Aripiprazole 1mg/ml Oral Solution

• 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.

The name of your medicine is Aripiprazole 1mg/ml Oral Solution but it will be referred to as ‘Aripiprazole’ throughout 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

• 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) 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 with 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.

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 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, an 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 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 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.

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

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 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.

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.

Fructose: This medicine contains 200mg of fructose in each ml of dose. 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.

Sucrose: This product contains 400mg of sucrose in each ml of dose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This should be taken into account in patients with diabetes mellitus.

May be harmful to the teeth.

Methyl parahydroxybenzoate (E218) and ethyl parahydroxybenzoate (E214):

May cause allergic reactions (possibly delayed).

Sodium: This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.

The recommended dose for adolescents is 10ml solution (corresponding to 10mg aripiprazole) once a day.

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

• this medicinal product must be taken orally
• the dose of Aripiprazole must be measured using the oral syringe supplied in the carton.

Instructions for the use of syringe:

a) Open the bottle: press the cap and turn it anticlockwise (figure 1).

b) Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is properly fixed. Take the syringe and put it in the adaptor opening (figure 4).

c) Turn the bottle upside down. Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upwards in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

d) Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B).

e) Empty the contents of the syringe into the patient’s mouth by pushing the piston to the bottom of the syringe (figure 7). The contents of the syringe should be emptied into the side cheek of the patient’s mouth to avoid a choking hazard. Close the bottle with the plastic screw cap. Wash the syringe with water (figure 8).

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 Aripiprazole.

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 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 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 Aripiprazole 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 (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).

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 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.

The active substance is aripiprazole.

Each ml of oral solution contains 1mg of aripiprazole.

The other ingredients are disodium edetate, fructose, glycerol, malic acid, methyl parahydroxybenzoate (E218), propylene glycol, ethyl parahydroxybenzoate (E214), sodium hydroxide, sucrose, orange flavour [flavouring preparations, natural flavouring substances and propylene glycol (E1520)] and purified water.

Aripiprazole is a clear colourless to light yellow liquid solution with odour of orange supplied in PET amber bottles with a tamper evident, child resistant white plastic cap and an expanded polyethylene (EPE) liner with a 10ml oral syringe having 0.5ml graduation mark and an adaptor for the syringe.

Aripiprazole is supplied in a bottle containing 150ml oral solution.

POM

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