QUETIAPINA 50 mg Extended-Release Tablet

Зміст інструкції

1. Quetiapina Sandoz BV 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets
   1. What is Quetiapina Sandoz BV and what it is used for
   2. What you need to know before taking Quetiapina Sandoz BV
2. Quetiapina Sandoz BV should be discontinued and/or treatment should be administered.
   1. How to take Quetiapina Sandoz BV
   2. Possible side effects
   3. How to store Quetiapina Sandoz BV
   4. Contents of the pack and other information

Quetiapina Sandoz BV 50 mg, 150 mg, 200 mg, 300 mg, 400 mg prolonged-release tablets

prolonged
Generic medicine

Read this 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Quetiapina Sandoz BV contains a substance called quetiapine. This substance belongs to a
group of medicines called antipsychotics. Quetiapina Sandoz BV can be used to treat
several illnesses, 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, with feelings of guilt, lacking energy, lacking appetite or with difficulty sleeping.
• Mania: you may feel very excited, euphoric, agitated, enthusiastic or hyperactive or have poor judgment, including states of aggression or destructiveness.
• Schizophrenia: you have the sensation of hearing or perceiving things that are not actually present, you may become convinced of things that are not true or you may feel unusually suspicious, anxious, confused, with feelings of guilt, 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.
The doctor may continue to prescribe Quetiapina Sandoz BV even if you feel better.

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

Do not take Quetiapina Sandoz BV

• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• if you are taking any of the following medicines:

o some medicines for HIV infection
o azole medicines (for infections caused by fungi)
o erythromycin or clarithromycin (for infections)
o nefazodone (for depression)
Do not take Quetiapina Sandoz BV if you fall into one of the categories above. If you have any doubts, ask your doctor or pharmacist before taking Quetiapina Sandoz BV.

Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapina Sandoz BV if:

• You or someone in your family has or has had heart problems in the past, for example, irregular heartbeat, weakening of the heart muscle or inflammation of the heart, or if you are taking medicines that can 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 (fits).
• You suffer from diabetes or are at risk of developing diabetes. In this case, your doctor may check your blood sugar levels while you are taking Quetiapina Sandoz BV.
• You are aware that you have had low levels of white blood cells in the past (caused or not by other medicines).
• You are an elderly person suffering from dementia (loss of some brain functions). In this case, you should not take Quetiapina Sandoz BV, because this class of medicines, to which Quetiapina Sandoz BV belongs, can 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 blood clots, as medicines of this type can promote the formation of blood clots.
• You suffer from or have suffered from a condition where you stop breathing for short periods during normal sleep (called "sleep apnea") and are taking medicines that slow down normal brain activity ("central nervous system depressants").
• You suffer from or have suffered from a condition where you cannot completely empty your bladder (urinary retention), have an enlarged prostate, a bowel obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect the way nerve cells work and are used to treat some diseases.
• If you have or have had problems with alcohol or drug abuse.

Immediately inform your doctor if you experience any of the following symptoms after
taking Quetiapina Sandoz BV:

• Fever accompanied by severe muscle stiffness, sweating or decreased level of consciousness (a condition called “neuroleptic malignant syndrome”). You may need immediate medical attention.
• Uncontrollable movements, mainly of the face or tongue.
• Dizziness or an intense feeling of sleepiness. This may increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (fits).
• Persistent and painful erection (Priapism).

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

• Fever, flu-like symptoms, sore throat or any other infection, as these may be a consequence of a very low white blood cell count, which may require that

Quetiapina Sandoz BV should be discontinued and/or treatment should be administered.

• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as this could lead to a more serious intestinal blockage.

Thoughts of suicide and worsening of depression
If you are depressed, you may sometimes feel the need to harm yourself or kill yourself. These feelings may be more intense at the beginning of treatment, as these medicines need time to work, usually about two weeks but sometimes even longer.
These thoughts may also intensify if you suddenly stop taking the medicine. You are more likely to have these feelings if you are a young adult.
Information from clinical studies has shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults with depression under the age of 25.
If at any time you realize you are having thoughts of self-harm or suicide, contact your doctor or go to the hospital immediately. It may be helpful to tell a relative or them to warn you if they think your depression is getting worse or if they are worried about any changes in your behavior.

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

Children and adolescents
Quetiapina Sandoz BV should not be used in children and adolescents under the age of 18 years.

Other medicines and Quetiapina Sandoz BV
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Do not take Quetiapina Sandoz BV if you are taking any of the following medicines:

• Some medicines for the Human Immunodeficiency Virus (HIV).
• Azole medicines (for infections caused by fungi).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

In particular, tell 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 the heartbeat, for example medicines that can cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (pills that increase urine production) or some antibiotics (medicines for treating infections).
• Medicines that can cause constipation.
• Medicines (called “anticholinergics”) that act on how nerve cells function and are used to treat certain diseases.

Before stopping taking any medicine, talk to your doctor.

