ARIPIPRAZOLE 30 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Aripiprazole Medical Valley, 5 mg, tablets
3. Aripiprazole Medical Valley, 10 mg, tablets
4. Aripiprazole Medical Valley, 15 mg, tablets
5. Aripiprazole Medical Valley, 30 mg, tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
6. What is Aripiprazole Medical Valley and what is it used for
7. Important information before taking Aripiprazole Medical Valley
   1. When not to take Aripiprazole Medical Valley
   2. Warnings and precautions
   3. Children and adolescents
   4. Aripiprazole Medical Valley and other medicines
   5. Aripiprazole Medical Valley with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Aripiprazole Medical Valley contains lactose
8. How to take Aripiprazole Medical Valley
   1. Use in children and adolescents
   2. Aripiprazole Medical Valley tablets should be taken once a day at the same time.
   3. Taking a higher dose of Aripiprazole Medical Valley than recommended
   4. Missing a dose of Aripiprazole Medical Valley
   5. Stopping treatment with Aripiprazole Medical Valley
9. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Additional side effects in children and adolescents
   4. Reporting side effects
10. How to store Aripiprazole Medical Valley
11. Contents of the packaging and other information
    1. What Aripiprazole Medical Valley contains
    2. What Aripiprazole Medical Valley looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    7. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Aripiprazole Medical Valley, 5 mg, tablets

Aripiprazole Medical Valley, 10 mg, tablets

Aripiprazole Medical Valley, 15 mg, tablets

Aripiprazole Medical Valley, 30 mg, tablets

Aripiprazole

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Aripiprazole Medical Valley and what is it 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 packaging and other information

1. What is Aripiprazole Medical Valley and what is it 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 and older who suffer from a disease characterized by symptoms such as: seeing, hearing, and feeling things that do not exist in reality, suspiciousness, beliefs that are inconsistent with reality, chaotic speech and behavior, and emotional numbness. Patients with these symptoms may feel sad, anxious, or tense, and may also have a sense of guilt.
Aripiprazole Medical Valley is used to treat adults and adolescents aged 13 and older whose disease is characterized by symptoms such as severe excitement, excessive energy, reduced need for sleep, very rapid speech, racing thoughts, and sometimes severe irritability. In adults, this medicine also prevents the recurrence of these symptoms in patients who have responded to treatment with Aripiprazole Medical Valley.

2. Important information before taking Aripiprazole Medical Valley

When not to take Aripiprazole Medical Valley

Warnings and precautions

Before starting to take Aripiprazole Medical Valley, discuss it with your doctor.
During treatment with aripiprazole, suicidal thoughts and behaviors have been reported. You should immediately inform your doctor if you experience thoughts or feelings related to self-harm.
Before starting to take Aripiprazole Medical Valley, tell your doctor if you have:

• high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and feeling of weakness) or a family history of diabetes
• seizures (epilepsy), as this may mean that your doctor will want to monitor you closely
• involuntary, irregular muscle movements, especially of the face
• heart or blood vessel disease, a family history of heart or blood vessel disease, stroke, or "mini" stroke, abnormal blood pressure
• blood clots or a history of blood clots, as the use of antipsychotic medicines is associated with the formation of blood clots
• a history of gambling addiction

If you notice an increase in weight, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor.
If an elderly patient has dementia (loss of memory and other mental abilities), they or their caregiver or relative should inform the doctor if the patient has ever had a stroke or "mini" stroke.
You should immediately inform your doctor if you experience thoughts or feelings related to self-harm. During treatment with aripiprazole, suicidal thoughts and behaviors have been reported.
You should immediately inform your doctor if you experience muscle stiffness or stiffness with high fever, sweating, mental disorders, or very rapid or irregular heartbeat.
If you or your family or caregiver notice that you are starting to feel the urge or desire to behave in an unusual way, and you cannot resist the impulse, drive, or temptation to engage in activities that may harm you or others, you should tell your doctor.
These phenomena are called impulse control disorders and may manifest as behaviors such as:

• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive
• uncontrolled excessive shopping or spending money
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger)
• urge to wander

Your doctor may consider changing the dose or discontinuing the medicine.
Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls.
Caution should be exercised, 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 and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those that are available without a prescription.
Blood pressure-lowering medicines: Aripiprazole Medical Valley may enhance the effects of blood pressure-lowering medicines. If you are taking blood pressure-lowering medicines, you should inform your doctor.
Taking Aripiprazole Medical Valley with other medicines may require a change in the dose of Aripiprazole Medical Valley. It is especially important to inform your doctor about the use of the following medicines:

• medicines used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide)
• antidepressant medicines 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)
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

Taking these medicines may increase the risk of side effects or reduce the effectiveness of Aripiprazole Medical Valley. If you experience any unusual symptoms while taking these medicines with Aripiprazole Medical Valley, you should tell your doctor.
Medicines that increase serotonin levels are usually used to treat depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat depression, generalized 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 to treat depression, OCD, panic, and anxiety
• other antidepressant medicines (such as venlafaxine and tryptophan) used to treat severe depression
• tricyclic medicines (such as clomipramine and amitriptyline) used to treat depression
• St. John's Wort (Hypericum perforatum) used as a herbal remedy for mild depression
• pain relievers (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 side effects; if you experience any unusual symptoms while taking any of these medicines with Aripiprazole Medical Valley, you should contact your doctor.

Aripiprazole Medical Valley with food, drink, and alcohol

This medicine can be taken with or without food.
You should avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, you should consult your doctor before taking this medicine.
In newborns whose mothers took Aripiprazole Medical Valley during the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice such symptoms in your baby, you should contact your doctor.
If you are taking Aripiprazole Medical Valley, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take the medicine and breastfeed. You should discuss with your doctor the best methods of feeding your baby if you are taking this medicine.

Driving and using machines

During treatment with this medicine, dizziness and vision disturbances may occur (see section 4). You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aripiprazole Medical Valley contains lactose

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Aripiprazole Medical Valley

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The recommended dose of Aripiprazole Medical Valley for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in children and adolescents

Aripiprazole treatment may be started with 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 a day. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.
If you feel that the effect of Aripiprazole Medical Valley is too strong or too weak, you should consult your doctor or pharmacist.

Aripiprazole Medical Valley tablets should be taken once a 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 washed down with water.
Even if you feel better,you should not change the dose or stop taking Aripiprazole Medical Valley without first discussing it with your doctor.
Aripiprazole Medical Valley 15 mg: The dividing line on the tablet is not intended for breaking the tablet.

Taking a higher dose of Aripiprazole Medical Valley than recommended

If you have taken more Aripiprazole Medical Valley than your doctor recommended (or if someone else has taken some of the medicine not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medicine packaging with you.
In patients who have taken too much aripiprazole, the following symptoms have occurred:

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

Other symptoms may include:

• severe confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, changes in blood pressure, and changes in heart rate, fainting (malignant neuroleptic syndrome)
• seizures

If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missing a dose of Aripiprazole Medical Valley

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

Stopping treatment with Aripiprazole Medical Valley

You should not stop treatment just because you feel better. It is very important to take Aripiprazole Medical Valley exactly as directed by your doctor and for the duration recommended by your doctor.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aripiprazole Medical Valley can cause side effects, although not everybody gets them.

Common side effects (may affect up to 1 in 10 people):

• diabetes
• sleep disturbances
• feeling anxious
• feeling restless and unable to sit or stand still
• akathisia (unpleasant feeling of inner restlessness and an irresistible urge to be in constant motion)
• uncontrolled trembling, jerking movements, or writhing movements
• trembling
• headaches
• fatigue
• drowsiness
• feeling of emptiness in the head
• blurred vision and double vision
• decreased bowel movements or difficulty passing stools
• nausea
• vomiting
• excessive salivation
• feeling tired

Uncommon side effects (may affect up to 1 in 100 people):

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

The following side effects have been reported after the marketing of aripiprazole tablets, but the frequency of their occurrence is not known:

