Aripiprazole Krka

PACKAGE LEAFLET

Package leaflet: Information for the patient

ARIPIPRAZOLE KRKA 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets

Aripiprazole
Generic medicine
Please read this leaflet carefully before 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 give it to others, 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 KRKA is and what it is used for
2. What you need to know before taking ARIPIPRAZOLE KRKA
3. How to take ARIPIPRAZOLE KRKA
4. Possible side effects
5. How to store ARIPIPRAZOLE KRKA
6. Contents of the pack and other information

1. What ARIPIPRAZOLO KRKA is and what it is used for

ARIPIPRAZOLO KRKA 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, incoherent speech and behaviour, and blunted
emotions. People with this condition may also feel depressed, guilty, anxious or tense.
ARIPIPRAZOLO KRKA is 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, not needing
sleep as 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
ARIPIPRAZOLO KRKA.

2. What you need to know before taking ARIPIPRAZOLO KRKA

Do not take ARIPIPRAZOLO KRKA:

• 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 KRKA.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole. Inform your
doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with ARIPIPRAZOLO KRKA, 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 tired) 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 ischaemic attack (TIA), or blood pressure abnormalities;
• history of blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of excessive gambling.

If you notice weight gain, develop unusual movements, feel drowsy to the point that it interferes with normal daily activities, have difficulty swallowing, or 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 ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience numbness or muscle stiffness with high fever, sweating, altered mental status, 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 may harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as compulsive gambling, compulsive eating, compulsive spending, unusually increased sexual drive, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust the dose or discontinue your treatment.

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 ARIPIPRAZOLO KRKA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Medicines that lower blood pressure: ARIPIPRAZOLO KRKA tablets 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 ARIPIPRAZOLO KRKA tablets with other medicines may mean that your doctor needs to change the dose of ARIPIPRAZOLO KRKA or of the other medicines. It is important to inform your doctor especially if you are taking 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 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 ARIPIPRAZOLO KRKA; consult your doctor if you experience any unusual symptoms while taking any of these medicines together with ARIPIPRAZOLO KRKA.
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;
• 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 amitriptiline) 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 ARIPIPRAZOLO KRKA.

ARIPIPRAZOLO KRKA with food, drinks, and alcohol
This medicine can be taken regardless of food intake.
Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns of mothers who have used aripiprazole during the third trimester (last three months of pregnancy): tremors, 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 ARIPIPRAZOLO KRKA, 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. You should not do both. 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 requiring full alertness, such as driving a vehicle or operating machinery.

ARIPIPRAZOLO KRKA contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take ARIPIPRAZOLE KRKA

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
Treatment may be initiated with a lower dose using the oral solution (liquid) of
aripiprazole. 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.
The appropriate formulation (e.g., 1 mg/ml solution) of ARIPIPRAZOLE KRKA is not
available. An alternative product containing the same active substance must be used.
If you feel that the effect of ARIPIPRAZOLE KRKA is too strong or too weak, consult
your doctor or pharmacist.
Try to take ARIPIPRAZOLE KRKA tablets at the same time each 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 KRKA
without first consulting your doctor.
If you take more ARIPIPRAZOLE KRKA than you should
If you realize you have taken more ARIPIPRAZOLE KRKA than prescribed by your doctor (or if someone else has taken ARIPIPRAZOLE KRKA), 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 an overdose of aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech difficulties;
• 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 somnolence, 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 ARIPIPRAZOLE KRKA
If you miss a dose, take it as soon as you remember, but do not take two doses on the same
day.
If you stop taking ARIPIPRAZOLE KRKA
Do not stop treatment just because you feel better. It is important that you continue taking
ARIPIPRAZOLE KRKA for as long as prescribed by your doctor. If you have any doubts about the use
of 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 sitting,
• uncontrollable contractions, spasms or jerking movements, restless legs,
• tremor,
• headache,
• tiredness,
• drowsiness,
• feeling of light-headedness,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• feeling unwell,
• increased production of saliva,
• vomiting,
• feeling of fatigue.

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

• increased levels of the hormone prolactin in the blood,
• increased 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),
• double vision,
• rapid heartbeat,
• drop in blood pressure upon standing causing dizziness, feeling faint or lightheadedness, or fainting,
• hiccup.

The following side effects have been reported since the beginning of the 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,
• aggression,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and sudden changes in blood pressure and heart rhythm; 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,
• unexplained sudden death,
• life-threatening irregular heartbeat,
• heart attack,
• slow heartbeat,
• blood clots (thrombi, i.e. blood clots in veins), especially in the legs (symptoms include swelling, pain and redness of 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 immediate medical advice),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• muscle spasm around the throat,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal pain,
• stomach ache,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• abnormal liver function test results,
• skin rash,
• sensitivity to light,
• hair loss,
• excessive sweating,
• abnormal muscle breakdown which may lead to 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 condition of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: fluctuations in blood sugar levels, increased glycated haemoglobin,
• inability to resist the impulse, drive 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 hunger).
• 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, increased numbers of deaths have been reported during treatment with 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 type and frequency to those in adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and tiredness, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable movements of limbs, and feeling dizzy, especially when rising from a lying or sitting position, which have been 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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIPIPRAZOLE KRKA

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 packaging after EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 ARIPIPRAZOLE KRKA contains

• The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose (E460), maize starch, hydroxypropyl cellulose (E463), red iron oxide (E172) – only in 10 mg and 30 mg tablets, yellow iron oxide (E172) – only in 15 mg tablets, indigotine (E132) – only in 5 mg tablets, and magnesium stearate (E470b). See section 2 "ARIPIPRAZOLE KRKA contains lactose".

Description of the appearance of ARIPIPRAZOLE KRKA and contents of the pack
5 mg tablets: Blue, round, bevelled-edged tablets with possible darker and lighter spots
(diameter: 5 mm, thickness: 1.4–2.4 mm).
10 mg tablets: Light pink, rectangular tablets with possible darker and lighter spots,
marked "A10" on one side (length: 8 mm, width: 4.5 mm, thickness: 2.1–3.1 mm).
15 mg tablets: Light yellow to brownish-yellow, round, slightly biconvex, bevelled-edged tablets with possible darker and lighter spots, marked "A15" on one side (diameter: 7.5 mm, thickness: 2.5–3.7 mm).
30 mg tablets: Light pink, round, biconvex, bevelled-edged tablets with possible darker and lighter spots, marked "A30" on one side (diameter: 9 mm, thickness: 3.9–5.3 mm).
ARIPIPRAZOLE KRKA is available in cardboard boxes containing 14, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA D.D. Novo Mesto, Smarjeska Cesta 6, Novo Mesto, Slovenia

Local representative in Italy:
KRKA Farmaceutici Milano S.r.l., Viale Achille Papa 30, 20149 Milan, Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names: