Betesda

Leaflet accompanying the packaging: information for the user

Betesda, 20 mg/ml, oral drops, solution

Escitalopram

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Betesda and what is it used for

Betesda contains the active substance escitalopram. Betesda belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the levels of serotonin. Disruptions to the serotonin system in the brain are 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 to treat depression (episodes of severe depression) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder). It may take a few weeks before the patient feels better. The patient should continue to take Betesda, even if it takes some time to improve their condition. The patient must talk 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 a group called non-selective irreversible monoamine oxidase inhibitors (MAOIs), including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If the patient was born with an irregular heart rhythm or had an episode of irregular heart rhythm (visible on an ECG, a test that allows the heart's activity to be checked).
• If the patient is taking medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm (see section 2, "Betesda and other medicines").

Warnings and precautions

Before starting to use Betesda, the patient should discuss it with their doctor or pharmacist. The patient should tell their doctor if they have any other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their doctor:

• If they have epilepsy. Treatment with Betesda should be discontinued if seizures occur for the first time or if their frequency increases (see also section 4, "Possible side effects").
• If they have liver or kidney function disorders. A dose adjustment may be required by the doctor.
• If they have diabetes. Treatment with Betesda may disrupt blood glucose control. An adjustment of insulin dose and/or oral hypoglycemic agents may be required.
• If they have low sodium levels in the blood.
• If they have an increased tendency to bleed, bruise, or if they are pregnant (see "Pregnancy, breastfeeding, and fertility").
• If they are being treated with electroconvulsive therapy.
• If they have coronary heart disease.
• If they have or have had heart disease or have recently had a heart attack.
• If they have low resting heart rate and/or know that they have a salt deficiency due to prolonged, severe diarrhea and vomiting or the use of diuretic medicines.
• If they experience a fast or irregular heartbeat, fainting, collapse, or dizziness when changing position to standing, which may indicate abnormal heart function.
• If they have or have had eye problems, such as glaucoma with a narrow angle of filtration (increased pressure in the eye).

Note:

In some patients with affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, the patient should consult their doctor. In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may occur. If such symptoms appear, the patient should immediately inform their doctor. Medicines like Betesda (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

Suicidal thoughts and worsening of depression or anxiety disorder

In the case of depression and/or anxiety disorders, thoughts of self-harm or suicidal thoughts may also occur. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medicines, as these medicines usually start to work only after about 2 weeks, sometimes later. The likelihood of such thoughts occurring is higher if:

• the patient has previously had suicidal thoughts or self-harm
• the patient is an adult at a young age. Information from clinical trials has shown an increased risk of suicidal behavior in adults under 25 years of age with mental disorders who were treated with antidepressant medicines.

If suicidal thoughts or self-harm thoughts ever occur, the patient should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friendsthat the patient has depression or anxiety disorders and ask them to read this leaflet. The patient may ask them to inform them if they notice that their depression or anxiety has worsened or if worrying changes in behavior have occurred.

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 from this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Betesda to patients under 18 years of age if they decide that it is in their best interest. If Betesda has been prescribed to a patient under 18 years of age and there are any doubts about it, the patient should contact their doctor again. If any of the above symptoms occur in a patient under 18 years of age taking Betesda, the patient should inform their doctor. Additionally, the long-term effects of Betesda on safety, including effects on growth, maturation, and cognitive development, have not been established in this age group.

Betesda and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor if they are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting to take Betesda. After stopping treatment with 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 to treat depression).
• Irreversible monoamine oxidase B (MAO-B) inhibitors containing selegiline (used to treat Parkinson's disease). These medicines increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used to treat bipolar affective disorder (a disease in which periods of depression alternate with periods of excessive happiness and euphoria) and tryptophan.
• Imipramine and desipramine (both medicines used to treat depression).
• Sumatriptan and similar medicines (used to treat migraines) and buprenorphine and 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 those that control eye movements, excitement, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If such symptoms occur, the patient should contact their doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may cause an increase in escitalopram levels in the blood.
• St. John's Wort (Hypericum perforatum) - a herbal medicine used to treat depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory medicines (medicines used for pain relief or to thin the blood, so-called anticoagulant medicines). They may increase the tendency to bleed.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulant medicines). The doctor will likely order a blood clotting test at the beginning and after stopping treatment with Betesda to determine if the dose of the anticoagulant medicine is still appropriate.

and

• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat severe mental illness characterized by symptoms such as delusions, seeing things that do not exist (hallucinations), and gradual changes in personality (schizophrenia), as well as mental illness in which control over one's own behavior and actions is impaired (psychosis)) and antidepressant medicines (tricyclic antidepressant medicines and selective serotonin reuptake inhibitors - SSRIs) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used to treat cardiovascular diseases), clomipramine and nortriptyline (antidepressant medicines), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Betesda may be required.
• Medicines that decrease potassium or magnesium levels in the blood, as they may increase the risk of life-threatening heart rhythm disorders.

DO NOT USE Betesdaif the patient is taking medicines used to treat heart diseases or medicines that may affect heart rhythm, such as antiarrhythmic medicines of class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, and some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin administered intravenously, pentamidine, antimalarial medicines, especially halofantrine), some antihistamine medicines (astemizole, hydroxyzine, mizolastine). If the patient has doubts about taking the medicine, they should contact their doctor.

Betesda with food, drink, or alcohol

Betesda can be taken with or without food (see section 3, "How to use Betesda"). As with many medicines, it is not recommended to take Betesda and alcohol at the same time, although interactions between Betesda and alcohol are not expected.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Betesda should not be used if the patient is pregnant or breastfeeding before discussing the risks and benefits of treatment with their doctor. If the patient is taking Betesda in the last 3 months of pregnancy, they should be aware that the following symptoms may occur in the newborn: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood sugar, muscle stiffness or flaccidity, increased reflexes, tremors, nervousness, irritability, lethargy, tearfulness, and sleep disturbances. If any of these symptoms occur in the newborn, the patient should immediately contact their doctor. The patient should inform their doctor and/or midwife about taking Betesda. Taking medicines like Betesda during pregnancy, especially in the last three months, may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue skin in the child. These symptoms usually occur within the first 24 hours after birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife. Taking Betesda at the end of pregnancy may increase the risk of severe vaginal bleeding occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Betesda, they should inform their doctor or midwife so that they can provide appropriate advice. Betesda should not be stopped abruptly during pregnancy. It is expected that Betesda will pass into breast milk. In animal studies, citalopram, a medicine similar to escitalopram, affected sperm quality. This may theoretically affect fertility, but no such effect has been observed in humans yet.

Driving and using machines

The patient will be advised not to drive or operate machines until they know how they react to Betesda.

Betesda contains ethanol

This medicine contains 94 mg of alcohol (ethanol) per ml, which is 9.4% by volume. The amount of alcohol in this medicine will not have noticeable effects.

Betesda contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to use Betesda

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The bottle should be turned upside down. If no drop comes out, the patient should gently tap the bottom of the bottle with their hand to initiate the dosing of the drops.

The patient should count out the required number of drops into a drink (water, orange juice, or apple juice), mix quickly, and then drink the whole thing. Betesda should not be mixed with other liquids or other medicines.

Adult patients

Depression
The recommended dose of Betesda is 10 mg (10 drops) and is taken as a single dose per day. The dose may be increased by the doctor to a maximum dose of 20 mg (20 drops) per day.
Panic disorder
The initial dose of Betesda is 5 mg (5 drops) once a day for the first week of treatment, then the dose is increased to 10 mg (10 drops) per day. The dose may then be increased by the doctor to a maximum of 20 mg (20 drops) per day.
Social phobia
The recommended dose of Betesda is 10 mg (10 drops) and is taken as a single dose per day. The dose may then be decreased by the doctor to 5 mg (5 drops) per day or increased to a maximum of 20 mg (20 drops) per day, depending on the patient's response to the medicine.
Generalized anxiety disorder
The recommended dose of Betesda is 10 mg (10 drops) and is taken as a single dose per day. The dose may then be increased by the doctor to a maximum of 20 mg (20 drops) per day.
Obsessive-compulsive disorder (OCD)
The recommended dose of Betesda is 10 mg (10 drops) and is taken as a single dose per day. The dose may be increased by the doctor 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) and is taken as a single dose per day. 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, the patient should refer to section 2, "Important information before using Betesda".
Kidney function disorders
Caution should be exercised in patients with severe kidney function disorders. The medicine should be used as directed by the doctor.
Liver function disorders
Patients with liver function disorders should not exceed a dose of 10 mg per day. The medicine should be used as directed by the doctor.
Patients who are slow metabolizers of medicines via the CYP2C19 isoenzyme
Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used as directed by the doctor.

