Aripiprazole Flas Sandoz 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aripiprazole Flas Sandoz 10 mg orodispersible tablets EFG

Aripiprazole Flas Sandoz 15 mg orodispersible tablets EFG

Aripiprazole Flas Sandoz 30 mg orodispersible tablets EFG

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

Contents of the leaflet

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

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

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

Aripiprazol Flas Sandoz orodispersible tablets are used to treat adults and adolescents aged 13 years and 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 orodispersible tablets.

2. What you need to know before taking Aripiprazole Flas Sandoz

Do not take Aripiprazole Flas Sandoz

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Aripiprazole Flas Sandoz.

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 Flas Sandoz, inform 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,
• involuntary and irregular muscle movements, especially in the face,
• cardiovascular diseases (heart and circulatory 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 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 develop allergic symptoms, please inform your doctor.

If you are an elderly patient with dementia (memory loss and other mental impairments), 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.

Inform your doctor immediately if you notice muscle stiffness or numbness accompanied by high fever, sweating, altered mental status, 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 ways unusual for 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 gambling addiction, excessive eating or spending, abnormally increased 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 ability to move and maintain balance, which could lead to falls.

Caution should be exercised, especially if you are an elderly patient or have some degree of 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 Aripiprazole Flas Sandoz

Inform 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 blood pressure.

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

• 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 (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 experience any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Medicines that increase serotonin levels are generally used for 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 amitriptyline) 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 inform your doctor.

Taking Aripiprazole Flas Sandoz 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 third trimester of pregnancy (last three months of pregnancy): tremor, 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.

Aripiprazole Flas Sandoz contains lactose, sodium, aspartame, benzyl alcohol, and propylene glycol

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

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

Aripiprazole Flas Sandoz 10 mg

This medicine contains 1.0 mg of aspartame in each orodispersable tablet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains up to 0.0036 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Aripiprazole Flas Sandoz 15 mg

This medicine contains 1.5 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains up to 0.0054 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Aripiprazole Flas Sandoz 30 mg

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

Aspartame contains a source of phenylalanine which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

This medicine contains up to 0.0108 mg of benzyl alcohol in each orodispersible tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease or if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Aripiprazole Flas Sandoz

Follow exactly the instructions for using this medicine 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

This medicine should be initiated with the oral solution (liquid) at a low dose. Gradually, the dose may be increased to the recommended dose for adolescents of 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.

Try to take the aripiprazole orodispersible tablet 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. To take a tablet, open the packaging and lift off the aluminum foil from the blister so that the tablet becomes visible. Do not push the tablet through the aluminum foil, as this could damage it. 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 may be taken with or without liquid.

Alternatively, the tablet may be dispersed in water and the resulting suspension drunk.

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

If you take more Aripiprazole Flas Sandoz than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91.562.04.20, indicating the medicine and the amount ingested.

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

• rapid heartbeat, agitation/aggression, speech 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 rigidity and drowsiness, slower breathing, suffocation, 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 Aripiprazole Flas Sandoz

If you forget a dose, take the missed dose as soon as you remember, but do not take two doses on the same day.

If you stop taking Aripiprazole Flas Sandoz

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Flas Sandoz for as long as your doctor has instructed.

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 produce adverse effects, although not everyone experiences them.

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

• diabetes mellitus,
• sleep disturbances,
• anxiety,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an uncomfortable inner restlessness and an urgent need to keep moving),
• uncontrollable twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shakiness and blurred vision,
• difficulty passing stools or reduced bowel movements,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

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

• 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),
• muscle disorder causing twisting movements (dystonia),
• double vision,
• restless legs,
• sensitivity of the eyes to light,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting,
• hiccups.

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

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g., swelling of 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,
• low levels of sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt, and suicide,
• aggression,
• agitation,
• nervousness,
• a 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),
• speech disorder,
• fixed eye position,
• unexplained sudden death,
• potentially life-threatening irregular heartbeat,
• heart attack,
• slower heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (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,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• abnormal liver function test results,
• rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms with a facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia),
• abnormal breakdown of muscle tissue 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 controlling core body temperature or overheating,
• chest pain,
• swollen hands, ankles, or feet,
• in blood tests: fluctuations in blood sugar levels, increased

glycated hemoglobin,

• inability to resist the impulse, instinct, or temptation to perform 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 behavior that is concerning to you or others, for example, increased sex drive,

• uncontrollable excessive shopping,

• binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger),

• tendency to wander.

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

In elderly patients with dementia, an increased number of fatal cases has been reported while taking aripiprazole. Additionally, cases of stroke or "mini" strokes have been reported.

Additional adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in type and frequency to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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 upon standing up from lying down or sitting—which were common (may affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly 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 Sandoz

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister pack and outer packaging, after CAD/EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and other information

Composition of Aripiprazole Flas Sandoz

• The active substance is aripiprazole.

Aripiprazole Flas Sandoz 10 mg orodispersible tablets: Each orodispersible tablet contains 10 mg of aripiprazole.

Aripiprazole Flas Sandoz 15 mg orodispersible tablets: Each orodispersible tablet contains 15 mg of aripiprazole.

Aripiprazole Flas Sandoz 30 mg orodispersible tablets: Each orodispersible tablet contains 30 mg of aripiprazole.

• The other components of Aripiprazole Flas Sandoz 10 mg and 30 mg orodispersible tablets are: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, colloidal anhydrous silica, aspartame (E 951), magnesium stearate (E 470b), iron oxide red (E 172), and vanilla flavour (containing maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavouring).

• The other components of Aripiprazole Flas Sandoz 15 mg orodispersible tablets are: lactose monohydrate, microcrystalline cellulose (E 460), sodium croscarmellose, colloidal anhydrous silica, aspartame (E 951), magnesium stearate (E 470b), iron oxide yellow (E 172), and vanilla flavour (containing maltodextrin, gum arabic, propylene glycol, benzyl alcohol, vanilla flavouring).

See section 2: Aripiprazole Flas Sandoz contains lactose, sodium, aspartame and benzyl alcohol.

Nature of the product and pack contents

Aripiprazole Flas Sandoz 10 mg orodispersible tablets:

Round, flat, pink tablets, engraved with "10" on one side and smooth on the other, with a diameter of 8.0 mm ± 0.1 mm.

Aripiprazole Flas Sandoz 15 mg orodispersible tablets:

Round, flat, yellow tablets, engraved with "15" on one side and smooth on the other, with a diameter of 9.0 mm ± 0.1 mm.

Aripiprazole Flas Sandoz 30 mg orodispersible tablets:

Round, flat, pink tablets, engraved with "30" on one side and smooth on the other, with a diameter of 10.0 mm ± 0.1 mm.

The orodispersible tablets are packaged in peelable paper/PET/aluminum //PVC/aluminum/OPA blisters, contained in cardboard boxes.

Pack sizes:

Blister: 10, 14, 28, 30, 49, 56, 98 orodispersible tablets.

Unit dose blister: 10 x 1, 14 x 1, 28 x 1, 30 x 1, 49 x 1, 56 x 1, 98 x 1 orodispersible tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.

Products Area of Larissa,

P.O. Box 3012

GR-41004 Larissa

Greece

or

Genepharm S.A.

18th km Marathonos Ave,

Pallini Attiki, 15351

Greece

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179 Barleben,

Germany

or

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

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

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http:// www.aemps.gob.es/