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ARIPIPRAZOLE DR. REDDYS 15 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user

Aripiprazole 5 mg, 10 mg, 15 mg, 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,
pharmacist or nurse.
 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, pharmacist
or nurse. 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 use Aripiprazole
3. How to use 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 tablets contain the active substance aripiprazole
and belong to a group of medicines called antipsychotics.
Aripiprazole 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.
Aripiprazole 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE
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, pharmacist or nurse 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 of age. 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 a change
in 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, 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
symptoms taking any of these medicines together with
Aripiprazole, you should see your doctor.
Aripiprazole with food, drink and alcohol
Aripiprazole 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 or
pharmacist 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 breastfeeding. If you are taking Aripiprazole, you should not breastfeed.
Driving and using machines
Do not drive or use any tools or machines until you know how
Aripiprazole affects you.
Aripiprazole tablets contain lactose monohydrate
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.
3. HOW TO USE 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 which is available from other licence
holders. 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.
Try to take the Aripiprazole tablet 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 without first consulting your doctor.
If you take more Aripiprazole 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 Aripiprazole
If you miss a dose, take the missed dose as soon as you
remember but do not take two doses in one day. Do not take
a double dose to make up for a forgotten dose.
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 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.
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):
uncontrollable twitching or jerking movements, headache,
tiredness, nausea, vomiting, an uncomfortable feeling in the
stomach, constipation, increased production of saliva, lightheadedness, trouble sleeping, restlessness, feeling anxious,
sleepiness, shaking and blurred vision.
Uncommon side effects (may affect up to 1 in
100 people): some people may feel dizzy, especially when
getting up from a lying or sitting position, or may experience a
fast heart rate or double vision. Some people may feel
depressed. Some people may experience altered or
increased sexual interest and increased blood levels of the
hormone prolactin.
The following side effects have been reported since the
marketing of aripiprazole but the frequency for them to occur
is not known (frequency cannot be estimated from the
available data):
 changes in the levels of some blood cells
 unusual heart beat
 sudden unexplained death
 heart attack
 allergic reaction (e.g. swelling in the mouth, tongue, face
and throat, itching, rash)
 high blood sugar, onset or worsening of diabetes,
ketoacidosis (ketones in the blood and urine) or coma,
low sodium level in the blood
 weight gain, weight loss, anorexia
 aggression, nervousness, agitation, feeling anxious,
excessive gambling; thoughts of suicide, suicide attempt
and suicide
 speech disorder, seizure, serotonin syndrome (a reaction
which may cause feelings of great happiness,
drowsiness, clumsiness, restlessness, feeling of being
drunk, fever, sweating or rigid muscles), combination of
fever, muscle stiffness, faster breathing, sweating,
reduced consciousness and sudden changes in blood
pressure and heart rate
 fainting, high blood pressure, 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)
 spasm of the muscles around the voice box, accidental
inhalation of food with risk of pneumonia, difficulty in
swallowing
 inflammation of the pancreas







liver failure, inflammation of the liver, yellowing of the
skin and white part of eyes, reports of abnormal liver test
values, abdominal and stomach discomfort, diarrhoea
skin rash and sensitivity to light, unusual hair loss or
thinning, excessive sweating; stiffness or cramps, muscle
pain, weakness
involuntary loss of urine, difficulty in passing urine
prolonged and/or painful erection
difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands, ankles or
feet.

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.
5. HOW TO STORE ARIPIPRAZOLE
This medicinal product does not require any special storage
conditions.
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 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
What Aripiprazole tablets contain
 The active substance is aripiprazole.
Each 5 mg tablet contains 5 mg of aripiprazole.
Each 10 mg tablet contains 10 mg of aripiprazole.
Each 15 mg tablet contains 15 mg of aripiprazole.
Each 30 mg tablet contains 30 mg of aripiprazole.
 The other ingredients are: lactose monohydrate, maize
starch, microcrystalline cellulose, hydroxypropylcellulose,
magnesium stearate. The 5 mg tablets also contain
indigo carmine (E132). The 10 mg and 30 mg tablets
also contain red iron oxide (E172). The 15 mg tablets
also contain yellow iron oxide (E172).
What Aripiprazole tablets look like and contents of the
pack
Aripiprazole 5 mg are presented as elliptic, shallow and
convex blue tablets. Aripiprazole 10 mg are presented as
elliptic, shallow and convex pink tablets. Aripiprazole 15 mg
are presented as round, shallow and convex yellow tablets.
Aripiprazole 30 mg are presented as round, shallow and
convex pink tablets.
Aripiprazole is available in packages of 14, 28, 48 and 98
tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 12/2015

Package leaflet: Information for the user

Aripiprazole 5 mg, 10 mg, 15 mg, 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,
pharmacist or nurse.

