ApaloZ 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Apaloz 10 mg orodispersible tablets EFG

Aripiprazole

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Apaloz orodispersible tablets are and what they are used for
2. What you need to know before taking Apaloz orodispersible tablets
3. How to take Apaloz orodispersible tablets
4. Possible side effects
5. How to store Apaloz orodispersible tablets
6. Contents of the pack and other information

1. What Apaloz orodispersible tablets are and what they are used for

Apaloz orodispersible tablets contain the active substance aripiprazole and belong to a group of medicines called antipsychotics.

They are used to treat adults and adolescents aged 15 years and older who have a disorder 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.

Apaloz 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 Apaloz orodispersible tablets.

2. What you need to know before taking Apaloz orodispersible tablets

Do not take Apaloz orodispersible tablets

• 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 Apaloz orodispersible tablets 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;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular 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;
• 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 should be taken, especially if you are elderly or have any weakness.

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 suffer 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.

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 status, or very rapid or irregular heartbeat.

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.

Taking Apaloz orodispersible tablets with other medicines

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: Apaloz orodispersible tablets 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 blood pressure.

If you are taking Apaloz orodispersible tablets with any other medicine, you may need to adjust your dose of Apaloz orodispersible tablets. It is especially important to tell your doctor about the following:

• Medicines to correct heart rhythm
• Antidepressants or herbal remedies used to treat depression and anxiety
• Antifungals
• Certain medicines used to treat HIV infection
• Anticonvulsants used to treat epilepsy

Medicines that increase serotonin levels: triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St. John's wort, and venlafaxine. These medicines increase the risk of adverse effects; if you notice any unusual symptoms when taking any of these medicines together with Apaloz orodispersible tablets, you must inform your doctor.

Taking Apaloz orodispersible tablets with food, drinks, and alcohol

Apaloz orodispersible tablets 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 Apaloz orodispersible tablets 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 immediately.

Make sure to inform your doctor immediately if you are breastfeeding.

If you are taking Apaloz orodispersible tablets, you should not breastfeed.

Driving and using machines

Do not drive or operate tools or machinery until you know how Apaloz orodispersible tablets affect you.

Apaloz contains aspartame

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

3. How to take Apaloz orodispersible tablets

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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. 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 think that the effect of Apaloz orodispersible tablets is too strong or too weak, tell your doctor or pharmacist.

Try to take Apaloz orodispersible tablets 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 aluminium foil so that the tablet becomes visible. Do not push the tablet through the foil, as this may damage it. Once the blister has been opened, with dry hands, take the tablet and place the complete 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 Apaloz orodispersible tablets without first consulting your doctor.

If you take more Apaloz orodispersible tablets than you should

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

If you forget to take Apaloz orodispersible tablets

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 forgotten dose.

If you stop taking Apaloz orodispersible tablets

Do not stop your treatment just because you feel better. It is important that you continue taking Apaloz orodispersible 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 patients):

• diabetes mellitus;
• sleep disturbances;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty remaining seated;
• uncontrollable twisting, writhing, or spasmodic movements, restless legs;
• tremor;
• headache;
• fatigue;
• somnolence;
• dizziness;
• shakiness and blurred vision;
• difficulty defecating 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 levels of the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscular disorder causing twisting movements (dystonia);
• 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 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 blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, suicide attempt, and suicide;
• gambling addiction;
• aggressiveness;
• agitation;
• nervousness;
• 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;
• 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 difficulty breathing (if you experience any of these symptoms, contact your doctor immediately);
• elevated 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 test results;
• rash;
• light sensitivity;
• baldness;
• excessive sweating;
• abnormal breakdown of muscle tissue which may cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns following 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: fluctuation in blood sugar levels, increased glycated hemoglobin;
• fixation of the eyeballs in one position.

In elderly patients with dementia, increased numbers 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 or 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 (affects 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 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 may 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 Apaloz orodispersible tablets

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

Store in the original packaging to protect from moisture.

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.

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

6. Contents of the pack and other information

Composition of Apaloz

• The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole.
• The other components are maltose, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, aspartame, ethyl vanillin, red iron oxide (E172) and magnesium stearate.

Nature of the product and contents of the pack

Apaloz 10 mg is presented as pink, round, flat, unmarked orodispersible tablets.

Each pack contains 14 or 28 orodispersible tablets, packaged in blisters made of Polyamide/Al/PVC-Al.

Only certain pack sizes may be marketed.

Other presentations:

Apaloz 15 mg orodispersible tablets EFG

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: June 2020.

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