Leaflet: Information for the User

Abik 1 mg/ml Oral Solution EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Abik is and what it is used for

2. What you need to know before you start taking Abik

3. How to take Abik

4. Possible side effects

5. Storage of Abik

6. Contents of the pack and additional information

Abik contains the active ingredient aripiprazol andbelongs to a group of medications known as antipsychotics.

It is used to treat adults and adolescents 15 years of age or older who suffer from a condition characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and monotony of emotional and behavioral state. People in this state may also feel depressed, guilty, anxious, or tense.

Aripiprazol is used to treat adults and adolescents 13 years of age or older who suffer from a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking rapidly with flight of ideas, and sometimes, severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with aripiprazol.

Do not take Abik

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

Warnings and precautions

Consult your doctor before starting this medication if you have:

• High blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling weak) 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 family history of blood clots, as antipsychotics have been associated with the formation of blood clots.
• History of addiction to gambling.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness 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 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. 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, altered mental state, or a very fast or irregular heartbeat.

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 cause falls. You should be cautious, 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 old. The safety and effectiveness of this medication in these patients are unknown.

Taking Abik with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 any other medication, you may need to change your aripiprazole dose. It is especially important to mention the following to your doctor:

• 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, amitriptyline), petidina, St. John's Wort, and venlafaxine. These medications increase the risk of producing 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

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

It is recommended to avoid consuming alcohol while taking this medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

The following symptoms may occur in newborn babies, from 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.

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

If you are taking aripiprazole, do not breastfeed.

Driving and operating machines

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

Abik contains saccharose

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

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

Abik contains fructose

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

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

Abik contains p-hydroxybenzoic acid methyl ester and p-hydroxybenzoic acid propyl ester

It may cause allergic reactions (possibly delayed) because it contains p-hydroxybenzoic acid methyl ester and p-hydroxybenzoic acid propyl ester.

Abik contains ethanol

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

Follow exactly the administration instructions for this medication as 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 aripiprazol) once a day.However, your doctor may prescribe lower and higher doses up to a maximum of 30 mg (i.e., 30 ml) once a day.

Use in children and adolescents

Aripiprazol should be initiated with oral solution (liquid) at a low dose. The dose can gradually be increased tothe recommended dose for adolescents, which is 10 ml of solution (which corresponds to 10 mg of aripiprazol) 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 aripiprazol oral solution should be measured using the calibrated dropper or dosing syringe that comes in the package.

If you estimate that the action of aripiprazol is too strong or too weak, inform your doctor or pharmacist.

Try to take aripiprazol oral solution at the same time every day.It does not matter if you take it with or without food. However, do not dilute with other liquids or mix with other foods before taking this medication.

Even if you feel better,do not alter or interrupt the daily dose of aripiprazol 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 medication and the amount ingested.

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

If you forget to take Abik

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Abik

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects (can affect up to 1 in 10 patients):

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

Less frequent side effects (can affect up to 1 in 100 patients):

• increased levels of prolactin hormone in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• involuntary movements of the mouth, tongue and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• double vision;
• rapid heartbeat;
• drop in blood pressure when standing, causing dizziness, fainting or syncope;
• hypotension,
• photosensitivity of the eyes.

The following side 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);
• appearance or worsening of diabetes, ketoacidosis (ketones in the 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;
• anxiety;
• combination of fever, muscle rigidity, 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 intense feelings of happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden and unexplained death;
• potentially fatal irregular heartbeat;
• heart attack;
• slower heart rate;
• 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 immediate medical attention);
• 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);
• inflammation of the pancreas;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellow discoloration of the skin and the white part of the eyes;
• abnormal liver analysis;
• hives;
• light sensitivity;
• hair loss;
• excessive sweating;
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal in newborns due to exposure to medications during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen hands, ankles or feet;
• in blood tests: fluctuations in blood sugar levels, increased hemoglobin A1c.

In elderly patients with dementia, there have been reported a higher number of fatal cases 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 drowsiness, involuntary spasms or 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 getting up from a lying or sitting position, which were frequent (affects up to 1 in 10 patients).

Reporting of side effects

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

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

No special storage conditions are required.

Once the container is opened, use within 12 months.

Do not use this medication after the expiration date that appears on the container after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE drop-off point at the pharmacy.If in doubt, ask your pharmacist how to dispose of containers and unused medications.By doing so, you will help protect the environment.

Composition of Abik

-The active ingredient is aripiprazol. Each ml contains 1 mg of aripiprazol.

-The other components are edetate disodium, 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 contents of the packaging

Abik 1 mg/ml oral solution is a transparent, colorless to pale yellow liquid, presented in amber polyethylene bottles with polypropylene child-resistant closures, 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.

Holder of the marketing authorization and responsible for manufacture

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: June 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/