ARIPIPRAZOLE KRKA 15 mg TABLETS

Introduction

Package Leaflet:Information for the Patient

Aripiprazol Krka 5 mg tablets EFG

Aripiprazol Krka 10 mg tablets EFG

Aripiprazol Krka 15 mg tablets EFG

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

• Keep this package leaflet, as 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

1. What Aripiprazol Krka is and what it is used for

Aripiprazol Krka contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged 15 years and older who suffer from a disease characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and emotional and behavioral monotony. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazol Krka tablets are used to treat adults and adolescents aged 13 years and older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, talking very quickly with flight of ideas, and sometimes severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with aripiprazole.

2. What you need to know before you take Aripiprazol Krka

Do not take Aripiprazol Krka:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you have:

There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazol Krka, tell your doctor if you suffer from:

• High blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) or a family history of diabetes

• Seizures, as your doctor may want to monitor you more closely;

• Irrregular and involuntary muscle movements, especially in the face
• Cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure

• Blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• History of gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you suffer from dementia (loss of memory and other mental abilities), you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

Tell your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, especially if you are an elderly patient or have some weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Aripiprazol Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Medicines that lower blood pressure: aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you use any medicine to control blood pressure.

If you are using this medicine with another medicine, it may mean that your doctor needs to change your dose of aripiprazole. It is especially important to mention to your doctor the following:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide); antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir);
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazol Krka; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Krka, you should tell your doctor.

Medicines that increase serotonin levels are commonly used in diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive illnesses;
• St. John's Wort (Hypericum perforatum) used in herbal medicines for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Krka, you should tell your doctor.

Taking Aripiprazol Krka with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided.

Pregnancy, breast-feeding, and fertility

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

The following symptoms may occur in newborn babies of mothers who have been treated with aripiprazole in the last trimester (last three months of their pregnancy): tremor, stiffness and/or muscle weakness, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking Aripiprazol Krka, your doctor will discuss with you whether you should breast-feed, considering the benefit of treatment for you and the benefit of breast-feeding for your baby. If you are being treated with Aripiprazol Krka, you should not breast-feed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Aripiprazol Krka contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Aripiprazol Krka

Take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day.However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

Treatment should be initiated with the oral solution (liquid) at a low dose. The dose can be gradually increased to the recommended dose for adolescents of 10 mg once a day.However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

The most suitable formulation (e.g., 1 mg/ml solution) of Aripiprazol Krka is not available. An alternative product with the same active substance should be used.

If you think that the effect of Aripiprazol Krka is too strong or too weak, tell your doctor or pharmacist.

Try to take Aripiprazol Krka at the same time each day. It does not matter if you take it with or without food.

Always take the tablets with water and swallow them whole.

Even if you feel better, do not change or stop the daily dose of Aripiprazol Krka without consulting your doctor first.

If you take more Aripiprazol Krka than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medicine and the amount taken.

Patient who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, language problems;
• unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle stiffness and somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or the nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Aripiprazol Krka

If you forget a dose, take the forgotten dose as soon as you remember, but do not take a double dose to make up for the forgotten dose.

If you stop taking Aripiprazol Krka

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazol Krka for the time your doctor has indicated.

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 all people suffer from them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• torsion, contortion, or uncontrolled spasmodic movements, restless legs;
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shivering and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

Uncommon Adverse Effects (may affect up to 1 in 100 patients):

• increase or decrease in prolactin hormone levels in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing torsion movements (dystonia);
• double vision;
• ocular photosensitivity
• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, drowsiness, or fainting;
• hypo.

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, and redness);
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
• high blood sugar,
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• nervousness;
• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
• seizures;
• serotonin syndrome (a reaction that can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of 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);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• muscle spasms around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver values;
• rash;
• skin photosensitivity,
• hair loss;
• excessive sweating;
• abnormal muscle breakdown that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuation in blood sugar levels, increased hemoglobin glycosylated.
• • inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and worrisome behavior for you or others, for example, increased sexual appetite;
• uncontrollable excessive shopping;
• binge eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than necessary to satisfy hunger);

• tendency to wander,

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other Adverse Effects in Children and Adolescents

Adolescents 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrolled contractions, restlessness, and fatigue, which were very frequent (may affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness, especially when standing up after being lying down or sitting, which were frequent (affects up to 1 in 10 patients).

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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Krka

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol Krka

• The active ingredient is aripiprazole. Each tablet contains 5 mg, 10 mg, or 15 mg of aripiprazole.
• The other components are lactose monohydrate, microcrystalline cellulose (E-460), cornstarch, hydroxypropylcellulose (E-463), red iron oxide (E172) - only in 10 mg tablets, yellow iron oxide - only in 15 mg tablets, carmine indigo (E-132) - only in 5 mg tablets, and magnesium stearate (E-470b). See section 2 "Aripiprazol Krka contains lactose"

Product Appearance and Package Contents

Aripiprazol Krka 5 mg tablets are blue, round with beveled edges, and may have dark and light spots (diameter: 5 mm, thickness: 1.4-2.4 mm).

Aripiprazol Krka 10 mg tablets are light pink, rectangular with possible dark and light spots, and engraved with A10 on one side (length: 8 mm, width: 4.5 mm, thickness: 2.1-3.1 mm).

Aripiprazol Krka 15 mg tablets are light yellow to yellowish in color, round, slightly biconvex with beveled edges, and may have dark and light spots, and engraved with A15 on one side (diameter: 7.5 mm, thickness: 2.5-3.7 mm).

Each package contains 28 tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

Date of the last revision of this prospectus:August 2023

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