ABILIFY 300 mg Порошок И Раствор Для Инъекционной Суспензии

Содержание инструкции

1. What is Abilify Maintena and what it is used for
2. What you need to know before you receive Abilify Maintena
3. How to administer Abilify Maintena
4. Possible side effects
5. How to store Abilify Maintena
6. Contents of the pack and other information
7. What is Abilify Maintena and what it is used for
8. What you need to know before you receive Abilify Maintena
9. How to administer Abilify Maintena
10. Possible side effects
11. How to store Abilify Maintena
12. Contents of the pack and other information
13. What is Abilify Maintena and what is it used for
14. What you need to know before you receive Abilify Maintena
15. How to administer Abilify Maintena
16. Possible side effects
17. How to store Abilify Maintena
18. Contents of the pack and other information

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension
Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension
aripiprazole (aripiprazolum)

Read this leaflet carefully before you receive 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 nurse.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Abilify Maintena is and what it is used for
• 2. What you need to know before you receive Abilify Maintena
• 3. How Abilify Maintena is administered
• 4. Possible side effects
• 5. How to store Abilify Maintena
• 6. Contents of the pack and other information

1. What is Abilify Maintena and what it is used for

Abilify Maintena contains the active ingredient aripiprazole in a vial. Aripiprazole belongs to
a group of medicines called antipsychotics. Abilify Maintena is used in the treatment of
schizophrenia, a disease characterized by symptoms such as hearing, seeing or perceiving non-existent things,
suspiciousness, false beliefs, incoherent speech and behavior, and flattening of emotions.
People affected by this condition may also feel depressed, guilty, anxious or tense.
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilized
during treatment with aripiprazole administered orally.

2. What you need to know before you receive Abilify Maintena

Do not use Abilify Maintena

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

Warnings and precautions
Talk to your doctor or nurse before you receive Abilify Maintena.
Thoughts and behaviours of self-harm have been reported during treatment with this medicine.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm before
or after receiving Abilify Maintena.
Before treatment with Abilify Maintena, tell your doctor if you suffer from:

• a state of acute agitation or severe psychotic state;
• heart problems or previous stroke, especially if you know you have other risk factors for stroke;
• high blood sugar levels (characterised by symptoms such as excessive thirst, producing 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;
• a combination of fever, sweating, rapid breathing, muscle rigidity and drowsiness or sleepiness (these may be signs of neuroleptic malignant syndrome);
• dementia (memory loss and other mental abilities) especially if you are elderly;
• cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities;
• irregular heartbeat or if someone else in your family has had a history of irregular heartbeat (including the so-called prolongation of the QT interval which is observed with monitoring of the electrocardiogram (ECG));
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• difficulty swallowing;
• a previous experience of excessive gambling;
• severe liver problems.

If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which
interferes with normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, please
tell your doctor immediately.
Tell your doctor if you, your family members or your caregivers notice that you are developing a
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, overeating or excessive shopping, an unusually high sexual drive or preoccupation with
increased sexual thoughts or feelings.
Your doctor may need to adjust your dose or stop your therapy.
This medicine can cause drowsiness, low blood pressure when standing up, dizziness and changes in
your ability to move and maintain balance, which can cause
falls. Be careful, especially if you are elderly or in some way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 18 years. It is not known whether it is safe
and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Medicines that lower blood pressure: Abilify Maintena may increase the effect of
medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to
control your blood pressure.
Using Abilify Maintena together with some medicines may mean that your doctor will need to
change the dose of Abilify Maintena or the other medicines. It is particularly important to tell
your doctor about 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, St John’s wort);
• antifungal medicines (e.g. itraconazole);
• ketoconazole (used for the treatment of Cushing’s syndrome, when the body produces an excess of cortisol);
• some medicines for treating HIV infection (e.g. efavirenz, nevirapine, and protease inhibitors such as indinavir and ritonavir);
• anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin);
• medicines known to prolong the QT interval.

These medicines may increase the risk of side effects or reduce the effect of Abilify
Maintena; consult your doctor if you experience any unusual symptoms while taking any
of these medicines together with Abilify Maintena.
The medicines that increase the level of serotonin are typically used in conditions such as
depression, generalised 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, generalised 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 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 Abilify
Maintena.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you might be pregnant or are planning to become pregnant, ask your doctor for advice before receiving this medicine.

You must not use Abilify Maintena if you are pregnant, unless you havediscussed the
situation with your doctor. If you are pregnant, suspect you might be pregnant
inform your doctor immediately.
Newborn babies of mothers who receive Abilify Maintena in the last three months of pregnancy (last
trimester) may experience the following symptoms:
tremor, rigidity and/or muscle weakness, sleepiness, agitation, breathing problems and difficulty
swallowing.
If the baby develops any of these symptoms, seek medical attention.
If you are receiving Abilify Maintena, your doctor will discuss with you whether to breastfeed, considering
the benefit of the therapy for you and the benefit of breastfeeding for the baby. One excludes the other.
If you are receiving Abilify Maintena, discuss with your doctor the best way to feed your baby.

Driving and using machines
Dizziness and vision disturbances may occur during treatment with this medicine
(see section 4). This should be taken into account in cases where full alertness is required, for
example when driving a vehicle or using machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to administer Abilify Maintena

This medicine is presented in powder form, which your doctor or nurse will use to make a
suspension.
The doctor will decide what dose of Abilify Maintena is suitable for you. The recommended starting dose is
400 mg, unless your doctor decides to prescribe a lower starting or follow-up dose.
There are two ways to start Abilify Maintena; your doctor will decide which one is right for you.

• If you receive an injection of Abilify Maintena on the first day, oral aripiprazole treatment will continue for 14 days after the first injection.
• If you receive two injections of Abilify Maintena on the first day, you will also take an aripiprazole tablet orally during this visit.

Subsequently, treatment is administered with injections of Abilify Maintena, unless
otherwise indicated by your doctor.
Your doctor will administer it as a single injection into the gluteal or deltoid muscle (buttock or shoulder)
once a month. You may feel a slight pain during the injection. The doctor will alternate the injections
between the right and left sides. Injections will not be administered intravenously.

If you receive more Abilify Maintena than you should
This medicine will be administered under medical supervision; it is therefore unlikely that you will receive
too much. If you consult more than one doctor, be sure to inform them that you are being treated with Abilify
Maintena.
Patients who have received an excessive amount of this medicine 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 sleepiness, slow breathing, feeling of suffocation, high or low blood pressure, heart rhythm changes.

Contact your doctor or hospital immediately if you experience any of these symptoms.

If you miss an Abilify Maintena injection
It is important not to miss your scheduled dose. You must have an injection every month,
but not before 26 days after the last injection. If you miss an injection, contact your doctor to
arrange the next one as soon as possible.

If you stop receiving Abilify Maintena
Do not stop treatment just because you feel better. It is important to continue taking Abilify
Maintena for the entire period indicated by your doctor.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
If you experience any of the following serious side effects, inform your doctor immediately.

• a combination of any of these symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle rigidity or tremor, fever, weakness, irritability, aggression, anxiety, increased blood pressure or convulsions that can lead to loss of consciousness;
• unusual movement, mainly affecting the face or tongue, as a result of which the doctor may decide to reduce your dose;
• symptoms such as swelling, pain and redness of the leg, which may indicate the presence of a blood clot, capable of moving through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle rigidity and drowsiness or sleepiness, as it may be a sign of a condition called malignant neuroleptic syndrome (MNS);
• more thirst than usual, needing to urinate more than usual, intense hunger, feeling weak or tired, nausea, feeling confused or fruity-smelling breath, as it may be a sign of diabetes;
• suicidal thoughts, behaviors or feelings, or self-harm.

After taking Abilify Maintena, the following side effects may also appear.
Contact your doctor or nurse if you experience any of these side effects:

Common side effects (may affect up to 1 in 10 people):

• weight gain;
• diabetes mellitus;
• weight loss;
• feeling of restlessness;
• feeling of anxiety;
• inability to stay still, difficulty remaining seated;
• difficulty sleeping (insomnia);
• spasmodic resistance to passive movement, while the muscles contract and relax, increased abnormal muscle tone, slow body movement;
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously);
• shaking or tremor;
• uncontrollable movements characterized by jerks, tics or contortions;
• changes in level of alertness, drowsiness;
• sleepiness;
• dizziness;
• headache;
• dry mouth;
• muscle rigidity;
• inability to obtain or maintain an erection during sexual intercourse;
• pain at the injection site, hardening of the skin at the injection site;
• weakness, loss of strength or extreme fatigue;
• when performing blood tests, the doctor may find higher levels of creatine phosphokinase (an enzyme important for muscle function);

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

• low levels of a specific type of white blood cells (neutropenia), hemoglobin or red blood cells and platelets;
• allergic reactions (hypersensitivity);
• increased or decreased levels of the hormone prolactin in the plasma;
• hyperglycemia;
• increased fats in the blood, such as high cholesterol, high triglycerides, but also low levels of cholesterol and triglycerides;
• increased levels of insulin, a hormone that regulates blood sugar levels;
• decreased or increased appetite;
• thoughts related to suicide;
• mental disorder characterized by a lack or absence of contact with reality;
• hallucinations;
• delirium;
• increased sexual interest;
• panic reaction;
• depression;
• emotional lability;
• state of indifference with a lack of emotions, feelings of emotional and mental discomfort;
• sleep disorder;
• teeth grinding or jaw clenching;
• reduced sexual interest (libido is reduced);
• altered mood;
• muscle problems;
• muscle movements that cannot be controlled, such as grimacing, lip smacking, and tongue movements. These usually affect the face and mouth first, but can also involve other parts of the body. These could be signs of a condition called "tardive dyskinesia";
• parkinsonism: a medical condition with many different symptoms, including reduced or slowed movements, slowness of thought, jerky movements when bending the limbs (cogwheel rigidity), shuffling gait, hurried steps, tremor, limited or absent facial expression, muscle rigidity, drooling;
• problems moving;
• extreme restlessness and agitation of the legs;
• alteration of the senses of taste and smell;
• eyeballs fixed in a single position;
• blurred vision;
• eye pain;
• double vision;
• eye sensitivity to light;
• abnormal heartbeat, slow or fast heartbeat, abnormalities in the electrical conduction of the heart, abnormalities on the electrocardiogram;
• high blood pressure;
• dizziness upon standing up from a lying or sitting position, due to a decrease in blood pressure;
• cough;
• hiccups;
• gastroesophageal reflux. An excessive amount of gastric juice returns (refluxes) into the esophagus (the tube that connects the mouth to the stomach, through which food passes), causing heartburn and sometimes damaging the esophagus;
• heartburn;
• vomiting;
• diarrhea;
• nausea;
• stomach pain;
• stomach discomfort;
• constipation;
• frequent bowel movements;
• loss of saliva, amount of saliva higher than normal;
• abnormal hair loss;
• acne, a skin condition of the face where the nose and cheeks are unusually reddened, eczema, skin hardening;
• muscle rigidity, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), pain in the extremities;
• joint pain (arthralgia), back pain, reduced range of motion of the joints, neck stiffness, limited opening of the mouth;
• kidney stones, sugar (glucose) in the urine;
• spontaneous leakage of milk from the breasts (galactorrhea);
• enlargement of the breasts in men, breasts painful to the touch, vaginal dryness;
• fever;
• loss of strength;
• gait disturbances;
• chest discomfort;
• reactions at the injection site such as redness, swelling, discomfort and itching;
• thirst;
• laziness;
• liver function tests may show abnormal results;
• when performing the tests, the doctor may find
• higher levels of liver enzymes;
• higher levels of alanine aminotransferase;
• higher levels of gamma-glutamyltransferase;
• higher levels of bilirubin in the blood;
• higher or reduced levels of aspartate aminotransferase;
• higher or lower levels of sugar in the blood;
• higher levels of glycated hemoglobin;
• reduced levels of cholesterol in the blood;
• reduced levels of triglycerides in the blood;
• an increase in abdominal circumference.

The following side effects have been reported after the marketing of medicines

containing the same active ingredient taken orally, but the frequency with which they occur

is unknown (it is not possible to estimate the frequency from available data):

• low levels of white blood cells;
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives), skin rash;
• abnormal heartbeat, unexplained sudden death, heart attack;
• diabetic ketoacidosis (ketones in the blood and urine) or diabetic coma;
• loss of appetite (anorexia), difficulty swallowing;
• low level of sodium in the blood;
• suicide and attempted suicide;
• inability to resist the urge, drive or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example, an increase in sexual drive;
• excessive and uncontrollable shopping;
• 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 your appetite);
• tendency to wander. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.
• nervousness;
• aggression;
• malignant neuroleptic syndrome (a syndrome with symptoms such as fever, muscle rigidity, rapid breathing, sweating, decreased state of consciousness, and sudden changes in blood pressure and heart rate);
• convulsions (seizures);
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle rigidity);
• speech disorders;
• heart problems including torsades de pointes, cardiac arrest, irregular heartbeat that can be caused by abnormal nerve impulses reaching the heart, abnormalities in the reading of the electrocardiogram (ECG), prolonged QT;
• fainting;
• symptoms related to the formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can move along the blood vessels reaching the lungs where they cause pain and difficulty breathing;
• spasm of the muscles surrounding the vocal cords;
• accidental inhalation of food with risk of pneumonia (lung infection);
• inflammation of the pancreas;
• difficulty swallowing;
• liver failure;
• jaundice (yellowing of the skin and whites of the eyes);
• inflammation of the liver;
• skin rash;
• skin sensitivity to light;
• excessive sweating;
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS manifests initially with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests, and an increase in a type of white blood cells (eosinophilia).
• weakness, tenderness or pain in the muscles and especially if at the same time you have a feeling of malaise, elevated body temperature and dark urine. This may be caused by abnormal muscle breakdown, potentially fatal and which may lead to kidney problems (a condition called rhabdomyolysis).
• difficulty urinating;
• involuntary loss of urine (incontinence);
• withdrawal symptoms in the newborn;
• prolonged and/or painful erection;
• difficulty controlling body temperature or conditions of excessive heat;
• chest pain;
• swelling at the level of hands, ankles or feet;
• when performing the tests, the doctor may find
• higher levels of alkaline phosphatase;
• fluctuating results in tests to measure blood sugar.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national
reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Abilify Maintena

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 pack and the vial. The
expiry date refers to the last day of that month.
Do not freeze.
The reconstituted suspension must be used immediately, but may be stored at temperatures
below 25 °C for a maximum of 4 hours in the vial. Do not store the reconstituted suspension
in the syringe.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains

• The active substance is aripiprazole. Each vial contains 300 mg of aripiprazole. After reconstitution, each mL of suspension contains 200 mg of aripiprazole. Each vial contains 400 mg of aripiprazole. After reconstitution, each mL of suspension contains 200 mg of aripiprazole.
• The other ingredients are: Sodium Carmellose, mannitol (E421), monobasic sodium phosphate monohydrate (E339), sodium hydroxide (E524) Solvent Water for injections

Description of the appearance of Abilify Maintena and contents of the pack
Abilify Maintena consists of powder and solvent for prolonged-release injectable suspension.
The powder of Abilify Maintena is white to off-white in colour and is contained in a
transparent glass vial. The doctor or nurse will reconstitute the suspension to be injected using the
vial of solvent from Abilify Maintena, which appears as a clear solution in a
transparent glass vial.

Single pack
Each single pack contains one vial of powder, one 2 mL vial of solvent, one
3 mL Luer-lock syringe with a pre-attached 38 mm (1.5 inches) 21 gauge safety hypodermic needle with needle cover, one 3 mL single-use syringe with Luer-lock connector, a vial adapter and three safety hypodermic needles: one 25 mm 23 gauge, one 38 mm 22 gauge and one
51 mm 21 gauge.

Multipack
Pack of 3 single packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer

• H. Lundbeck A/S Ottiliavej 9, 2500 Valby Denmark

For further information on this medicine, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 79 79

Lietuva

• H. Lundbeck A/S Tel: +45 36301311

България
Lundbeck Export A/S Representative Office
Tel: +359 2 962 4696

Luxembourg/Luxemburg
Lundbeck S.A.
Tél: +32 2 535 79 79

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Malta

• H. Lundbeck A/S Tel: +45 36301311

Deutschland
Otsuka Pharma GmbH
Tel: +49 69 1700860

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Lundbeck A/S Tel: +45 36301311 NorgeOtsuka Pharma Scandinavia AB Tel: +46 8 54528660

Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033

España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20

Ελλάδα
Lundbeck Hellas S.A.
Τηλ: +30 210 610 5036

Polska
Lundbeck Poland Sp. z o. o.
Tel.: +48 22 626 93 00

France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

Portugal
Lundbeck Portugal – Produtos Farmacêuticos,
Unipessoal Lda.
Tel: +351 21 00 45 900

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: +385 1 644 82 63

România
Lundbeck Romania SRL
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Otsuka Pharmaceutical Italy S.r.l
Tel: +39 02 00 63 27 10

Suomi/Finland
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Latvija

• H. Lundbeck A/S Tel: +45 36301311 United Kingdom (Northern Ireland)Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
-----------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Unused medicine and waste materials derived from this medicine must be disposed of in accordance
with local regulations.

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension
Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension
aripiprazole
Step 1: preparation before reconstitution of the powder.
Arrange the components and verify the presence of the following:

• Vial of powder
• 2 mL vial of solvent Important: the solvent vial contains a device to prevent overfilling.
• One 3 mL Luer-lock syringe with a pre-attached 38 mm (1.5 inches) 21 gauge safety hypodermic needle with needle cover
• One 3 mL single-use syringe with Luer-lock connector
• A vial adapter
• One 25 mm (1 inch) 23 gauge safety hypodermic needle with needle cover
• One 38 mm (1.5 inches) 22 gauge safety hypodermic needle with needle cover
• One 51 mm (2 inches) 21 gauge safety hypodermic needle with needle cover
• Syringe and needle instructions

Step 2: reconstitution of the powder
a) Remove the caps from the solvent vial and the powder vial and clean the tops of the
containers with a sterile alcohol swab.
b) Using the syringe with the pre-attached needle, draw up the predetermined volume of solvent from its
vial.
300 mg vial:
Add 1.5 mL of solvent to reconstitute the powder.
400 mg vial:
Add 1.9 mL of solvent to reconstitute the powder.
After drawing up, a small amount of residual solvent will remain in the vial. Any
excess should be discarded.

Water
c) Slowly inject the solvent into the vial containing the powder.
d) To balance the pressure in the vial, draw back slightly on the
plunger to aspirate air.

e) Then, remove the needle from the vial.
Attach the needle cover using the one-handed technique.
Gently press the sheath against a flat surface until the needle is firmly
seated in the needle cover sheath.
Visually confirm that the needle is fully seated in the needle cover sheath and
dispose of the entire piece.

Cover Dispose
f) Vigorously shake the vial for at least 30 seconds until the suspension appears
uniform.

g) Before administration, visually inspect the reconstituted suspension for
the presence of particulate matter or colour change. The reconstituted medicine is a
fluid suspension ranging in colour from white to off-white. Do not use if the reconstituted
suspension contains particulate matter or shows any colour change.
h) If the injection is not performed immediately after reconstitution, store the vial at
temperatures below 25 °C for a maximum of 4 hours and shake vigorously for at least
60 seconds before injection to resuspend the product.
i) Do not store the reconstituted suspension in the syringe.
Step 3: preparation before injection
a) Remove the packaging, but not the adapter, from the packaging.
b) Handling the vial adapter through the adapter packaging, attach
the syringe with pre-attached Luer-lock connector to the adapter.

c) Remove the vial adapter from the packaging using the syringe with Luer-lock
connector and discard the adapter packaging. Never touch the piercing end
of the adapter.

Abilify Maintena
d) Determine the recommended volume for injection.
e) Clean the top of the reconstituted suspension vial using a sterile
alcohol swab.
f) Place and hold the reconstituted suspension vial on a rigid surface. Attach the
adapter-syringe assembly to the vial by holding the outer surface of the adapter and
firmly push its piercer through the rubber stopper until the adapter
clicks into place.

g) To allow injection, slowly draw the recommended volume into the
syringe with Luer-lock connector’.
A small amount of product will remain in the vial.

Abilify Maintena
Step 4: injection procedure
a) Detach the syringe with Luer-lock connector containing the recommended volume of
reconstituted Abilify Maintena suspension from the vial.
b) Select one of the following safety hypodermic needles depending on the injection site and
patient weight, and attach the needle to the syringe with Luer-lock connector containing the injectable
suspension. Ensure that the needle is securely inserted into the needle cover by pushing and rotating
simultaneously, then immediately remove the cap from the needle.

c) Slowly inject the recommended volume as a single intramuscular injection into the gluteal or
deltoid muscle. Do not massage the injection site. Take care to avoid
accidental intravascular injection. Do not inject into areas with signs of inflammation,
skin lesions, nodules and/or bruising.
For deep intramuscular injection into the gluteal or deltoid muscle only.

deltoid gluteal
Remember to alternate injection sites between the two gluteal or deltoid muscles.
If treatment is initiated according to the two-injection-based regimen, inject into two different
muscles. DO NOT perform both injections simultaneously in the
same deltoid or gluteal muscle.
In patients known to be poor CYP2D6 metabolizers, administer into two distinct deltoid muscles or in one deltoid and one gluteal. DO NOT inject into both gluteal muscles.
Check for any signs or symptoms of accidental intravascular administration.
Step 5: procedures after injection
Attach the needle cover as described in Step 2 e). After the injection, dispose of the
vials, adapter, needles and syringe appropriately.

Cover Dispose

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
aripiprazole

Read this leaflet carefully before you receive 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 nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

• 1. What Abilify Maintena is and what it is used for
• 2. What you need to know before you receive Abilify Maintena
• 3. How Abilify Maintena is administered
• 4. Possible side effects
• 5. How to store Abilify Maintena
• 6. Contents of the pack and other information

1. What is Abilify Maintena and what it is used for

Abilify Maintena contains the active ingredient aripiprazole in a prefilled syringe. Aripiprazole
belongs to a group of medicines called antipsychotics. Abilify Maintena is used in the
treatment of schizophrenia, a disease characterized by symptoms such as hearing, seeing or perceiving
things that are not there, suspicion, false beliefs, incoherent speech and behavior, and
flattening of emotions. People affected by this condition may also feel
depressed, guilty, anxious or tense.
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilized
during treatment with aripiprazole administered orally.

2. What you need to know before you receive Abilify Maintena

Do not use Abilify Maintena

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

Warnings and precautions
Talk to your doctor or nurse before you receive Abilify Maintena.
Thoughts and behaviours of self-harm have been reported during treatment with this medicine.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm before
or after receiving Abilify Maintena.
Before treatment with Abilify Maintena, tell your doctor if you suffer from:

• a state of acute agitation or severe psychotic state;
• heart problems or previous stroke, especially if you know you have other risk factors for stroke;
• high blood sugar levels (characterised by symptoms such as excessive thirst, producing 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;
• a combination of fever, sweating, rapid breathing, muscle stiffness and drowsiness or sleepiness (these may be signs of neuroleptic malignant syndrome);
• dementia (memory loss and other mental abilities) especially if you are elderly;
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities;
• irregular heartbeat or if someone else in your family has had a history of irregular heartbeat (including the so-called prolongation of the QT interval which is observed with monitoring of the electrocardiogram (ECG));
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• difficulty swallowing;
• a previous experience of excessive gambling;
• severe liver problems.

If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy which
interferes with normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, please
tell your doctor immediately.
Tell your doctor if you, your family members or those who care for you, notice that you are developing a
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. Such
phenomena are called impulse control disorders and may include behaviours such as
gambling, overeating or excessive shopping, an unusually high sexual drive or preoccupation with
increased sexual thoughts or feelings.
Your doctor may need to adjust the dose or stop the therapy.
This medicine can cause drowsiness, low blood pressure when standing up, dizziness and changes in the ability to move and maintain balance, which can cause
falls. Be careful, especially if you are elderly or in some way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 18 years. It is not known if it is safe
and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Medicines that lower blood pressure: Abilify Maintena can increase the effect of
medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to
control your blood pressure.
Using Abilify Maintena together with some medicines may mean that your doctor will need to
change the dose of Abilify Maintena or the other medicines. It is particularly important to tell
your doctor about 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, St John's wort);
• antifungal medicines (e.g. itraconazole);
• ketoconazole (used for the treatment of Cushing's syndrome, when the body produces an excess of cortisol);
• some medicines for treating HIV infection (e.g. efavirenz, nevirapine, and protease inhibitors such as indinavir and ritonavir);
• anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin);
• medicines known to prolong the QT interval.

These medicines can increase the risk of side effects or reduce the effect of Abilify
Maintena; consult your doctor if you experience any unusual symptoms while taking any
of these medicines together with Abilify Maintena.
The medicines that increase the level of serotonin 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 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 can increase the risk of side effects; consult your doctor if you experience
any unusual symptoms while taking any of these medicines together with Abilify
Maintena.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before receiving this medicine.
Do not use Abilify Maintena if you are pregnant, unless you havediscussed the
situation with your doctor. If you are pregnant, suspect you may be pregnant
inform your doctor immediately.
Newborn babies of mothers who receive Abilify Maintena in the last three months of pregnancy (last
trimester) may present the following symptoms:
tremor, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems and difficulty
sucking.
If the baby presents any of these symptoms, seek medical attention.
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breastfeed, considering
the benefit of therapy for you and the benefit of breastfeeding for the baby. One excludes the other.
If you are receiving Abilify Maintena, 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 cases where full alertness is required, for
example when driving a vehicle or using machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to administer Abilify Maintena

This medicine is presented in pre-filled syringe form.
Your doctor will decide what dose of Abilify Maintena is appropriate for you. The recommended initial
dose is 400 mg, unless your doctor decides to prescribe you a lower initial or follow-
up dose.
There are two ways to start Abilify Maintena; your doctor will decide which one is right for you.

• If you receive an injection of Abilify Maintena on the first day, oral aripiprazole treatment will continue for 14 days after the first injection.
• If you receive two injections of Abilify Maintena on the first day, you will also take an aripiprazole tablet orally during this visit.

Subsequently, treatment is administered with injections of Abilify Maintena, unless
otherwise indicated by your doctor.
Your doctor will administer it as a single injection into the gluteal or deltoid muscle (buttock or shoulder)
once a month. You may feel a slight pain during the injection. The doctor will alternate the
injections between the right and left sides. The injections will not be administered intravenously.

If you receive more Abilify Maintena than you should
This medicine will be administered under medical supervision; it is therefore unlikely that you will receive
too much. If you see more than one doctor, be sure to inform them that you are being treated with Abilify
Maintena.
Patients who have received an excessive amount of this medicine 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 sleepiness, slowed breathing, feeling of suffocation, high or low blood pressure, heart rhythm changes.

Contact your doctor or hospital immediately if you experience any of these symptoms.

If you forget an Abilify Maintena injection
It is important not to forget your scheduled dose. You must have an injection every month,
but not before 26 days after your last injection. If you forget an injection, contact your doctor to
arrange the next one as soon as possible.

If you stop receiving Abilify Maintena
Do not stop treatment just because you feel better. It is important to continue taking Abilify
Maintena for the entire period indicated by your doctor.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
If you get any of the serious side effects described below, tell your doctor immediately.

• a combination of any of the following symptoms: excessive sleepiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle rigidity or tremor, fever, weakness, irritability, aggression, anxiety, increased blood pressure or convulsions that can lead to loss of consciousness;
• unusual movements, mainly affecting the face or tongue, as a result of which your doctor may decide to reduce the dose;
• symptoms such as swelling, pain and redness of the leg, which may indicate the presence of a blood clot that can move through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle rigidity and drowsiness or sleepiness, as it may be a sign of a condition called neuroleptic malignant syndrome (NMS);
• more thirst than usual, needing to urinate more than usual, intense hunger, feeling weak or tired, nausea, feeling confused or fruity-smelling breath, as it could be a sign of diabetes;
• suicidal thoughts, behaviors or feelings, or self-harm.

After taking Abilify Maintena, the following side effects may also occur.
Contact your doctor or nurse if you experience any of these side effects:

Common side effects (may affect up to 1 in 10 people):

• weight gain;
• diabetes mellitus;
• weight loss;
• feeling restless;
• feeling anxious;
• inability to stay still, difficulty remaining seated;
• difficulty sleeping (insomnia);
• spasmodic resistance to passive movement, while muscles contract and relax, increased abnormal muscle tone, slow body movement;
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously);
• shaking or tremor;
• uncontrollable movements characterized by jerks, twitches or contortions;
• changes in level of alertness, drowsiness;
• sleepiness;
• dizziness;
• headache;
• dry mouth;
• muscle rigidity;
• inability to get or maintain an erection during sexual intercourse;
• pain at the injection site, hardening of the skin at the injection site;
• weakness, loss of strength or extreme fatigue;
• when performing blood tests, the doctor may find higher levels of creatine phosphokinase (an enzyme important for muscle function);

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

• low levels of a specific type of white blood cells (neutropenia), hemoglobin or red blood cells and platelets;
• allergic reactions (hypersensitivity);
• increased or decreased levels of the hormone prolactin in the blood;
• hyperglycemia;
• increased fats in the blood, such as high cholesterol, high triglycerides, but also low levels of cholesterol and triglycerides;
• increased levels of insulin, a hormone that regulates blood sugar levels;
• decreased or increased appetite;
• thoughts related to suicide;
• mental disorder characterized by a lack or absence of contact with reality;
• hallucinations;
• delirium;
• increased sexual interest;
• panic reaction;
• depression;
• emotional lability;
• state of indifference with lack of emotions, feelings of emotional and mental discomfort;
• sleep disorder;
• teeth grinding or jaw clenching;
• reduced sexual interest (libido is reduced);
• mood alteration;
• muscle problems;
• muscle movements that you cannot control, such as grimacing, lip smacking, and tongue movements. These usually start in the face and mouth, but can also affect other parts of the body. These could be signs of a condition called "tardive dyskinesia";
• parkinsonism: medical condition with many different symptoms, including reduced or slowed movements, slowness of thought, jerky movements when bending the limbs (cogwheel rigidity), shuffling gait, hurried steps, tremor, limited or absent facial expression, muscle rigidity, drooling;
• problems moving;
• extreme restlessness and agitation of the legs;
• alteration of the senses of taste and smell;
• eye bulbs fixed in a single position;
• blurred vision;
• eye pain;
• double vision;
• eye sensitivity to light;
• abnormal heartbeat, slow or fast heartbeat, abnormalities in the heart's electrical conduction, abnormalities on the electrocardiogram;
• high blood pressure;
• dizziness when getting up from a lying or sitting position, due to a decrease in blood pressure;
• cough;
• hiccups;
• gastroesophageal reflux. An excessive amount of gastric juice returns (refluxes) into the esophagus (the tube that connects the mouth to the stomach, through which food passes), causing heartburn and sometimes damaging the esophagus;
• heartburn;
• vomiting;
• diarrhea;
• nausea;
• stomach pain;
• stomach discomfort;
• constipation;
• frequent bowel movements;
• loss of saliva, amount of saliva higher than normal;
• abnormal hair loss;
• acne, a skin condition of the face where the nose and cheeks are unusually reddened, eczema, skin hardening;
• muscle rigidity, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), pain in the extremities;
• joint pain (arthralgia), back pain, reduced range of motion of the joints, neck stiffness, limited opening of the mouth;
• kidney stones, sugar (glucose) in the urine;
• spontaneous leakage of milk from the breasts (galactorrhea);
• enlargement of the breasts in men, breasts painful to the touch, vaginal dryness;
• fever;
• loss of strength;
• walking disorders;
• chest discomfort;
• reactions at the injection site such as redness, swelling, discomfort and itching;
• thirst;
• laziness;
• liver function tests may show abnormal results;
• when performing the tests the doctor may find
• higher levels of liver enzymes;
• higher levels of alanine aminotransferase;
• higher levels of gamma-glutamyltransferase;
• higher levels of bilirubin in the blood;
• higher or reduced levels of sugar in the blood;
• higher levels of glycated hemoglobin;
• reduced levels of cholesterol in the blood;
• reduced levels of triglycerides in the blood;
• an increase in abdominal circumference.

