Quetiapine Alter

Package leaflet: Information for the user

QUETIAPINE ALTER 25 mg film-coated tablets, 100 mg film-coated tablets, 150 mg film-coated tablets, 200 mg film-coated tablets, 300 mg film-coated tablets

Quetiapine
Generic medicine
Read all of 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 their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Quetiapina Alter film-coated tablets contain a substance called quetiapine. This substance belongs to a group of medicines known as antipsychotics. Quetiapina Alter film-coated tablets can be used to treat several conditions, such as the following:

• Bipolar depression: you may feel sad or depressed, guilty, lack energy, have no 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.

Your doctor may continue to prescribe Quetiapina Alter film-coated tablets even if you feel well.

2. What you should know before taking Quetiapine Alter

Do not take Quetiapine Alter film-coated tablets:

• if you are allergic (hypersensitive) 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 drugs (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression).

Do not take Quetiapine Alter if you fall into any of the above categories. If you have any doubts, consult your doctor or pharmacist before taking Quetiapine Alter film-coated tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Quetiapine Alter film-coated tablets. In particular, inform your doctor if:

• You or someone in your family has had 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.
• Your blood pressure is low.
• You have had a stroke, especially if you are elderly.
• You have liver problems.
• You have had seizures (epileptic fits).
• You have diabetes or are at risk of developing diabetes. In this case, your doctor may monitor your blood sugar levels while you are taking Quetiapine Alter film-coated tablets.
• You know you have previously had low levels of white blood cells in your blood (whether caused by other medicines or not).
• You are an elderly person with dementia (loss of some brain functions). In this case, Quetiapine Alter film-coated tablets should not be taken, as this class of medicines, to which Quetiapine Alter belongs, may 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 conditions related to blood clots, since medicines of this type may promote blood clot formation.
• 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”).
• You have or have previously had a condition in which you are unable to fully 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.
• You have a history of alcohol or drug abuse.

Inform your doctor immediately if you experience any of the following symptoms after taking Quetiapine Alter film-coated tablets:

• rapid or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor will need to check your heart and, if necessary, refer you immediately to a cardiologist.
• fever associated with severe muscle stiffness, sweating, or reduced level of consciousness (a condition called “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• uncontrollable movements, mainly of the face or tongue.
• dizziness or intense drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• seizures (epileptic fits).
• prolonged and painful erection (priapism).

The following conditions may be caused by the type of medicine you are taking. Inform your doctor as soon as possible if you experience:

• 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 discontinuation of Quetiapine Alter and/or additional treatment;
• 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 occasionally feel the urge to harm yourself or to die. 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 such feelings if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behavior in young adults under 25 years of age with depression.

If at any time you experience thoughts of self-harm or suicide, contact your doctor or go immediately to the hospital. You may find it helpful to inform a close family member or friend that you suffer from depression and ask them to read this leaflet. You may wish to ask them to alert you if they think your depression is worsening or if they are concerned about changes in your behavior.

Severe cutaneous adverse reactions (SCARs)

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

• Stevens-Johnson Syndrome (SJS), a widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals.
• Toxic Epidermal Necrolysis (TEN), a more severe form causing extensive skin peeling.
• Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), characterized by flu-like symptoms with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes).
• Acute Generalized Exanthematous Pustulosis (AGEP), small pus-filled blisters.
• Erythema Multiforme (EM), a skin rash with irregular, red, itchy spots.

Stop using Quetiapine Alter if you develop any of these symptoms and contact your doctor or seek immediate medical attention.

Weight gain

Weight gain has been reported in patients treated with Quetiapine Alter film-coated tablets. It is important that your body weight is regularly monitored by both you and your doctor.

Children and adolescents

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

Other medicines and Quetiapine Alter film-coated tablets

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

Do not take Quetiapine Alter film-coated tablets if you are taking any of the following medicines:

• Certain medicines for HIV virus.
• Azole drugs (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for 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 (for sleep disorders).
• Thioridazine or Lithium (other antipsychotic medicines).
• Medicines that affect heart rhythm, for example, medicines that may cause electrolyte imbalance (low levels of potassium or magnesium), such as diuretics (pills that increase urine production) or certain antibiotics (medicines for treating infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function and are used to treat certain medical conditions.