• decreased white blood cell count
• decreased platelet count
• allergic reactions (e.g., swelling of the mouth, tongue, face, and throat, itching, hives)
• onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine), or diabetic coma
• high blood sugar levels
• low sodium levels in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• suicidal thoughts, attempted suicide, and completed suicide
• feeling aggressive
• agitation
• nervousness
• simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, changes in blood pressure, and changes in heart rate, fainting (malignant neuroleptic syndrome)
• seizures
• serotonin syndrome (a reaction that can cause feelings of great happiness, drowsiness, clumsiness, restlessness, especially motor restlessness, feeling of intoxication, fever, sweating)
• speech disorders
• fixation of the eyeballs in one position
• sudden unexplained death
• life-threatening irregular heartbeat
• heart attack (myocardial infarction)
• slow heartbeat
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the legs), which can travel through the bloodstream to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, you must immediately contact your doctor)
• high blood pressure
• fainting
• accidental choking on food with a risk of pneumonia
• spasm of the muscles around the vocal cords
• pancreatitis
• difficulty swallowing
• diarrhea
• abdominal discomfort
• stomach discomfort
• liver failure
• hepatitis
• jaundice
• abnormal liver test results
• skin rash
• sensitivity to light
• 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, and then a rash appears on other parts of the body, high fever, swollen lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia)
• abnormal breakdown of muscle leading to kidney dysfunction
• muscle pain
• stiffness
• involuntary urination (incontinence)
• difficulty urinating
• withdrawal syndrome in newborns in case of exposure to the medicine during pregnancy
• prolonged and/or painful erection
• difficulty regulating body temperature or overheating
• chest pain
• swelling of the hands, ankles, or feet
• in blood tests: increased or fluctuating blood sugar levels, increased glycated hemoglobin levels
• inability to resist the impulse, drive, or temptation to engage in activities that may harm you or others, including behaviors such as:
• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive
• uncontrolled excessive shopping or spending money
• uncontrolled overeating or compulsive eating (eating more food than usual and more than needed to satisfy hunger)
• urge to wander

If you experience such behaviors, you should tell your doctor, who will discuss with you ways to treat or reduce these symptoms.
In elderly patients with dementia taking aripiprazole, more deaths have been reported. Additionally, cases of stroke or "mini" stroke have been noted.

Additional side effects in children and adolescents

In adolescents aged 13 and older, side effects have occurred with a similar frequency and type as in adults, except for drowsiness, uncontrolled trembling or jerking movements, restlessness, and fatigue, which have occurred very frequently (may affect more than 1 in 10 patients), as well as upper abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, tremor, uncontrolled limb movements, and dizziness, especially when standing up from a lying or sitting position, which have occurred frequently (may affect up to 1 in 100 patients).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aripiprazole Medical Valley

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aripiprazole Medical Valley contains

• The active substance of the medicine 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.
• Other ingredients are: lactose monohydrate, cornstarch, microcrystalline cellulose, hydroxypropyl cellulose, magnesium stearate, red iron oxide (E 172).

What Aripiprazole Medical Valley looks like and contents of the pack

Aripiprazole Medical Valley, 5 mg, tablets: Round, flat tablets of light pink color.
Aripiprazole Medical Valley, 10 mg, tablets: Round, biconvex tablets of light pink color.
Aripiprazole Medical Valley, 15 mg, tablets: Round, biconvex tablets of light pink color with a dividing line on one side.
Aripiprazole Medical Valley, 30 mg, tablets: Round, biconvex tablets of light pink color.
The medicine is packaged in aluminum/aluminum blisters in cardboard boxes containing 14, 28, 49, 56, or 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

Denmark
Aripiprazole Medical Valley 5/10/15/30 mg tablets
France
Aripiprazole Almus 5/10/15 mg tablets
Netherlands
Aripiprazol Xiromed 5/10/15/30 mg tablets
Iceland
Aripiprazole Medical Valley
Norway
Aripiprazole Medical Valley
Poland
Aripiprazole Medical Valley
Sweden
Aripiprazole Medical Valley 5/10/15/30 mg tablets
United Kingdom
Aripiprazole 5/10/15/30 mg tablets

Date of last revision of the leaflet: