Quetiapine Sandoz GmbH: detailed information

Package leaflet: Information for the patient

Quetiapine Sandoz GmbH 100 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets

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

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

Contents of this leaflet:

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

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

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

Schizophrenia: a condition in which you may feel you are hearing or sensing things that do not exist, believe in things that are not real, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.
Mania: a condition in which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behaviors.
Bipolar depression: conditions in which you may feel sad. You may feel depressed, guilty, lack energy, have no appetite, or have difficulty sleeping.

Your doctor may continue to prescribe Quetiapina Sandoz GmbH even after you start feeling better.

2. What you should know before taking Quetiapina Sandoz GmbH

Do not take Quetiapina Sandoz GmbH
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 used to treat HIV infection
azole medicines (medicines used to treat fungal infections)
erythromycin or clarithromycin (medicines used to treat bacterial infections)
nefazodone (a medicine used to treat depression). Do not take Quetiapina Sandoz GmbH if any of the above situations apply to you. If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Sandoz GmbH.

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

if you or someone in your family has or has had heart problems, such as irregular heartbeat, weakened heart muscle, or inflammation of the heart, or if you are taking other 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 (epilepsy).
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 Quetiapina Sandoz GmbH.
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 patient with dementia (loss of brain function). In this case, Quetiapina Sandoz GmbH should not be used because the group of medicines to which it belongs may increase the risk of stroke, or in some cases, the risk of death, in elderly patients with dementia.
if you are an elderly patient with Parkinson’s disease/parkinsonism
if 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.
if you suffer or have suffered from a condition where you stop breathing for short periods during normal sleep (called "sleep apnea") and you are taking medicines that slow down normal brain activity ("central nervous system depressants").
if you suffer or have suffered from a condition where you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside the eye. These conditions are sometimes caused by medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions.
if you have a history of alcohol or drug abuse.

Tell your doctor if you experience any of the following conditions after taking Quetiapina Sandoz GmbH:

A combination of fever, severe muscle stiffness, sweating, or reduced level of consciousness (a condition called "neuroleptic malignant syndrome"). Immediate medical treatment may be required.
Uncontrollable movements, especially of the face or tongue.
Dizziness or severe drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
Seizures (epilepsy)
Prolonged and painful erection (priapism)

These conditions may be caused by this type of medicine.
Tell your doctor as soon as possible if you have:

fever, flu-like symptoms, sore throat, or any other infection, as this could be due to a very low blood cell count, which may require stopping and/or starting treatment with Quetiapina Sandoz GmbH;
constipation with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more serious intestinal obstruction. Suicidal thoughts and worsening of depression

If you are depressed, you may experience thoughts of self-harm or suicide. These may increase
when starting treatment for the first time, as these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may increase if you suddenly stop treatment. You may be more prone to such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or behaviours in young adults under 25 years of age with depression.
If at any time you start having thoughts of self-harm or suicide, contact your doctor immediately or go to hospital. It may be helpful to inform a relative or close friend about your depression and ask them to read this leaflet. You may ask them to tell 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 observed in patients taking Quetiapina Sandoz GmbH. You and your doctor should monitor your weight regularly.
Children and adolescents Quetiapina Sandoz GmbH must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapina Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Quetiapina Sandoz GmbH if you are taking any of the following medicines:

Certain medicines used to treat HIV infection.
Azole medicines (medicines used to treat fungal infections).
Erythromycin or clarithromycin (medicines used to treat bacterial infections).
Nefazodone (a medicine used to treat depression).

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 (medicines used to treat sleep disorders).
Thioridazine or lithium (other antipsychotic medicines).
Medicines that affect heart rhythm, for example, medicines that may cause an imbalance in electrolytes (low levels of potassium or magnesium), such as diuretics (tablets that help eliminate water) or certain antibiotics (medicines used to treat bacterial infections).
Medicines that may cause constipation.
Medicines (called anticholinergics) that affect how nerve cells function and are used to treat certain medical conditions.

Talk to your doctor or pharmacist before stopping any other medicine.
Quetiapina Sandoz GmbH with food, drinks and alcohol

Food: see section 3 “Instructions for use”.
Be cautious about the amount of alcohol you drink. Taking Quetiapina Sandoz GmbH with alcohol may cause drowsiness.
Do not drink grapefruit juice while being treated with Quetiapina Sandoz GmbH: grapefruit juice may interfere with the effects of quetiapine.

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.

Do not take Quetiapina Sandoz GmbH during pregnancy unless discussed with your doctor first. The following symptoms may occur in newborns of mothers who took Quetiapina Sandoz GmbH during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby shows any of these symptoms, you should contact your doctor.
Quetiapina Sandoz GmbH must not be taken during breastfeeding.

Driving and using machines
Your tablets may cause drowsiness and dizziness. Do not drive or operate tools or machinery until you know how this medicine affects you.
Effect on urine drug tests
If you are about to undergo a drug test to detect the presence of drugs in urine, taking Quetiapina Sandoz GmbH may result in positive test results for methadone or certain antidepressant drugs called tricyclic antidepressants (TCA) when certain types of tests are used, even if you are not taking methadone or TCAs. In such cases, a more specific test can be performed.
Quetiapina Sandoz GmbH contains sodium, lactose
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Quetiapina Sandoz GmbH

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
For doses that cannot be achieved/practically administered with this medicine, alternative medicinal products containing
lower amounts of quetiapine are available.
The recommended dose is:
Adults
Your doctor will determine the starting dose. The maintenance dose (daily dose) will depend on your type of
illness and individual needs, but will generally range between 150 mg and 800 mg. You will take the tablets once
daily at bedtime, or twice daily depending on your condition.
Elderly patients
If you are elderly, your doctor may adjust your dose.
Liver problems
Your doctor may adjust your dose if you have liver problems.
Use in children and adolescents
Quetiapina Sandoz GmbH must not be used in children and adolescents under 18 years of age.
Method of administration
For oral use.

Quetiapina Sandoz GmbH 300 mg film-coated tablets The tablet can be divided into two equal doses. If necessary, place it on a hard surface with the scored side facing upwards. Then press with both thumbs simultaneously on both ends.
Quetiapina Sandoz GmbH 100 mg film-coated tablets
Quetiapina Sandoz GmbH 200 mg film-coated tablets The tablet can be divided into four equal doses. If necessary, place it on a hard surface with the scored side facing upwards. Then press the tablet in the center with your thumb.
Swallow the tablets with a glass of water.
You may take the tablets with or without food.
Do not drink grapefruit juice while taking Quetiapina Sandoz, as it may affect the medicine's mechanism of action.

Duration of treatment:
This will be determined by your doctor. Do not stop taking the tablets, even if you feel better, unless your
doctor tells you otherwise.
If you take more Quetiapina Sandoz GmbH than you should
If you take more Quetiapina Sandoz GmbH than prescribed, you may experience drowsiness, dizziness,
and abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the tablets with you.
If you forget to take Quetiapina Sandoz GmbH
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 Sandoz GmbH
If you suddenly stop taking Quetiapina Sandoz GmbH, you may have difficulty sleeping (insomnia), feel unwell (nausea), or experience headache, diarrhoea, 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 everyone will experience them.
Stop taking Quetiapina Sandoz GmbH immediately and contact your doctor or go to the nearest hospital if you experience any of the following side effects:
Uncommon side effects, may affect up to 1 in 100 people:

seizures or epileptic fits
uncontrollable movements, particularly of the face or tongue

Rare side effects, may affect up to 1 in 1,000 people:

a combination of high temperature (fever), sweating, muscle stiffness, feeling extremely tired or faint (a condition known as "neuroleptic malignant syndrome")
persistent and painful erection (priapism)
blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the legs), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties
a combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count (a condition known as agranulocytosis)

Very rare side effects, may affect up to 1 in 10,000 people:

severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
a severe allergic reaction (anaphylaxis), which may cause breathing difficulties or shock
rapid swelling of the skin, usually around the eyes, lips and throat (angioedema)

Not known, frequency cannot be estimated from the available data:

severe and sudden allergic reaction with symptoms such as fever, skin blisters and skin peeling (toxic epidermal necrolysis).
skin rash with irregular red spots (erythema multiforme)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Widespread rash, high body temperature, 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 using Quetiapina Sandoz GmbH if you develop these symptoms and contact your doctor or seek immediate medical help.

