Package leaflet: Information for the user

Aripiprazole Sandoz 5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets, 30 mg tablets

aripiprazole
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 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazole Sandoz 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 present,
suspiciousness, false beliefs, disorganised speech and behaviour, and flattening of emotions. People with
this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Sandoz is also used to treat adults and adolescents from the age of 13 affected by a
condition characterised 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 the recurrence of this condition in adults who have responded to
treatment with Aripiprazole Sandoz.

2. What you should know before taking Aripiprazole Sandoz

Do not take Aripiprazole Sandoz

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 Sandoz.
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 Aripiprazole Sandoz, 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 circulation problems), family history of cardiovascular disease, stroke or transient ischaemic attack (TIA), or blood pressure abnormalities;
a history of 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 you are gaining weight, develop unusual movements, feel drowsiness that interferes with your 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), 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 state, 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 called impulse control disorders and may include behaviours such as gambling addiction, excessive eating or spending, abnormally increased sexual drive, or preoccupation due to increased sexual thoughts or feelings.
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 movement 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 Aripiprazole Sandoz
Tell 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: Aripiprazole Sandoz 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 Sandoz with other medicines may require your doctor to adjust the dose of Aripiprazole Sandoz or of the other medicines. It is particularly important to inform your doctor about the following medicines:

medicines used to regulate 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 Aripiprazole Sandoz. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Sandoz.
Medicines that increase serotonin levels are typically used to treat conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

triptans, tramadol, and tryptophan used for depression, generalized anxiety disorder, OCD, social phobia, 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;
painkillers (e.g. tramadol and pethidine) 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 Aripiprazole Sandoz.

Aripiprazole Sandoz with food, drinks, and alcohol
Aripiprazole Sandoz can be taken with or without food.
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 whose mothers have taken Aripiprazole Sandoz during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing problems, and feeding difficulties. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Sandoz, 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 may occur during treatment with this medicine (see section 4). This should be taken into account in situations where full alertness is required, for example when driving a vehicle or operating machinery.

Aripiprazole Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Aripiprazolo Sandoz

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 or using an alternative formulation (oral solution – liquid), which may be more suitable than Aripiprazolo Sandoz. 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 Aripiprazolo Sandoz is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazolo Sandoz 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 Aripiprazolo Sandoz without first consulting your doctor.
If you take more Aripiprazolo Sandoz than you should
If you realize you have taken more Aripiprazolo Sandoz than your doctor has prescribed (or if someone else has taken it), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the package 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, 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 Sandoz
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aripiprazolo Sandoz
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazolo Sandoz 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

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 stay still, difficulty remaining seated,
akathisia (an unpleasant sensation of inner restlessness and an irresistible urge to keep moving),
uncontrollable muscle contractions, jerky movements or twisting,
tremors,
headache,
fatigue,
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 tiredness.

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

increased or decreased 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),
a muscular disorder causing twisting movements (dystonia),
restlessness in the legs,
double vision,
sensitivity of the eyes to light,
rapid heartbeat,
drop in blood pressure when standing up, 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 of aggressiveness,
agitation,
nervousness,
combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, and 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,
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 experience any of these symptoms, seek immediate medical advice),
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 test results,
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 skin 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,
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: fluctuation in blood sugar levels, increased glycated haemoglobin, inability to resist the impulse, drive or temptation to perform an action that may 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.

In elderly patients with dementia, there have been reports of increased fatal cases while taking 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 drowsiness, uncontrollable muscle contractions or jerky movements, restlessness and fatigue, which have been very common (more than 1 in 10 patients), and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrolled limb movements and dizziness, 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. Details are provided in Annex V. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Aripiprazole Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle, and carton after “Exp.” or “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Use within 3 months after first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Aripiprazole Sandoz contains
Aripiprazole Sandoz 5 mg tablets

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, indigotine (E 132) aluminium lake.

Aripiprazole Sandoz 10 mg tablets

The active substance is aripiprazole. Each tablet contains 10 mg of aripiprazole.
The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E 172).

Aripiprazole Sandoz 15 mg tablets

The active substance is aripiprazole. Each tablet contains 15 mg of aripiprazole.
The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, yellow iron oxide.

Aripiprazole Sandoz 20 mg tablets

The active substance is aripiprazole. Each tablet contains 20 mg of aripiprazole.
The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate.

Aripiprazole Sandoz 30 mg tablets

The active substance is aripiprazole. Each tablet contains 30 mg of aripiprazole.
The other ingredients are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E 172).

Description of the appearance of Aripiprazole Sandoz and package contents
Aripiprazole Sandoz 5 mg tablets
Aripiprazole Sandoz 5 mg tablets are mottled blue, round-shaped, with an approximate diameter of 6.0 mm, marked with “SZ” on one side and “444” on the other side.

Aripiprazole Sandoz 10 mg tablets
Aripiprazole Sandoz 10 mg tablets are mottled pink, round-shaped, with an approximate diameter of 6.0 mm, marked with “SZ” on one side and “446” on the other side.

Aripiprazole Sandoz 15 mg tablets
Aripiprazole Sandoz 15 mg tablets are mottled yellow, round-shaped, with an approximate diameter of 7.0 mm, marked with “SZ” on one side and “447” on the other side.

Aripiprazole Sandoz 20 mg tablets
Aripiprazole Sandoz 20 mg tablets are white, round-shaped, with an approximate diameter of 7.8 mm, marked with “SZ” on one side and “448” on the other side.

Aripiprazole Sandoz 30 mg tablets
Aripiprazole Sandoz 30 mg tablets are mottled pink, round-shaped, with an approximate diameter of 9.0 mm, marked with “SZ” on one side and “449” on the other side.

The 5 mg, 10 mg, 15 mg and 30 mg tablets are available in the following pack sizes:
Aluminum/aluminum blisters in cartons containing 10, 14, 16, 28, 30, 35, 56 or 70 tablets.
Unit-dose divisible aluminum/aluminum blisters in cartons containing 14 x 1, 28 x 1, 49 x 1, 56 x 1 or 98 x 1 tablets.
HDPE bottles containing silica gel as desiccant and filler material in cartons containing 100 tablets.

The 20 mg tablets are available in blisters in cartons containing 14, 28, 49, 56 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
S.C. Sandoz, S.R.L.
Str. Livezeni nr. 7A
Târgu Mureş 540472
Romania
Lek S.A.
ul. Domaniewska 50 C
02-672 Warszawa
Poland

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Sandoz nv/sa Sandoz Pharmaceuticals d.d. filialas
Medialaan 40 Šeimyniškių 3A,
B-1800 Vilvoorde LT 09312 Vilnius
Tél/Tel.: +32 2 722 97 97 Tel: +370 5 26 36 037
[email protected] [email protected]

България Luxembourg/Luxemburg
Regulatory Affairs Department Sandoz nv/sa
Branch Office Sandoz d.d. Medialaan 40
55 Nikola Vaptzarov blvd. B-1800 Vilvoorde
Building 4, floor 4 Tél/Tel.: +32 2 722 97 97
1407 Sofia, Bulgaria [email protected]
Teл.: + 359 2 970 47 47
[email protected]

Česká republika Magyarország
Sandoz s.r.o. Sandoz Hungária Kft.
Na Pankráci 1724/129 Tel.: +36 1 430 2890
CZ-140 00 Praha 4 - Nusle
Tel: +420 225 775 111
[email protected]

Danmark Malta
Sandoz A/S Sandoz Pharmaceuticals d.d.
Edvard Thomsens Vej 14 Tel: +356 21222872
DK-2300 København S

Deutschland Nederland
Hexal AG Sandoz B.V.
Industriestrasse 25 Veluwezoom 22
D-83607 Holzkirchen NL-1327 AH Almere
Tel: +49 8024 908 0 Tel: +31 36 5241600
E-mail: [email protected] [email protected]

Eesti Norge
Sandoz d.d. Eesti filiaal Sandoz A/S
Pärnu mnt105 Edvard Thomsens Vej 14
EE-11312 Tallinn DK-2300 København S
Tel.: +372 665 2400 Danmark
[email protected] Tlf: + 45 6395 1000
[email protected]

Ελλάδα Österreich
Novartis (Hellas) A.E.B.E. Sandoz GmbH
Τηλ: +30 210 281 17 12 Biochemiestr. 10
A-6250 Kundl
Tel: +43 5338 2000

España Polska
Sandoz Farmacéutica, S.A. Sandoz Polska Sp. z o.o.
Centro empresarial Parque Norte ul. Domaniewska 50C
Edificio Roble 02-672 Warszawa
C/Serrano Galvache, N°56 Tel.: + 48 22 209 70 00
28033 Madrid [email protected]

France Portugal
Sandoz SAS Sandoz Farmacêutica Lda.
49 Avenue Georges Pompidou Avenida Professor Doutor Cavaco Silva, n.º 10E
92300 Levallois-Perret Taguspark
Tél: + 33 1 49 64 48 00 2740-255 Porto Salvo
Tel: +351 21 196 40 00

Hrvatska România
Sandoz d.o.o. Sandoz S.R.L.
Maksimirska 120 Str. Livezeni nr.7A,
10000 Zagreb 540472 Târgu Mureş
Tel: + 385 1 2353111 +40 21 4075160
e-mail: [email protected]

Ireland Slovenija
Rowex Ltd., Lek farmacevtska družba d.d.
Bantry, Co. Cork, Verovškova ulica 57
Ireland, 1526 Ljubljana
P75 V009 Tel: +386 1 580 21 11
Tel: + 353 27 50077
e-mail: [email protected]

Ísland Slovenská republika
Sandoz A/S Sandoz d.d. organizačná zložka
Edvard Thomsens Vej 14 Žižkova 22B
DK-2300 Kaupmaannahöfn S SK-811 02 Bratislava
Danmörk Tel: + 421 2 50 706 111
Tlf: + 45 6395 1000 [email protected]
[email protected]

Italia Suomi/Finland
Sandoz S.p.A Sandoz A/S
Largo Umberto Boccioni 1 Edvard Thomsens Vej 14
I - 21040 Origgio/VA DK-2300 Kööpenhamina S
Tel: + 39 02 96541 Danmark
Puh: + 358 010 6133 400
[email protected]

Κύπρος Sverige
Sandoz Pharmaceuticals d.d. Sandoz A/S
Τηλ: +357 22 69 0690 Edvard Thomsens Vej 14
DK-2300 Köpenhamn S
Danmark
Tel: + 45 6395 1000
[email protected]

Latvija United Kingdom (Northern Ireland)
Sandoz d.d. Latvia filiāle Sandoz Limited
K.Valdemāra iela 33-29 Park View, Riverside Way
Rīga, LV1010 Watchmoore Park
Tel: + 371 67892006 Camberley, Surrey
GU15 3YL, United Kingdom
Tel: + 44 1276 698020
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu