Quetiapine fair-med

Package leaflet: Information for the user

Quetiapine Fair-Med, 25 mg, film-coated tablets
Quetiapine Fair-Med, 100 mg, film-coated tablets
Quetiapine Fair-Med, 150 mg, film-coated tablets
Quetiapine Fair-Med, 200 mg, film-coated tablets
Quetiapine Fair-Med, 300 mg, film-coated tablets
quetiapine
Please read the entire leaflet before taking this medicine, as it contains important information for you.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others.
• This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

• depressive episodes in bipolar affective disorder, when the patient feels sadness, depression, lack of energy, loss of appetite, guilt, or has difficulty sleeping;
• mania, when the patient is highly excited, elated, overactive, enthusiastic, or excessively active, or has impaired critical judgment, is aggressive or troublesome;
• schizophrenia, when the patient hears or senses non-existent voices or things, has hallucinations, or is excessively suspicious, fearful, disoriented, or experiences feelings of guilt, tension, or depression.

Your doctor may recommend continuing treatment with Quetiapine Fair-Med even if your condition improves.

2. Information before taking Quetiapine Fair-Med

When not to take Quetiapine Fair-Med:

• if the patient is allergic to the active substance or to any of the other
  components of this medicine (listed in section 6)
• if the patient is currently taking any of the following medicines: certain medicines used to treat HIV infection, azole antifungals (used to treat fungal infections),
• erythromycin or clarithromycin (used to treat infections)
• nefazodone (used to treat depression).

If any of the above situations apply, Quetiapine Fair-Med must not be used.
If in doubt, consult a doctor or pharmacist before taking Quetiapine Fair-Med.

Warnings and precautions

Before starting Quetiapine Fair-Med, inform your doctor or pharmacist if:

• the patient or someone in their family has ever had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart muscle, or if the patient is taking any medicines that may affect heart rhythm
• the patient has low blood pressure
• the patient has had a stroke, especially if they are elderly
• the patient has liver problems
• the patient has ever had a seizure (epilepsy)
• the patient has diabetes or an increased risk of developing diabetes; in such cases, the doctor may recommend regular blood sugar monitoring during treatment with Quetiapine Fair-Med
• the patient has ever had a low white blood cell count (regardless of whether it was caused by other medicines or not)
• the patient is an elderly person with dementia (age-related cognitive decline); such patients 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, risk of death in elderly patients with dementia
• if the patient is an elderly person with Parkinson’s disease / parkinsonism
• the patient or a family member has ever had blood clots, as use of medicines in this class has been associated with clot formation
• the patient has or has had episodes of temporary breathing cessation during sleep (‘sleep apnoea’) or is taking medicines that depress brain activity (‘depressants’)
• the patient has or has had a condition in which the bladder cannot be completely emptied (urinary retention), has an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These symptoms may sometimes be caused by medicines (so-called anticholinergic medicines) that affect nerve cell function, used in the treatment of certain conditions
• the patient has previously abused alcohol or drugs

Immediately inform a doctor if any of the following symptoms occur after taking Quetiapine Fair-Med:

• a combination of fever, severe muscle stiffness, excessive sweating, or reduced level of consciousness (a condition known as neuroleptic malignant syndrome). Immediate medical attention may be required
• involuntary movements, especially of the face or tongue
• dizziness or extreme drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients
• a seizure (convulsion)
• prolonged and painful erection (priapism)
• rapid or irregular heartbeat, even at rest, palpitations, difficulty breathing, chest pain, or unexplained fatigue. The doctor will need to examine the heart and, if necessary, refer the patient immediately to a cardiologist.

All of these symptoms may be caused by this type of medicine.

Immediately inform a doctor if the patient experiences:

• fever, flu-like symptoms, sore throat, or any other infection, as this may be due to a very low number of white blood cells in the blood, which may require discontinuation of Quetiapine Fair-Med and/or appropriate treatment
• constipation accompanied by persistent abdominal pain or constipation that does not resolve with treatment, as this may lead to a more serious intestinal blockage

Suicidal thoughts and worsening 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 take about 2 weeks, or sometimes longer, to take effect. Such thoughts may also worsen if the patient suddenly stops taking the medicine. These thoughts are more likely to occur if the patient is a young adult. Clinical trial data indicate an increased risk of suicidal thoughts and/or behaviour in young adults under 25 years of age with depression.

If the patient has suicidal thoughts or thoughts of self-harm, they should immediately contact a doctor or go to hospital. It may be helpful to inform family members or friends about the depression and ask them to read this leaflet. The patient may ask for help from family or friends and ask them to inform them if they notice worsening depression or anxiety, or concerning changes in the patient’s behaviour.

Drug reaction with eosinophilia and systemic symptoms (DRESS)

Widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome). If the patient experiences these symptoms, Quetiapine Fair-Med must be discontinued and the patient should immediately contact their doctor or seek medical help.

Weight gain

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

Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take.

