Apoescitaxin oro: detailed information

Package leaflet: Information for the patient

ApoEscitaxin ORO, 5 mg, orodispersible tablets
ApoEscitaxin ORO, 10 mg, orodispersible tablets
ApoEscitaxin ORO, 20 mg, orodispersible tablets
Escitalopram
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 you only. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

What ApoEscitaxin ORO is and what it is used for
What you need to know before taking ApoEscitaxin ORO
How to take ApoEscitaxin ORO
Possible side effects
How to store ApoEscitaxin ORO
Contents of the pack and other information

1. What ApoEscitaxin ORO is and what it is used for

ApoEscitaxin ORO contains the active substance escitalopram. ApoEscitaxin ORO belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing the concentration of serotonin. It is believed that disturbances in the function of the serotonergic system play an important role in the development of depression and associated disorders.

ApoEscitaxin ORO containing escitalopram is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take several weeks of treatment before improvement begins. You should continue taking ApoEscitaxin ORO even if it takes some time before you feel better.

If no improvement occurs or if you feel worse, please consult your doctor.

2. Important information before using ApoEscitaxin ORO

When not to use ApoEscitaxin ORO:

if the patient is allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (listed in section 6).
if the patient is taking other medicines belonging to a group called 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 was born with congenital abnormal heart rhythm or if the patient has experienced an episode of abnormal heart rhythm (visible on ECG; a test assessing heart function).
if the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2 "ApoEscitaxin ORO with other medicines").

Warnings and precautions
Before starting ApoEscitaxin ORO, discuss this with your doctor or
pharmacist.
Inform your doctor about all other symptoms 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 ApoEscitaxin ORO should be discontinued (see also section 4 "Possible side effects").
if the patient has liver or kidney function disorders. Dose adjustment by the doctor may be necessary.
if the patient has diabetes. Treatment with ApoEscitaxin ORO may alter blood glucose levels. Adjustment of insulin and/or oral glucose-lowering medications may be required.
if the patient has low sodium levels in the blood.
if the patient has an increased tendency to bleed or bruise, 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 heart conditions or recently suffered a heart attack.
if the patient has a slow resting heart rate and/or may have electrolyte deficiency due to prolonged, severe diarrhea and vomiting or use of diuretics (water tablets).
if the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances.
if the patient has or has had eye disorders, such as certain types of glaucoma (increased intraocular pressure).
if the patient is taking medicinal products containing buprenorphine. Concurrent use of these medicines with ApoEscitaxin ORO may lead to serotonin syndrome, a potentially life-threatening condition (see "ApoEscitaxin ORO with other medicines").
Medicines such as ApoEscitaxin ORO (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.

Note
Some patients with bipolar affective disorder may experience a manic phase. This is
characterized by unusual and rapidly changing thoughts, unjustified feelings of happiness, and
excessive physical activity. If these symptoms occur, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty remaining
still may also occur. If such symptoms occur, inform your doctor immediately.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm
or suicide. These symptoms or behaviors may worsen at the beginning of treatment with
antidepressant medicines, as these medicines usually take about 2 weeks, sometimes longer,
to start working.
These symptoms are more likely in:

patients who previously experienced suicidal thoughts or self-harm.
young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If the patient develops thoughts of self-harm or suicide, seek immediate medical advice or go to a hospital.
It may be helpful to inform a relative or friend about the depression or anxiety disorder and to have them read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behavior.
Children and adolescents
ApoEscitaxin ORO should not be used in children and adolescents under 18 years of age. It should also be noted that in patients under 18 years of age taking medicines of this class, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviors, and expressions of anger). Nevertheless, a doctor may prescribe ApoEscitaxin ORO to patients under 18 years of age if he or she decides it is beneficial for them. If ApoEscitaxin ORO has been prescribed to a patient under 18 years of age and you have any doubts, contact the prescribing doctor again. If any of the above-mentioned symptoms occur or worsen in a patient under 18 years of age taking ApoEscitaxin ORO, inform the doctor. Furthermore, the long-term safety of ApoEscitaxin ORO regarding growth, maturation, cognitive development, and behavioral development in this age group has not yet been established.
ApoEscitaxin ORO with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Inform your doctor if the patient is taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed before starting ApoEscitaxin ORO. After discontinuing ApoEscitaxin ORO, a 7-day interval should be observed before starting any of these medicines.
Reversible, selective monoamine oxidase A (MAO-A) inhibitors, including moclobemide (used in the treatment of depression).
Irreversible monoamine oxidase B (MAO-B) inhibitors, including selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects.
The antibiotic linezolid.
Lithium (used in the treatment of bipolar disorder) and tryptophan.
Imipramine and desipramine (used in the treatment of depression).
Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol (used in the treatment of severe pain). These medicines increase the risk of adverse effects.
Cimetidine, lanzoprazole, and omeprazole (used in the treatment of peptic ulcer disease), fluconazole (used in the treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase escitalopram blood levels.
St. John's wort (Hypericum perforatum) - a herbal remedy used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning agents, known as anticoagulants). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (blood-thinning agents, known as anticoagulants). Your doctor may order blood clotting time tests at the beginning and after discontinuation of ApoEscitaxin ORO to determine whether the anticoagulant dose remains appropriate.
Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain) due to possible risk of lowering the seizure threshold.
Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the risk of lowering the seizure threshold.
Flecainide, propafenone, and metoprolol (used in cardiovascular disorders), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose adjustment of ApoEscitaxin ORO may be required.
Medicines that reduce potassium or magnesium levels in the blood, as this may increase the risk of life-threatening heart rhythm disturbances.

Some medicines may worsen the side effects of ApoEscitaxin ORO and sometimes cause very
serious reactions. Do not take any other medicines while taking ApoEscitaxin ORO without
first consulting your doctor, especially:

medicines containing buprenorphine. These medicines may interact with ApoEscitaxin ORO and may cause symptoms such as involuntary rhythmic muscle contractions, including muscles controlling eye movement, agitation,
hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tension, body temperature above 38°C. If such symptoms occur, contact your doctor.
Do not use ApoEscitaxin ORO simultaneously with medicines used for 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 regarding the use of this medicine, consult your doctor.
ApoEscitaxin ORO with food, drink, and alcohol
ApoEscitaxin ORO can be taken during meals or independently of meals (see section 3 "How to take ApoEscitaxin ORO").
As with many medicines, concomitant use of ApoEscitaxin ORO with alcohol is not recommended, although interactions (effects) between ApoEscitaxin ORO and alcohol are not expected.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The patient should not use ApoEscitaxin ORO during pregnancy or while breastfeeding unless she has discussed the risks and benefits of treatment with her doctor.
If the patient takes ApoEscitaxin ORO during the last three months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflex activity, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and difficulty falling asleep. If any of these symptoms occur in the newborn, seek immediate medical advice.
Inform your doctor and/or midwife about the use of ApoEscitaxin ORO.
Taking this medicine during pregnancy, especially during the last three months, may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and cyanosis and usually occurs within the first day after birth. If such symptoms occur in the newborn, contact your doctor and/or midwife immediately.
Do not abruptly discontinue ApoEscitaxin ORO during pregnancy.
Taking ApoEscitaxin ORO towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking ApoEscitaxin ORO, she should inform her doctor or midwife so they can provide appropriate advice.
Escitalopram is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on human fertility has been observed to date.
Driving and operating machinery
The patient should not drive or operate machinery until it is known how ApoEscitaxin ORO affects them.
ApoEscitaxin ORO contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
ApoEscitaxin ORO contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take ApoEscitaxin ORO

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
ApoEscitaxin ORO, orally disintegrating tablets, should be taken daily as a single dose.
ApoEscitaxin ORO may be taken with or without food.
ApoEscitaxin ORO tablets are fragile and should be handled with care.
Do not handle the tablets with wet hands, as they may disintegrate.

Holding the blister pack by the edges, carefully separate one tablet from the rest of the strip by tearing gently along the perforation.
Carefully peel back the backing foil.
Place the tablet on the tongue. The tablet will dissolve very quickly and can be swallowed without water.

