Patient leaflet - ABILIFY 10 MG TABLETS
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Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if 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 take any other medicines, including medicines obtained without a prescription.
Blood pressure-lowering medicines: ABILIFY may increase the effect of medicines used to lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood pressure under control.
Taking ABILIFY with some medicines may mean the doctor will need to change your dose of ABILIFY or the other medicines. It is especially important to mention the following to your doctor:
§ medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)
§ antidepressants or herbal remedy used to treat depression and anxiety ( such as fluoxetine, paroxetine, venlafaxine, St. John’s Wort)
§ antifungal medicines (such as ketoconazole, itraconazole)
§ certain medicines to treat HIV infection (such as efavirenz, nevirapine, an protease inhibitors e.g. 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 riskofside effects or reduce the effect of ABILIFY; if you get any unusual symptom taking any of these medicines together with ABILIFY you should see your doctor.
Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:
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triptans, tramadol and tryptophan used for conditions including depression, generalised 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 anti-depressants (such as venlafaxine and tryptophan) used in major depression tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
St John’s Wort (Hypericum perforatum ) used as a herbal remedy for mild depression pain killers (such as tramadol and pethidine) used for pain relief triptans (such as sumatriptan and zolmitripitan) used for treating migraine
These medicines may increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with ABILIFY, you should see your doctor.
ABILIFY with food, drink and alcohol
This medicine can be taken regardless of meals.
Alcohol should be avoided.
Pregnancy, breast-feeding 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 taking this medicine.
The following symptoms may occur in newborn babies, of mothers that have used ABILIFY in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/ or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
If you are taking ABILIFY, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding.
You should not do both. Talk to your doctor about the best way to feed your baby 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 considered in cases where full alertness is required, e.g. when driving a car or handling machines.
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.
(2) 3. How to take ABILIFY
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 mg once a day.
Use in children and adolescents
This medicinal product may be started at a low dose with the oral solution (liquid) form.
The dose may be gradually increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may prescribe a lower or higher dose to a maximum of30 mg once a day.
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 whether you take it with or without food. Always take the tablet with water and swallow it whole.
Even if you feel better, do not alter or discontinue the daily dose of ABILIFY without first consulting your doctor.
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If you take more ABILIFY than you should
If you realise you have taken moreABILIFY than your doctor has recommended (or if someone else has taken some of your ABILIFY), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.
Patients who have taken too much aripiprazole have experienced the following symptoms: § rapid heartbeat, agitation/aggressiveness, problems with speech.
§ 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, faster breathing, sweating,
muscle stiffness, and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.
Contact your doctor or hospital immediately if you experience any ofthe above.
If you forget to take ABILIFY
If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.
If you stop taking ABILIFY
Do not stop your treatment just because you feel better. It is important that you carry on taking ABILIFY for as long as your doctor has told you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
/b 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect upto 1 in 10 people):
§ diabetes mellitus,
§ difficulty sleeping,
§ feeling anxious,
§ feeling restless and unable to keep still, difficulty sitting still,
§ akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
§ uncontrollable twitching, jerking or writhing movements,
§ trembling,
§ headache,
§ tiredness,
§ sleepiness,
§ light-headedness,
§ shaking and blurred vision,
§ decreased number of or difficulty making bowel movements,
§ indigestion,
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§ feeling sick,
§ more saliva in mouth than normal,
§ vomiting,
§ feeling tired.
Uncommon side effects (may affect upto 1 in 100 people):
§ increased blood levels of the hormone prolactin,
§ too much sugar in the blood,
§ depression,
§ altered or increased sexual interest,
§ uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia),
§ muscle disorder causing twisting movements (dystonia),
§ restless legs,
§ double vision,
§ eye sensitivity to light,
§ fast heartbeat,
§ a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting,
§ hiccups.
The following side effects have been reported since the marketing of oral aripiprazole but the frequency for them to occur is not known:
low levels of white blood cells,
low levels of blood platelets,
allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma, high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
thoughts of suicide, suicide attempt and suicide,
feeling aggressive,
agitation,
nervousness,
combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
seizure,
serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), speech disorder,
fixation of the eyeballs in one position,
sudden unexplained death,
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§ 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 in breathing (if you notice any of these symptoms, seek medical advice immediately),
§ high blood pressure,
§ fainting,
§ accidental inhalation of food with risk of pneumonia (lung infection),
§ spasm of the muscles around the voice box,
§ inflammation of the pancreas,
§ difficulty swallowing,
§§diarrhoea,
abdominal discomfort,
§ stomach discomfort,
§§liver failure,
inflammation of the liver,
§ yellowing of the skin and white part of eyes,
§§reports of abnormal liver tests values,
skin rash,
§ skin sensitivity to light,
§baldness,
excessive sweating,
§ serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
§ abnormal muscle breakdown which can lead to kidney problems,
§ muscle pain,
§§stiffness,
involuntary loss of urine (incontinence),
§ difficulty in passing urine,
§§withdrawal symptoms in newborn babies in case of exposure during pregnancy, prolonged and/or painful erection,
§ difficulty controlling core body temperature or overheating,
§§chest pain,
swelling of hands, ankles or feet,
§ in blood tests: increased or fluctuating blood sugar, increased glycosylated haemoglobin.
§ Inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:
– strong impulse to gamble excessively despite serious personal or family consequences
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– altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
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– uncontrollable excessive shopping
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– binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
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– a tendency to wander away.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
03 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 blister and on the carton after EXP. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
§ The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose and magnesium stearate.
Tablet coat
ABILIFY 5 mg tablets: Indigo carmine aluminium lake (E 132)
ABILIFY10 mgtablets: Red iron oxide (E 172)
ABILIFY 15 mg tablets: Yellow iron oxide (E 172)
ABILIFY30 mgtablets: Red iron oxide (E 172)
What ABILIFY looks like and contents of the pack
ABILIFY 5 mg tablets are rectangular and blue, marked with ‘A-007’ and ‘5’ on one side.
ABILIFY 10 mg tablets are rectangular and pink, marked with ‘A-008’ and ‘10’ on one side.
ABILIFY 15 mg tablets are round and yellow, marked with ‘A-009’ and ‘15’ on one side.
ABILIFY 30 mg tablets are round and pink, marked with ‘A-011’ and ‘30’ on one side.
ABILIFY tablets are supplied in perforated unit dose blisters packed in cartons containing
14 × 1, 28 × 1,49 × 1, 56 × 1, or 98 × 1 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292
1101 CT, Amsterdam
Netherlands
Manufacturer
Elaiapharm
2881 Route des Cretes, Z.I. Les Bouilides-Sophia Antipolis,
06560 Valbonne
France
For any information about this medicine, please contact:
United Kingdom
Otsuka Pharmaceuticals (UK) Ltd.
Tel: +44 (0) 203 747 5300
This leaflet was last revised in 05/2021
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(D 6. Contents of the pack and other information
What ABILIFY contains
§ The active substance is aripiprazole.
Each tablet contains 5 mg of aripiprazole.
Each tablet contains 10 mg of aripiprazole.
Each tablet contains 15 mg of aripiprazole.
Each tablet contains 30 mg of aripiprazole.
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