Duration of treatment

The patient may not feel better until after a few weeks of treatment. Therefore, the patient should continue to take Betesda, even if it takes some time to improve their condition. The patient should not change the dose without consulting their doctor. Betesda should be used for as long as the doctor recommends. If the patient stops treatment too early, the symptoms may return. It is recommended to continue treatment for at least 6 months after feeling better.

Using a higher dose of Betesda than recommended

If the patient has taken a higher dose of Betesda than prescribed, they should immediately contact their doctor or go to the nearest hospital. This should be done even if the patient does not feel any discomfort. Symptoms of overdose include dizziness, tremors, excitement, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. The patient should take the packaging/bottle of Betesda with them to the doctor or hospital.

Missing a dose of Betesda

The patient should not take a double dose to make up for a missed dose. If the patient forgets to take a dose and remembers before bedtime, they should take the missed dose immediately. The next day, they should take the medicine as directed. If the patient remembers that they missed a dose at night or the next day, they should skip the missed dose and take the next dose at the usual time.

Stopping treatment with Betesda

The patient should not stop taking Betesda unless their doctor advises them to do so. When the patient finishes treatment, it is usually recommended to gradually reduce the dose of Betesda over a period of several weeks. After stopping treatment with Betesda, especially suddenly, the patient may experience withdrawal symptoms. These symptoms often occur after stopping treatment with Betesda. The risk is higher if Betesda was used for a long time or in high doses, or if the dose was reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. In some patients, however, they may be more severe or last longer (2-3 months or longer). If severe withdrawal symptoms occur after stopping treatment with Betesda, the patient should contact their doctor. The doctor may recommend restarting the drops and tapering off the medicine more slowly. Withdrawal symptoms include dizziness (unsteady gait or balance disorders), tingling sensation, burning sensation, and (less often) a feeling of electric shock (including in the head), sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea (nausea), sweating (including night sweats), restlessness or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, palpitations (palpitations). If the patient has any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Betesda can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. It should be remembered that some of these side effects may also be symptoms of the disease and will disappear as the patient's condition improves.

The patient should immediately contact their doctor or go to the hospital if any of the following side effects occur during treatment:

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

• Unusual bleeding, including gastrointestinal bleeding.

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

• Swelling of the skin, tongue, lips, throat, or face, hives, or difficulty breathing or swallowing (severe allergic reaction).
• High fever, excitement, confusion, tremors, and sudden muscle contractions, which may be symptoms of a rare disorder called serotonin syndrome.

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

• Difficulty urinating.
• Seizures, see also section 2, "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, which is a sign of liver function disorders/liver inflammation.
• Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes.
• Suicidal thoughts or suicidal thoughts, see also section 2, "Warnings and precautions".

In addition to the above, the following side effects have been reported for medicines with a similar mechanism of action to escitalopram (the active substance of Betesda):

• Restlessness (akathisia).
• Lack of appetite.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Betesda

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the label or carton after "EXP". The expiry date refers to the last day of the month stated.
• After opening, the drops should be used within 8 weeks and stored at a temperature below 25°C.
• The bottle should be kept tightly closed and in an upright position.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Betesda contains

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

What Betesda looks like and contents of the pack

The medicine is a clear solution. Available pack sizes: 1 bottle of 15 ml or 5 bottles of 15 ml in a carton. Bottle made of type III glass with a dropper made of PE, closed with a PP/PE cap that protects against children, in a carton. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aristo Pharma Sp. z o.o. ul. Baletowa 30 02-867 Warsaw

Manufacturer/Importer

Chanelle Medical Unlimited Company Dublin Road IDA Industrial Estate Loughrea, Co. Galway Ireland Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 90449 Nürnberg Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands Rualalit 20mg/ml druppels voor oraal gebruik, oplossing Germany Escitalopram Heumann 20 mg/ml Tropfen zum Einnehmen, Lösung Poland Betesda Italy Escitalopram Aurobindo Italia 20 mg/ml gocce orali, soluzione Date of last revision of the leaflet:November 2024