Quetiapine Laboratori Alter: detailed information

Patient Information Leaflet

Quetiapine Laboratori Alter 50 mg prolonged-release 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 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 Quetiapine Laboratori Alter is and what it is used for
What you need to know before taking Quetiapine Laboratori Alter
How to take Quetiapine Laboratori Alter
Possible side effects
How to store Quetiapine Laboratori Alter
Contents of the pack and other information

1. What Quetiapine Laboratori Alter is and what it is used for

Quetiapine Laboratori Alter contains a substance called quetiapine. This substance
belongs to a group of medicines known as antipsychotics. Quetiapine Laboratori Alter 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 reduced appetite, or have difficulty sleeping.
Mania: you may feel highly excited, euphoric, restless, enthusiastic, or hyperactive, or have poor judgment, including aggressive or destructive behaviour.
Schizophrenia: you may experience hearing or sensing things that are not actually present, believe things that are not true, or feel unusually suspicious, anxious, confused, guilty, tense, or depressed.

When Quetiapine Laboratori Alter is used to treat major depressive episodes
in major depressive disorder, it will be taken in addition to another medicine
used to treat this condition.
Your doctor may continue to prescribe Quetiapine Laboratori Alter even after you start
feeling better.

2. What you need to know before taking Quetiapine Laboratori Alter

Do not take Quetiapine Laboratori Alter:

if you are allergic to quetiapine or to any of the other ingredients of this medicine (listed in section 6)
if you are taking any of the following medicines:
certain medicines for HIV virus
azole medicines (for fungal infections)
erythromycin or clarithromycin (for infections)
nefazodone (for depression).

If you have any doubts, ask your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking quetiapine:

You or someone in your family has or has previously had heart problems, such as irregular heart rhythm, weakened heart muscle, or inflammation of the heart, or if you are taking medicines that may affect your heartbeat.
If your blood pressure is low.
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 this medicine.
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 certain brain functions). In this case, you should not take quetiapine, because this class of medicines, to which quetiapine belongs, may increase the risk of stroke, or in some cases, the risk of death.
if you are an elderly person 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 promote blood clot formation.
If you have or have previously had a condition (called "sleep apnea") in which you stop breathing for short periods during normal nighttime sleep and you are taking medicines that slow down normal brain activity ("depressants").
If you have or have previously had a condition in which you are unable to completely empty your bladder (urinary retention), have an enlarged prostate, intestinal 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.

Inform your doctor immediately if you experience any of the following effects after taking quetiapine:

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.
Uncontrolled movements, mainly of the face or tongue.
Dizziness or feeling very sleepy. This may increase the risk of accidental injuries (falls) in elderly patients.
Seizures (fits).
A prolonged and painful erection (priapism).
Fast or irregular heartbeat, even at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist. These disorders 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 these could be signs of a very low white blood cell count, which may require that quetiapine be stopped and/or additional treatment 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.

Suicidal thoughts and worsening of depression

If you are depressed, you may sometimes feel the need to harm yourself or to kill yourself. 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 have these types of feelings if you are a young adult. Data from clinical trials have indeed 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 notice that you are having thoughts of self-harm or suicide, contact your doctor or go immediately to the hospital. You may find it helpful to inform a relative or close friend that you suffer from depression and ask them to read this leaflet. You may ask them to alert you if they think your depression is worsening or if they are concerned about any changes in your behaviour.

Weight gain
Weight gain has been reported in patients treated with quetiapine. It is necessary that your body weight be monitored regularly by both you and your doctor.
Children and adolescents
Quetiapine must not be used in children and adolescents under 18 years of age.
Other medicines and Quetiapine Laboratori Alter
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
Inform your doctor if you are using 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 can cause an electrolyte imbalance (low levels of potassium or magnesium) such as diuretics (medicines to increase urination) or certain antibiotics (medicines to treat infections).
Medicines that can cause constipation.
Medicines (called "anticholinergics") that affect how nerve cells function and are used to treat certain medical conditions. Consult your doctor before stopping treatment with any of these medicines.

Quetiapine Laboratori Alter with food, drinks and alcohol

Quetiapine may be affected by food; therefore, you should take the tablets at least one hour before a meal or before going to bed.
Be cautious about the amount of alcohol you consume. This is important because the combined effect of quetiapine and alcohol may increase the likelihood of drowsiness.
Do not drink grapefruit juice while taking quetiapine, as it may affect the action of the medicine.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. You must not take quetiapine during pregnancy without first discussing it with your doctor.
Quetiapine must not be taken during breastfeeding.
The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took quetiapine 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, contact your doctor.
Driving and using machines
The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.
Quetiapine Laboratori Alter contains lactose
Quetiapine Laboratori Alter contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
Effect on urine screening tests
If you need to undergo a urine screening test, taking Quetiapine Laboratori Alter may lead to false positive results for methadone or certain antidepressant medicines 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.

