• 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.

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

• If you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Talk to your doctor before taking Aripiprazole.

Suicidal thoughts and behaviours have been reported during aripiprazole treatment. Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.

Before treatment with Aripiprazole, tell your doctor 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.
• Fits (seizures), your doctor may want to monitor you more closely.
• Involuntary, irregular muscle movements, especially in the face.
• Cardiovascular diseases (diseases of the heart and circulation), 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 sleepiness 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 heartbeat.

Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Aripiprazole may cause sleepiness, fall in blood pressure when standing up, dizziness and changes in your ability to move and balance, which may lead to falls. Caution should be taken, particularly if you are an elderly patient or have some debility.

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.

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 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 mean the doctor will need to change your dose of Aripiprazole or the other medicines.

It is especially important to mention the following to your doctor:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide).
• Antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s Wort).
• Antifungal agents (such as ketoconazole, itraconazole).
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine or protease inhibitors e.g. indinavir, ritonavir).
• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital).
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole; if you get any unusual symptom taking any of these medicines together with Aripiprazole you should see your doctor.

Medicines that increase the level of serotonin are typically used in conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain:

• Triptans, tramadol and tryptophan used for conditions including depression, generalised anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia as well as migraine and pain.
• Selective-serotonin-reuptake-inhibitors (SSRIs) (such as paroxetine and fluoxetine), used for depression, OCD, panic and anxiety.
• Other anti-depressants (such as venlafaxine and tryptophan) used in major depression.
• Tricyclic’s (such as clomipramine, amitriptyline) used for depressive illnesses.
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression.
• Pain killers (such as tramadol and pethidine) used for pain relief.
• Triptans (such as sumatriptan and zolmitriptan) used for treating migraine.

These medicines may 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 can be taken regardless of meals.

Alcohol should be avoided when taking Aripiprazole.

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 when mothers 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.

If you are taking this medicine, your doctor will discuss with you whether you should breast-feed considering the benefit to you of your therapy and the benefit to your baby of breast-feeding. You should not do both. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Dizziness and vision problems may occur during treatment with this medicine (see section 4).

This should be considered in cases where full alertness is required, e.g. when driving a car or handling machines.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine 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 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 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.

Patients who have taken too much Aripiprazole have experienced the following symptoms:

• Rapid heartbeat, agitation/aggressiveness, problems with speech.
• Unusual movements (especially of the face or tongue) and reduced level of consciousness.

Other symptoms may include:

• Acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating.
• Muscle stiffness and drowsiness or sleepiness, slower breathing, choking, high or low blood pressure, abnormal rhythms of the heart.

Contact your doctor or hospital immediately if you experience any of the above.

If you miss a dose, take the missed dose as soon as you remember but do not take two doses in one day.

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.

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 (may affect more 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 (may affect up to 1 in 10 patients).

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) or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is aripiprazole. Each tablet contains 5, 10, 15 or 30mg of aripiprazole respectively.
• The other ingredients for 5mg tablets are maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, indigo carmine (E132) and magnesium stearate.
• The other ingredients for 10 and 30mg tablets are maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide red (E172) and magnesium stearate.
• The other ingredients for 15mg tablets are maltose, microcrystalline cellulose, pregelatinised starch, croscarmellose sodium, iron oxide yellow (E172) and magnesium stearate.

Aripiprazole 5mg tablets are light blue to blue, mottled, round and biconvex tablets of 6.1mm in diameter, engraved with ‘5’ on one side.

Aripiprazole 10mg tablets are pink, round and biconvex tablets of 8.1mm in diameter, engraved with ‘10’ on one side.

Aripiprazole 15mg tablets are yellow, round and biconvex tablets of 10.1mm in diameter, engraved with ‘15’ on one side.

Aripiprazole 30mg tablets are pink, oval and biconvex tablets of 17.1mm in length, 8.1mm in width, engraved with ‘30’ on one side.

They are supplied in PA/Alu/PVC-aluminium foil perforated blisters packed in a cardboard box containing 14, 28, 49, 56 or 98 tablets.

Not all pack sizes may be marketed.

or