QUETIAPINE AUROBINDO

Package leaflet: Information for the user

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

Generic medicinal product
Please read all of this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Quetiapine Aurobindo is and what it is used for
2. What you need to know before taking Quetiapine Aurobindo
3. How to take Quetiapine Aurobindo
4. Possible side effects
5. How to store Quetiapine Aurobindo
6. Contents of the pack and other information

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

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

• bipolar depression: you may feel sad, depressed, guilty, without energy, without appetite, or have difficulty sleeping
• mania: you may feel highly excited, euphoric, restless, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behavior
• 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

Your doctor may continue prescribing Quetiapina Aurobindo even if you feel better.

2. What you should know before taking Quetiapine Aurobindo

Do not take Quetiapine Aurobindo:

• 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 medicines (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression).

Do not take Quetiapine Aurobindo if you fall into any of the categories listed above. If you have any doubts, consult your doctor or pharmacist before taking Quetiapine Aurobindo.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Aurobindo.
Inform your doctor 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 suffer from liver problems
• you have ever 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 Aurobindo
• you know you have previously had low levels of white blood cells (with or without other medicines)
• you are an elderly person with dementia (loss of some brain functions). In this case, Quetiapine Aurobindo should not be taken, as this class of medicines to which Quetiapine Aurobindo 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, as medicines of this type may increase the risk of blood clot formation
• you have a history of alcohol or drug abuse
• you have or have previously had a condition in which you stop breathing for short periods 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 are unable to completely empty your bladder (urinary retention), 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, after taking Quetiapine Aurobindo, you notice any of the following effects:

• Fever associated with severe muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
• Uncontrollable movements, mainly of the face, tongue, jaw, facial grimacing, rapid blinking, or uncontrollable movements of the arms, legs, hands, or feet. These may be signs of "tardive dyskinesia".
• Dizziness or intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients
• Seizures (epileptic fits)
• Painful and prolonged erection (priapism)

These symptoms 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 infection, as this could result from a very low count of white blood cells, which may require stopping Quetiapine Aurobindo and/or receiving treatment.
• Constipation together with persistent abdominal pain, or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage.

Suicidal thoughts and worsening of 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 take time to work, usually about two weeks but sometimes longer. These thoughts may also worsen if you suddenly stop taking the medicine. You are more likely to have such feelings if you are a young adult. Clinical trial data have shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults with depression under the age of 25.
If at any time you experience 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.
Weight gain
Weight gain has been observed in patients taking Quetiapine Aurobindo. You and your doctor should monitor your weight regularly.
Children and adolescents
Quetiapine Aurobindo must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Quetiapine Aurobindo if you are taking any of the following medicines:

• Certain medicines for HIV virus
• "Azole" medicines (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 an 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 first.
Quetiapine Aurobindo with food, drinks and alcohol
Quetiapine Aurobindo can be taken regardless of food intake.
Be cautious about the amount of alcohol you consume. This is because combining Quetiapine Aurobindo with alcohol may cause drowsiness.
Do not drink grapefruit juice while taking Quetiapine Aurobindo, as it may affect the medicine's action.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

• You must not take Quetiapine Aurobindo during pregnancy unless you have discussed it with your doctor.
• Quetiapine Aurobindo must not be taken if you are breastfeeding.

The following symptoms, which may represent withdrawal, may occur in newborns whose mothers used quetiapine during the third trimester of pregnancy (last 3 months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. Consult your doctor if your baby shows any of these symptoms.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate tools or machinery until you know how the tablets affect you.
Quetiapine Aurobindo contains lactose
Quetiapine Aurobindo contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Effect of the medicine on urine testing
If you undergo a urine test, taking Quetiapine Aurobindo may give a positive result for methadone or for certain medicines used to treat depression, known as tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or other TCAs. If this occurs, more specific tests should be performed.

3. How to take Quetiapina Aurobindo

Take Quetiapina Aurobindo exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
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 and 800 mg.

Method of administration

• Take the tablets once daily at bedtime, or twice daily, depending on the condition being treated.
• Swallow the tablets whole with a glass of water.
• You may take the tablets with or without food.
• Do not drink grapefruit juice while taking Quetiapina Aurobindo, as it may affect the medicine's action.
• Do not stop taking the tablets, even if you feel better, until your doctor tells you it is safe to do so.

Patients with hepatic impairment
If you have liver problems, your doctor may adjust your dose.

Elderly patients
If you are elderly, your doctor may adjust your dose.

Use in children and adolescents
Quetiapina Aurobindo must not be used in children and adolescents under 18 years of age.

If you take more Quetiapina Aurobindo than you should
If you take more Quetiapina Aurobindo than prescribed, you may feel very sleepy, experience dizziness, or notice an irregular heartbeat. Contact your doctor or go to the nearest hospital immediately. Take the tablets with you.

