Aciprex

Leaflet accompanying the packaging: patient information

Aciprex, 10 mg, film-coated tablets

Escitalopram

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aciprex and what is it used for

Aciprex contains escitalopram and is used to treat depression (major depressive episodes), anxiety disorders (such as panic attacks with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder). Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines affect the functioning of the serotonin system in the brain, increasing serotonin levels. Disrupted serotonin system function is considered a significant factor in the development of depression and related disorders. It may take several weeks of treatment before improvement begins. You should continue taking Aciprex, even if it takes some time to improve your condition. If there is no improvement or if you feel worse, you should consult your doctor.

2. Important information before taking Aciprex

When not to take Aciprex

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other medicines belonging to the group of monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), or linezolid (an antibiotic).
• if you have congenital heart rhythm disorders or have had them in the past (detected in an ECG - a test used to evaluate heart function).
• if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "Aciprex and other medicines").

Warnings and precautions

Before starting treatment with Aciprex, you should discuss it with your doctor. You should tell your doctor about other complaints or diseases you have, as they may need to be taken into account. In particular, you should inform your doctor:

• if you have epilepsy. If you experience seizures for the first time or if their frequency increases, you should stop taking Aciprex (see also section 4 "Possible side effects").
• if you have liver or kidney function disorders. Your doctor may need to adjust the dosage.
• if you have diabetes. Taking Aciprex may affect blood glucose control. Your doctor may need to adjust the dosage of insulin and/or oral antidiabetic medicines.
• if you have low sodium levels in your blood.
• if you have an increased tendency to bleeding or bruising.
• if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").
• if you are undergoing electroconvulsive therapy.
• if you have coronary heart disease.
• if you have or have had heart problems or have recently had a heart attack.
• if you have a low resting heart rate and/or know that you may have a salt deficiency due to prolonged severe diarrhea and vomiting or the use of diuretics (medicines that increase urine production).
• if you experience rapid or irregular heartbeat, weakness, fainting, or dizziness when standing up, which may indicate abnormal heart function.
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure inside the eyeball).

Caution

As with other medicines used to treat depression or similar diseases, improvement in the patient's condition does not occur immediately after starting treatment. Improvement in well-being may only occur after several weeks of taking Aciprex. In the case of panic attacks, improvement usually occurs after 2-4 weeks of treatment. During the initial period of therapy, some patients may experience increased anxiety, which will subside if treatment is continued. Therefore, you should strictly follow your doctor's recommendations and not stop taking the medicine or change the dosage without prior consultation with your doctor.

Suicidal thoughts and worsening of depression or anxiety symptoms

Depression and/or anxiety disorders can be accompanied bythoughts related toself-harm orsuicidal thoughts. These symptoms may worsen during the initial phase of therapy with antidepressant medicines, as these medicines usually start working only after about two weeks. This period can sometimes be longer.Those more likely to experience such symptoms are:people who have had suicidal thoughts or self-harm thoughts before.Adult patients at a young age. Information obtained during clinical trials indicates an increased risk of suicidal behavior in adult patients under 25 years of age with mental disorders treated with antidepressant medicines.If you experience thoughts of self-harm or suicidal thoughts,you should contact your doctor immediatelyor go to the hospital.It may be helpful for the patient to inform their relatives or friends that they are suffering from depression or anxiety disorders and ask them to read this leaflet. The patient may ask these people to tell them if they notice any worsening of depression or anxiety symptoms or any disturbing changes in behavior.In some patients with manic-depressive disorder, a manic phase may occur.This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. In such cases, you should definitely consult your doctor.During the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms occur, you should contact your doctor immediately.Patient may not be aware of the above symptoms. Therefore, it may be helpful to ask a friend or family member to pay attention to any changes in behavior.In case of disturbing thoughts or experiences and in case of any of the above symptoms, you should contact your doctor immediately or go to the nearest hospital.Medicines such as Aciprex (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Children and adolescents

Aciprex should not normally be used in children and adolescents under 18 years of age. It should be remembered that in the case of taking medicines from this group, patients under 18 years of age are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and anger). Nevertheless, the doctor may prescribe Aciprex to patients of this age group if they consider it necessary. If the doctor has prescribed Aciprex to a patient in this age group and you have doubts about it, you should consult your doctor again. You should also contact your doctor if the above symptoms occur or worsen in patients under 18 years of age taking Aciprex. So far, there is no data on the long-term safety of using Aciprex in this age group in terms of growth, maturation, cognitive and behavioral development.

