ARIPIPRAZOLE 10mg & 15mg ORODISPERSIBLE TABLETS – patient leaflet, side effects, dosage

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

• Anticonvulsants used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

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

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

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.

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 tryptophanused for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain

Aripiprazole orodispersible 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 orodispersible tablets.

• 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

2. What you need to know before you take Aripiprazole orodispersible tablets

• tricyclic’s (such as clomipramine and amitriptyline) used for depressive illness
• St John’s Wort (Hypericum perforatum) used as a herbal remedy for mild depression

Do not take Aripiprazole Orodispersible Tablets

• pain killers (such as tramadol and pethidine) used for pain relief
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions
• triptans (such as sumatriptan and zolmitripitan) used for treating migraine

Talk to your doctor before taking Aripiprazole orodispersible tablets.

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

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.

Aripiprazole Orodispersible Tablets with food, drink and alcohol

Before treatment with Aripiprazole Orodispersible Tablets, tell your doctor if you suffer from

Aripiprazole Orodispersible Tablets can be taken regardless of meals.

• 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

  Alcohol should be avoided.

  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 Orodispersible 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.

• 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

  If you are taking Aripiprazole Orodispersible Tablets, 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.

• 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.

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.

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.

Aripiprazole Orodispersible Tablets contain aspartame

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.

Aripiprazole 10mg Orodispersible Tablets: This medicine contains 2mg aspartame in each tablet. Aripiprazole 15mg Orodispersible Tablets: This medicine contains 3mg aspartame in each tablet. 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.

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 for 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.

3. How to take Aripiprazole orodispersible 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.

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

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

This medicinal product 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.

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 Orodispersible Tablets

If you have the impression that the effects of Aripiprazole orodispersible tablets are too strong or too weak, talk to your doctor or pharmacist. Try to take your Aripiprazole 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

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 Orodispersible 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 orodispersible tablets with some medicines may need to change your dose of Aripiprazole Orodispersible Tablets. It is especially important to mention the following to your doctor:

• Medicines to correct heart rhythm (such as quinidine, amiodarone, flecainide)

Product: Aripiprazole 10mg & 15mg Orodispersible Tablets

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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 Orodispersible Tablets without first consulting your doctor.

If you take more Aripiprazole orodispersible tablets than you should

If you 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.

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 bloodpressure, abnormal rhythms of the heart. Contact your doctor or hospital immediately if you experience any of the above.

If you forget to take Aripiprazole orodispersible 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 stop taking Aripiprazole orodispersible tablets

Do not stop your treatment just because you feel better. It is important that you carry on taking Aripiprazole orodispersible tablets 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. Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep still, difficulty sitting still,
• akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
• uncontrollable twitching, jerking or writhing movements,
• 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),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heartbeat,
• 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 oral aripiprazole but the frequency for them to occur is not known:

• low levels of white blood cells,
• low levels of blood platelets,
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives),
• 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,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle stiffness, faster breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizure,
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles),
• speech disorder,
• fixation of the eyeballs in one position,
• sudden unexplained death,
• life-threatening irregular heartbeat,
• heart attack,
• slower heartbeat,
• 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),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),

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• spasm of the muscles around the voice box,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and white part of eyes,
• reports of abnormal liver tests values,
• skin rash,
• skin sensitivity to light,
• baldness,
• excessive sweating,
• serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia),
• abnormal muscle breakdown which can lead to kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty in passing urine,
• withdrawal symptoms in newborn babies in case of exposure during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or 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 toothers, 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.

Tell your doctor if you experience any of these behaviours; he/she will discuss ways of managing or reducing the symptoms.

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 at: 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.

5. How to store Aripiprazol orodispersible 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 after EXP. The expiry date refers to the last day of that month. Store below 25°C.

Store in the original package in order to protect from moisture.

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 orodispersible tablets contain

• The active substance is aripiprazole.

  Each orodispersible tablet contains 10mg of aripiprazole.

• The other ingredients are: Calcium silicate, Microcrystalline cellulose, Crospovidone, Croscarmellose sodium, Silica colloidal anhydrous, Xylitol, Aspartame (E951), Acesulfame potassium, Tartaric acid, Magnesium stearate, Vanillin, Red iron oxide (E172)
• Each orodispersible tablet contains 15mg of aripiprazole.
• The other ingredients are: Calcium silicate, Microcrystalline cellulose, Crospovidone, Croscarmellose sodium, Silica colloidal anhydrous, Xylitol, Aspartame (E951), Acesulfame potassium, Tartaric acid, Magnesium stearate, Vanillin, Yellow iron oxide (E172)

What Aripiprazole orodispersible tablets look like and contents of the pack

10mg: Pale pink, round tablets

15mg: Pale brown, round tablets

14 tablets, 28 tablets, 49 tablets, 56 tablets and 98 tablets. Not all pack sizes may be marketed Marketing Authorisation Holder

Crescent Pharma Ltd., Key House,

Sarum Hill, Basingstoke, RG21 8SR, UK. Manufacturer

ELPEN Pharmaceutical Co. Inc., 95 Marathonos Ave., GR-19009, Pikermi Attica, Greece.

PL 20416/1193-1194

This leaflet was last revised in February 2026.

P3757T