Package Insert: Information for the Patient

Aripiprazol TAD 30mg Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Aripiprazol TAD and how is it used

2.What you need to knowbeforestarting totake Aripiprazol TAD

3.How to take Aripiprazol TAD

4.Possible adverse effects

5.Storage of Aripiprazol TAD

6. Contents of the package and additional information

Aripiprazol TADcontains the active ingredient aripiprazol andbelong to a group of medicines called 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 TADtabletsare 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 much less sleep than usual, speaking 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 aripiprazol.

Do not take Aripiprazol TAD:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

Patients have reported cases of thoughts and behaviors of suicide during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or intentions of suicide.

Before starting treatment with Aripiprazol TAD, tell your doctor if you have:

• high levels of sugar in the blood (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes;
• seizures (convulsions), as your doctor may want to monitor it 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 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 daily normal activities, having difficulty swallowing, or presenting allergic symptoms, please inform your doctor.

If you are an elderly person and suffer from dementia (loss of memory and other mental abilities), you or the person who cares for you or your family 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 who experience thoughts and behaviors of suicide during treatment with aripiprazol 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 very fast or irregular heartbeat.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way in you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is known as impulse control disorder and may include behaviors such as addiction to gambling, excessive intake or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. Caution should be taken, especially if you are an elderly patient or have weakness.

Children and adolescents

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

Other medications and Aripiprazol TAD

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

Medications that lower blood pressure: aripiprazol 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, it may mean that your doctor needs to change your aripiprazol dose. It is especially important to mention to your doctor the following:

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medications to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);

• certain medications 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 medications may increase the risk of adverse effects or reduce the effect of Aripiprazol TAD; if you observe any unusual symptoms when taking any of these medications with Aripiprazol TAD, inform your doctor.

Medications that increase serotonin levels are generally used to treat 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 to treat diseases such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used to treat severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depressive diseases;
• St. John's Wort (Hypericum perforatum) used in herbal remedies to treat mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medications may increase the risk of adverse effects; if you observe any unusual symptoms when taking any of these medications with Aripiprazol TAD, inform your doctor.

Aripiprazol TAD with food, drinks, and alcohol

This medication can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, lactation, and fertility

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

The following symptoms may occur in newborn babies, from mothers who have been treated with aripiprazol 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, contact your doctor.

If you are taking Aripiprazol TAD, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated with Aripiprazol TAD, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medication.

Driving and operating machinery

During treatment with aripiprazol, 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.

Aripiprazol TAD contains lactose

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

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 15mg 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

Thetreatmentshould start with the oral solution (liquid) at a low dose.

The dose can be gradually 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.

Theappropriateformulations(e.g.,1mg/mlsolution)ofAripiprazolTAD are not available. A suitable alternative product with the same active ingredient should be used.

If you estimate that the effect of Aripiprazol TAD is too strong or too weak, inform your doctor or pharmacist.

Try to take Aripiprazol TAD at the same time everyday.You can take it with or without food.Always take the tablets with water and swallow them whole.

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

If you take more Aripiprazol TAD than youshould

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91.562.04.20, indicating the medication and the amount ingested.

Patients who have taken too much aripiprazol have experienced the following symptoms:

• rapid heartbeats, 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 drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Aripiprazol TAD

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 Aripiprazol TAD

Do not stop treatment just because you feel better. It is essential to continue taking Aripiprazol TAD for the time your doctor has indicated.

If you have any other questions 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):

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

The following side effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• 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 experience any of these symptoms, seek immediate medical attention);
• high blood pressure;
• fainting;
• accidental inhalation of food with a 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;
• inflammation of the liver;
• yellowing of the skin and the white part of the eyes;
• abnormal liver function test results;
• hives;
• sensitivity to light;
• hair loss;
• excessive sweating;
• severe allergic reactions,such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as pseudogripal symptoms with facial rash, and later with prolonged skin rash, high temperature, swollen lymph nodes, elevated liver enzyme levels observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• abnormal muscle degradation that can cause kidney problems;
• muscle pain;
• rigidity;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to medication during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating;
• chest pain;
• swollen hands, ankles or feet;
• in blood tests: increased fluctuations in blood sugar levels, increased hemoglobin A1c.
• inability to resist the impulse, instinct or temptation to perform an action that may be harmful to yourself or others, which may include: