Abilify 7.5 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ABILIFY 7.5 mg/ml solution for injection

aripiprazole

Read the entire leaflet carefully before receiving this medicine because it contains important information for you.

• Keep this leaflet as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What ABILIFY is and what it is used for

ABILIFY contains the active substance aripiprazole and belongs to a group of medicines called antipsychotics. ABILIFY is used to rapidly treat symptoms of agitation and behavioural disturbances that may occur in a condition characterised by symptoms such as:

• hearing, seeing or sensing things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. People in this state may also feel depressed, guilty, restless or tense.
• feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability.

ABILIFY is administered when treatment with oral formulations is not suitable. Your doctor will switch your treatment to oral ABILIFY as soon as possible.

2. What you need to know before you are given ABILIFY

Do not use ABILIFY

• 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 starting treatment with ABILIFY.

Cases of patients experiencing suicidal thoughts and behaviors during treatment with this medicine have been reported. Inform your doctor immediately if you have thoughts or feelings of harming yourself before or after taking ABILIFY.

Before starting treatment with ABILIFY, tell your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, increased appetite, and feeling weak) or a family history of diabetes;
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face;
• cardiovascular diseases (heart and circulation problems), family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressure;
• blood clots or a family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of gambling addiction.

If you notice that you are gaining weight, develop unusual movements, experience drowsiness that interferes with your normal daily activities, have difficulty swallowing, or show allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities), you or your caregiver or family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Inform your doctor or nurse if you feel dizzy or faint after the injection. You will likely need to lie down until you feel better. Your doctor may also need to check your blood pressure and pulse.

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior during treatment with aripiprazole have been reported.

Speak to your doctor immediately if you notice muscle stiffness or numbness with high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that could harm you or others. This is called impulse control disorder and may include behaviors such as gambling addiction, excessive eating or spending, abnormally high sex drive, or preoccupation with increased sexual thoughts and feelings.

Your doctor may consider adjusting or stopping your dose.

This medicine may cause drowsiness, low blood pressure upon standing, dizziness, and changes in your ability to move and maintain balance, which could lead to falls. Caution is advised, especially if you are an elderly patient or have some degree of weakness.

Children and adolescents

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

Other medicines and ABILIFY

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

Medicines that lower blood pressure: ABILIFY may increase the effect of medicines used to lower blood pressure. Be sure to inform your doctor if you are taking any medicine to control blood pressure.

If you are receiving ABILIFY with another medicine, it may mean that your doctor needs to adjust your dose of ABILIFY or the other medicines. It is especially important to tell your doctor if you are taking:

• medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide);
• antidepressants or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s wort);
• medicines to treat fungal infections (antifungals) (such as itraconazole);
• ketoconazole (used to treat Cushing's syndrome when the body produces too much cortisol);
• certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir);
• anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of ABILIFY; if you notice any unusual symptoms while taking any of these medicines together with ABILIFY, you must inform your doctor.

Medicines that increase serotonin levels are generally used for conditions including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive disorders;
• St. John’s wort (Hypericum perforatum) used in herbal medicines for mild depression;
• painkillers (such as tramadol and pethidine) used to relieve pain;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms while taking any of these medicines together with ABILIFY, you must inform your doctor.

The combination of ABILIFY with other medicines used for anxiety may make you feel drowsy or dizzy. Take ABILIFY with other medicines only if your doctor recommends it.

Use of ABILIFY with food, drinks, and alcohol

This medicine can be administered regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies whose mothers have been treated with ABILIFY during the third trimester of pregnancy (last three months of pregnancy): tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing problems, and feeding difficulties. If your baby develops any of these symptoms, contact your doctor.

If you are receiving ABILIFY, your doctor will discuss with you whether you should breastfeed, considering the benefit of treatment for you and the benefit of breastfeeding for your baby. If you are being treated with ABILIFY, you should not breastfeed. Talk to your doctor about the best way to feed your baby if you are receiving this medicine.

Driving and using machines

Dizziness and vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

ABILIFY contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; that is, essentially "sodium-free."

3. How ABILIFY is administered

Your doctor will decide how much ABILIFY you need and for how long you need it. The recommended dose is 9.75 mg (1.3 ml) for the first injection. Up to three injections may be administered within 24 hours. The total daily dose of ABILIFY (all formulations combined) must not exceed 30 mg.

ABILIFY is ready for use. Your doctor or nurse will inject the correct amount of solution intramuscularly.