Aciprex and other medicines

You should 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. You should inform your doctor or pharmacist about taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs), including phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you are taking any of these, you should wait 14 days before starting Aciprex. After discontinuing Aciprex, you should wait 7 days before starting any of these medicines.
• Reversible inhibitors of monoamine oxidase A (RIMAs), including moclobemide (used to treat depression).
• Irreversible inhibitors of monoamine oxidase B (MAO-B), including selegiline (used to treat Parkinson's disease). These medicines increase the risk of adverse reactions.
• Linezolid (an antibiotic).
• Lithium (used to treat manic-depressive disorders) and tryptophan.
• Imipramine and desipramine (antidepressant medicines).
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used to treat severe pain). These medicines increase the risk of adverse reactions.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant medicine), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the levels of Aciprex in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal remedy with antidepressant properties.
• Acetylsalicylic acid and non-steroidal anti-inflammatory medicines (used as painkillers and to thin the blood, so-called anticoagulant medicines). These medicines may increase the tendency to bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines with anticoagulant properties). At the beginning and after discontinuation of Aciprex, your doctor will check your blood clotting time to ensure that the dosage of the anticoagulant medicine is still appropriate.
• Mefloquine (an antimalarial medicine), bupropion (an antidepressant medicine), and tramadol (a medicine used to treat severe pain) due to the risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia and psychosis) due to the risk of lowering the seizure threshold and antidepressant medicines.
• Flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressant medicines), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). In the case of taking these medicines, it may be necessary to modify the dosage of Aciprex.
• Medicines that lower potassium or magnesium levels in the blood increase the risk of life-threatening heart rhythm disorders.

You should not take Aciprex if you are taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines - especially halofantrine), and certain antihistamine medicines (astemizole, mizolastine). If you have any further doubts about this, you should consult your doctor.

Taking Aciprex with food, drink, and alcohol

Aciprex can be taken with or without food (see section 3 "How to take Aciprex"). Interactions (interactions) of Aciprex with alcohol are not expected. Nevertheless, as with many other medicines, it is not recommended to drink alcohol during treatment with Aciprex.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Pregnancy Women should not take Aciprex during pregnancy unless they have discussed the risks and benefits with their doctor. The patient should be aware that taking Aciprex in the last three months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, bluish discoloration of the skin, seizures, fluctuations in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or weakness, increased reflexes, trembling, tremors, nervousness, drowsiness, or difficulty sleeping. If the newborn experiences any of these symptoms, you should immediately consult a doctor. You should ensure that the midwife and/or doctor know that you are taking Aciprex. The use of medicines such as Aciprex during pregnancy, especially in the last three months, may increase the risk of a serious condition in the child, known as persistent pulmonary hypertension in newborns (PPHN), which is characterized by rapid breathing and bluish discoloration of the skin. These symptoms usually occur within the first 24 hours after birth. If the newborn experiences any of these symptoms, you should immediately inform the midwife and/or doctor. You should not stop taking Aciprex abruptly during pregnancy. Taking Aciprex at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if you have a history of bleeding disorders. If you are taking Aciprex, you should inform your doctor or midwife so that they can provide you with appropriate advice. Breastfeeding You should not take Aciprex during breastfeeding unless you have discussed the risks and benefits with your doctor. It is assumed that escitalopram passes into breast milk. Fertility In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, lowers sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.

Driving and using machines

You should not drive vehicles or operate machines until you have determined how Aciprex affects you. The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, which means that the medicine is considered "sodium-free".

3. How to take Aciprex

This medicine should always be taken as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist. Adults DepressionThe recommended dose of Aciprex is 10 mg once daily. Your doctor may increase the dose to a maximum of 20 mg daily. Panic disorder (panic attacks)The initial dose of Aciprex is 5 mg once daily for the first week of treatment. The dose is then increased to 10 mg daily. Your doctor may recommend further increasing the dose to a maximum of 20 mg daily. Social anxiety disorderThe recommended dose of Aciprex is 10 mg once daily. Depending on the patient's response to treatment, the doctor may reduce the dose to 5 mg daily or increase it to a maximum of 20 mg daily. Generalized anxiety disorderThe recommended dose of Aciprex is 10 mg, taken as a single dose daily. The dose may be increased by the doctor to a maximum of 20 mg daily. Obsessive-compulsive disorderThe recommended dose of Aciprex is 10 mg once daily. The doctor may increase the dose to a maximum of 20 mg daily. Elderly patients (over 65 years) The recommended initial dose of Aciprex is 5 mg once daily. The doctor may increase the dose to 10 mg daily. Use in children and adolescents Aciprex should not normally be used in children and adolescents. Additional information - see section 2 "Children and adolescents (under 18 years of age)". Renal impairment Caution should be exercised in patients with severe renal impairment. The medicine should be taken as directed by the doctor. Hepatic impairment Patients with hepatic impairment should not exceed a dose of 10 mg daily. The medicine should be taken as directed by the doctor. Patients who are slow metabolizers of medicines via the CYP2C19 isoenzyme Patients with this known genotype should not exceed a dose of 10 mg daily. The medicine should be taken as directed by the doctor.

How to take Aciprex

Aciprex can be taken with or without food (see section 3 "How to take Aciprex"). The tablet should be swallowed with water. Do not chew the tablet, as it tastes bitter. If necessary, the tablet can be broken in half. To do this, place the tablet on a flat surface with the scored side facing up. Then, you can break the tablet by pressing down on both ends with your index fingers.

Duration of treatment

Improvement may only occur after several weeks of treatment. Therefore, you should take Aciprex, even if you do not feel better at first. Do not change the dose of the medicine without prior consultation with your doctor. Aciprex should be taken for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is recommended to continue treatment for at least 6 months after improvement occurs.

Taking a higher dose of Aciprex than recommended

If you take a higher dose of Aciprex than recommended, you should immediately consult your doctor or go to the emergency room of the nearest hospital. This is necessary even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte imbalance. When consulting a doctor or going to the hospital, you should take the packaging of Aciprex with you.

Missing a dose of Aciprex

You should not take a double dose to make up for a missed dose. If you miss a dose and remember before going to bed, you should take the missed dose immediately. The next day, you should continue taking the medicine as scheduled. If you remember that you missed a dose only at night or the next day, you should not take the missed dose, but take the next dose at the usual time.

Stopping treatment with Aciprex

You should not stop taking Aciprex unless your doctor recommends it. If you plan to stop treatment, you should gradually reduce the dose of Aciprex over a period of several weeks. After discontinuing Aciprex, especially if treatment is stopped abruptly, withdrawal symptoms may occur. These symptoms are often observed after discontinuing Aciprex. The risk is higher in the case of long-term use of the medicine, taking high doses, or rapid dose reduction. In most patients, the symptoms are mild and resolve on their own within two weeks. In some patients, withdrawal symptoms may be severe or persist for a longer period (2-3 months or even longer). If you experience severe withdrawal symptoms after stopping Aciprex, you should consult your doctor. The doctor may recommend resuming treatment with the medicine and then gradually discontinuing it. Withdrawal symptoms include dizziness (balance problems), tingling and burning sensations, and (less commonly) a sensation of electric shock, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headaches, nausea, excessive sweating (including night sweats), restlessness or agitation, tremors, confusion or disorientation, mood swings or irritability, diarrhea, vision disturbances, or palpitations (heart pounding). If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Aciprex can cause side effects, although not everybody gets them. Side effects usually subside after a few weeks of treatment. You should remember that many of the observed symptoms may be symptoms of the treated disease and will subside as your condition improves.

If you experience any of the following side effects during treatment, you should consult your doctor:

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

• abnormal bleeding, including gastrointestinal bleeding.

Rare(may affect up to 1 in 1,000 people):

• swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (allergic reaction) - you should immediately consult your doctor or go to the emergency room of the nearest hospital.
• high fever, agitation, confusion, tremors, and sudden muscle contractions may be symptoms of a rare disorder called serotonin syndrome.

