Aripiprazole Krka 15 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Aripiprazole Krka 5 mg tablets EFG

Aripiprazole Krka 10 mg tablets EFG

Aripiprazole Krka 15 mg tablets EFG

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

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

Contents of the leaflet

1. What Aripiprazole Krka is and what it is used for
2. What you need to know before taking Aripiprazole Krka
3. How to take Aripiprazole Krka
4. Possible side effects
5. How to store Aripiprazole Krka
6. Contents of the pack and other 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 have an illness characterised by symptoms such as hearing, seeing, and feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. 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 have a disorder characterised by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Aripiprazole Krka

Do not take Aripiprazole Krka:

• if you are allergic to aripiprazole or to 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:

Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with Aripiprazole Krka, tell your doctor if you have:

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

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

• Irregular and involuntary muscle movements, especially of the face

• Cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or "mini" stroke (transient ischemic attack), or abnormal blood pressure

• Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation

• History of gambling addiction

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

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

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior have been reported during treatment with aripiprazole.

Speak to your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in ways that are unusual for you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping the dose.

Your doctor may consider adjusting or stopping the dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which could lead to falls. Caution should be exercised, especially if you are elderly or have any degree of physical weakness.

Children and adolescents

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

Other medicines and Aripiprazole Krka

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

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

If you are taking this medicine together with any other medicine, your doctor may need to adjust your aripiprazole dose. It is especially important to tell your doctor about 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 Aripiprazole Krka; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole Krka, you must inform your doctor.

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

• Triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, OCD, social phobia, 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 amitriptiline) used in depressive disorders

• 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 while taking any of these medicines together with Aripiprazole Krka, you must inform your doctor.

Taking Aripiprazole 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, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

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

Aripiprazole Krka contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Aripiprazole Krka

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

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

Use in children and adolescents

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

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

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

Try to take Aripiprazole Krka at the same time each day. It does not matter whether 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 your daily dose of Aripiprazole Krka without first consulting your doctor.

If you take more Aripiprazole Krka than you should

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

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

• rapid heartbeat, agitation/aggression, speech 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 rigidity and drowsiness, slowed breathing, suffocation, 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 forget to take Aripiprazole Krka

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

If you stop taking Aripiprazole Krka

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Krka for as long as your doctor has instructed.

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.

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

• diabetes mellitus;
• sleep disturbances;
• anxiety;
• feeling restless and unable to stay still, difficulty remaining seated;
• uncontrollable twisting, writhing, or spasmodic movements, restless legs;
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shakiness and blurred vision;
• difficulty passing stools or reduced frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of tiredness.

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

• increased or decreased levels of the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• a muscle disorder causing twisting movements (dystonia);
• double vision;
• ocular photosensitivity;
• rapid heartbeat;
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
• hiccups.

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

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling of 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;
• low sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, suicide attempt, and suicide;
• aggression;
• agitation;
• nervousness;
• a 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorder;
• fixed eye position (oculogyria);
• unexplained sudden death;
• potentially life-threatening irregular heartbeat;
• heart attack;
• slower heartbeat;
• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, contact your doctor immediately);
• elevated blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• spasms of muscles around the glottis (a part of the larynx);
• inflammation of the pancreas;
• difficulty swallowing;
• diarrhoea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and whites of the eyes (jaundice);
• abnormal liver function tests;
• rash;
• cutaneous photosensitivity;
• hair loss;
• excessive sweating;
• abnormal muscle breakdown that may lead to kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns following exposure to medication during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling core body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: increased fluctuation in blood sugar levels, increased glycated haemoglobin.

• inability to resist the impulse, urge, or temptation to perform an action that may be harmful to you or others, which may include:

• strong urge to gamble excessively despite serious personal or family consequences;

• altered or increased sexual interest and behaviour that is concerning to you or others, for example, increased sex drive;

• uncontrollable excessive shopping;

• binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);

• tendency to wander.

If you experience any of these behaviours, inform your doctor; they 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. In addition, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in type and frequency to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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 lying down or sitting—which were common (affects up to 1 in 10 patients).

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. Aripiprazole Krka Storage

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine 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 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 Aripiprazole Krka

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

Appearance of the product and contents of the pack

Aripiprazole Krka 5 mg tablets are blue, round, with bevelled edges and possible dark and light specks (diameter: 5 mm, thickness: 1.4–2.4 mm).

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

Aripiprazole Krka 15 mg tablets are light yellow to yellowish-brown, round, slightly biconvex, with bevelled edges and possible dark and light specks, engraved with "A15" on one side (diameter: 7.5 mm, thickness: 2.5–3.7 mm).

Each pack contains 28 tablets in blisters.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

Date of the most recent revision of this leaflet: August 2023

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