If you are given more ABILIFY than you should

This medicine will be administered under medical supervision, so it is unlikely that you will receive too much. If you are being seen by more than one doctor, make sure you inform them that you are receiving ABILIFY.

Patients who have received an overdose of this medicine have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems.
• unusual movements (especially of the face or tongue), and decreased level of consciousness.

Other possible symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness, slowed breathing, suffocation, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the symptoms listed above.

If you miss your dose of ABILIFY

It is important not to miss your scheduled dose. If you miss an injection, you should contact your doctor to schedule the next injection as soon as possible.

If ABILIFY administration is stopped

Do not stop your treatment just because you feel better. It is important to continue receiving ABILIFY for the duration prescribed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

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

Frequent adverse effects (may affect up to 1 in 10 patients):

• diabetes mellitus;
• sleep problems;
• anxiety;
• restlessness and inability to stay still, difficulty remaining seated;
• akathisia (a distressing inner restlessness and an overwhelming need to keep moving constantly);
• uncontrollable twisting, writhing, or spasmodic movements;
• tremor;
• headache;
• fatigue;
• drowsiness;
• dizziness;
• trembling and blurred vision;
• difficulty passing stools or reduced frequency of bowel movements (constipation);
• indigestion;
• nausea;
• increased saliva production;
• vomiting;
• feeling of tiredness.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• increased or decreased levels of the hormone prolactin in the blood;
• excessively high blood sugar levels;
• depression;
• altered or increased sex drive;
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia);
• a muscular disorder causing twisting movements (dystonia);
• restless legs;
• double vision;
• eye photosensitivity;
• rapid heartbeat;
• increased diastolic blood pressure;
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting;
• hiccups;
• dry mouth.

The following adverse effects have been reported during the post-marketing phase of oral aripiprazole, but their frequency is unknown:

• low white blood cell count;
• low platelet count;
• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness);
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma;
• elevated blood sugar;
• low sodium levels in blood;
• loss of appetite (anorexia);
• weight loss;
• weight gain;
• suicidal thoughts, suicide attempt, and suicide;
• aggression;
• agitation;
• nervousness;
• a combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, abrupt changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome);
• seizures;
• serotonin syndrome (a reaction that may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness);
• speech disorder;
• fixation of the eyeballs in one position;
• unexplained sudden death;
• potentially life-threatening irregular heartbeat;
• heart attack;
• slower 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 difficulty breathing (if you notice any of these symptoms, contact your doctor immediately);
• high blood pressure;
• fainting;
• accidental inhalation of food with risk of pneumonia (lung infection);
• spasms of the muscles around the glottis (a part of the larynx);
• inflammation of the pancreas;
• difficulty swallowing;
• diarrhea;
• abdominal discomfort;
• stomach upset;
• liver failure;
• inflammation of the liver;
• yellowing of the skin and whites of the eyes;
• abnormal liver function test results;
• rash;
• skin photosensitivity;
• hair loss;
• excessive sweating;
• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with a facial rash, followed later by generalized skin rash, high fever, enlarged lymph nodes, increased liver enzyme concentrations observed in blood tests, and increased levels of a type of white blood cell (eosinophilia);
• abnormal muscle breakdown that may lead to kidney problems;
• muscle pain;
• stiffness;
• involuntary loss of urine (incontinence);
• difficulty urinating;
• withdrawal symptoms in newborns due to exposure to medication during pregnancy;
• prolonged and/or painful erection;
• difficulty controlling core body temperature or overheating;
• chest pain;
• swollen hands, ankles, or feet;
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin;
• inability to resist the impulse, urge, or temptation to carry out 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 concerning to you or others, for example, increased sexual appetite;
  • uncontrollable excessive shopping;
  • binge eating (consuming 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.

Inform your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ABILIFY

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store the vial in the outer packaging to protect it from light.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of ABILIFY

• The active substance is aripiprazole.

Each ml contains 7.5 mg of aripiprazole.

One vial contains 9.75 mg (1.3 ml) of aripiprazole.

• The other components are sulfobutylether β-cyclodextrin (SBECD), tartaric acid, sodium hydroxide, and water for injections.

Appearance of ABILIFY and contents of the container

ABILIFY injection solution is a clear, colourless, aqueous solution.

Each carton contains a single-use type I glass vial with a butyl rubber stopper and an aluminium tear-off cap.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands B.V.

Herikerbergweg 292

1101 CT, Amsterdam

The Netherlands

Manufacturer

Zambon S.p.A.

Via della Chimica, 9

I-36100 Vicenza (VI)

Italy

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet: {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.