Package leaflet: Information for the patient

Aciprex, 10 mg, coated tablets
Escitalopram
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

What Aciprex is and what it is used for
Important information before taking Aciprex
How to take Aciprex
Possible side effects
How to store Aciprex
Contents of the pack and other information

1. What Aciprex is and what it is used for

Aciprex contains escitalopram and is used in the treatment of depression (major depressive episodes),
anxiety disorders (such as panic disorder with or without agoraphobia (fear of being in places where help may be difficult to obtain), social anxiety disorder (fear of social interactions), generalized anxiety disorder), and obsessive-compulsive disorder.
Escitalopram belongs to a group of antidepressants called selective serotonin reuptake inhibitors (SSRIs). These medicines affect the function of the serotonergic system in the brain by increasing serotonin levels. Impaired function of the serotonergic system is considered an important factor in the development of depression and associated disorders.
It may take several weeks of treatment before improvement begins. You should continue taking Aciprex even if it takes some time before your condition improves.
If no improvement occurs or if you feel worse, consult your doctor.

2. Important information before taking Aciprex

When not to take Aciprex

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

Warnings and precautions
Before starting to take Aciprex, discuss this with your doctor.
Inform your doctor about any other illnesses or medical conditions, as these may need to be taken into account. In particular, inform your doctor:

if the patient has epilepsy. If seizures occur for the first time or increase in frequency, treatment with Aciprex should be discontinued (see also section 4 "Possible side effects").
if the patient has impaired liver or kidney function. Dose adjustment by the doctor may be necessary.
if the patient has diabetes. Taking Aciprex may affect blood glucose control. Adjustment of insulin and/or oral antidiabetic medicines may be required.
if the patient has low sodium levels in the blood.
if the patient has an increased tendency to bleeding or subcutaneous haemorrhages.
if there is a history of blood clotting disorders or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on fertility").
if the patient is undergoing electroconvulsive therapy.
if the patient has ischemic heart disease.
if the patient has or has had heart problems, or recently suffered a heart attack.
if the patient has a low resting heart rate and/or knows they may have salt deficiency due to prolonged acute diarrhoea and vomiting or use of diuretics (medicines that increase urine excretion).
if the patient experiences rapid or irregular heartbeat, weakness, fainting, or dizziness upon standing, which may indicate abnormal heart function.
if the patient has or has had eye problems, such as certain types of glaucoma (increased pressure inside the eye).

Note
As with other medicines used to treat depression or similar conditions, improvement in the patient's condition does not occur immediately after starting treatment. Improvement in well-being may take several weeks of taking Aciprex.
In panic disorder, improvement usually occurs within 2–4 weeks of treatment.
During the initial phase of therapy, some patients may experience increased anxiety, which will subside if treatment is continued. Therefore, it is essential to strictly follow the doctor's instructions and not discontinue the medicine or change the dosage without prior consultation with the doctor.
Suicidal thoughts and worsening of symptoms of depression or anxiety disorders
Depression and/or anxiety disorders may be associated with thoughts of self-harm or
suicidal thoughts. These symptoms may worsen in the initial phase of treatment with
antidepressant medicines, as these medicines usually start to work only after about two
weeks. Sometimes this period may be longer.
Individuals more at risk of experiencing such symptoms are:
those who previously had suicidal thoughts or thoughts related to
self-harm.
younger adult patients. Clinical trial data indicate an increased risk of suicidal behaviour in adult patients under 25 years of age
with psychiatric disorders treated with antidepressant medicines.
If thoughts of self-harm or suicidal thoughts occur, seek immediate medical advice
from your doctor or go to the nearest hospital.
It may be helpful for the patient to inform family members or friends that they suffer from
depression or anxiety disorders, and to ask them to read this leaflet. The patient may ask
these individuals to inform them if they notice worsening of depression or anxiety symptoms or concerning changes in behaviour.
In some patients with bipolar disorder, a manic phase may occur.
It is characterised by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. In such cases, it is essential to contact a doctor immediately.
During the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms occur, contact a doctor immediately.
Patients may sometimes be unaware of the above symptoms. Therefore, it may be helpful to ask a friend or family member to watch for any changes in behaviour.
If disturbing thoughts or experiences occur, or if any of the above symptoms appear, contact your doctor immediately or go to the nearest hospital.
Medicines such as Aciprex (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Aciprex should generally not be used in children and adolescents under 18 years of age.
It should be noted that when taking medicines from this group, patients under 18 years of age are at increased risk of experiencing adverse effects such as suicide attempts, suicidal thoughts, and hostility (especially aggression, oppositional behaviour, and anger). Nevertheless, a doctor may prescribe Aciprex to patients in this age group if they consider it necessary. If your doctor has prescribed Aciprex for a patient in this age group and you have any doubts, consult your doctor again. You should also contact your doctor if any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Aciprex. There are currently no data on the long-term safety of Aciprex in this age group regarding growth, maturation, cognitive and behavioural development.
Aciprex with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Inform your doctor or pharmacist if you are taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs), including: phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If taking any of these, wait 14 days before starting Aciprex. After stopping Aciprex, wait 7 days before starting any of these medicines.
Selective, reversible MAO-A inhibitors, including moclobemide (a medicine used to treat depression).
Irreversible MAO-B inhibitors, including selegiline (a medicine used to treat Parkinson's disease). These medicines increase the risk of adverse effects.
Linezolid (an antibiotic).
Lithium (used in the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (antidepressant medicines).
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). These medicines increase the risk of adverse effects.
Cimetidine, lansoprazole, and omeprazole (used to treat peptic ulcer disease), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant medicine), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of Aciprex.
St. John's wort (Hypericum perforatum) - a herbal remedy with antidepressant properties.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (used as painkillers and for blood thinning, so-called anticoagulant medicines). These medicines may increase the tendency to bleeding.
Warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, i.e. anticoagulants). At the beginning and after discontinuation of Aciprex, your doctor will check blood clotting time to ensure the dosage of the anticoagulant medicine remains 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 other antidepressant medicines.
Flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressant medicines), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). Dose adjustment of Aciprex may be necessary when taking these medicines.
Medicines that lower blood potassium or magnesium levels, which increase the risk of life-threatening heart rhythm disorders.