Adults
Depression
The usual recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Panic disorder (anxiety disorder with panic attacks)
The initial dose of ApoEscitaxin ORO is 5 mg once daily during the first week of treatment,
then the dose is increased to 10 mg once daily. Your doctor may further increase the dose
up to a maximum of 20 mg per day.
Social phobia
The usual recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may
then reduce the dose to 5 mg per day or increase it up to a maximum of 20 mg per day,
depending on the patient's response to the medicine.
Generalized anxiety disorder
The usual recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose of ApoEscitaxin ORO is 10 mg once daily. Your doctor may
increase the dose up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The usual recommended starting dose of ApoEscitaxin ORO is 5 mg once daily. Your doctor
may recommend increasing the dose to 10 mg per day.
Use in children and adolescents
ApoEscitaxin ORO is generally not used in children and adolescents. Additional
information is provided in section 2, "Important information before taking ApoEscitaxin ORO".
Duration of treatment
Improvement may not be felt until several weeks after starting treatment. Therefore, continue
taking ApoEscitaxin ORO as prescribed, even if there is no immediate improvement in well-being.
Do not change the dosage without first consulting your doctor.
Continue taking the medicine for as long as your doctor recommends. If treatment is stopped
too early, symptoms may return. Therefore, treatment should be continued for at least 6
months after improvement is achieved.
Taking more ApoEscitaxin ORO than prescribed
If you have taken more ApoEscitaxin ORO than prescribed by your doctor, contact your
doctor immediately or go to the emergency department of your nearest hospital, even if you
do not feel unwell. Symptoms of overdose may include dizziness, tremors, agitation,
seizures, coma, nausea, vomiting, irregular heartbeat, low blood pressure, and disturbances
in fluid and electrolyte balance. When going to the doctor or hospital, bring the medicine
packaging of ApoEscitaxin ORO with you.
If you miss a dose of ApoEscitaxin ORO
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 sleep, take the missed dose immediately. Take the next dose
the following day at the usual time. If you remember about the missed dose during the
night or the next day, skip the missed dose and take the next dose at the usual time.
Stopping ApoEscitaxin ORO
Do not stop taking ApoEscitaxin ORO unless your doctor advises you to do so.
When stopping treatment, your doctor will usually recommend gradually reducing the
dose of ApoEscitaxin ORO over several weeks.
After stopping ApoEscitaxin ORO, especially if stopped abruptly, you may experience
withdrawal symptoms. These symptoms are common when stopping ApoEscitaxin ORO. The
risk is greater if ApoEscitaxin ORO has been taken for a long time or in high doses, or if the
dose was reduced too quickly. In most patients, symptoms are mild and resolve on their
own within two weeks. However, in some patients, symptoms may be more severe or last
longer (2–3 months or more). If you experience severe withdrawal symptoms after
stopping ApoEscitaxin ORO, contact your doctor. Your doctor may recommend restarting
the medicine and tapering it more slowly.
Withdrawal symptoms may include: dizziness (unsteadiness, balance disturbances),
tingling sensations, burning sensations, and (less commonly) electric shock-like sensations,
including in the head; sleep disturbances (vivid dreams, nightmares, insomnia); feelings of
anxiety; headache; nausea; excessive sweating (including night sweats); psychomotor
agitation or restlessness; tremors; confusion or disorientation; emotional instability or
irritability; diarrhoea (loose stools); visual disturbances; palpitations (fluttering or pounding
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 will
experience them.
Adverse reactions usually subside after a few weeks of treatment. It should be remembered
that some of these reactions may also be symptoms of the illness itself and will resolve as
the patient's condition improves.
If any of the following adverse reactions occur during treatment,
you should contact your doctor or go to hospital immediately:
Uncommon (occurring in fewer than 1 in 100 people):

unusual bleeding, including gastrointestinal bleeding.

Rare (occurring in fewer than 1 in 1000 people):

swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing (allergic reaction)
high fever, agitation, confusion (disorientation), tremors, and sudden muscle spasms, which may be symptoms of a rare condition called serotonin syndrome.

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

difficulty urinating
seizures, see also section “Warnings and precautions”
yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis
rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as torsades de pointes
suicidal thoughts and behaviour, see also section “Warnings and precautions”.

In addition to the reactions listed above, the following adverse reactions have also been reported:
Very common (occurring in more than 1 in 10 people):

nausea
headache.

Common (occurring in fewer than 1 in 10 people):

nasal congestion or runny nose (sinusitis)
decreased or increased appetite
anxiety, psychomotor agitation, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
diarrhoea, constipation, vomiting, dryness of the oral mucosa
excessive sweating
muscle and joint pain
sexual dysfunction (delayed ejaculation, erectile dysfunction, reduced libido, and difficulty achieving orgasm in women)
fatigue, fever
weight gain.

