Aripiprazole Ratiopharm 5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Aripiprazole ratiopharm 5 mg tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it may 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 ratiopharm is and what it is used for
2. What you need to know before taking Aripiprazole ratiopharm
3. How to take Aripiprazole ratiopharm
4. Possible side effects
5. How to store Aripiprazole ratiopharm
6. Contents of the pack and other information

1. What Aripiprazol ratiopharm is and what it is used for

Aripiprazol ratiopharm contains the active substance aripiprazol 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 characterised by symptoms such as hearing, seeing, or feeling things that do not exist, mistrust, false beliefs, incoherent speech, and emotional and behavioural flatness. People in this state may also feel depressed, guilty, restless, or tense.

Aripiprazol ratiopharm is used to treat adults and adolescents aged 13 years and older who have a disorder characterised 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 Aripiprazol ratiopharm.

2. What you need to know before taking Aripiprazole ratiopharm

Do not take Aripiprazole ratiopharm

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

Warnings and precautions

Talk to your doctor before starting aripiprazole.

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

Contact your doctor immediately if you notice muscle stiffness or numbness accompanied by high fever, sweating, altered mental state, or very rapid or irregular heartbeat.

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 wish to monitor you more closely
• Irregular and involuntary muscle movements, especially of the face
• Cardiovascular diseases (heart and circulation conditions), family history of cardiovascular disease, stroke or "mini" stroke, or abnormal blood pressure
• Blood clots or a 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, having difficulty swallowing, or showing 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.

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

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 should be taken, especially if you are elderly or have any 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...

Taking Aripiprazole ratiopharm with other medicines

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

Medicines that lower blood pressure: Aripiprazole may increase the effect of medicines used to lower blood pressure. Make sure to inform your doctor if you are taking any medicine to control your blood pressure. Taking aripiprazole with other medicines may mean your doctor needs to adjust the dose of aripiprazole or of other medicines. It is especially important to tell your doctor if you are taking:

• Medicines to regulate heart rhythm (such as quinidine, amiodarone, flecainide)
• Antidepressants or herbal remedies used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John’s wort)
• Antifungals (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, primidone)
• Certain antibiotics used to treat tuberculosis (rifabutin, rifampicin)

These medicines may increase the risk of adverse effects or reduce the effect 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 to treat conditions including depression, generalized anxiety disorder, obsessive-compulsive 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 in depressive disorders;
• St. John’s wort (Hypericum perforatum) used in herbal 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 notice any unusual symptoms when taking any of these medicines together with Aripiprazole ratiopharm, you must inform your doctor.

Taking Aripiprazole ratiopharm 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, think you may be pregnant, or are planning 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

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

Aripiprazole ratiopharm contains lactose and sodium

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

This medicine contains less than 23 mg (1 mmol) of sodium per tablet and is therefore considered essentially "sodium-free".

3. How to take Aripiprazole ratiopharm

Follow exactly the instructions for use of 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

Aripiprazole should be initiated with the oral solution (liquid) at a low dose. The dose may then be gradually 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 feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Aripiprazole ratiopharm is for oral use.

Try to take the Aripiprazole ratiopharm tablet 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 the daily dose of Aripiprazole ratiopharm without first consulting your doctor.

If you take more Aripiprazole ratiopharm than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91.562.04.20, indicating the medicine and the amount ingested.

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

• rapid heartbeat, agitation/aggression, speech 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, slowed 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 ratiopharm

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

If you stop taking Aripiprazole ratiopharm

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 will experience them.

Frequent adverse effects (may affect up to 1 in 10 patients):

• diabetes mellitus,
• sleep disturbances,
• anxiety,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (a distressing inner restlessness and an urgent need to keep moving),
• uncontrollable twisting, writhing, or spasmodic movements,
• tremor,
• headache,
• fatigue,
• somnolence,
• dizziness,
• shakiness and blurred vision,
• difficulty passing stools or reduced frequency of bowel movements (constipation),
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of tiredness

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

• 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 post-marketing use of aripiprazole, but their frequency is unknown (cannot be estimated from available data):

• low white blood cell count,
• low platelet count,
• allergic reaction (e.g., swelling of the mouth, tongue, face, and throat, itching and redness),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine), or coma,
• low levels of sodium in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt, and suicide,
• aggression,
• agitation,
• nervousness,
• neuroleptic malignant syndrome (a combination of fever, muscle rigidity, rapid breathing, sweating, decreased level of consciousness, sudden changes in blood pressure and heart rate, and fainting),
• 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,
• 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 notice any of these symptoms, contact your doctor immediately),
• elevated blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• muscle spasms around the glottis (a part of the larynx),
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach upset,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• abnormal liver function test results,
• rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents as flu-like symptoms with a facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme levels 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 exposed 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: increased or fluctuating blood sugar levels, increased glycated hemoglobin,
• inability to resist the impulse, instinct, or temptation to carry out an action that may be harmful to yourself or others, which may include:
  • a strong urge to gamble excessively despite serious personal or family consequences;
  • altered or increased sexual interest and behavior that is concerning to you or others, for example, increased sexual 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 behaviors; 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 type and frequency to those in adults, except for somnolence, spasms or uncontrollable contractions, restlessness, and fatigue, which were very common (affects 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 after lying down or sitting—which were common (affects more than 1 in 100 patients).

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects 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 ratiopharm

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 packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aripiprazole ratiopharm

The active substance is aripiprazole. Each tablet contains 5 mg of aripiprazole.
The other components are monohydrate lactose, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, sodium croscarmellose, yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Aripiprazole ratiopharm 5 mg tablets are light yellow, round, flat, with bevelled edges, engraved with "5" on one side and smooth on the other.

Available in OPA-Aluminium-PVC/Aluminium blisters packed in cartons containing 10, 14, 28, 30, 49, 56 or 98 tablets.

Also available in unit dose OPA-Aluminium-PVC/Aluminium blisters packed in cartons containing 28 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder

Teva Pharma, S.L.U
Anabel Segura 11. Edificio Albatros B, 1st floor.
28108 Alcobendas. Madrid.
Spain

Manufacturer

Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren.
Germany

or

PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd)
Prilaz baruna Filipovica 25, Zagreb
10000 Zagreb
Croatia

or

Teva Operations Poland Sp.z.o.o.
Ul. Mogilska 80
31-546 Krakow
Poland

or

Actavis Ltd,
BLB 015-016, Bulebel Industrial Estate,
Zejtun, ZTN3000
Malta

or

Pharmapath S.A.
28is Oktovriou 1
Agia, Varvara, 123 51
Greece

This medicinal product is authorized in Member States under the following names:

Date of the most recent review of this leaflet: June 2024

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