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Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user

Aripiprazole Macleods 15 mg Tablets
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
Ÿ Keep this leaflet. You may need to read it again.
Ÿ If you have any further questions, ask your doctor or pharmacist.
Ÿ 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.
Ÿ 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 Macleods Tablets are and what they are used
2. What you need to know before you take Aripiprazole Macleods
3. How to take Aripiprazole Macleods Tablets
4. Possible side effects
5. How to store Aripiprazole Macleods Tablets
6. Contents of the pack and other information
1. What Aripiprazole Macleods Tablets are and what they are
used for
Aripiprazole Macleods Tablets contain the active substance
aripiprazole and belong to a group of medicines called
antipsychotics. Its 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 Macleods Tablets are 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 Macleods Tablets.
2. What you need to know before you take Aripiprazole
Macleods Tablets
Do not take Aripiprazole Macleods Tablets:
Ÿ 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 Macleods Tablets if
you suffer from:
Ÿ 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
Ÿ seizure

Ÿ involuntary, irregular muscle movements, especially in the face
Ÿ cardiovascular diseases, family history of cardiovascular
disease, stroke or "mini" stroke, abnormal blood pressure
Ÿ blood clots, or family history of blood clots, as antipsychotics
have been associated with formation of blood clots
Ÿ past experience of excessive gambling.

The following symptoms may occur in newborn babies, of mothers
that have used Aripiprazole Macleods Tablets 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.

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.

Be sure to tell your doctor immediately if you are breast-feeding.

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 Macleods Tablets
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 Macleods 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 Macleods Tablets with some medicines may
need to change your dose of Aripiprazole Macleods Tablets. It is
especially important to mention the following to your doctor:
Ÿ Medicines to correct heart rhythm
Ÿ Antidepressants or herbal remedy used to treat depression and
Ÿ Antifungal agents
Ÿ Certain medicines to treat HIV infection
Ÿ 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 Macleods Tablets, you should see your doctor.
Aripiprazole Macleods Tablets with food, drink and alcohol
Aripiprazole Macleods Tablets can be taken regardless of meals.
Alcohol should be avoided
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have baby, ask your doctor for advice before taking
this medicine.

If you are taking Aripiprazole Macleods Tablets, you should not
Driving and using machines
Do not drive or use any tools or machines, until you know how
Aripiprazole Macleods Tablets affect you.
Aripiprazole Macleods 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.
3. How to take Aripiprazole Macleods Tablets
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
This medicinal product 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 Macleods
Tablets are too strong or too weak, talk to your doctor or pharmacist.
Try to take your Aripiprazole Macleods 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 Macleods tablets without first consulting your doctor.
If you take more Aripiprazole Macleods Tablets than you should
If you realise you have taken more Aripiprazole Macleods Tablets
than your doctor has recommended (or if someone else has taken
some of your Aripiprazole Macleods 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 Macleods Tablets
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 Macleods Tablets
Do not stop your treatment just because you feel better. It is important
that you carry on taking your Aripiprazole Macleods 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 or pharmacist.

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,
shaking and blurred vision,
decreased number of or difficulty making bowel movements,
feeling sick,
more saliva in mouth than normal,
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,
altered or increased sexual interest,
uncontrollable movements of mouth, tongue and limbs (tardive
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,

The following side effects have been reported since the marketing of
oral aripiprazole but the frequency for them to occur is not known:
Ÿ low levels of white blood cells,
Ÿ low levels of blood platelets,
Ÿ allergic reaction (e.g. swelling in the mouth, tongue, face and
throat, itching, hives),
Ÿ onset or worsening of diabetes, ketoacidosis (ketones in the
blood and urine) or coma,
Ÿ high blood sugar,
Ÿ not enough sodium in the blood,
Ÿ loss of appetite (anorexia),
Ÿ weight loss,
Ÿ weight gain,
Ÿ thoughts of suicide, suicide attempt and suicide,
Ÿ excessive gambling,
Ÿ feeling aggressive,
Ÿ agitation,
Ÿ nervousness,
Ÿ combination of fever, muscle stiffness, faster breathing,




sweating, reduced consciousness and sudden changes in blood
pressure and heart rate, fainting (neuroleptic malignant
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,
accidental inhalation of food with risk of pneumonia (lung
spasm of the muscles around the voice box,
inflammation of the pancreas,
difficulty swallowing,
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,
excessive sweating,
abnormal muscle breakdown which can lead to kidney problems,
muscle pain,
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

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
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Aripiprazole Macleods Tablets
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
blister 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
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 Macleods Tablets contain
Ÿ The active substance is aripiprazole. Each tablet contains 15 mg
of aripiprazole.
Ÿ The other ingredients are Lactose monohydrate, Cellulose
Microcrystalline (PH-101), Maize starch, Ferric oxide yellow (E
172), Low – substituted Hydroxy Propyl Cellulose (LH-21),
Magnesium stearate.
What Aripiprazole Macleods Tablets look like and contents of
the pack
Aripiprazole Macleods 15 mg tablets are Yellow, round shaped,
uncoated tablets debossed with 'CL 75' on one side and plain on the
other side.
They are supplied in cold form (Alu-Alu) blister pack. Aripiprazole
Macleods Tablets are contained in packs of 14's, 28's, 49's, 56's or
98's for 15mg strength.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma UK Limited
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB, United Kingdom.
Mawdsleys Brooks and Co Ltd
Unit 22, Quest Park, Wheatley Hall Road,
Doncaster, DN2 4LT, United Kingdom.
PL 34771/0164
This leaflet was last revised in {08/2016}.


4. Possible side effects

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Further information

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