Aripiprazole medical valley

Package leaflet: Information for the patient

Aripiprazole Medical Valley, 5 mg, tablets
Aripiprazole Medical Valley, 10 mg, tablets
Aripiprazole Medical Valley, 15 mg, tablets
Aripiprazole Medical Valley, 30 mg, tablets
Aripiprazolum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Aripiprazole Medical Valley is and what it is used for
2. Important information before taking Aripiprazole Medical Valley
3. How to take Aripiprazole Medical Valley
4. Possible side effects
5. How to store Aripiprazole Medical Valley
6. Contents of the pack and other information

1. What Aripiprazole Medical Valley is and what it is used for

Aripiprazole Medical Valley 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 have a disorder characterized by symptoms such as seeing, hearing, or sensing things that are not real, suspiciousness, beliefs that are not based in reality, disorganized speech and behavior, and emotional blunting. Patients with these symptoms may also experience sadness, anxiety, tension, or feelings of guilt.
Aripiprazole Medical Valley is also used to treat adults and adolescents aged 13 years and older whose condition is characterized by symptoms such as extreme excitement, overwhelming energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also helps prevent the recurrence of these symptoms in patients who have responded to treatment with Aripiprazole Medical Valley.

2. Important information before using Aripiprazole Medical Valley

When not to use Aripiprazole Medical Valley

• if the patient is allergic to aripiprazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Aripiprazole Medical Valley, discuss this with the doctor.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform the doctor if there are any thoughts or feelings related to harming oneself.
Before starting treatment with Aripiprazole Medical Valley, inform the treating doctor if the patient has:

• high blood sugar levels (typical symptoms include: excessive thirst, passing large amounts of urine, increased appetite, and feeling weak) or a family history of diabetes
• seizures (fits), as this may mean the doctor will want to monitor the patient closely
• involuntary, irregular movements of muscles, especially facial muscles
• cardiovascular diseases (heart and circulation disorders), family history of circulatory disorders, stroke or "mini" stroke (transient ischaemic attack), or abnormal blood pressure
• blood clots or a family history of blood clots, because use of antipsychotic medicines has been associated with blood clot formation
• a history of gambling addiction

If the patient notices weight gain, development of unusual movements, drowsiness interfering with daily activities, any difficulties with swallowing, or allergic symptoms, they should inform the treating doctor.
If the patient is elderly and has dementia (loss of memory and other mental abilities), the patient, their caregiver, or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
Immediately inform the doctor about any thoughts or feelings related to harming oneself. Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Immediately inform the doctor if the patient develops muscle stiffness or stiffness with high fever, sweating, altered mental status, or very rapid or irregular heartbeat.
If the patient or their family or caregiver notices that the patient starts feeling an urge or desire to behave in an unusual way and cannot resist an impulse, drive, or temptation to perform activities that could harm themselves or others, they should tell the doctor.
These phenomena are called impulse control disorders and may manifest as behaviours such as compulsive gambling, binge eating, or excessive spending, increased sexual drive, or increased frequency and intensity of sexual thoughts or feelings.
The doctor may consider it appropriate to change the dose or discontinue the medicine.
Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in mobility and balance, which may lead to falls.
Exercise caution, especially in elderly or weakened patients.

Children and adolescents
This medicine should not be used in children and adolescents under 13 years of age. It is not known whether the use of this medicine is safe and effective in these patients.

Aripiprazole Medical Valley with other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
Medicines that lower blood pressure: Aripiprazole Medical Valley may enhance the effect of medicines that lower blood pressure. If the patient is taking blood pressure-lowering medicines, they should inform the treating doctor.
Taking Aripiprazole Medical Valley with other medicines may require a dose adjustment of Aripiprazole Medical Valley. It is especially important to inform the treating doctor about the use of the following medicines:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide)
• antidepressants or herbal medicines used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's wort)
• antifungal medicines (such as ketoconazole, itraconazole)
• certain medicines used to treat HIV infection (such as efavirenz, nevirapine, protease inhibitors, e.g. indinavir, ritonavir)
• antiepileptic medicines used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital)
• specific antibiotics used to treat tuberculosis (rifabutin, rifampicin)

Taking these medicines may increase the risk of adverse effects or reduce the effectiveness of Aripiprazole Medical Valley. If the patient experiences any unusual symptoms while taking these medicines with Aripiprazole Medical Valley, they should inform the doctor.

