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Aripiprazole 1mg/ml Oral Solution

Active Ingredient:
Brillpharma Limited See contact details
ATC code: 
About Medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
Last updated on emc: 05 Dec 2023

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 40496/0033.

Aripiprazole 1mg/ml Oral Solution

Package Leaflet: Information for the User

Aripiprazole 1mg/ml Oral Solution


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 onto others. It may harm them, even if their symptoms 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 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.

1. What Aripiprazole is and what it is used for

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

Aripiprazole 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.
  • 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.

2. What you need to know before you take Aripiprazole
Do not take Aripiprazole:
  • if you are allergic to Aripiprazole or any of the other ingredients of this medicine (see section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Aripiprazole if you suffer from:

  • 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
  • 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
  • involuntary, irregular muscle movements, especially in the face
  • fits (seizures) since your doctor may want to monitor you more closely
  • past experience of excessive gambling

Please tell your doctor 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.

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.

If you suffer from muscle stiffness or inflexibility with high fever, sweating, altered mental status, or very rapid or irregular heart beat, please tell your doctor immediately.

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 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

Please do not use this solution for children and adolescents under 13 years. It is not known if it is safe and effective in these patients.

Other medicines and Aripiprazole :

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Taking Aripiprazole with some medicines may need to change your dose of Aripiprazole or the other medicines.

Especially tell your doctor if you are taking any of the following types of medicines:

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

These medicines 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.

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.

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, tryptophan used for conditions including depression, generalised anxiety disorder, obsessive compulsive disorder (OCD) and social phobia as well as migraine and pain
  • SSRIs selective-serotonin-reuptake-inhibitors (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 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, you should see your doctor.

Taking Aripiprazole with food, drink and alcohol

This solution can be taken regardless of meals. However, this solution should not be diluted with other liquids or mixed with any food prior to administration.

You should not take alcohol while taking this medicine.

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 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, 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 contains methyl parahydroxy- benzoate (E218), propyl parahydroxybenzoate (E216), fructose, sucrose, propylene glycol (E1520), glycerol (E422) and sodium

This medicines also contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216), which may cause allergic reactions (possibly delayed).

This medicine also contains 200 mg fructose in each ml. Fructose may damage teeth. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

This medicine also contains 400mg of sucrose in each ml. This should be taken into account in patients with diabetes mellitus. Sucrose may be harmful to the teeth.

This medicine contains 100 mg propylene glycol (E 1520) in each ml which is equivalent to 1.43 mg/kg.

If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

Information on sodium content

This medicine also contains less than 1 mmol sodium (23 mg) per daily maximum dose 30mg (30 ml), that is to say essentially ‘sodium-free’.

3. How to take Aripiprazole

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose for adults is 15 ml solution (corresponding to 15 mg aripiprazole) once a day.

However your doctor may prescribe a lower or higher dose to a maximum of 30 mg (i.e. 30 ml) once a day.

Use in children and adolescents

The recommended dose for adolescents is 10ml solution (corresponding to 10 mg aripiprazole) once a day. However your doctor may prescribe a lower or higher dose to a maximum of 30 ml (i.e. 30 mg) once a day.

The dose of Aripiprazole must be measured using the calibrated 30ml cup or a 2ml graduated oral syringe supplied in the carton.

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 at the same time each day. It does not matter whether you take it with or without food. However, you should not dilute with other liquids or mix with other food prior to taking this solution.

Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole without first consulting your doctor.

If you take more Aripiprazole than you should

If you realise you have taken more Aripiprazole than your doctor has recommended (or if someone else has taken some of your Aripiprazole), 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 forget to take Aripiprazole

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

Do not stop your treatment just because you feel better. It is important that you carry on taking Aripiprazole for as long as your doctor has told you to. Ask your doctor or pharmacist if you have any further questions on the use of this product.

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 or decreased 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 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 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 heart beat,
  • heart attack,
  • slower heart beat,
  • 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),
  • 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 as 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: 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.

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 Yellow Card Scheme Website: 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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle 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 use after 6 months of first opening the bottle.

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 contains
  • The active substance is Aripiprazole. Each ml of oral solution contains 1mg of Aripiprazole.
  • The other ingredients are: methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), glycerol (E422), malic acid, fructose, sucrose, disodium edetate, orange flavour, sodium hydroxide and purified water

What Aripiprazole looks like and contents of the pack

Aripiprazole is a clear, colourless to light yellow liquid.

This medicine is available in 150 ml amber colored bottle with a child resistant tamper-evident closure, 30 ml measuring cup (graduated at every 2.5 ml equivalent to 2.5 mg) and a 2 ml oral syringe (graduated at every 0.5 ml equivalent to 0.5 mg) with an adaptor packed in a carton.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Name and address

Brillpharma Limited
6 Sovereign Park
United Kingdom


LM Manufacturing Limited
Sandretto Building
Cavalry Hill Industrial Park
United Kingdom

Aripiprazole 1mg/ml Oral Solution; PL 40496/0033

This leaflet was last revised in April 2023.

To request a copy of this leaflet in Braille, large print or audio format then please contact the marketing authorisation holder at the address (or email) above.

V13 18-04-23 D0


Brillpharma Limited
Company image
6 Sovereign Park, Luton, LU4 8EL, UK