Aripiprazole EG

Package leaflet: Information for the user

ARIPIPRAZOLE EG 5 mg tablets

Aripiprazole
Generic medicine
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 you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

ARIPIPRAZOLO EG 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 are affected by 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.

ARIPIPRAZOLO EG is also used to treat adults and adolescents aged 13 years and older who are affected by a condition characterized by symptoms such as feeling "high", having excessive energy, reduced need for sleep compared to usual, speaking very rapidly with "racing thoughts", and sometimes severe irritability. In addition, it prevents relapse of this condition in adults who have responded to treatment with ARIPIPRAZOLO EG.

2. What you need to know before taking ARIPIPRAZOLE EG

DO NOT take ARIPIPRAZOLE EG

• 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 EG 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;
• seizures;
• irregular, involuntary muscle movements, especially of the face;
• cardiovascular disorders, family history of cardiovascular disorders, stroke or transient ischemic attack, abnormal blood pressure;
• blood clots (venous thrombosis) or family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of excessive gambling.

If you notice that you are gaining weight, develop unusual movements, feel drowsiness that 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 a "mini" stroke.
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 numbness or muscle stiffness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

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 EG
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Medicines that lower blood pressure
Aripiprazole may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control blood pressure.
If you take ARIPIPRAZOLE EG with other medicines, it may be necessary to adjust the dose of ARIPIPRAZOLE EG. It is important to inform your doctor, especially if you are taking the following medicines:

• medicines that regulate heart rhythm;
• antidepressants or herbal remedies used to treat depression and anxiety;
• antifungal agents;
• certain medicines used to treat HIV infection;
• anticonvulsants used to treat epilepsy.

Medicines that increase serotonin levels
Triptans, tramadol, tryptophan, Selective Serotonin Reuptake Inhibitors [SSRIs (such as paroxetine and fluoxetine)], tricyclics (such as clomipramine, amitriptyline), pethidine, St. John's wort, and venlafaxine. These medicines increase the risk of adverse effects; if you experience any unusual symptoms while taking any of these medicines together with ARIPIPRAZOLE EG, you should consult your doctor.

ARIPIPRAZOLE EG with food, drinks, and alcohol
ARIPIPRAZOLE EG can be taken regardless of food intake.
Avoid alcohol consumption.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
The following symptoms may occur in newborns whose mothers have used aripiprazole 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.
Inform your doctor immediately if you are breastfeeding.
If you are taking ARIPIPRAZOLE EG, you must not breastfeed.

Driving and using machines
Do not drive or operate tools or machinery until you know how ARIPIPRAZOLE EG affects you.

ARIPIPRAZOLE EG 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 EG

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults
The recommended dose in 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
Aripiprazole treatment may be initiated at a lower dose using the oral (liquid) solution. If an oral
solution is needed, your doctor will recommend another aripiprazole-containing product. The dose
may be gradually increased 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 effects of ARIPIPRAZOLE EG are too strong or too weak, consult your
doctor or pharmacist.
Method of administration
Try to take the ARIPIPRAZOLE EG tablet 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 EG without first
consulting your doctor.
If you take more ARIPIPRAZOLE EG than you should
If you realize that you have taken more ARIPIPRAZOLE EG tablets than prescribed (or if someone else
has taken some of your ARIPIPRAZOLE EG tablets), contact your doctor immediately. If you cannot
reach your doctor, go to the nearest hospital and bring the packaging with you.
If you forget to take ARIPIPRAZOLE EG
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
Do not take a double dose to make up for a forgotten dose.
If you stop taking ARIPIPRAZOLE EG
Do not stop treatment just because you feel better. It is important to continue taking
ARIPIPRAZOLE EG for the entire period 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 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 remain still, difficulty staying seated;
• uncontrollable muscle contractions, jerky movements or twisting motions, restlessness in the legs;
• tremors;
• headache;
• tiredness;
• drowsiness;
• feeling lightheaded;
• 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;
• change or increase in 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, lightheadedness, or fainting;
• hiccups.

Not known (frequency cannot be estimated from the available data):
The following side effects have been reported since the start of oral aripiprazole marketing, 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;
• excessive gambling;
• feeling aggressive;
• agitation;
• nervousness;
• a 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;
• unexplained sudden death;
• potentially fatal irregular heartbeat;
• heart attack;
• slow 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);
• muscle spasms 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;
• sensitivity to light;
• hair loss;
• excessive sweating;
• 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: fluctuations in blood sugar levels, increased glycosylated haemoglobin. In elderly patients with dementia, increased numbers of fatal cases 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 frequency and type to those in adults, except for the following:
Very common side effects (may affect more than 1 in 10 people):
drowsiness, uncontrollable muscle contractions or jerky movements, restlessness, and tiredness.
Common side effects (may affect up to 1 in 10 people):
upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable movements of limbs, and dizziness, especially when rising from a lying or sitting position.

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/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIPIPRAZOLE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
This medicine does not require any special storage temperature.
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 ARIPIPRAZOLE EG contains

• The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
• The other components are mannitol, maltodextrin, microcrystalline cellulose, crospovidone type B (Ph. Eur.), sodium bicarbonate, tartaric acid, anhydrous colloidal silica, sodium saccharin (E954), vanilla cream flavour (flavouring substances, natural flavouring substances, lactose, magnesium carbonate hydroxide), magnesium stearate (Ph. Eur.), indigo carmine aluminium lake (E 132).

Description of the appearance of ARIPIPRAZOLE EG and contents of the pack
ARIPIPRAZOLE EG 5 mg tablets are supplied as round, flat, light blue tablets with scattered specks and a diameter of 6 mm.
They are available in blisters packed in cardboard boxes containing 14, 28, 49, or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 - Milan, Italy

Manufacturers
STADA Arzneimittel AG, Stadastrasse 2 – 18, 61118 Bad Vilbel (Germany)
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary (Ireland)

This medicinal product is authorized in the Member States of the European Economic Area under the following names: