QUETIAPINE HEC PHARM 100 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the patient

Quetiapine HEC Pharm 25 mg film-coated tablets EFG

Quetiapine HEC Pharm 100 mg film-coated tablets EFG

Quetiapine HEC Pharm 150 mg film-coated tablets EFG

Quetiapine HEC Pharm 200 mg film-coated tablets EFG

Quetiapine HEC Pharm 300 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Quetiapine HEC Pharm is and what it is used for

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

• Bipolar depression: where you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite or cannot sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or show poor judgment including being aggressive or violent.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel abnormally suspicious, anxious, confused, guilty, tense or depressed.

Your doctor may continue to prescribe you this medicine even when you feel better.

2. What you need to know before you take Quetiapine HEC Pharm

Do not takeQuetiapine HEC Pharm:

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

• some medicines for HIV
• azole-type medicines (for fungal infections)
• erythromycin or clarithromycin (for infections)
• nefazodone (for depression).

If you are in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you, or someone in your family, have or have had any heart problems, such as problems with the heart rhythm, weakening of the heart muscle or inflammation of the heart, or if you are taking any medicine that may affect your heart beat.
• 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 ever had a seizure (convulsion).
• if you have diabetes or are at risk of developing diabetes. If so, your doctor may monitor your blood sugar levels while you are taking this medicine.
• if you know that you have had low white blood cell counts in the past (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain function). If so, you should not take this medicine because the group of medicines that quetiapine belongs to may increase the risk of stroke, or in some cases the risk of death, in these people.
• if you are an elderly person with Parkinson's disease/parkinsonism
• if you or someone in your family has a history of blood clots, as medicines like this one have been associated with the formation of blood clots.
• if you have or have had a disorder where you stop breathing for short periods during normal sleep (called "sleep apnea") and are taking medicines that reduce the normal activity of the brain ("antidepressants").
• if you have or have had a disorder where you cannot empty your bladder completely (urinary retention), have an enlarged prostate, a blockage in the intestine, or increased pressure inside the eye. These disorders are sometimes caused by medicines (called "anticholinergics") that affect the functioning of nerve cells to treat certain diseases.
• if you have a history of alcohol or drug abuse.
• if you have depression or other conditions that are treated with antidepressants. The use of these medicines with Quetiapine HEC Pharm may cause a condition called serotonin syndrome, a potentially life-threatening condition (see "Other medicines and Quetiapine HEC Pharm").

Tell your doctor immediately if after taking this medicine you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or a decrease in the level of consciousness (a disorder called "neuroleptic malignant syndrome"). You may need immediate medical treatment.
• Uncontrolled movements, mainly of your face or tongue.
• Dizziness or feeling very drowsy. This can increase the risk of accidental injuries (falls) in elderly patients.
• Seizures (convulsions).
• A prolonged and painful erection (priapism).
• Fast and irregular heartbeats, even when you are at rest, palpitations, breathing problems, chest pain, or unexplained tiredness. Your doctor should examine your heart and if necessary, refer you to a cardiologist immediately.

These disorders can 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 it could be a consequence of a very low white blood cell count and may require interruption of treatment with this medicine and/or additional treatment.
• Constipation along with persistent abdominal pain, or constipation that has not responded to treatment, as it could lead to a more serious blockage of the intestine.

• Thoughts of suicide and worsening of your depression

If you are depressed, you may sometimes think of harming or killing yourself. This may increase when you first start treatment, as all these medicines take time to work, usually around two weeks but sometimes more. These thoughts may also increase if you stop taking the medicine abruptly. You are more likely to think this way if you are a young adult. Information from clinical trials has 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 think of harming or killing yourself, contact your doctor or go to a hospital immediately. It may help to tell a relative or close friend that you are depressed and ask them to read this leaflet. You can ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior.

Severe skin reactions (SCAR)

Very rarely, severe skin reactions (SCAR) have been reported during treatment with this medicine. These reactions can be life-threatening or fatal. They are commonly manifested as:

• Stevens-Johnson syndrome (SJS), a widespread skin rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals.
• Toxic epidermal necrolysis (TEN), a more severe form that causes widespread peeling of the skin.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms, accompanied by a skin rash, fever, swelling of the lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pus-filled blisters.
• ERYthema multiforme (EM), a skin rash with irregular, red, and irritating patches.

If you experience these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.

Weight gain

Weight gain has been observed in patients taking this medicine. You and your doctor should monitor your weight regularly.

Effect on urine drug screening tests

If you are undergoing a urine drug screening test, taking this medicine may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when some analysis methods are used, even if you are not taking methadone or TCAs. If this happens, a more specific test can be performed.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapine HEC Pharm

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

Do not take this medicine if you are using any of the following medicines:

• Some medicines for HIV.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).

