Leaflet: information for the user

Aripiprazol Macleods 5 mg tablets EFG

Aripiprazol Macleods 10 mg tablets EFG

Aripiprazol Macleods 15 mg tablets EFG

Aripiprazol Macleods 30 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAripiprazol Macleodsand what it is used for

2. What you need to know before starting to takeAripiprazol Macleods

3. How to takeAripiprazol Macleods

4. Possible side effects

5. Storage ofAripiprazol Macleods

6. Contents of the pack and additional informationl

Aripiprazol Macleods contains the active ingredient aripiprazol and belongs to a group of medicines called antipsychotics.

It is used to treat adults and adolescents of 15 years or more who suffer from a condition characterised by symptoms such as hearing, seeing and feeling things that do not exist, distrust, false beliefs, incoherent speech and monotony of emotional and behavioural state. People in this state may also feel depressed, guilty, restless or tense.

Aripiprazol is used to treat adults and adolescents of 13 years or more who suffer from a disorder characterised by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking very quickly with flight of ideas and sometimes, severe irritability. In adults, it also prevents this situation in patients who have responded to treatment with Aripiprazol.

Do not take Aripiprazol Macleods:

-if you are allergic to aripiprazol or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take aripiprazol.

Cases of patients experiencing thoughts and behaviors of self-harm have been reported during treatment with aripiprazol. Inform your doctor immediately if you have thoughts or feelings of self-harm.

Before starting treatment with aripiprazol, tell your doctor if you have:

• high levels of sugar in the blood (characterized by symptoms such as excessive thirst, increased urine production, increased appetite, and feeling weak) or a family history of diabetes
• seizures, as your doctor may want to monitor you more closely;
• irregular and involuntary muscle movements, especially in the face
• cardiovascular diseases (heart and circulation diseases), family history of cardiovascular disease, stroke or mini-stroke, abnormal blood pressurecoagulation disorders or family history of coagulation disorders, as antipsychotics have been associated with the formation of blood clots
• history of addiction to gambling.

If you notice that you are gaining weight, developing unusual movements, experiencing drowsiness that interferes with your normal daily activities, having difficulty swallowing, or experiencing allergic symptoms, please inform your doctor.

If you have dementia (loss of memory and other mental abilities),you or the person caring for you or a family member should inform your doctor if you have ever had a stroke or "mini" stroke.

Talk to your doctor immediately if you have thoughts or feelings of self-harm. Cases of patients experiencing thoughts and behaviors of self-harm have been reported during treatment with aripiprazol.

Talk to your doctor immediately if you notice numbness or stiffness of the muscles with high fever, sweating, altered mental state, or very fast or irregular heartbeat.

Inform your doctor if you, your family, or caregiver notice that you are developing impulses or urges to behave in an unusual way in you and that you cannot resist the impulse, instinct, or temptation to carry out certain activities that may harm you or others. This is called impulse control disorder and may include behaviors such as addiction to gambling, excessive intake or spending, abnormally high sex drive, or excessive concern about an increase in sexual thoughts and feelings.

Your doctor may consider adjusting or interrupting the dose.

Aripiprazol may cause drowsiness, low blood pressure when standing up, dizziness, and changes in the ability to move and maintain balance, which could cause falls. Caution should be exercised, especially if you are an elderly patient or have weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years old. Its safety and effectiveness in these patients are unknown.

Other medicines and Aripiprazol Macleods

Inform your doctor or pharmacist if you are taking,have takenrecentlyor may have to take any other medicine, including over-the-counter medicines.

Medicines that lower blood pressure: aripiprazol may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you use any medicine to control blood pressure.

If you are taking aripiprazol with any other medicine, it may mean that your doctor needs to change your dose of aripiprazol or the dose of the other medicinesIt is especially important to mention to your doctor if you are taking:

• medicines to correct heart rhythm(such as quinidine, amiodarone, flecainide);
• antidepressants or plant-based medicines used to treat depression and anxiety(such as fluoxetine, paroxetine, venlafaxine, St. John's Wort);
• medicines to treat fungal infections (antifungals) (such as ketoconazole, itraconazole);
• certain medicines to treat HIV infection(such as efavirenz, nevirapine, and protease inhibitors such as, for example, 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 adverse effects or reduce the effect of aripiprazol; if you observe any unusual symptoms when taking any of these medicines at the same time as aripiprazol, you should inform your doctor.

Medicines that increase serotonin levels are generally used to treat diseases that include depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain:

• triptans, tramadol, and tryptophan used to treat diseases such as depression, generalized anxiety 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 antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used in depressive diseases;
• St. John's Wort (Hypericum perforatum) used in plant-based medicines for mild depression;
• analgesics (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 you observe any unusual symptoms when taking any of these medicines at the same time as aripiprazol, you should inform your doctor.

Taking Aripiprazol Macleods with food, drinks, and alcohol

This medicine can be taken regardless of meals.

Alcohol consumption should be avoided.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medicine.

The following symptoms may occur in newborn babies, from mothers who have been treated witharipiprazolin the last trimester of pregnancy (last three months of your pregnancy): tremors, stiffness, and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby develops any of these symptoms, contact your doctor.

If you are takingaripiprazol, your doctor will discuss with you whether you should breastfeed your baby, considering the benefit of your treatment and the benefit of breastfeeding for your baby. If you are being treated witharipiprazol, do not breastfeed. Talk to your doctor about the best way to feed your baby if you are taking this medicine.

Driving and operating machinery

During treatment with this medicine, dizziness and vision problems (see section 4) may occur. This should be taken into account when requiring maximum attention, for example, when driving or operating machinery.

Aripiprazol Macleods contains lactose

If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for adults is 15 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

Use in children and adolescentsand adolescents

This medication should be started with the oral solution (liquid) at a low dose. Gradually the dose may be increased tothe recommended dose for adolescents of 10 mg once a day. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once a day.

If you estimate that the action of aripiprazole is too strong or weak, inform your doctor or pharmacist.

Try to take Aripiprazol Macleods at the same time every day. It does not matter if you take it with or without food. Take the tablets with water and swallow them whole.

Even if you feel better, do not alter or interrupt the daily dose of aripiprazole without consulting your doctor first.

If you take more Aripiprazol Macleods than you should

If you realize that you have taken more aripiprazole tablets than your doctor has recommended (or if someone else has taken some of your aripiprazole tablets), contact your doctor immediately. If you cannot communicate with your doctor, go to the nearest hospital and bring the packaging with you.

Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeats, agitation/aggression, language problems;
• unusual movements (especially of the face or tongue) and decreased level of consciousness.

Other symptoms may include:

• acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating;
• muscle rigidity and drowsiness, slower breathing, choking, high or low blood pressure, abnormal heart rhythms.

Contact your doctor or nearest hospital immediately if you experience any of the above symptoms.

If you forget to take Aripiprazol Macleods

If you forget a dose, take the missed dose as soon as you remember butdo not take a double dose to compensate for the missed dose.

If you interrupt treatment with Aripiprazol Macleods

Do not stop treatment just because you feel better. It is essential that you continue taking aripiprazole for the time your doctor has indicated.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

• diabetes mellitus,
• sleep problems,
• anxiety,
• akathisia (an uncomfortable feeling of internal restlessness and an overwhelming need to move constantly),
• involuntary movements of twisting, contorting, or spasmodic movements
• shaking,
• headache,
• fatigue,
• drowsiness,
• dizziness,
• shivering and blurred vision,
• decreased number or difficulty urinating
• indigestion
• sensation of illness,
• increased saliva production,
• vomiting,
• sensation of fatigue.

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

• increased or decreased levels of prolactin hormone in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sex drive,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light
• rapid heartbeat,
• low blood pressure when standing, causing dizziness, confusion, or fainting
• hypotension.