The class of medicines to which Quetiapina Sandoz GmbH belongs can cause heart rhythm problems, which may be serious and, in severe cases, may be fatal.
You may experience any of the other side effects listed below, categorized by frequency:
Very common, may affect more than 1 in 10 people:

dizziness (may lead to falls), headache, dry mouth
drowsiness (this may decrease over time with continued treatment with Quetiapina Sandoz GmbH) (may lead to falls)
withdrawal symptoms (symptoms that occur when you stop taking Quetiapina Sandoz GmbH), including difficulty sleeping (insomnia), feeling unwell (nausea), headache, diarrhoea, feeling unwell (vomiting), dizziness and irritability. Gradual discontinuation over a period of at least 1-2 weeks is recommended
weight gain
abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling restless or muscle stiffness without pain
changes in 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 beats
Constipation, stomach discomfort (indigestion)
Feeling weak
Swelling of arms or legs
Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls)
Increased blood sugar levels
Blurred vision
Abnormal dreams and nightmares
Increased appetite
Irritability
Speech and language disturbances
Suicidal thoughts and worsening of depression
Shortness of breath
Vomiting (especially in elderly people)
Fever
Changes in blood levels of thyroid hormones
Decreased number of certain types of blood cells
Increased liver enzymes in blood tests
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 breast gland in both men and women
absence or irregularity of menstrual cycle in women. Uncommon, may affect up to 1 in 100 people:
Allergic reactions which may include raised skin rashes (sores), skin swelling and swelling around the mouth
Unpleasant sensations in the legs (also known as restless legs syndrome)
Difficulty swallowing
Sexual dysfunction
Diabetes
Changes in the heart's electrical activity visible on ECG (QT prolongation)
Slower than normal heartbeat, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting
Difficulty passing urine
Fainting (may lead to falls)
Stuffy nose
Decreased number of red blood cells
Decreased sodium levels in the blood
Worsening of pre-existing diabetes

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

Yellowing of the skin and eyes (jaundice)
Inflammation of the liver (hepatitis)
Breast swelling and unexpected milk production from the breast (galactorrhea)
Menstrual disorders
Walking, talking, eating or performing other activities during sleep
Reduced body temperature (hypothermia)
Inflammation of the pancreas
A condition called "metabolic syndrome", where you may have a combination of three or more of the following factors: 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
Intestinal obstruction
Increased serum creatine phosphokinase (a substance present in muscles)

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

severe skin rash, blisters or red spots on the skin
inadequate secretion of a hormone that controls urine volume
breakdown of muscle fibres and muscle pain (rhabdomyolysis)

Not known, frequency cannot be estimated from the available data:

withdrawal symptoms may occur in newborns of mothers who took Quetiapina Sandoz GmbH during pregnancy
heart attack

Some side effects are only detectable through blood tests. These include changes in levels of certain blood fats (triglycerides and total cholesterol) or blood sugar, changes in blood levels of certain thyroid hormones, increased liver enzyme levels, reduced number of certain types of blood cells, reduced number of red blood cells, increased blood creatine phosphokinase (a substance present in muscles), reduced blood sodium levels, and increased levels of a hormone called prolactin in the blood. Increases in the prolactin hormone may, in rare cases, lead to the following consequences:

Breast enlargement and unexpected milk production from the breast, in both men and women.
Absence or irregularity of menstrual cycle in women.

Your doctor may ask you from time to time to have blood tests.
Side effects in children and adolescents
The same side effects that may occur 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 levels of a hormone called prolactin in the blood. This may, in rare cases, lead to:
breast swelling and unexpected milk secretion in both men and women
absence or irregularity of menstrual cycle in women
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 more than 1 in 10 people:

feeling weak
fainting (may lead to falls)
stuffy nose
feeling irritable

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult 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 GmbH

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 carton and blister after Exp. . The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Validity after first opening of the bottle:
do not use more than 6 months after first opening.
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 Sandoz GmbH Contains
The active substance is quetiapine (as fumarate).
Each film-coated tablet contains 100 mg of quetiapine (as fumarate).
Each film-coated tablet contains 200 mg of quetiapine (as fumarate).
Each film-coated tablet contains 300 mg of quetiapine (as fumarate).

