Quetiapine Ratiopharm 300 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Quetiapine ratiopharm 300 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, 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 they are

effects not listed in this leaflet. See Section 4.

Contents of the leaflet:

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

1. What Quetiapine ratiopharm is and what it is used for

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

• Bipolar depression and major depressive episodes in major depressive disorder: in which you feel sad. You may find that you feel depressed, guilty, lack energy, lose your appetite, or are unable to sleep.
• Mania: in which you may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive, or have poor judgment, including aggressive or violent behaviour.
• 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.

When Quetiapine ratiopharm prolonged-release tablets are used to treat major depressive episodes in major depressive disorder, they are taken in addition to another medicine you are already using for this condition.

Your doctor may continue prescribing Quetiapine ratiopharm even after you start feeling better.

2. What you need to know before taking Quetiapine ratiopharm

Do not take Quetiapine ratiopharm:

• 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 any doubt, consult your doctor or pharmacist before taking Quetiapine ratiopharm.

Warnings and precautions

Talk to your doctor or pharmacist before starting Quetiapine ratiopharm if:

• you, or a family member, have or have had any heart problems, for example, heart rhythm problems, weakening of the heart muscle, or inflammation of the heart, or if you are taking any medicine that may affect your heartbeat.
• you have low blood pressure.
• you have had a stroke, especially if you are elderly.
• you have liver problems.
• you have ever had a seizure (epileptic fit).
• you suffer from depression or other conditions treated with antidepressants. The use of these medicines together with quetiapine may cause serotonin syndrome, a potentially life-threatening condition (see “Use of Quetiapine ratiopharm with other medicines”).
• 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.
• you know you have previously had low levels of white blood cells (which may or may not have been caused by other medicines).
• you are an elderly person with dementia (loss of brain function). In this case, you should not take quetiapine, as the group of medicines to which Quetiapine ratiopharm belongs may increase the risk of stroke, or in some cases the risk of death, in people with dementia.
• you are an elderly person with Parkinson’s disease/parkinsonism.
• you or a family member has a history of blood clots, as medicines like this have been associated with blood clot formation.
• 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”).
• 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.
• you have a history of alcohol or drug abuse.

Contact your doctor immediately if, after taking Quetiapine ratiopharm, you experience any of the following:

• 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 necessary.
• Fast or irregular heartbeats, even at rest, palpitations, breathing difficulties, chest pain, or unexplained tiredness. 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 (epileptic fits).
• A 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 stopping treatment with quetiapine 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 your depression

If you are depressed, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts 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 your medication abruptly. You may be more likely to have such thoughts if you are a young adult. Data from clinical trials have shown an increased risk of suicidal thoughts and/or suicidal behaviour 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 ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Serious cutaneous adverse reactions (SCARs)

Very rarely, serious skin 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 rashes with irregular red spots that itch.

If you develop any of these symptoms, stop using Quetiapine ratiopharm 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 ratiopharm must not be used in children and adolescents under 18 years of age.

Use of Quetiapine ratiopharm with other medicines

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

Do not take Quetiapine ratiopharm 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 ratiopharm, and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those controlling eye movement, restlessness, hallucinations, coma, excessive sweating, tremor, exaggerated reflexes, increased muscle tension, 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 (medicines to increase urination) 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.

Do not stop taking any of your medicines without first consulting your doctor.

Taking Quetiapine ratiopharm with food, drinks and alcohol

• Quetiapine ratiopharm may be affected by food, and 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 ratiopharm and alcohol may make you drowsy.
• Do not drink grapefruit juice while taking Quetiapine ratiopharm. 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 ratiopharm during pregnancy unless advised by your doctor. You should not use Quetiapine ratiopharm if you are breastfeeding.

The following symptoms, which may represent a withdrawal syndrome, may occur in newborns whose mothers have used quetiapine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, 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.

Effect on urine drug screening tests

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

Quetiapina ratiopharm contains sodium

This medicine contains less than 1 mmol of sodium (23 mg), i.e., essentially "sodium-free".

3. How to take Quetiapine ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again. Your doctor will determine your initial dose. The maintenance dose (daily dose) will depend on your condition and individual needs, but will usually be between 150 mg and 800 mg.

? Take your tablets once daily.

? 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 ratiopharm. It may affect how the medicine works.

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

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

If you take more Quetiapine ratiopharm than you should

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

You can also call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Quetiapine ratiopharm

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 Quetiapine ratiopharm

If you stop taking Quetiapine ratiopharm abruptly, you may have difficulty sleeping (insomnia), or may experience nausea, 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 gets them.

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

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

• Suicidal thoughts and worsening of your depression.

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

• Sudden fever, especially with sore throat and flu-like symptoms. These may be signs of a very low white blood cell count.
• Signs of skin reactions such as rash, hives, wheals, redness, itching, possibly with swelling of the face, eyelids and lips. This could also cause difficulty breathing, dizziness or shock.
• Seizures or convulsions.
• Uncontrollable movements, mainly of your face or tongue (tardive dyskinesia).
• Feeling that your heart is pounding strongly or beating very fast, together with dizziness or fainting. This may be a sign of serious heart rhythm problems and, in severe cases, may be fatal.

