ARIPIPRAZOL ACCORD 15 mg TABLETS

2. What you need to know before you take Aripiprazol Accord

Do not take Aripiprazol Accord

• 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 Aripiprazol Accord.

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

Before starting treatment with Aripiprazol Accord, tell your doctor if you suffer from

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling of weakness) or a family history of diabetes;
• 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), 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;
• 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, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you suffer from 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 suicidal thoughts and behaviors 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.

Tell your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way that you cannot resist, which may harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sexual appetite, or concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

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

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe and effective in these patients.

Other medicines and Aripiprazol Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Medicines that lower blood pressure: Aripiprazol Accord may increase the effect of medicines used to lower blood pressure. Make sure to tell your doctor if you use any medicine to control blood pressure.

If you are taking Aripiprazol Accord with another medicine, it may mean that your doctor needs to change your dose of Aripiprazol Accord or the other medicine. It is especially important that you 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 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 Aripiprazol Accord; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Accord, you should tell your doctor.

Medicines that increase serotonin levels are commonly used in 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 for diseases 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 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 side effects; if you notice any unusual symptoms when taking any of these medicines at the same time as Aripiprazol Accord, you should tell your doctor.

Taking Aripiprazol Accord with food, drinks, and alcohol

This medicine can be taken with or without food.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies of mothers who have been treated with this medicine in the last trimester of pregnancy (last three months of pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, you should contact your doctor.

If you are taking Aripiprazol Accord, 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 Aripiprazol Accord, 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

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

Aripiprazol Accord contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Aripiprazol Accord

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

To initiate treatment with a low dose, an alternative formulation (oral liquid solution) may be used, which is more suitable than Aripiprazol Accord.

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

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Try to take Aripiprazol Accord at the same time each day. It does not matter if 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 interrupt the daily dose of this medicine without consulting your doctor first.

If you take more Aripiprazol Accord than you should

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

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

• rapid heartbeat, agitation/aggression, 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 stiffness and drowsiness, slower breathing, choking, 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 Aripiprazol Accord

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

If you stop taking Aripiprazol Accord

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

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 all people suffer from them.

Common adverse effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleeping problems;
• anxiety;
• feeling of restlessness and inability to stay still, difficulty staying seated;
  • akathisia (an uncomfortable feeling of inner restlessness and an urgent need to move constantly);

• twisting, contorting, or spasmodic uncontrollable movements,
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• shaking and blurred vision;
• difficulty evacuating or decreased frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of fatigue.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• increase in prolactin hormone levels in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sexual interest;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• muscle disorder that causes twisting movements (dystonia);
  • restless legs;

• double vision;
• ocular photosensitivity;
• rapid heartbeat;
• drop in blood pressure when standing up, causing dizziness, lightheadedness, or fainting;
• hypo.

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

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling in 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,
• insufficient sodium levels in the blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, attempted suicide, and suicide;
• aggression;
• agitation;
• nervousness;
• 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 can cause feelings of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in a position;
• sudden unexplained death;
• potentially fatal 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 can travel through the bloodstream to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical attention 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);
• pancreatitis;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• abnormal liver values in blood tests;
• rash;
• skin photosensitivity;
• hair loss;
• excessive sweating;
  • severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as flu-like symptoms with a rash on the face and later with a generalized rash, high temperature, swollen lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased eosinophilia;

• abnormal muscle breakdown that can cause kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to drugs during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: fluctuation of blood sugar levels, increased hemoglobin glycosylated.
  • inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and worrying behavior for you or others, for example, increased sexual appetite;
• uncontrollable excessive shopping;
• binge eating (consuming large amounts of food in a short period) or compulsive eating (consuming 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, a higher number of fatal cases have been reported while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other adverse effects in children and adolescents

Adolescents 13 years or older experienced adverse effects similar in frequency and type to those of adults, except for drowsiness, spasms, or uncontrollable contractions, restlessness, and fatigue, which were very frequent (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 when standing up after sitting or lying down, which were frequent (may affect up to 1 in 100 patients).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Aripiprazol Accord

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

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

The HDPE bottle should be used within 30 days of first opening (for 30-tablet bottles)

The HDPE bottle should be used within 100 days of first opening (for 100-tablet bottles)

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Aripiprazol Accord

• The active ingredient is aripiprazole.

Aripiprazol Accord 5 mg tablets: Each tablet contains 5 mg of aripiprazole.

Aripiprazol Accord 10 mg tablets: Each tablet contains 10 mg of aripiprazole.

Aripiprazol Accord 15 mg tablets: Each tablet contains 15 mg of aripiprazole.

Aripiprazol Accord 30 mg tablets: Each tablet contains 30 mg of aripiprazole.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, cornstarch, hydroxypropylcellulose, magnesium stearate, and carmine indigo (E 132) (for 5 mg), iron oxide red (E 172) (for 10 mg and 30 mg), and iron oxide yellow (E 172) (for 15 mg).

Appearance of the Product and Package Contents

Aripiprazol Accord 5 mg tablets are uncoated blue tablets, approximately 8.1 mm in length and 4.6 mm in width, modified rectangular shape, biconvex, engraved with "A5" on one side, and smooth on the other.

Aripiprazol Accord 10 mg tablets are uncoated pink tablets, approximately 8.1 mm in length and 4.6 mm in width, modified rectangular shape, biconvex, engraved with "A10" on one side, and smooth on the other.

Aripiprazol Accord 15 mg tablets are uncoated yellow round tablets, approximately 7.14 mm in diameter, biconvex, engraved with "A15" on one side, and smooth on the other.

Aripiprazol Accord 30 mg tablets are uncoated yellow round tablets, approximately 9.1 mm in diameter, biconvex, engraved with "A30" on one side, and smooth on the other.

Aripiprazol Accord is presented in perforated unit-dose blisters (aluminum/aluminum) packaged in boxes containing 14 x 1, 28 x 1, 49 x 1, 56 x 1, or 98 x 1 tablets.

Aripiprazol Accord 5/10/15 mg tablets also come in HDPE bottles with PPCRC caps containing 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona,

s/n, Edifici Est 6ª planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

The Netherlands

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice, Poland

Accord Healthcare single member S.A.

64th Km National Road Athens,

Lamia, Schimatari,

32009, Greece

Date of the Last Revision of this Leaflet:

Other Sources of Information

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