Do not take Aciprex if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarials – particularly halofantrine), and certain antihistamines (astemizole, mizolastine).
If you have any further doubts on this matter, 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 between Aciprex and alcohol are not expected. Nevertheless, as with many other medicines, alcohol consumption is not recommended during treatment with Aciprex.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Pregnant women should not take Aciprex without first discussing the risks and benefits with their doctor.
The patient should be aware that taking Aciprex during the last three months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, cyanosis, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, restlessness, drowsiness, constant crying, sleepiness, or difficulty falling asleep. If any of these symptoms occur in the newborn, seek medical advice immediately.
Ensure that the midwife and/or doctor are aware that the patient is taking Aciprex. Taking medicines such as Aciprex during pregnancy, especially in the last three months, may increase the risk of a serious condition in the child called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue discolouration of the newborn's skin.
These symptoms usually occur within the first 24 hours after birth. If any of these symptoms occur in the newborn, report them immediately to the midwife and/or doctor.
Treatment with Aciprex during pregnancy should not be stopped abruptly.
Taking Aciprex towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Aciprex, she should inform her doctor or midwife so they can provide appropriate advice.
Breastfeeding
Do not take Aciprex during breastfeeding without first discussing the risks and benefits with your doctor.
It is believed that escitalopram passes into breast milk.
Effect on fertility
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces semen quality. This may theoretically affect fertility, although no effect on human fertility has been observed so far.
Driving and operating machinery
Driving vehicles and operating machinery is not recommended until the patient knows how Aciprex affects them.
The medicine contains less than 1 mmol (23 mg) of sodium per maximum daily dose, meaning the medicine is considered "sodium-free".

3. How to take Aciprex

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
Adults
Depression
The usual recommended dose of Aciprex is 10 mg once daily. Your doctor may increase the dose to
the maximum dose of 20 mg per day.
Panic disorder (panic attacks)
The initial dose of Aciprex is 5 mg once daily during the first week of treatment. The dose is then
increased to 10 mg per day. Your doctor may further increase the dose up to the maximum dose of
20 mg per day.
Social anxiety disorder
The usual recommended dose of Aciprex is 10 mg once daily. Depending on the patient's response
to treatment, your doctor may reduce the dose to 5 mg per day or increase it to the maximum dose
of 20 mg per day.
Generalized anxiety disorder
The usual recommended dose of Aciprex is 10 mg, taken as a single daily dose. The dose may be
increased by your doctor up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of Aciprex is 10 mg once daily. Your doctor may increase the dose to
the maximum dose of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Aciprex is 5 mg once daily. Your doctor may increase the dose to
10 mg per day.
Use in children and adolescents
Aciprex should generally not be used in children and adolescents. For further information – see
section 2 "Children and adolescents (under 18 years of age)".
Renal impairment
Caution is advised in patients with severe renal impairment. This medicine should be used according
to your doctor's instructions.
Hepatic impairment
Patients with impaired liver function should not exceed a dose of 10 mg per day. This medicine should
be used according to your doctor's instructions.
Patients who are poor metabolizers via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. This medicine should
be used according to your doctor's instructions.
How to take Aciprex
Aciprex may be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as
it has a bitter taste.
If necessary, the tablet may be divided in half. To do this, place the tablet on a flat surface with the
side containing the score facing upwards. The tablet can then be broken by pressing down with both
index fingers on each end.
Duration of treatment
Improvement may take several weeks of treatment. Therefore, continue taking Aciprex even if there
is no immediate improvement in well-being.
Do not change the dose of this medicine without first consulting your doctor.
Continue taking Aciprex 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 more Aciprex than recommended
If you take more Aciprex than recommended, contact your doctor or the nearest hospital emergency
department immediately. This is necessary even if no symptoms are felt. Symptoms of overdose may
include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood
pressure, and disturbances in fluid and electrolyte balance. When seeking medical help, bring the
Aciprex packaging with you.
If you miss a dose of Aciprex
Do not take a double dose to make up for a missed dose.
If you forget to take a dose and remember before going to bed, take the missed dose immediately.
Continue taking the medicine as usual the next day. If you remember about the missed dose during
the night or the next day, do not take the missed dose; instead, take the next dose at the usual time.
Stopping Aciprex
Do not stop taking Aciprex unless your doctor advises you to do so.
If stopping treatment is planned, the dose of Aciprex should be gradually reduced over a period of
several weeks.
After stopping Aciprex, especially if treatment was abruptly discontinued, withdrawal symptoms may
occur. These are commonly observed after discontinuation of Aciprex. The risk is greater after long-
term use, high doses, or too rapid dose reduction. In most patients, withdrawal symptoms are mild
and resolve spontaneously within two weeks. However, in some patients, withdrawal symptoms may
be severe or persist for a longer period (2–3 months or longer). If severe symptoms occur after
stopping Aciprex, consult your doctor. Your doctor may recommend restarting the medicine and then
tapering it more slowly.
Withdrawal symptoms include: dizziness (problems with balance), tingling and burning sensations, and
(less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams,
nightmares, insomnia), anxiety, headache, nausea, excessive sweating (including night sweats),
restlessness or agitation, tremor, confusion or disorientation, emotional lability or irritability,
diarrhea, visual disturbances, palpitations or rapid heartbeat.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions usually resolve after a few weeks of treatment. It is important to remember that many
of the observed symptoms may be manifestations of the underlying illness and may improve as the
patient's condition improves.
If any of the following adverse reactions occur during treatment,
you should consult a doctor immediately:
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, larynx or face, hives or difficulty breathing or swallowing (allergic reaction) – seek immediate medical attention from a doctor or at the nearest hospital.
High fever, agitation, confusion, tremor, and sudden muscle contractions may be symptoms of a rare condition known as serotonin syndrome.

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

Difficulty urinating;
Seizures (epileptic fits) – see also section 2 "Warnings and precautions";
Yellowing of the skin and whites of the eyes (indicative of impaired liver function and/or hepatitis);
Rapid or irregular heartbeat, fainting – these may be symptoms of a life-threatening condition known as torsade de pointes;
Suicidal thoughts and behaviour (such cases have been reported during escitalopram therapy and shortly after discontinuation of treatment – see also section 2 "Warnings and precautions");
Sudden swelling of the skin or mucous membranes (angioedema).

The following adverse reactions have also been reported:
Very common (may affect more than 1 in 10 people):

Nausea
Headache

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

Nasal congestion or runny nose (sinusitis);
Increased or decreased appetite;
Anxiety, restlessness (especially motor restlessness), unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremor, tingling;
Diarrhoea, constipation, vomiting, dry mouth;
Excessive sweating;
Joint and 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, confusion;
Sleep disturbances, taste disturbances, fainting;
Pupil dilation, visual disturbances, tinnitus;
Hair loss;
Heavy menstrual bleeding;
Irregular menstruation;
Weight loss;
Increased heart rate;
Swelling of hands and feet;
Nosebleeds.

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

Aggression, depersonalization (feeling of loss of self-identity), hallucinations;
Slowed heart rate;

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

Decreased sodium concentration in blood (manifesting as nausea, malaise, muscle weakness or confusion);
Dizziness upon rapid standing due to low blood pressure (orthostatic hypotension);
Abnormal liver function test results (increased liver enzyme activity in blood);
Movement disorders (involuntary muscle movements);
Persistent and painful erection (priapism);
Bleeding disorders, including bleeding into the skin and mucous membranes (purpura) and low platelet count (thrombocytopenia);
Increased secretion of antidiuretic hormone (ADH), leading to water retention, blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion);
Milk secretion in men and in women not breastfeeding;
Mania;
Increased risk of bone fractures observed in patients taking this type of medicine (selective serotonin reuptake inhibitors or tricyclic antidepressants);
Changes in heart rhythm (so-called "QT interval prolongation", observed on ECG – electrocardiogram);
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage) – see additional information in subsection "Pregnancy, breastfeeding and fertility" in section 2.

Also known are adverse reactions occurring with drugs that have a mechanism of action similar to escitalopram (the active substance in Aciprex), such as:

Motor restlessness (akathisia);
Loss of appetite.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Aciprex

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the blister pack and the outer cardboard
pack after the words "Expiry date:".
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the
environment.

6. Contents of the packaging and other information

What Aciprex contains

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

What Aciprex looks like and contents of the pack
Aciprex is available as film-coated tablets, the appearance of which is described below:
Aciprex, 10 mg
White, oval-shaped (approx. 8.1 x 5.6 mm) film-coated tablets with a single-scored line on one side.
The tablet can be divided into two equal doses.
Aciprex is available in the following pack sizes:
7, 10, 14, 20, 28, 30 or 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań