Aripiprazole Aurovitas 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Aurovitas 10 mg 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 adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Aripiprazole Aurovitas is and what it is used for

Aripiprazole Aurovitas 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 characterised by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterised 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 Aripiprazole Aurovitas

Do not take Aripiprazole Aurovitas

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

Warnings and precautions

Talk to your doctor before starting to take Aripiprazole Aurovitas.

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

Before starting treatment with Aripiprazole Aurovitas, inform your doctor if you have:

• High blood sugar levels (characterized by symptoms such as excessive thirst, increased amount of urine, increased appetite, and feeling of weakness) 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 diseases), family history of cardiovascular disease, stroke or "mini" strokes, or 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.

Inform your doctor if you notice weight gain, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms.

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or the person or family member caring for you 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 behaviour have been reported during treatment with aripiprazole.

Speak to your doctor immediately if you notice numbness or stiffness of muscles 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 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 behaviours such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may need to adjust or stop your dose.

Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in your ability to move and balance, which may lead to falls. Caution should be taken, especially if you are an elderly patient 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 Aripiprazole Aurovitas

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

Medicines that lower blood pressure: aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you are taking any medicine to control blood pressure.

If you are taking Aripiprazole Aurovitas with any other medicine, your doctor may need to change 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).
• Antifungals (such as ketoconazole, itraconazole).
• Certain medicines for treating HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g., 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), 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), 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, 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 when using any of these medicines together with Aripiprazole Aurovitas, you must tell your doctor.

Taking Aripiprazole Aurovitas with food, drinks and alcohol

Aripiprazole Aurovitas can be taken regardless of meals.

Alcohol consumption should be avoided while taking aripiprazole.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborns of mothers who have used Aripiprazole Aurovitas during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

If you are taking Aripiprazole Aurovitas, 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. You should not do both. 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 Aurovitas contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Aripiprazole Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor. 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 your Aripiprazole Aurovitas tablet at the same time each day. It does not matter whether you take it with or without food. Always take the tablets with water and swallow them whole.

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

If you have taken more Aripiprazole Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

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 Aurovitas

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

If you stop taking Aripiprazole Aurovitas

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole Aurovitas tablets 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 cause adverse effects, although not everyone experiences them.

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

• diabetes mellitus,
• sleep problems,
• anxiety,
• feeling of restlessness and inability to stay still, difficulty remaining seated,
• uncontrollable twisting, writhing, or spasmodic movements, restless legs,
• tremor,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shakiness and blurred vision,
• difficulty passing stools or reduced frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of tiredness.

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 muscular disorder causing twisting movements (dystonia),
• double vision, eye photosensitivity,
• 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:

Frequency not known: cannot be estimated from available data

• low white blood cell count,

• low platelet count,

• 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,

• elevated blood sugar,

• low sodium levels in blood,

• loss of appetite (anorexia),

• weight loss,

• weight gain,

• suicidal thoughts, suicide attempt, and suicide,

• aggression,

• agitation,

• nervousness,

• combination of fever, muscle stiffness, rapid breathing, sweating, decreased consciousness, and sudden changes in blood pressure and heart rate; 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 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 experience any of these symptoms, contact your doctor 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),

• 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 tests,

• skin rash,

• light sensitivity,

• hair loss,

• excessive sweating,

• 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 controlling 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 may be harmful to yourself or others, which may include:

• strong urge to gamble excessively despite serious personal or family consequences;

• altered or increased sex drive and concerning behavior to yourself or others, for example, increased sexual appetite;

• 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 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 drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness—especially upon standing up after lying down or sitting—which were common (affect more than 1 in 100 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Aurovitas

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

Do not use this medicine after the expiry date stated on the packaging after 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. Dispose of empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Aripiprazole Aurovitas

• The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
• The other components are: monohydrate lactose, microcrystalline cellulose, corn starch, hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and package contents

Uncoated white, rectangular tablet, marked with "63" on one side and "H" on the other. Size: 8 mm × 4.5 mm.

Aripiprazole Aurovitas is available in blister packs made of Polyamide/Aluminum/PVC/Aluminum foil.

Pack sizes: 14 and 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: December 2022

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