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,
pharmacist or nurse. 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 use Aripiprazole
3. How to use 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 tablets contain the active substance aripiprazole
and belong to a group of medicines called antipsychotics.
Aripiprazole 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.

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. Ask your doctor or pharmacist for advice before
taking Aripiprazole.
Other medicines and Aripiprazole
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
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 a change
in 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, 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
symptoms taking any of these medicines together with
Aripiprazole, you should see your doctor.

Aripiprazole tablets may also be prescribed to treat
conditions not listed in this leaflet. If you have any questions,
ask your doctor or pharmacist.

Aripiprazole with food, drink and alcohol
Aripiprazole can be taken regardless of meals.
Alcohol should be avoided when taking Aripiprazole.

2. WHAT YOU NEED TO KNOW BEFORE YOU
USE 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 or
pharmacist for advice before taking this medicine.

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, pharmacist or nurse 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.

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 breastfeeding. If you are taking Aripiprazole, you should not breastfeed.
Driving and using machines
Do not drive or use any tools or machines until you know how
Aripiprazole affects you.
Aripiprazole tablets contain lactose monohydrate
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking
this medicinal product.

3. HOW TO USE 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 which is available from other licence
holders. 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.
Try to take the Aripiprazole tablet 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 without first consulting your doctor.
If you take more Aripiprazole 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 Aripiprazole
If you miss a dose, take the missed dose as soon as you
remember but do not take two doses in one day. Do not take
a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

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):
uncontrollable twitching or jerking movements, headache,
tiredness, nausea, vomiting, an uncomfortable feeling in the
stomach, constipation, increased production of saliva, lightheadedness, trouble sleeping, restlessness, feeling anxious,
sleepiness, shaking and blurred vision.
Uncommon side effects (may affect up to 1 in
100 people): some people may feel dizzy, especially when
getting up from a lying or sitting position, or may experience a
fast heart rate or double vision. Some people may feel
depressed.
The following side effects have been reported since the
marketing of aripiprazole but the frequency for them to occur
is not known (frequency cannot be estimated from the
available data):

changes in the levels of some blood cells

unusual heart beat

sudden unexplained death

heart attack

allergic reaction (e.g. swelling in the mouth, tongue,
face and throat, itching, rash)

high blood sugar, onset or worsening of diabetes,
ketoacidosis (ketones in the blood and urine) or coma,
low sodium level in the blood

weight gain, weight loss, anorexia

nervousness, agitation, feeling anxious, excessive
gambling; thoughts of suicide, suicide attempt and
suicide

speech disorder, seizure, serotonin syndrome (a
reaction which may cause feelings of great happiness,
drowsiness, clumsiness, restlessness, feeling of being
drunk, fever, sweating or rigid muscles), combination of
fever, muscle stiffness, faster breathing, sweating,
reduced consciousness and sudden changes in blood
pressure and heart rate

fainting, high blood pressure, 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)

spasm of the muscles around the voice box, accidental
inhalation of food with risk of pneumonia, difficulty in
swallowing

inflammation of the pancreas

liver failure, inflammation of the liver, yellowing of the
skin and white part of eyes, reports of abnormal liver
test values, abdominal and stomach discomfort,
diarrhoea

skin rash and sensitivity to light, unusual hair loss or
thinning, excessive sweating; stiffness or cramps,
muscle pain, weakness

involuntary loss of urine, difficulty in passing urine




prolonged and/or painful erection
difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands, ankles
or feet.
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, website www.mhra.gov.uk/yellowcard. By
reporting side effects you can help provide more information
on the safety of this medicine.

5. HOW TO STORE ARIPIPRAZOLE
This medicinal product does not require any special storage
conditions.
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 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
What Aripiprazole tablets contain

The active substance is aripiprazole.
Each 5 mg tablet contains 5 mg of aripiprazole.
Each 10 mg tablet contains 10 mg of aripiprazole.
Each 15 mg tablet contains 15 mg of aripiprazole.
Each 30 mg tablet contains 30 mg of aripiprazole.

The other ingredients are: lactose monohydrate, maize
starch, microcrystalline cellulose,
hydroxypropylcellulose, magnesium stearate.
The 5 mg tablets also contain indigo carmine (E132).
The 10 mg and 30 mg tablets also contain red iron
oxide (E172).
The 15 mg tablets also contain yellow iron oxide
(E172).
What Aripiprazole tablets look like and contents of the
pack
Aripiprazole 5 mg are presented as elliptic, shallow and
convex blue tablets.
Aripiprazole 10 mg are presented as elliptic, shallow and
convex pink tablets.
Aripiprazole 15 mg are presented as round, shallow and
convex yellow tablets.
Aripiprazole 30 mg are presented as round, shallow and
convex pink tablets.
Aripiprazole is available in packages of 14, 28, 48 and 98
tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra,
Portugal
This leaflet was last revised in 12/2014

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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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