Arpoya

Package leaflet: Information for the user

ARPOYA 5 mg tablets, 10 mg tablets, 15 mg tablets

Aripiprazole
Generic medicine
Please read this leaflet carefully before taking this medicine as 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ARPOYA is and what it is used for

ARPOYA contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. It is used to treat adults and adolescents from the age of 15 who have a disorder 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.

ARPOYA is also used to treat adults and adolescents from the age of 13 who have a condition characterized by symptoms such as feeling "high", having excessive energy, needing less sleep than usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents this condition in adults who have responded to treatment with ARPOYA.

2. What you need to know before taking ARPOYA

Do not take ARPOYA

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

Warnings and precautions
Before starting treatment with ARPOYA, inform your doctor if you have

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

If you notice that your weight is increasing, if you develop unusual movements, if you experience drowsiness that interferes with normal daily activities, if you have difficulty swallowing, or if you have 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 a transient ischemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal thoughts and behaviors have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or rigidity with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
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, inform your doctor. These phenomena are called impulse control disorders and may include behaviors such as gambling addiction, excessive eating or spending, abnormally increased sexual desire, or preoccupation due to increased thoughts or sexual 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 ARPOYA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Medicines that lower blood pressure: ARPOYA 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 ARPOYA together with certain medicines may require your doctor to adjust the dose of ARPOYA or of the other medicines. It is particularly 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 effectiveness of ARPOYA. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with ARPOYA.
Medicines that increase serotonin levels 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 depressive disorder
• 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 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 ARPOYA.

ARPOYA with food, drinks, and alcohol
This medicine can be taken regardless of food intake.
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 ARPOYA during the third trimester (last three months of pregnancy): tremor, muscle rigidity and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If the baby shows any of these symptoms, it may be necessary to contact the doctor.
If you are taking ARPOYA, 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 (see section 4) may occur during treatment with this medicine. This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.

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

ARPOYA contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. How to take ARPOYA

Take this medicine exactly as directed 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
This medicine may be started at a lower dose using ABILIFY oral solution (liquid).
The dose may be gradually increased up to the recommended dose for adolescents of 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 ARPOYA is too strong or too weak, talk to your doctor or pharmacist.
Try to take ARPOYA 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 your daily dose of ARPOYA without first consulting your doctor.
If you take more ARPOYA than you should
If you realize you have taken more ARPOYA than prescribed by your doctor (or if someone else has taken ARPOYA), 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 sedation, slowed 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 ARPOYA
If you forget a dose, take it as soon as you remember. Do not take a double dose to make up for the forgotten dose.
If you stop taking ARPOYA
Do not stop treatment just because you feel better. It is important to continue taking ARPOYA for the full duration indicated by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 urge to keep moving),
• uncontrollable muscle contractions, jerking movements or twisting,
• 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 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 upon standing, 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 aggressive,
• 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 well-being, 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 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 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 tests,
• 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 which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests and increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscle tissue which may cause kidney problems,
• muscle pain,
• muscle 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: increased or fluctuating blood sugar levels, increased glycated haemoglobin,
• inability to resist the impulse, drive or temptation to perform 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 during treatment with aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents

Adolescents from the age of 13 years 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 (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable limb movements and dizziness, especially when rising from a lying or sitting position, which were common (more than 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 at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARPOYA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater 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 ARPOYA contains

• The active substance is aripiprazole. Each ARPOYA 5 mg tablet contains 5 mg of aripiprazole. Each ARPOYA 10 mg tablet contains 10 mg of aripiprazole. Each ARPOYA 15 mg tablet contains 15 mg of aripiprazole.
• The other components are: Tablet core: crystalline maltose, microcrystalline cellulose, pregelatinized starch, sodium croscarmellose and magnesium stearate.

Tablet coating:
ARPOYA 5 mg tablets
Indigo carmine (E132)
ARPOYA 10 mg tablets
Red iron oxide (E172)
ARPOYA 15 mg tablets
Yellow iron oxide (E172)

Description of the appearance of ARPOYA and packaging contents
ARPOYA 5 mg tablets are blue to turquoise, mottled, round, biconvex, 6.1 mm in diameter, with "5" engraved on one side.
ARPOYA 10 mg tablets are pink, round, biconvex, 8.1 mm in diameter, with "10" engraved on one side.
ARPOYA 15 mg tablets are yellow, round, biconvex, 10.1 mm in diameter, with "15" engraved on one side.
They are supplied in unit-dose aluminum PA/Alu/PVC-Aluminum blisters packed in cardboard boxes containing 14, 28, 42, 49, 56, 84, 91 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sintesy Pharma S.r.l.
Via G. Mazzini, 20
20123 - Milano (Italy)

Manufacturer
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture, Block No 5,
Rodopi 69300,
Greece
or
Pharmathen S.A.
6, Dervenakion
Pallini 15351
Attiki,
Greece