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ARIPIPRAZOLE MILPHARM 10 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Milpharm
Package leaflet: Information for the user

Aripiprazole 5 mg tablets
Aripiprazole 10 mg tablets
Aripiprazole 15 mg tablets
Aripiprazole 30 mg tablets
aripiprazole
Read all of this leaflet carefully before you start using 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 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.
2. What you need to know before you take Aripiprazole
Milpharm

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P150

Aripiprazole

Aripiprazole

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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:
v
Medicines to correct heart rhythm
v
Antidepressants or herbal remedy used to treat depression and
anxiety
v
Antifungal agents
v
Certain medicines to treat HIV infection
v
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.
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 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.

Do not take Aripiprazole
v
If you are allergic to aripiprazole or any of the other ingredients
of this medicine (listed in section 6).

Aripiprazole contains lactose monohydrate. If you have been told
by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

Warnings and precautions
Talk to your doctor before taking Aripiprazole if you suffer from
v
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
v
Seizure
v
Involuntary, irregular muscle movements, especially in the face
Cardiovascular diseases, family history of cardiovascular
disease, stroke or "mini" stroke, abnormal blood pressure
v
Blood clots, or family history of blood clots, as antipsychotics
have been associated with formation of blood clots
v
Past experience of excessive gambling

3. How to take Aripiprazole

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. 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.

Black

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.
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.
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):
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. Some
people may feel depressed, 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; 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.
The following side effects have been reported since the marketing
of oral aripiprazole but the frequency for them to occur is not
known: Aggression.
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 or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the national
reporting system listed in 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 label, carton and bottle after EXP. The expiry date refers to the
last day of that month.
The medicinal product does not require any special storage
conditions.

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
v
The active substance is aripiprazole.
Each tablet contains 5 mg of aripiprazole.
Each tablet contains 10 mg of aripiprazole.
Each tablet contains 15 mg of aripiprazole.
Each tablet contains 30 mg of aripiprazole.
v
The other ingredients are lactose monohydrate,
microcrystalline cellulose, maize starch, indigo carmine
aluminium lake (E132) (For 5 mg strength only), hydroxypropyl
cellulose, silica colloidal anhydrous, magnesium stearate.
What Aripiprazole looks like and contents of the pack
Tablet.
Aripiprazole 5 mg tablets
Blue colored, modified rectangular shaped, uncoated tablets
debossed with ‘62’ on one side and ‘H’ on other side. The size is
8 mm x 4.5 mm.
Aripiprazole 10 mg tablets
White colored, modified rectangular shaped, uncoated tablets
debossed with ‘63’ on one side and ‘H’ on other side. The size is
8 mm x 4.5 mm.
Aripiprazole 15 mg tablets
White colored, round shaped (diameter 7 mm), uncoated tablets
debossed with ‘64’ on one side and ‘H’ on other side.
Aripiprazole 30 mg tablets
White colored, round shaped (diameter 9 mm), uncoated tablets
debossed with ‘66’ on one side and ‘H’ on other side.
Aripiprazole tablets are available in Polyamide/ Aluminium/ PVC/
Aluminium foil blister pack and HDPE bottle with polypropylene
closure containing silica gel as dessicant.
Pack sizes:
Blister packs: 14, 28, 30, 49, 56 and 98 tablets
HDPE bottle packs: 30, 100, 250 and 500 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
Hf26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Milpharm Limited
Ares Block, Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
This leaflet was last revised in 04/2015.

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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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