Do not take Quetiapine Fair-Med if the patient is taking any of the following medicines:

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

Tell the doctor if the patient is taking:

• antiepileptic medicines (such as phenytoin or carbamazepine)
• antihypertensive medicines
• barbiturates (medicines used for sleep disorders)
• thioridazine or lithium (other antipsychotic medicines)
• medicines that affect heart rhythm, such as those altering electrolyte levels (low potassium or magnesium), for example diuretics (water tablets) or certain antibiotics (medicines used to treat infections)
• medicines that may cause constipation
• so-called anticholinergic medicines, which affect nerve cell function, used in the treatment of certain conditions

Do not stop taking any medicine without first consulting a doctor.

Quetiapine Fair-Med with food, drink and alcohol

• Quetiapine Fair-Med may be taken with or without food
• be cautious about alcohol consumption. Taking Quetiapine Fair-Med with alcohol may increase drowsiness
• do not drink grapefruit juice during treatment with Quetiapine Fair-Med. This may affect how the medicine works

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor before taking this medicine.

Quetiapine Fair-Med should not be used during pregnancy unless advised by a doctor. Quetiapine Fair-Med should not be used during breastfeeding.

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

Driving and using machines

The tablets may cause drowsiness. Do not drive, use tools, or operate machinery until the patient knows how these tablets affect them.

Effect on drug screening tests in urine

In patients taking Quetiapine Fair-Med, urine drug screening tests using certain methods may show the presence of methadone or certain antidepressants known as tricyclic antidepressants (TCA), even if the patient is not taking these medicines. Confirmation of results using alternative testing methods is recommended.

Quetiapine Fair-Med 25 mg contains sunset yellow (E110), which may cause allergic reactions.

Quetiapine Fair-Med contains lactose monohydrate.
If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult a doctor before taking this medicine.

3. How to take Quetiapine Fair-Med

Quetiapine Fair-Med must always be taken exactly as directed by the doctor. In case of
doubt, consult your doctor or pharmacist.
The initial dose will be determined by your doctor. The maintenance dose (daily dose) of
Quetiapine Fair-Med will depend on the condition being treated and the patient's needs, but usually
ranges from 150 mg to 800 mg.

• Tablets should be taken once daily at night or twice daily, depending on the condition the patient has.
• Tablets should be swallowed whole with water.
• Tablets may be taken with or without food.
• Do not drink grapefruit juice during treatment with Quetiapine Fair-Med. This may affect how the medicine works.
• Do not stop taking the medicine, even if the patient feels better, unless advised otherwise by the doctor.

Patients with hepatic impairment
The doctor may adjust the dose of the medicine in patients with impaired liver function.
Elderly patients
The doctor may adjust the dose of the medicine in elderly patients.
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 recommended dose of Quetiapine Fair-Med
If more Quetiapine Fair-Med is taken than recommended, the patient may experience drowsiness, dizziness, and heart rhythm disturbances. Seek immediate medical advice from a doctor or go to the nearest hospital. Bring the medicine pack with you.
Missed dose of Quetiapine Fair-Med
If a dose of Quetiapine Fair-Med is missed, take it as soon as possible. If it is almost time for the next dose, take the next dose at the scheduled time and skip the missed dose.
Do not take a double dose to make up for a missed dose.
Stopping Quetiapine Fair-Med
If Quetiapine Fair-Med is stopped suddenly, the patient may experience difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, or irritability. The doctor may recommend gradually reducing the dose before stopping treatment.
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 will experience them.

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

• dizziness (which may lead to falls), headache, dry mouth
• somnolence (may lead to falls; this effect often diminishes during continued treatment with Quetiapine Fair-Med)
• withdrawal symptoms (symptoms which may occur after stopping Quetiapine Fair-Med), including: difficulty sleeping (insomnia), nausea, headache, diarrhoea, vomiting, dizziness or irritability. Gradual discontinuation of the medicine over a period of at least 1 to 2 weeks is recommended
• weight gain
• abnormal muscle movements; this may include difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness
• changes in blood levels of certain lipids (triglycerides and total cholesterol)

Common (may occur in less than 1 in 10 people):

• rapid heartbeat
• sensation of strong, fast or irregular heartbeat or missed beats
• constipation, indigestion
• weakness
• swelling of hands or feet
• low blood pressure upon standing. This may cause dizziness or fainting (may lead to falls)
• increased blood glucose levels
• blurred vision
• unusual dreams and nightmares
• increased feeling of hunger
• feeling of irritability
• speech and articulation disorders
• suicidal thoughts and worsening of depression
• shortness of breath
• vomiting (mainly in elderly patients)
• fever
• changes in blood levels of thyroid hormones
• decreased number of certain types of blood cells
• increased levels of liver enzymes in blood
• increased levels of the hormone prolactin in blood; elevated prolactin levels may lead to:
  • breast enlargement in both men and women, and unexpected production of milk
  • absence or irregular menstruation in women

Uncommon (may occur in less than 1 in 100 people):

• seizures
• hypersensitivity reactions, which may include skin rashes and blisters, swelling of the skin and around the mouth
• unpleasant sensations in the lower limbs (so-called restless legs syndrome)
• difficulty swallowing
• uncontrolled movements, mainly of facial muscles or tongue
• sexual dysfunction
• diabetes
• changes in the electrical activity of the heart seen on ECG (prolongation of QT interval)
• slower than usual heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
• difficulty in urination
• fainting (may lead to falls)
• nasal congestion
• decreased number of red blood cells in blood
• decreased sodium levels in blood
• worsening of pre-existing diabetes

Rare (may occur in less than 1 in 1,000 people):

• combination of high body temperature (fever), excessive sweating, muscle stiffness, increased drowsiness or fainting (a condition known as neuroleptic malignant syndrome)
• yellowing of the skin and eyes (jaundice)
• hepatitis
• prolonged and painful erection (priapism)
• breast enlargement and unexpected milk production (galactorrhea)
• menstrual disorders
• venous thrombosis, particularly in the lower limbs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If any of these symptoms occur, seek medical advice immediately
• walking, talking, eating or performing other activities while asleep
• decreased body temperature (hypothermia)
• pancreatitis
• a condition (referred to as metabolic syndrome) involving a combination of three or more of the following: increased abdominal fat, decreased levels of "good cholesterol" (HDL-C), increased levels of certain blood lipids (triglycerides), high blood pressure, and increased blood sugar levels
• occurrence of fever, flu-like symptoms, sore throat, or any other infection with a very low number of white blood cells in blood (a condition known as agranulocytosis)
• intestinal obstruction
• increased creatine kinase levels in blood (a substance derived from muscles)

Very rare (may occur in less than 1 in 10,000 people):

• severe rash, blisters, red spots on the skin
• severe hypersensitivity reaction (called anaphylaxis), which may cause breathing difficulties or shock
• rapidly developing swelling of the skin, usually around the eyes, mouth or throat (angioedema)
• formation of blisters on the skin, mouth, eyes and genital organs (Stevens-Johnson syndrome)
• inappropriate secretion of the hormone regulating urine volume
• breakdown of muscle fibres and muscle pain (rhabdomyolysis)

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

• skin rash with irregular red patches (erythema multiforme)
• severe, sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis)
• withdrawal symptoms may occur in newborns of mothers who took Quetiapine Fair-Med during pregnancy
• stroke
• 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 Fair-Med belongs may cause disturbances in heart rhythm, which may be serious and, in rare cases, may lead to death.

Some adverse effects can only be detected through blood laboratory tests. These include changes in blood levels of certain lipids (triglycerides and total cholesterol) or glucose, changes in blood levels of thyroid hormones, increased levels of liver enzymes in blood, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine kinase levels in blood (a substance present in muscles), decreased sodium levels in blood, and increased levels of the hormone prolactin in blood. Elevated prolactin levels may, in rare cases, lead to:

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

Your doctor may occasionally recommend control tests.

Additional adverse effects in children and adolescents

The same adverse effects observed in adults may also occur in children and adolescents.

The following adverse effects occurred more frequently in children and adolescents than in adult patients, or were not observed at all in adults:

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

• increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to the following disorders:
  • in boys and girls – breast swelling and unexpected milk production
  • in girls – absence or irregular menstruation
• increased appetite
• vomiting
• abnormal muscle contractions, including difficulty initiating movement, tremor, motor restlessness or painless muscle stiffness
• increased blood pressure

Common (may occur in less than 1 in 10 people):

• feeling of weakness, fainting (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:

Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Quetiapine Fair-Med

No special storage precautions 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
EXP mark. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
Doing so helps 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 of quetiapine (as quetiapine fumarate)
Each 100 mg tablet contains 100 mg of quetiapine (as quetiapine fumarate)
Each 150 mg tablet contains 150 mg of quetiapine (as quetiapine fumarate)
Each 200 mg tablet contains 200 mg of quetiapine (as quetiapine fumarate)
Each 300 mg tablet contains 300 mg of quetiapine (as quetiapine fumarate)

Other ingredients are:
Tablet core:
Hypromellose
Calcium hydrogen phosphate dihydrate
Lactose monohydrate
Corn starch
Sodium carboxymethyl starch (type A)
Magnesium stearate
Microcrystalline cellulose
Talc
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-coloured, round, biconvex film-coated tablets with a diameter of approximately 5.7 mm.

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

150 mg:
Pale yellow, round, biconvex film-coated tablets with a diameter of approximately 10.45 mm.

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

300 mg:
White, oblong, biconvex film-coated tablets with a score line on one side. The tablet is approximately 7 mm thick, 19 mm long and 9 mm wide.

Tablets of 100 mg, 200 mg and 300 mg 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Fairmed Healthcare GmbH
Dorotheenstraße 48
22301 Hamburg
Germany
[email protected]

Manufacturer
Genepharm S.A.
18th Km. Marathon Ave.
153 51 Pallini
Greece

This medicinal product is authorised 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