Arizol Flas 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Arizol Flas 30 mg orodispersible tablets EFG

Aripiprazole

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

Leaflet contents:

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

1. What Arizol Flas is and what it is used for

Arizol Flas 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, uneasy, 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 Arizol Flas

Do not take Arizol Flas

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

Warnings and precautions

Consult your doctor before starting to take Arizol Flas.

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 diseases), 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, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, have difficulty swallowing, or develop allergic symptoms, please inform your doctor.

If you have 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 experience muscle stiffness or numbness with 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 an unusual way and are unable to 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 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 your ability to move and maintain balance, which could lead to falls. Caution is advised, especially if you are elderly or have any degree of physical 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 Arizol Flas Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

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

If you are taking this medicine 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 that you tell your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
• antidepressants or herbal medicines 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 adverse effects or reduce the effectiveness of this medicine; if you notice any unusual symptoms while taking any of these medicines together with this medicine, you must inform 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, amitriptiline) used in depressive disorders
• analgesics (such as tramadol and pethidine) used to relieve pain
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine

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

Taking Arizol Flas 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 are planning 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): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.

If you are taking Arizol Flas, 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 Arizol Flas, 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.

Arizol Flas 30 mg contains 3 mg of aspartame (E-951) per tablet. Aspartame contains a source of phenylalanine, which may be harmful for people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

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

This medicine contains 0.0108 mg of benzyl alcohol in each tablet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist 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). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis). Benzyl alcohol has been associated with the risk of serious adverse effects including breathing problems ("gasping syndrome") in children. Do not administer this medicine to your newborn (up to 4 weeks of age) unless recommended by your doctor. This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

3. How to take Arizol Flas

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

This medicine should be started with the oral solution (liquid) at a low dose. The dose may then be gradually 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 peel back the aluminum foil from the blister so that the tablet becomes visible. Do not push the tablet through the foil, as this may 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 dissolved in water and the resulting suspension drunk.

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

If you take more Arizol Flas than you should

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

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, slowed breathing, choking, high or low blood pressure, abnormal heart rhythms.

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

If you forget to take Arizol Flas

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 Arizol Flas

Do not stop your treatment just because you feel better. It is important that you continue taking Arizol Flas 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 will experience 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 sensation of 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 frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of tiredness.

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);
• a muscular disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
• ocular 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:

• 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;
• high blood sugar;
• low sodium levels 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 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;
• 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 of 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);
• muscle spasms around the glottis (a part of the larynx);
• inflammation of the pancreas;
• difficulty swallowing;
• diarrhoea;
• 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;
• cutaneous photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed later by generalized skin rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• abnormal muscle breakdown which 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 haemoglobin;
• inability to resist the impulse, instinct, or temptation to carry out an action that may be harmful to you or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behaviour that is concerning to you 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 behaviours; 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 type and frequency to those in adults, except for drowsiness, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (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 lying down or sitting, which were common (affects 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 website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Arizol Flas

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 is the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Arizol Flas

• The active substance is aripiprazole. Each orodispersible tablet contains 30 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), sodium croscarmellose, anhydrous colloidal silica, purified water, magnesium stearate (E470b), aspartame (E951), vanilla flavour (containing benzyl alcohol), and red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

The Arizol Flas 30 mg orodispersible tablets are round, flat, pink in colour, and engraved with the number "30" on one side.

They are supplied in packs of 28 tablets in peelable aluminum/aluminum blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer

Rontis Hellas Medical and Pharmaceuticals Products, S.A.

Larissa Industrial Area, P.O. Box 3012, Larissa,

41500

Greece

or

Genepharm, S.A.

18th km Marathonos Ave, Pallini Attiki

15351 Greece

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

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices: http://www.aemps.gob.es