Quetiapine Sandoz: detailed information

Patient Information Leaflet

Quetiapina Sandoz 25 mg Film-coated Tablets

Generic medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could 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:

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

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

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

Schizophrenia: a condition in which you may feel as if you hear or sense 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 behaviours.
Bipolar depression: a condition 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 even after you start feeling better.

2. What you need to know before taking Quetiapine Sandoz

Do not take Quetiapine Sandoz
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 antifungals (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 Quetiapine Sandoz if any of the above situations apply to you. If you have
any doubts, consult your doctor or pharmacist before taking Quetiapine Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine Sandoz:

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 during treatment with Quetiapine Sandoz.
if you know you have previously had low levels of white blood cells in your blood (whether caused by other medicines or not)
if you are an elderly person with dementia (loss of brain function). In this case, Quetiapine Sandoz should not be used, as the group of medicines to which Quetiapine Sandoz 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 person with Parkinson’s disease/parkinsonism
if you or someone in your family has a history of blood clotting disorders, as medicines of this type may increase the risk of blood clots.
if you suffer or have suffered from 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 suffer or have suffered from a condition where you are unable to empty your bladder completely (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 or have had problems with alcohol or drug abuse

Inform your doctor if any of the following conditions occur after taking
Quetiapine Sandoz:

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)
Painful and prolonged erection (priapism)

These conditions may be caused by this type of medicine.
Inform 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 white blood cell count, which may require stopping and/or starting treatment with Quetiapine Sandoz.
Constipation with persistent abdominal pain, or constipation that has not responded to treatment, as this could lead to a more severe intestinal obstruction.

Suicidal thoughts and worsening depression
If you are depressed, you may experience thoughts of self-harm or suicide. These
thoughts may increase when you first start treatment, as these medicines take time to work, usually about two weeks, but sometimes longer. These thoughts may also increase if you suddenly stop treatment.
You may be more prone to such thoughts if you are a young adult. Data from clinical studies 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 family member or close friend about your depression and ask them to read this leaflet. You may wish to 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 Quetiapine Sandoz. You and your doctor should monitor your weight regularly.
Children and adolescents
Quetiapine Sandoz must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Quetiapine Sandoz if you are taking any of the following medicines:

Certain medicines used to treat HIV infection.
Azole antifungals (medicines used to treat fungal infections).
Erythromycin or clarithromycin (medicines used to treat bacterial infections).
Nefazodone (a medicine used to treat 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 (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.
Quetiapine Sandoz with food, drinks and alcohol

Food: see section 3 “How to take Quetiapine Sandoz”.
Be cautious about the amount of alcohol you drink. Taking Quetiapine Sandoz with alcohol may cause drowsiness. Do not drink grapefruit juice during treatment with Quetiapine Sandoz, as it 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.
You must not take Quetiapine Sandoz during pregnancy unless discussed with your doctor.
The following symptoms may occur in newborns whose mothers have taken Quetiapine Sandoz 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.
Quetiapine Sandoz must not be taken during breastfeeding.
Driving and using machines
The 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 due to undergo a drug screening test, taking Quetiapine Sandoz may result in a positive test for methadone or certain antidepressants 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.
Quetiapine Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially sodium-free.
Quetiapine Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Quetiapine Sandoz

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
For doses that are not achievable/practical with this medicine, medicinal products containing higher titrations of quetiapine are available.

Recommended dose:
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 should take the tablets once daily at bedtime, or twice daily depending on your condition.

Elderly patients
Your doctor may adjust your dose if you are elderly.

Liver problems
If you have liver problems, your doctor may adjust your dose.

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

Instructions for administration
For oral use.

Swallow the tablets with a glass of water.
You may take the tablets with or without food.
Do not drink grapefruit juice while taking Quetiapine 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 Quetiapine Sandoz than you should
If you take more Quetiapine Sandoz 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 Quetiapine Sandoz
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 tablet.

If you stop taking Quetiapine Sandoz
If you stop taking Quetiapine Sandoz suddenly, 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.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking Quetiapine Sandoz immediately and contact your doctor or go to the nearest hospital straight away 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, extreme tiredness or fainting (a serious 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 in the legs), which may travel through the bloodstream 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:

a severe blistering rash affecting 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)

Frequency 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 reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome). Stop using Quetiapine Sandoz if you develop these symptoms and contact your doctor or seek immediate medical help.

The class of medicines to which Quetiapine Sandoz belongs can cause problems with heart rhythm, which can 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 Quetiapine Sandoz) (may lead to falls)
withdrawal symptoms (symptoms that occur when you stop taking Quetiapine Sandoz), 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, restlessness or painless muscle stiffness
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, forceful or irregular heartbeat (palpitations)
constipation, stomach discomfort (indigestion)
feeling weak
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
abnormal dreams and nightmares
increased appetite
irritability
speech and language disorders
suicidal thoughts and worsening of depression
shortness of breath
vomiting (especially in elderly patients)
fever
changes in blood levels of thyroid hormones
decrease in the 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 lead to the following conditions:
breast enlargement and unexpected milk production from the mammary 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 (hives), 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
decrease in the number of red blood cells (anaemia)
decrease in 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 (galactorrhoea)
menstrual disorders
walking, talking, eating or performing other activities while asleep
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 found 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 (syndrome of inappropriate antidiuretic hormone secretion, SIADH)
breakdown of muscle fibres and muscle pain (rhabdomyolysis)

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

withdrawal symptoms may occur in newborns of mothers who took Quetiapine Sandoz 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 levels of certain hormones produced by the thyroid gland, increased liver enzymes, changes in the number of certain types of blood cells, reduced number of red blood cells, increased blood creatine phosphokinase (a substance found in muscles), reduced sodium levels in blood, and increased levels of a hormone called prolactin in the blood. Increased prolactin levels 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 to have blood tests from time to time.

Additional 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. In rare cases, this may lead to:
breast swelling and unexpected milk secretion in both males and females
absence or irregularity of menstrual cycle in females
increased appetite
vomiting
abnormal muscle movements, including difficulty initiating muscle movements, tremors, restlessness or painless muscle stiffness
increased blood pressure

Common, may affect up to 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, 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 quetiapine Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the
blister or bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Usability after first opening of the bottle:
Do not use more than 6 months after first opening.
Do not dispose of any medicine 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 contains
The active substance is quetiapine (as fumarate).
Each film-coated tablet contains 25 mg of quetiapine (as fumarate).
The other components are:

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

Description of the appearance of Quetiapina Sandoz and package contents
25 mg film-coated tablets
The film-coated tablets are salmon-pink in colour and round (approximately 6.0 mm in diameter).
The film-coated tablets are packed in PVC/COC/PVDC/Aluminum blisters and placed in cardboard boxes or packed in HDPE bottles closed with a PP or PE screw cap, including a desiccant. Pack sizes:

Blister packs of 6, 10, 14, 20, 30, 50, 60, 90, 100, 100x1 or 120 film-coated tablets
Bottles containing 50, 60, 100 or 500 film-coated tablets.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A. – L. go U. Boccioni, 1 - 21040 – ORIGGIO (VA)
Manufacturers
Salutas Pharma GmbH – Otto Von Guericke Allee 1 – 39179 Barleben (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 authorised in the Member States of the European Economic Area under the following names:
Austria:
Quetiapin Sandoz 25 mg - Filmtabletten
Belgium:
Quetiapine Sandoz 25 mg filmomhulde tabletten
Denmark:
Quetiapin Sandoz
Finland:
Quetiapin Sandoz 25 mg tabletti, kalvopäällysteinen
Italy:
QUETIAPINA SANDOZ
Norway:
Quetiapin Sandoz 25 mg filmdrasjerte tabletter
Netherlands:
Quetiapine Sandoz 25 mg, filmomhulde tabletten
United Kingdom:
Quetiapine 25 mg film-coated Tablets
Slovenia:
Kvelux 25 mg filmsko obložene tablete
Sweden:
Quetiapin Sandoz 25 mg filmdragerade tabletter