10 mg / 15 mg / 30 mg orodispersible tablets 
aripiprazole

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What ABILIFY is and what it is used for 
2. What you need to know before using ABILIFY 
3. How to use ABILIFY 
4. Possible side effects 
5. How to store ABILIFY 
6. Contents of the packaging 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 antipsychotic medicines. It is used to treat adults and adolescents aged 15 and up who suffer from a disease characterized by the person hearing, seeing, or experiencing things that are not there, are suspicious, believe wrong things, speak and behave inconsistently and show a deficiency in emotions. People in this condition may also feel depressed, guilty, anxious, or tense.

ABILIFY is used to treat adults and adolescents aged 13 and up who suffer from a condition that manifests itself in the person, for example, feeling “high”, has excess energy, needs much less sleep than usual, speaks very quickly and with a fast flow of ideas and sometimes is strongly annoyed. In adult patients who have been treated with ABILIFY, the medicine also prevents the condition from recurring.

2. What you need to know before using ABILIFY

Do not use ABILIFY

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

Warnings and cautions

Talk to your doctor before using ABILIFY,

Suicidal ideation and suicidal ideation have been reported during treatment with aripiprazole. Tell your doctor immediately if you have thoughts or a feeling of wanting to hurt yourself.

Before receiving treatment with ABILIFY, tell your doctor if you have

  • high blood sugar (which can cause symptoms such as excessive thirst, large amounts of urine, increased appetite, and feeling weak) or if diabetes is in the family
  • seizures (seizures) because your doctor may want to monitor you more closely
  • involuntary, irregular muscle movements, especially of the face
  • cardiovascular disease, cardiovascular disease in the family, stroke or “mini-stroke”, abnormal blood pressure
  • blood clots, or blood clots in the family, because an association between antipsychotic drugs and the formation of blood clots has been seen
  • former game mania

Tell your doctor if you notice that you are gaining weight, develop an abnormal movement pattern, experience fatigue that affects normal daily activities, experience difficulty swallowing, or have allergic symptoms.

If you are elderly and suffer from dementia (have memory loss or suffer from any other mental disorders), you or a relative/guardian should tell your doctor if you have ever had a stroke or transient, mild stroke

Tell your doctor immediately if you have thoughts or a feeling of wanting to hurt yourself. Suicidal ideation and suicidal ideation have been reported during aripiprazole treatment.

Tell your doctor immediately if you suffer from muscle stiffness or immobility with high fever, sweating, altered state of mind, or very fast or irregular heartbeat.

Tell a doctor if you or your family/caregiver notices that you are developing impulses or requests to behave in a way that is unusual for you and that you cannot resist the impulse, the drive, or the temptation to perform activities that may harm yourself or others. This is called disturbed impulse control. It may include behavior such as gambling addiction, excessive eating or buying behavior, abnormally high sex drive, or increased preoccupation with constant thoughts of sex or sexual feelings.

Your doctor may need to adjust your dose or stop your medication.

Aripiprazole can cause drowsiness, drops in blood pressure that occurs when you get up, dizziness and changes in mobility, and the ability to keep your balance, which can lead to falls. Caution should be exercised, especially if you are an elderly or debilitated patient.

Children and young people

Children and adolescents under 13 years of age should not use this medicine. It is not known if it is safe and effective for these patients.

Other medicines and ABILIFY

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Antihypertensive drugs: ABILIFY may increase the effect of drugs used to lower blood pressure. Therefore, tell your doctor if you are taking any medicine to keep your blood pressure under control

When ABILIFY is taken with certain medicines, the doctor may need to change the dose of one of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:

  • drugs to correct the heart rhythm (such as quinidine, amiodarone, flecainide )
  • antidepressants or herbal remedies used to treat depression and anxiety, (such as fluoxetine, paroxetine, venlafaxine, St. John’s wort )
  • medicines for fungal infections (such as ketoconazole, itraconazole)
  • certain drugs for the treatment of HIV – infection (as efavirenz, nevirapine, and protease inhibitors such as indinavir, ritonavir)
  • antispasmodics 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 get any unusual symptoms while taking any of these medicines with ABILIFY, you must consult a doctor.

