Quetiapine Teva Italia: detailed information

Package Leaflet: Information for the User

Quetiapine Teva Italia 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
Equivalent medicine
Please read this entire leaflet carefully before taking this medicine, as 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 others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4. Contents of this leaflet:
1. What Quetiapine Teva Italia is and what it is used for
2. What you need to know before taking Quetiapine Teva Italia
3. How to take Quetiapine Teva Italia
4. Possible side effects
5. How to store Quetiapine Teva Italia
6. Contents of the pack and other information

1. What Quetiapine Teva Italia is and what it is used for

Quetiapine Teva Italia contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quetiapine Teva Italia 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, experience guilt, lack energy, have no appetite, or have difficulty sleeping.
Mania: you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behaviors.
Schizophrenia: you may hear or sense things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

When Quetiapine Teva Italia is taken for the treatment of major depressive episodes associated with major depressive disorder, it must be used in addition to another medicine indicated for the treatment of this condition.

Your doctor may continue to prescribe Quetiapine Teva Italia even if you feel better.

2. What you should know before taking Quetiapina Teva Italia

Do not take Quetiapina Teva Italia:

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 Quetiapina Teva Italia if you belong to any of the above categories. If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Teva Italia.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapina Teva Italia 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 Quetiapina Teva Italia.
you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not).
you are an elderly person with dementia (loss of some brain functions). In this case, Quetiapina Teva Italia should not be taken, as this class of medicines to which Quetiapina Teva Italia belongs may increase the risk of stroke, or in some cases the risk of death in elderly patients with dementia.
you or someone in your family has a history of conditions related to blood clots, since medicines of this type may increase the risk of blood clot formation.
you have or have previously had a condition (called "sleep apnoea") in which you stop breathing for short periods during normal night sleep, and you are taking medicines that slow down normal brain activity ("depressants").
you have or have previously had a condition in which you are unable to completely empty your bladder (urinary retention), or you have an enlarged prostate, intestinal blockage, 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. Inform your doctor immediately if you experience any of the following symptoms after taking Quetiapina Teva Italia:
fever associated with severe muscle stiffness, sweating, or decreased level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
fast 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.
uncontrollable movements, mainly of the face or tongue.
dizziness or intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
seizures (epileptic fits).
prolonged and painful erection (priapism).

The following conditions may be caused by the type of medicine you are taking.
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 stopping Quetiapina Teva Italia prolonged-release tablets and/or starting treatment.
constipation together with persistent abdominal pain or constipation that has not responded to treatment, as these could lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes feel the need to harm yourself or commit suicide. These feelings may be stronger at the beginning of treatment, as these medicines take time to work, usually about two weeks but sometimes longer. These thoughts may also worsen if you suddenly stop taking the medicine.
It is more likely that you may have these types of feelings if you are a young adult. Clinical studies 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 notice that you are having thoughts of self-harm or suicide, contact your doctor or go to 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 warn you if they think your depression is getting worse or if they are concerned about any changes in your behaviour.
Weight gain
Weight gain has been reported in patients treated with quetiapine. It is important that your body weight is monitored regularly by you and your doctor.
Children and adolescents
Quetiapina Teva Italia prolonged-release tablets must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapina Teva Italia
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Do not take Quetiapina Teva Italia 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 heartbeat, 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.

Before stopping any medicine, talk to your doctor.
Quetiapina Teva Italia with food, drinks and alcohol

The effect of Quetiapina Teva Italia 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 Quetiapina Teva Italia and alcohol may increase drowsiness.
Do not drink grapefruit juice while taking Quetiapina Teva Italia, 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, consult your doctor before taking this medicine. You must not take Quetiapina Teva Italia during pregnancy without first discussing it with your doctor. Quetiapina Teva Italia 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 third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, 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 screening tests
If you need to undergo a urine screening test, taking Quetiapina Teva Italia 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.
Quetiapina Teva Italia 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 Teva Italia

Take this medicine exactly as instructed by your doctor. 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.

Take the tablets once daily.
The tablets must not be divided, 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 timing).
Do not drink grapefruit juice while taking Quetiapine Teva Italia, 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 Teva Italia must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Teva Italia than you should
If you take more Quetiapine Teva Italia than prescribed, you may feel drowsy, experience dizziness, or notice an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and bring the pack of Quetiapine Teva Italia prolonged-release tablets with you.
If you forget to take Quetiapine Teva Italia
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 missed tablet.
If you stop taking Quetiapine Teva Italia
If you stop treatment with Quetiapine Teva Italia suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking Quetiapina Teva Italia
and go to the doctor or the nearest hospital immediately:

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

Suicidal thoughts and worsening of depression

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

Sudden fever, especially with sore throat and other flu-like symptoms. These may be signs of an abnormally low white blood cell count
Signs of skin reactions such as rashes, hives, lumps, redness, itching with swelling of the face, eyelids and lips. This may also lead to breathing difficulties, dizziness or shock
Seizures or convulsions
Uncontrollable movements, mainly of the face or tongue (tardive dyskinesia)
Feeling your heart beat strongly, associated with dizziness and fainting. These may be signs of serious heart rhythm problems and, in severe cases, may be fatal

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

Severe pain and/or swelling and redness in one of the legs; sudden severe chest pain that may radiate to the left arm or sudden shortness of breath. These may be signs of blood clots in the veins
Severe upper abdominal pain, often radiating to the back, sometimes with nausea and vomiting. This may be a sign of inflammation of the pancreas
Constipation together with persistent abdominal pain or constipation unresponsive to treatment, as this could lead to a more serious intestinal blockage
Yellowing of the skin and eyes (jaundice), dark-coloured urine, especially with unusual fatigue or fever (signs of hepatitis)
A prolonged and painful erection
A combination of fever, sweating, stiff muscles, drowsiness or weakness (a condition called "Neuroleptic Malignant Syndrome")

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

Severe skin reactions with rashes or blisters, irregular red spots or patches and/or peeling of the skin, around the mouth, eyes or genitals, often together with sudden fever or flu-like symptoms. These reactions may develop rapidly
Unexplained muscle pain, tenderness or weakness. These could be early signs of potentially severe muscle breakdown.

Not known (frequency cannot be estimated from the available data):

Heart muscle disorder (cardiomyopathy)
Inflammation of the heart muscle (myocarditis)

Drug Rash with Eosinophilia and Systemic Symptoms (DRESS).
Widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other body organs (Drug Rash with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome).
Stop taking Quetiapina Teva Italia if you develop these symptoms and contact your doctor or seek immediate medical help.

Other possible side effects

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

Dizziness (which may lead to falls), headache, dry mouth
Drowsiness (which may decrease over time with continued treatment with Quetiapina Teva Italia) (this may lead to falls)
Withdrawal symptoms (symptoms that occur when you stop taking Quetiapina Teva Italia), 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, restlessness or muscle stiffness without pain
Decrease in haemoglobin levels (a protein in red blood cells that carries oxygen)
Changes in levels of certain fats (triglycerides and total cholesterol).

Common side effects (may affect less than 1 in 10 people):

Fast heartbeat
Sensation of rapid heartbeat, pounding heartbeat or sensation of missed beats
Constipation, stomach discomfort (indigestion)
Feeling of weakness
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 disorders
Shortness of breath
Vomiting (especially in elderly people)
Fever
Changes in levels of thyroid hormones in the blood
Changes in the number of certain types of blood cells
Increases in liver enzymes measured in the blood
Increases in the level of the hormone prolactin in the blood. Increased prolactin levels may, in rare cases, lead to the following:
- Men and women may experience breast enlargement and unexpected production of breast milk
- Women may experience absent or irregular menstrual cycles.

Uncommon side effects (may affect less than 1 in 100 people):

Unpleasant sensation in the legs (also known as restless legs syndrome)
Difficulty swallowing
Sexual dysfunction
Diabetes
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)
Stuffy nose
Reduction in the amount of sodium in the blood
Worsening of pre-existing diabetes.

Rare side effects (may affect less than 1 in 1,000 people):

Breast enlargement and unexpected milk production from the mammary gland (galactorrhoea)
Menstrual disorders
Sleepwalking and other related events (such as sleep talking and sleep-related eating disorders)
Decrease in body temperature (hypothermia)
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 fat in the blood called triglycerides, high blood pressure and increased blood sugar levels
Increased blood levels of creatine phosphokinase (a substance from muscles).

