Leaflet:Information for the patient

Aripiprazol Krka 5 mg tablets EFG

Aripiprazol Krka 10 mg tablets EFG

Aripiprazol Krka 15 mg tablets EFG

Read this 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to knowbeforestarting totake Aripiprazol Krka

3.How to take Aripiprazol Krka

4.Possible side effects

5.Storage of Aripiprazol Krka

6.Contents of the pack and additional information

Aripiprazol Krkacontains the active ingredient aripiprazol andbelongs to a group of medicines called antipsychotics.

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

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

Do not take Aripiprazol Krka:

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

Warnings and precautions

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

Cases of patients who experience thoughts and behaviors of self-harm during treatment with aripiprazol have been reported. Inform your doctor immediately if you have thoughts or feelings of self-harm.

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 weak) or a family history of diabetes

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

• Irregular 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

• Clots or family history of clots, as antipsychotics have been associated with clot formation
• History of addiction to gambling

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

If you have 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.

Tell your doctor immediately if you have thoughts or feelings of self-harm. Cases of patients who experience thoughts and behaviors of self-harm during treatment with aripiprazol have been reported.

Tell 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.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way in you 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 addiction to gambling, excessive intake or spending, abnormally high sexual appetite, or excessive 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.

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

Children and adolescents

Do not use thismedicinein children and adolescents under 13 years old. Its safety and effectiveness in these patients is unknown.

Other medicines and Aripiprazol Krka

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine,including over-the-countermedicines.

Medicines that lower blood pressure: aripiprazol may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are using any medicine to control blood pressure.

If you are using this medicine with any other medicine,it may mean that your doctorneeds to change your aripiprazol dose. 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 totreat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• some medicines to treat HIV infection(such as efavirenz, nevirapine, and protease inhibitors such as, for example, indinavir, ritonavir);
• anticonvulsants used to treat epilepsy(such as carbamazepine, phenytoin, phenobarbital)
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

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

Medicines that increase serotonin levels are generally used to treat 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 to treat diseases such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive diseases;
• St. John's Wort (Hypericum perforatum)used in herbal remedies 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 adverse effects; if you observe any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Krka, you should inform your doctor.

Taking Aripiprazol Krka with food, drinks, and alcohol

This medicine can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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

If you are takingAripiprazol Krka, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated withAripiprazol Krka, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

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 certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

Treatment should start with the oral solution (liquid) at a low dose. The dose can gradually be increased tothe 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. A product alternative with the same active ingredient should be used.

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

Try to take Aripiprazol Krka at the same time every 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 alter or interrupt 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 Toxicological Information Service, phone: 91.562.04.20 indicating the medication and the amount ingested.

Patients who have taken too much aripiprazol have experienced the following symptoms:

• rapid heartbeats, agitation/aggressiveness, 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 drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If you forgot to take Aripiprazol Krka

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol KrkaKrka

Do not stop treatment just because you feel better. It is essential that you continue taking AripiprazolKrkafor the time your doctor has indicated.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• restlessness and inability to stay still, difficulty staying seated;
• involuntary twisting, contorting, or spasmodic movements, restless legs;
• tremors;
• headaches;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling tired.

Less frequent side effects (may affect up to 1 in 100 patients):

• increased or decreased levels of prolactin hormone in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• double vision;
• eye sensitivity to light
• rapid heart rate;
• low blood pressure upon standing, causing dizziness, confusion, or fainting;
• hypotension.

The following side 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);
• appearance or worsening of diabetes, ketoacidosis (ketones in the 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 rigidity, 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 intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slow heart rate;
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention);
• high blood pressure;
• fainting;
• accidental inhalation of food, which can lead to pneumonia (lung infection);
• spasms of the muscles around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and the white part of the eyes;
• abnormal liver analysis;
• hives;
• skin sensitivity to light,
• hair loss;
• excessive sweating;
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal in newborns due to exposure to medications during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests:increasedfluctuation of blood sugar levels, increased hemoglobin A1c.
• • 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 sex drive and concerning behavior for yourself or others, such as increased sex drive;
• uncontrollable excessive buying;
• binge eating (ingesting large amounts of food in a short period) or compulsive eating (ingesting more food than normal and more than needed 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, there have been reported a higher number of fatal cases while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experienced side effects similar in frequency and type to those of adults, except for drowsiness, involuntary spasms or 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,fasciculationsmuscular, involuntary movements of the limbs, and dizziness, especially when getting up from lying or sitting, which were frequent(affects up to 1 in 10 patients).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aripiprazol Krka

• The active ingredient is aripiprazol. Each tablet contains5 mg, 10 mg or 15 mgof aripiprazol.
• The other components are lactose monohydrate, microcrystalline cellulose (E-460), cornstarch, hydroxypropylcellulose (E-463), iron oxide red (E172) – only in the 10 mg tablets, iron oxide yellow – only in the 15 mg tablets, indigo carmine (E-132) – only in the 5 mg tablets and magnesium stearate (E-470b). See section 2 “Aripiprazol Krka contains lactose”

Appearance of the product and contents of the packaging

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

The 10 mg Aripiprazol Krka 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).

The 15 mg Aripiprazol Krka tablets are light yellow to yellowish-brown, round, slightly biconvex with beveled edges and possible 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

Responsible for Manufacturing

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

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

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

Last review date of this leaflet:August 2023

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