Quetiapine CINFA 200 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

quetiapina cinfa 200 mg prolonged-release tablets EFG

Quetiapine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What quetiapina cinfa is and what it is used for

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

• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, guilty, lack energy, have loss of appetite, or are unable to sleep.
• Mania: where you may feel extremely excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or violent behavior.
• Schizophrenia: where you may hear or sense things that are not there, believe things that are not true, or feel abnormally suspicious, anxious, confused, guilty, tense, or depressed.

When quetiapina cinfa is used to treat major depressive episodes in major depressive disorder, it is taken in addition to another medicine you are already using to treat this condition.

Your doctor may continue prescribing quetiapina cinfa even after you start feeling better.

2. What you need to know before taking quetiapine cinfa

Do not take quetiapine cinfa

• 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:
  • Some medicines for HIV
  • 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 quetiapine cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take quetiapine cinfa:

• if you, or a family member, have or have had any heart problems, for example, heart rhythm disorders, weakened heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• if you have low blood pressure.
• if you have had a stroke, especially if you are an elderly patient.
• if you have liver problems.
• if you have ever had a seizure (convulsion).
• if you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine cinfa may cause serotonin syndrome, a potentially life-threatening condition (see “Other medicines and quetiapine cinfa”).
• 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 quetiapine cinfa.
• 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 patient with dementia (loss of brain function). In this case, you should not take quetiapine cinfa, as the group of medicines to which it belongs may increase the risk of stroke, or in some cases the risk of death, in elderly patients with dementia.
• if you are an elderly person with Parkinson’s disease/parkinsonism.
• if you or 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 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.

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

• A combination of fever, severe muscle stiffness, sweating, or decreased level of consciousness (a disorder known as “neuroleptic malignant syndrome”). Immediate medical treatment may be required.
• Fast or irregular heartbeat, even at rest, palpitations, breathing difficulties, chest pain, or unexplained fatigue. Your doctor should examine your heart and, if necessary, refer you immediately to a cardiologist.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or excessive drowsiness. This may increase the risk of accidental injury (falls) in elderly patients.
• Seizures (fits).
• Prolonged and painful erection (priapism).

These disorders may be caused by this type of medicine.

Inform your doctor as soon as possible if you experience:

• Fever, flu-like symptoms, sore throat, or any other infection that could be due to a low white blood cell count, which may require stopping treatment with quetiapine cinfa and/or additional treatment.
• Constipation with persistent abdominal pain, or constipation that has not responded to treatment, which could lead to serious intestinal blockage problems.

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. These thoughts may also increase if you stop taking the medicine 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 think about 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 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 cutaneous adverse reactions (SCARs)

Very rarely, serious cutaneous adverse reactions (SCARs), which may be life-threatening or fatal, have been reported with the use of this medicine. These commonly manifest 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 cell count (eosinophilia) and elevated liver enzymes).
• Acute generalized exanthematous pustulosis (AGEP), small pustules filled with pus.
• Erythema multiforme (EM), skin eruptions with irregular red spots 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

Quetiapine cinfa is not indicated for use in children or adolescents under 18 years of age.

Other medicines and quetiapine cinfa

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

Do not take quetiapine cinfa 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).

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 difficulty sleeping).
• Thioridazine or lithium (other antipsychotic medicines).
• Antidepressants. These medicines may interact with quetiapine cinfa, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including muscles controlling eye movement, 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.
• Medicines that affect your heartbeat, for example, medicines that may cause an electrolyte imbalance (low potassium or magnesium levels), such as diuretics (“water pills”) 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.

Quetiapine cinfa with food, drinks, and alcohol

• Quetiapine cinfa may be affected by food; therefore, you should take your tablets at least one hour before a meal or before bedtime.
• Be cautious about the amount of alcohol you consume. This is because the combined effect of quetiapine cinfa and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking quetiapine cinfa. 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 should not take quetiapine cinfa during pregnancy unless advised by your doctor. You should not use quetiapine cinfa if you are breastfeeding.

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

Driving and using machines

Quetiapine cinfa may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.

Effect on urine drug screening tests

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

Quetiapine cinfa contains sodium

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

3. How to take quetiapine cinfa

Follow exactly the instructions for use of this medicine given by your doctor. 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 a day.
• Do not split, chew, or crush the tablets.
• Swallow your tablets whole with water.
• Take the tablets without food (at least one hour before a meal or at bedtime; your doctor will tell you when).
• Do not drink grapefruit juice while taking quetiapine cinfa. 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 an elderly patient, your doctor may adjust your dose.

Use in children and adolescents

quetiapine cinfa must not be used in children and adolescents under 18 years of age.

If you take more quetiapine cinfa than you should

If you take more quetiapine cinfa than prescribed by your doctor, you may feel drowsy, dizzy, or experience abnormal heartbeats. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and the amount ingested. Bring the quetiapine cinfa tablets with you.

If you forget to take quetiapine cinfa

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 forgotten doses.

If you stop taking quetiapine cinfa

If you stop taking quetiapine cinfa suddenly, you may have difficulty sleeping (insomnia), or may feel nauseous, or may experience headache, diarrhea, vomiting, dizziness, or irritability.

Your doctor may advise you to gradually reduce 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.

If you experience any of the following serious adverse effects, stop taking quetiapine cinfa and go to your doctor or nearest hospital immediately:

Frequent adverse effects (may affect up to 1 in 10 people)

• Suicidal thoughts and worsening of depression.