Very rare side effects (may affect less than 1 in 10,000 people):

Inappropriate secretion of a hormone that controls urine volume.

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

Withdrawal symptoms may occur in newborns of mothers who took Quetiapina Teva Italia during pregnancy
Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple raised spots.

Some side effects can only be detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased serum creatine phosphokinase (a substance found in muscles), decreased sodium levels in the blood, and increased levels of the hormone prolactin in the blood. Increased levels of the hormone prolact inflammazione dei vasi sanguigni (vasculite), spesso con eruzione cutanea con piccole protuberanze rosse o viola. Alcuni effetti indesiderati sono visibili solo dopo aver effettuato un esame del sangue. Tra questi vi sono le variazioni della quantità di alcuni grassi (trigliceridi e colesterolo totale) o zuccheri presenti nel sangue, variazioni dei livelli ematici degli ormoni tiroidei, l’aumento degli enzimi epatici, la diminuzione del numero di alcuni tipi di cellule del sangue, la diminuzione della quantità dei globuli rossi, l’aumento della creatin fosfochinasi sierica (una sostanza presente nei muscoli), la diminuzione della quantità di sodio nel sangue, ed aumenti della quantità dell’ormone prolattina presente nel sangue. Gli incrementi dei livelli dell’ormone prolattina possono, in rari casi, avere le seguenti conseguenze:

Breast enlargement and unexpected milk production from the mammary gland in both men and women
Absence or irregularity of menstrual cycle in women

Your doctor will therefore 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 side effects (may affect more than 1 in 10 people):

Increased blood levels of a hormone called prolactin. In rare cases, these increases in prolactin levels may cause the following conditions:
- Breast enlargement and unexpected milk production from the mammary gland in boys and girls
- Absence or irregularity of menstrual cycle in girls
Increased appetite
Vomiting
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, restlessness or muscle stiffness without pain
Increased blood pressure

Common side effects (may affect less than 1 in 10 people):

Weakness, fainting (may lead to falls)
Stuffy nose
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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Quetiapina Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use Quetiapina Teva Italia after the expiry date which is stated on the pack and blister after the abbreviation "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Quetiapina Teva Italia does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Quetiapina Teva Italia contains

The active substance is quetiapine. Quetiapina Teva Italia tablets contain 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
The other ingredients (excipients) are:
Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate.
Tablet coating: titanium dioxide (E171), hypromellose, macrogol/PEG 400, polysorbate 80.
The 50 mg, 200 mg and 300 mg tablets also 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 Teva Italia and pack contents

Quetiapina Teva Italia 50 mg prolonged-release tablets: Film-coated tablets, brown in colour, biconvex, oblong, with “Q 50” engraved on one side.
Quetiapina Teva Italia 150 mg prolonged-release tablets: Film-coated tablets, white in colour, biconvex, oblong, with “Q 150” engraved on one side.
Quetiapina Teva Italia 200 mg prolonged-release tablets: Film-coated tablets, yellow in colour, biconvex, oblong, with “Q 200” engraved on one side.
Quetiapina Teva Italia 300 mg prolonged-release tablets:
Film-coated tablets, light yellow in colour, biconvex, oblong, with “Q 300” engraved on one side.
Quetiapina Teva Italia 400 mg prolonged-release tablets: Film-coated tablets, white in colour, biconvex, oblong, with “Q 400” engraved on one side.

Pack sizes of 10, 20, 30, 50, 50x1 (perforated blister for unit dose) (hospital pack), 56 (calendar pack), 60, 90 and 100 tablets are registered for all strengths. Not all pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Teva Italia S.r.l.
Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers:
TEVA Pharmaceutical Works Private Limited Company
Pallagi út 13, 4042 Debrecen, Hungary
Pharmachemie B.V.
Swensweg 5, 2031 GA Haarlem, Netherlands
TEVA Czech Industries s.r.o.
Ostravska 29 c.p. 305, 74770 Opava-Komárov, Czech Republic
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków, Poland
TEVA Pharma S.L.U.
C/C, no.4 Poligono Industrial Malpica, 50016 Zaragoza, Spain
Merckle GmbH
Ludwig-Merckle Straße 3, 89143 Blaubeuren, Germany