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ARIPIPRAZOLE 20 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the patient

Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 20 mg tablets
Aripiprazole 30 mg 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
This medicine contains 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.
This medicine is used to treat adults and adolescents aged 13 years and older who suffer from a condition
with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than
usual, talking very quickly with racing ideas and sometimes severe irritability. In adults it also prevents
this condition from returning in patients who have responded to the treatment with aripiprazole.

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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 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 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.

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2. What you need to know before you take Aripiprazole
Do not take Aripiprazole:
• if you are allergic to the active substance or any of the other ingredients of this medicine
(listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist 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
Aripiprazole is not for use 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 or have recently taken or might take any other medicines,
including medicines obtained without a prescription
Blood pressure-lowering medicines: Aripiprazole tablets 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 tablets with some medicines may need to change your dose of Aripiprazole tablets. 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, 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 food and drink
Aripiprazole can be taken regardless of meals.
Alcohol should be avoided when taking Aripiprazole.
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 new-born 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 this medicine, 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.
Aripiprazole tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

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Try to take your Aripiprazole tablets 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 Aripiprazole tablets without first
consulting your doctor.
If you take more Aripiprazole tablets than you should
If you realise you have taken more Aripiprazole 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 your Aripiprazole tablets
If you forget to take a dose at the usual time, take it as soon as you remember, unless it is time to take your
next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Aripiprazole tablets
Do not stop your treatment just because you feel better. It is important that you carry on taking your
Aripiprazole 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, pharmacist or nurse.

5. How to store Aripiprazole
• Keep this medicine out of the sight and reach of children.
• This medicinal product does not require any special storage conditions.
• Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date
refers to the last day of that month.
• 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.

6. Contents of the pack and other information

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What Aripiprazole tablets contain
• The active substance is aripiprazole.Each tablet contains 5mg, 10mg, 15mg, 20mg or 30mg of aripiprazole.
• The other ingredients are: Lactose monohydrate, Maize starch, Microcrystalline cellulose, Hydroxypropyl
cellulose, Magnesium stearate. In addition 5 mg tablet contains Indigo carmine aluminium lake (E132),
10mg and 30mg tablets contain Ironoxide red (E172), 15mg tablet contains Iron oxide yellow (E172).
What Aripiprazole tablets look like and contents of the pack
• 5 mg: Light blue to blue, modified rectangular bevel edged biconvex tablets debossed with ‘I’ on one
side and ‘95’ on other side.
• 10 mg: Light pink to pink, modified rectangular, bevel edged biconvex tablets debossed with ‘I’ on one
side and ‘96’ on other side.
• 15 mg: Light yellow to yellow, round, bevel edged biconvex tablets debossed with ‘I’ on one side and
‘97’on other side.
• 20 mg: White to off-white, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘98’
on other side.
• 30 mg: Light pink to pink, round, bevel edged biconvex tablets debossed with ‘I’ on one side and ‘99’
on other side.
• This medicine is available in packs of 14, 28, 30, 48, 49, 50, 56, 60, 84, 90, 98 and 100. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road,Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG
Telephone: 0044 (0) 1442 200922
Fax:
0044 (0) 1442 873717
Email:
info@bristol-labs.co.uk
Aripiprazole 5 mg Tablets; PL 17907/0602
Aripiprazole 10 mg Tablets; PL 17907/0603
Aripiprazole 15 mg Tablets; PL 17907/0604
Aripiprazole 20 mg Tablets; PL 17907/0605
Aripiprazole 30 mg Tablets; PL 17907/0606
This leaflet was last revised in August 2017
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at
the address (or telephone, fax, email) above.
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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, 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 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), double vision, fast heart beat, 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, 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, life-threatening irregular heart beat, heart attack, slower heart beat, 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,
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, pharmacist or nurse. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the
safety of this medicine.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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