The following side effects have been reported after the marketing of medicines

containing the same active ingredient to be taken orally, but the frequency with which they occur

is unknown (cannot be estimated from available data):

• low levels of white blood cells;
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives), skin rash;
• abnormal heartbeat, sudden unexplained death, heart attack;
• diabetic ketoacidosis (ketones in the blood and urine) or diabetic coma;
• loss of appetite (anorexia), difficulty swallowing;
• low level of sodium in the blood;
• suicide and attempted suicide;
• inability to resist the urge, drive or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example, an increase in sexual drive;
• excessive and uncontrollable shopping;
• 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 your appetite);
• tendency to withdraw. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.
• nervousness;
• aggression;
• neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle rigidity, rapid breathing, sweating, decreased state of consciousness, and sudden changes in blood pressure and heart rate);
• convulsions (seizures);
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity);
• speech disorders;
• heart problems including cardiac arrest, torsades de pointes, irregularities in the heart rhythm that can be caused by abnormal nerve impulses reaching the heart, abnormalities in the electrocardiogram (ECG), prolonged QT;
• fainting;
• symptoms related to the formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can move along the blood vessels to the lungs where they cause chest pain and difficulty breathing;
• spasm of the muscles surrounding the vocal cords;
• accidental inhalation of food with risk of pneumonia (lung infection);
• inflammation of the pancreas;
• difficulty swallowing;
• liver failure;
• jaundice (yellowing of the skin and the white of the eyes);
• liver inflammation;
• skin rash;
• skin sensitivity to light;
• excessive sweating;
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, swollen lymph nodes, increased levels of liver enzymes found in blood tests, and an increase in a type of white blood cells (eosinophilia).
• weakness, tenderness or pain in the muscles and especially if at the same time you have a feeling of malaise, high body temperature and dark urine. This may be caused by an abnormal breakdown of muscle tissue, potentially fatal and which can lead to kidney problems (a condition called rhabdomyolysis).
• difficulty urinating;
• involuntary loss of urine (incontinence);
• withdrawal symptoms in the newborn;
• prolonged and/or painful erection;
• difficulty controlling internal body temperature or conditions of excessive heat;
• chest pain;
• swelling of hands, ankles or feet;
• when performing the tests the doctor may find
• higher levels of alkaline phosphatase;
• fluctuating results on tests to measure blood sugar.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Abilify Maintena

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 pack and on the pre-filled syringe.
The expiry date refers to the last day of that month.
Do not freeze.
Store the pre-filled syringe in the outer packaging to protect it from light.
If the injection is not performed immediately after reconstitution, the syringe may be
stored at temperatures below 25 °C for a maximum of 2 hours.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains

• The active substance is aripiprazole. Each pre-filled syringe contains 300 mg of aripiprazole. After reconstitution, each mL of suspension contains 200 mg of aripiprazole. Each pre-filled syringe contains 400 mg of aripiprazole. After reconstitution, each mL of suspension contains 200 mg of aripiprazole.
• The other ingredients are: Sodium Carmellose, mannitol (E421), sodium dihydrogen phosphate monohydrate (E339), sodium hydroxide (E524) Solvent Water for injections

Description of the appearance of Abilify Maintena and contents of the pack
Abilify Maintena is presented in a pre-filled syringe containing a powder from white to
off-white in the front chamber and a clear solvent in the rear chamber. The doctor will prepare
a suspension which will be injected into you.

Single pack
Each single pack contains one pre-filled syringe and three hypodermic safety needles: one of
25 mm 23 gauge, one of 38 mm 22 gauge and one of 51 mm 21 gauge.

Multipack
Pack of 3 single packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer

• H. Lundbeck A/S Ottiliavej 9, 2500 Valby Denmark

Elaiapharm
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis
06550 Valbonne
France
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 79 79

Lietuva

• H. Lundbeck A/S Tel: +45 36301311

България
Lundbeck Export A/S Representative Office
Tel: +359 2 962 4696

Luxembourg/Luxemburg
Lundbeck S.A.
Tél: +32 2 535 79 79

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Malta

• H. Lundbeck A/S Tel: +45 36301311

Deutschland
Otsuka Pharma GmbH
Tel: +49 69 1700860

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Lundbeck A/S Tel: +45 36301311 NorgeOtsuka Pharma Scandinavia AB Tel: +46 8 54528660

Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033

España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20

Ελλάδα
Lundbeck Hellas S.A.
Τηλ: +30 210 610 5036

Polska
Lundbeck Poland Sp. z o. o.
Tel.: +48 22 626 93 00

France
Otsuka Pharmaceutical France SAS
Tél: +33 (0) 1 47 08 00 00

Portugal
Lundbeck Portugal – Produtos Farmacêuticos,
Unipessoal Lda.
Tel: +351 21 00 45 900

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: +385 1 644 82 63

România
Lundbeck Romania SRL
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Otsuka Pharmaceutical Italy S.r.l
Tel: +39 02 00 63 27 10

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Latvija

• H. Lundbeck A/S Tel: +45 36301311 United Kingdom (Northern Ireland)Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu .
-----------------------------------------------------------------------------------------------------------------
The following information is intended for healthcare professionals only:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.

Abilify Maintena 300 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
Abilify Maintena 400 mg powder and solvent for prolonged-release injectable suspension in
pre-filled syringe
aripiprazole
Step 1: preparation before reconstitution of the powder.
Arrange the components and verify the presence of the following:

• One pre-filled syringe of Abilify Maintena
• One hypodermic safety needle 25 mm (1 inch) 23 gauge with needle cover
• One hypodermic safety needle 38 mm (1.5 inches) 22 gauge with needle cover
• One hypodermic safety needle 51 mm (2 inches) 21 gauge with needle cover
• Instructions for the syringe and needle

Step 2: reconstitution of the powder
a) Gently push the plunger rod inward to insert it into the threaded part. Then, to
release the diluent, rotate the plunger rod until the rotation locks. When
the plunger rod is fully locked, the intermediate stopper will be aligned with the
indicator mark.
Indicator
mark

Plunger
rod
b) Shake the syringe vigorously in a vertical direction for 20 seconds until the reconstituted
suspension is uniform. The suspension must be injected immediately after
reconstitution .
Uniform
milky suspension

20 seconds
c) Before administration, visually inspect the syringe for the presence of any
particulate matter and colour change. The reconstituted suspension of the product must
appear as a uniform, homogeneous, opaque, milky suspension.
d) If the injection is not performed immediately after reconstitution, the syringe may be
stored at temperatures below 25 °C for a maximum of 2 hours. Shake the
syringe vigorously for at least 20 seconds to resuspend the product before injection,
if the syringe has been stored for more than 15 minutes.
Step 3: injection procedure
a) Rotate and remove the needle cap and the stopper.
Rotate +
remove

Needle cap
Stopper Rotate + remove
b) Select one of the following hypodermic safety needles depending on the injection site and
patient weight.

c) While holding the needle hub, check that the needle is securely attached to the safety
device by pushing it down and rotating clockwise until it is firmly
inserted.

