling, and swelling around the mouth
• unpleasant sensations in the lower limbs (restless legs syndrome)
• difficulty swallowing
• uncontrolled movements, mainly of the face or tongue
• sexual disorders
• diabetes
• changes in the electrical activity of the heart visible on an ECG (QT interval prolongation)
• slower than normal heart rate, which may occur when starting treatment and may be associated with decreased blood pressure and fainting
• difficulty urinating
• fainting (which may lead to falls)
• stuffy nose
• decrease in red blood cell count
• decrease in sodium levels in the blood
• worsening of existing diabetes

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

• a combination of high body temperature (fever), excessive sweating, muscle stiffness, increased drowsiness, or fainting (a condition called malignant neuroleptic syndrome)
• yellowing of the skin and eyes (jaundice)
• liver inflammation
• prolonged and painful erection (priapism)
• breast swelling and unexpected milk production (galactorrhea)
• menstrual disorders
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, the patient should immediately consult their doctor
• walking, talking, eating, and performing other activities while asleep
• low body temperature (hypothermia)
• pancreatitis
• a condition (known as metabolic syndrome) in which there is a combination of three or more of the following features: increased abdominal fat, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, high blood pressure, and increased blood sugar levels
• the simultaneous occurrence of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count in the blood (a condition known as agranulocytosis)
• intestinal obstruction
• increased creatine kinase levels in the blood (a substance from muscles)

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

• severe rash, blisters, red spots on the skin
• severe allergic reaction (known as anaphylaxis), which may cause difficulty breathing or shock
• rapidly developing swelling of the skin, usually around the eyes, mouth, or throat (angioedema)
• blisters on the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome)
• abnormal secretion of the hormone that regulates urine volume
• muscle fiber breakdown and muscle pain (rhabdomyolysis)

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

• skin rash with irregular red spots (erythema multiforme)
• severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling (toxic epidermal necrolysis)
• withdrawal symptoms in newborns whose mothers took Quetiapine Fair-Med during pregnancy
• stroke
• heart muscle disorders (cardiomyopathy)
• heart muscle inflammation
• blood vessel inflammation (vasculitis), often with a skin rash with small red or purple spots

Medicines in the same class as Quetiapine Fair-Med may cause heart rhythm disturbances, which can be severe and, in rare cases, fatal. Some side effects can only be detected by blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels, increased liver enzyme levels, decreased white blood cell count, decreased red blood cell count, increased creatine kinase levels, decreased sodium levels, and increased prolactin hormone levels. Increased prolactin levels may rarely lead to:

• breast swelling and unexpected milk production in both men and women
• absence or irregular menstrual periods in women

The doctor may occasionally recommend blood tests.

Additional side effects in children and adolescents

The same side effects that occur in adults may also occur in children and adolescents. The following side effects occurred more frequently in children and adolescents than in adult patients, or did not occur at all in adult patients: Very commonside effects (may affect more than 1 in 10 people):

• increased prolactin hormone levels in the blood. Increased prolactin levels may rarely lead to:
• in boys and girls - breast swelling and unexpected milk production

in girls - absence or irregular menstrual periods

• increased appetite
• vomiting
• abnormal muscle movements, including: difficulty starting movement, tremors, restlessness, or muscle stiffness without pain
• increased blood pressure

Commonside effects (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 not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Quetiapine Fair-Med

No special precautions for storage are required. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after the expiry date. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Quetiapine Fair-Med contains

The active substance of Quetiapine Fair-Med is quetiapine. Each 25 mg tablet contains 25 mg quetiapine (as quetiapine fumarate). Each 100 mg tablet contains 100 mg quetiapine (as quetiapine fumarate). Each 150 mg tablet contains 150 mg quetiapine (as quetiapine fumarate). Each 200 mg tablet contains 200 mg quetiapine (as quetiapine fumarate). Each 300 mg tablet contains 300 mg quetiapine (as quetiapine fumarate). The other ingredients are: tablet core: hypromellose, calcium hydrogen phosphate dihydrate, lactose monohydrate, cornstarch, sodium carboxymethylcellulose (type A), magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, tablet coating: 25 mg: iron oxide red (E172), iron oxide yellow (E172), hypromellose, titanium dioxide (E171), macrogol 400, orange yellow S (E110), 100 mg: iron oxide yellow (E172), hypromellose, titanium dioxide (E171), macrogol 400, 150 mg: iron oxide yellow (E172), hypromellose, titanium dioxide (E171), macrogol 400, hydroxypropylcellulose, talc, 200 and 300 mg: hydroxypropylcellulose, hypromellose, talc, titanium dioxide (E171)

What Quetiapine Fair-Med looks like and contents of the pack

25 mg: peach-colored, round, biconvex, film-coated tablets with a diameter of about 5.7 mm. 100 mg: yellow, round, biconvex, film-coated tablets with a score line on one side, with a diameter of about 9.1 mm. 150 mg: pale yellow, round, biconvex, film-coated tablets with a diameter of about 10.45 mm. 200 mg: white, round, biconvex, film-coated tablets with a score line on one side, with a diameter of about 12.1 mm. 300 mg: white, oval, biconvex, film-coated tablets with a score line on one side. The tablet is about 7 mm thick, 19 mm long, and 9 mm wide. The 100, 200, and 300 mg tablets can be divided into equal doses. Pack sizes: 25 mg: 10, 30, 100, 100 mg: 30, 60, 90, 100, 150 mg: 30, 60, 90, 100, 200 mg: 30, 60, 90, 100, 300 mg: 30, 60, 90, 100. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holderFairmed Healthcare GmbH Dorotheenstraße 48 22301 Hamburg Germany pv@fair-med.com ManufacturerGenepharm S.A. 18th Km. Marathon Ave. 153 51 Pallini Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany Quetiapin Fair-Med Healthcare 25, 100, 150, 200, 300 mg film-coated tablets Denmark Quetiapin "Fair-Med" Spain Quetiapina Fair-Med 25, 100, 150, 200, 300 mg film-coated tablets Ireland Quetiapine Fair-Med 25, 100, 150, 200, 300 mg film-coated tablets Netherlands Quetiapine Fair-Med 25, 100, 150, 200, 300 mg film-coated tablets Poland Quetiapine Fair-Med Portugal Quetiapina Fair-Med 25, 100, 150, 200, 300 mg film-coated tablets Sweden Quetiapin Fair-Med, 25, 100, 150, 200, 300 mg film-coated tablets

Date of last revision of the leaflet: