Aripiprazole TAD 30 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aripiprazole TAD 30 mg tablets EFG

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 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Aripiprazol TAD is and what it is used for

Aripiprazol TAD 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, disorganized speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazol TAD 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.

2. What you need to know before taking Aripiprazole TAD

Do not take Aripiprazole TAD:

• 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 or pharmacist before starting this medicine.

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

Before starting treatment with Aripiprazole TAD, 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 (fits), as your doctor may wish to monitor you more closely;
• involuntary and irregular muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation problems), a family history of cardiovascular disease, stroke or "mini" stroke, 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.

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 person 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 behaviour have been reported during treatment with aripiprazole.

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 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 behaviours 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 motor function and balance, which could lead to falls. Exercise caution, 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 Aripiprazole TAD

Tell 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 enhance 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 this medicine together with any other medicine, your doctor may need to adjust your aripiprazole dose. It is especially important to tell your doctor about the following:

• medicines used 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);
• antifungal medicines used to treat fungal infections (such as ketoconazole, itraconazole);
• certain medicines used 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 effectiveness of Aripiprazole TAD; if you notice any unusual symptoms while taking any of these medicines together with Aripiprazole TAD, 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), social phobia, 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 for pain relief;
• 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 TAD, you must inform your doctor.

Taking Aripiprazole TAD 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 before using this medicine.

The following symptoms may occur in newborn babies whose mothers were 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 TAD, 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 TAD, 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 aripiprazole.

This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazole TAD contains lactose

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

3. How to take Aripiprazole TAD

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, 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

Treatment should be initiated with the oral solution (liquid) at a low dose.

The dose may gradually 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.

Appropriate formulations (e.g., 1 mg/ml solution) of Aripiprazole TAD are not available. An alternative product with the same active substance should be used.

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

Try to take Aripiprazole TAD 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 TAD without first consulting your doctor.

If you take more Aripiprazole TAD 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, indicating the medicine and the amount ingested.

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 nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Aripiprazole TAD

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

If you stop taking Aripiprazole TAD

Do not stop your treatment just because you feel better. It is important that you continue taking Aripiprazole TAD 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.

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 prolactin hormone 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);
• 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 blood;

• loss of appetite (anorexia);

• weight loss;

• weight gain;

• suicidal thoughts, suicide attempt, and suicide;

• aggression;

• 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;

• fixed eye position (oculogyria);

• 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 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 (jaundice);

• abnormal liver function test results;

• rash;

• skin 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 prolonged skin rash, high fever, swollen lymph nodes, elevated liver enzyme levels in blood tests, and increased levels of a type of white blood cell (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 fluctuation in blood sugar levels, increased glycated hemoglobin;

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

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, increased numbers of fatal cases have been reported while taking aripiprazole. Additionally, 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, uncontrollable spasms or contractions, restlessness, and fatigue, which were very common (may affect 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 or sitting down—which were common (may 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 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 TAD

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 Point at your pharmacy. If you have any doubts, 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 Aripiprazole TAD

• The active substance is aripiprazole. Each tablet contains 30 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), maize starch, hydroxypropylcellulose (E463), red iron oxide (E172) and magnesium stearate (E470b). See section 2, "Aripiprazole TAD contains lactose".

Appearance of the product and contents of the pack

Aripiprazole TAD 30 mg tablets are light pink, round, biconvex, with bevelled edges, may have darker and lighter specks, and are engraved with "A30" on one side (diameter: 9 mm, thickness: 3.9–5.3 mm).

Each pack contains 14, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany.

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany.

For more information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain.

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

Date of the last revision of this leaflet: May 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/.