Leaflet: information for the user

Apaloz 10 mg buccal dispersible tablets EFG

Aripiprazole

Read this leaflet carefully before you start taking this medicine, as 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 Apaloz buccal dispersible tablets are and what they are used for

2. What you need to know before you start taking Apaloz buccal dispersible tablets

3. How to take Apaloz buccal dispersible tablets

4. Possible side effects

5. Storage of Apaloz buccal dispersible tablets

6. Contents of the pack and additional information

Apalozbuccal tablets contain the active ingredient aripiprazol andbelong to a group of medicines called antipsychotics.

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

Apaloz buccal tablets are used to treat adults and adolescents aged 13 years or over who suffer from a condition characterised by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking quickly with a flight of ideas and sometimes, severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with Apaloz buccal tablets.

Do not take Apaloz buccal tablets

•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 Apaloz buccal tablets 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, a 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 addiction to gambling;

•the 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.

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.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years old. Its safety and effectiveness in these patients are unknown.

Taking Apaloz buccal tablets with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines.

Medicines that lower blood pressure: Apaloz buccal tablets may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are using any blood pressure-lowering medication.

If you are using Apaloz buccal tablets with any other medicine, you may need to change your dose of Apaloz buccal tablets. It is especially important to mention the following to your doctor:

•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, SSRIs (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 adverse effects; if you observe any unusual symptoms when using any of these medicines with Apaloz buccal tablets, you should inform your doctor.

Taking Apaloz buccal tablets with food, drinks, and alcohol

Apaloz buccal tablets 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 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 Apaloz buccal tablets 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.

Ensure you inform your doctor immediately if you are breastfeeding.

If you are taking Apaloz buccal tablets, do not breastfeed.

Driving and operating machinery

Do not drive or operate tools or machines until you know how Apaloz buccal tablets affect you.

Apaloz contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

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

Use in children and adolescents

This medication should be started with the oral solution (liquid) at a low dose. Gradually the dose may be increased tothe 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 estimate that the action of Apaloz tablets is too strong or too weak, inform your doctor or pharmacist.

Try to takeApaloz tabletsat the same time every day.
It does not matter if you take it with or without food.

Do not open the blister pack until you are about to take it. To take a tablet, open the package and remove the aluminum from the blister pack, leaving the tablet visible. Do not press the tablet through the aluminum as this could damage it. Once the blister pack is opened, with dry hands, take the tablet and place the buccal tablet completely on the tongue. The disintegration of the tablet occurs quickly with saliva. The buccal 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 Apaloz tablets without consulting your doctor first.

If you take more Apaloztabletsthan you should

If you realize that you have taken more Apaloz than your doctor recommended (or if someone else has taken part of your Apaloz), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the package with you.

If you forget to take Apaloztablets

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 Apaloz tablets

Do not interrupt your treatment just because you feel better. It is essential that you continue taking Apaloz tablets 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 (may affect up to 1 in 10 patients):

• diabetes mellitus;mellitus;

• difficulty sleeping;

• anxiety;

• feeling of restlessness and inability to stay still, difficulty staying seated;

• involuntary twisting, contorting or spasmodic movements, restless legs;

• tremor;

• headache;

• fatigue;

• drowsiness;

• dizziness;

• shakiness 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 (may 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);

• muscular disorder causing twisting movements (dystonia);

• double vision;

• eye sensitivity to light;

• rapid heartbeat;

• drop in blood pressure when standing, causing dizziness, fainting, or loss of consciousness;

• hiccups.

The following side effects have been reported during the post-marketing phase of 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;

• gaming addiction;

• aggression;

• agitation;

• nervousness;

• 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;

• sudden 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, which can lead to 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;

• inflammation of the liver;

• yellowing of the skin and white part of the eyes;

• abnormal liver function test results;

• hives;

• light sensitivity;

• hair loss;

• excessive sweating;

• abnormal muscle degradation that can cause kidney problems;

• muscle pain;

• stiffness;

• 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;

•fixation of the eyeballs in a position.

In elderly patients with dementia, there have been more reported cases of fatal outcomes 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 lying or sitting, which were frequent (affects 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 does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect it from moisture.

Do not use this medication after the expiration date that appears on the packaging 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Apaloz

- The active principle is aripiprazol. Each buccal dispersible tablet contains 10 mg of aripiprazol.

- The other components are maltose, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, aspartame, ethyl vanillin, iron oxide red (E172), and magnesium stearate.

Appearance of the product and contents of the packaging

Apaloz 10 mg is presented in the form of pink, round, flat, and non-scored buccal dispersible tablets.

Each package contains 14 and 28 buccal dispersible tablets conditioned in blisters of Poliamida/Al/PVC-Al.

Only some package sizes may be commercially marketed.

Other presentations:

Apaloz 15 mg buccal dispersible tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

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/