ARIPIPRAZOLO 5 mg Tablet

Зміст інструкції

1. Aripiprazolo Accord 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets
   1. What is Aripiprazolo Accord and what it is used for
   2. What you need to know before taking Aripiprazolo Accord
   3. How to take Aripiprazolo Accord
   4. Possible side effects
   5. How to store Aripiprazolo Accord
   6. Package Contents and Other Information
2. Aripiprazolo Accord 5 mg tablets: Each tablet contains 5 mg of aripiprazole, 10 mg tablets: Each tablet contains 10 mg of aripiprazole, 15 mg tablets: Each tablet contains 15 mg of aripiprazole.

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

aripiprazolo

Read 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 others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazolo Accord contains the active ingredient aripiprazole and belongs to a group of medicines
called antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who
suffer from schizophrenia, a disease characterized by symptoms such as hearing, seeing or perceiving things
that are not present, suspicion, false beliefs, incoherent speech and behavior, and
flattening of emotions. People with this condition may also feel
depressed, guilty, anxious or tense.
This medicine is used for the treatment of adults and adolescents starting from 13 years of age who are
affected by Bipolar Disorder type I, a condition characterized by symptoms such as feeling “up
” , having excessive energy, not needing to sleep as usual, talking very
quickly with “flight of ideas” and sometimes severe irritability. In addition, it prevents this condition in
adults who have responded to treatment with this medicine.

2. What you need to know before taking Aripiprazolo Accord

Do not take Aripiprazolo 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 Aripiprazolo Accord.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole. Tell your
doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Accord, tell your doctor if you suffer from

• high blood sugar levels (characterised by symptoms such as excessive thirst, producing 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 movements, especially of the face
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots
• previous experience of excessive gambling

If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which
interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic
symptoms, tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or
your caregiver must inform the doctor if you have had a stroke or a
transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Thoughts of suicide, attempted suicide have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever,
sweating, altered mental status or a very fast or irregular heartbeat.
Tell 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 are unable to resist the impulse, urge or temptation to carry out certain activities that could harm yourself or others. Such
phenomena are called impulse control disorders and may include behaviours such as
gambling addiction, excessive eating or spending, unusually high sexual drive or preoccupation with sexual thoughts or sensations.
Your doctor may need to adjust your dose or stop your therapy.
Aripiprazolo can cause drowsiness, low blood pressure when getting up,
dizziness and changes in your ability to move and stay balanced, which can lead to
falls. Be careful, especially if you are elderly or in some way debilitated.

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

Other medicines and Aripiprazolo 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: Aripiprazolo Accord can increase the effect of
medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to
control your blood pressure.
Taking Aripiprazolo Accord together with other medicines may mean that your doctor will need to
change the dose of Aripiprazolo Accord or the other medicines. It is particularly important
to tell your doctor about the following medicines:

• medicines 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 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 Aripiprazolo
Accord. Consult your doctor if you experience any unusual symptoms while taking any of
these medicines together with Aripiprazolo Accord.
The medicines that increase the level of serotonin are typically used in conditions such as
depression, generalized 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, generalized 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;
• pain relievers (e.g. tramadol and pethidine) used to relieve pain;
• triptans (e.g. sumatriptan and zolmitriptan) used for the treatment of 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
Aripiprazolo Accord.

Aripiprazolo Accord with food, beverages and alcohol
This medicine can be taken independently of food.
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used this medicine
in the last trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness,
drowsiness, agitation, breathing problems, and feeding difficulties. If the baby presents any
of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Accord, your doctor will discuss with you whether you should breastfeed, considering the
benefit you receive from the therapy 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 operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where full alertness is required, for
example when driving a vehicle or operating machinery.

Aripiprazolo Accord contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.

3. How to take Aripiprazolo Accord

Take Aripiprazolo Accord following the instructions of your doctor or pharmacist exactly. If you
have any doubts, ask your doctor or pharmacist.

