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ARIPIPRAZOLE RIVOPHARM 30 MG TABLETS

Active substance(s): ARIPIPRAZOLE

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PACKAGE LEAFLET

Package leaflet: Information for the user
Aripiprazole Rivopharm 5 mg tablets
Aripiprazole Rivopharm 10 mg tablets
Aripiprazole Rivopharm 15 mg tablets
Aripiprazole Rivopharm 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 Rivopharm is and what it is used for
2.
What you need to know before you take Aripiprazole Rivopharm
3.
How to take Aripiprazole Rivopharm
4.
Possible side effects
5.
How to store Aripiprazole Rivopharm
6.
Contents of the pack and other information

1.

What Aripiprazole Rivopharm is and what it is used for

Aripiprazole Rivopharm 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 Rivopharm 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
Rivopharm.

2.

What you need to know before you take Aripiprazole Rivopharm

Do not take Aripiprazole Rivopharm
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 Rivopharm 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 Rivopharm is not for use in children and adolescents under 13 years. Ask your doctor or
pharmacist for advice before taking Aripiprazole Rivopharm.
Other medicines and Aripiprazole Rivopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Blood pressure-lowering medicines: Aripiprazole Rivopharm 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 Rivopharm with some medicines may need to change your dose of Aripiprazole
Rivopharm. 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 Rivopharm, you should see your doctor.
Aripiprazole Rivopharm with food, drink and alcohol
Aripiprazole Rivopharm can be taken regardless of meals.
Alcohol should be avoided when taking Aripiprazole Rivopharm.
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 Rivopharm
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 Rivopharm, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how Aripiprazole Rivopharm affects you.
Aripiprazole Rivopharm 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 Rivopharm

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 Rivopharm 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 Rivopharm is too strong or too weak, talk to your
doctor or pharmacist.
Try to take the Aripiprazole Rivopharm 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 Rivopharm without first
consulting your doctor.
If you take more Aripiprazole Rivopharm than you should
If you realise you have taken more Aripiprazole Rivopharm tablets than your doctor has recommended (or if
someone else has taken some of your Aripiprazole Rivopharm 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 Rivopharm
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. Increased blood levels of the hormone prolactin.

The following side effects have been reported since the marketing of Aripiprazole Rivopharm but the
frequency for them to occur is not known (frequency cannot be estimated from the available data):
- Agression.
- 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.
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 Rivopharm

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 Rivopharm 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 Rivopharm looks like and contents of the pack
Aripiprazole Rivopharm 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 Rivopharm 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 Rivopharm 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 Rivopharm 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 and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd
Ash Road North, Wrexham Ind.
Estate; Wrexham, LL13 9DZ
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

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 June 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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