Quetiapine Fair-med

Package Leaflet: 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

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is Quetiapine Fair-Med and what is it used for
• 2. Before you take 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, which belongs to a group of medicines called antipsychotics. Quetiapine Fair-Med can be used to treat several diseases, such as:

• depressive episodes in bipolar disorder, when you feel sad, depressed, lack energy, lose your appetite, feel guilty or can't sleep;
• mania, when you are very excited, agitated, or irritable, or have disturbed thinking;
• schizophrenia, when you hear or feel things that are not there, have hallucinations, or are suspicious, anxious, or confused.

Your doctor may continue to prescribe Quetiapine Fair-Med even if you feel better.

2. Before you take Quetiapine Fair-Med

When not to take Quetiapine Fair-Med:

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)

if you are taking any of the following medicines:

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

If any of the above applies to you, do not take Quetiapine Fair-Med. If you are not sure, consult your doctor or pharmacist before taking Quetiapine Fair-Med.

Warnings and precautions

Before taking Quetiapine Fair-Med, tell your doctor if:

• you or someone in your family has or has had heart problems, such as irregular heart rhythm, weakened heart muscle, or inflammation of the heart muscle, or if you are taking any medicines that may affect your heart rhythm
• you have low blood pressure
• you have had a stroke, especially if you are elderly
• you have liver problems
• you have had seizures (epilepsy)
• you have diabetes or are at risk of developing diabetes; your doctor may recommend blood sugar tests while taking Quetiapine Fair-Med
• you have ever had a low white blood cell count (regardless of whether it was caused by taking other medicines or not)
• you are elderly and have dementia (reduced mental ability); you should not take Quetiapine Fair-Med, as medicines in this group may increase the risk of stroke and, in some cases, death in elderly people with dementia
• you are elderly and have Parkinson's disease/parkinsonism
• you or a family member have had blood clots, as taking medicines in this group has been associated with the development of blood clots
• you have or have had sleep apnea (pauses in breathing during sleep) and are taking medicines that slow down brain activity (such as sedatives)
• you have or have had urinary retention (inability to empty the bladder), enlarged prostate, intestinal obstruction, or increased eye pressure. These symptoms can sometimes be caused by medicines (such as anticholinergic medicines) that affect the functioning of nerve cells, used to treat certain diseases
• you have a history of alcohol or drug abuse

Tell your doctor immediately if you experience any of the following symptoms after taking Quetiapine Fair-Med:

• a combination of fever, stiff muscles, sweating, or lowered consciousness (a condition called neuroleptic malignant syndrome). You may need immediate medical attention
• involuntary movements, especially of the face or tongue
• dizziness or excessive drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients
• seizures
• prolonged and painful erections (priapism)
• rapid or irregular heartbeat, even at rest, palpitations, shortness of breath, chest pain, or unexplained fatigue. Your doctor will need to examine your heart and, if necessary, refer you to a cardiologist

All these symptoms can be caused by the action of this type of medicine.

Tell your doctor immediately if you experience:

• fever, flu-like symptoms, sore throat, or any other infection, as this may be a sign of a very low white blood cell count in the blood, which may require discontinuation of Quetiapine Fair-Med and/or appropriate treatment
• constipation with persistent abdominal pain or constipation that does not respond to 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 can worsen at the start of treatment, as the medicine starts to work, usually within 2 weeks, or sometimes later. These thoughts can also worsen if you suddenly stop taking the medicine.

Data from clinical trials indicate an increased risk of suicidal thoughts and/or behaviors in young adults under 25 years of age with depression.

If you experience suicidal thoughts or thoughts of self-harm, contact your doctor or go to the hospital immediately. It may be helpful to inform your relatives or friends about your depression and ask them to read this leaflet.

DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms)

A widespread rash, high body temperature, increased liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (DRESS syndrome). If you experience these symptoms, stop taking Quetiapine Fair-Med and seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking Quetiapine Fair-Med. You and your doctor should regularly monitor your weight.

