Caduceus

PHARMA LTD

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.

•    The full name of this medicine is Aripiprazole 10mg and 15mg Orodispersible Tablets but within the leaflet it will be referred to as Aripiprazole tablets.

What is in this leaflet

1.    What Aripiprazole tablets are and what they are 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 are and what they are used for

Aripiprazole tablets contain the active substance aripiprazole and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents aged l5 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 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 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 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.

Package leaflet: Information for the user

Aripiprazole 10mg and 15mg Orodispersible Tablets

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 tablets are not for use in children and adolescents under 13 years. Ask your doctor or pharmacist for advice before taking Aripiprazole tablets.

Other medicines and Aripiprazole tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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 symptoms 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 when taking Aripiprazole tablets.

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 breastfeeding. 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 contain aspartame

Patients who cannot take phenylalanine should note that Aripiprazole orodispersible tablets contain aspartame, which is a source of phenylalanine. May be harmful for people with phenylketonuria.

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 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 tablets 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 tablets is too strong or too weak, talk to your doctor or pharmacist.

Try to take the Aripiprazole orodispersible tablet at the same time each day. It does not matter whether you take it with or without food.

Immediately upon opening the blister, using dry hands, remove the tablet and place the entire orodispersible tablet on the tongue. Tablet disintegration occurs rapidly in saliva. The orodispersible tablet can be taken with or without liquid. Alternatively, disperse the tablet in water and drink the resulting suspension.

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

Ifyou realise you have taken more Aripiprazole orodispersible tablets than your doctor has recommended (or if someone else has taken some of your Aripiprazole orodispersible 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 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, lightheadedness, 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 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 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.

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 contain

•    The active substance is aripiprazole. Each orodispersible tablet contains 10mg, 15mg of aripiprazole.

•    The other ingredients are:

Silicified microcrystalline cellulose, Aspartame (E951), Vanilla flavour (501469TP0551), Magnesium stearate, Croscarmellose sodium (E468).

Yellow iron oxide (E172) for 15mg orodispersible.

What Aripiprazole tablets look like and contents of the pack

Orodispersible tablet 10mg

Round and white, 7mm with "1" debossed on one side and "ZT" on the other.

Orodispersible tablet 15mg

Round and yellow mottled, 8mm with "2"debossed on one side and "ZT"on the other.

Packsizes:

Blisters:

•    Push-through blisters packed in cartons containing 28 orodispersible tablets.

Marketing Authorisation Holder

Caduceus Pharma Ltd 6th Floor

94 Wigmore Street London W1U 3RF UK

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate Zejtun ZTN 3000 Malta

This leaflet was revised in October 2014