If you forget to take Quetiapina Aurobindo
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 Quetiapina Aurobindo

• Do not stop taking the tablets, even if you feel better, unless your doctor tells you to do so.
• If you stop taking Quetiapina Aurobindo suddenly, you may experience difficulty sleeping (insomnia), feel unwell (nausea), or develop 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop treatment with
Quetiapine Aurobindo and contact your doctor immediately or go to the nearest hospital. Urgent
medical intervention may be required:
Uncommon (may affect up to 1 in 100 people):

• allergic reactions which may include raised lumps on the skin (wheals), swelling of the skin and around the mouth
• epileptic fits or seizures
• uncontrolled movements, especially of the tongue, mouth and jaw, but also of the arms, legs, fingers or toes, facial grimacing and rapid blinking. These may be symptoms of a condition known as "tardive dyskinesia"
• increased susceptibility to infections. This could be a sign of an abnormal reduction in certain types of white blood cells (neutropenia). Rare (may affect up to 1 in 1,000 people):
• A combination of elevated body temperature (fever), sweating, muscle stiffness, extreme drowsiness or fainting, frequent changes in blood pressure and rapid heartbeat (a condition known as "neuroleptic malignant syndrome")
• yellowing of the skin and eyes (jaundice)
• inflammation of the liver (hepatitis)
• a persistent and painful erection (priapism)
• 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
• inflammation of the pancreas (pancreatitis). Symptoms may include severe abdominal and back pain, nausea and vomiting
• a combination of fever, flu-like symptoms, sore throat or any other infection with a very low white blood cell count, a condition called agranulocytosis.

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

• 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)
• a serious condition with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• abnormal breakdown of muscle tissue (rhabdomyolysis) with symptoms such as muscle pain, weakness and swelling, which may cause kidney problems (urine may become dark)

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

• Severe, immediate allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis)
• Skin rash with irregular red patches (erythema multiforme)

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

• Dizziness (may cause falls), headache, dry mouth
• Drowsiness (may resolve over time while continuing treatment with Quetiapine Aurobindo) (may cause falls)
• Withdrawal symptoms (symptoms occurring when you stop taking Quetiapine Aurobindo), including sleep disturbances (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling unwell (vomiting), dizziness and irritability. Gradual discontinuation over a period of at least 1 to 2 weeks is recommended.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness or muscle stiffness without pain.
• Changes in levels of certain fats (triglycerides and cholesterol) in the blood
• Weight gain
• Reduction in levels of a certain protein in red blood cells (haemoglobin)

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

• Rapid heartbeat
• Sensation of a racing, pounding or irregular heartbeat
• Shortness of breath
• Low blood pressure when standing up, which may present as dizziness or feeling faint (may cause falls)
• Constipation, stomach ache (indigestion)
• Vomiting (mainly in elderly people)
• Abnormal dreams and nightmares
• Suicidal thoughts and worsening of depression
• Increased appetite
• Speech and language difficulties
• Increased levels of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following effects:
• breast enlargement and unexpected milk production in both men and women
• absence of menstruation or irregular menstrual cycle in women
• Blurred vision
• Feeling irritable
• Fever
• Increased liver enzymes measured in blood
• Changes in thyroid hormone levels in the blood
• Decreased number of certain blood cells
• Increased blood sugar levels
• Feeling weak
• Swelling of arms and legs

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

• Unpleasant sensation in the legs (also known as restless legs syndrome)
• Difficulty swallowing
• Changes in the electrical activity of the heart observed on ECG (QT interval prolongation)
• Diabetes
• Sexual dysfunction
• Reduced number of red blood cells (anaemia) or platelets in the blood (thrombocytopenia)
• Reduced sodium levels in the blood (hyponatraemia)
• Slower than normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
• Nasal congestion
• Fainting (may lead to falls)
• Difficulty urinating
• Worsening of pre-existing diabetes

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

• Breast enlargement and unexpected milk production from the mammary gland (galactorrhoea)
• Menstrual disorders
• A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following symptoms: increased abdominal fat, reduced “good” cholesterol (HDL-C), increased levels of a type of fat in the blood called triglycerides, high blood pressure and increased blood sugar
• Walking, talking, eating or performing other activities while asleep
• Reduced body temperature (hypothermia)
• Intestinal obstruction
• Increased creatine phosphokinase in the blood (a muscle substance)

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

• Inappropriate secretion of a hormone that controls urine volume may cause low sodium levels in the blood. This may lead to symptoms such as headache, nausea, confusion and weakness. Not known (frequency cannot be estimated from the available data):
• Withdrawal symptoms may occur in newborns whose mothers have used quetiapine during pregnancy.

