Package leaflet: Information for the user

Betesda, 10 mg, film-coated tablets
Escitalopram
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any 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 someone else even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Betesda is and what it is used for

Betesda contains the active substance escitalopram. Betesda belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines act on the serotonergic system in the brain by increasing serotonin levels. Impairment of the serotonergic system in the brain is an important factor in the development of depression and similar disorders.
Betesda is used to treat depression (episodes of severe depression) and anxiety disorders [such as: panic disorder with or without agoraphobia (fear of open spaces), social phobia, generalized anxiety disorder, and obsessive-compulsive disorder].
It may take several weeks before you start to feel better. However, you should continue taking Betesda during this time.
Be sure to talk to your doctor if you do not feel better or if you feel worse.

2. Important information before taking Betesda

When not to take Betesda

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 a group called non-selective, irreversible 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 an abnormal heart rhythm or has had an episode of irregular heartbeat (visible on ECG, a test used to check how the heart is working)
if the patient is taking medicines used for heart rhythm disorders or medicines that may affect heart rhythm (see section 2 “Betesda with other medicines”).

Warnings and precautions
Before starting Betesda, discuss this with your doctor or pharmacist.
Tell your doctor if the patient has any other disorders or diseases, as the doctor should take this information into account. In particular, inform the doctor if:

The patient has epilepsy. Treatment with Betesda should be discontinued if seizures occur or their frequency increases (see also section 4 “Possible side effects”).
The patient has impaired liver or kidney function. A dose adjustment by the doctor may be required.
The patient has diabetes. Treatment with Betesda may interfere with blood glucose control. Adjustment of insulin and/or oral glucose-lowering medicines may be required.
The patient has low sodium levels in the blood.
The patient has an increased tendency to bleed or bruise, or if the patient is pregnant (see “Pregnancy, breastfeeding and fertility”).
The patient is undergoing electroconvulsive therapy.
The patient has ischemic heart disease.
The patient has heart disease or has previously suffered from heart problems, or recently had a heart attack.
The patient has a low resting heart rate and/or is known to have salt deficiency due to prolonged, severe diarrhoea and vomiting or use of diuretics (water tablets).
The patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function.
The patient has current or previous eye problems, such as narrow-angle glaucoma (increased pressure in the eye).

Note:
Some patients with bipolar affective disorder may experience a manic phase.
This is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, consult a doctor.
During the first weeks of treatment, restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Medicines such as Betesda (so-called SSRIs or SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorder
In cases of depression and/or anxiety disorders, thoughts about self-harm or suicidal thoughts may sometimes occur. Such symptoms or behaviours may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The likelihood of such thoughts occurring is higher if:

the patient has previously experienced suicidal thoughts or self-harm
the patient is a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If suicidal thoughts or thoughts about self-harm ever occur, contact your doctor immediately or go to hospital.
It may be helpful to inform family members or friends that the patient has depression or anxiety disorders and ask them to read this leaflet. The patient may ask them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behaviour.
Children and adolescents
Betesda should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age taking medicines in this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, oppositional behaviour, and anger). Nevertheless, a doctor may prescribe Betesda to patients under 18 years of age if he or she decides it is in their best interest. If Betesda has been prescribed to a patient under 18 years of age and you have any doubts about this, contact your doctor again.
If any of the symptoms listed above appear or worsen in a patient under 18 years of age taking Betesda, inform your doctor. Furthermore, the long-term impact of Betesda on safety regarding growth, maturation, and cognitive development in this age group has not yet been established.
Betesda with other medicines
Tell your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Inform your doctor if the patient is taking any of the following medicines:

Non-selective monoamine oxidase inhibitors (MAOIs) containing the active substances: phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Betesda. After stopping Betesda, the patient must wait 7 days before taking any of these medicines.
Reversible, selective monoamine oxidase A (MAO-A) inhibitors containing moclobemide (used in the treatment of depression).
Irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used in the treatment of Parkinson’s disease). These medicines increase the risk of adverse reactions.
The antibiotic linezolid.
Lithium (used in the treatment of bipolar affective disorder) and tryptophan.
Imipramine and desipramine (both used in the treatment of depression).
Sumatriptan and similar medicines (used in the treatment of migraine) and tramadol (used for severe pain). These medicines may increase the risk of adverse reactions.
Cimetidine and omeprazole (used in the treatment of stomach ulcers), 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) – an herbal medicine used for depression.
Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or anticoagulants, so-called antithrombotic agents). These may increase the tendency to bleed.
Warfarin, dipyridamole, and phenprocoumon (anticoagulant medicines, so-called antithrombotic agents). The doctor may likely order blood clotting time tests at the beginning and after stopping Betesda 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 (used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants) due to possible risk of lowering the seizure threshold.
Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Betesda may be required.
Medicines that reduce potassium or magnesium levels in the blood, as in such cases there is a risk of life-threatening heart rhythm disturbances.

