Zykador 15 mg tablets EFG

Package Leaflet: Information for the user

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 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 pass it on to other people, even if they have the same symptoms as you, because it could be harmful to them.

• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Zykalor is and what it is used for
2. What you need to know before taking Zykalor
3. How to take Zykalor
4. Possible adverse effects
5. How to store Zykalor
6. Contents of the pack and other information

1. What Zykalor is and what it is 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 or older who have an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Zykalor is used to treat adults and adolescents aged 13 years or older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very quickly with racing thoughts, and sometimes severe irritability. In adults, it also prevents this condition in patients who have responded to treatment with Zykalor.

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

Do not take Zykalor:

• 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 before starting to take Zykalor.

Cases of patients experiencing suicidal thoughts and behaviour have been reported during treatment with aripiprazole. 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 urination, 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 (transient ischaemic attack), or abnormal blood pressure;
• Blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
• 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 showing allergic symptoms, please inform your doctor.

If you suffer from 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 behaviour 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 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 known as impulse control disorder and may include behaviours 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 your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution is advised, 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 Zykalor

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

Medicines that lower blood pressure: aripiprazole may increase 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 Zykalor together with another medicine, this may mean your doctor needs to adjust the dose of Zykalor or of the other medicines. It is especially important that you tell your doctor if 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 adverse effects or reduce the effect of Zykalor; if you notice any unusual symptoms while taking any of these medicines together with Zykalor, you must inform your doctor.

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

• triptans, tramadol, and tryptophan used for conditions 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 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 increase the risk of adverse effects; if you notice any unusual symptoms while taking any of these medicines together with Zykalor, you must inform your doctor.

Taking Zykalor with food, drinks, and alcohol

Zykalor 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 of mothers who have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. 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, considering the benefit of treatment for you 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

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.

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

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

3. How to take Zykalor

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. 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

This medicine 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.

There is no appropriate formulation (oral solution) of Zykalor available. An alternative product containing the same active ingredient should be used.

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

Try to take your Zykalor tablet 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 Zykalor without first consulting your doctor.

If you take more Zykalor than you should

If you realize 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 reach your doctor, go to the nearest hospital and take the packaging with you.

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

• rapid heartbeat, agitation/aggression, speech difficulties;
• 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 the nearest hospital immediately if you experience any of the symptoms listed above.

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

If you forget to take Zykalor

If you forget a dose, take it as soon as you remember. However, do not take a double dose to make up for the missed 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 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 of restlessness and inability to stay still, difficulty remaining seated,
• akathisia (an uncomfortable sensation of inner restlessness and an urgent need to keep moving constantly);
• uncontrollable twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• somnolence,
• 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 prolactin hormone in the blood,

• excessively high blood sugar levels,

• depression,

• altered or increased sexual interest,

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

• a muscular disorder causing twisting movements (dystonia),

  • ocular photosensitivity,
  • restless legs,

• double vision,

• 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,

• elevated blood sugar,

• low sodium levels in blood,

• loss of appetite (anorexia),

• weight loss,

• weight gain,

• suicidal thoughts, suicide attempt, and suicide,

• aggression,

• agitation,

• nervousness,

• a 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 may cause intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),

• 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 swelling, pain, and redness of the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (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 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,

• yellowish discoloration of the skin and whites of the eyes,

• abnormal liver function test results,

• rash,

• sensitivity to light,

• baldness,

• excessive sweating,

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed later by generalized rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);

• abnormal breakdown of muscle tissue that may lead to kidney problems,

• muscle pain,

• stiffness,

• involuntary loss of urine (incontinence),

• difficulty urinating,

• withdrawal symptoms in newborns due to exposure to medicines during pregnancy,

• prolonged and/or painful erection,

• difficulty regulating core body temperature or overheating,

• chest pain,

• swollen hands, ankles, or feet,

• in blood tests: fluctuation in blood sugar levels, increased glycated hemoglobin.

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

  • strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behavior concerning to yourself or others, for example, increased sexual 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.

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

In elderly patients with dementia, an increased number of fatal cases has been reported while taking aripiprazole. Additionally, 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 frequency and type to those in adults, except for somnolence, uncontrollable 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 limb movements, and dizziness, especially when standing up after lying down or sitting, which were common (may affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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. Storage of Zykalor

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via the wastewater system or in household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zykalor

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

• Other components are

Common to all: lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate.

5 mg tablets: aluminium lake with indigo carmine (E132)

10 mg tablets: red iron oxide (E172)

15 mg tablets: yellow iron oxide (E172)

Appearance of Zykalor and contents of the pack

5 mg tablets

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

10 mg tablets

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

15 mg tablets

Round, light yellow tablets with a diameter of approximately 7.0 mm.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder Medochemie Ltd
1-10 Constantinoupoleos Street,
3011 Limassol,
Cyprus

Manufacturer responsible Medochemie Ltd, Factory AZ: 2 Michael Erakleous Street,
Agios Athanassios Industrial Area,
Agios Athanassios,
Limassol,
Cyprus

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

Átika Pharma,
Calle Viera y Clavijo, 30, 2º,
35002 Las Palmas de Gran Canaria, Las Palmas,
Spain

Date of the most recent revision of this leaflet: August 2022