Tell 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 difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that affect your heart rhythm, such as medicines that can cause an imbalance in electrolytes (low potassium or magnesium levels) such as diuretics (medicines to urinate) or certain antibiotics (medicines to treat infections).
• Medicines that can cause constipation.
• Medicines (called "anticholinergics") that affect the functioning of nerve cells to treat certain diseases.
• Antidepressants. These medicines can interact with Quetiapine HEC Pharm and you may experience symptoms such as involuntary muscle contractions and rhythmic movements of the muscles, including the muscles that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, increased muscle tone, and body temperature above 38°C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Before stopping any of your medicines, consult your doctor first.

Taking Quetiapine HEC Pharm with food, drinks, and alcohol

• Be careful with the amount of alcohol you drink. This is because the combined effect of this medicine and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking this medicine. It may affect how the medicine works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not take quetiapine during pregnancy, unless you have discussed this with your doctor.

The following symptoms, which may represent a withdrawal syndrome, may appear in newborn babies of mothers who have used quetiapine in the last trimester (last three months of their pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn develops any of these symptoms, you may need to contact your doctor.

Quetiapine should not be used during breastfeeding.

Driving and using machines

Quetiapine may make you feel drowsy. Do not drive or use tools or machines until you know how this medicine affects you.

Quetiapine HEC Pharm contains lactose

This medicine contains lactose, which is a type of sugar. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Quetiapine HEC Pharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

3. How to take Quetiapine HEC Pharm

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will decide your initial dose. The maintenance dose (daily dose) will depend on your disease and needs but will normally be between 150 mg and 800 mg.

• You will take your tablets once a day, at bedtime, or twice a day, depending on your disease.

Elderly people

If you are elderly, your doctor may change your dose.

Liver problems

If you have liver problems, your doctor may change your dose.

Use in children and adolescents

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

Method of administration.

Quetiapine HEC Pharm is administered orally.

• Swallow the tablets whole with a little water.
• Do not drink grapefruit juice while taking Quetiapine HEC Pharm, it may affect the functioning of the medicine.
• You can take the tablets with or without food.

If you take moreQuetiapine HEC Pharmthan you should

If you take more Quetiapine HEC Pharm than your doctor has prescribed, you may feel drowsy, dizzy, and experience abnormal heartbeats. Contact your doctor or the nearest hospital immediately. Take the Quetiapine HEC Pharm tablets with you.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to takeQuetiapine HEC Pharm

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 then. Do not take a double dose to make up for the forgotten tablet.

If you stop takingQuetiapine HEC Pharm

Do not stop taking the tablets even if you feel better, unless your doctor tells you to.

If you stop taking Quetiapine HEC Pharm abruptly, you may experience insomnia, or you may feel nauseous, or you may experience headache, diarrhea, vomiting, dizziness, or irritability. Your doctor may suggest gradually reducing the dose before stopping treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Very Common Adverse Effects: may affect more than 1 in 10 people

• Dizziness (which may lead to falls), headache, dry mouth.
• Feeling of drowsiness (which may disappear over time, as you continue taking this medicine, (may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), which include inability to sleep (insomnia), feeling nauseous, headache, diarrhea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is advised.
• Weight gain.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Changes in the amount of certain fats (triglycerides and total cholesterol).

Common Adverse Effects: may affect up to 1 in 10 people

• Rapid heartbeat.
• Feeling like your heart is beating strongly, beating fast, or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing up. This can make you feel dizzy or faint (may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Speech and language disorder.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increase in liver enzymes measured in the blood.
• Increase in the amount of prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:
• • Both in men and women, having swollen breasts and unexpected milk production.
  • In women, not having menstrual periods or having irregular periods.

Uncommon Adverse Effects: may affect up to 1 in 100 people

• Seizures or convulsions.
• Allergic reactions that can include hives, skin swelling, and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Diabetes.
• Change in the electrical activity of the heart seen on the ECG (prolongation of the QT interval).
• Slower than normal heart rate that can occur at the start of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in the blood.
• Decrease in the amount of sodium in the blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), sweating, muscle stiffness, feeling very drowsy or dizzy (a disorder called "neuroleptic malignant syndrome").
• Yellowish color of the skin and eyes (jaundice).
• Liver inflammation (hepatitis).
• Prolonged and painful erection (priapism).
• Swollen breasts and unexpected milk production (galactorrhea).
• Menstrual disorder.
• Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, seek medical attention immediately.
• Walking, talking, eating, or other activities while you are asleep.
• Decreased body temperature (hypothermia).
• Pancreas inflammation.
• A state (called "metabolic syndrome") in which you may have a combination of three or more of the following effects: increased fat around your abdomen, decreased "good" cholesterol (HDL-C), increased triglycerides in the blood, increased blood pressure, and increased blood sugar.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with a very low white blood cell count, a condition called agranulocytosis.
• Intestinal obstruction.
• Increased creatine phosphokinase in the blood (a substance found in muscles).

