ARIPIPRAZOLE HEC PHARM 5 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 HEC is and what it is used for

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

• 3. How to take Aripiprazole HEC

• 4. Possible side effects

• 5. How to store Aripiprazole HEC

• 6. Contents of the pack and other information

1.

Aripiprazole HEC 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 HEC 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 this medicine.

2.

Do not take Aripiprazole HEC

• 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 HEC.

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 HEC, 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, 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 your dose or stop the treatment.

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 HEC

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 HEC 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 HEC with some medicines may mean the doctor will need to change your dose of Aripiprazole HEC 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, 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 HEC; if you get any unusual symptom taking any of these medicines together with Aripiprazole HEC tell your doctor.

Medicines that increase the level of serotonin are typically used in conditions including obsessive-compulsive disorder (OCD) and 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 HEC, you should tell your doctor.

Aripiprazole HEC with alcohol

Avoid alcohol consumption during the treatment with this medicine.

Pregnancy and breast-feeding

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 taken this medicine 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 contact your doctor.

If you are taking Aripiprazole HEC, 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. Donot 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.

3.

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

This medicine 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 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 HEC is too strong or too weak, talk to your doctor or pharmacist.

Aripiprazole HEC is for oral use.

Try to take Aripiprazole HEC 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 HEC without first consulting your doctor.

If you take more Aripiprazole HEC than you should

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

If you miss a dose, take the missed dose as soon as you remember. Do not take two doses in one day.

If you stop taking Aripiprazole HEC

Do not stop your treatment just because you feel better. It is important that you carry on taking this medicine 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: 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 of or difficulty making bowel movements,
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.

Uncommon : 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.

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,
• 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,
• 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: 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 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:

Very common : may affect more than 1 in 10 people

sleepiness, uncontrollable twitching or jerking movements, restlessness, and tiredness

Common: may affect up to 1 in 10 people

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.

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.

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.

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.

Each tablet contains 5 mg of aripiprazole.

Each tablet contains 10 mg of aripiprazole.

• The other ingredients are mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.

What Aripiprazole HEC looks like and contents of the pack

Aripiprazole HEC 5 mg tablets are white or almost white modified rectangle tablets, debossed “L86” on one side while blank on the other.

Aripiprazole HEC 10 mg tablets are white or almost white drop-shaped tablets, debossed “C23” on one side while blank on the other.

Aripiprazole HEC tablets are supplied in blisters packed in cartons containing, 28, 49, or 98 tablets per carton.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

HEC Pharm GmbH,

Gabriele-Tergit-Promenade 17,

10963 Berlin, Germany

Tel.: 030–3300 7721

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b

14167 Berlin

Germany

This medicinal product is authorised in the Member States of the EEA under the following names:

Member Proposed Name

State

Germany Aripiprazol HEC Pharm 5 mg Tabletten

Aripiprazol HEC Pharm 10 mg Tabletten

United Aripiprazole HEC Pharm 5 mg Tablets kingdom Aripiprazole HEC Pharm 10 mg Tablets

France Aripiprazole HEC Pharm 5 mg comprime Aripiprazole HEC Pharm 10 mg comprime

Italy Aripiprazolo HEC Pharm 5 mg compresse

Aripiprazolo HEC Pharm 10 mg compresse

Spain Aripiprazol HEC Pharm 5 mg comprimidos Aripiprazol HEC Pharm 10 mg comprimidos

This leaflet was last revised in May 2020.