The class of medicines to which Quetiapine Aurobindo belongs may cause problems with heart rhythm, which can be serious and, in severe cases, may be fatal.
Some side effects have been identified 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, decreased red blood cell count, increased creatine phosphokinase (a muscle substance), decreased sodium levels in the blood and increased levels of prolactin hormone in the blood. Increases in prolactin hormone may, in rare cases, lead to the following effects:

• breast enlargement and unexpected milk production in both men and women
• absence or irregularity of menstrual cycle in women
  Your doctor may ask you to have blood tests from time to time.

Side effects in children and adolescents
Children and adolescents may experience the same side effects as adults.
The following side effects have been reported more frequently in children and adolescents or were not observed in adults:
Very common (may affect more than 1 in 10 people):

• increased levels of a hormone known as prolactin in the blood. In rare cases, increased prolactin levels may cause:
• breast enlargement in boys and girls and unexpected milk production
• absence or irregularity of menstrual cycle in girls
• increased appetite
• vomiting
• abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness or muscle stiffness without pain
• increased blood pressure

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

• Feeling weak, fainting (may lead to falls)
• Nasal congestion
• Feeling restless

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 the website http://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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label, and blister pack after "EXP". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Aurobindo contains

• The active substance is quetiapine. Quetiapina Aurobindo film-coated tablets contain 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
• The other components are: Tablet core: Microcrystalline cellulose, povidone K29-32, calcium hydrogen phosphate dihydrate, sodium starch glycolate (type A), lactose monohydrate, magnesium stearate. Tablet coating: Hypromellose 6cP (E 464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide yellow (E172) (in 25 mg, 100 mg and 150 mg tablets) and iron oxide red (E172) (only in 25 mg tablets).

Description of the appearance of Quetiapina Aurobindo and package contents
Quetiapina Aurobindo 25 mg film-coated tablets are round, 5.5 mm in diameter, biconvex, light orange tablets with "Q" imprinted on one side.
Quetiapina Aurobindo 100 mg film-coated tablets are round, 8.5 mm in diameter, biconvex, yellow tablets with "Q" imprinted on one side.
Quetiapina Aurobindo 150 mg film-coated tablets are oval, biconvex, 6.9 x 13.8 mm, light yellow tablets with "Q" imprinted on one side.
Quetiapina Aurobindo 200 mg film-coated tablets are oval, biconvex, 16 x 8.2 mm, white tablets with "Q" imprinted on one side.
Quetiapina Aurobindo 300 mg film-coated tablets are oval, biconvex, 19 x 7.6 mm, white tablets with "Q" imprinted on one side and "300" on the other.

Pack sizes:
Blister packs:
Quetiapina Aurobindo 25 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90, 100 tablets
Quetiapina Aurobindo 100 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90, 100 tablets
Quetiapina Aurobindo 150 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90, 100 tablets
Quetiapina Aurobindo 200 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90, 100 tablets
Quetiapina Aurobindo 300 mg film-coated tablets: 6, 10, 20, 30, 50, 60, 90, 100 tablets

Bottles:
Quetiapina Aurobindo 25 mg film-coated tablets: 100, 250 tablets
Quetiapina Aurobindo 100 mg film-coated tablets: 100, 250 tablets
Quetiapina Aurobindo 150 mg film-coated tablets: 100, 250 tablets
Quetiapina Aurobindo 200 mg film-coated tablets: 100, 250 tablets
Quetiapina Aurobindo 300 mg film-coated tablets: 60, 100 and 250 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder:
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA)

Manufacturers:
Actavis Ltd., BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, (Malta)
Actavis hf., Reykjavikurvegur 78, IS-220 Hafnarfjörður (Iceland)
Manufacturing Packaging Farmaca (MPF) B.V. Appelhof 13,
Oudehaske, 8465RX,
Netherlands
Manufacturing Packaging Farmaca (MPF) B.V. Neptunus 12,
Herenveen, 8448CN,
Netherlands
Actavis Group PTC ehf.
Reykjavikurvegur 78
IS-220 Hafnarfjordur
Iceland

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Quetiapin Actavis 25 mg, 100 mg, 150 mg, 200 mg, 300 mg Filmtabletten
Belgium Quetiapin AB
Denmark Quetiapin Actavis
Finland Quetiapin Actavis 25mg, 100mg, 150mg, 200mg, 300mg tabletti, kalvopäällysteinen
Germany Quetiapin Puren 25 mg, 100 mg, 150 mg, 200 mg, 300 mg Filmtabletten
Greece Quetiapine/Actavis
Ireland Quetiapine Actavis
Italy Quetiapina Aurobindo
Norway Quetiapin Actavis
Netherlands Quetiapine AB 25 mg, 100 mg, 150 mg, 200 mg, 300 mg filmomhulde tabletten
Portugal Quetiapina Aurovitas
United Kingdom Quetiapine 25 mg, 100 mg, 150 mg, 200 mg, 300 mg Film coated tablets
Sweden Quetiapin Actavis