3. How to take Quetiapine Laboratori Alter

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine your starting dose. 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 daily.
Do not split, chew or crush 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 advise you when).
Do not drink grapefruit juice while taking this medicine, as it may affect the medicine's action.
Do not stop taking the tablets even if you feel better, unless your doctor tells you otherwise.

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
Quetiapine must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Laboratori Alter than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the toxicology information service, stating the name of the medicine and the amount taken.
If you take more quetiapine than prescribed, you may experience drowsiness, dizziness and abnormal heartbeats.
If you forget to take Quetiapine Laboratori Alter
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 a forgotten tablet.
If you stop taking Quetiapine Laboratori Alter
If you stop treatment with quetiapine abruptly, 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Very common: may affect more than 1 in 10 people

Dizziness (which may lead to falls), headache, dry mouth.
Drowsiness (which fades over time as treatment with quetiapine continues) (which may lead to falls).
Withdrawal symptoms (symptoms that occur when you stop taking quetiapine, including inability to sleep (insomnia), feeling unwell, headache, diarrhoea, vomiting, dizziness, and irritability). 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 muscle movement, tremor, feeling of restlessness, or muscle rigidity without pain.
Changes in levels of certain 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 heartbeats.
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 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 levels of thyroid hormones in the blood.
Reduction in the number of certain types of blood cells.
Increase in liver enzyme levels measured in blood.
Increase in the level of prolactin hormone in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
- 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 (wheals), swelling of the skin and area 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 may occur when starting treatment and may be associated with low blood pressure and fainting.
Difficulty urinating.
Fainting (may lead to falls).
Stuffy nose.
Reduction in the number of red blood cells in the blood.
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 stiffness, marked drowsiness or fainting (a condition called "neuroleptic malignant syndrome").
Yellowing of the skin and eyes (jaundice).
Inflammation of the liver (hepatitis).
Prolonged and painful erection (priapism).
Breast enlargement and unexpected production of milk from the mammary gland (galactorrhoea).
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 notice any of these symptoms, contact your doctor immediately.
Sleepwalking and other related events (such as talking during sleep and sleep-related eating disorders).
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 levels of a fat in the blood 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 known as agranulocytosis.
Intestinal obstruction.
Increased blood levels of creatine phosphokinase (a substance found in 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 blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
Damage to muscle fibres and muscle pain (rhabdomyolysis).

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

Skin rash associated with appearance of irregular red patches (erythema multiforme).
Sudden, severe 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 used quetiapine during pregnancy.
Stroke.
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 lumps.

The class of medicines to which quetiapine belongs can cause problems with heart rhythm, which may be serious and, in some cases, fatal.

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

Breast enlargement and unexpected production of milk from the mammary gland in both men and women.
Absence or irregularity of menstrual cycles in women.

Your doctor will therefore occasionally prescribe blood tests for you.

Additional 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 reported 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. In rare cases, these increased prolactin levels may cause the following conditions:
- Breast enlargement and unexpected production of milk from the mammary gland in boys and girls.
- Absence or irregularity of menstrual cycles in girls.
Increased appetite.
Vomiting.
Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness, or muscle rigidity without pain.
Increased blood pressure.

Common: may affect up to 1 in 10 people

Weakness, fainting (may lead to falls).
Stuffy nose.
Irritability.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Quetiapine Laboratori Alter

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.
Quetiapine Laboratori Alter does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. These measures will help protect
the environment.

6. Package contents and other information

What Quetiapina Laboratori Alter contains

The active substance is quetiapine. Quetiapina Laboratori Alter tablets contain 50 mg of quetiapine (as quetiapine fumarate).
The other components are:
Tablet core: methacrylic acid-ethyl acrylate copolymer (1:1), anhydrous lactose (lactose), crystalline maltose, talc powder, magnesium stearate
Tablet coating: methacrylic acid-ethyl acrylate copolymer (1:1), triethyl citrate

Description of the appearance of Quetiapina Laboratori Alter and package contents
Quetiapina Laboratori Alter 50 mg tablets are white to off-white, round, biconvex, with "50" engraved on one side.
Blister packs made of polychlorotrifluoroethylene and polyvinyl chloride with aluminium.
Pack sizes:
Quetiapina Laboratori Alter 50 mg: 10 or 60 tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratori Alter s.r.l.
Via Egadi 7
20144 Milano, Italy

Manufacturer:
Pharmathen International S.A
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
or
Pharmathen S.A.
Dervenakion 6
Pallini 15351
Attiki,
Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Italy: Quetiapina Laboratori Alter 50 mg prolonged-release tablets
Spain: Quetiapina Alter 50 mg prolonged-release tablets EFG