Quetiapina Sandoz BV with food, drinks and alcohol

• The effect of Quetiapina Sandoz BV may be affected by food and therefore you should take the tablets at least one hour before a meal or before going to bed.
• Be careful about the amount of alcohol you consume. This is important because the combined effect of Quetiapina Sandoz BV and alcohol can promote the onset of drowsiness.
• Do not drink grapefruit juice while taking Quetiapina Sandoz BV, as it can affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Quetiapina Sandoz BV during pregnancy without first discussing it with your doctor. Quetiapina Sandoz BV should not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns of mothers who have taken Quetiapina Sandoz BV during the last trimester (the last three months of pregnancy): tremor, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.

Driving and operating machinery
The tablets can 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 Sandoz BV may lead to false positive results for methadone or for some medicines for depression, called tricyclic antidepressants (TCAs) when certain testing methods are used, even if you are not taking methadone or TCAs. If this happens, more specific tests must be performed.

Quetiapina Sandoz BV contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking this medicine.

3. How to take Quetiapina Sandoz BV

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The doctor will decide what is the most appropriate initial 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 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 Quetiapina Sandoz BV, as it may affect the action of the medicine.
• Do not stop taking the tablets even if you feel better, unless your doctor tells you to.

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

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

Use in children and adolescents (under 18 years of age)
Quetiapina Sandoz BV should not be used in children and adolescents under 18 years
of age.

If you take more Quetiapina Sandoz BV than you should
If you take more Quetiapina Sandoz BV than prescribed by your doctor, you may feel sleepy, experience
dizziness and perceive an irregular heartbeat. Contact your doctor or the nearest
hospital immediately, bringing the Quetiapina Sandoz BV packaging with you.

If you forget to take a dose of Quetiapina Sandoz BV
If you forget to take a dose, take it as soon as you remember. If it is almost time to take the
next dose, wait until the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Quetiapina Sandoz BV
If you suddenly stop taking Quetiapina Sandoz BV, you may have difficulty
sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhea, feeling sick (vomiting), dizziness or irritability.
The doctor may suggest you gradually reduce the dose before stopping treatment.
If you have any doubts 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 everyone will experience them.

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

• Dizziness (may cause falls), headache, dry mouth.
• Feeling sleepy - which disappears over time, continuing treatment with Quetiapina Sandoz BV - (may cause falls).
• Withdrawal symptoms (symptoms that appear when you stop taking Quetiapina Sandoz BV), which include inability to sleep (insomnia), nausea, headache, diarrhea, vomiting, dizziness and irritability. Gradual discontinuation of the medicine is recommended, over a period of at least 1 or 2 weeks.
• Weight gain.
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, a feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Feeling that the heart is racing, beating strongly or feeling of missed beats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the arms or legs.
• Low blood pressure when standing up. This can cause dizziness or fainting (which can cause falls).
• Increased blood sugar levels.
• Blurred vision.
• Strange dreams and nightmares.
• Increased feeling of hunger.
• Irritability.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decreases in the number of certain types of blood cells.
• Increases in the amount of liver enzymes measured in the blood.
• Increases in the amount of the hormone prolactin in the blood. Increases in the hormone prolactin may, in rare cases, lead to the following: o Men and women may experience breast enlargement and unexpected milk production. o Women may experience absent or irregular menstrual cycles.

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

• Convulsions or seizures.
• Allergic reactions including swelling (hives), swelling of the skin and around the mouth.
• Unpleasant sensation in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Alteration of the electrical activity of the heart detected on ECG (prolongation of the QT interval).
• A slowing of the normal heartbeat that can 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 the amount of sodium in the blood
• Worsening of pre-existing diabetes.

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

• High body temperature (fever) associated with sweating, muscle rigidity, a heightened feeling of stiffness 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 of the legs), which can move through the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately.
• Walking, talking, eating or other activities while sleeping.
• 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 fat around the abdomen, decreased “good” cholesterol (HDL-C), increased type of fat in the blood called triglycerides, high blood pressure and increased blood sugar levels.
• Association 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.
• Increase in blood 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) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually in the area around the eyes, lips and throat (angioedema).
• Severe condition characterized by blistering of the skin, in the mouth, eyes and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of the hormone that controls urine volume.
• Damage to muscle fibers and muscle pain (rhabdomyolysis).

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

• Skin rash associated with the appearance of irregular red patches (erythema multiforme).
• Severe sudden allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis).
• Withdrawal symptoms may occur in newborns of mothers who have used Quetiapina Sandoz BV during pregnancy.

The class of medicines to which Quetiapina Sandoz BV belongs can cause problems with the heart rhythm, which can be serious and even fatal in some cases.
Some side effects are only visible after a blood test. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugars in the blood, changes in blood levels of thyroid hormones, increased liver enzymes, decreased number of certain types of blood cells, decreased amount of red blood cells, increased serum creatine phosphokinase (a substance present in muscles), decreased amount of sodium in the blood, and increases in the amount of the hormone prolactin in the blood. Increases in prolactin levels may, in rare cases, have the following consequences:
o Men and women may experience breast enlargement and unexpected milk production.
o Women may experience absent or irregular menstrual cycles.
The doctor will therefore prescribe blood tests from time to time.

