ARIPIPRAZOLE 30 MG 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 tablet is and what it is used for

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

• 3. How to take Aripiprazole tablet

• 4. Possible side effects

• 5. How to store Aripiprazole tablet

• 6. Contents of the pack and other information

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

Aripiprazole tablet 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 tablet 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 tablet.

2. what you need to know before you take aripiprazole tabletif 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 tablet

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 tablets, 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 (seizure) since 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 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 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.

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 tablet

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 tablet 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 tablet with some medicines may mean the doctor will need to change your dose of Aripiprazole tablet 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 remedy used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s Wort)
• Antifungal medicines (such as ketoconazole, itraconazole)
• Certain medicines to treat HIV infection (such as efavirenz, nevirapine, and 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 tablets; if you get any unusual symptom taking any of these medicines together with Aripiprazole tablets 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
• 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
• tricyclics (such as clomipramine and amitriptyline) used for depressive illness
• 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 zolmitripitan) used for treating migraine.

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

Aripiprazole tablet with food, drink and alcohol

Aripiprazole tablet can be taken regardless of meals.

Alcohol should be avoided when taking Aripiprazole tablet.

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 tablet 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 tablets, your doctor will discuss with you whether you should breastfeed considering the benefit to you of your therapy and the benefit to your baby of breastfeeding. 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 tablet 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 tablet

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 tablet may be started at a low dose with an 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 tablet 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 tablet

without first consulting your doctor.

If you take more Aripiprazole tablet 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. Patients who have taken too much aripiprazole have experienced the following symptoms: a lack of energy, high blood pressure, sleepiness or drowsiness, rapid heartbeat, nausea, vomiting, diarrhoea.

.

• Other symptoms may include:
• reduced level of consciousness, drug-induced movement disorders, symptoms include continuous spasms, muscle contractions, restlessness,
• muscle stiffness, slowness of movement, tremor, and irregular, jerky movements..

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

If you forget to take Aripiprazole tablet

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 take a double dose to make up for a forgotten dose.

If you stop taking Aripiprazole tablet

Do not stop your treatment just because you feel better. It is important that you carry on taking your Aripiprazole tablet 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 this medicine and contact your doctor immediately if you experience any of the following serious side effects:

Common side effects (may affect up to 1 in 10 people):

• feeling more thirsty or hungrier then usual, need to urinate more often, feeling confused, weak, tired or your breath may smell fruity, these are signs of diabetes.

Unknown frequency (cannot be estimated from the available data):

• severe itching of the skin (with raised lumps) or swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing or breathing (angioedema)
• life-threatening irregular heartbeat
• seizure
• sudden unexplained death, abnormal bruising, bleeding, or signs of infection such as a sore throat and high temperature (can indicate reduced number of white blood cells or platelets)
• thoughts of suicide or suicide attempt and suicide
• swelling, pain, and redness in the leg indicating a blood clot in the veins, which may

travel through blood vessels to the lungs causing chest pain and difficulty in breathing

• yellowing of the skin and white part of eyes (jaundice), dark urine, nausea, diarrhoea, tiredness, flu like symptoms, swollen abdomen, bleeding easily or confusion (can be symptoms of liver inflammation or liver failure)
• fever, muscle stiffness, muscle pains, vomiting, sweating, dark urine, or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”)
• prolonged and/or painful erection
• inflammation of the pancreas
• abnormal muscle breakdown which can lead to kidney problems
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• heart attack.

The following side effects could happen:

• feeling anxious
• feeling restless and unable to keep still, difficulty sitting still, uncontrollable twitching, jerking or writhing movements, restless legs
• trembling
• headache
• tiredness
• sleepiness
• light-headedness
• shaking and blurred vision
• decreased number of or difficulty making bowel movements
• indigestion
• feeling sick
• more saliva in mouth than normal
• vomiting
• feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

• increased blood levels of the hormone prolactin
• too much sugar in the blood
• depression
• altered or increased sexual interest
• uncontrollable movements of mouth, tongue and limbs (tardive dyskinesia)
• muscle disorder causing twisting movements (dystonia)
• double vision
• eye sensitivity to light
• fast heart beat
• a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting
• hiccups.

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

• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma
• high blood sugar
• not enough sodium in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• thoughts of suicide, suicide attempt and suicide
• excessive gambling
• feeling aggressive
• agitation
• nervousness, ,
• speech disorder
• slower heart beat
• high blood pressure
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection)
• spasm of the muscles around the voice box,
• fixation of the eyeballs in one position
• difficulty swallowing
• diarrhoea
• abdominal discomfort
• stomach discomfort
• reports of abnormal liver tests values
• skin rash
• sensitivity to light
• hair loss (alopecia)
• excessive sweating
• muscle pain
• stiffness,
• involuntary loss of urine (incontinence)
• difficulty in passing urine,
• withdrawal symptoms in newborn babies in case of exposure during pregnancy
• difficulty controlling core body temperature or overheating
• chest pain,
• swelling of hands, ankles or feet
• in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.
• 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 (may affect more than 1 in 10people) 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 people).

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: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 tablet

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.

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.

Aripiprazole 5 mg tablets: each tablet contains 5 mg of aripiprazole.

Aripiprazole 10 mg tablets: each tablet contains 10 mg of aripiprazole.

Aripiprazole 15 mg tablets: each tablet contains 15 mg of aripiprazole.

Aripiprazole 30 mg tablets: each tablet contains 30 mg of aripiprazole.

The other ingredients are lactose monohydrate, cellulose microcrystalline (Type 101), maize starch, croscaramellose sodium, hydroxypropyl­cellulose EF (E463), magnesium stearate, indigo carmine aluminium lake (E132). 10/30 mg – iron oxide red (E172); 15 mg – iron oxide

yellow (E172)

What Aripiprazole looks like and contents of the pack

Aripiprazole 5 mg tablets: Blue, modified rectangular tablets, upper face debossed with ‘BS09’ and lower face with ‘5’. The pack size of 28 tablets is registered.

Aripiprazole 10 mg tablets: Pink, modified rectangular tablets, upper face with a breakline, left of the breakline debossed with ‘BS’, right of breakline with ‘09’ and lower face with ‘10’. The tablet can be divided into equal doses. The pack size of 28 tablets is registered.

Aripiprazole 15 mg tablets: Light yellow, round tablets, upper face

debossed with ‘BS09’, lower face with ‘15’. The pack size of 28 tablets is registered.

Aripiprazole 30 mg tablets: Pink, round tablets, upper face with a breakline, upper side of breakline debossed with ‘BS’, lower side of breakline with ‘09’ and lower face with ‘30’. The tablet can be divided into equal doses. The pack size of 28 tablets is registered.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

DAWA Limited

5 Sandridge Close, Harrow,

Middlesex, HA1 1XD,

United Kingdom

This leaflet was last revised in May 2021