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

Quetiapine Alter film-coated tablets with food, drinks, and alcohol

• Quetiapine Alter can be taken regardless of meals.
• Be cautious about the amount of alcohol you consume. This is important because the combined effect of Quetiapine Alter and alcohol may increase drowsiness.
• Do not drink grapefruit juice while taking Quetiapine Alter, 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 Alter during pregnancy without first discussing it with your doctor. Quetiapine Alter must not be taken during breastfeeding.

The following symptoms, which may represent withdrawal, have been observed in newborns whose mothers took Quetiapine Alter film-coated tablets during the third trimester (the last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and using machines

The tablets may cause drowsiness. Do not drive or operate any tools or machinery until you know how the tablets affect you.

Quetiapine Alter contains lactose

Quetiapine Alter film-coated tablets contain lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Effect on urine drug screening tests

If you undergo a urine drug screening test, taking Quetiapine Alter may lead to false positive results for methadone or certain antidepressants called tricyclic antidepressants (TCA), when certain testing methods are used, even if you are not taking methadone or TCAs. If this occurs, more specific tests should be performed.

3. How to take Quetiapine Alter film-coated tablets

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Your doctor will decide the most appropriate starting dose for you. The maintenance dose (daily dose) will depend on the type of illness and individual needs, but is usually between 150 mg and 800 mg.

• You will take the tablets either once daily, in the evening before going to bed, or twice daily, depending on the condition being treated.
• Swallow the tablets whole with a glass of water.
• You may take the tablets regardless of meals.
• Do not drink grapefruit juice while taking Quetiapine Alter, 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
If you are elderly, your doctor may adjust your dose.
Use in children and adolescents
Quetiapine Alter must not be used in children and adolescents under 18 years of age.
If you take more Quetiapine Alter film-coated tablets than you should
If you take more Quetiapine Alter than prescribed by your doctor, you may feel drowsy, dizzy, or experience an abnormal heartbeat. Contact your doctor or the nearest hospital immediately, and take the medicine pack with you.
If you forget to take Quetiapine Alter film-coated tablets
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 forgotten tablet.
If you stop taking Quetiapine Alter film-coated tablets
If you stop treatment with Quetiapine Alter suddenly, you may have difficulty sleeping (insomnia), feel unwell (nausea), or develop headache, diarrhoea, malaise (vomiting), dizziness, or irritability. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
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 gets them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which fades over time with continued treatment with Quetiapine Alter) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking Quetiapine Alter), including inability to sleep (insomnia), nausea, 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 (which should be regularly monitored).
• Abnormal muscle movements, including difficulty initiating muscle movement, tremor, feeling of restlessness or muscle stiffness without pain.
• Changes in the levels of certain blood fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Sensation of rapid or forceful heartbeat, or awareness of missed heartbeats.
• Constipation, stomach discomfort (indigestion).
• Feeling of weakness.
• Swelling of the arms or legs.
• Low blood pressure when standing up. This may cause dizziness or fainting (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Irritability.
• Speech and language disturbances.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (especially in elderly patients).
• Fever.
• Changes in the levels of thyroid hormones in the blood.
• Decreased number of certain types of blood cells.
• Increased levels of liver enzymes in blood tests.
• Increased levels of the hormone prolactin in the blood. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected production of breast milk in both men and women.
  • Absent or irregular menstrual cycles in women.

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

• Seizures or epileptic fits.
• Allergic reactions including swellings (hives), skin swelling, and swelling around the mouth.
• Unpleasant sensation in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Involuntary movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Changes in the heart's electrical activity seen on ECG (prolongation of the QT interval).
• A 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.
• Decreased number of red blood cells in the blood (anaemia).
• Decreased sodium levels in the blood (hyponatraemia).
• Worsening of pre-existing diabetes.
• Confusion.

