AKITEX 15 mg TABLETS

2. What you need to know before you take Akitex

Do not take Akitex

• 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 this medicine.

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 aripiprazole, 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;
• 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;
• 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 somnolence that interferes with your daily activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you suffer from dementia (loss of memory and other mental abilities), you or the person who cares for you or a family member should inform your doctor if you have ever had a stroke or a "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 that you cannot resist, such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings. 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 somnolence, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could lead to falls. Caution should be exercised, 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 Akitex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

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

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based 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);
• 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; if you notice any unusual symptoms when taking any of these medicines at the same time as aripiprazole, 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 diseases;
• St. John's Wort (Hypericum perforatum) used in plant-based 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 when taking any of these medicines at the same time as aripiprazole, you should tell your doctor.

Taking Akitex with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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, somnolence, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking aripiprazole, 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, 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.

Akitex contains aspartame

Akitex 5 mg EFG tablets:

This medicine contains 1 mg of aspartame in each tablet.

Akitex 10 mg EFG tablets:

This medicine contains 2 mg of aspartame in each tablet.

Akitex 15 mg EFG tablets:

This medicine contains 3 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

3. How to take Akitex

Follow exactly the instructions of administration of this medicine 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 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.

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

Try to take aripiprazole 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 aripiprazole without consulting your doctor first.

If you take more Akitex than you should

If you realize that you have taken more aripiprazole than your doctor recommended (or if someone else has taken part of your aripiprazole), 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 somnolence, 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 Akitex

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 doses.

If you stop taking Akitex

Do not stop your treatment just because you feel better. It is important that you continue taking this medicine for the time your doctor has indicated.

If you have any further questions on 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 uncontrolled spasmodic 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;
• uncontrolled movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing torsion movements (dystonia);
• restless legs;
• double vision;
• ocular photosensitivity;
• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, lightheadedness, or fainting;
• 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 a feeling 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);
• spasms of the muscles 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;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as flu-like symptoms with a rash on the face and later with a generalized rash, high temperature, swollen 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 drugs during pregnancy;

• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: increased or fluctuating blood sugar levels, increased 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 impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and worrying behavior for yourself or others, for example, increased sexual appetite;
• uncontrollable excessive shopping;
• binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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, 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 uncontrolled contractions, restlessness, and fatigue, which were very frequent (affecting 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 sitting or lying down, which were frequent (affecting 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 them 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 Akitex

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

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

This medicine does not require special storage conditions.

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

6. Package Contents and Additional Information

Akitex Composition

• The active ingredient is aripiprazole.

Akitex 5 mg EFG tablets: Each tablet contains 5 mg of aripiprazole.

Akitex 10 mg EFG tablets: Each tablet contains 10 mg of aripiprazole.

Akitex 15 mg EFG tablets: Each tablet contains 15 mg of aripiprazole.

• The other components (excipients) are: mannitol (E 421), crospovidone, aspartame (E951), and calcium stearate.

Akitex 10 mg and 15 mg, also contain:

Mint flavor.

Product Appearance and Packaging Contents

Akitex 5 mg tablets are white or off-white, oval, biconvex, with the inscription "5" engraved on one side and smooth on the other. The tablet dimensions are 6.3 mm in length and 3.1 mm in width.

Akitex 10 mg tablets are white or off-white, oval, with the inscription "ZE 4" engraved on one side and smooth on the other. The tablet dimensions are 8 mm in length and 4 mm in width.

Akitex 15 mg tablets are white or off-white, round, biconvex, with the inscription "ZE 14" engraved on one side and smooth on the other. The tablet diameter is 7.5 mm.

OPA/Aluminum/PVC-Aluminum blisters. Packages containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22,

Alcobendas,

28108 Madrid

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the Last Revision of this Prospectus: October 2024

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