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ARIPIPRAZOLE RIVOPHARM 5 MG TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE

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40 mm

Size: 200 mm (Width)

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 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.

Size: 325 mm (Height)

What is in this leaflet:
1. What Aripiprazole tablets is and what it is used for
2. What you need to know before you take Aripiprazole tablets
3. How to take Aripiprazole tablets
4. Possible side effects
5. How to store Aripiprazole tablets
6. Contents of the pack and other information
1. What Aripiprazole tablets is and what it is used for
Aripiprazole tablets 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 tablets 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 tablets.
2. What you need to know before you take Aripiprazole tablets
Do not take Aripiprazole tablets
- 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 tablets 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 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 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 tablets with some medicines may need to
change your dose of Aripiprazole tablets.
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
tablets, you should see your doctor.
Aripiprazole tablets with food, drink and alcohol
Aripiprazole tablets 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 for advice before taking
this medicine.
The following symptoms may occur in newborn babies, of mothers
that have used Aripiprazole 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.
Be sure to tell your doctor immediately if you are breast-feeding.
If you are taking Aripiprazole tablets, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how
Aripiprazole tablets affects you.

Aripiprazole tablets 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 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 an 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 tablets 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 tablets without first consulting your doctor.
If you take more Aripiprazole tablets 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 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 tablets
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 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
- uncontrolable twitching, jerking or writhing movementes, 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
Aripiprazole Rivopharm 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, hive, 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 test values
- skin rash
- sensitivity to light

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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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Rivopharm UK Ltd
30th Floor
40 Bank Street
Canary Wharf
London
E14 5NR
United Kingdom
Manufacturer
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola, PLA 3000;
Malta
or
Hetero Malta Ltd
KW20A Corradino Industrial Estate,
Paola, PLA 3000;
Malta

Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the
safety of this medicinee.
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 tablets contains
- The active substance is aripiprazole.
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.
- The active substance is aripiprazole.
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.
- The active substance is aripiprazole.
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 and.
- The active substance is aripiprazole.
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 tablets looks like and contents of the pack
Aripiprazole 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 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 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 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.

This medicinal product is authorised in the Member States of the
EEA under the following names:
Czech Republic:

Aripiprazol Alpha 10 mg tablety
Aripiprazol Alpha 15 mg tablety

Germany:

Aripiprazol Hetero 5 mg Tabletten
Aripiprazol Hetero 10 mg Tabletten
Aripiprazol Hetero 15 mg Tabletten
Aripiprazol Hetero 30 mg Tabletten

Iceland:

Aripiprazol LYFIS

Portugal:

Aripiprazol Hetero

Spain:

Aripiprazol Hetero 5 mg Comprimidos EFG
Aripiprazol Hetero 10 mg Comprimidos EFG
Aripiprazol Hetero 15 mg Comprimidos EFG

The Netherlands:

Aripiprazol Hetero 5 mg, tabletten
Aripiprazol Hetero 10 mg, tabletten
Aripiprazol Hetero 15 mg, tabletten
Aripiprazol Hetero 30 mg, tabletten

United Kingdom:

Aripiprazole Rivopharm 5 mg, Tablets
Aripiprazole Rivopharm 10 mg, Tablets
Aripiprazole Rivopharm 15 mg, Tablets
Aripiprazole Rivopharm 30 mg, Tablets

This leaflet was last revised in October 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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