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

• Severe pain or swelling and redness in one of your legs; sudden severe chest pain that may radiate to the left arm or sudden shortness of breath. These may be signs of blood clots in the veins.
• Severe upper abdominal pain, often radiating to the back, sometimes with nausea and vomiting. This may be a sign of inflammation of the pancreas.
• Constipation together with persistent abdominal pain or constipation that has not responded to treatment, as this may lead to a more serious intestinal blockage.
• Yellowing of the skin and eyes (jaundice), dark urine, especially with unusual tiredness or fever (signs of hepatitis).
• A prolonged and painful erection.
• A combination of fever, sweating, stiff muscles, drowsiness or fainting (a disorder called "neuroleptic malignant syndrome").

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) 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). See section 2.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and muscle pain (rhabdomyolysis).

Adverse effects not known (frequency cannot be estimated from available data)

• Skin rashes with irregular red spots (erythema multiforme). See section 2.
• Rapid appearance 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.
• 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), consisting of flu-like symptoms with skin rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes). See section 2.
• Heart muscle disorder (cardiomyopathy).
• Inflammation of the heart muscle (myocarditis).
• Stroke.

Other possible adverse effects

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

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

• Dizziness (which may lead to falls), headache, dry mouth.
• Drowsiness (which may disappear over time as you continue taking quetiapine) (which may lead to falls).
• Withdrawal symptoms (symptoms that occur when you stop taking quetiapine), including inability to sleep (insomnia), feeling nauseous, 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 stiffness.
• Decreased levels of haemoglobin (proteins in red blood cells that carry oxygen).
• Changes in levels of certain fats (triglycerides and total cholesterol).

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

• Fast heartbeat.

• Feeling that your heart is pounding strongly, beating rapidly or having irregular beats.

• Constipation, upset stomach (indigestion).

• Feeling weak.

• 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.

• Feeling hungrier.

• Feeling irritable.

• Speech and language disorder.

• Shortness of breath.

• Vomiting (mainly in elderly people).

• Fever.

• Changes in levels of thyroid hormones in the blood.

• Changes in the number of certain types of blood cells.

• Increases in liver enzymes measured in blood.

• Increases in the amount of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.

• 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 at the beginning of treatment and may be associated with low blood pressure and fainting.
• Difficulty urinating.
• Fainting (which may lead to falls).
• Stuffy nose.
• Decrease in the number of red blood cells in blood.
• Decrease in the amount of sodium in blood.
• Worsening of pre-existing diabetes.
• Confusion.

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

• Breast enlargement 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 experience a combination of 3 or more of the following effects: increased fat around the abdomen, decreased “good cholesterol” (HDL-C), increased levels of a type of fat in the blood called triglycerides, increased blood pressure and increased blood sugar.
• Intestinal obstruction.
• 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 during pregnancy.
• Inflammation of blood vessels (vasculitis), often with a skin rash with 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 your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decreased number of red blood cells, increased creatine phosphokinase in blood (a substance found in muscles), decreased sodium levels in blood and increased levels of prolactin hormone in blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both men and women: breast enlargement and unexpected milk production.
• 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 amount of a hormone called prolactin in the blood. Increases in prolactin hormone could, in rare cases, lead to the following:

• In both boys and girls: breast enlargement and unexpected milk production.

• 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 stiffness.
  • Increased blood pressure.

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

• Feeling weak, fainting (which may lead to falls).
• Stuffy nose.
• Feeling irritable.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist or nurse, 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 ratiopharm

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.

Quetiapine ratiopharm does not require any special storage temperature conditions.

For bottles only:

After first opening the container, the product should be used within 60 days.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Quetiapine ratiopharm

The active substance is quetiapine. Quetiapine ratiopharm tablets contain 300 mg of quetiapine (as quetiapine fumarate).

The other components are:

Tablet core: hypromellose, microcrystalline cellulose, anhydrous sodium citrate, magnesium stearate

Tablet coating: titanium dioxide (E171), hypromellose, macrogol/PEG 400, polysorbate 80, yellow iron oxide (E172), red iron oxide (E172), and black iron oxide (E172)

Appearance of Quetiapine ratiopharm and contents of the pack

The tablets are light yellow, biconvex, oblong, film-coated, and marked with "Q 300" on one side.

They are available in packs of 10, 20, 30, 50, 50x1 (perforated unit-dose blister) (hospital pack), 56 (calendar pack), 60, 90 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1st floor.

28108 Alcobendas. Madrid

Manufacturer

PHARMACHEMIE B.V. Swensweg, 5. P.O. Box 552 (Haarlem) - NL-2003 RN - The Netherlands

MERCKLE GMBH Ludwig-Merckle-Strasse, 3 (Blaubeuren) - D-89143 - Germany

TEVA UK LIMITED Brampton Road, Hampden Park (Eastbourne, East Sussex) - BN22 9AG - United Kingdom

TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY Pallagi ut 13 (Debrecen) - H-4042 - Hungary

TEVA CZECH INDUSTRIES S.R.O. Ostravska 29, c.p. 305, Building No 80 Small OSD and building No 881 NOSD (Opava-Komarov) - 747 70 - Czech Republic

TEVA PHARMA, S.L.U. C/ C, n 4 Polígono Industrial Malpica (Zaragoza) - 50016 - Spain

TEVA OPERATIONS POLAND SP.Z.O.O. Ul. Mogilska 80 (Krakow) - 31-546 – Poland

Date of the most recent review of this leaflet: July 2024

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