Patient Information Leaflet

Aripiprazole Aurobindo 5 mg tablets, 10 mg tablets, 15 mg tablets

Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as 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:

What Aripiprazole Aurobindo is and what it is used for
What you need to know before taking Aripiprazole Aurobindo
How to take Aripiprazole Aurobindo
Possible side effects
How to store Aripiprazole Aurobindo
Contents of the pack and other information

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

Aripiprazole Aurobindo 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 are affected by a
condition characterised by symptoms such as hearing, seeing or perceiving things that are not there,
suspiciousness, false beliefs, disorganised speech and behaviour, and blunted emotions. People with this
condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Aurobindo is used to treat adults and adolescents from the age of 13 affected by a condition
characterised by symptoms such as feeling "high", having an excessive amount of energy, needing much
less sleep than usual, talking very rapidly with "racing thoughts", and sometimes severe irritability. In
addition, it prevents the recurrence of this condition in adults who have responded to treatment with
Aripiprazole Aurobindo.

2. What you should know before taking Aripiprazole Aurobindo

Do not take Aripiprazole Aurobindo:

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 Aurobindo 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 diseases, family history of cardiovascular diseases, stroke or "mini" strokes, abnormal blood pressure;
blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation;
a past history of excessive gambling;
aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in ability to move and maintain balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise debilitated.

If you notice that your weight is increasing, if you develop unusual movements, if you experience drowsiness interfering 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/a family member should inform your doctor if you have previously had a "mini" stroke or transient ischemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, altered mental status, 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 Aurobindo
Inform 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 Aurobindo 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 Aurobindo together with other medicines may require adjustment of the dose of Aripiprazole Aurobindo. 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 for the treatment of 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), meperidine, St. John’s wort, and venlafaxine. These medicines increase the risk of side effects; if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Aurobindo, you should consult your doctor.

Aripiprazole Aurobindo with food, drinks and alcohol
Aripiprazole Aurobindo can be taken regardless of food intake.
Alcohol should be avoided when taking Aripiprazole Aurobindo.

Pregnancy, breastfeeding and fertility
If you are pregnant, think 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 taken Aripiprazole Aurobindo during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the baby shows any of these symptoms, it may be necessary to contact the doctor.
Inform your doctor immediately if you are breastfeeding.
If you are taking Aripiprazole Aurobindo, you must not breastfeed.

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

Aripiprazole Aurobindo contains lactose monohydrate.
If your doctor has informed you that you are intolerant to certain sugars, contact him before taking this medicine.

3. How to take Aripiprazole Aurobindo

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 with this medicine may be started at a low dose using the oral solution (liquid). The dose may then 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 Aripiprazole Aurobindo is too strong or too weak, consult your doctor or pharmacist.
Try to take the Aripiprazole Aurobindo tablet at the same time every day. It does not matter whether you take it with or without food. Always take the tablet with water, swallowing it whole.
Even if you feel well, do not change or stop the daily dose of Aripiprazole Aurobindo without first consulting your doctor.
If you take more Aripiprazole Aurobindo than you should
If you realize you have taken more tablets of Aripiprazole Aurobindo than your doctor has recommended (or if someone else has taken some of your tablets), contact your doctor immediately.
If you cannot reach your doctor, go to the nearest hospital and take the packaging with you.
If you forget to take Aripiprazole Aurobindo
If you forget a dose, take it as soon as you remember. However, do not take two doses on the same day.
If you stop taking Aripiprazole Aurobindo
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Aurobindo 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

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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
uncontrollable contractions, spasms, jerking movements, restlessness in the legs
tremors
headache
tiredness
drowsiness
mild confusion
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, or limbs (tardive dyskinesia)
a muscle disorder causing twisting movements (dystonia)
double vision
rapid heartbeat
drop in blood pressure when standing up, causing dizziness, mild confusion, or fainting
hiccups

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 in the blood
low levels of platelets in the blood
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, attempted suicide, and suicide
excessive gambling
feeling of aggression
agitation
nervousness
a combination of fever, muscle stiffness, rapid breathing, sweating, reduced level of consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome) 4 of 7
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
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 immediate medical advice)
high blood pressure
fainting
accidental inhalation of food with risk of pneumonia (lung infection)
muscle spasm around the vocal cords
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
abnormal liver function test results
skin rash
sensitivity to light
hair loss
excessive sweating
abnormal breakdown of muscle tissue 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 conditions of excessive heat
chest pain
swelling of the hands, ankles, or feet
in blood tests: changes in blood sugar levels, increased levels of glycated haemoglobin
eyes fixed in one position

In elderly patients with dementia, more 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 type and frequency to adults, except that drowsiness, uncontrollable muscle contractions or jerking movements, restlessness, and fatigue have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contractions, uncontrollable limb movements, and dizziness—especially when rising from a lying or sitting position—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.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 Aripiprazole Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack 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 Aripiprazolo Aurobindo contains

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole. Each tablet contains 10 mg of aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other components are monohydrate lactose, microcrystalline cellulose, maize starch, indigo carmine aluminium lake (E132) (only for the 5 mg strength), hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Aripiprazolo Aurobindo and pack contents
Tablet.
Aripiprazolo Aurobindo 5 mg tablets
Blue, modified rectangular, uncoated tablets, embossed with "62" on one side and "H" on the other side. Tablet size is 8 mm x 4.5 mm.
Aripiprazolo Aurobindo 10 mg tablets
White, modified rectangular, uncoated tablets, embossed with "63" on one side and "H" on the other side. Tablet size is 8 mm x 4.5 mm.
Aripiprazolo Aurobindo 15 mg tablets
White, round tablets (7 mm diameter), uncoated, embossed with "64" on one side and "H" on the other side.
Aripiprazolo Aurobindo tablets are available in blister packs made of
Polyamide/Aluminium/PVC/Aluminium foil.
Pack sizes: 14 and 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l., via San Giuseppe 102, 21047 Saronno (VA)

Manufacturer
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APL Swift Services (Malta) Ltd., HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Ltd., Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Aripiprazol Aurovitas
Italy: Aripiprazolo Aurobindo
Spain: Aripiprazol Aurovitas 5 mg/10 mg/15 mg tablets EFG
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