Package Insert: Information for the User

Zykalor 5 mg Tablets EFG

Zykalor 10 mg Tablets EFG

Zykalor 15 mg Tablets EFG

aripiprazol

Read this package insert carefully before starting to take this medication, as it contains important information for you.

-Keep this package insert, as you may need to read it again.
-If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Zykalor and for what it is used

2. What you need to know before starting to take Zykalor

3. How to take Zykalor

4. Possible adverse effects

5. Storage of Zykalor

6. Contents of the package and additional information

Zykalor contains the active ingredient aripiprazol and belongs to a group of medications known as antipsychotics.

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

Zykalor is used to treat adults and adolescents 13 years of age or older who suffer from a disorder characterized 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 Zykalor.

Do not take Zykalor:

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

Warnings and precautions

Consult your doctor before starting to take Zykalor.

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

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

• 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), a 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;
• A history of addiction to gambling.

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 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 harming yourself. Cases of patients experiencing suicidal thoughts and behaviors during treatment with aripiprazole 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 known as impulse control disorder and may include behaviors such as addiction to gambling, excessive eating or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole 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 this medication in children and adolescents under 13 years old. The safety and effectiveness of this medication in these patients are unknown.

Other medications and Zykalor

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Medications that lower blood pressure: aripiprazole may increase the effect of medications used to lower blood pressure. Make sure to inform your doctor if you are using any medication to control blood pressure.

If you are using Zykalor with any other medication, it may mean that your doctor needs to change your dose of Zykalor or the dose of the other medications. It is especially important to mention to your doctor that you are taking:

• Medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• Antidepressants or plant-based medications used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• Medications to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);Certain medications to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as, for example, indinavir, ritonavir);
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

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

Medications 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 in depressive diseases;
• St. John's Wort (Hypericum perforatum) used in plant-based medications for mild depression;
• Analgesics (such as tramadol and pethidine) used to relieve pain;
• Triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications at the same time as Zykalor, you should inform your doctor.

Taking Zykalor with food, drinks, and alcohol

Zykalorcan be taken regardless of meals. Avoid consuming alcohol.

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 medication.

The following symptoms may occur in newborn babies, from mothers who have been treated with aripiprazole in the last trimester of pregnancy (last three months of pregnancy): tremors, 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 taking Zykalor, 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 with Zykalor, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medication.

Driving and operating machinery

During treatment with this medication, 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.

Zykalor contains lactose.If your doctor has told you that you have a intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per unit dose; it is essentially "sodium-free".

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

This medication should be started with the oral solution (liquid) at a low dose. Gradually the dose may 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..

No suitable formulation (oral solution) of Zykalor is available. A suitable alternative product with the same active ingredient should be used..

If you estimate that the action of Zykalor is too strong or too weak, inform your doctor or pharmacist.

Try to take the Zykalor tablet at the same time every day.You can 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 Zykalor without consulting your doctor first.

If you take more Zykalor than you should

If you realize that you have taken more Zykalor than your doctor recommended (or if someone else has taken part of your Zykalor), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the packaging with you.

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 rigidity 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.

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 medication and the amount ingested.

If you forgot to take Zykalor

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 Zykalor

Do not stop treatment just because you feel better. It is essential that you continue taking Zykalor for 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,

•akathisia (an uncomfortable feeling of internal restlessness and an overwhelming need to move constantly);

•involuntary movements of twisting, contorting or spasmodic movements,

•shaking,

•headache,

•fatigue,

•drowsiness,

•dizziness,

•shivering and blurred vision,

•difficulty passing stools or decreased frequency of bowel movements (constipation),

•indigestion,

•nausea,

•increased saliva production,

•vomiting,

•feeling of fatigue.

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

•increased or decreased levels of prolactin hormone in the blood,

•excessively high levels of sugar in the blood,

•depression,

•altered or increased sex drive,

•uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),

•muscle disorder causing twisting movements (dystonia),

• eye sensitivity to light,
• restless legs,

•double vision,

•rapid heartbeat,

•low blood pressure when standing, causing dizziness, confusion or fainting,

•hypo.

The following side effects have been reported during the post-marketing phase of aripiprazole oral, 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, attempt and suicide,

•aggression,

•agitation,

•anxiety,

•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 a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),

•speech disorder,

•fixed gaze of the eyes in a position,

•sudden and 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 with risk of pneumonia (lung infection),

•spasms of the muscles around the glottis (a part of the larynx),

•inflammation of the pancreas,

•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 function test results,

•hives,

•light sensitivity,

•hair loss,

•excessive sweating,

•severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudogripal symptoms with a rash on the face and later with a generalized rash, high temperature, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);

•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 medication during pregnancy,

•prolonged and/or painful erection,

•difficulty controlling central body temperature or overheating,

•chest pain,

•swollen hands, ankles or feet,

•in blood tests: fluctuations in blood sugar levels, increased hemoglobin A1c.

•inability to resist the impulse, instinct or temptation to perform an action that may be harmful to you 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 you or others, for example, increased sex drive;

- excessive and uncontrolled buying;

- binge eating (eating 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.

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, there have been reported cases of stroke or "mini" stroke.

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 common (affects 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 getting up from lying down or sitting, which were common (may affect up to 1 in 10 patients).

Reporting of 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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.

No special storage conditions are required.

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

Composition of Zykalor

The active ingredient is aripiprazol. Each tablet contains 5 mg, 10 mg, or 15 mg of aripiprazol.

• The other components are

Common:monohydrate lactose,microcrystalline cellulose, cornstarch, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate.

5mg tablets:aluminum lacquer with indigo carmine (E132)

10mg tablets: red iron oxide (E172)

15mg tablets: yellow iron oxide (E172)

Appearance of Zykalor and content of the container

5 mg tablets

Modified rectangular tablets, blue, approximately 8.0 x 4.5 mm.

10 mg tablets

Modified rectangular tablets, pink, approximately 8.5 x 4.0 mm, with a notch on one side. The tablets can be divided into equal doses.

15 mg tablets

Round tablets, yellowish in color with a diameter of approximately 7.0 mm.

OPA/Aluminum/PVC-Aluminum blisters, packaged in boxes of 14, 28, 30, 56, 60, 84, or 90 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holderMedochemie Ltd

1-10 Constantinoupoleos Street,

3011 Limassol,

Cyprus

Responsible for manufacturingMedochemie LtdFactory AZ: 2 Michael Erakleous street,

Agios Athanassios Industrial Area,

Agios Athanassios,

Limassol

Cyprus

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

Medochemie Iberia S.A., Branch in Spain

Avenida de las Águilas, nº 2 B; 5th floor, office 6,

28044 Madrid

SPAIN

Last review date of this leaflet:August 2022