The other components are:

Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K 29/32), colloidal hydrated silica, sodium starch glycolate (type A).
Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171). 100 mg: iron oxide yellow (E172) (only for 100 mg tablets).

Description of the Appearance of Quetiapina Sandoz GmbH and Package Contents
100 mg film-coated tablets
The film-coated tablets are yellow, round (approximately 8.8 mm in diameter), with a breakline on one side.

200 mg film-coated tablets
The film-coated tablets are white, round (approximately 11.5 mm in diameter), with a breakline on one side.

300 mg film-coated tablets
The film-coated tablets are white, oval (approximately 18 mm long and 8.8 mm wide), with a breakline on both sides.

The film-coated tablets are packaged in PVC/COC/PVDC/ALU blisters contained in cardboard boxes, or in HDPE bottles with PP or PE screw caps and desiccant (silica gel).

Pack sizes:
100 mg and 300 mg film-coated tablets:
Blister packs: 6, 10, 20, 30, 50, 60, 90, 100, 1x100, 120 or 180 film-coated tablets
Bottles: 100, 120, 250 or 500 film-coated tablets

200 mg film-coated tablets:
Blister packs: 6, 10, 20, 30, 50, 60, 90, 100, 1x100, 120 or 180 film-coated tablets
Bottles: 100, 250 or 500 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl (Austria)
Representative in Italy: Sandoz S.p.A., Largo U. Boccioni 1, 21040 Origgio (VA)

Manufacturers
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben (Germany)
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen (Germany)
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana (Slovenia)
Lek S.A., Ul. Podlipie 16 C, 95 010 Strykow (Poland)
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava (Slovenia)
Lek S.A., Ul. Domaniewska, 50C, 02-672 Warszawa (Poland)
S.C. Sandoz S.R.L., 7A Livezeni Street, 540472 Targu Mures, Jud. Mures (Romania)

This medicinal product has been authorized in the Member States of the European Economic Area under the following names:

Austria:
Quetiapin Sandoz 100 mg - Filmtabletten
Quetiapin Sandoz 200 mg - Filmtabletten
Quetiapin Sandoz 300 mg - Filmtabletten

Belgium:
Quetiapine Sandoz 100 mg filmomhulde tabletten
Quetiapine Sandoz 200 mg filmomhulde tabletten
Quetiapine Sandoz 300 mg filmomhulde tabletten

Bulgaria:
КВЕЛУКС 100 MG ФИЛМИРАНИ ТАБЛЕТКИ
КВЕЛУКС 200 MG ФИЛМИРАНИ ТАБЛЕТКИ

Denmark:
Quetiapin Sandoz

Finland:
Quetiapin Sandoz 100 mg kalvopäällysteinen tabletti
Quetiapin Sandoz 200 mg kalvopäällysteinen tabletti
Quetiapin Sandoz 300 mg kalvopäällysteinen tabletti

Italy:
QUETIAPINA SANDOZ GmbH

Netherlands:
Quetiapine Sandoz 100 mg, FILMOMHULDE TABLETTEN
Quetiapine Sandoz 200 mg, FILMOMHULDE TABLETTEN
Quetiapine Sandoz 300 mg, FILMOMHULDE TABLETTEN

Norway:
Quetiapin Sandoz 100 mg filmdrasjerte tabletter
Quetiapin Sandoz 200 mg filmdrasjerte tabletter
Quetiapin Sandoz 300 mg filmdrasjerte tabletter

Slovenia:
Kvelux 100 mg filmsko obložene tablete
Kvelux 200 mg filmsko obložene tablete
Kvelux 300 mg filmsko obložene tablete

Sweden:
Quetiapin Sandoz 100 mg filmdragerade tabletter
Quetiapin Sandoz 200 mg filmdragerade tabletter

United Kingdom:
Quetiapine 100 mg Film-coated Tablets
Quetiapine 150 mg Film-coated Tablets
Quetiapine 200 mg Film-coated Tablets
Quetiapine 300 mg Film-coated Tablets