Quetiapine Combix 300 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Quetiapina Combix 300 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

Quetiapina Combix contains a substance called quetiapine. It belongs to a group of medicines known as antipsychotics. Quetiapina Combix can be used to treat several conditions, such as:

• Schizophrenia: in which 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.
• Mania: in which you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including being aggressive or displaying destructive or aggressive behaviors.
• Bipolar depression: in which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.

Your doctor may continue prescribing Quetiapina Combix even after you feel better.

2. What you need to know before taking Quetiapina Combix

Do not take Quetiapina Combix:

• if you are allergic to quetiapine or to any of the other components of this medicine (listed in section 6).

• if you are taking any of the following medicines:

• certain HIV medications

• azole-type medicines (for fungal infections)

• erythromycin or clarithromycin (for infections)

• nefazodone (for depression).

If you have any doubts, consult your doctor or pharmacist before taking Quetiapina Combix.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapina Combix:

• if you, or a family member, have or have had any heart problems, for example, heart rhythm disorders, weakening of the heart muscle, or inflammation of the heart, or if you are taking 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 ever had a seizure (epileptic fit).
• 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 Quetiapina Combix.
• if you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• if you are an elderly person with dementia (loss of brain functions). In this case, you should not take Quetiapina Combix because the group of medicines it belongs to may increase the risk of stroke, or in some cases, the risk of death, in elderly people with dementia.
• if you are an elderly person with Parkinson’s disease/parkinsonism.
• if you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• if you have or have had a condition in which your breathing stops for short periods during normal nighttime sleep (called “sleep apnea”) and you are taking medicines that reduce normal brain activity (“depressants”).
• if you have or have had a condition in which you cannot completely empty your bladder (urinary retention), have an enlarged prostate, intestinal obstruction, or increased pressure inside your eye. These conditions can sometimes be caused by medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.
• if you have a history of alcohol or drug abuse.
• if you suffer from depression or other conditions treated with antidepressants.

Using these medicines together with Quetiapina Combix may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Quetiapina Combix”).

Inform your doctor immediately if, after taking Quetiapina Combix, you experience any of the following:

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be necessary.

• Uncontrollable movements, mainly of your face or tongue.

• Dizziness or feeling very drowsy. This may increase the risk of accidental injuries (falls) in elderly patients.

• Seizure (convulsions).

• Prolonged and painful erection (priapism).

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 this could be due to a very low count of white blood cells and may require discontinuation of Quetiapina Combix and/or additional treatment.

• Constipation along 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 your depression

If you are depressed, you may sometimes think about harming yourself or committing suicide. This risk may increase at the beginning of treatment, as all these medicines take time to work—usually about two weeks, but sometimes longer. This risk may also increase if you stop your medication abruptly. You may be more likely to have such thoughts if you are a young adult. Clinical trial data 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 have thoughts of harming yourself or committing suicide, contact your doctor or go to a hospital immediately. It may help to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may also ask them to let you know if they think your depression is getting worse or if they are concerned about changes in your behavior.

Serious skin adverse reactions (SCARs)

Very rarely, serious skin adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with this medicine. These commonly present as:

• Stevens-Johnson syndrome (SJS), a widespread rash with blistering and peeling of the skin, 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 lymph nodes, 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), skin rashes with irregular red patches that itch.

If you develop any of these symptoms, stop using quetiapine and contact your doctor or seek immediate medical attention.

Weight gain

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

Children and adolescents

Quetiapina Combix must not be used in children and adolescents under 18 years of age.

Other medicines and Quetiapina Combix

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

Do not take Quetiapina Combix if you are using any of the following medicines:

• Certain HIV medications.
• Azole-type medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).
• Antidepressants. These medicines may interact with Quetiapina Combix and you may experience symptoms such as involuntary rhythmic muscle contractions, including of the eye movement muscles, agitation, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tone, and body temperature above 38 °C (serotonin syndrome). Contact your doctor if you experience these symptoms.

Talk to 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 difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Medicines that may affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium and magnesium levels) such as diuretics (medicines to increase urine production), or certain antibiotics (medicines to treat infections).
• Medicines that may cause constipation.
• Medicines (called “anticholinergics”) that affect how nerve cells function, used to treat certain medical conditions.

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

Quetiapina Combix with food, drinks, and alcohol

• Quetiapina Combix may be taken with or without food.
• Be cautious about how much alcohol you drink. This is because the combined effect of Quetiapina Combix and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapina Combix. 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 become pregnant, consult your doctor before using this medicine. You must not take Quetiapina Combix during pregnancy unless you have discussed it with your doctor. You must not use Quetiapina Combix while breastfeeding.

The following symptoms, which may represent withdrawal syndrome, may occur in newborns of mothers who have taken quetiapine during the third trimester (the last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn develops any of these symptoms, you may need to contact your doctor.

Driving and using machines

These tablets may make you feel drowsy. Do not drive or operate tools or machinery until you know how these tablets affect you.

Quetiapina Combix contains lactose

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

Quetiapina Combix contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per dose unit; thus, it is essentially “sodium-free”.

Effect on Urine Drug Screening Tests

If you are undergoing a urine drug screening test, taking Quetiapina Combix may produce positive results for methadone or certain antidepressant medicines called tricyclic antidepressants (TCAs) when certain testing methods are used, even though you may not be taking methadone or TCAs. If this occurs, a more specific test can be performed.

3. How to take Quetiapina Combix

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide your starting dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

• You will take your tablets once daily at bedtime or twice daily, depending on your condition.
• Swallow your tablets whole with water.
• You may take the tablets with or without food.
• Do not drink grapefruit juice while being treated with Quetiapina Combix. It may affect how the medicine works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you to.

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

Quetiapina Combix must not be used in children and adolescents under 18 years of age.

If you take more Quetiapina Combix than you should

If you take more Quetiapina Combix than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. Contact your doctor or nearest hospital immediately. Keep the Quetiapina Combix tablets with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount taken.

If you forget to take Quetiapina Combix

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 taking Quetiapina Combix

If you stop taking Quetiapina Combix abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, headache, diarrhoea, vomiting, dizziness, or irritability. Your doctor may recommend gradually reducing the dose before stopping treatment.

If you have any further questions about 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 everyone will experience them.

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may diminish over time as you continue taking Quetiapina Combix) (may lead to falls).
• Discontinuation symptoms (symptoms occurring when you stop taking Quetiapina Combix), including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremor, restlessness, or painless muscle rigidity.
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.
• Feeling that your heart is pounding, racing, or beating irregularly.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• Low blood pressure when standing. This may cause dizziness or fainting (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorders.
• Suicidal thoughts and worsening of depression.
• Shortness of breath.
• Vomiting (mainly in elderly people).
• Fever.
• Changes in levels of thyroid hormones in the blood.
• Decrease in the number of certain types of blood cells.
• Increases in liver enzyme levels measured in blood.
• Increases in blood levels of prolactin hormone. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

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

• Epileptic seizures or convulsions.
• Allergic reactions which may include raised, itchy rashes (hives), skin swelling, or swelling around the mouth.
• Dizziness (which may lead to falls).
• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Uncontrolled movements, mainly of the face or tongue.
• Sexual dysfunction.
• Nasal congestion.
• Diabetes.
• Changes in the heart's electrical activity detected on ECG (prolongation of the QT interval).
• Decrease in normal heart rate, which may occur at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Decrease in the number of red blood cells in blood.
• Decrease in blood sodium levels.
• Worsening of pre-existing diabetes.
• Confusion.

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

• A combination of high temperature (fever), sweating, muscle stiffness, and extreme drowsiness or dizziness (a disorder known as “neuroleptic malignant syndrome”).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• Prolonged and painful erection (priapism).
• Menstrual disorders.
• Blood clots in veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.
• Walking, talking, eating, or performing other activities while asleep.
• Decrease in body temperature (hypothermia).
• Breast enlargement and unexpected milk production (galactorrhoea).
• Inflammation of the pancreas.
• A condition (called “metabolic syndrome”) in which you may have a combination of 3 or more of the following: increased abdominal fat, decreased “good” cholesterol (HDL-C), increased levels of blood fats called triglycerides, 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 known as agranulocytosis.
• Intestinal obstruction.
• Increased blood creatine phosphokinase (a muscle substance).

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

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

Frequency not known (frequency cannot be estimated from available data)

• Skin rash with irregular red spots (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.
• Sudden and severe allergic reaction with symptoms such as fever, skin blisters, and skin peeling (toxic epidermal necrolysis). See section 2.
• Drug reaction with eosinophilia and systemic symptoms (DRESS), characterised by flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results (including increased white blood cells (eosinophilia) and elevated liver enzymes). See section 2.
• Withdrawal symptoms may occur in newborns of mothers who have used Quetiapina Combix 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 spots.

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

Some adverse effects are only detected through blood tests. These include changes in levels of certain fats (triglycerides and total cholesterol) or blood sugar, changes in thyroid hormone levels in the blood, increased liver enzymes, decreased numbers of certain types of blood cells, decreased red blood cell count, increased serum creatine phosphokinase (a muscle substance), decreased blood sodium levels, and increased blood levels of the hormone prolactin. Elevated prolactin levels may, in rare cases, lead to the following:

• Breast enlargement and unexpected milk production in both men and women.
• In women, absence of menstrual periods or irregular periods.

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

Additional adverse effects in children and adolescents

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

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

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

• Increase in blood levels of a hormone called prolactin. Elevated prolactin levels may, in rare cases, lead to the following:
  • Breast enlargement and unexpected milk production in both boys and girls.
  • In girls, absence of menstrual periods or irregular periods.
• Increased appetite.
• Vomiting.
• Abnormal muscle movements. These include difficulty initiating muscle movements, tremors, restlessness, or painless muscle rigidity.
• Increased blood pressure.

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

• Feeling weak, fainting (which may lead to falls).
• Nasal congestion.
• Feeling irritable.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Quetiapine Combix

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

No special storage conditions are required.

Do not use Quetiapine Combix after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine Combix

The active substance is quetiapine hemifumarate.

Each tablet contains 300 mg of quetiapine (as quetiapine hemifumarate).

The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, magnesium stearate (E470b), sodium carboxymethylstarch potato (Type A) and dicalcium phosphate dihydrate.

Tablet coating: hypromellose E-5, titanium dioxide and macrogol 400.

Appearance of Quetiapine Combix and pack contents

Quetiapine Combix 300 mg are capsule-shaped, white or almost white, biconvex, film-coated tablets marked with "300" on one side and flat on the reverse.

Quetiapine Combix 300 mg film-coated tablets are available in packs of 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Manufacturer

Laboratori FUNDACIO DAU,

C/ De la letra C, 12-14,

Poligono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

or

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

or

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, Schimatari, 32009, Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names

Date of the most recent review of this leaflet: October 2024.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.