ARIPIPRAZOLE VALE 10 MG ORODISPERSIBLE TABLETS - patient leaflet, side effects, dosage

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 Vale is and what it is used for

• 2. What you need to know before you take Aripiprazole Vale

• 3. How to take Aripiprazole Vale

• 4. Possible side effects

• 5. How to store Aripiprazole Vale

• 6. Contents of the pack and other information

1. what aripiprazole vale is and what it is used for

Aripiprazole Vale contains the active substance aripiprazole, which 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 Vale 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 Vale.

2. what you need to know before you take aripiprazole vale 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 Vale if you suffer from or have ever suffered 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
• seizures
• involuntary, irregular muscle movements, especially in the face
• heart diseases, family history of heart disease, heart failure, abnormal heart rhythm, stroke or ‘mini’ stroke,
• conditions which would lead to reduced blood pressure such as loss of fluid, reduced blood volume and use of blood pressure lowering medicines
• increased 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
• a condition known as attention-deficit hyperactivity disorder (ADHD) (with symptoms such as difficulty in maintaining focus on one task, struggle to follow instructions, hyperactive) and are taking medicines to treat this condition.

During treatment

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.

Tell your doctor if you suffer from shaking, decreased heart rate, muscle stiffness and balance disorders while on treatment with this medicine. These may be signs of a condition known as parkinsonism.

If you are an elderly patient suffering from Alzheimer’s di­sease, 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. Your doctor may consider stopping your treatment with aripiprazole.

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.

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 Vale

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 Vale 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.

If you are taking Aripiprazole Vale with some other medicines, you may need to change your dose of Aripiprazole Vale. It is especially important to mention the following to your doctor:

• quinidine (medicines to correct heart rhythm)
• escitalopram, fluoxetine, paroxetine (antidepressant) or St. John's Wort (herbal remedy) used to treat depression and anxiety
• ketoconazole, itraconazole (antifungal agents)
• medicines that may cause changes in heart rhythm which may be seen in tests (such as alfuzosin, amiodarone, chloroquine)
• medicines that may alter the level of blood salts (such as hydrocortisone, prednisolone, furosemide)
• ritonavir, indinavir, nelfinavir, efavirenz, nevirapine (medicines to treat HIV infection)
• diltiazem, carbamazepine, phenytoin, phenobarbital, primidone (anticonvulsants used to treat epilepsy)
• rifampicin and rifabutin (antibiotics used to treat tuberculosis)

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, selective-serotonin-reuptake-inhibitors 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 Vale, you should see your doctor.

Aripiprazole Vale with food and alcohol

Aripiprazole Vale can be taken regardless of meals.

Alcohol should be avoided when taking Aripiprazole Vale.

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 or pharmacist for advice before taking this medicine.

The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole Vale 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 Aripiprazole Vale, 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.

Driving and using machines

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.

Aripiprazole Vale contains aspartame, sulphite ammonia caramel (E150d), sucrose and sodium Each Aripiprazole Vale 10 mg tablet contains 2 mg of aspartame. Each Aripiprazole Vale 15 mg tablet contains 3 mg of aspartame. Each Aripiprazole Vale 30 mg tablet contains 6 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

Aripiprazole Vale contains sulphite ammonia caramel (E150d), which may rarely cause severe hypersensitivity reactions and bronchospasm.

Aripiprazole Vale contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Aripiprazole Vale contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take aripiprazole vale

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.

Elderly

If you are elderly your doctor may start your treatment with a dose lower than the recommended dose.

Patients with liver problems

Tell your doctor if you are suffering from severe liver problems as your doctor may need to adjust the dose of your medicine.

Use in children and adolescents

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

Try to take your Aripiprazole Vale orodispersible tablets at the same time each day. It does not matter whether you take it with or without food. Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. 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 Vale without first consulting your doctor.

If you take more Aripiprazole Vale than you should

If you realise you have taken more Aripiprazole Vale orodispersible tablets than your doctor has recommended (or if someone else has taken some of your Aripiprazole Vale orodispersible tablets), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you. Signs and symptoms of overdose may include unusual tiredness, increased blood pressure, feeling sleepy, fast heart rate, feeling sick (nausea), diarrhoea and being sick (vomiting).

If you forget to take Aripiprazole Vale

If you miss a dose, take the missed dose as soon as you remember but do not take a double dose to make up for a forgotten dose.

If you stop taking Aripiprazole Vale

Do not stop your treatment just because you feel better. It is important that you carry on taking Aripiprazole Vale 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.

Stop taking your medicine and contact a doctor immediately if you experience any of the following side effects:

Common (may affect up to 1 in 10 people)

• – weight loss, increased thirst, increased urination. These may be signs of high glucose levels in the blood (diabetes mellitus)

Not known (frequency cannot be estimated from the available data):

• – reduction in blood platelets resulting in bleeding or bruising more easily than normal

• – changes in the levels of some blood cells, which can be seen on a blood test and lead to getting more infections than normal

• – heart attack (cardiac arrest)

• – sudden unexplained death

• – unusual slow heart beat or abnormal heart rhythm, which may be seen in tests

• – allergic reaction (e.g. swelling in the mouth, tongue, face and throat, difficulty in breathing and swallowing, itching, rash)

• – onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma

• – suicide, thoughts of suicide, suicide attempt

• – seizures

• – 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 (neuroleptic malignant syndrome)

• – 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

• – accidental inhalation of food with risk of pneumonia

• – inflammation of the pancreas, which causes severe upper stomach pain, often with feeling sick (nausea) and being sick (vomiting)

• – difficulty in passing urine (urinary retention)

• – liver failure, inflammation of the liver, yellowing of the skin and white part of eyes

• – muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown which can be lifethreatening and lead to kidney problems.

Other possible side effects:

Common (may affect up to 1 in 10 people)

• – uncontrollable twitching or jerking movements, headache, drowsiness, sleepiness, dizziness, shaking, trembling

• – unable to keep still, difficulty sitting still

• – tiredness

• – feeling sick (nausea), being sick (vomiting), indigestion, constipation, increased production of saliva

• – trouble sleeping, restlessness, feeling anxious

• – blurred vision.

Uncommon (may affect up to 1 in 100 people)

• – uncontrollable movements of mouth, tongue or limbs (tardive dyskinesia)

• – uncontrollable muscle spasms affecting the eyes, head, neck or body (dystonia)

• – dizziness, light-headedness or fainting when you stand up from sitting or lying down

• – fast heart rate

• – double vision

• – eye sensitivity to light

• – depression

• – increased or altered sexual interest

• – high levels of the hormone prolactin, which may be seen in blood tests

• – high blood sugar, which may be seen in blood tests

• – hiccups.

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

• – low sodium level in the blood, which may be seen in blood tests

• – weight gain, weight loss, loss of appetite (anorexia)

• – nervousness, agitation, aggression

• – speech disorder

• – fixation of the eyeballs in one position

• – fainting, high blood pressure

• – spasm of the muscles around the voice box, difficulty in swallowing

• – abdominal and stomach discomfort, diarrhoea

• – skin rash, skin sensitivity to light, unusual hair loss or thinning, excessive sweating

• – stiffness, muscle pain

• – uncontrollable passing of urine (urinary incontinence)

• – withdrawal symptoms in newborn babies in case of exposure during pregnancy (see section 2 ‘Pregnancy’)

• – prolonged and/or painful erection

• – difficulty controlling core body temperature or overheating, chest pain, and swelling of hands, ankles or feet

• – abnormal liver function tests, which may be seen in blood tests

• – increased or fluctuating blood sugar, increased glycosylated haemoglobin, which may be seen in blood tests.

• – inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include:

• – strong impulse to gamble excessively despite serious personal or family consequences

• – altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

• – uncontrollable excessive shopping

• – binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)

• – a tendency to wander away.

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 Yellow Card Scheme at 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.

5. how to store aripiprazole vale

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 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 informationthe active substance is aripiprazole. each orodispersible tablet contains 10 mg, 15 mg or 30 mg of aripiprazole.

The other ingredients are: microcrystalline cellulose, aspartame (E951) (see section 2 ‘Aripiprazole Vale contains aspartame’), xylitol (E967), acesulfame potassium (E 950), pregelatinised maize starch, croscarmellose sodium, crospovidone (type B), tartaric acid, colloidal anhydrous silica, magnesium stearate, vanilla flavour (sucrose (see section 2 ‘Aripiprazole Vale contains sucrose’), maltodextrin, starch sodium octenyl succinate, sulphite ammonia caramel, propylene glycol, flavouring substances (including vanillin), natural flavouring substances, flavouring preparations). The 10 mg and 30 mg tablets also contain red iron oxide (E172); the 15 mg tablets contain yellow iron oxide (E172). See section 2 ‘Aripiprazole Vale contains aspartame, sulphite ammonia caramel (E150d), sucrose and sodium’

What Aripiprazole Vale looks like and contents of the pack

Aripiprazole Vale 10 mg orodispersible tablets are light pink, round, plain tablets, approximately 7 mm in diameter.

Aripiprazole Vale 15 mg orodispersible tablets are light yellow, round, plain tablets, approximately 8 mm in diameter.

Aripiprazole Vale 30 mg orodispersible tablets are light pink, round, plain tablets, approximately 10 mm in diameter.

Aripiprazole Vale is available in perforated blister packs of 28 or 28×1 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder

Mylan,

Potters Bar,

Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Atlantic Pharma – Producoes Farmaceuticas, S.A.

Rua da Tapada Grande, n°2, Abrunheira, Sintra, 2710–089, Portugal

This leaflet was last revised in 06/2020

8