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ARIPIPRAZOLE DR. REDDYS 1 MG/ ML ORAL SOLUTION

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE

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Package leaflet: Information for the user

Aripiprazole 1 mg/ml Oral Solution
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 oral solution 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.
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 take
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 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 ml solution
(corresponding to 15 mg aripiprazole) once a day.
However your doctor may prescribe a lower or higher dose
to a maximum of 30 mg (i.e. 30 ml) once a day.
Use in children and adolescents
The recommended dose for adolescents is 10 ml
solution (corresponding to 10 mg aripiprazole) once a
day. However your doctor may prescribe a lower or higher
dose to a maximum of 30 ml (i.e. 30 mg) once a day.
Measuring dose
The dose of Aripiprazole oral solution must be measured
using the measuring cup or the 5 ml syringe supplied in the
carton.
Open the bottle and make sure
that the syringe is firmly
inserted into the adaptor
(Figure 1).

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.

Turn the bottle upside down
with the syringe still in place
(Figure 2).

Pull the plunger down and fill
the syringe with a quantity of
solution slightly beyond the
prescribed dose (Figure 3).

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 heartbeat.
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 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, 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, drink and alcohol
Aripiprazole can be taken regardless of meals. However, the
oral solution should not be diluted with other liquids or
mixed with any food prior to administration.
Alcohol should be avoided.

If any bubbles appear in the
syringe, keep the bottle upside
down and slightly push in the
plunger and pull it back again.
Repeat until there are no
bubbles in the syringe
(Figure 4).

Push the plunger in slowly to
the graduation mark
corresponding to the quantity
in millilitres (ml) prescribed by
your doctor (Figure 5).

Turn the bottle the right way
up and remove the syringe
(Figure 6).

Wash the syringe and the cup with water after use and
close the bottle with the plastic screw cap.
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 oral solution at the same
time each day. It does not matter whether you take it with
or without food. However, you should not dilute with other
liquids or mix with other food prior to taking Aripiprazole
oral solution.
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 oral
solution than your doctor has recommended (or if
someone else has taken some of your Aripiprazole oral
solution), 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 Aripiprazole 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.
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
serotoninseizure 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 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, 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
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 bottle 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 conditions.
Use within 6 months after first opening.
Store in the original bottle in order to protect from light.
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 contains
The active substance is aripiprazole. Each ml contains 1 mg
of aripiprazole.
The other ingredients are:
Propylene glycol (E1520)
Macrogol 4000
Phosphoric acid
Hypromellose 2910
Erythritol (E 968)
Sucralose (E 955)
Sodium benzoate (E211)
Disodium edetate
Grape flavour (contains propylene glycol)
Water, purified
What Aripiprazole looks like and contents of the pack
Aripiprazole 1 mg/ml oral solution is a clear, colourless
liquid supplied in amber coloured glass bottles containing
150 ml per bottle.
Each bottle is closed with white plastic (polyethylene HD)
“Child proof” screw caps with a white polypropylene
adaptor (plug).
Each carton contains 1 bottle, a leaflet and measuring
devices a 5 ml oral syringe and a measuring cup.
The syringe body is made of PP-resins and the plunger is
made of HDPE and is graduated for dosing of 0.5 ml and 1
ml, and then every 0.5 ml up to 5 ml.
The measuring cup is made of polypropylene and is
graduated for dosing of 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and
maximum volume of 30 ml.
Marketing Authorisation Holder
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
Manufacturer
betapharm Arzneimittel GmbH, Kobelweg 95, Augsburg,
86156, Germany
This leaflet was last revised in 12/2016

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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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