Abilify 1 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ABILIFY 1mg/ml oral solution

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, 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ABILIFY is and what it is used for

ABILIFY 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, and 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.

ABILIFY is 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, ABILIFY also prevents the recurrence of this condition in patients who have responded to treatment with ABILIFY.

2. What you need to know before taking ABILIFY

Do not take ABILIFY

• 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 before starting to take ABILIFY.

Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with this medicine. Inform your doctor immediately if you have thoughts or feelings of harming yourself, either before or after taking ABILIFY.

Before starting treatment with ABILIFY, 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 of the face;
• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or mini-stroke (transient ischemic attack), 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, 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 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 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 that you cannot 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 high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

This medicine 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 taken, 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 ABILIFY

Tell 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: ABILIFY may enhance 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 ABILIFY with any other medicine, it may mean that your doctor needs to adjust your dose of ABILIFY 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 itraconazole);
• ketoconazole (used to treat Cushing's syndrome when the body produces excess cortisol);
• 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 ABILIFY; if you notice any unusual symptoms while taking any of these medicines together with ABILIFY, 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 ABILIFY, you must inform your doctor.

Taking ABILIFY with food, drinks, and alcohol

This medicine can be taken regardless of meals. However, the oral solution must not be diluted with other liquids or mixed with food before administration.

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 ABILIFY 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 ABILIFY, 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 ABILIFY, 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.

ABILIFY contains fructose

This medicine contains 200 mg of fructose per ml. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the patient cannot break down fructose, consult your doctor before taking or receiving this medicine. Fructose may damage teeth.

ABILIFY contains sucrose

This medicine contains 400 mg of sucrose per ml. This should be taken into account in patients with diabetes mellitus. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine. Sucrose may damage teeth.

ABILIFY contains parahydroxybenzoates

May cause allergic reactions (possibly delayed).

ABILIFY contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; essentially "sodium-free".

3. How to take ABILIFY

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 ml of solution (corresponding to 15 mg of aripiprazole) once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once daily.

Use in children and adolescents

The recommended dose for adolescents is 10 ml of solution (corresponding to 10 mg of aripiprazole) once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 ml (i.e., 30 mg) once daily.

This ABILIFY dose must be measured using the calibrated cap or the 2 ml calibrated dropper pipette provided in the package.

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

Try to take ABILIFY at the same time each day. It does not matter whether you take it with or without food. However, do not dilute it with other liquids or mix it with other foods before taking ABILIFY.

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

If you take more ABILIFY than you should

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

Patients who have taken an overdose of this medicine 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 the nearest hospital immediately if you experience any of the above symptoms.

If you forget to take ABILIFY

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

If you stop taking ABILIFY

Do not stop your treatment just because you feel better. It is important that you continue taking ABILIFY 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 of restlessness and inability 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 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 levels of white blood cells;
• low platelet levels;
• 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 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 (oculogyric crisis);
• 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 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;
• 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 generalized 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 breakdown of muscle tissue, 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 regulating 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, urge, or temptation to perform an action that may be harmful to you or others, which may include:
  • a 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 spending;
  • binge eating (consuming large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than necessary 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. In addition, cases of stroke or "mini" strokes (transient ischemic attacks) have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years or 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 (affecting 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 (affecting 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 through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ABILIFY

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

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

This medicine does not require any special storage conditions.

After opening the container, use within 6 months.

Medicines must not be disposed of via wastewater or household waste. 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 ABILIFY

• The active substance is aripiprazole.

Each ml contains 1 mg of aripiprazole.

• The other components are disodium edetate, fructose, glycerol, lactic acid, methyl parahydroxybenzoate (E 218), propylene glycol, propyl parahydroxybenzoate (E 216), sodium hydroxide, sucrose, purified water, and orange flavour.

What ABILIFY looks like and contents of the pack

ABILIFY 1 mg/ml oral solution is a clear, colourless to slightly yellow liquid supplied in bottles with child-resistant closures made of polypropylene, containing 50 ml, 150 ml or 480 ml per bottle.

Each carton contains one bottle, a calibrated polypropylene dosing cap, and a calibrated low-density polyethylene and polypropylene dropper pipette.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

The Netherlands

Manufacturer responsible for batch release

Elaiapharm

2881 Route des Crêtes, Z.I. Les Bouilides-Sophia Antipolis,

06560 Valbonne

France

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.