Needle hub
d) Then pullthe needle cap straight up.
Needle cap Pull

e) Keeping the syringe in a vertical position, slowly advance the plunger rod
to expel the air. If you cannot advance the plunger rod to expel the air,
check that the plunger rod has been rotated fully to lock. After
expelling the air from the syringe, it is no longer possible to resuspend the product.
Expel air until the base of the
needle is filled with the
suspension*

*If you encounter resistance or
difficulty expelling the air,
check that the plunger rod has been rotated fully
to lock.
f) Inject slowly into the gluteal or deltoid muscle. Do not massage the injection site.
Take care to avoid accidental injection into a blood vessel. Do not inject into
areas with signs of inflammation, skin lesions, nodules and/or bruising.
Only for deep intramuscular injection into the gluteal or deltoid muscle.

Deltoid gluteal
Remember to alternate the injection sites between the two gluteal or deltoid muscles .
If treatment is initiated according to the regimen based on two injections, inject into two
different sites in two different muscles. DO NOT perform both injections at the same time in
the same deltoid or gluteal muscle.
In patients known to be poor CYP2D6 metabolizers, administer into the two distinct deltoid
muscles or into one deltoid and one gluteal muscle. DO NOT inject into the two gluteal muscles.
Check for any signs or symptoms of accidental intravascular administration.
Step 4: procedures after injection
Snap the needle safety cover into place. After the injection, dispose of the pre-filled syringe
and needle appropriately.

Cover Dispose
Abilify Maintena 720 mg prolonged-release injectable suspension in pre-filled syringe
Abilify Maintena 960 mg prolonged-release injectable suspension in pre-filled syringe
aripiprazole (aripiprazolum)

Read this leaflet carefully before you receive 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 nurse.
• If you get any side effects, see section 4 and talk to your doctor or nurse.

Contents of this leaflet

• 1. What Abilify Maintena is and what it is used for
• 2. What you need to know before you receive Abilify Maintena
• 3. How Abilify Maintena is administered
• 4. Possible side effects
• 5. How to store Abilify Maintena
• 6. Contents of the pack and other information

1. What is Abilify Maintena and what is it used for

Abilify Maintena contains the active substance aripiprazole in a prefilled syringe. Aripiprazole
belongs to a group of medicines called antipsychotics. Abilify Maintena is used in the
treatment of schizophrenia, a disease characterized by symptoms such as hearing, seeing or perceiving
things that are not there, suspiciousness, false beliefs, incoherent speech and behavior, and
blunting of emotions. People affected by this condition may also feel
depressed, guilty, anxious or tense.
Abilify Maintena is intended for adult patients with schizophrenia who are sufficiently stabilized
during treatment with aripiprazole.
If you have responded well to treatment with aripiprazole orally or with the medicine Abilify Maintena,
your doctor may start treatment with Abilify Maintena. It can help to relieve the symptoms of your
illness and avoid the risk of them recurring.

2. What you need to know before you receive Abilify Maintena

Do not use Abilify Maintena

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

Warnings and precautions
Talk to your doctor or nurse before you receive Abilify Maintena.
Thoughts and behaviours of self-harm have been reported during treatment with this medicine.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm before
or after receiving Abilify Maintena.
Before treatment with this medicine, tell your doctor if you suffer from:

• a state of acute agitation or severe psychotic state;
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or transient ischemic attack, blood pressure abnormalities;
• heart problems or previous stroke, especially if you know you have other risk factors for stroke;
• blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots;
• irregular heartbeat or if someone else in your family has a history of irregular heartbeat (including the so-called prolongation of the QT interval observed with electrocardiogram (ECG) monitoring);
• involuntary, irregular muscle movements, especially of the face (tardive dyskinesia);
• a combination of fever, sweating, rapid breathing, muscle rigidity and stupor or drowsiness (these may be signs of neuroleptic malignant syndrome);
• epilepsy (seizures) as the doctor may decide to monitor you more closely;
• dementia (memory loss and other mental abilities) especially if you are elderly;
• high blood sugar levels (characterised by symptoms such as excessive thirst, production of large amounts of urine, increased appetite and feeling of weakness) or a family history of diabetes;
• difficulty swallowing;
• a previous experience of excessive gambling.

If you notice that your weight is increasing, if you develop unusual movements, if you feel drowsy that
interferes with normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, please
inform your doctor immediately.
Tell your doctor if you, your family members or your caregivers notice that you are developing a
urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, drive or
temptation to carry out certain activities that may harm yourself or others. Such
phenomena are called impulse control disorders and may include behaviours such as
gambling addiction, excessive eating or spending, unusually high sexual drive or preoccupation with
increased sexual thoughts or feelings.
The doctor may need to adjust the dose or stop the therapy.
This medicine can cause drowsiness, low blood pressure when getting up
standing, dizziness and changes in the ability to move and maintain balance, which can cause
falls. Be careful, especially if you are elderly or in any way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 18 years. It is not known whether it is safe
and effective in these patients.

Other medicines and Abilify Maintena
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Medicines that lower blood pressure: Abilify Maintena can increase the effect of
medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to
control your blood pressure.
Using Abilify Maintena together with some medicines may mean that your doctor will need to
change the dose of Abilify Maintena or the other medicines. It is particularly important to tell
your doctor about the following medicines:

• medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide, diltiazem);
• antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, escitalopram ,St John's wort);
• antifungal medicines (e.g. itraconazole);
• ketoconazole (used for the treatment of Cushing's syndrome, when the body produces an excess of cortisol);
• some medicines for treating HIV infection (e.g. efavirenz, nevirapine, and protease inhibitors, such as indinavir and ritonavir);
• anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital, primidone);
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin);
• medicines known to prolong the QT interval.

These medicines can increase the risk of side effects or reduce the effect of Abilify
Maintena; consult your doctor if you experience any unusual symptoms while taking any
of these medicines together with Abilify Maintena.
The medicines that increase the level of serotonin 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, OCD and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors (SSRIs/SNRIs), such as 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;
• pain relievers (e.g. tramadol and pethidine) used to relieve pain;
• triptans (e.g. sumatriptan and zolmitriptan) used for the treatment of migraine.

These medicines can increase the risk of side effects; consult your doctor if you experience
any unusual symptoms while taking any of these medicines together with Abilify
Maintena.

Abilify Maintena with alcohol
Alcohol should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor for advice before receiving this medicine.

Do not use Abilify Maintena if you are pregnant, unless you havediscussed the
situation with your doctor. If you are pregnant, suspect you may be pregnant
inform your doctor immediately.
Newborn babies of mothers who receive this medicine in the last three months of pregnancy (last
trimester) may experience the following symptoms:
tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems and difficulty
suction.
If the baby experiences any of these symptoms, contact your doctor.
If you are receiving Abilify Maintena, your doctor will discuss with you whether you should breastfeed, considering
the benefit of therapy for you and the benefit of breastfeeding for the baby. One choice excludes the other.
If you are receiving 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 cases where full alertness is required, for
example when driving or using machines.

Abilify Maintena contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to administer Abilify Maintena

Abilify Maintena is presented in the form of a suspension in a prefilled syringe which will be administered to you by your doctor or nurse.
The doctor will decide what dose is appropriate for you. The recommended initial dose is 960 mg to be injected
once every 2 months (56 days after the previous injection), unless the doctor decides to
prescribe a lower initial or follow-up dose (720 mg) to be injected once every 2 months
(56 days after the previous injection).
There are three ways to start treatment with Abilify Maintena 960 mg; the doctor will decide which one is
suitable for you.

• If you have received Abilify Maintena 400 mg 1 or more months before the doctor started treatment with Abilify Maintena 960 mg, the next dose may be replaced with an injection of Abilify Maintena 960 mg.
• If you receive an injection of Abilify Maintena 960 mg on the first day without having had an administration of Abilify Maintena 400 mg 1 month before, the treatment with aripiprazole orally will continue for 14 days after the first injection.
• If you receive two injections (one of Abilify Maintena 960 mg and one of Abilify Maintena 400 mg) on the first day, on this visit you will also take a tablet of aripiprazole orally. The doctor will give you the injections in two different sites.

Subsequently the treatment is administered with injections of Abilify Maintena 960 mg or
720 mg, unless otherwise indicated by the doctor.
The doctor will administer a single injection into the gluteal muscle (buttock) once every two months.
You may feel a slight pain during the injection. The doctor will alternate the injections on the right
and left side. The injections will not be administered intravenously.

If you receive more Abilify Maintena than you should
This medicine will be administered under medical supervision; it is therefore unlikely that you will receive
too much. If you consult more than one doctor, make sure you inform them that you are being treated with this
medicine.
Patients who have received an excessive amount of this medicine 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 sleepiness, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or hospital immediately if you have any of these symptoms.

If you miss an Abilify Maintena injection
It is important not to forget the scheduled dose. You must have an injection once
every 2 months. If you miss an injection, contact your doctor to arrange the next one as
soon as possible.

If you stop receiving Abilify Maintena
Do not stop treatment just because you feel better. It is important to continue taking this
medicine for the entire period indicated by your doctor.
If you have any questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Serious side effects
If you experience any of the serious side effects listed below, inform your doctor immediately.

• a combination of any of these symptoms: excessive drowsiness, dizziness, confusion, disorientation, difficulty speaking, difficulty walking, muscle rigidity or tremors, fever, weakness, irritability, aggressiveness, anxiety, increased blood pressure or convulsions that can lead to loss of consciousness;
• unusual movement, mainly affecting the face or tongue, as a result of which the doctor may decide to reduce the dose;
• symptoms such as swelling, pain and redness of the leg, which may indicate the presence of a blood clot capable of moving through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle rigidity and drowsiness or sleepiness, as it may be a sign of a condition called neuroleptic malignant syndrome (NMS);
• more thirst than usual, needing to urinate more than usual, intense hunger, feeling weak or tired, nausea, feeling confused or fruity-smelling breath, as it may be a sign of diabetes;
• suicidal thoughts, behaviors or feelings, or self-harming thoughts.

After taking Abilify Maintena, the following side effects may also appear.
Contact your doctor or nurse if you experience any of these side effects:

Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus;
• feeling of restlessness;
• feeling of anxiety;
• inability to stay still, difficulty remaining seated;
• difficulty sleeping (insomnia);
• spasmodic resistance to passive movement, while muscles contract and relax, abnormally increased muscle tone, slow body movement;
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously);
• shaking or trembling;
• uncontrollable movements characterized by contractions, jerks or contortions;
• changes in level of alertness, drowsiness;
• sleepiness;
• dizziness;
• headache;
• dry mouth;
• muscle rigidity;
• inability to achieve or maintain an erection during sexual intercourse;
• pain at the injection site, hardening of the skin at the injection site;
• weakness, loss of strength or extreme fatigue;
• when performing blood tests, the doctor may find higher levels of creatine phosphokinase (an enzyme important for muscle function);
• weight gain;
• weight loss.

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

• low levels of a specific type of white blood cells (neutropenia), hemoglobin or red blood cells and platelets;
• allergic reactions (e.g. swelling of the mouth, tongue, face and throat, itching, hives);
• increased levels of the hormone prolactin in the plasma;
• hyperglycemia;
• increased fats in the blood, such as high cholesterol and high triglycerides;
• increased levels of insulin, a hormone that regulates blood sugar levels;
• decreased or increased appetite;
• thoughts related to suicide;
• mental disorder characterized by a lack or absence of contact with reality;
• hallucinations (e.g. seeing and hearing things that are not real);
• delirium (e.g. believing things that are not true);
• increased sexual interest (which may cause behaviors that cause significant concern to you or others);
• panic reaction;
• depression;
• emotional lability;
• state of indifference with a lack of emotions, emotional and mental discomfort;
• sleep disorder;
• teeth grinding or jaw clenching;
• reduced sexual interest (reduced libido);
• mood alteration;
• muscle problems;
• muscle movements that cannot be controlled, such as grimacing, lip smacking and tongue movements. These usually affect the face and mouth first, but also other parts of the body. These may be signs of a condition called "tardive dyskinesia";
• parkinsonism: medical condition with many different symptoms, including reduced or slowed movements, slowness of thought, jerky movements when bending the limbs (cogwheel rigidity), shuffling gait, hurried steps, tremor, limited or absent facial expression, stiffness of the muscles, drooling;
• problems moving;
• extreme restlessness and agitation of the legs;
• eyeballs fixed in a single position;
• blurred vision;
• eye pain;
• double vision;
• eye sensitivity to light;
• alteration of the senses of taste and smell;
• abnormal heartbeat, slow or fast heartbeat;
• high blood pressure;
• dizziness upon standing up from a lying or sitting position, due to a decrease in blood pressure;
• cough;
• hiccups;
• gastroesophageal reflux. An excessive amount of gastric juice returns (refluxes) into the esophagus (the tube that connects the mouth to the stomach, through which food passes), causing heartburn and sometimes damaging the esophagus.
• heartburn;
• vomiting;
• diarrhea;
• nausea;
• stomach pain;
• stomach discomfort;
• constipation;
• frequent bowel movements;
• loss of saliva, amount of saliva higher than normal;
• abnormal hair loss;
• acne, a skin condition of the face where the nose and cheeks are unusually reddened, eczema, skin hardening;
• muscle rigidity, muscle spasms, muscle contractions, muscle tension, muscle pain (myalgia), pain in the extremities;
• joint pain (arthralgia), back pain, reduced range of motion of the joints, neck stiffness, limited opening of the mouth;
• kidney stones, sugar (glucose) in the urine;
• spontaneous leakage of milk from the breasts (galactorrhea);
• enlargement of the breasts in men, breasts painful to the touch, vaginal dryness;
• fever;
• loss of strength;
• gait disturbances;
• chest discomfort;
• reactions at the injection site such as redness, swelling, discomfort and itching;
• thirst;
• laziness;
• when performing the tests the doctor may find
• higher or lower amounts of sugar in the blood;
• higher levels of glycated hemoglobin;
• an increase in abdominal circumference;
• reduced amounts of cholesterol in the blood;
• reduced amounts of triglycerides in the blood;
• reduced amounts of white blood cells and neutrophils in the blood;
• higher levels of liver enzymes;
• reduced levels of prolactin hormone in the blood;
• abnormalities during a heart test (electrocardiogram, ECG) (e.g., decrease or inversion of the T wave amplitude);
• higher levels of alanine aminotransferase;
• higher levels of gamma-glutamyl transferase;
• higher levels of bilirubin in the blood;
• higher levels of aspartate aminotransferase;
• liver function tests may show abnormal results.

