ARIPIPRAZOLE HEC PHARM 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Aripiprazole HEC Pharm 10 mg Orodispersible Tablets EFG

aripiprazole

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 questions, ask 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 Aripiprazole HEC Pharm is and what it is used for
2. What you need to know before taking Aripiprazole HEC Pharm
3. How to take Aripiprazole HEC Pharm
4. Possible side effects
5. Storage of Aripiprazole HEC Pharm
6. Contents of the pack and further information

1. What Aripiprazole HEC Pharm is and what it is used for

This medication contains the active substance aripiprazole and belongs 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.

This medication 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 this medication.

2. What you need to know before taking Aripiprazole HEC Pharm

Do not take Aripiprazole HEC Pharm

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

Warnings and Precautions

Consult your doctor before starting to take this medication.

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

Before starting treatment with this medication, tell your doctor 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, as your doctor may want to monitor you 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 a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• a history of gambling addiction.

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

If you are an elderly patient suffering 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. There have been reports of patients experiencing suicidal thoughts and behaviors 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 rapid 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 and cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause somnolence, low 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 suffer from 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.

Other Medications and Aripiprazole HEC Pharm

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those without a prescription.

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 use any medication to control blood pressure.

If you are taking this medication with another medication, it may mean that your doctor needs to change the dose of this medication or the other medication. It is especially important to mention to your doctor if you are taking:

• medications to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal medications 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 side effects or reduce the effect of this medication; if you notice any unusual symptoms when taking any of these medications at the same time as this medication, inform your doctor.

Medications that increase serotonin levels are commonly used in 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 for diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• SSRIs (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive diseases;
• St. John's Wort (Hypericum perforatum) used in herbal medications for 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 side effects; if you notice any unusual symptoms when taking any of these medications at the same time as this medication, inform your doctor.

Taking Aripiprazole HEC Pharm with Food, Drinks, and Alcohol

This medication can be taken independently 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 medication.

The following symptoms may occur in newborn babies of mothers who have been treated with this medication 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, contact your doctor.

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

Driving and Using Machines

During treatment with this medication, dizziness and vision problems (see section 4) may occur. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazole HEC Pharm Contains Aspartame (E 951)

This medication contains 3 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

Aripiprazole HEC Pharm Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

3. How to Take Aripiprazole HEC Pharm

Follow the instructions for administration of this medication exactly as indicated by your doctor or pharmacist. If you are unsure, 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

This medication should be started 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 this medication is too strong or too weak, inform your doctor or pharmacist.

This medication is administered orally.

Try to take Aripiprazole HEC Pharm 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 ready to take it. To take a tablet, open the package and remove the aluminum from the blister to reveal the tablet. Do not press the tablet through the aluminum, as this may damage it. Once the blister is open, with dry hands, take the tablet and place the entire orodispersible tablet on the tongue. The tablet will dissolve 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 change or interrupt the daily dose of this medication without consulting your doctor first.

If You Take More Aripiprazole HEC Pharm Than You Should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Patient who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, 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 somnolence, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If You Forget to Take Aripiprazole HEC Pharm

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

If You Interrupt Treatment with Aripiprazole HEC Pharm

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

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Common adverse effects (may affect up to 1 in 10 patients):

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

Uncommon adverse effects (may affect up to 1 in 100 patients):

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

The following adverse 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);
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
• high blood sugar,
• insufficient sodium levels in blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• 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, drowsiness, 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 bloodstream to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• muscle spasms around the glottis (a part of the larynx);
• pancreatitis;
• difficulty swallowing;
• abdominal discomfort;
• stomach upset;
• liver failure;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver function test results;
• rash;
• photosensitivity;
• hair loss;
• excessive sweating;
• abnormal muscle breakdown that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• symptoms of withdrawal 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 hemoglobin glycosylated;
• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to yourself or others, which may include:
• • strong impulse to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and worrying behavior for you or others, for example, increased sexual appetite;
  • uncontrollable excessive shopping;
  • binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming more food than normal and more than needed to satisfy hunger);
  • tendency to wander.

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

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 Adverse Effects in Children and Adolescents

Adolescents 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrollable 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 standing up after being seated or lying down, which were frequent (affects up to 1 in 10 patients).

Reporting Adverse Effects

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

5. Storage of Aripiprazol HEC Pharm

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

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

This medicine does not require special storage conditions.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol HEC Pharm

• The active ingredient is aripiprazole.

Each orodispersible tablet contains 10 mg of aripiprazole

• The other ingredients are mannitol, anhydrous colloidal silica, sodium glycolate starch type A (potato starch), crospovidone, aspartame (E 951), cherry flavor, magnesium stearate.

Appearance of Aripiprazol HEC Pharm and Package Contents

Aripiprazol HEC Pharm 10 mg orodispersible tablets are round, white or almost white tablets, with the inscription "C5" engraved on one side and smooth on the other side. The tablet size is 7.0 mm.

Aripiprazol HEC Pharm orodispersible tablets are presented in aluminum OPA/AL/PVC blisters packaged in boxes containing 28 or 49 orodispersible tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17

10963 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

D-14167 Berlin

Germany

This medicine has been authorized by the member states of the European Economic Area with the following names:

Date of the Last Revision of this Prospectus: September 2020

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Health Products (aemps)