Children and adolescents

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

Quetiapine Fair-Med with other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Do not take Quetiapine Fair-Med if you are taking any of the following medicines:

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

Tell your doctor if you 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 balance (low potassium or magnesium levels), such as diuretics or certain antibiotics
• medicines that can cause constipation
• anticholinergic medicines, which affect the functioning of nerve cells, used to treat certain diseases

Before stopping any medicine, consult your doctor.

Quetiapine Fair-Med with food, drink, and alcohol

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine.

Do not take Quetiapine Fair-Med during pregnancy, unless your doctor advises you to. Do not take Quetiapine Fair-Med while breastfeeding.

The following symptoms, which may indicate withdrawal syndrome, may occur in newborns whose mothers took quetiapine during the last 3 months of pregnancy: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby experiences any of these symptoms, contact your doctor.

Driving and using machines

The tablets may cause drowsiness. Do not drive, use tools, or operate machinery until you are sure how the tablets affect you.

Effect on urine tests for drugs

In patients taking Quetiapine Fair-Med, urine tests for drugs using certain methods may show the presence of methadone or certain antidepressants (tricyclic antidepressants), even if you are 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 you have been told that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Quetiapine Fair-Med

Always take Quetiapine Fair-Med exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Your doctor will determine the starting dose. The maintenance dose (daily dose) of Quetiapine Fair-Med will depend on your disease and needs, but it is usually between 150 mg and 800 mg.

• take the tablets once a day at bedtime or twice a day, depending on the disease you are suffering from
• swallow the tablets whole with water
• you can take the tablets with or without food
• do not drink grapefruit juice while taking Quetiapine Fair-Med, as it may affect the way the medicine works
• do not stop taking Quetiapine Fair-Med, even if you feel better, unless your doctor advises you to

Patients with liver function disorders

Your doctor may recommend a dose change if you have liver function disorders.

Elderly patients

Your doctor may recommend a dose change if you are an elderly patient.

Use in children and adolescents

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

Taking more than the prescribed dose of Quetiapine Fair-Med

If you take more Quetiapine Fair-Med than your doctor prescribed, you may feel drowsy, dizzy, and have heart problems. Contact your doctor or go to the hospital immediately. Take the Quetiapine Fair-Med packaging with you.

Forgetting to take a dose of Quetiapine Fair-Med

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Quetiapine Fair-Med

If you stop taking Quetiapine Fair-Med suddenly, you may experience difficulty sleeping (insomnia), nausea, headaches, diarrhea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions on the use of this medicine, ask your 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 a period of at least 1 to 2 weeks
• weight gain
• abnormal muscle movements; this may include 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
• irritability
• 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
• decreased levels of certain types of blood cells
• increased levels of liver enzymes in the blood
• increased levels of the hormone prolactin in the blood; increased prolactin levels may rarely lead to:
• breast swelling and unexpected production of milk 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 skin rashes and blisters, swelling of the skin and around the mouth
• unpleasant sensations in the legs (restless legs syndrome)
• difficulty swallowing
• involuntary movements, mainly of the face or tongue
• sexual disorders
• diabetes
• changes in the electrical activity of the heart, visible on an ECG (prolonged QT interval)
• slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting
• difficulty urinating
• fainting (which may lead to falls)
• stuffy nose
• decreased red blood cell count
• decreased 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, sweating, stiff muscles, and lowered consciousness (neuroleptic malignant syndrome)
• yellowing of the skin and eyes (jaundice)
• liver inflammation
• prolonged and painful erections (priapism)
• breast swelling and unexpected production of milk in both men and women
• menstrual disorders
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel to the lungs and cause chest pain and difficulty breathing. If you experience any of these symptoms, contact your doctor immediately
• walking, talking, eating, and performing other activities while asleep
• low body temperature (hypothermia)
• pancreatitis
• a condition (known as metabolic syndrome) in which you have a combination of three or more of the following: increased waist circumference, low "good" cholesterol (HDL-C), high levels of a certain type of fat in the blood (triglycerides), high blood pressure, and high blood sugar levels
• a combination 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 levels of creatine phosphokinase in the blood (a substance found in muscles)

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

• severe skin rash, blisters, and red patches on the skin
• severe allergic reaction (anaphylaxis), which may cause difficulty breathing or shock
• rapid 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 breakdown and muscle pain (rhabdomyolysis)

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

• skin rash with irregular red patches (erythema multiforme)
• severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (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 this group may cause heart rhythm disorders, which can be serious 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 levels of certain types of blood cells, decreased red blood cell count, increased levels of creatine phosphokinase in the blood (a substance found in muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:

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

Your doctor may perform regular blood tests to monitor your condition.

Additional side effects in children and adolescents

The same side effects that occur in adults can 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 levels of the hormone prolactin in the blood. Increased prolactin levels may rarely lead to:
• in boys and girls - breast swelling and unexpected production of milk

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):

• weakness, fainting (which may lead to falls)
• stuffy nose
• irritability

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects directly to the national reporting system:

Department for Monitoring of Adverse Reactions to Medicinal Products

Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych

Al. Jerozolimskie 181C

PL-02 222 Warszawa

Tel.: + 48 22 49 21 301

Fax: + 48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

You can also report side effects to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Quetiapine Fair-Med

No special precautions for storage are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Quetiapine Fair-Med contains

The active substance 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

Corn starch

Sodium carboxymethyl starch (type A)

Magnesium stearate

Microcrystalline cellulose

Colloidal anhydrous silica

Tablet coating:

25 mg:

Iron oxide red (E 172)

Iron oxide yellow (E 172)

Hypromellose

Titanium dioxide (E 171)

Macrogol 400

Orange yellow S (E 110)

100 mg:

Iron oxide yellow (E 172)

Hypromellose

Titanium dioxide (E 171)

Macrogol 400

150 mg:

Iron oxide yellow (E 172)

Hypromellose

Titanium dioxide (E 171)

Macrogol 400

Hydroxypropylcellulose

Talc

200 and 300 mg:

Hydroxypropylcellulose

Hypromellose

Talc

Titanium dioxide (E 171)

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

25 mg:

Peach-colored, round, biconvex, film-coated tablets, approximately 5.7 mm in diameter.

100 mg:

Yellow, round, biconvex, film-coated tablets with a score line on one side, approximately 9.1 mm in diameter.

150 mg:

Pale yellow, round, biconvex, film-coated tablets, approximately 10.45 mm in diameter.

200 mg:

White, round, biconvex, film-coated tablets with a score line on one side, approximately 12.1 mm in diameter.

300 mg:

White, oval, biconvex, film-coated tablets with a score line on one side, approximately 7 mm thick, 19 mm long, and 9 mm wide.

The 100, 200, and 300 mg tablets can be divided into equal doses.

Package 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 holder

Fairmed Healthcare GmbH

Dorotheenstraße 48

22301 Hamburg

Germany

pv@fair-med.com

Manufacturer

Genepharm 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 Filmtabletten

Denmark

Quetiapin "Fair-Med"

Spain

Quetiapina Fair-Med 25, 100, 150, 200, 300 mg comprimidos recubiertos con película EFG

Ireland

Quetiapine Fair-Med 25, 100, 150, 200, 300 mg film-coated tablets

Netherlands

Quetiapine Fair-Med 25, 100, 150, 200, 300 mg, filmomhulde tabletten

Poland

Quetiapine Fair-Med

Portugal

Quetiapina Fair-Med 25, 100, 150, 200, 300 mg comprimidos revestidos por película

Sweden

Quetiapin Fair-Med, 25, 100, 150, 200, 300 mg filmdragerad tablet

Date of last revision of the package leaflet: