ABIK 1 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Abik 1 mg/ml Oral Solution EFG

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Abik and what is it used for

Abik 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.

Aripiprazole 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 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 you take Abik

Do not take Abik

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

Warnings and precautions

Consult your doctor before starting to take this medicine 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.
• 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 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.

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

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, alteration of mental status, or 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. Precaution should be taken, especially if you are an elderly or weak patient.

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.

Taking Abik with other medicines

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 this medicine with another medicine, you may need to change your dose of aripiprazole. It is especially important to mention to your doctor the following:

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

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

Taking Abik with food, drinks, and alcohol

This medicine can be taken independently of meals. However, the oral solution should not be diluted with other liquids or mixed with food before administration.

Consumption of alcohol should be avoided while taking this medicine.

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, 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 medicine affects you.

Abik contains sucrose

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 0.4 g of sucrose per mg of dose.

Abik contains fructose

This medicine contains fructose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking/using this medicine.

Patients with diabetes mellitus should note that this medicine contains 0.2 g of fructose per mg of dose.

Abik contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

It may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

Abik contains ethanol

This medicine contains 0.028% ethanol (alcohol), which corresponds to 0.5 mg per 1 ml of oral solution.

3. How to take Abik

Follow exactly the administration instructions 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 ml of solution (which corresponds to 15 mg of aripiprazole) once a day.However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg (i.e., 30 ml) once a day.

Use in children and adolescents

Aripiprazole should be started with the oral solution (liquid) at a low dose. Gradually, the dose may be increased to the recommended dose for adolescents, which is 10 ml of solution (which corresponds to 10 mg of aripiprazole) once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg (i.e., 30 ml) once a day.

This dose of aripiprazole oral solution should be measured using the calibrated cup or the dosing syringe that comes in the pack.

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

Try to take aripiprazole oral solution at the same time every day.It does not matter if you take it with or without food. However, it should not be diluted with other liquids or mixed with food before taking this medicine.

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

If you take more Abik than you should

If you realize that 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 medicine and the amount ingested.

It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Abik

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 Abik

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
• twisting, contorting, or spasmodic uncontrollable 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 people):

• increase 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 that causes twisting movements (dystonia);
• double vision;
• rapid heartbeat;
• drop in blood pressure when standing up that causes dizziness, dizziness, or fainting;
• hypothermia,
• photosensitivity of the eyes.

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 of 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, altered mental status, or 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 move 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 analyzes;
• rash;
• sensitivity to light;
• hair loss;
• excessive sweating;
• abnormal breakdown of muscles 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: fluctuation of blood sugar levels, increase in glycosylated hemoglobin.

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 and older experienced side effects similar in frequency and type to those of adults, except for somnolence, spasms, or uncontrollable 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 being lying down or sitting, which were frequent (affecting up to 1 in 10 patients).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Abik

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

No special storage conditions are required.

Once the package is opened, use within 12 months.

Do not use this medicine after the expiration date that appears on the package after "EXP". The expiration date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Abik

• The active substance is aripiprazole. Each ml contains 1 mg of aripiprazole.
• The other ingredients are disodium edetate, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), glycerol (E-422), propylene glycol (E-1520), sucrose, fructose, orange flavor (which contains small amounts of ethanol), diluted hydrochloric acid (for pH adjustment), and purified water.

Appearance of the product and package contents

Abik 1 mg/ml oral solution is a clear, colorless to light yellow liquid, presented in amber polyethylene bottles with a child-resistant polypropylene cap, containing 150 ml of solution.

Each pack contains a bottle, a calibrated cup, a dosing syringe, and a leaflet.

The cup has a maximum capacity of 30 ml and a scale of 5 ml.

The syringe has a maximum capacity of 10 ml and a scale of 0.25 ml.

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 leaflet: June 2020

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