The following side effects have been reported during the marketing of oral aripiprazole, but the frequency of occurrence is unknown:

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling in the mouth, tongue, face, and throat, itching, redness),
• appearance or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma,
• high blood sugar,
• insufficient sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain
• thoughts of suicide, attempted suicide, and suicide,
• aggression,
• agitation,
• anxiety,
• combination of fever, muscle rigidity, rapid breathing, sweating, decreased consciousness, sudden changes in blood pressure and heart rate, and fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of intense happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),
• speech disorder,
• fixation of the eyeballs in a position
• sudden and unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slower heart rate,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can travel through the blood vessels to the lungs, causing chest pain and difficulty breathing (if you notice any of these symptoms, seek immediate medical attention),
• high blood pressure,
• fainting,
• accidental inhalation of food with a risk of pneumonia (lung infection),
• pancreatitis inflammation,
• difficulty swallowing
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver
• yellowing of the skin and the white part of the eyes,
• abnormal liver test results,
• hives,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions, such as drug-induced eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially appears as pseudogripal symptoms with facial rash and later with generalized rash, high temperature, enlarged lymph nodes, elevated liver enzyme levels observed in blood tests, and increased eosinophil count,
• abnormal muscle degradation that can cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns due to exposure to medication during pregnancy,
• prolonged and/or painful erection;
• difficulty controlling central body temperature or overheating,
• chest pain
• swollen hands, ankles, or feet;
• in blood tests: fluctuations in blood sugar levels, increased hemoglobin A1c

• inability to resist the impulse, instinct, or temptation to perform an action that may be harmful to you or others, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences;
• altered or increased sex drive and concerning behavior for you or others, for example, increased sex drive;
• uncontrollable excessive buying;
• binge eating (eating large amounts of food in a short period) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);
• tendency to wander.

Inform your doctor if you experience any of these behaviors; he will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been reported a higher number of fatal cases while taking aripiprazole. Additionally, cases of stroke or "mini" stroke have been reported.

Other side effects in children and adolescents

Adolescents aged 13 years or older experienced side effects similar in frequency and type to those of adults, except for drowsiness, involuntary spasms or contractions, restlessness, and fatigue, which were very frequent (affects more than 1 in 10 patients) and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary movements of the limbs, and dizziness, especially when getting up after lying down or sitting, which were frequent (affects up to 1 in 10 patients).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directlythrough the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister or on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or in the trash.Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, please ask your pharmacist how to dispose of the packaging and medications you no longerneed.By doing so, you will help protect the environment.

Aripiprazol Macleods Composition

• The active ingredient is aripiprazol. Each tablet contains 5 mg, 10 mg, 15 mg or 30 mg of aripiprazol.
• The other components are lactose monohydrate, microcrystalline cellulose (PH-101), cornstarch, FD & C Blue No. 2 [forAripiprazol Macleods 5 mg tablets EFG],red iron oxide (E-172) [forAripiprazol Macleods 10 mg and 30 mg tablets EFG],yellow iron oxide (E-172)[for Aripiprazol Macleods 15 mg tablets EFG],low-substituted hydroxypropyl cellulose (LH-21),magnesium stearate.

Appearance of the product and contents of the package

Aripiprazol Macleods 5 mg tablets are non-coated, rectangular, blue tablets, engraved with “CL 73” on one face and smooth on the other face.

Aripiprazol Macleods 10 mg tablets are non-coated, rectangular, pink tablets, engraved with “CL 74” on one face and smooth on the other face.

Aripiprazol Macleods 15 mg tablets are non-coated, round, yellow tablets, engraved with “CL 75” on one face and smooth on the other face.

Aripiprazol Macleods 30 mg tablets are non-coated, round, pink tablets, engraved with “CL 78” on one face and smooth on the other face.

They are presented in a cold-form blister pack (Alu-Alu) containing 14, 28, 49, 56 or 98 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Macleods Pharma España S.L.U.

World Trade Center Barcelona

Moll de Barcelona, s/n,

08039 Barcelona, Spain

Responsible Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

Synoptis Industrial Sp. z o.o.

ul. Rabowicka 15

62-020 Swarzedz

Poland

Local Representative:

UXAfarma, S.A.

Last review date of this leaflet:January 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/