ABIK 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Abik10mgorodispersible tabletsEFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Abik is and what it is used for
2. What you need to know before taking Abik
3. How to take Abik
4. Possible side effects
5. Storage of Abik
6. Package Contents and Additional Information

1. What Abik is and what it is used for

Abikcontains the active substance aripiprazole andbelongs to a group of medications called antipsychotics.

It is used to treat adults and adolescents aged 15 years or 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, anxious, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years or 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 flight of ideas, and sometimes severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Abik

Do not takeAbik

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

Warnings and Precautions

Consult your doctor before starting to take this medication if you have:

• 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
• Irregular and involuntary muscle movements, especially in the face
• Cardiovascular 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
• History of gambling addiction

If you notice that you are gaining weight, developing unusual movements, experiencing somnolence that interferes with your normal daily activities, having difficulty swallowing, or presenting 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.

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

Talk to your doctor immediately if you experience numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast or irregular heartbeat.

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 have some weakness.

Children and Adolescents

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

Taking Abik with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, 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 this medication with another medication, you may need to change your dose of aripiprazole. It is especially important to mention to your doctor the following:

• Medications to correct heart rhythm
• Antidepressants or herbal remedies used to treat depression and anxiety
• Antifungals
• Certain medications to treat HIV infection
• Anticonvulsants used to treat epilepsy

Medications that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine and amitriptyline), pethidine, St. John's Wort, and venlafaxine. These medications increase the risk of adverse effects; if you observe any unusual symptoms when using any of these medications with aripiprazole, you should inform your doctor.

Taking Abik with Food, Drinks, and Alcohol

Aripiprazole can be taken independently of meals.

Alcohol consumption should be avoided while taking this medication.

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 medication.

The following symptoms may occur in newborns 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.

Make sure to inform your doctor immediately if you are breastfeeding.

If you are taking aripiprazole, you should not breastfeed.

Driving and Using Machines

Do not drive or operate tools or machines until you know how this medication affects you.

Abik contains aspartame

Patients who cannot take phenylalanine should note that Abik contains aspartame, which is a source of phenylalanine.

3. How to Take Abik

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

Use in Children and Adolescents

Aripiprazole should be initiated 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, inform your doctor or pharmacist.

Try to take the aripiprazole orodispersible tablet at the same time every day.It does not matter if you take it with or without food.

Do not open the blister until you are going to take it. To take a tablet, open the package and remove the aluminum from the blister, leaving the tablet in sight. Do not press the tablet through the aluminum, as this could damage it. Once the blister is open, with dry hands, take the tablet and place the entire orodispersible tablet on your tongue. The tablet disintegrates quickly with saliva. The orodispersible tablet can be taken with or without liquid.

Another option is to dissolve the tablet in water and drink the resulting suspension.

Even if you feel better, do not alter or interrupt the daily dose of aripiprazole without consulting your doctor first.

If you take moreAbikthan you should

If you realize you have taken more Abik than your doctor recommended (or if someone else has taken part of your Abik), consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

It is recommended to bring the package and package leaflet of the medication to the healthcare professional.

If you forget to takeAbik

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 interrupt treatment with Abik

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not all people experience them.

Frequent Side Effects (may affect up to 1 in 10 patients): spasms or

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• twisting, contorting, or spasmodic involuntary movements, restless legs;
• tremors;
• headache;
• fatigue;
• sleepiness;
• dizziness;
• shivering and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

Uncommon Side Effects (may affect up to 1 in 100 patients):

• increased levels of the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder that causes twisting movements (dystonia);
• double vision;
• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, dizziness, or fainting;
• hypo,
• ocular photosensitivity.

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);
• 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;
• gambling addiction;
• 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, sleepiness, 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, go to your doctor 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 tests;
• rash;
• photosensitivity;
• hair loss;
• excessive sweating;
• 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 medications 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.

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 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 somnolence, spasms or 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 Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Abik

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

No special storage conditions are required.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Abik

• The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
• The other components are xylitol (E-967), sodium carmellose, silicified microcrystalline cellulose, sodium croscarmellose, tartaric acid, aspartame, magnesium stearate, vanilla flavor (contains maltodextrin and gum arabic), and red iron oxide (E-172).

Appearance of the Product and Package Contents

The Abik 10 mg orodispersible tablets are pink, round, and biconvex.

Each normal package contains 28 tablets, packaged in blisters.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Package Leaflet: June 2020

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