The following side effects have been reported after the marketing of medicines

containing the same active ingredient taken orally, but the frequency with which they occur

is unknown (it is not possible to estimate the frequency from the available data):

• low levels of white blood cells;
• decreased appetite
• low sodium levels in the blood;
• suicide and attempted suicide;
• inability to resist the impulse, urge or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences;
• excessive and uncontrollable shopping;
• 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 your appetite);
• a tendency to withdraw. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.
• nervousness;
• aggressiveness;
• neuroleptic malignant syndrome (a syndrome with symptoms such as fever, muscle rigidity, rapid breathing, sweating, decreased state of consciousness and sudden changes in blood pressure and heart rate);
• convulsions (seizures);
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity);
• speech disorders;
• diabetic ketoacidosis (ketones in the blood and urine) or diabetic coma;
• fainting;
• heart problems including cardiac arrest, torsades de pointes, irregular heart rhythms that can be caused by abnormal nerve impulses reaching the heart;
• symptoms related to the formation of blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can move along the blood vessels reaching the lungs where they cause chest pain and difficulty breathing;
• spasm in the throat that can cause a feeling of having a large object stuck in the throat;
• spasm of the muscles surrounding the vocal cords;
• accidental inhalation of food with a risk of pneumonia (lung infection);
• inflammation of the pancreas;
• difficulty swallowing;
• liver failure;
• jaundice (yellowing of the skin and whites of the eyes);
• inflammation of the liver;
• skin rash;
• skin sensitivity to light;
• excessive sweating;
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia).
• weakness, tenderness or pain in the muscles and especially if at the same time you have a feeling of malaise, high body temperature or dark urine. This may be caused by abnormal muscle breakdown, potentially fatal and which may lead to kidney problems (a condition called rhabdomyolysis).
• difficulty urinating;
• involuntary loss of urine (incontinence);
• withdrawal symptoms in the newborn;
• prolonged and/or painful erection;
• sudden unexplained death;
• difficulty controlling body temperature or conditions of excessive heat;
• chest pain;
• swelling at the level of hands, ankles or feet;
• when performing the tests the doctor may find
• fluctuating results on tests to measure blood sugar;
• prolongation of the QT (abnormalities on the electrocardiogram [ECG]);
• higher levels of alkaline phosphatase in the blood.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or nurse. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can contribute to providing more information on the safety of this medicine.

5. How to store Abilify Maintena

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 pack and on the pre-filled syringe.
The expiry date refers to the last day of that month.
Do not freeze.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Abilify Maintena contains

• The active substance is aripiprazole.

Abilify Maintena 720 mg injectable suspension for prolonged release in a pre-filled syringe
Each pre-filled syringe contains 720 mg of aripiprazole.
Abilify Maintena 960 mg injectable suspension for prolonged release in a pre-filled syringe
Each pre-filled syringe contains 960 mg of aripiprazole.

• The other ingredients are: Sodium carboxymethylcellulose, macrogol, povidone (E1201), sodium chloride, monobasic sodium phosphate monohydrate (E339), sodium hydroxide (E524) (see section 2, Abilify Maintena contains sodium), water for injections.

Description of Abilify Maintena and contents of the pack
Abilify Maintena is an injectable suspension for prolonged release in a pre-filled syringe.
Abilify Maintena is a white to off-white coloured suspension for prolonged release injectable suspension in a
pre-filled syringe.

Pack
Each 720 mg pack contains one pre-filled syringe and two sterile safety needles: one
38 mm (1.5 inches), 22 Gauge and one 51 mm (2 inches), 21 Gauge.
Each 960 mg pack contains one pre-filled syringe and two sterile safety needles: one
38 mm (1.5 inches), 22 Gauge and one 51 mm (2 inches), 21 Gauge.

Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands

Manufacturer
Elaiapharm
2881 Route des Crêtes Z.I Les Bouillides Sophia Antipolis
06550 Valbonne
France
For further information on this medicine, contact the local representative of the marketing authorisation holder:

België/Belgique/Belgien
Lundbeck S.A./N.V.
Tél/Tel: +32 2 535 79 79

Lietuva

• H. Lundbeck A/S Tel: +45 36301311

България
Lundbeck Export A/S Representative Office
Tel: +359 2 962 4696

Luxembourg/Luxemburg
Lundbeck S.A.
Tél: +32 2 535 79 79

Magyarország
Lundbeck Hungaria Kft.
Tel: +36 1 4369980

Danmark
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Česká republika
Lundbeck Česká republika s.r.o.
Tel: +420 225 275 600

Malta

• H. Lundbeck A/S Tel: +45 36301311

Deutschland
Otsuka Pharma GmbH
Tel: +49 69 1700860

Nederland
Lundbeck B.V.
Tel: +31 20 697 1901

Eesti

• H. Lundbeck A/S Tel: +45 36301311 NorgeOtsuka Pharma Scandinavia AB Tel: +46 8 54528660

Ελλάδα
Lundbeck Hellas S.A.
Τηλ: +30 210 610 5036

Österreich
Lundbeck Austria GmbH
Tel: +43 1 253 621 6033

España
Otsuka Pharmaceutical S.A.
Tel: +34 93 208 10 20

Polska
Lundbeck Poland Sp. z o. o.
Tel.: +48 22 626 93 00

France
Otsuka Pharmaceutical France SAS
Tél: +33 (0)1 47 08 00 00

Portugal
Lundbeck Portugal – Produtos Farmacêuticos,
Unipessoal Lda.
Tel: +351 21 00 45 900

Hrvatska
Lundbeck Croatia d.o.o.
Tel.: +385 1 644 82 63

România
Lundbeck Romania SRL
Tel: +40 21319 88 26

Ireland
Lundbeck (Ireland) Limited
Tel: +353 1 468 9800

Slovenija
Lundbeck Pharma d.o.o.
Tel.: +386 2 229 4500

Slovenská republika
Lundbeck Slovensko s.r.o.
Tel: +421 2 5341 42 18

Italia
Otsuka Pharmaceutical Italy S.r.l
Tel: +39 02 00 63 27 10

Ísland
Vistor hf.
Sími: +354 535 7000

Suomi/Finland
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Κύπρος
Lundbeck Hellas A.E
Τηλ.: +357 22490305

Sverige
Otsuka Pharma Scandinavia AB
Tel: +46 8 54528660

Latvija

• H. Lundbeck A/S Tel: +45 36301311 United Kingdom (Northern Ireland)Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/ .
---------------------------------------------------------------------------------------------------------------------------
The following information is intended exclusively for physicians or healthcare professionals:

INSTRUCTIONS FOR HEALTHCARE PROFESSIONALS
Unused medicine and waste materials from this medicine must be disposed of in accordance with
current local regulations.
Abilify Maintena 720 mg injectable suspension for prolonged release in a pre-filled syringe
Abilify Maintena 960 mg injectable suspension for prolonged release in a pre-filled syringe
aripiprazole

• Must be administered by a healthcare professional once every 2 months. Read the full instructions before use.
• The injectable suspension is for single use only.
• For intramuscular use only. Gluteal injection site only. Donot use other routes of administration.
• Before administration, visually inspect the syringe for particulate matter and colour change.
• The suspension should appear uniform, homogeneous, opaque and milky white in colour. Do not use Abilify Maintena if the colour is altered or if particulate matter is present.

Kit contents
Verify that the following components have been supplied:

• One pre-filled syringe containing Abilify Maintena 960 mg or 720 mg prolonged-release injectable suspension and two safety needles.
• One sterile needle 38 mm (1.5 inches), 22 Gauge with black hub.
• One sterile needle 51 mm (2 inches), 21 Gauge with green hub.

Prepare the injection

• Remove the syringe from the pack.
• Tap the syringe on the hand at least 10 times.
• After tapping, vigorously shake the syringe for at least 10 seconds.

Select the appropriate needle
For intramuscular administration into the gluteus muscle only.
Needle selection is based on the patient's body weight.

Attach the needle

• Twist and pull off the syringe cap.
• Holding the needle hub, check that the needle is securely attached to the safety device by pushing it down and gently rotating clockwise until it clicks into place.

Expel the air

• When ready to administer the injection, hold the syringe vertically and remove the needle cap by pulling it straight up. Donot rotate the needle cap as this may loosen the needle on the syringe.

• Slowly advance the plunger upwards to expel the air, continuing until the suspension fills the base of the needle.
• Inject immediately after expelling the air from the syringe.

Inject the dose

• Slowly inject the entire contents intramuscularly into the patient's gluteal muscle. Do not administerby any other route.
• Do not massage the injection site.

• Remember to alternate injection sites between the two gluteal muscles.
• If treatment is started with the option involving two injections, the latter must be administered in two different gluteal muscles. DO NOT administer both injections simultaneously into the same gluteal muscle.
• Check for any signs or symptoms of accidental intravascular administration.

Disposal procedure

• After the injection, insert the needle safety device by pressing the safety shield onto a hard surface to cover the needle and lock the shield onto it.

• Immediately dispose of the used syringe and unused needle in an approved sharps container.
• The unused needle should not be stored for future use.