Side effects in children and adolescents
The same side effects observed in adults can also occur in children and adolescents.
The following side effects have been observed more frequently in children and adolescents or have not been reported in adults:

• Very common(may affect more than 1 in 10): Increased levels in the blood of a hormone called prolactin. Increases in the hormone prolactin may, in rare cases, lead to the following:

o Boys and girls may experience breast enlargement and unexpected milk
production
o Girls may experience absent or irregular menstrual cycles

• Increased appetite
• Vomiting
• Abnormal muscle movements, including difficulty starting a muscle movement, tremor, a feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common(may affect up to 1 in 10):

• Weakness, fainting (may cause falls).
• Nasal congestion.
• Irritability.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at
http:// www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa ”.
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 within the expiry date which is stated on the packaging
after EXP.
Quetiapina Sandoz BV does not require any special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Quetiapina Sandoz BV contains

• The active ingredient is quetiapine. Quetiapina Sandoz BV contains 50 mg, 150 mg, 200 mg, 300 mg or 400 mg of quetiapine (as quetiapine fumarate).
• The other ingredients 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 contents of the pack
The 50 mg prolonged-release tablets are tablets of colour from white to off-white,
round, biconvex with ‘50’ engraved on one side, 7.1 mm in diameter and 3.2 mm in thickness.
The 150 mg prolonged-release tablets are tablets of colour from white to off-white,
oblong, biconvex with ‘150’ engraved on one side, 13.6 mm in length, 6.6 mm in width and 4.2
mm in thickness.
The 200 mg prolonged-release tablets are tablets of colour from white to off-white,
oblong, biconvex with ‘200’ engraved on one side, 15.2 mm in length, 7.7 mm in width and 4.8
mm in thickness.
The 300 mg prolonged-release tablets are tablets of colour from white to off-white,
oblong, biconvex with ‘300’ engraved on one side, 18.2 mm in length, 8.2 mm in width and 5.4
mm in thickness.
The 400 mg prolonged-release tablets are tablets of colour from white to off-white,
oval, biconvex with ‘400’ engraved on one side, 20.7 mm in length, 10.2 mm in width and 6.3 mm
in thickness.

• Quetiapina Sandoz BV is available in PVC/PCTFE-aluminium blisters inserted in a cardboard box.
• Quetiapina Sandoz BV prolonged-release tablets are also available in an opaque white HDPE bottle with a child-resistant screw cap and a tamper-evident seal.

The blister packs contain: 0, 30, 50, 56, 60 and 100 tablets
The bottle packs contain: 60 and 120 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz B.V.
Veluwezoom 22
1327 AH Almere
The Netherlands

Legal Representative in Italy: Sandoz S.p.A, Largo U. Boccioni 1, 21040 Origgio (VA)

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 authorised in the Member States of the European Economic Area with the
following denominations:
Austria
Belgium
Bulgaria
Quesery 50 mg/150 mg/200 mg/300 mg/400 mg Retardtabletten
Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg tabletten met verlengde afg
Kvelux XR 50 mg/150 mg/200 mg/300 mg/400 mg prolonged release
tablet
Germany Quetiapin HEXAL® 50/150/200/300/400 Retardtabletten
Denmark
Greece
Finland
Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter
Quetiapine Sandoz
Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletti
France
Croatia
Quetiapin Sandoz LP 50 mg/150 mg/200 mg/300 mg/400 mg,
comprimé à libération prolongée
Volqer 50 mg/200 mg/300 mg/400 mg tablete s produljenim
oslobađanjem
Hungary
Ireland
Iceland
Quetiapine Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg retard tabletta
Quetex XR 50 mg/200 mg/300 mg/400 mg Prolonged-release tablets
Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg forðatöflur
Italy
Luxembourg
Netherlands
Quetiapina Sandoz BV
Quetibloxus 50 mg/150 mg/200 mg/300 mg/400 mg comprimé à
libération prolongée
Quetiapine Sandoz SR 50 mg/150 mg/200 mg/300 mg/400 mg, tabletten
verlengde afgifte
Poland Kvelux SR
Portugal Quetiapine Sandoz
Romania
Sweden
Slovenia
Natiapin 50mg/150 mg/200 mg/300 mg/400 mg mg comprimate cu eliber
prelungită
Quetiapin Hexal 50 mg/150 mg/200 mg/300 mg/400 mg depottabletter
Kvelux SR 50 mg/150 mg/200 mg/300 mg/400 mg tablete s
podaljšanim sproščanjem
Slovak Republic Quetiapin Sandoz 50 mg/150 mg/200 mg/300 mg/400 mg
United Kingdom Psyquet XL 50 mg/150 mg/200 mg/300 mg/400 mg prolonged-
Release tablets