ZYKALOR 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Zykalor 5 mg tablets EFG

Zykalor 10 mg tablets EFG

Zykalor 15 mg tablets EFG

aripiprazole

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

-Keep this package leaflet, 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 is Zykalor and what is it used for
2. What you need to know before you take Zykalor
3. How to take Zykalor
4. Possible side effects
5. Storage of Zykalor
6. Contents of the pack and further information

1. What is Zykalor and what is it used for

Zykalor 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.

Zykalor is 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 a flight of ideas, and sometimes severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with Zykalor.

2. What you need to know before you take Zykalor

Do not take Zykalor:

• 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 before starting to take Zykalor.

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 Zykalor, 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;
• A 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 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 that you 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.

Aripiprazole may cause drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. You should be cautious, especially if you are an elderly patient or suffer from 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 Zykalor

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

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 Zykalor with another medicine, it may mean that your doctor needs to change your dose of Zykalor or the other medicine. It is especially important that you mention to your doctor that you are taking:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• Antidepressants or herbal medicines 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);
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Zykalor; if you notice any unusual symptoms when taking any of these medicines at the same time as Zykalor, 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;
• Pain relievers (such as tramadol and pethidine) used to relieve pain;
• Triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

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

Taking Zykalor with food, drinks, and alcohol

Zykalor can be taken with or without food. You should avoid consuming alcohol.

Pregnancy, breastfeeding, and fertility

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

The following symptoms may occur in newborn babies of 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, you should 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, 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

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.

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

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

3. How to take Zykalor

Follow exactly the administration instructions of this medicine given 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 or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescents

This medicine should be started 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.

Zykalor is not available in an appropriate formulation (oral solution). An alternative product with the same active ingredient should be used.

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

Try to take the Zykalor tablet 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 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 contact your doctor, go to the nearest hospital and take the package with you.

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

• rapid heartbeat, 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 the 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 medicine and the amount ingested.

If you forget to take Zykalor

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 Zykalor

Do not stop your treatment just because you feel better. It is important that you continue taking Zykalor 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,
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly);
• torsion, contortion, or spasmodic uncontrollable movements,
• 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,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscular disorder causing torsion movements (dystonia),
• ocular photosensitivity,
• restless legs,

• double vision,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, fainting, or loss of consciousness,
• 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 blood vessels 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 in blood tests,
• rash,
• photosensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudo-flu-like symptoms with a rash on the face and later with a generalized rash, high temperature, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased eosinophilia;
• 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 medication during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• in blood tests: fluctuation of 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 disturbing 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 uncontrollable contractions, restlessness, and fatigue, which were very frequent (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 standing up after being seated or lying down, which were frequent (may affect 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 it 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 Zykalor

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

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

No special storage conditions are required.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Zykalor Composition

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

• The other components are

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

5mg tablets:Aluminum lake with carmine (E132)

10mg tablets: Red iron oxide (E172)

15mg tablets: Yellow iron oxide (E172)

Appearance of Zykalor and Package Contents

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, light yellow, 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 package sizes may be marketed.

Marketing Authorization HolderMedochemie Ltd

1-10 Constantinoupoleos Street,

3011 Limassol,

Cyprus

ManufacturerMedochemie Ltd Factory AZ: 2 Michael Erakleous street,

Agios Athanassios Industrial Area,

Agios Athanassios,

Limassol

Cyprus

You can request more information about this medicine 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

Date of the last revision of this prospectus:August 2022