ARIPIPRAZOLE 1 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Aripiprazole 1 mg/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 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:

What Aripiprazole 1 mg/ml oral solution is and what it is used for

What you need to know before you take Aripiprazole

• 1 mg/ml oral solution

How to take Aripiprazole 1 mg/ml oral solution

Possible side effects

How to store Aripiprazole 1 mg/ml oral solution

Contents of the pack and other information

What Aripiprazole 1 mg/ml oral solution is and what it is used for

Aripiprazole 1 mg/ml oral solution 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 1 mg/ml oral solution 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 1 mg/ml oral solution.

2. what you need to know before you take aripiprazole

• 1 mg/ml oral solution

DO NOT take Aripiprazole 1 mg/ml oral solution

• – 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 before taking Aripiprazole 1 mg/ml oral solution 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

• – Seizure

• – Involuntary, irregular muscle movements, especially in the face

• – Cardiovascular diseases, 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 ifit is safe and effective in these patients.

Other medicines and Aripiprazole 1 mg/ml oral solution 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 1 mg/ml oral solution 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 1 mg/ml oral solution with some medicines may need to change your dose of Aripiprazole 1 mg/ml oral solution. It is especially important to mention the following to your doctor:

• – Medicines to correct heart rhythm

• – Antidepressants or herbal remedy used to treat depression and anxiety

• – Antifungal agents

• – Certain medicines to treat HIV infection

• – Anticonvulsants used to treat epilepsy

Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, 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 symptom taking any of these medicines together with Aripiprazole 1 mg/ml oral solution, you should see your doctor.

Aripiprazole 1 mg/ml oral solution with food, drink and alcohol

Aripiprazole 1 mg/ml oral solution 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.

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 1 mg/ml oral solution 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.

Be sure to tell your doctor immediately if you are breast-feeding.

If you are taking Aripiprazole 1 mg/ml oral solution, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines until you know how Aripiprazole 1 mg/ml oral solution affects you.

Aripiprazole 1mg/ml oral solution contains sodium benzoate (E211), propylene glycol (E1520) and sodium

Sodium benzoate (E211)

This medicine contains 1 mg sodium benzoate (E211) in each ml of solution.

Propylene glycol (E1520)

This medicine contains 80 mg propylene glycol (E1520) in each ml of solution.

If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are taking this medicine.

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.

Sodium

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

3. how to take aripiprazole 1 mg/ml oral solution

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 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 10 ml 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.

Measuring dose:

• – Doses up to 5 ml should be measured using the 5 ml syringe supplied in the carton.

• – Doses of 10 ml and more should be measured using the measuring cup or the 5 ml syringe supplied in the carton.

Turn the bottle upside down with the syringe still in place (Figure 2).

If any bubbles appear in the syringe, keep the bottle upside down and slightly push in the plunger and pull it back again. Repeat until there are no bubbles in the syringe (Figure 4).

Turn the bottle the right way up and remove the syringe (Figure 6).

Push the plunger in slowly to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor (Figure 5).

Open the bottle and make sure that the syringe is firmly inserted into the adaptor (Figure 1).

Pull the plunger down and fill the syringe with a quantity of solution slightly beyond the prescribed dose (Figure 3).

Wash the syringe and the cup with water after use and close the bottle with the plastic screw cap.

If you have the impression that the effect of Aripiprazole 1 mg/ml oral solution is too strong or too weak, talk to your doctor or pharmacist.

Try to take the Aripiprazole 1 mg/ml oral solution 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 1 mg/ml oral solution.

Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole 1 mg/ml oral solution without first consulting your doctor.

If you take more Aripiprazole 1 mg/ml oral solution than you should

If you realise you have taken more Aripiprazole 1 mg/ml oral solution than your doctor has recommended (or if someone else has taken some of your Aripiprazole 1 mg/ml oral solution), contact your doctor right away. If you cannot reach your doctor, go to the nearest hospital and take the pack with you.

If you forget to take Aripiprazole 1 mg/ml oral solution 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 1 mg/ml oral solution Do not stop your treatment just because you feel better.

It is important that you carry on taking Aripiprazole 1 mg/ml oral solution 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
• uncontrollable twitching, jerking or writhing movements, restless legs
• trembling
• headache
• tiredness
• sleepiness
• light-headedness
• shaking and blurred vision
• decreased number ofor 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 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 (frequency cannot be estimated from the available data):

• 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
• excessive gambling
• 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)
• 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
• 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

5. how to store aripiprazole 1 mg/ml oral solution

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 bottle and on the carton.

Use within 6 months after first opening.

Do not refrigerate or freeze.

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

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 1 mg/ml oral solution contains The active substance is aripiprazole.

Each ml contains 1 mg of aripiprazole.

The other ingredients are: Propylene glycol (E1520) Macrogol 4000 Phosphoric acid Hypromellose 2910 Erythritol (E968) Sucralose (E955) Sodium benzoate (E211) Disodium edetate N&A Flavour for grape 26436: Flavouring ingredients Propylene glycol (E1520) Water, purified

What Aripiprazole 1 mg/ml oral solution looks like and contents of the pack.

Aripiprazole 1 mg/ml oral solution is a clear, colourless liquid supplied in amber glass bottles containing 150 ml per bottle.

Each bottle is closed with plastic (polyethylene HD/polypropylene) “Child proof” screw cap with a polyethylene adaptor (plug).

Each carton contains 1 bottle, a leaflet and measuring devices, a 5 ml oral syringe and a 30 ml measuring cup.

The syringe body is PP and the plunger HDPE and is graduated for dosing of 0.5 ml and 1 ml, and then every 0.5 ml upto 5 ml.

The measuring cup is PP and is graduated for dosing of 5 ml, 10 ml, 15 ml, 20 ml, 25 ml and maximum volume of 30 ml.

Marketing Authorisation Holder

Thornton & Ross Limited

Linthwaite Huddersfield

HD7 5QH

United Kingdom

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18, 61118 Bad Vilbel, Germany

Stada Nordic ApS.

Marielundvej 46A, 2730 Herlev, Denmark

Balkanpharma Troyan AD 1 Krayrechna Str.

Troyan 5600 Bulgaria

This leaflet was last revised in July 2021