Do not take Betesda if the patient is taking medicines used for heart conditions or medicines that may affect heart rhythm, such as: class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, and certain antibacterial agents (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials especially halofantrine), certain antihistamines (e.g. astemizole, hydroxyzine, mizolastine). If the patient has any doubts about taking the medicine, they should contact their doctor.
Betesda with food, drink or alcohol
Betesda may be taken during meals or independently of meals (see section 3 “How to take Betesda”).
As with many medicines, it is not recommended to take Betesda together with alcohol, although interactions between Betesda and alcohol are not expected.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Do not take Betesda if the patient is pregnant or breastfeeding without discussing the risks and benefits of treatment with her doctor.
If the patient takes Betesda during the last 3 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 glucose levels, muscle stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, contact a doctor immediately.
Inform the doctor and/or midwife about the use of Betesda. Taking medicines such as Betesda 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), which causes rapid breathing and cyanosis in the infant. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the newborn, contact the doctor and/or midwife immediately.
Taking Betesda 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 Betesda, she should inform her doctor or midwife so they can provide appropriate advice.
Do not suddenly stop taking Betesda during pregnancy.
Betesda is expected to pass into human milk.
In animal studies, citalopram, a medicine similar to escitalopram, affected sperm quality. Theoretically, this may impair fertility, but such an effect on human fertility has not yet been observed.
Driving and operating machinery
The patient should be advised not to drive or operate machinery until they know how Betesda affects them.
Betesda contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to use Betesda

This medicine should always be taken as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Adult patients
Depression
The usual recommended dose of Betesda is 10 mg taken once daily. The dose may
be increased by the doctor up to a maximum dose of 20 mg per day.
Panic disorder
The initial dose of Betesda is 5 mg once daily during the first week of treatment, then
the dose is increased to 10 mg per day. The dose may then be increased by the doctor
up to a maximum of 20 mg per day.
Social phobia
The recommended dose of Betesda is 10 mg taken once daily. The dose may then
be reduced by the doctor to 5 mg per day or increased up to a maximum of 20 mg per day,
depending on the patient's response to the medicine.
Generalized anxiety disorder
The recommended dose of Betesda is 10 mg taken once daily. The dose may then
be increased by the doctor up to a maximum of 20 mg per day.
Obsessive-compulsive disorder (OCD)
The recommended dose of Betesda is 10 mg taken once daily. The dose may be
increased by the doctor up to a maximum of 20 mg per day.
Elderly patients (over 65 years of age)
The recommended initial dose of Betesda is 5 mg taken once daily. The dose may be
increased by the doctor to 10 mg per day.
Use in children and adolescents
Betesda should not be used in children and adolescents. For further information,
please refer to section 2 "Warnings and precautions".
Renal impairment
Caution should be exercised in patients with severe renal impairment. The medicine should
be used according to the doctor's instructions.
Hepatic impairment
Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should
be used according to the doctor's instructions.
Poor metabolizers of drugs involving the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should
be used according to the doctor's instructions.
How to use Betesda
Betesda may be taken with or without food. Swallow the coated tablets whole, with a small amount of water. Do not chew the tablets, as they have a bitter taste.
The tablet may be divided into equal doses.
Duration of treatment
Improvement may only be felt after several weeks of treatment. Therefore, continue
taking Betesda even if it takes some time before well-being improves. Do not change
the dosage without consulting your doctor.
Betesda should be taken for as long as recommended by the doctor. If treatment is stopped
too early, symptoms may return. Therefore, it is recommended to continue treatment for at least
6 months after regaining good well-being.
Taking more Betesda than recommended
If a patient takes more Betesda than prescribed, they should contact their doctor immediately
or go to the nearest hospital. This should be done even if the patient does not experience
any symptoms. Symptoms of overdose include: dizziness, tremors, agitation, seizures,
coma, nausea, vomiting, cardiac arrhythmias, hypotension, and disturbances in water-electrolyte balance. Bring the packaging/container of Betesda to the doctor or hospital.
Missed dose of Betesda
Do not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before going to sleep, they should take the missed dose immediately. The next day, continue taking the medicine as directed. If the patient remembers about the missed dose during the night or the next day, they should skip the missed dose and take the next dose at the usual time.
Stopping Betesda
Do not stop taking Betesda unless advised by the doctor. When ending treatment, it is usually recommended to gradually reduce the dose of Betesda over a period of several weeks.
After stopping Betesda, especially abruptly, the patient may experience withdrawal symptoms. These symptoms are common after discontinuation of Betesda treatment. The risk is
higher if Betesda has been used for a long time or at high doses, or if the dose was reduced too quickly. In most patients, symptoms are mild and resolve spontaneously within
two weeks. In some patients, however, symptoms may be more severe or last longer
(2–3 months or longer). If severe withdrawal symptoms occur after stopping Betesda, contact the doctor. The doctor may recommend restarting the tablets and tapering the medicine more slowly.
Withdrawal symptoms include: dizziness (unsteady gait or balance disturbances),
tingling sensation, burning sensation, and (less commonly) electric shock-like sensations
(also in the head), sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache,
nausea, sweating (including night sweats), psychomotor restlessness or agitation,
tremors, feeling of disorientation, emotional instability or irritability, diarrhea (loose stools),
visual disturbances, palpitations (fluttering or pounding of the heart).
If in doubt about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions usually resolve within a few weeks of treatment. It should be remembered that some
of these reactions may also be symptoms of the underlying illness and will subside as the patient's condition improves.
You should contact your doctor immediately or go to hospital if any of the following adverse reactions occur during treatment:

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

Unusual bleeding, including gastrointestinal bleeding.

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

Swelling of the skin, tongue, lips, throat or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
High fever, agitation, confusion, 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 in passing urine.
Seizures, see section 2 "Warnings and precautions".
Yellowing of the skin and whites of the eyes, indicating liver dysfunction/hepatitis.
Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes.
Thoughts of self-harm or suicide, see also section 2 "Warnings and precautions".
Sudden swelling of the skin or mucous membranes (angioedema).
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy, breastfeeding and effects on fertility" in section 2.

In addition to the reactions listed above, the following adverse reactions have also been reported:

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

Nausea.
Headache.

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

Nasal congestion or runny nose (sinusitis).
Decreased or increased appetite.
Anxiety, psychomotor agitation, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, skin tingling.
Diarrhoea, constipation, vomiting, dry mouth.
Excessive sweating.
Muscle and joint pain.
Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and in women difficulty achieving orgasm).
Feeling of fatigue, fever.
Weight gain.

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

Hives, rash, itching.
Teeth grinding, agitation, nervousness, panic attacks, confusion.
Sleep disturbances, taste disturbances, fainting.
Pupil dilation, visual disturbances, ringing in the ears (tinnitus).
Hair loss.
Heavy menstrual bleeding.
Irregular menstrual bleeding.
Weight loss.
Rapid heartbeat.
Swelling of upper or lower limbs.
Nosebleeds.

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

Aggression, depersonalization (feeling detached from one's body or mind), 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).
Signs of unusual bleeding, e.g. from skin or mucous membranes.
Increased secretion of a hormone called ADH, which causes water retention in the body, blood dilution, and reduced sodium levels in blood (syndrome of inappropriate antidiuretic hormone secretion).
Galactorrhoea (milk production) in men and women who are not breastfeeding.
Mania.
Increased risk of bone fractures, observed in patients taking this type of medicine.
Heart rhythm disorders (known as QT interval prolongation, observed on ECG recording the heart's electrical activity).

Additionally, adverse reactions known with medicines having a similar mechanism of action to escitalopram
(active substance in Betesda) include:

Psychomotor agitation (akathisia).
Loss of appetite.

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

5. How to store Betesda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack or the cardboard
container following "EXP". The expiry date refers to the last day of the specified month.
Store below 30 °C.
Medicines must not be disposed of via wastewater 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 Betesda contains
The active substance is escitalopram. Each coated tablet of Betesda contains 10 mg of escitalopram (equivalent to 12.775 mg escitalopram oxalate).
The other ingredients are:
Tablet core: microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, talc, and magnesium stearate.
Coating: titanium dioxide (E 171), hypromellose 3 cP, hypromellose 6 cP, polyethylene glycol 400, and polysorbate 80.

What Betesda looks like and contents of the pack
Betesda is available as 10 mg coated tablets. The appearance of the tablets is described below.
White or almost white, oval, film-coated tablets with a break line on one side and engraved with "J" on one side and "2" on the other.

Betesda is available in the following pack sizes:
Blister packs (white) in cardboard packaging: 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
Ul. Baletowa 30
02-867 Warsaw
Poland

Manufacturer/Importer:
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg
Germany

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the Marketing Authorisation Holder.