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ARIPIPRAZOLE WOCKHARDT 10 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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Package leaflet: Information for the user
Aripiprazole Wockhardt 5 mg tablets
Aripiprazole Wockhardt 10 mg tablets
Aripiprazole Wockhardt 15 mg tablets
Aripiprazole Wockhardt 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 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 Wockhardt Tablets
6. Contents of the pack and other information
1. What aripiprazole is and what it is used for
Aripiprazole Wockhardt Tablets contain the active
substance aripiprazole, which belongs 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 Wockhardt Tablets.
2. What you need to know before you take
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 or pharmacist 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
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 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 Wockhardt Tablets can be taken regardless
of meals.
Alcohol should be avoided when taking aripiprazole.
Pregnancy and breast-feeding
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.
Aripiprazole contains 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
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 15mg once a
day. However your doctor may prescribe a lower or higher
dose to a maximum of 30mg 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 10mg once a day. However your doctor may prescribe
a lower or higher dose to a maximum of 30mg 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 Wockhardt 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 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.
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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, light-headedness, 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. 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 or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the national reporting systems listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2;
Tel: +353 1 6764971; Fax: +353 1 6762517;
Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store aripiprazole 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. 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 Wockhardt Tablets contains
- 5mg tablet
Each tablet contains 5 mg of aripiprazole.
The other ingredients are lactose monohydrate; maize
starch; cellulose, microcrystalline; hydroxypropyl
cellulose; magnesium stearate and FD&C blue.
- 10mg tablet
Each tablet contains 10 mg of aripiprazole.
The other ingredients are lactose monohydrate; maize
starch; cellulose, microcrystalline; hydroxypropyl
cellulose; ferric oxide red and magnesium stearate.
- 15mg tablet
Each tablet contains 15 mg of aripiprazole.
The other ingredients are lactose monohydrate; maize
starch; cellulose, microcrystalline; ferric oxide yellow;
hydroxypropyl cellulose and magnesium stearate
- 30mg tablet
Each tablet contains 30 mg of aripiprazole.
The other ingredients are lactose monohydrate; maize
starch; cellulose, microcrystalline; hydroxypropyl
cellulose; ferric oxide red and magnesium stearate.
What Aripiprazole Wockhardt Tablets looks like and
contents of the pack
Aripiprazole Wockhardt 5 mg tablets are light blue to blue,
modified rectangular, bevel edged, biconvex; debossed
with ‘I’ on one side and ‘95’ on other side. They are
supplied in Alu-Alu blisters packed in cartons containing
14, 28, 49, 56, 98 or 100 tablets.
Aripiprazole Wockhardt 10 mg tablets are light pink to
pink, modified rectangular, bevel edged, biconvex;
debossed with ‘I’ on one side and ‘96’ on other side. They
are supplied in Alu-Alu blisters packed in cartons
containing 14, 28, 49, 56, 98 or 100 tablets.
Aripiprazole Wockhardt 15 mg tablets are light yellow to
yellow, round, bevel edged, biconvex; debossed with ‘I’ on
one side and ‘97’ on other side. They are supplied in
Alu-Alu blisters packed in cartons containing 14, 28, 49,
56, 98 or 100 tablets.
Aripiprazole Wockhardt 30 mg tablets are light pink to
pink, round, bevel edged, biconvex; debossed with ‘I’ on
one side and ‘99’ on other side. They are supplied in
Alu-Alu blisters packed in cartons containing 14, 28, 49,
56, 98 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham,
LL13 9UF, UK
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK only).
Please be ready to give the following information:
Product name

Reference
number

Aripiprazole Wockhardt 5 mg tablets

29831/0626

This is a service provided by the Royal National Institute
of Blind People.
For patients in the Republic of Ireland please call
+44 1978 669272
This medicinal product is authorised in the Member
States of the EEA under the following names:
UK & Ireland: Aripiprazole Wockhardt 5mg, 10mg,
15mg, 30mg tablets
This leaflet was last revised in 05/2016

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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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