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ARIPIPRAZOLE DR. REDDYS 5 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
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.

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):
• 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, 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 and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 06/2016

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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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