Drugs that increase serotonin levels are mainly used in diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraines and pain:

  • triptans, tramadol, and tryptophan used in diseases such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia as well as migraines and pain
  • selective serotonin reuptake inhibitors ( SSRIs ) (such as paroxetine and fluoxetine) used in depression, OCD, panic disorder, and anxiety
  • other antidepressant drugs (such as venlafaxine and tryptophan) used in major depression
  • tricyclic antidepressants (such as clomipramine and amitriptyline) used in depression
  • St. John’s wort ( Hypericum perforatum ) used as a natural remedy for mild depression
  • painkillers (such as tramadol and pethidine) used to relieve pain
  • triptans (such as sumatriptan and zolmitriptan) used to treat migraines

These medicines may increase the risk of side effects. If you get any unusual symptoms while taking any of these medicines with ABILIFY, you must consult a doctor.

ABILIFY with food, drink, and alcohol

This medicine can be taken with or without food.

Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

In newborns whose mothers have taken ABILIFY during the last trimester (the last three months of pregnancy), the following symptoms may occur: tremors, stiff and/or weak muscles, drowsiness, agitation, breathing problems, and difficulty eating. If your child gets any of these symptoms, you may need to contact your doctor.

If you are taking ABILIFY, your doctor and you will discuss whether or not to breast-feed. You should then consider what benefit the treatment has for you compared to what benefit the child has from breastfeeding. You must not both breast-feed and take the medicine at the same time. Talk to your doctor about the best way to feed your child if you are taking this medicine.

Driving and using machines

Dizziness and vision problems may occur during treatment with this medicine (see section 4). This should be taken into account in cases where full attention is required, e.g. when driving or handling machines.

ABILIFY contains aspartame

ABILIFY 10 mg orodispersible tablets: This medicine contains 2 mg aspartame per tablet.

ABILIFY 15 mg orodispersible tablets: This medicine contains 3 mg aspartame per tablet.

ABILIFY 30 mg orodispersible tablets: This medicine contains 6 mg of aspartame per tablet.

Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that causes high levels of phenylalanine in your body.

ABILIFY contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

ABILIFY  contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use ABILIFY

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for adults is 15 mg once daily. However, your doctor may need to reduce or increase the dose one (up to a maximum of 30 mg once daily).

Use for children and adolescents

You should start with a low dose of the oral solution (in liquid form) of this medicine. Dose one can then be gradually increased up to the recommended dose one of 10 mg once daily for adolescents. However, your doctor may need to reduce or increase the dose one (up to a maximum of 30 mg once daily).

If you have the impression that the effect of ABILIFY is too strong or too weak, talk to your doctor or pharmacist

Try to take ABILIFY at the same time each day. It does not matter if you take them with or without food.

Do not open the blister until you take the tablet. To remove a single tablet, open the package and tear off the foil on the blister to make the tablet visible. Do not push the tablet through the foil, as this may damage the tablet. Immediately after opening the blister, the entire orodispersible tablet, taken with dry hands, is placed on the tongue. The tablet dissolves quickly in saliva and can be taken with or without liquid. 
Alternatively, the tablet can be dissolved in water to a suspension and drunk.

Even if you feel better, do not change or refrain from taking your daily dose of ABILIFY without first talking to your doctor.

If you take more ABILIFY than you should

If you realize that you have taken more ABILIFY than your doctor has recommended (or if someone else has taken any of your ABILIFY tablets), contact a doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the medicine pack with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

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

Other symptoms may include:

  • acute confusion, seizures ( epilepsy ), coma, a combination of fever, faster breathing, sweating.
  • muscle stiffness and drowsiness or drowsiness, slower breathing, suffocation, high or low blood pressure, abnormal heart rhythm.

Contact a doctor or hospital immediately if you experience any of the symptoms described above.

If you forget to take ABILIFY

If you miss a dose, take it as soon as you remember, but do not take a double done on the same day.

If you stop taking ABILIFY

Do not stop treatment just to make you feel better. It is important that you continue to take ABILIFY for as long as your doctor tells you.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

  • diabetes mellitus,
  • difficulty sleeping,
  • anxiety,
  • the feeling of restlessness and inability to be still, difficulty sitting still,
  • akathisia (an unpleasant feeling of inner restlessness and a strong need to move constantly),
  • uncontrollable jerking, jerking or twisting movements,
  • shaking,
  • headache,
  • fatigue,
  • somnolence,
  • fainting,
  • tremors and blurred vision,
  • decreased bowel movements or difficulty in bowel movements,
  • indigestion,
  • nausea,
  • abnormally high saliva in the mouth,
  • vomiting,
  • feeling tired.

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

  • increased levels of the hormone et prolactin in the blood,
  • too much sugar in the blood,
  • Depression,
  • altered or increased sexual interest,
  • uncontrollable movements of the mouth, tongue, arms, and legs ( tardive dyskinesia ),
  • muscle disease that causes twisting movements ( dystonia ),
  • restless legs,
  • double vision,
  • photosensitive eyes,
  • high heart rate,
  • a drop in blood pressure that occurs when you get up, which causes dizziness, fainting or fainting,
  • hiccup.

The following adverse reactions have been reported following the introduction of oral aripiprazole, but their frequency is unknown:

  • low levels of white blood cells,
  • low levels of platelets,
  • allergic reactions (eg swelling of the mouth, tongue, face, and throat, itching , rash),
  • onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
  • high blood sugar,
  • insufficient level of sodium in the blood,
  • loss of appetite ( anorexia ),
  • weight loss,
  • weight gain,
  • suicidal thoughts, suicide attempts, and suicide,
  • aggressiveness,
  • agitation,
  • concern,
  • a combination of fever, muscle stiffness, faster breathing, sweating, decreased consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
  • seizures,
  • serotonergic syndrome (a reaction that can cause happiness, drowsiness, clumsiness, restlessness, intoxication, fever, sweating, or stiff muscles),
  • speech changes,
  • that the eyeballs are fixed in one position,
  • sudden unexplained death,
  • life-threatening irregular heartbeat,
  • heart attack,
  • slower heart rate,
  • blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the bone), which can be transported through the blood vessels to the lungs and cause chest pain and difficulty breathing (if you notice any of these symptoms you must seek medical help immediately),
  • high blood pressure,
  • fainting,
  • unintentional inhalation of food with the risk of pneumonia,
  • spasm in the muscles around the larynx,
  • inflammation of the pancreas,
  • difficulty swallowing,
  • diarrhea,
  • a feeling of discomfort in the abdomen,
  • stomach upset,
  • liver failure,
  • inflammation of the liver,
  • yellowing of the skin and whites of the eyes,
  • reports of abnormal liver values,
  • rash,
  • photosensitive skin,
  • hair loss,
  • heavy sweating,
  • severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially appears as flu-like symptoms with rash on the face and then widespread skin rash, high body temperature, enlarged lymph nodes, elevated levels of liver enzymes detected by blood tests and an elevated number of a certain type of white blood cell ( eosinophilia ),
  • abnormal muscle breakdown which can lead to kidney problems,
  • muscle pain,
  • stiffness,
  • involuntary urination ( incontinence ),
  • difficulty urinating,
  • withdrawal symptoms in newborns after exposure during pregnancy,
  • persistent and/or painful erection,
  • disorders of body temperature regulation (eg fever),
  • chest pain,
  • swelling of hands, ankles, or feet,
  • in blood tests: rising and falling blood sugar, increase in glycosylated hemoglobin.
  • inability to resist the impulse, drive, or desire to perform an act that may be harmful to yourself and others, which may include:
  • a strong impulse to play excessively much despite serious personal or family consequences,
  • altered or increased sexual interest and behavior, of significant inconvenience to you or others, such as increased sexual drive,
  • uncontrollable excessive buying behavior or wasting money,
  • binge eating (eating large amounts of food for a short time) or compulsive eating (eating larger amounts of food than normal and more than is needed to satisfy hunger),
  • a tendency to wander away

Tell your doctor if you experience any of the above behaviors. He or she will discuss how to manage or reduce the symptoms.

In elderly patients with dementia, more deaths have been reported among those using aripiprazole. Furthermore, strokes or transient, mild strokes have been reported.

Additional side effects are in children and adolescents

Adolescents 13 years of age and older experienced side effects similar to those of adults in frequency and type with the exception that drowsiness, uncontrollable twitching or jerky movements, restlessness, and fatigue were very common (occurs in more than 1 in 10 users) and abdominal pain in the upper back region, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements, and dizziness, especially when getting up from a lying or sitting position, were common (occurs in 1-10 out of 100 users).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store ABILIFY

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 carton and blister after EXP. The expiration date is the last day of the specified month.

Store in the original package. Moisture sensitive.

The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is aripiprazole. Each orodispersible tablet contains 10 mg of aripiprazole. Each orodispersible tablet contains 15 mg of aripiprazole. Each orodispersible tablet contains 30 mg of aripiprazole.
  • The other ingredients are calcium silicate, croscarmellose sodium, crospovidone, silica, xylitol, microcrystalline cellulose, aspartame, acesulfame potassium, vanilla flavor (contains lactose ), tartaric acid, magnesium stearate.

ABILIFY 10 mg orodispersible tablets:ABILIFY 15 mg orodispersible tablets:ABILIFY 30 mg orodispersible tablets: red iron oxide (E 172)yellow iron oxide (E 172)red iron oxide (E 172)

What the medicine looks like and the contents of the pack

ABILIFY 10 mg orodispersible tablets are round and cut marked with “A “over” 640 “on one side and “10” on the other side.

ABILIFY 15 mg orodispersible tablets are round and yellow marked with “A “over” 641 “on one side and “15” on the other side.

ABILIFY 30 mg orodispersible tablets are round and cut marked with “A “over” 643 “on one side and “30” on the other side.

ABILIFY orodispersible tablets are marketed in perforated unit dose blisters packed in cartons of 14 × 1, 28 × 1, or 49 × 1 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Otsuka Pharmaceutical Netherlands BV

Herikerbergweg 292

1101 CT, Amsterdam

Netherlands

Manufacturer 
Elaiapharm

2881 Route des Crêtes, ZI Les Bouilides-Sophia Antipolis,

06560 Valbonne

France

Contact the representative of the marketing authorization holder to find out more about this medicine

Belgium / Belgique / BelgienOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 LithuaniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
BulgariaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 Luxembourg / LuxemburgOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
Czech RepublicOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 HungaryOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
DenmarkOtsuka Pharma Scandinavia ABTel: +46 (0) 8 545 286 60 MaltaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
GermanyOtsuka Pharma GmbHTel: +49 (0) 69 1700 86‑0 The NetherlandsOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
EestiOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 NorwayOtsuka Pharma Scandinavia ABTel: +46 (0) 8 545 286 60
GreeceOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 AustriaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
SpainOtsuka Pharmaceutical, SATel: +34 93 550 01 00 PolandOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
FranceOtsuka Pharmaceutical France SASTel: +33 (0) 1 47 08 00 00 PortugalLundbeck Portugal LdaTel: +351 (0) 21 00 45 900
CroatiaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 RomaniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
IrelandOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 SloveniaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
IcelandVistor hf.Phone: +354 (0) 535 7000 Slovak RepublicOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555
ItalyOtsuka Pharmaceutical Italy SrlTel: +39 (0) 2 00 63 2710 Finland / FinlandOtsuka Pharma Scandinavia ABPuh / Tel: +46 (0) 8 545 286 60
ΚύπροςOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 SwedenOtsuka Pharma Scandinavia ABTel: +46 (0) 8 545 286 60
LatviaOtsuka Pharmaceutical Netherlands BVTel: +31 (0) 20 85 46 555 United KingdomOtsuka Pharmaceuticals (UK) Ltd.Tel: +44 (0) 203 747 5300

Muhammad Nadeem

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