Quetiapine Mylan: detailed information

Package leaflet: Information for the patient

Quetiapine Mylan 50 mg prolonged-release tablets, 150 mg prolonged-release tablets, 200 mg prolonged-release tablets, 300 mg prolonged-release tablets, 400 mg prolonged-release tablets

quetiapine
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Quetiapine Mylan is and what it is used for
What you need to know before taking Quetiapine Mylan
How to take Quetiapine Mylan
Possible side effects
How to store Quetiapine Mylan
Contents of the pack and other information

1. What Quetiapina Mylan is and what it is used for

Quetiapina Mylan contains a substance called quetiapine. This substance belongs to a group
of medicines known as antipsychotics. Quetiapina Mylan can be used to treat several conditions,
such as the following:

Bipolar depression and major depressive episodes associated with major depressive disorder: you may feel sad or depressed, guilty, without energy, without appetite, or have difficulty sleeping.
Mania: you may feel very excited, euphoric, restless, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behaviors.
Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

When Quetiapina Mylan is taken to treat major depressive episodes associated with
major depressive disorder, it must be used in addition to another medicine indicated for treating
this condition.
Your doctor may continue to prescribe Quetiapina Mylan even if you feel better.

2. What you need to know before taking Quetiapine Mylan

Do not take Quetiapine Mylan:

if you are allergic to quetiapine or to any of the other ingredients of this medicine (listed in section 6)
if you are taking any of the following medicines:
certain medicines for HIV virus
azole drugs (for fungal infections)
erythromycin or clarithromycin (for infections)
nefazodone (for depression).

Do not take Quetiapine Mylan if you fall into any of the categories listed above. If you have any doubts, consult your
doctor or pharmacist before taking Quetiapine Mylan.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Mylan if:

You or someone in your family has or has previously had heart problems, such as irregular heartbeat, weakened heart muscle or heart inflammation, or if you are taking medicines that may affect your heartbeat.
Your blood pressure is low.
You have had a stroke, especially if you are elderly.
You have liver problems.
You have had seizures (epileptic fits).
You have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetiapine Mylan.
You know you have previously had low levels of white blood cells in your blood (whether caused by other medicines or not).
You are an elderly person with dementia (loss of some brain functions). In this case, you should not take Quetiapine Mylan, because this class of medicines, to which Quetiapine Mylan belongs, may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
You are an elderly person with Parkinson’s disease/parkinsonism.
You or someone in your family has a history of conditions related to blood clots, as these types of medicines may promote blood clot formation.
You have or have previously had a condition where you stop breathing briefly during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that slow down normal brain activity (“depressants”).
You have or have previously had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.
You have previously had problems with alcohol or drugs.
If you suffer from depression or other conditions treated with antidepressants. Using these medicines together with Quetiapine Mylan may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapine Mylan”).

Contact your doctor immediately if you experience the following symptoms after taking Quetiapine Mylan:

Rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should check your heart and, if necessary, refer you immediately to a cardiologist.
Fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
Uncontrollable movements, mainly of the face or tongue.
Dizziness or a strong feeling of drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
Seizures (epileptic fits).
Persistent and painful erection (priapism).

The following conditions may be caused by this type of medicine.
Inform your doctor as soon as possible if you experience:

Fever, flu-like symptoms, sore throat, or any other infection, as these could be signs of a very low white blood cell count, which may require that Quetiapine Mylan be stopped and/or treatment be administered.
Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these may lead to a more serious intestinal blockage.

Suicidal thoughts and worsening depression
If you are depressed, you may sometimes feel like harming yourself or committing suicide. These feelings
may be stronger at the beginning of treatment, as these medicines need time to work, usually about two weeks but sometimes longer. These thoughts may also intensify
if you suddenly stop taking the medicine.
You are more likely to have such feelings if you are a young adult. Data from
clinical trials have shown an increased risk of suicidal thoughts and/or suicidal
behaviour in young adults with depression under 25 years of age.
If at any time you realize you are having thoughts of self-harm or suicide,
contact your doctor or go to the hospital immediately. You may find it helpful to inform a relative
or close friend that you suffer from depression, and ask them to read this leaflet.
You may ask them to alert you if they think your depression is worsening or if they are
concerned about any changes in your behaviour.
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), which may be life-threatening or fatal, have been
very rarely reported in association with treatment with this medicine. These commonly manifest as:

Stevens-Johnson syndrome (SJS), widespread skin rash with blisters and skin peeling, particularly 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), consisting of flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes)
Acute generalized exanthematous pustulosis (AGEP), a condition causing an eruption of superficial pustules
Erythema multiforme (EM), skin rash with irregular red, itchy spots

Stop using Quetiapine Mylan if you develop these symptoms and contact your doctor or seek
immediate medical assistance.
Weight gain
Weight gain has been reported in patients treated with quetiapine. It is necessary that your body weight
be monitored regularly by both you and your doctor.
Children and adolescents
Quetiapine Mylan must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Mylan
Inform your doctor if you are taking, have recently taken, or might take any other
medicines, including those without a prescription and herbal medicines.
Do not take Quetiapine Mylan if you are taking any of the following medicines:

Certain medicines for HIV virus.
Azole drugs (for fungal infections).
Erythromycin or clarithromycin (for infections).
Nefazodone (for depression).

Inform your doctor if you are taking any of the following medicines:

Medicines for epilepsy (such as phenytoin or carbamazepine).
Medicines for high blood pressure.
Barbiturates (for sleep disorders).
Thioridazine or lithium (other antipsychotic medicines).
Medicines that affect heart rhythm, for example medicines that may cause electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
Medicines that may cause constipation.
Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.
Antidepressants. These medicines may interact with Quetiapine Mylan and symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, body temperature above 38°C (serotonin syndrome) may occur. Consult your doctor if these symptoms occur.

Before stopping any medicine, talk to your doctor.
Quetiapine Mylan with food, drinks and alcohol

The effect of Quetiapine Mylan may be affected by food; therefore, you should take the tablets at least one hour before a meal or before going to sleep.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quetiapine Mylan and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Quetiapine Mylan, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before taking this medicine.
You should not take Quetiapine Mylan during pregnancy without first discussing it with your doctor.
Quetiapine Mylan must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who
took quetiapine during the last trimester (the last three months of pregnancy): tremor, muscle stiffness
and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
If your baby shows any of these symptoms, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how
the tablets affect you.
Effect on urine drug screening tests
If you need to undergo a urine drug screening test, taking quetiapine may lead to false-positive results
for methadone or certain antidepressants called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, more specific tests should be performed.
Quetiapine Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Quetiapine Mylan

Take Quetiapine Mylan exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist. Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

You must take the tablets once daily.
The tablets must not be split, chewed, or crushed.
Swallow the tablets whole with a glass of water.
Take the tablets away from meals (at least one hour before a meal or at bedtime; your doctor will advise you on the appropriate time).
Do not drink grapefruit juice while taking Quetiapine Mylan, as it may affect the medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you to do so.

Liver problems
If you have liver problems, your doctor may adjust your dose.
Elderly
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Quetiapine Mylan must not be used in children and adolescents under 18 years of age.

If you take more Quetiapine Mylan than you should
If you take more Quetiapine Mylan than prescribed, you may feel drowsy, experience dizziness, or notice an irregular heartbeat. Contact your doctor or the nearest hospital immediately. Take the Quetiapine Mylan tablets with you.

If you forget to take Quetiapine Mylan
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Quetiapine Mylan
If you stop treatment with Quetiapine Mylan suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, feeling unwell (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist.

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

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (which diminishes over time with continued treatment) (may lead to falls).
Withdrawal symptoms (symptoms occurring when you stop taking this medicine), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual discontinuation of the medicine over a period of at least 1 or 2 weeks is recommended.
Increase in body weight.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle stiffness.
Changes in the levels of certain fats (triglycerides and total cholesterol).

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

Fast heartbeat
Sensation of rapid or forceful heartbeat, or awareness of missed beats
Constipation, stomach discomfort (indigestion)
Feeling weak
Swelling of arms or legs
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 feeling of hunger
Irritability
Speech and language disturbances
Suicidal thoughts and worsening of depression
Shortness of breath
Vomiting (especially in elderly patients)
Fever
Changes in thyroid hormone levels in the blood
Decreased number of certain types of blood cells
Increased levels of liver enzymes in the blood
Increased levels of prolactin hormone in the blood. Increased prolactin levels may, in rare cases, lead to the following:
o Breast enlargement and unexpected production of breast milk in both men and women.
o Absent or irregular menstrual cycles in women.

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

Seizures or epileptic fits.
Allergic reactions including swellings (wheals), skin swelling, and swelling around the mouth.
Combination of fever, flu-like symptoms, sore throat or any other infection with a very low white blood cell count, a condition called neutropenia.
Unpleasant sensation in the legs (also known as restless legs syndrome)
Difficulty swallowing.
Uncontrollable movements, mainly of the face or tongue.
Sexual dysfunction.
Diabetes.
Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval)
A slowing of the normal heart rate may occur when starting treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may lead to falls).
Nasal congestion.
Reduction in the number of red blood cells in the blood.
Reduction in the amount of sodium in the blood.
Worsening of pre-existing diabetes.
Confusion.

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

High body temperature (fever) associated with sweating, muscle stiffness, marked drowsiness or fainting (a condition called "neuroleptic malignant syndrome")
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Prolonged and painful erection (priapism).
Breast enlargement and unexpected milk production from the mammary gland (galactorrhoea).
Menstrual disorders.
Blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you experience any of these symptoms, contact your doctor immediately.
Sleepwalking and other related events (such as sleep talking and sleep-related eating disorders).
Decrease in body temperature (hypothermia).
Inflammation of the pancreas.
A condition (called "Metabolic Syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
Intestinal obstruction.
Increased blood levels of creatine phosphokinase (a muscle substance).

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

Severe skin rash, blisters or red patches on the skin.
Severe allergic reaction (called anaphylaxis) which may cause difficulty breathing or shock.
Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
Severe condition characterised by blister formation on the skin, in the mouth, eyes and genitals (Stevens-Johnson syndrome). See section 2.
Inappropriate secretion of the hormone controlling urine volume.
Damage to muscle fibres and muscle pain (rhabdomyolysis).

Not known (frequency cannot be estimated from available data)

Skin rash associated with appearance of irregular red patches (erythema multiforme).
Sudden severe allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis). See section 2.
Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
Drug rash with Eosinophilia and Systemic Symptoms (DRESS). Widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (Drug rash with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2.
Generalised pustular eruption (AGEP), eruption of superficial pustules.

Stop taking Quetiapine Mylan and seek immediate medical help if you develop any of these symptoms.

Stroke with symptoms including collapse, numbness or weakness in arms or legs, headache, dizziness, confusion, visual disturbances, difficulty swallowing, or speech problems such as slurred speech and loss of speech.
Heart muscle disorder (cardiomyopathy).
Inflammation of the heart muscle (myocarditis).
Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple bumps.

The class of medicines to which quetiapine belongs can cause problems with heart rhythm, which may be serious and, in the most severe cases, may be fatal.

Some side effects are detectable only through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, decreased number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance found in muscles), reduced sodium levels in the blood, and increased levels of prolactin hormone in the blood.

Your doctor will occasionally prescribe blood tests for you.

Side effects in children and adolescents

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

The following side effects have been reported more frequently in children and adolescents, or were not reported in adults:

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

Increased blood levels of a hormone called prolactin. In rare cases, these increased prolactin levels may cause the following conditions:
o Breast enlargement and unexpected milk production from the mammary gland in boys and girls
o Absence or irregularity of menstrual cycles in girls
Increased appetite
Vomiting
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or painless muscle stiffness
Increased blood pressure.

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

Weakness, fainting (may lead to falls)
Nasal congestion
Irritability.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Quetiapina Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Quetiapina Mylan contains

The active substance is quetiapine. Each tablet contains 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
The other components are: Tablet core: hypromellose 2910, hypromellose 2208, microcrystalline cellulose, anhydrous sodium citrate (see section 2 “Quetiapina Mylan contains sodium”), magnesium stearate. Tablet coating: titanium dioxide (E171), hypromellose 2910, macrogol 400, polysorbate 80. The 50 mg, 200 mg and 300 mg tablets contain yellow iron oxide (E172) and red iron oxide (E172). The 50 mg and 300 mg tablets also contain black iron oxide (E172).

Description of the appearance of Quetiapina Mylan and package contents
All formulations of Quetiapina Mylan prolonged-release tablets are biconvex,
oblong, film-coated tablets.
The 50 mg tablets are brown, printed with “Q 50” on one side.
The 150 mg tablets are white, printed with “Q 150” on one side.
The 200 mg tablets are yellow, printed with “Q 200” on one side.
The 300 mg tablets are light yellow, printed with “Q 300” on one side.
The 400 mg tablets are white, printed with “Q 400” on one side.
This medicine is available in plastic bottles containing 60 prolonged-release tablets or in
blister packs contained in cardboard boxes containing:
50 mg: 10, 10 x 1 (unit dose with perforated blister), 30, 30 x 1 (unit dose with perforated blister), 60
or 60 x 1 (unit dose with perforated blister) prolonged-release tablets.
150 mg: 30, 30 x 1 (unit dose with perforated blister), 60 or 60 x 1 (unit dose with perforated blister)
prolonged-release tablets.
200 mg: 10, 10 x 1 (unit dose with perforated blister), 30, 30 x 1 (unit dose with perforated blister),
60, 60 x 1 (unit dose with perforated blister), 100 or 100 x 1 (unit dose with perforated blister)
prolonged-release tablets.
300 mg: 10, 10 x 1 (unit dose with perforated blister), 30, 30 x 1 (unit dose with perforated blister),
60, 60 x 1 (unit dose with perforated blister), 100 or 100 x 1 (unit dose with perforated blister)
prolonged-release tablets.
400 mg: 10, 10 x 1 (unit dose with perforated blister), 30, 30 x 1 (unit dose with perforated blister),
60, 60 x 1 (unit dose with perforated blister), 100 or 100 x 1 (unit dose with perforated blister)
prolonged-release tablets.

Marketing Authorization Holder and Manufacturer
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany
Mylan Hungary Kft., H-2900 Komárom, Mylan utca 1, Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
United Kingdom: Alaquet XL
Belgium: Quetiapine Retard Mylan 50 mg, 150 mg, 200 mg, 300 mg, 400 mg tabletten met verlengde
afgifte/comprimés à libération prolongée/Retardtabletten
Czech Republic: Quetiapine Viatris 200 mg, 300 mg, 400 mg tablety s prodlouženým uvolňováním
Greece: Quetiapine Mylan 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged release tablets
Spain: Quetiapina Viatris 50 mg, 150 mg, 200 mg, 300 mg, 400 mg comprimidos de liberación
prolongada EFG
France: QUETIAPINE VIATRIS 50 mg, 150 mg, 200 mg, 300 mg, 400 mg comprimé à libération
prolongée
Italy: Quetiapina Mylan
Poland: Etiagen XR
Portugal: Quetiapina Mylan
Slovakia: Quetiapin Mylan 200mg, 300mg, 400mg tablety s predĺženým uvoľňovaním
Netherlands: Quetiapine Retard Mylan 50 mg; 200 mg; 300 mg; 400 mg, tabletten met verlengde afgifte