Quetiapine Sandoz BV

Package leaflet: Information for the patient

Quetiapine Sandoz BV 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

Generic medicine
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 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, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Quetiapina Sandoz BV is and what it is used for

Quetiapina Sandoz BV contains a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quetiapina Sandoz BV 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. You may notice that you feel depressed, guilty, lack energy, have loss of appetite, or have difficulty sleeping.
• Mania: you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behavior.
• Schizophrenia: you may have the sensation of hearing or perceiving things that are not actually present, may believe things that are not true, or may feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

When Quetiapina Sandoz BV is taken for the treatment of major depressive episodes associated with major depressive disorder, it will be administered in addition to another medicine used to treat this condition.
Your doctor may continue to prescribe Quetiapina Sandoz BV even if you start feeling better.

2. What you need to know before taking Quetiapine Sandoz BV

Do not take Quetiapine Sandoz BV

• 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 antiviral medicines for HIV, antifungal azole medicines, erythromycin or clarithromycin (for infections), or nefazodone (for depression)

Do not take Quetiapine Sandoz BV if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Quetiapine Sandoz BV.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetiapine Sandoz BV:

• 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.
• if you have low blood pressure.
• if you have had a stroke, especially if you are elderly.
• if you have liver problems.
• if you have had seizures (epileptic fits).
• if 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 Sandoz BV.
• if you know you have previously had low levels of white blood cells in your blood (whether caused by medicines or not).
• if you are an elderly person with dementia (loss of some brain functions). In this case, you should not take Quetiapine Sandoz BV, as this class of medicines, to which Quetiapine Sandoz BV belongs, may increase the risk of stroke or, in some cases, death in elderly patients with dementia.
• if you are an elderly person with Parkinson’s disease/parkinsonism.
• if you or someone in your family has a history of blood clots, as medicines of this type may increase the risk of blood clot formation.
• if you have or have previously had a condition where you stop breathing briefly during normal sleep (called "sleep apnea") and you are taking medicines that slow down normal brain activity ("central nervous system depressants").
• if you have or have previously had a condition where you cannot fully empty your bladder (urinary retention), have an enlarged prostate, intestinal blockage, or increased pressure inside the eye. These conditions may sometimes be caused by medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain diseases.
• if you have or have previously had a history of alcohol or drug abuse.
• if you have depression or other conditions treated with antidepressants. Taking these medicines together with Quetiapine Sandoz BV may lead to serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine Sandoz BV").

Contact your doctor immediately if you experience any of the following symptoms after taking Quetiapine Sandoz BV:

• 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 intense drowsiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (epileptic fits).
• Persistent and painful erection (Priapism).
• Rapid or irregular heartbeat (palpitations) even at rest, breathing difficulties, chest pain, or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.

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 may be signs of very low white blood cell count, which may require stopping Quetiapine Sandoz BV and/or starting treatment.
• 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 of depression

If you are depressed, you may occasionally have thoughts of harming yourself or of 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 intensify if you suddenly stop taking the medicine. You are more likely to experience such 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 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 family member or close friend that you are depressed and ask them to read this leaflet. You may also ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behaviour.

Serious cutaneous adverse reactions (SCARs)

Serious cutaneous adverse reactions (SCARs), which may be potentially life-threatening or fatal, have been very rarely reported during treatment with this medicine. These commonly include:

• Stevens-Johnson syndrome (SJS), a widespread 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), characterized by flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes)
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus
• Erythema multiforme (EM), a skin rash with irregular, red, itchy patches

Stop using Quetiapine Sandoz BV and contact your doctor or seek immediate medical help if you develop any of these symptoms.

Weight gain

Weight gain has been reported in patients treated with Quetiapine Sandoz BV. It is important that your body weight is regularly monitored by both you and your doctor.