Rare side effects (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 milk production 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 experience any of these symptoms, contact your doctor immediately.
• Sleepwalking and other related events (such as talking during sleep and sleep-related eating disorders).
• Decreased body temperature (hypothermia).
• Inflammation of the pancreas.
• A condition (called "metabolic syndrome") in which you may have a combination of 3 or more of the following symptoms: increased abdominal fat, decreased "good cholesterol" (HDL-C), increased levels of a blood fat called triglycerides, high blood pressure, and increased blood sugar levels.
• Combination of fever, flu-like symptoms, sore throat or any other infection with a very low white blood cell count, a condition known as agranulocytosis.
• Intestinal obstruction.
• Increased levels of creatine phosphokinase in the blood (a substance from muscles).

Very rare side effects (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). See section 2.
• Inappropriate secretion of the hormone controlling urine volume (syndrome of inappropriate antidiuretic hormone secretion, SIADH).
• Muscle fibre damage and muscle pain (rhabdomyolysis).
• Worsening of pre-existing diabetes.

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

• Skin rash associated with appearance of irregular red patches (erythema multiforme). See section 2.
• Rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow fluid), known as acute generalised exanthematous pustulosis (AGEP). See section 2.
• 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 organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS or drug hypersensitivity syndrome). See section 2. Stop using Quetiapine Alter and contact your doctor or seek immediate medical help if you develop these symptoms.
• Sudden, severe allergic reaction with symptoms such as fever, blistering of the skin and skin peeling (toxic epidermal necrolysis). See section 2.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Inflammation of blood vessels (vasculitis), often with a rash showing small red or purple bumps.
• Stroke.
• Withdrawal symptoms may occur in newborns of mothers who used Quetiapine Alter during pregnancy.

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

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

• Breast enlargement and unexpected milk production from the mammary gland in both men and women.
• Absence or irregularity of menstrual cycles in women. Your doctor may therefore prescribe periodic blood tests.

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 side effects (may affect more than 1 in 10 people):

• 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 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 stiffness without pain.
• Increased blood pressure.

Common side effects (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 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 Alter

Keep this medicine out of the sight and reach of children.
Do not use Quetiapina Alter after the expiry date stated on the packaging after the abbreviation
"Exp". The expiry date refers to the last day of that month.
Store the tablets in their original packaging.
Do not dispose of any medicine via 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 Alter contains
Each 25 mg film-coated tablet contains:

• The active substance is quetiapine fumarate 28.80 mg (equivalent to free quetiapine base 25 mg)
• The other components are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, hypromellose, calcium stearate, titanium dioxide, sodium starch glycolate, glycerol triacetate.

Each 100 mg film-coated tablet contains:

• The active substance is quetiapine fumarate 115.20 mg (equivalent to free quetiapine base 100 mg)
• The other components are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, hypromellose, calcium stearate, titanium dioxide, sodium starch glycolate, glycerol triacetate.

Each 150 mg film-coated tablet contains:

• Active substance: quetiapine fumarate 172.80 mg (equivalent to free quetiapine base 150 mg)
• The other components are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, hypromellose, calcium stearate, titanium dioxide, sodium starch glycolate, glycerol triacetate.

Each 200 mg film-coated tablet contains:

• The active substance is quetiapine fumarate 230.40 mg (equivalent to free quetiapine base 200 mg)
• The other components are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, hypromellose, calcium stearate, titanium dioxide, sodium starch glycolate, glycerol triacetate.

Each 300 mg film-coated tablet contains:

• The active substance is quetiapine fumarate 345.60 mg (equivalent to free quetiapine base 300 mg)
• The other components are: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, hypromellose, calcium stearate, titanium dioxide, sodium starch glycolate, glycerol triacetate.

Description of the appearance of Quetiapina Alter and contents of the pack
Film-coated tablets.
Quetiapina Alter 25 mg film-coated tablets: 6 and 30 white, round, biconvex tablets.
Quetiapina Alter 100 mg film-coated tablets: 30 and 60 white, round, biconvex tablets.
Quetiapina Alter 150 mg film-coated tablets: 30 white, oblong tablets.
Quetiapina Alter 200 mg film-coated tablets: 30 white, oblong tablets.
Quetiapina Alter 300 mg film-coated tablets: 30 white, oblong tablets.
Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer
Laboratori Alter S.r.l. – Via Egadi, 7 – 20144 Milano, Italy
Manufacturer
Laboratorios Alter, S.A., c/Mateo Inurria, 30 - 28036 Madrid, Spain