Prospect: information for the user

ABILIFY 10 mg buccal tablets

ABILIFY 15 mg buccal tablets

ABILIFY 30 mg buccal tablets

aripiprazol

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What is ABILIFY and for what it is used

2. What you need to know before starting to take ABILIFY

3. How to take ABILIFY

4. Possible adverse effects

5. Storage of ABILIFY

6. Contents of the package and additional information

ABILIFY contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents 15 years of age or older who suffer from a condition characterized by symptoms such as hearing, seeing, and feeling things that do not exist, distrust, false beliefs, incoherent speech, and monotony of emotional and behavioral state. People in this state may also feel depressed, guilty, anxious, or tense.

ABILIFY is used to treat adults and adolescents 13 years of age or older who suffer from a condition characterized by symptoms such as feeling euphoric, having excessive energy, needing less sleep than usual, speaking rapidly with flight of ideas, and sometimes, severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with ABILIFY.

Do not take ABILIFY

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

Warnings and precautions

Consult your doctor before starting to take ABILIFY.

There have been reports of patients experiencing thoughts and behaviors of self-harm during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

Before starting treatment with ABILIFY, tell your doctor if you have

• high blood sugar levels (characterized by excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history ofdiabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• antecedents of addiction to gaming.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Talk to your doctor immediately if you have thoughts or feelings of harming yourself. There have been reports of patients experiencing thoughts and behaviors of self-harm during treatment with aripiprazole.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or a very fast 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 in you and 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 behaviors such as addiction to gaming, excessive intake or spending, abnormally high sexual appetite, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazole may cause drowsiness, a drop in blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. You should be cautious, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years old. The safety and effectiveness of this medicine in these patients are unknown.

Other medicines and ABILIFY

Inform your doctor or pharmacist if you are taking, have taken recently, or may need totake any other medicine, including over-the-counter medicines.

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

If you are taking ABILIFY with any other medicine, it may mean that your doctor needs to change your dose of ABILIFY or the dose of the other medicines. It is especially important to mention to your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based 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, for example, 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 effect of ABILIFY; if you observe any unusual symptoms when taking any of these medicines at the same time as ABILIFY, you should inform your doctor.

Medicines that increase serotonin levels are generally used to treat diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat diseases such as depression, generalized anxiety disorder, OCD, and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs)(such as paroxetine and fluoxetine) used to treat 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 diseases;
• St. John's Wort (Hypericum perforatum)used in plant-based 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 adverse effects; if you observe any unusual symptoms when taking any of these medicines at the same time as ABILIFY, you should inform your doctor.

ABILIFY 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, or 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, from mothers who have been treated with ABILIFY in the last trimester of pregnancy (last three months of your pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. 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 your baby, considering the benefit to you of your treatment and the benefit to your baby of breastfeeding. If you are being treated with ABILIFY, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

ABILIFY contains aspartame

ABILIFY 10 mg buccal tablets: This medicine contains 2 mg of aspartame ineach tablet.

ABILIFY 15 mg buccal tablets: This medicine contains 3 mg of aspartame in each tablet.

ABILIFY 30 mg buccal tablets: This medicine contains 6 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine thatmay be harmful in the case of phenylketonuria (PKU),a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

ABILIFY contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him beforetaking this medicine.

ABILIFY contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is, essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day.However, your doctor may prescribe lower and higher doses up to a maximum of 30 mg, once a day.

Use in children and adolescents

This medication should be started with the oral solution (liquid) at a low dose.

The dose can be gradually increased tothe recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

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

Try to take ABILIFY at the same time every day. It does not matter if you take it with or without food. Do not open the blister pack until you are about to take it. To take a tablet, open the package and remove the aluminum from the blister pack, leaving the tablet visible. Do not press the tablet through the aluminum because this could damage it. Once the blister pack is opened, with dry hands, take the tablet and place the buccal dispersible tablet completely on the tongue. The tablet disintegration occurs quickly with saliva. The buccal dispersible tablet can be taken with or without liquid. Another option is to dissolve the tablet in water and drink the resulting suspension.

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

If you take more ABILIFY than you should

If you realize that 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 communicate with your doctor, go to the nearest hospital and bring the package with you.

Patients who have taken too much aripiprazol have experienced the following symptoms:

• rapid heartbeats, agitation/aggressiveness, language 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, choking, 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 ABILIFY

If you forget a dose, take the missed dose as soon as you remember, but do not take a double dose to compensate for the missed dose.

If you interrupt treatment with ABILIFY

Do not stop treatment just because you feel better. It is essential that you continue taking ABILIFY for the time your doctor has indicated.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects (can affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• sensation of restlessness and inability to stay still, difficulty staying seated;
• involuntary twisting, contorting, or spasmodic movements, restless legs;
• tremors;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• sensation of fatigue.

Less frequent side effects (can affect up to 1 in 100 patients):

• increased levels of prolactin hormone in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• involuntary movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder causing twisting movements (dystonia);
• double vision;
• eye sensitivity to light;
• rapid heart rate;
• drop in blood pressure upon standing, causing dizziness, confusion, or fainting;
• hypotension.

The following side effects have been reported during the post-marketing phase of oral aripiprazole, but the frequency of occurrence is unknown:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sex drive and concerning behavior for yourself or others, such as increased sex drive;
• uncontrollable excessive buying;
• binge eating (ingesting large amounts of food in a short period) orcompulsive eating (ingesting more food than normal and more than needed to satisfy hunger);
• tendency to wander.

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been reported a higher number of fatal cases while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experienced side effects similar in frequency and type to those of adults, except for drowsiness, involuntary spasms or contractions, restlessness, and fatigue, which were very frequent (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 getting up after lying down or sitting, which were frequent (affects up to 1 in 10 patients).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in the Appendix V.Mediante the reporting of side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

ABILIFY Composition

Each buccal dispersible tablet contains 10 mg of aripiprazol.

Each buccal dispersible tablet contains 15 mg of aripiprazol.

Each buccal dispersible tablet contains 30 mg of aripiprazol.

Tablet Coating

ABILIFY 10 mg buccal dispersible tablets: iron oxide red (E 172)

ABILIFY 15 mg buccal dispersible tablets: iron oxide yellow (E 172)

ABILIFY 30 mg buccal dispersible tablets: iron oxide red (E 172)

Appearance of ABILIFY and packaging contents

ABILIFY 10 mg buccal dispersible tablets are round and pink, engraved with ""A" above "640" on one side and “10” on the other.

ABILIFY 15 mg buccal dispersible tablets are round and yellow, engraved with ""A" above "641"" on one side and “15” on the other.

ABILIFY 30 mg buccal dispersible tablets are round and pink, engraved with ""A" above "643"" on one side and “30” on the other.

ABILIFY buccal dispersible tablets are presented in single-dose blisters packaged in boxes containing 14 × 1, 28 × 1 or 49 × 1 buccal dispersible tablets.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Responsible Person for Manufacturing

Elaiapharm

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

06560 Valbonne

France

For more information about this medicine, please contact the local representative of the marketing authorization holder..

Spain

Otsuka Pharmaceutical, S.A. Tel: +34 93 550 01 00

Last review date of this leaflet: {MM/AAAA}

Other sources of information

Detailed information about this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.