Aripiprazole Flas Stada 15 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Aripiprazole Flas Stada 10 mg orodispersible tablets EFG

Aripiprazole Flas Stada 15 mg orodispersible tablets EFG

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aripiprazol Flas Stada is and what it is used for

Aripiprazol Flas Stada 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 or older who have an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, disorganized speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years or older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with aripiprazole.

2. What you need to know before taking Aripiprazol Flas Stada

DO NOT take Aripiprazol Flas Stada

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

Warnings and precautions

Talk to your doctor before starting aripiprazole.

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

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

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes
• seizures, as your doctor may wish to monitor you more closely
• irregular and involuntary muscle movements, especially in the face
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or "mini" strokes, abnormal blood pressure
• blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation
• a history of gambling addiction

If you notice that you are gaining weight, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or show allergic symptoms, please inform your doctor.

If you are an elderly patient with 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.

Speak 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.

Speak to your doctor immediately if you notice muscle stiffness or numbness with high fever, sweating, altered mental state, or very 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 could harm you or others. This is known as impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings. Your doctor may consider adjusting or stopping your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution is advised, especially if you are elderly or have any weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.

Other medicines and Aripiprazol Flas Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.

Medicines that lower blood pressure:

Aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control your blood pressure.

If you are taking aripiprazole with any other medicine, it may mean that your doctor needs to change your dose of aripiprazole or the dose of the other medicines. It is especially important to tell your doctor if you are taking:

• Medicines 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);
• Medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• Certain medicines 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 medicines may increase the risk of side effects or reduce the effect of aripiprazole; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must tell your doctor.

Medicines that increase serotonin levels are generally used in conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (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 amitriptiline) used in depressive disorders;
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression;
• analgesics (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must tell your doctor.

Taking Aripiprazol Flas Stada with food, drinks, and alcohol

This medicine 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 whose mothers have been treated with aripiprazole during the last trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

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

Driving and using machines

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

Aripiprazol Flas Stada contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Aripiprazole Flas Stada

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.

Use in children and adolescents

Aripiprazole should be initiated with an oral solution (liquid) at a low dose. If an oral solution is required, your doctor will prescribe another product containing aripiprazole. The dose may then be gradually increased to the recommended dose for adolescents, which is 10 mg once daily. However, your doctor may prescribe lower or higher doses, up to a maximum of 30 mg once daily.

If you feel that the effect of aripiprazole is too strong or too weak, inform your doctor or pharmacist.

Method of administration

Try to take aripiprazole at the same time each day. It does not matter whether you take it with or without food.

• Do not open the blister pack until you are ready to take the tablet.
• Once the blister is opened, with dry hands, take the tablet and place the entire orodispersible tablet on the tongue. The tablet disintegrates rapidly in saliva.
• The orodispersible tablet can be taken with or without liquid. Alternatively, the tablet may be dissolved in water and the resulting suspension swallowed.

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

If you take more Aripiprazole Flas Stada than you should

If you realize that you have taken more orodispersible tablets of aripiprazole than prescribed (or if someone else has taken some of your orodispersible tablets of aripiprazole), contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91.562.04.20, stating the medicine and the amount taken, or go to the nearest hospital, taking the packaging with you.

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

• Rapid heartbeat, agitation/aggression, speech difficulties;
• 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 rigidity and drowsiness, slowed breathing, suffocation, 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 Flas Stada

If you miss a dose, take the missed dose as soon as you remember, but do not take two doses on the same day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aripiprazole Flas Stada

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for the length of time prescribed by your doctor.

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

4. Possible adverse effects

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

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

• diabetes mellitus
• sleep disturbances
• anxiety
• restlessness and inability to stay still, difficulty remaining seated
• akathisia (a distressing inner restlessness and a compelling need to keep moving constantly)
• uncontrollable twisting, writhing, or spasmodic movements, restless legs
• tremor
• headache
• fatigue
• somnolence
• dizziness
• shakiness and blurred vision
• difficulty passing stools or reduced frequency of bowel movements
• indigestion
• nausea
• increased saliva production
• vomiting
• feeling tired

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

• increased or decreased levels of the hormone prolactin in the blood
• excessively high blood sugar levels
• depression
• altered or increased sex drive
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia)
• a muscle disorder causing twisting movements (dystonia)
• restless legs
• double vision
• light sensitivity in the eyes
• rapid heartbeat
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting
• hiccups

Frequency not known (frequency cannot be estimated from available data):

The following adverse effects have been reported during post-marketing surveillance of aripiprazole, but their frequency is unknown.

• low white blood cell count

• low platelet count

• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, and hives)

• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma

• high blood sugar

• low sodium levels in blood

• loss of appetite (anorexia)

• weight loss

• weight gain

• suicidal thoughts, suicide attempt, and suicide

• aggression

• agitation

• nervousness

• a 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness)

• speech disorder

• fixed eye position (oculogyric crisis)

• unexplained sudden death

• potentially life-threatening irregular heartbeat

• heart attack

• slower heartbeat

• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties (if you notice any of these symptoms, contact 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 whites of the eyes (jaundice)

• abnormal liver function test results

• rash

• photosensitivity

• hair loss

• excessive sweating

• severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms and a facial rash, followed by widespread rash, high fever, enlarged lymph nodes, elevated liver enzymes seen in blood tests, and an increase in a type of white blood cells (eosinophilia)

• abnormal muscle breakdown that may lead to kidney problems

• muscle pain

• stiffness

• involuntary loss of urine (incontinence)

• difficulty urinating

• withdrawal symptoms in newborns due to exposure to medication during pregnancy

• prolonged and/or painful erection

• difficulty regulating core body temperature or overheating

• chest pain

• swollen hands, ankles, or feet

• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin

• inability to resist the impulse, instinct, or temptation to carry out an action that could be harmful to yourself or others, which may include:

  • strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and concerning behavior for yourself or others, such as increased libido;
  • uncontrollable excessive shopping;
  • binge eating (consuming large amounts of food in a short period of time) or compulsive overeating (eating more food than normal and more than needed to satisfy hunger);
  • tendency to wander aimlessly.

If you experience any of these behaviors, inform your doctor; they 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. In addition, cases of stroke or "mini" strokes have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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 lying down or sitting—which were very common (affecting up to 1 in 100 patients).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Flas Stada

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

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Keep in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole Flas Stada

• The active substance is aripiprazole.

Aripiprazole Flas Stada 10 mg orodispersible tablets EFG: each orodispersible tablet contains 10 mg of aripiprazole.

Aripiprazole Flas Stada 15 mg orodispersible tablets EFG: each orodispersible tablet contains 15 mg of aripiprazole.

• The other components are: mannitol, maltodextrin, microcrystalline cellulose, crospovidone Type B, sodium hydrogen carbonate, tartaric acid, anhydrous colloidal silica, sodium saccharin, vanilla cream flavour (flavouring substances, natural flavouring substances, lactose, magnesium carbonate hydroxide), magnesium stearate.

Aripiprazole Flas Stada 10 mg orodispersible tablets EFG: iron oxide red (E 172).

Aripiprazole Flas Stada 15 mg orodispersible tablets EFG: iron oxide yellow (E 172).

Appearance of the product and contents of the pack

Aripiprazole Flas Stada 10 mg orodispersible tablets are round, flat, pale pink tablets with dispersed speckles, 8 mm in diameter.

They are supplied in blister packs contained in cardboard boxes with 7, 14, 28, 30, 49, 56, 60, 84, 90, 98 or 100 orodispersible tablets, or 7x1, 14x1, 28x1, 30x1, 49x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 orodispersible tablets.

Aripiprazole Flas Stada 15 mg orodispersible tablets are round, flat, pale yellow tablets with dispersed speckles, 10 mm in diameter.

They are supplied in blister packs contained in cardboard boxes with 7, 14, 28, 30, 49, 56, 60, 84, 90, 98 or 100 orodispersible tablets, or 7x1, 14x1, 28x1, 30x1, 49x1, 56x1, 60x1, 84x1, 90x1, 98x1 or 100x1 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

DK: Aripiprazol STADA

ES: Aripiprazol Flas Stada 10 mg comprimidos bucodispersables EFG

Aripiprazol Flas Stada 15 mg comprimidos bucodispersables EFG

FI: Aripiprazol STADA

FR: Aripiprazole EG 10 mg comprimé orodispersible

Aripiprazole EG 15 mg comprimé orodispersible

SE: Aripiprazol STADA

SK: Aripiprazol STADA 10 mg orodispergovatelné tablety

Aripiprazol STADA 15 mg orodispergovatelné tablety

Date of the most recent revision of this leaflet: March 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/