Aripiprazole Olpha 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aripiprazole Olpha 5 mg tablets EFG

Aripiprazole Olpha 10 mg tablets EFG

Aripiprazole Olpha 15 mg tablets EFG

Aripiprazole Olpha 30 mg tablets EFG

Read the entire 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, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

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

1. What Aripiprazole Olpha is and what it is used for

Aripiprazole Olpha 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 an illness characterized by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioral flatness. People in this condition may also feel depressed, guilty, restless, or tense.

Aripiprazole is used to treat adults and adolescents aged 13 years and older who have a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In adults, it also prevents recurrence of this condition in patients who have responded to treatment with Aripiprazole.

2. What you need to know before taking Aripiprazol Macleods

Do not take Aripiprazol Olpha:

• if you are allergic to aripiprazole or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting aripiprazole.

Cases of patients experiencing suicidal thoughts and behaviors have been reported during treatment with aripiprazole. Inform your doctor immediately if you have thoughts or feelings of harming yourself.

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

• high blood sugar levels (characterized by symptoms such as excessive thirst, increased urination, 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 problems), family history of cardiovascular disease, stroke or mini-stroke (transient ischemic attack), abnormal blood pressure, blood clots or family history of blood clots, as antipsychotics have been associated with blood clot formation;
• a history of gambling addiction.

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

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

Speak to your doctor immediately if you have thoughts or feelings of harming yourself. Cases of patients experiencing suicidal thoughts and behavior have been reported during treatment with aripiprazole.

Speak to your doctor immediately if you experience muscle stiffness or numbness with high fever, sweating, changes in mental state, or very rapid 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 that you cannot resist. This may include behaviors such as gambling addiction, excessive eating or spending, abnormally increased sex drive, or preoccupation with increased sexual thoughts and feelings. This is known as impulse control disorder.

Your doctor may consider adjusting or stopping your dose.

Aripiprazole may cause drowsiness, low blood pressure upon standing, dizziness, and changes in motor function and balance, which could lead to falls. Caution is advised, especially if you are an elderly patient or have some degree of physical weakness.

Children and adolescents

Do not use this medicine in children and adolescents under 13 years of age. It is not known whether it is safe and effective in these patients.

Other medicines and Aripiprazol Olpha

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Medicines that lower blood pressure: aripiprazole may enhance the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medication to control your blood pressure.

Taking aripiprazole with other medicines may mean that your doctor needs to adjust the dose of aripiprazole or of the other medicines. It is especially important to tell your doctor if you are taking:

• medicines to correct heart rhythm (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 used to treat fungal infections (such as ketoconazole, itraconazole);
• certain medicines used to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors like 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 effectiveness of aripiprazole. If you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

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

• triptans, tramadol, and tryptophan used for conditions such as depression, generalized anxiety disorder, OCD, social phobia, migraine, and pain;
• selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used for depression, OCD, panic, and anxiety;
• other antidepressants (such as venlafaxine and tryptophan) used in severe depression;
• tricyclic antidepressants (such as clomipramine and amitriptyline) used for depressive disorders;
• St. John's wort (Hypericum perforatum) used in herbal medicines for mild depression;
• analgesics (such as tramadol and pethidine) used for pain relief;
• triptans (such as sumatriptan and zolmitriptan) used to treat migraine.

These medicines may increase the risk of side effects; if you notice any unusual symptoms while taking any of these medicines together with aripiprazole, you must inform your doctor.

Taking Aripiprazol Olpha 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, breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

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

Driving and using machines

This medicine may cause dizziness and vision problems (see section 4). This should be taken into account when maximum attention is required, for example, when driving or operating machinery.

Aripiprazol Olpha contains lactose

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

3. How to take Aripiprazole Olpha

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

Use in children and adolescents

This medicine should be initiated with the oral solution (liquid) at a low dose. The dose may gradually be increased to the recommended dose for adolescents of 10 mg once daily. However, your doctor may prescribe lower or higher doses up to a maximum of 30 mg once daily.

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

Try to take Aripiprazole Olpha at the same time each day. It does not matter whether you take it with or without food. Always take the tablets with water and swallow them whole.

Even if you feel better, do not change or stop your daily dose of aripiprazole without first consulting your doctor.

If you take more Aripiprazole Olpha than you should

If you realize you have taken more aripiprazole tablets than prescribed by your doctor (or if someone else has taken some of your aripiprazole tablets), contact your doctor immediately. If you cannot reach 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 heartbeat, agitation/aggression, speech difficulties;
• 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, suffocation, high or low blood pressure, abnormal heart rhythms.

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

If you forget to take Aripiprazole Olpha

If you miss a dose, take the missed dose as soon as you remember. However, do not take a double dose to make up for the missed dose.

If you stop taking Aripiprazole Olpha

Do not stop your treatment just because you feel better. It is important that you continue taking aripiprazole for as long as your doctor has instructed.

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

4. Possible adverse effects

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

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

• diabetes mellitus,
• sleep problems,
• anxiety,
• akathisia (an uncomfortable feeling of inner restlessness and an urgent need to keep moving),
• uncontrollable twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• somnolence,
• dizziness,
• shakiness and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• feeling unwell,
• increased saliva production,
• vomiting,
• feeling tired.

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

• increased or decreased levels of the hormone prolactin in the blood,
• excessively high blood sugar levels,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of the mouth, tongue, and limbs (tardive dyskinesia),
• a muscular disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• ocular photosensitivity,
• rapid heartbeat,
• drop in blood pressure upon standing, causing dizziness, lightheadedness, or fainting,
• hiccups.

The following adverse effects have been reported during the post-marketing use of oral aripiprazole, but their frequency is unknown:

• low white blood cell count,

• low platelet count,

• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching, redness),

• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,

• elevated blood sugar,

• low sodium levels in blood,

• loss of appetite (anorexia),

• weight loss,

• weight gain,

• suicidal thoughts, suicide attempt, and suicide,

• aggression,

• agitation,

• nervousness,

• a 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 may cause intense feelings of well-being, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating, or muscle stiffness),

• speech disorder,

• fixed eye position (oculogyria),

• unexplained sudden death,

• potentially life-threatening irregular heartbeat,

• heart attack,

• slower heartbeat,

• blood clots in the veins, especially in the legs (symptoms include leg swelling, pain, and redness), which may travel through blood vessels to the lungs and cause chest pain and breathing difficulties (if you experience any of these symptoms, contact your doctor immediately),

• high blood pressure,

• fainting,

• accidental inhalation of food with risk of pneumonia (lung infection),

• pancreatitis,

• difficulty swallowing,

• diarrhoea,

• abdominal discomfort,

• stomach upset,

• liver failure,

• liver inflammation,

• yellowing of the skin and whites of the eyes (jaundice),

• abnormal liver function test results,

• rash,

• skin photosensitivity,

• hair loss,

• excessive sweating,

• severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). DRESS syndrome initially presents as flu-like symptoms with facial rash, followed by generalized rash, high fever, swollen lymph nodes, increased liver enzyme concentrations in blood tests, and increased levels of a type of white blood cell (eosinophilia),

• abnormal muscle breakdown that may lead to 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 core body temperature or overheating,

• chest pain,

• swollen hands, ankles, or feet,

• in blood tests: fluctuations in blood sugar levels, increased glycated haemoglobin,

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

• strong urge to gamble excessively despite serious personal or family consequences;

• altered or increased sexual interest and behaviour that is concerning to you or others, for example, increased sex drive;

• uncontrollable excessive shopping;

• binge eating (consuming large amounts of food in a short period of time) 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 behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, an increased number of fatal cases have been reported while taking aripiprazole. In addition, cases of stroke or "mini" stroke have been reported.

Other adverse effects in children and adolescents

Adolescents aged 13 years and older experienced adverse effects similar in frequency and type to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affect more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle fasciculations, involuntary limb movements, and dizziness—especially when standing up from lying or sitting down—which were common (affect up to 1 in 10 patients).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aripiprazole Olpha

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

Do not use this medicine after the expiry date stated on the blister or container, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials, including packaging, should be handed in at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole Olpha

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

Appearance of the product and contents of the pack

Aripiprazole Olpha 5 mg tablets are uncoated, rectangular, blue tablets, marked with “CL 73” on one side and smooth on the other side.

Aripiprazole Olpha 10 mg tablets are uncoated, rectangular, pink tablets, marked with “CL 74” on one side and smooth on the other side.

Aripiprazole Olpha 15 mg tablets are uncoated, round, yellow tablets, marked with “CL 75” on one side and smooth on the other side.

Aripiprazole Olpha 30 mg tablets are uncoated, round, pink tablets, marked with “CL 78” on one side and smooth on the other side.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Olpha AS,

Rupnicu iela 5,

Olaine, Olaines novads, LV-2114,

Latvia

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

Date of the most recent review of this leaflet:

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/