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ARIPIPRAZOLE TORRENT 15 MG ORODISPERSIBLE TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user
Aripiprazole 10 mg Orodispersible Tablets
Aripiprazole 15 mg Orodispersible Tablets
Aripiprazole
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Aripiprazole is and what it is used for
2. What you need to know before you take Aripiprazole
3. How to take Aripiprazole
4. Possible side effects
5. How to store Aripiprazole
6. Contents of the pack and other information
1. What Aripiprazole is and what it is used for
Aripiprazole contain the active substance aripiprazole and belongs to a group of medicines called
antipsychotics. It is used to treat adults and adolescents aged 15 years and older who suffer from a
disease characterised by symptoms such as hearing, seeing or sensing things which are not there,
suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness. People with
this condition may also feel depressed, guilty, anxious or tense.
2. What you need to know before you take Aripiprazole
Do not take Aripiprazole
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 before taking Aripiprazole if you suffer from
High blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of
urine, increase in appetite, and feeling weak) or family history of diabetes
Seizure
Involuntary, irregular muscle movements, especially in the face
Cardiovascular diseases, family history of cardiovascular disease, stroke or "mini" stroke, abnormal
blood pressure
Blood clots, or family history of blood clots, as antipsychotics have been associated with formation
of blood clots
Past experience of excessive gambling
If you notice you are gaining weight, develop unusual movements, experience somnolence that interferes
with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or
your carer/relative should tell your doctor if you have ever had a stroke or "mini" stroke.
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever, sweating,
altered mental status, or very rapid or irregular heart beat.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years. It is not known if it is safe and
effective in these patients.
Other medicines and Aripiprazole
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: Aripiprazole 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 Aripiprazole with some medicines may need to change your dose of Aripiprazole. It is especially
important to mention the following to your doctor:
Medicines to correct heart rhythm
Antidepressants or herbal remedy used to treat depression and anxiety
Antifungal agents
Certain medicines to treat HIV infection
Anticonvulsants used to treat epilepsy
Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, selective serotonin
re-uptake inhibitors [SSRIs (such as paroxetine and fluoxetine)], tricyclics (such as clomipramine,
amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side
effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole, you
should see your doctor.
Aripiprazole with alcohol
Alcohol should be avoided when taking Aripiprazole.
Pregnancy and breast-feeding
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 Aripiprazole 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.
Be sure to tell your doctor immediately if you are breast-feeding.
If you are taking Aripiprazole, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how Aripiprazole affects you.
3. How to take Aripiprazole
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
Aripiprazole may be started at a low dose with an 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 of 30 mg once a day.
If you have the impression that the effect of Aripiprazole is too strong or too weak, talk to your doctor or
pharmacist.
Aripiprazole is for oral use
Try to take the Aripiprazole orodispersible tablet at the same time each day. It does not matter whether
you take it with or without food.
Do not remove the orodispersible tablet from the blister until ready to administer. Place the entire
orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible
tablet can be taken with or without liquid.
Alternatively, disperse the tablet in water and drink the resulting suspension.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole without first consulting
your doctor.
If you take more Aripiprazole than you should
If you realise you have taken more Aripiprazole orodispersible tablets than your doctor has recommended
(or if someone else has taken some of your Aripiprazole tablets), contact your doctor right away. If you
cannot reach your doctor, go to the nearest hospital and take the pack with you.
If you forget to take Aripiprazole
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 Aripiprazole
Do not stop your treatment just because you feel better. It is important that you carry on taking your
Aripiprazole orodispersible tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any side effects listed below, please seek medical advice immediately taking your medicines
with you.
low levels of white blood cells which makes infections more likely (feeling tired, difficulty
conncentating, become dizzy easily)
low levels of blood platelets which increases risk of bleeding or bruising (ulcers in the mouth,
wounds that take long to heal)
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
thoughts of suicide, suicide attempt and suicide
combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and
sudden changes in blood pressure and heart rate), fainting (neuroleptic malignant syndrome)
serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
life-threatening irregular heart beat

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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)
Common side effects (may affect up to 1 in 10 people):
diabetes mellitus,
difficulty sleeping,
feeling anxious,
feeling restless and unable to keep still, difficulty sitting still,
uncontrollable twitching, jerking or writhing movements, restless legs,
trembling,
headache,
tiredness,
sleepiness,
light-headedness,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
indigestion,
feeling sick,
more saliva in mouth than normal,
vomiting,
feeling tired.
Uncommon side effects (may affect up to 1 in 100 people):
increased blood levels of the hormone prolactine,
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),
double vision,
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 (frequency cannot be estimated from the available data):
high blood sugar,
not enough sodium in the blood,
loss of appetite (anorexia),
weight loss,
weight gain,
excessive gambling,
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,
sudden unexplained death,
heart attack,
slower heartbeat,
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 test values,
skin rash,
sensitivity to light,
baldness,
excessive sweating,
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: fluctuating blood sugar, increased glycosylated haemoglobin.
In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In
addition, cases of stroke or "mini" stroke have been reported.
Additional side effects in children and adolescents
Adolescents aged 13 years and older experienced side effects that were similar in frequency and type to
those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness, and
tiredness were very common (greater than 1 in 10 patients) and upper abdominal pain, dry mouth,
increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled movements of the
limbs, and feeling dizzy, especially when getting up from a lying or sitting position, were common (greater
than 1 in 100 patients).
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 Yellow Card Scheme,
Website: www.mhra.gov.uk/yellowcard 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.
5. How to store Aripiprazole
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.
This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Aripiprazole contains
The active substance is aripiprazole.
Each orodispersible tablet contains 10 mg of aripiprazole.
Each orodispersible tablet contains 15 mg of aripiprazole.
The other ingredients are mannitol, crospovidone (type B), colloidal anhydrous silica, hydroxypropyl
cellulose, microcrystalline cellulose, acesulfame potassium, vanilla flavour (including nature
identical flavourings, natural flavours, maize maltodextrin, modified corn starch, triacetin), tartaric
acid, magnesium stearate.
What Aripiprazole looks like and contents of the pack
Aripiprazole 10 mg orodispersible tablets are white to off white, round uncoated tablets debossed with
“10” on one side and plain on other side with an approx. diameter of 7.1mm.
Aripiprazole 15 mg orodispersible tablets are white to off white, round uncoated tablets debossed with
“15” on one side and plain on other side with an approx. diameter of 7.9mm.
Aripiprazole orodispersible tablets are supplied in blisters packed in cartons containing 10, 14, 28, 30, 49,
56 or 60 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Torrent Pharma (UK) Ltd.
Unit 4, Charlwood Court
County Oak Way
Crawley
West Sussex
RH11 7XA
United Kingdom
This leaflet was last revised in 02/2018.

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