Children and adolescents

Quetiapine Sandoz BV must not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine Sandoz BV

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Quetiapine Sandoz BV if you are taking any of the following medicines:

• Certain antiviral medicines for HIV.
• Antifungal azole medicines.
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

In particular, 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 potassium or magnesium levels), such as diuretics ("water 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 diseases.
• Antidepressants. These medicines may interact with Quetiapine Sandoz BV and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle rigidity, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Do not stop taking any medicine without first discussing it with your doctor.

Quetiapine Sandoz BV with food, drinks, and alcohol

• The effect of Quetiapine Sandoz BV may be affected by food; therefore, 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 Sandoz BV and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Quetiapine Sandoz BV, 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 Sandoz BV during pregnancy unless discussed with your doctor. Quetiapine Sandoz BV must not be taken during breastfeeding.

The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took Quetiapine Sandoz BV during the third trimester (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 tools or machinery until you know how the tablets affect you.

Effect on urine drug screening tests

If you undergo a urine drug screening test, taking Quetiapine Sandoz BV may result in 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 Sandoz BV contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Quetiapine Sandoz BV

Take this medicine exactly as your doctor or pharmacist 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.

• Take the tablets once a day.
• Do not divide, chew or break the tablets.
• 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 tell you when).
• Do not drink grapefruit juice during treatment with Quetiapine Sandoz BV, 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 patients
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents (under 18 years of age)
Quetiapine Sandoz BV must not be used in children and adolescents under 18
years of age.
If you take more Quetiapine Sandoz BV than you should
If you take more Quetiapine Sandoz BV than prescribed by your doctor, you may feel drowsy,
experience dizziness or notice an irregular heartbeat. Contact your doctor or the nearest hospital immediately, taking the Quetiapine Sandoz BV package with you.
If you forget to take a dose of Quetiapine Sandoz BV
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next
dose, wait until the scheduled time. Do not take a double dose to make up for
the missed dose.
If you stop taking Quetiapine Sandoz BV
If you stop treatment with Quetiapine Sandoz BV 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• Dizziness (may cause falls), headache, dry mouth.
• Drowsiness – which decreases over time with continued treatment with Quetiapine Sandoz BV – (may cause falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Quetiapine Sandoz BV), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. A 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 movement, tremor, feeling of restlessness, or muscle stiffness without pain.
• Changes in the levels of certain blood 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 heartbeats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the 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.
• Reduction in the number of certain types of blood cells.
• Increase in liver enzyme levels in the blood.
• Increase in prolactin hormone levels in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
  • Both men and women may experience breast enlargement and unexpected production of breast milk.
  • Women may experience absent or irregular menstrual cycles.

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

• Seizures or epileptic fits.
• Allergic reactions including swellings (hives), skin swelling, and swelling around the mouth.
• 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 QT interval).
• Slowing of the normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may cause falls).
• Nasal congestion.
• Reduction in the number of red blood cells.
• Reduction in sodium levels 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).
• Persistent and painful erection (priapism).
• Breast enlargement and unexpected milk production from the mammary gland (galactorrhea).
• 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.
• Walking, talking, eating, or other activities during sleep.
• Decreased 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 type of blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
• Combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased blood levels of creatine phosphokinase (a substance from muscles).

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 breathing difficulties 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 that controls urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Damage to muscle fibres and muscle pain (rhabdomyolysis).

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

• Skin rash associated with appearance of irregular red patches (erythema multiforme).
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin, and skin peeling (toxic epidermal necrolysis).
• Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), consisting of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and increased liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who used quetiapine during pregnancy.
• Heart attack.
• 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 Sandoz BV belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

Some side effects can only be detected through blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, reduced number of certain types of blood cells, reduced number of red blood cells, increased serum creatine phosphokinase (a substance from muscles), reduced sodium levels in the blood, and increased levels of prolactin hormone in the blood. Increased prolactin levels may, in rare cases, lead to the following consequences:

• Men and women may experience breast enlargement and unexpected production of breast milk.
• Women may experience absent or irregular menstrual cycles.

Therefore, your doctor may periodically 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 observed 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. Elevated prolactin levels may, in rare cases, lead to the following:
  • Boys and girls may experience breast enlargement and unexpected production of breast milk.
  • Girls may experience absent or irregular menstrual cycles.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements, including difficulty initiating movement, tremor, feeling of restlessness, or muscle stiffness without pain.
• Increased blood pressure.

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 Sandoz BV

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
HDPE bottle: after first opening, use by the expiry date stated on the packaging after EXP.
Quetiapina Sandoz BV 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Quetiapina Sandoz BV contains

• The active substance is quetiapine. Quetiapina Sandoz BV contains 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
• The other components are:
  Tablet core: anhydrous lactose, methacrylic acid-ethyl acrylate copolymer (1:1), type A, crystalline maltose, magnesium stearate and talc
  Coating: methacrylic acid-ethyl acrylate copolymer (1:1), type A, triethyl citrate

Description of the appearance of Quetiapina Sandoz BV and the contents of the pack
The 50 mg prolonged-release tablets are white to off-white, round, biconvex tablets with '50' engraved on one side, 7.1 mm in diameter and 3.2 mm thick.
The 150 mg prolonged-release tablets are white to off-white, oblong, biconvex tablets with '150' engraved on one side, 13.6 mm long, 6.6 mm wide and 4.2 mm thick.
The 200 mg prolonged-release tablets are white to off-white, oblong, biconvex tablets with '200' engraved on one side, 15.2 mm long, 7.7 mm wide and 4.8 mm thick.
The 300 mg prolonged-release tablets are white to off-white, oblong, biconvex tablets with '300' engraved on one side, 18.2 mm long, 8.2 mm wide and 5.4 mm thick.
The 400 mg prolonged-release tablets are white to off-white, oval, biconvex tablets with '400' engraved on one side, 20.7 mm long, 10.2 mm wide and 6.3 mm thick.

• Quetiapina Sandoz BV is available in PVC/PCTFE-aluminium blisters packed in cardboard cartons.
• Quetiapina Sandoz BV prolonged-release tablets are also available in white opaque HDPE bottles with a child-resistant screw cap made of polypropylene and a breakable seal.

Blister packs contain: 10, 30, 50, 56, 60 and 100 tablets
Bottle packs contain: 60 and 120 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz B.V.
Hospitaaldreef 29,
1315 RC Almere
The Netherlands

Local representative in Italy:
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Pharmathen International S.A
Sapes Industrial Park Block 5, Rodopi, 69300 Greece
Pharmathen S.A
6, Dervenakion str., Pallini, Attiki, 15351 Greece
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

This medicinal product is authorized in the European Economic Area countries and in the United Kingdom (Northern Ireland) under the following names:
Austria Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg - Retardtabletten
Belgium Quetiapin Retard Sandoz 50 mg tabletten met verlengde afgifte
Quetiapin Retard Sandoz 200 mg tabletten met verlengde afgifte
Quetiapin Retard Sandoz 300 mg tabletten met verlengde afgifte
Quetiapin Retard Sandoz 400 mg tabletten met verlengde afgifte
Germany Quetiapin HEXAL® 50/150/200/300/400 Retardtabletten
Denmark Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter
Finland Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletti
France Quetiapin Sandoz LP 50 mg/300 mg/400 mg, comprimé à libération prolongée
Ireland Quetex XR 50 mg/200 mg/300 mg/400 mg Prolonged-release tablets
Iceland Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg forðatöflur
Italy Quetiapina Sandoz BV
Netherlands Quetiapine Sandoz SR 50 mg/150 mg/200 mg/300 mg/400 mg, tabletten met verlengde afgifte
Poland Kvelux SR
Portugal Quetiapina Sandoz
Sweden Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter
Slovenia Kvelux SR 50 mg/150 mg/200 mg/300 mg/400 mg tablete s podaljšanim sproščanjem
Spain Quetiapina Sandoz 50/150/200/300/400 mg comprimidos de liberación prolongada EFG
Slovakia Quetiapin Sandoz 200 mg/300 mg
United Kingdom Psyquet XL 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-release tablets