Frequency not known(cannot be estimated from the available data):

• urination difficulties;
• seizures (convulsions) - see also section 2 "Warnings and precautions";
• yellowing of the skin and whites of the eyes (symptoms of liver function disorders and/or hepatitis);
• rapid or irregular heartbeat, fainting - these may be symptoms of a life-threatening condition known as torsades de pointes;
• suicidal thoughts and behaviors (such cases have been reported during treatment with escitalopram and shortly after discontinuation of treatment, see also section 2 "Warnings and precautions");
• sudden swelling of the skin or mucous membranes (angioedema)

The following side effects have also been reported:

Very common(may affect more than 1 in 10 people):

• nausea
• headaches

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

• nasal congestion or cold (sinusitis);
• increased or decreased appetite;
• anxiety, restlessness (especially motor), unusual dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors;
• diarrhea, constipation, vomiting, dry mouth;
• excessive sweating;
• joint or muscle pain;
• sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, difficulty achieving orgasm in women);
• fatigue, fever;
• weight gain.

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

• hives, skin rash, itching;
• teeth grinding, agitation, nervousness, panic attacks, disorientation;
• sleep disturbances, taste disorders, fainting;
• pupil dilation, vision disturbances, tinnitus;
• hair loss;
• heavy menstrual bleeding;
• irregular menstrual periods;
• weight loss;
• rapid heartbeat;
• swelling of the hands and feet;
• nosebleeds.

Rare(may affect up to 1 in 1,000 people):

• aggression, depersonalization (feeling of loss of identity), hallucinations;
• slow heartbeat;

Frequency not known(frequency cannot be estimated from the available data):

• decreased sodium levels in the blood (causing symptoms such as nausea, malaise, muscle weakness, or disorientation);
• dizziness when standing up quickly due to low blood pressure (orthostatic hypotension);
• abnormal liver function test results (increased liver enzyme activity in the blood);
• movement disorders (involuntary muscle movements);
• prolonged and painful erections (priapism);
• bleeding disorders, including bleeding in the skin and mucous membranes (ecchymoses) and low platelet count (thrombocytopenia);
• increased antidiuretic hormone (ADH) secretion, causing water retention in the body, dilutional hyponatremia;
• milk secretion in men and in women who are not breastfeeding;
• mania;
• increased risk of fractures, as observed in patients taking this type of medicine (selective serotonin reuptake inhibitors or tricyclic antidepressant medicines);
• changes in heart rhythm (so-called "QT interval prolongation", observed in an ECG - a record of the electrical activity of the heart).
• Severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection Pregnancy, breastfeeding, and fertility, in section 2.

The following side effects are also known to occur with medicines with a similar mechanism of action to escitalopram (the active substance of Aciprex), such as:

• restlessness (akathisia);
• loss of appetite.

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 Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 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 gather more information on the safety of this medicine.

5. How to store Aciprex

The medicine should be stored out of the sight and reach of children. There are no special storage requirements. Do not take this medicine after the expiry date stated on the blister pack and carton after the words "Expiry date:". The expiry date refers to the last day of the month. 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 Aciprex contains

• The active substance of Aciprex is escitalopram. Each film-coated tablet of Aciprex contains 10 mg of escitalopram (as escitalopram oxalate).
• The other ingredients are: Tablet core: microcrystalline cellulose, sodium carboxymethylcellulose, anhydrous colloidal silica, magnesium stearate. Tablet coating: Opadry White Y-1-7000 (hypromellose 6cP, titanium dioxide (E 171), macrogol 400).

What Aciprex looks like and contents of the pack

Aciprex is available in the form of film-coated tablets, which are described below: Aciprex, 10 mg White, oval (approximately 8.1 x 5.6 mm) film-coated tablets with a single score line. The tablet can be divided into two equal doses. Aciprex is available in packs of: 7, 10, 14, 20, 28, 30, or 56 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań

Manufacturer

Biofarm Sp. z o.o. ul. Wałbrzyska 13 60-198 Poznań

Date of last revision of the leaflet: 15.03.2021