Betesda

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Betesda (Escitalopram Heumann), 20 mg/ml, oral drops, solution
Escitalopramum
Betesda and Escitalopram Heumann are different trade names for the same medicine.
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Betesda is and what it is used for
2. Important information before taking Betesda
3. How to take Betesda
4. Possible side effects
5. How to store Betesda
6. 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 serotonin system in the brain by increasing serotonin levels. Dysfunction of the brain's serotonin system is an important factor in the development of depression and similar disorders.

Betesda 20 mg/ml oral drops, solution contains escitalopram and is used in adults over 18 years of age for the treatment of depression (episodes of major 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 the patient starts to feel better. Continue taking Betesda even if it takes some time for the patient's condition to improve.

The patient must speak to their doctor if they do not feel better or if they feel worse.

2. Important Information Before Using Betesda

When not to use 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 the 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 experienced episodes of irregular heartbeat (visible on ECG, a test used to check how the heart works).
• 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 treatment with Betesda, discuss this with your doctor or pharmacist.
Inform your doctor if the patient has any other disorders or diseases, as the doctor should take such information into account. In particular, inform the doctor:

• If the patient has epilepsy. Treatment with Betesda should be discontinued if seizures occur for the first time or their frequency increases (see also section 4. "Possible side effects").
• If the patient has impaired liver or kidney function. Dose adjustment by the doctor may be required.
• If the patient has diabetes. Treatment with Betesda may interfere with blood glucose control. Adjustment of insulin and/or oral glucose-lowering agents may be necessary.
• 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 fertility").
• If the patient is receiving electroconvulsive therapy.
• If the patient has ischemic heart disease.
• If the patient has heart disease or recently suffered a heart attack.
• If the patient has a low resting heart rate and/or is known to have salt deficiency due to prolonged, severe diarrhea and vomiting or use of diuretics (water pills).
• If the patient experiences rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart function.
• If 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, contact the doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may 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 of self-harm or suicidal ideation may sometimes occur. These symptoms or behaviors may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks to start working, sometimes longer. The likelihood of such thoughts 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 behavior in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If thoughts of self-harm or suicidal thoughts ever occur, contact the doctor immediately or go to hospital.
Informing family members or friends may be helpful, as the patient has depression or anxiety disorders, and asking them to read this leaflet. The patient may ask them to inform him/her if they notice worsening of depression or anxiety, or concerning changes in behavior.
Children and adolescents under 18 years of age
Betesda should not be used in children and adolescents under 18 years of age. It should also be known 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, defiant behavior, and anger). Nevertheless, the doctor may prescribe Betesda to patients under 18 years of age if he/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, contact your doctor again.
If any of the above-mentioned symptoms 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
Inform 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 phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. 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 (a medicine 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 effects.

• The antibiotic linezolid.

• Lithium (used in the treatment of bipolar affective disorder—a condition where episodes of depression alternate with periods of excessive happiness and euphoria) and tryptophan.

• Imipramine and desipramine (both used in the treatment of depression).

• Sumatriptan and similar medicines (used in the treatment of migraine), as well as buprenorphine, tramadol, and similar medicines (opioids used for severe pain). These medicines may interact with Betesda and cause symptoms such as involuntary, rhythmic muscle contractions (including eye muscles), agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased muscle tone, body temperature above 38°C. If such symptoms occur, contact the doctor.

• Cimetidine, lansoprazole, 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)—a herbal remedy used for depression.

• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory drugs (medicines used for pain relief or blood thinning, so-called anticoagulants). These may increase the tendency to bleed.

• Warfarin, dipyridamole, and phenprocoumon (medicines used for blood thinning, so-called anticoagulants). The doctor will 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 (medicines used in the treatment of severe mental illness characterized by symptoms such as delusions, seeing things that do not exist (hallucinations), and gradual personality changes (schizophrenia), as well as mental illness where control over one's behavior and actions is impaired (psychosis)) and antidepressants (tricyclic antidepressants and selective serotonin reuptake inhibitors—SSRIs) 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). 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 USE 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), and certain antihistamines (astemizole, hydroxyzine, mizolastine). If the patient has any doubts about using the medicine, they should contact the doctor.
Betesda with food, drink, or alcohol
Betesda can be taken during meals or independently of meals (see section 3. "How to use 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 effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Betesda if the patient is pregnant or breastfeeding without discussing the risks and benefits of treatment with the 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, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflexes, tremors, nervousness, irritability, lethargy, excessive crying, drowsiness, and difficulty sleeping. If any of these symptoms occur in the newborn, seek medical advice 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 the doctor or midwife so appropriate advice can be provided.
Do not abruptly 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. This may theoretically impair fertility, but such an effect has not yet been observed in humans.
Driving and operating machinery
The patient should be advised not to drive or operate machinery until they know how they react to Betesda.
Betesda contains ethanol
This medicine contains 94 mg of alcohol (ethanol) per ml, which corresponds to 9.4% by volume.
The amount of alcohol in this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.
Betesda contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to take Betesda

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Turn the bottle upside down. If no drops come out, gently tap the palm of your hand against the bottom of the bottle to initiate drop dispensing.

Count the required number of drops into a drink (water, orange juice or apple juice), mix quickly, and then drink the entire mixture immediately.
Do not mix Betesda with other liquids or with other medicines.

Adult patients
Depression
The recommended dose of Betesda is 10 mg (10 drops), taken as a single daily dose.
The dose may be increased by the doctor up to a maximum dose of 20 mg (20 drops) per day.

Panic disorder
The initial dose of Betesda is 5 mg (5 drops) once daily during the first week of treatment, then the dose is increased to 10 mg (10 drops) per day. The dose may then be further increased by the doctor up to a maximum of 20 mg (20 drops) per day.

Social phobia
The recommended dose of Betesda is 10 mg (10 drops), taken as a single daily dose.
The dose may then be reduced by the doctor to 5 mg (5 drops) per day or increased up to a maximum of 20 mg (20 drops) per day, depending on the patient's response to the medicine.

Generalised anxiety disorder
The recommended dose of Betesda is 10 mg (10 drops), taken as a single daily dose.
The dose may then be increased by the doctor up to a maximum of 20 mg (20 drops) per day.

Obsessive-compulsive disorder (OCD)
The recommended dose of Betesda is 10 mg (10 drops), taken as a single daily dose.
The dose may be increased by the doctor up to a maximum of 20 mg (20 drops) per day.

Elderly patients (over 65 years of age)
The recommended initial dose of Betesda is 5 mg (5 drops), taken as a single daily dose.
The dose may be increased by the doctor to 10 mg (10 drops) per day.

Children and adolescents (under 18 years of age)
Betesda should not be used in children and adolescents. For further information, refer to section 2, "Important information before taking Betesda".

Renal function impairment
Exercise caution in patients with severe renal impairment. The medicine should be used according to the doctor's instructions.

Hepatic function 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.

Patients who are poor metabolisers of drugs via 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.

Duration of treatment
Improvement may not be felt until several weeks after starting treatment. Therefore, continue taking Betesda even if it takes some time before you feel better.
Do not change the dose without consulting your doctor.
Continue taking Betesda for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. It is therefore recommended to continue treatment for at least 6 months after regaining good well-being.

Taking more Betesda than recommended
If you have taken more Betesda than prescribed, contact your doctor immediately or go to the nearest hospital. This should be done even if you do not feel unwell. Symptoms of overdose may include: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, hypotension, and disturbances in water-electrolyte balance. Take the medicine container/bottle with you to the doctor or hospital.

Missed dose of Betesda
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. The next day, continue taking the medicine as directed. If you remember the missed dose during the night or the following day, skip the missed dose and take the next dose at the usual time.

Stopping Betesda
Do not stop taking Betesda unless your doctor advises you to do so. When ending treatment, your doctor will usually recommend gradually reducing the dose of Betesda over several weeks.
After stopping Betesda, particularly abruptly, you may experience withdrawal symptoms. These symptoms are common when stopping Betesda treatment. The risk is greater if Betesda has been taken 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. 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 Betesda, contact your doctor. Your doctor may recommend restarting the drops and tapering the dose more slowly.

Withdrawal symptoms include: dizziness (unsteady gait or balance disturbances), tingling sensations, burning sensations, 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, tremor, feelings of disorientation, emotional lability or irritability, diarrhoea (loose stools), visual disturbances, palpitations (fluttering or pounding heart).

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 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.
Immediately contact a doctor 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, urticaria (hives), or developing difficulty in breathing or swallowing (severe allergic reaction).
• High fever, agitation, confusion, tremors, and sudden muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty urinating.
• Seizure attacks; see also 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 suicidal thoughts; see also section 2. "Warnings and precautions".

In addition to the above, the following adverse reactions have 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 cold-like symptoms (sinusitis).
• Decreased or increased appetite.
• Anxiety, psychomotor agitation, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, prickling sensations in the skin.
• 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):

• Urticaria, rash, itching.
• Involuntary 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 the upper or lower limbs.
• Nosebleeds.

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

• Aggression, depersonalisation (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, malaise, 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 severe bleeding, e.g. from the skin and mucous membranes, and low platelet count (thrombocytopenia).
• Sudden swelling of the skin or mucous membranes (angioedema).
• Increased secretion of a hormone called ADH, leading to water retention in the body, blood dilution, and reduced sodium levels (syndrome of inappropriate antidiuretic hormone secretion).
• Increased blood levels of the hormone prolactin.
• Lactation in men and women who are not breastfeeding.
• Episodes of excessive elation associated with increased psychomotor activity (mania).
• Increased risk of bone fractures, observed in patients taking this type of medicine.
• Heart rhythm disturbances (referred to as QT interval prolongation, observed on ECG, which records the heart's electrical activity).
• 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, adverse reactions known with other 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 those 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betesda medicine

• Keep the medicine out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
• No special storage instructions apply.
• After opening, the drops should be used within 8 weeks and stored at a temperature below 25°C.
• Keep the bottle tightly closed and in an upright position.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Betesda contains

• The active substance is escitalopram. Each 1 ml of the medicinal product contains 20 mg of escitalopram (as escitalopram oxalate). One drop contains 1 mg of escitalopram.
• The other ingredients are: propyl gallate, citric acid, 96% ethanol, sodium hydroxide (see section 2), purified water.

What Betesda looks like and contents of the pack
Betesda is a clear solution.
Available pack sizes:
1 bottle of 15 ml in a cardboard box.
The bottle is made of glass (Type III) with a dropper made of PE, closed with a cap made of PP/PE, and contained in a cardboard box.
For further information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nuremberg
Germany

Manufacturer:
Chanelle Medical Unlimited Company
Dublin Road, Loughrea
Co Galway H62 FH90
Ireland

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

German Marketing Authorisation Number (country of export): 86825.00.00
Parallel Import Authorisation Number: 354/25

This medicinal product is authorised in the European Economic Area (EEA) under the following names:
Netherlands: Rualalit 20 mg/ml oral drops, solution
Germany: Escitalopram Heumann 20 mg/ml Tropfen zum Einnehmen, Lösung
Poland: Betesda
Italy: Escitalopram Aurobindo Italia 20 mg/ml gocce orali, soluzione