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

• Sudden fever, especially with sore throat and other flu-like symptoms. This may be due to an abnormally low white blood cell count.
• Skin reactions such as rash, hives, lumps, redness, itching, possibly with facial swelling, eyelids or lips. These may also cause difficulty breathing, dizziness or shock.
• Seizures or convulsions.
• Uncontrollable movements, mainly of the face or tongue (tardive dyskinesia).
• Sensation that the heart is pounding or beating rapidly, together with dizziness or fainting. These may be symptoms of serious heart rhythm problems and, in severe cases, could be fatal.

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

• Sudden severe pain and/or swelling and redness in one leg; sudden severe chest pain which may radiate to the left arm or sudden shortness of breath. These may be due to blood clots in the veins.
• Severe pain in the upper abdomen, which may extend to the back, sometimes accompanied by nausea and vomiting. This may be a symptom of pancreatitis.
• Constipation with persistent abdominal pain or constipation unresponsive to treatment, which may lead to a more serious intestinal blockage.
• Yellowing of the skin and eyes (jaundice), dark urine, together with unusual tiredness or fever (symptoms of hepatitis).
• Prolonged and painful erection.
• A combination of fever, sweating, muscle stiffness, feeling very dizzy or weak (a disorder known as "neuroleptic malignant syndrome").

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

• Severe skin reactions with rash or blisters, irregular red patches and/or skin peeling, around the mouth, eyes or genitals, often with sudden fever or flu-like symptoms. These reactions may develop rapidly.
• Severe allergic reaction (called anaphylaxis) which may cause difficulty breathing or shock.
• Unexpected muscle pain, tenderness or weakness. These may be early signs of severe muscle breakdown.

Not known (frequency cannot be estimated from available data)

• Rapid onset of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid known as Acute Generalized Exanthematous Pustulosis (AGEP). See section 2.
• Skin rash with irregular red spots (erythema multiforme). See section 2.
• Heart muscle disorder (cardiomyopathy)
• Inflammation of the heart muscle (myocarditis)
• Condition with insufficient blood flow to the brain (stroke). Typical signs may include sudden facial drooping, arm weakness, difficulty speaking, and inability to move or feel one side of the body.

Drug rash with eosinophilia and systemic symptoms (DRESS): widespread rash, elevated body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS). If you develop these symptoms, stop using quetiapine and contact your doctor or seek medical attention immediately.

Do not be alarmed if you see a tablet in your faeces after taking quetiapine cinfa. As the tablet passes through the gastrointestinal tract, quetiapine is slowly released. The tablet shell remains undissolved and is excreted in the faeces. Therefore, even if you see a tablet in your faeces, your dose of quetiapine has been absorbed.

Other possible adverse effects:

Very common adverse effects (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 quetiapine cinfa) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine cinfa) including inability to sleep (insomnia), nausea, headache, diarrhoea, vomiting, dizziness, and irritability. A gradual withdrawal over a period of at least 1 to 2 weeks is recommended.
• Weight gain.
• Abnormal muscle movements. This includes difficulty initiating muscle movements, tremor, restlessness or painless muscle stiffness.
• Decrease in haemoglobin levels (the protein in red blood cells that carries oxygen).
• Increase in certain fats (triglycerides and total cholesterol).

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

• Rapid heartbeat.
• Sensation that the heart is pounding, beating rapidly, or has irregular beats.
• Constipation, upset stomach (indigestion).
• Feeling of weakness.
• Swelling of arms or legs.
• Low blood pressure when standing. This may make you feel dizzy or faint (which may lead to falls).
• Increased blood sugar levels.
• Blurred vision.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritable.
• Speech and language disorder.
• Difficulty breathing.
• Vomiting (mainly in elderly patients).
• Fever.
• Changes in the amount of thyroid hormones in the blood.
• Changes in the number of certain blood cells.
• Increase in liver enzymes in the blood.
• Increase in prolactin hormone levels in the blood. This increase in prolactin could, in rare cases, lead to:
  • Breast swelling and unexpected milk production in both men and women.
  • In women, absence of menstrual periods or irregular periods.

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

• Unpleasant sensations in the legs (also known as restless legs syndrome).
• Difficulty swallowing.
• Sexual dysfunction.
• Diabetes.
• Slower than normal heart rate, which may occur when starting treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Nasal congestion.
• Decrease in blood sodium levels.
• Worsening of pre-existing diabetes.
• Confusion.

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

• Breast swelling and unexpected milk production (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other activities while asleep.
• Decrease in body temperature (hypothermia).
• A condition (called “metabolic syndrome”) where you may have a combination of 3 or more of the following: increased abdominal fat, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood called triglycerides, high blood pressure, and increased blood sugar.
• Increased blood creatine phosphokinase (a substance from muscles).

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

• Inappropriate secretion of a hormone that controls urine volume.

Not known (frequency cannot be estimated from available data)

• Withdrawal symptoms may occur in newborns of mothers who have used quetiapine cinfa during pregnancy.
• Inflammation of blood vessels (vasculitis), often with a skin rash showing small red or purple spots.

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 blood cell types, decreased red blood cell count, increased blood creatine phosphokinase (a muscle-derived substance), decreased blood sodium levels, and increased blood prolactin hormone levels.

Elevated prolactin levels may, in rare cases, lead to:

• Breast swelling 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.

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 have not been observed in adults:

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

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

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

• Feeling of weakness, 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 quetiapina cinfa

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

This medicine does not require any special storage temperature conditions.