Aripiprazole Accord

Package leaflet: Information for the user

Aripiprazole Accord 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets

aripiprazole

Please 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 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 be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Aripiprazole Accord is and what it is used for

Aripiprazole Accord 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
schizophrenia, a condition characterized by symptoms such as hearing, seeing, or perceiving things
that are not present, suspiciousness, false beliefs, disorganized speech and behavior, and blunted
emotions. People with this condition may also feel depressed, guilty, anxious, or tense.
This medicine is also used to treat adults and adolescents aged 13 years and older who have Bipolar
Disorder Type I, a condition characterized by symptoms such as feeling "over-excited", having excessive
energy, reduced need for sleep compared to usual, speaking very rapidly with "racing thoughts", and
sometimes severe irritability. In addition, it prevents recurrence of this condition in adults who have
responded to treatment with this medicine.

2. What you need to know before taking Aripiprazole Accord

Do not take Aripiprazole Accord

• 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 before taking Aripiprazole Accord.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Immediately inform your doctor if you experience any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Accord, inform your doctor if you have:

• high blood sugar levels (characterised by symptoms such as excessive thirst, production of large amounts of urine, increased appetite and feeling tired) or a family history of diabetes
• epilepsy (seizures), as your doctor may decide to monitor you more closely
• irregular, involuntary muscle movements, especially of the face
• cardiovascular diseases (heart and circulatory diseases), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities
• a history of blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation
• a previous history of excessive gambling

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy to the point that it interferes with your normal daily activities, if you have difficulty swallowing, or if you experience allergic symptoms, inform your doctor.
If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal thoughts and attempted suicide have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or rigidity with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as gambling addiction, binge eating, excessive spending, abnormally increased sex drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

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 Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: Aripiprazole Accord may enhance the effect of medicines used to lower blood pressure. Inform your doctor if you are taking a medicine to control your blood pressure.
Taking Aripiprazole Accord together with other medicines may mean that your doctor needs to change the dose of Aripiprazole Accord or of the other medicines. It is especially important to inform your doctor about the following medicines:

• medicines used to correct heart rhythm (e.g. quinidine, amiodarone, flecainide)
• antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John’s wort)
• antifungal medicines (e.g. ketoconazole, itraconazole)
• some medicines used to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor such as indinavir, ritonavir)
• anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital)
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Accord. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Accord.
Medicines that increase serotonin levels are typically used in conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used in conditions such as depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain
• selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine) used for depression, OCD, panic and anxiety
• other antidepressants (e.g. venlafaxine and tryptophan) used in major depression
• tricyclics (e.g. clomipramine and amitriptyline) used for depressive illness
• St John’s wort (Hypericum perforatum), used as a herbal remedy for mild depression
• painkillers (e.g. tramadol and meperidine) used to relieve pain
• triptans (e.g. sumatriptan and zolmitriptan) used to treat migraine

These medicines may increase the risk of side effects. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Accord.

Aripiprazole Accord with food, drinks and alcohol
This medicine can be taken with or without food.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns of mothers who have used this medicine during the third trimester (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Accord, your doctor will discuss with you whether you should breastfeed, considering the benefit you receive from the treatment and the benefit to the baby from breastfeeding. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations where full alertness is required, for example when driving a vehicle or operating machinery.

Aripiprazole Accord contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Aripiprazole Accord

Take Aripiprazole Accord exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.

Use in children and adolescents
To allow treatment to start at a lower dose, an alternative, more suitable pharmaceutical form (oral liquid solution) may be used instead of Aripiprazole Accord tablets.
The dose may be gradually increased up to the recommended dose for adolescents, which is 10 mg once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.

If you feel that the effect of Aripiprazole Accord is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Accord at the same time every day. It does not matter whether you take it with food or not. Always take the tablet with water, swallowing it whole.
Even if you feel well, do not change or stop the daily dose of Aripiprazole Accord without first consulting your doctor.

If you take more Aripiprazole Accord than you should
If you realize that you have taken more Aripiprazole Accord than prescribed by your doctor (or if someone else has taken this medicine), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and bring the package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems;
• unusual movements (especially of the face or tongue), and reduced level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness or lethargy, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.

If you forget to take Aripiprazole Accord
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.

If you stop taking Aripiprazole Accord
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Accord for the entire duration indicated by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aripiprazole Accord can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to sit still, difficulty remaining seated,
• akathisia (an unpleasant sensation of inner restlessness and an irresistible need to keep moving),
• uncontrollable muscle contractions, jerking movements or twisting motions,
• tremors,
• headache,
• tiredness,
• drowsiness,
• feeling of light-headedness,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of fatigue.

Uncommon side effects (may affect up to 1 in 100 people):

• increased or decreased levels of the hormone prolactin in the blood,
• 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),
• restlessness in the legs,
• double vision,
• sensitivity of the eyes to light,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, light-headedness or fainting,
• hiccups.

The following side effects have been reported since the start of marketing of oral aripiprazole, but their frequency is unknown:

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt and suicide,
• feeling of aggression,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• unexplained sudden death,
• potentially fatal irregular heartbeat,
• heart attack,
• slowed 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 breathing difficulties (if you experience any of these symptoms, seek medical advice immediately);
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• cases of abnormal liver function test results;
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face that then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and an increase in a type of white blood cell (eosinophilia),
• abnormal breakdown of muscle tissue which may cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling internal body temperature or conditions of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: fluctuation in blood sugar levels, increased glycated haemoglobin.
• inability to resist the impulse, urge or temptation to carry out an action that could be harmful to oneself or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example increased sexual drive,
  • excessive and uncontrollable shopping or spending,
  • uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy appetite),
  • tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been more reports of fatal cases while taking aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and older have experienced side effects similar in frequency and type to those in adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and tiredness, which were very common (may affect more than 1 in 10 patients), and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled limb movements, and feeling dizzy, especially when standing up from lying down or sitting positions, which were common (may affect up to 1 in 100 patients).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aripiprazole Accord

Keep Aripiprazole Accord out of the sight and reach of children.
Do not use Aripiprazole Accord after the expiry date stated on the blister or label and on the
carton after “Exp.” or “EXP.”. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
The HDPE bottle pack must be used within 30 days of first opening. (for 30)
The HDPE bottle pack must be used within 100 days of first opening. (for
100)
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Accord contains

• The active substance is aripiprazole. Aripiprazolo Accord 5 mg tablets: Each tablet contains 5 mg of aripiprazole. Aripiprazolo Accord 10 mg tablets: Each tablet contains 10 mg of aripiprazole. Aripiprazolo Accord 15 mg tablets: Each tablet contains 15 mg of aripiprazole. Aripiprazolo Accord 30 mg tablets: Each tablet contains 30 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose, maize starch, hydroxypropyl cellulose, magnesium stearate, and indigotine (E 132) aluminium lake (for 5 mg) or red iron oxide (E172) (for 10 mg and 30 mg) or yellow iron oxide (E172) (for 15 mg).

Description of the appearance of Aripiprazolo Accord and contents of the pack
Aripiprazolo Accord 5 mg tablets: blue, biconvex, uncoated tablets of approximately 8.1 mm in length and 4.6 mm in width, modified rectangular shape, imprinted with "A5" on one side and the other side smooth.
Aripiprazolo Accord 10 mg tablets: pink, biconvex, uncoated tablets of approximately 8.1 mm in length and 4.6 mm in width, modified rectangular shape, imprinted with "A10" on one side and the other side smooth.
Aripiprazolo Accord 15 mg tablets: yellow, biconvex, uncoated tablets of approximately 7.14 mm in diameter, round shape with bevelled edges, imprinted with "A15" on one side and the other side smooth.
Aripiprazolo Accord 30 mg tablets: pink, biconvex, uncoated tablets of approximately 9.1 mm in diameter, round shape with bevelled edges, imprinted with "A30" on one side and the other side smooth.
Aripiprazolo Accord 5/10/15/30 mg tablets are available in blisters (aluminium/aluminium), divisible into single doses, packed in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1 or 98 x 1 tablets.
Aripiprazolo Accord 5/10/15 mg tablets are also available in HDPE bottles with PPCRC closure containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF,
United Kingdom
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

Other sources of information
More detailed information on Aripiprazolo Accord is available on the website of the European Medicines Agency: http://www.ema.europa.eu.