PACKAGE LEAFLET: INFORMATION FOR THE USER

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CONSILIENT HEALTH u*

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.

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 is one of 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

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 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 15 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 can be taken regardless of meals.

Alcohol should be avoided when taking Aripiprazole.

Pregnancy and breast-feeding You should not take Aripiprazole if you are pregnant unless you have discussed this with your doctor.

Be sure to tell your doctor immediately if you are pregnant, think you may be pregnant, or if you are planning to become pregnant.

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 medicinal product.

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 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

Treatment may be started at a low dose with aripiprazole 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, 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.

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.

Additional side effects in children and adolescents

Adolescents aged 15 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 at: https://yellowcard.mhra.gov.uk.

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 packaging after EXP. The expiry date refers to the last day of that month.

This medicine 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

• The active substance is aripiprazole. Each

tablet contains 5 mg, 10 mg, 15 mg or 30 mg aripiprazole.

• The other ingredients are lactose monohydrate, microcrystalline cellulose (E460), maize starch, hydroxypropylcellulose (E463), red iron oxide (E172) - only in 10 mg and 30 mg tablets, yellow iron oxide (E172) - only in 15 mg tablets, indigo carmine (E132) - only in 5 mg tablets and magnesium stearate (E470b). See section 2 "Aripiprazole contains lactose”.

What Aripiprazole looks like and contents of the pack

5 mg tablets: Blue, round tablets with bevelled edges and with possible darker and lighter spots.

10 mg tablets: Light pink, rectangular tablets with possible darker and lighter spots and engraved with A10 on one side.

15 mg tablets: Light yellow to brownish yellow, round, slightly biconvex tablets with bevelled edges and with possible darker and lighter spots and engraved with A15 on one side.

30 mg tablets: Light pink, round, biconvex tablets with bevelled edges and with possible darker and lighter spots and engraved with A30 on one side.

Aripiprazole is available in boxes containing 14,28,30,50,56,60,84,90,98 or 100 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Consilient Health Ltd., 5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2,

Ireland

Manufacturer

KRKA, d. d., Novo mesto,

Smarjeska cesta 6, 8501 Novo mesto, Slovenia

This leaflet was last revised in 10/2014.

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