Very Rare Adverse Effects: may affect up to 1 in 10,000 people

• Severe rash, blisters, or red spots on the skin.
• Severe allergic reaction (called anaphylaxis) that can cause difficulty breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips, and throat (angioedema).
• A severe blistering condition of the skin, mouth, eyes, and genitals (Stevens-Johnson syndrome).
• Inappropriate secretion of a hormone that controls urine volume.
• Muscle fiber breakdown and muscle pain (rhabdomyolysis).

Unknown Frequency: cannot be estimated from available data

• Red spots on the skin with irregular edges (erythema multiforme).
• Sudden appearance of red skin areas covered with small pus-filled bumps (small blisters filled with white/yellow liquid, known as Acute Generalized Exanthematous Pustulosis (AGEP)). Sudden and severe allergic reaction with symptoms such as fever and blisters on the skin and skin peeling (toxic epidermal necrolysis).
• Drug reaction with eosinophilia and systemic symptoms (DRESS), which consists of flu-like symptoms, accompanied by skin rash, fever, swelling of the glands, and abnormal blood test results (including increased white blood cells, eosinophilia, and liver enzymes).
• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine during pregnancy.
• Stroke.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Inflammation of the blood vessels (vasculitis), often with a skin rash with small red or purple spots.

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

Some adverse effects are only observed when a blood test is performed. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, increased liver enzymes, decreased number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in the blood (a substance found in muscles), decreased sodium in the blood, and increased prolactin hormone in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in men and women, having swollen breasts and unexpected milk production.
• In women, not having menstrual periods or having irregular periods.

Your doctor may ask you to have blood tests from time to time.

Other Adverse Effects in Children and Adolescents

The same adverse effects that can occur in adults can also occur in children and adolescents.

The following adverse effects have been observed more frequently in children and adolescents or have not been observed in adults:

Very Common Adverse Effects: may affect more than 1 in 10 people

• Increased amount of a hormone called prolactin in the blood. The increases in prolactin hormone could, in rare cases, lead to the following:

• Both in boys and girls, having swollen breasts and unexpected milk production.
• In girls, not having menstrual periods or having irregular periods.

• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty starting muscle movements, tremors, feeling of restlessness or muscle stiffness without pain.
• Increased blood pressure.

Common Adverse Effects: may affect up to 1 in 10 people

• Feeling of weakness, fainting (may lead to falls).
• Stuffy nose.
• Feeling irritated.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist. Even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapina HEC Pharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Quetiapina HEC Pharm

• The active ingredient is quetiapine.

Each film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate)

Each film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate)

Each film-coated tablet contains 150 mg of quetiapine (as quetiapine fumarate)

Each film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate)

Each film-coated tablet contains 300 mg of quetiapine (as quetiapine fumarate)

• The other ingredients are:

Tablet core: povidone K29-32, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate Type A, lactose monohydrate, magnesium stearate.

Tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc. The 100 mg and 150 mg tablets also contain yellow iron oxide (E172) and the 150 mg tablets contain red iron oxide (E172).

Appearance of Quetiapina HEC Pharm and Package Contents

Quetiapina HEC Pharm 25 mg film-coated tablets are white or almost white, round film-coated tablets with a diameter of 5.6 mm, with the inscription «L74» on one side and no inscription on the other side.

Quetiapina HEC Pharm 100 mg film-coated tablets are yellow or light yellow, round film-coated tablets with a diameter of 8.6 mm, with the inscription «L46» on one side and no inscription on the other side.

Quetiapina HEC Pharm 150 mg film-coated tablets are pink or light pink, capsule-shaped film-coated tablets with dimensions of 6.6 mm × 14.1 mm, with the inscription «C21» on one side and no inscription on the other.

Quetiapina HEC Pharm 200 mg film-coated tablets are white or almost white, capsule-shaped film-coated tablets with dimensions of 7.6 mm × 15.6 mm, with the inscription «C22» on one side and no inscription on the other side.

Quetiapina HEC Pharm 300 mg film-coated tablets are white or almost white, capsule-shaped film-coated tablets with dimensions of 8.1 mm × 16.9 mm, with the inscription «L49» on one side and no inscription on the other side.

PVC/PVDC/Aluminum blisters

Package sizes: 30, 50, 60, and 100 film-coated tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

HEC Pharm GmbH,

Gabriele-Tergit-Promenade 17,

D-10963 Berlin

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: 04.2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es