Medicines that increase serotonin levels are usually used in conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain:

• triptans, tramadol, and tryptophan used to treat conditions involving depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), social phobia, migraine, and pain
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic, and anxiety
• other antidepressants (such as venlafaxine and tryptophan) used to treat major depression
• tricyclic antidepressants (such as clomipramine and amitriptyline) used to treat depression
• St. John's wort (Hypericum perforatum) used as a herbal remedy for mild depression
• painkillers (such as tramadol and pethidine) used to relieve pain
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine

These medicines may increase the risk of adverse effects; if any unusual symptoms occur while taking any of the above medicines together with Aripiprazole Medical Valley, contact the doctor.

Aripiprazole Medical Valley with food, drink, and alcohol
This medicine can be taken independently of meals.
Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the doctor before using this medicine.
Newborns whose mothers took Aripiprazole Medical Valley during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor.
If the patient is taking Aripiprazole Medical Valley, the doctor will discuss with her whether she should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. The patient should not take the medicine and breastfeed at the same time. Discuss with the doctor the best feeding methods for the baby if the patient is taking this medicine.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account when performing tasks requiring full attention, such as driving or operating machinery.

Aripiprazole Medical Valley contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact the doctor before taking this medicine.

3. How to use Aripiprazole Medical Valley

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.

The recommended dose in adults is 15 mg once daily. However, the doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

Use in children and adolescents
Aripiprazole treatment may be initiated at a low dose in the form of an oral solution (liquid). The dose may be gradually increased to the recommended dose for adolescents of 10 mg once daily. However, the treating doctor may prescribe a lower or higher dose, up to a maximum of 30 mg per day.

If the patient feels the effect of Aripiprazole Medical Valley is too strong or too weak, they should consult the doctor or pharmacist.

Aripiprazole Medical Valley tablets should be taken every day at the same time. It does not matter whether the tablet is taken with or without food. The tablet should be swallowed whole and taken with water.

Even if the patient feels an improvement in well-being, the dose should not be changed or the medicine discontinued without first consulting the treating doctor.

Aripiprazole Medical Valley 15 mg: The break line on the tablet is not intended for splitting the tablet.

Taking more Aripiprazole Medical Valley than recommended
If a patient takes more Aripiprazole Medical Valley than prescribed (or if someone else takes any amount of Aripiprazole Medical Valley not intended for them), contact the treating doctor immediately. If unable to contact the doctor, go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken an excessive dose of aripiprazole, the following symptoms have occurred:

• rapid heartbeat, restlessness/aggression, speech problems
• unusual body movements (especially of the face or tongue) and decreased level of consciousness

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, combination of fever, rapid breathing, excessive sweating
• muscle stiffness and drowsiness or lethargy, slowed breathing, choking, high or low blood pressure, irregular heart rhythm

If the patient experiences any of the above symptoms, contact a doctor or hospital immediately.

Missing a dose of Aripiprazole Medical Valley
If a dose is missed, the patient should take the missed dose as soon as they remember. Do not take two doses on the same day.

Stopping treatment with Aripiprazole Medical Valley
Do not stop treatment just because the patient feels better. It is very important to take Aripiprazole Medical Valley exactly as prescribed by the doctor and for the duration recommended by the doctor.

If there are any further doubts regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may affect 1 in 10 patients):

• diabetes,
• sleep disorders,
• feeling of anxiety,
• feeling of restlessness and inability to sit or stand still,
• akathisia (unpleasant inner restlessness and an irresistible need to be constantly moving),
• uncontrolled trembling, jerking movements or writhing movements,
• tremor,
• headache,
• fatigue,
• drowsiness,
• feeling of emptiness in the head,
• blurred vision and double vision,
• reduced number of bowel movements or difficulty in defecation,
• indigestion,
• nausea,
• excessive salivation,
• vomiting,
• feeling of tiredness.

Uncommon adverse effects (may affect 1 in 100 patients):

• increased or decreased prolactin blood levels,
• abnormally high blood sugar levels,
• depression,
• changes related to sexuality or excessive interest in sex,
• uncontrolled movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorders causing twisting movements (dystonia),
• restless legs syndrome,
• double vision,
• light sensitivity of the eyes,
• rapid heartbeat,
• decreased blood pressure when standing, causing dizziness, feeling of emptiness in the head or fainting,
• hiccups.

The following adverse effects have been reported after the marketing of aripiprazole in tablet form, but their frequency is unknown:

• decreased number of white blood cells,
• decreased number of platelets,
• allergic reactions (e.g. swelling of the mouth, tongue, face and throat, skin itching, urticaria),
• onset of diabetes or worsening of existing diabetes, ketoacidosis (presence of ketone bodies in blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempts and completed suicides,
• feeling of aggression,
• agitation,
• nervousness,
• occurrence of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction which may cause feelings of extreme well-being, drowsiness, lack of coordination, restlessness, especially motor restlessness, alcohol-like intoxication, fever, sweating or muscle stiffness),
• speech disorders,
• fixed eye position (oculogyria),
• sudden unexplained death,
• life-threatening irregular heart rhythm,
• heart attack (myocardial infarction),
• slow heartbeat,
• blood clots in veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which may travel through blood vessels to the lungs causing chest pain and difficulty breathing (if any of these symptoms occur, the patient must immediately contact a doctor),
• high blood pressure,
• fainting,
• accidental aspiration of food with risk of developing pneumonia,
• muscle spasm around the vocal cords,
• pancreatitis,
• difficulty swallowing,
• diarrhoea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• hepatitis,
• yellowing of the skin and whites of the eyes (jaundice),
• abnormal liver function test results,
• skin rash,
• light sensitivity,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, followed by a rash on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (seen in blood tests) and increased levels of a specific type of white blood cells (eosinophilia),
• abnormal muscle breakdown leading to kidney dysfunction,
• muscle pain,
• stiffness,
• involuntary urination (urinary incontinence),
• difficulty in urinating,
• withdrawal syndrome in newborns following exposure to the drug during pregnancy,
• prolonged and (or) painful erection (priapism),
• difficulty regulating core body temperature or overheating,
• chest pain,
• swelling of hands, ankles or feet,
• in blood tests: increased or fluctuating blood sugar levels, increased levels of glycated haemoglobin,
• inability to resist an impulse, drive or temptation to engage in an activity that may harm the patient or others, including behaviours such as:
  • strong impulse to gamble excessively despite serious personal or family consequences,
  • changed or increased interest in sexual activity and behaviours significantly disturbing to the patient or others, for example increased sexual drive,
  • uncontrolled excessive shopping or spending,
  • compulsive overeating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger),
  • impulse to wander aimlessly (pica).

If such behaviours occur in a patient, they should be reported to the doctor, who will discuss with the patient ways to treat or reduce these symptoms.

In elderly patients with dementia treated with aripiprazole, a higher number of fatal cases have been reported. In addition, cases of stroke or "mini" strokes (transient ischaemic attacks) have been observed.

Additional adverse effects in children and adolescents

In adolescents aged 13 years and older, adverse effects occurred at similar frequency and type as in adults, except for drowsiness, uncontrolled tremors or jerking movements, motor restlessness and fatigue, which occurred very commonly (may affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled limb movements, and dizziness, particularly upon standing up from lying or sitting position, which occurred commonly (may affect up to 1 in 100 patients).

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Adverse effects can also be reported to the marketing authorisation holder.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aripiprazole Medical Valley

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the specified month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures help protect the environment.

6. Contents of the pack and other information

What Aripiprazole Medical Valley contains

• The active substance is aripiprazole. Aripiprazole Medical Valley 5 mg tablets: Each tablet contains 5 mg of aripiprazole. Aripiprazole Medical Valley 10 mg tablets: Each tablet contains 10 mg of aripiprazole. Aripiprazole Medical Valley 15 mg tablets: Each tablet contains 15 mg of aripiprazole. Aripiprazole Medical Valley 30 mg tablets: Each tablet contains 30 mg of aripiprazole.
• The other ingredients are: lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, iron oxide red (E 172).

What Aripiprazole Medical Valley looks like and contents of the pack
Aripiprazole Medical Valley 5 mg tablets: Round, flat, light pink tablets.
Aripiprazole Medical Valley 10 mg tablets: Round, biconvex, light pink tablets.
Aripiprazole Medical Valley 15 mg tablets: Round, biconvex, light pink tablets with a score line on one side.
Aripiprazole Medical Valley 30 mg tablets: Round, biconvex, light pink tablets.
The medicine is packed in blisters made of Aluminium/Aluminium foil, in cardboard boxes containing 14, 28, 49, 56 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Medical Valley Invest AB
Brädgårdsvägen 28
236 32 Höllviken
Sweden
email: [email protected]

Manufacturer
Laboratorios LICONSA, S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara
Spain

J. Uriach y Compañia S.A.
Avinguda Cami Reial 51-57
Poligon Industrial Riera De Caldes
08184 Palau-Solita I Plegamans, Barcelona
Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark Aripiprazole Medical Valley 5/10/15/30 mg tabletter
France Aripiprazole Almus 5/10/15 mg comprimé
Netherlands Aripiprazol Xiromed 5/10/15/30 mg tabletten
Iceland Aripiprazole Medical Valley
Norway Aripiprazole Medical Valley
Poland Aripiprazole Medical Valley
Sweden Aripiprazole Medical Valley 5/10/15/30 mg tabletter
United Kingdom Aripiprazole 5/10/15/30 mg tablets