Uncommon (occurring in fewer than 1 in 100 people):

urticaria, rash, itching (pruritus)
teeth grinding, agitation, nervousness, panic attack, states of confusion (disorientation)
sleep disturbances, taste disturbances, fainting
pupil dilation, visual disturbances, ringing in the ears (tinnitus)
hair loss
heavy menstrual bleeding
irregular menstruation
weight loss
rapid heartbeat
swelling of the upper or lower limbs
nosebleeds.

Rare (occurring in fewer than 1 in 1000 people):

aggression, depersonalization (feeling of loss of self-identity, feeling detached from oneself), hallucinations
slow heartbeat.

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

decreased sodium concentration in blood (manifesting as nausea and malaise with muscle weakness or confusion)
dizziness upon standing due to low blood pressure (orthostatic hypotension)
abnormal liver function tests (increased liver enzyme activity in blood)
movement disorders (involuntary muscle movements)
painful penile erection (priapism)
symptoms indicating increased tendency to bleeding, e.g. in the skin and mucous membranes (petechiae)
sudden swelling of the skin or mucous membranes (angioedema)
increased urine output (syndrome of inappropriate antidiuretic hormone secretion – SIADH)
galactorrhea in men and in women who are not breastfeeding
mania
in patients taking medicines of this class, an increased risk of bone fractures has been observed
change in heart rhythm (known as “QT interval prolongation”, visible on ECG, a test assessing heart function)
heavy vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); for more information see section 2 “Pregnancy, breastfeeding and effect on fertility”.

Additionally, adverse reactions known with drugs having a similar mechanism of action to
escitalopram (the active substance in ApoEscitaxin ORO) include:

akathisia [restlessness, inability to remain still]
loss of appetite.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this
leaflet, you should consult your doctor or pharmacist.
Adverse reactions can be reported directly to the Department for Monitoring Adverse
Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder or its
representative in Poland. Reporting adverse reactions helps provide more information on
the safety of the medicine.

5. How to store ApoEscitaxin ORO

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
blister after: Expiry (EXP). The expiry date refers to the last day of the stated month.
The batch number follows the abbreviation "Lot".
There are no special requirements regarding the storage temperature of the medicinal product.
Store in the original packaging to protect from moisture and light.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What ApoEscitaxin ORO contains
The active substance is escitalopram.
Each orally disintegrating tablet of ApoEscitaxin ORO 5 mg contains 5 mg of escitalopram, equivalent to 6.3875 mg of escitalopram oxalate.
Each orally disintegrating tablet of ApoEscitaxin ORO 10 mg contains 10 mg of escitalopram, equivalent to 12.775 mg of escitalopram oxalate.
Each orally disintegrating tablet of ApoEscitaxin ORO 20 mg contains 20 mg of escitalopram, equivalent to 25.55 mg of escitalopram oxalate.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, potassium polacrilin, acesulfame potassium, neohesperidine dihydrochalcone, magnesium stearate,
peppermint flavour [containing maltodextrin (corn), modified starch (corn) and peppermint oil], hydrochloric acid concentrated (for pH adjustment).

What ApoEscitaxin ORO looks like and contents of the pack
ApoEscitaxin ORO 5 mg: white or almost white, round, flat tablets with bevelled edges, 7 mm in diameter, imprinted with the number "5" on one side.
ApoEscitaxin ORO 10 mg: white or almost white, round, flat tablets with bevelled edges, 9 mm in diameter, imprinted with the number "10" on one side.
ApoEscitaxin ORO 20 mg: white or almost white, round, flat tablets with bevelled edges, 12 mm in diameter, imprinted with the number "20" on one side.
ApoEscitaxin ORO is available in packs containing 28 orally disintegrating tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D lok.27
01-909 Warsaw
Poland

Manufacturers:
Genepharm S.A.
18km Marathon Avenue
15351 Pallini Attikis
Greece
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
Rontis Hellas S.A.
Medical and Pharmaceutical Products
Industrial Area of Larissa
P.O. Box 3012, GR41004 Larissa
Greece
Pharmapath S.A.
28is Oktovriou 1
Agia Varvara, 123 51
Greece