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

Use in children and adolescents
To allow treatment to start at a lower dose, an alternative pharmaceutical form more appropriate (oral solution – liquid) may be used instead of
Aripiprazolo Accord tablets.
The dose may be gradually increased to the recommended dose for adolescents, which is 10 mg
once a day. However, your doctor may prescribe a lower or higher dose up to
a maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Accord is too strong or too weak, talk to your
doctor or pharmacist.

Try to take Aripiprazolo Accord every day at the same time. 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 Aripiprazolo Accord without
first consulting your doctor.

If you take more Aripiprazolo Accord than you should
If you realize that you have taken more Aripiprazolo Accord than your doctor recommended
(or if someone else has taken Aripiprazolo Accord), contact your doctor immediately. If
you cannot reach your doctor, go to the nearest hospital and take the packaging 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 sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

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

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

If you stop taking Aripiprazolo Accord
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Accord for the entire period indicated by your doctor.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aripiprazolo Accord can cause side effects, although not everyone gets them.
Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
• uncontrollable muscle contractions, jerky or twisting movements, ,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling lightheaded,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty evacuating,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

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

• increase or decrease in the levels of the hormone prolactin in the blood,
• high blood sugar levels,
• depression,
• alteration or increase in sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heart rate,
• low blood pressure when getting up, which causes dizziness, lightheadedness or fainting,
• hiccups.

The following side effects have been reported since aripiprazole oral was launched but the frequency with which they have occurred is not known:

• 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 diabetic condition, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar levels,
• low sodium level in the blood;
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, attempted suicide and suicide,
• feeling aggressive
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• speech disorder,
• eyeballs fixed in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing (if you notice any of these symptoms, seek medical advice immediately);
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• spasm of the muscles around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and the whites of the eyes,
• cases of abnormal liver function test values;
• 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 manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns in case of exposure 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 of 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:
• strong urge to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example an increase in sexual drive
• excessive and uncontrollable shopping or spending
• binge 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 your appetite)
• tendency to wander. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the intake of 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 had side effects similar in frequency and type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue 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, uncontrollable movements of the limbs and feeling dizzy, especially when getting up from a lying or sitting position, which were common (may affect up to 1 in 100 patients).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Accord

Keep Aripiprazolo Accord out of the sight and reach of children.
Do not use Aripiprazolo Accord after the expiry date which is stated on the blister or the label and on the
box after “Scad.” or “EXP”. The expiry date refers to the last day of that month.
This medicinal product does not require any particular storage conditions.
The package with HDPE bottle must be used within 30 days of first opening. (for 30)
The package with HDPE bottle must be used within 100 days of first opening. (for
100)
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Aripiprazolo Accord Contains

• The active ingredient is aripiprazole.

Aripiprazolo Accord 5 mg tablets: Each tablet contains 5 mg of aripiprazole, 10 mg tablets: Each tablet contains 10 mg of aripiprazole, 15 mg tablets: Each tablet contains 15 mg of aripiprazole.

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

• The other ingredients are lactose monohydrate, microcrystalline cellulose, corn starch, hydroxypropyl cellulose, magnesium stearate and indigotine (E 132) aluminum 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 package contents
Aripiprazolo Accord 5 mg tablets: blue, uncoated biconvex tablets approximately 8.1 mm in
length and 4.6 mm in width, modified rectangular in shape, with "A5" imprinted on one side and
the other side smooth.
Aripiprazolo Accord 10 mg tablets: pink, uncoated biconvex tablets approximately 8.1 mm in
length and 4.6 mm in width, modified rectangular in shape, with "A10" imprinted on one side and
the other side smooth.
Aripiprazolo Accord 15 mg tablets: yellow, uncoated biconvex tablets approximately 7.14 mm in
diameter, round in shape with beveled edges, with "A15" imprinted on one side and the other side smooth.
Aripiprazolo Accord 30 mg tablets: pink, uncoated biconvex tablets approximately 9.1 mm in
diameter, round in shape with beveled edges, with "A30" imprinted on one side and the other side smooth.
The tablets of Aripiprazolo Accord 5/10/15/30 mg are available in blisters
(Aluminum/Aluminum) divisible for single doses in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1 or
98 x 1 tablets.
The tablets of Aripiprazolo Accord 5/10/15 mg 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,
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.