Betesda

Leaflet accompanying the packaging: information for the user

Betesda, 10 mg, coated tablets

Escitalopram

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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.
• If the patient experiences any side effects, including any 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 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 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 (SSRI). 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 is used 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 several weeks before the patient feels better. Nevertheless, the patient should continue taking Betesda during this time. The patient must talk to their doctor if they do not feel better or if they feel worse.

2. Important information before taking Betesda

When not to take Betesda

Warnings and precautions

Before starting to take Betesda, the patient should discuss it with their doctor or pharmacist. The patient should tell their doctor if they have other disorders or diseases, as the doctor should take this information into account. In particular, the patient should inform their 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 liver or kidney problems. A dose adjustment may be required by the doctor.
• The patient has diabetes. Treatment with Betesda may disrupt blood glucose control. A dose adjustment of insulin and/or oral hypoglycemic agents 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 being treated with electroconvulsive therapy.
• The patient has coronary heart disease.
• The patient has or has had heart problems or has recently had a heart attack.
• The patient has low resting heart rate and/or may have low salt levels due to prolonged, severe diarrhea and vomiting or the use of diuretic medicines.
• The patient has a fast or irregular heartbeat, fainting, collapse, or dizziness when changing position to standing, which may indicate abnormal heart function.
• The patient has or has had eye problems, such as glaucoma with a narrow angle.

Caution:

In some patients with bipolar affective disorder, a manic phase may occur. This 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, anxiety or difficulty sitting or standing still may also occur. If such symptoms appear, the patient should immediately inform their doctor. Medicines like Betesda (so-called SSRI or SNRI) may cause symptoms of sexual dysfunction (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, suicidal thoughts or self-harm thoughts may also occur. Such symptoms or behavior may worsen at the start of treatment with antidepressant medicines, as these medicines usually start working after about 2 weeks, sometimes later. The likelihood of such thoughts occurring is higher if:

• the patient has had suicidal thoughts or self-harm thoughts before
• the patient is an adult in their 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 the depression or anxiety has worsened or if worrying changes in behavior have occurred.

Children and adolescents

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 of this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). Nevertheless, the doctor may prescribe Betesda to patients under 18 years of age if they decide 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 or worsen in a patient under 18 years of age taking Betesda, the patient should inform their doctor. Additionally, the long-term safety of Betesda regarding growth, maturation, and cognitive development in this age group has not been established yet.

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 irreversible monoamine oxidase inhibitors (MAO) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. 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 inhibitors type A (RIMA) containing moclobemide (a medicine used to treat depression).
• Irreversible monoamine oxidase inhibitors type B (MAO-B) 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) and tryptophan.
• Imipramine and desipramine (both medicines used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). These medicines may increase the risk of side effects.
• Cimetidine and omeprazole (used to treat stomach ulcers), fluconazole (a medicine 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 and non-steroidal anti-inflammatory medicines (used as painkillers or to thin the blood, so-called anticoagulants). They may increase the risk of bleeding.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so-called anticoagulants). The doctor will probably prescribe a blood clotting test at the start and after stopping treatment with Betesda to determine if the dose of the anticoagulant is still appropriate.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to the possible risk of lowering the seizure threshold.
• Neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressant medicines (tricyclic antidepressant medicines) due to the possible risk of lowering the seizure threshold.
• Flecainide, propafenone, and metoprolol (used to treat heart conditions), clomipramine and nortriptyline (antidepressant medicines), and risperidone, thioridazine, and haloperidol (antipsychotic medicines). A dose adjustment of Betesda may be required.
• Medicines that lower potassium or magnesium levels in the blood, as there is a risk of life-threatening heart rhythm disorders in such situations.

Betesda should not be taken if the patient is taking medicines used to treat heart conditions or medicines that may affect the heartbeat, such as anti-arrhythmic medicines class IA and III, antipsychotic medicines (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressant medicines, and some antibacterial medicines (e.g., sparfloxacin, moxifloxacin, erythromycin given intravenously, pentamidine, antimalarial medicines, especially halofantrine), and some antihistamine medicines (e.g., 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 take 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 taking this medicine. Betesda should not be taken if the patient is pregnant or breastfeeding before discussing the risks and benefits of treatment with their doctor. If the patient takes 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, fluctuations in body temperature, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or flaccidity, increased reflexes, tremors, nervousness, irritability, lethargy, tearfulness, sleepiness, and difficulty sleeping. If any of these symptoms occur in the newborn, the patient should immediately consult their doctor. The patient should inform their doctor and/or midwife about taking Betesda. Taking medicines like Betesda, especially in the last three months of pregnancy, 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 baby. 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 shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient takes Betesda, they should inform their doctor or midwife so they can provide appropriate advice. Betesda should not be stopped abruptly during pregnancy. It is expected that Betesda passes into breast milk. In animal studies, citalopram, a medicine similar to escitalopram, affects sperm quality. This may theoretically affect fertility, but such an effect on fertility has not been observed in humans yet.

Driving and using machines

The patient will be advised not to drive or operate machinery until they know their reaction to Betesda.

Betesda contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Betesda

This medicine should always be taken exactly as prescribed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. Adult patients DepressionThe recommended dose of Betesda is usually 10 mg and is taken once a day. The dose may be increased by the doctor to a maximum of 20 mg per day. Panic disorderThe initial dose of Betesda is 5 mg once a day for the first week of treatment, then the dose is increased to 10 mg per day. The dose may then be increased by the doctor to a maximum of 20 mg per day. Social phobiaThe recommended dose of Betesda is 10 mg and is taken once a day. The dose may then be decreased by the doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on the patient's response to the medicine. Generalized anxiety disorderThe recommended dose of Betesda is 10 mg and is taken once a day. The dose may then be increased by the doctor to a maximum of 20 mg per day. Obsessive-compulsive disorder (OCD)The recommended dose of Betesda is 10 mg and is taken once a day. The dose may be increased by the doctor to a maximum of 20 mg per day. Elderly patients (over 65 years of age)The recommended initial dose of Betesda is 5 mg and is taken once a day. The dose may be increased by the doctor to 10 mg per day. Use in children and adolescentsBetesda should not be used in children and adolescents. For further information, see section 2 "Warnings and precautions". Renal impairment Caution should be exercised in patients with severe renal impairment. The medicine should be used as prescribed by the doctor. Hepatic impairment Patients with hepatic impairment should not exceed a dose of 10 mg per day. The medicine should be used as prescribed by the doctor. Patients who are poor metabolizers of medicines via the CYP2C19 enzyme Patients with this known genotype should not exceed a dose of 10 mg per day. The medicine should be used as prescribed by the doctor.

How to take Betesda

Betesda can be taken with or without food. The coated tablets should be swallowed with a small amount of water. The tablets should not be chewed, as they have a bitter taste. The tablet can be divided into equal doses.

Duration of treatment

The patient may feel better only after a few weeks of treatment. Therefore, the patient should continue taking Betesda, even if it takes some time before they feel better. The patient should not change the dose without consulting their doctor. Betesda should be taken for as long as prescribed by the doctor. 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.

Taking 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, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. The patient should take the packaging/container 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 has forgotten to take a dose and remembers before going to bed, they should take the missed dose immediately. The next day, the patient should take Betesda as prescribed. If the patient remembers missing a dose in the 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 stops 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 taken 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 Betesda, the patient should contact their doctor. The doctor may advise restarting treatment with Betesda and tapering it off more slowly. Withdrawal symptoms include dizziness (unsteady gait or balance disorders), tingling sensation, burning sensation, and (less commonly) a sensation like an electric shock (also in the head), sleep disturbances (vivid dreams, nightmares, insomnia), anxiety, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, or heart palpitations. If the patient has any doubts about taking the 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, agitation, 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 section 2 "Warnings and precautions".
• Yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction/hepatitis.
• Rapid or irregular heartbeat, fainting, which may be symptoms of a life-threatening condition called Torsades de Pointes.
• Suicidal thoughts or self-harm thoughts, see also section 2 "Warnings and precautions".
• Sudden swelling of the skin or mucous membranes (angioedema).
• Severe vaginal bleeding shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

In addition to the above, the following side effects have also been reported:

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

• Nausea.
• Headache.

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

• Nasal congestion or sinusitis (sinus infection).
• Decreased or increased appetite.
• Anxiety, restlessness, abnormal dreams, sleep disturbances, drowsiness, dizziness, yawning, tremors, tingling sensation.
• Diarrhea, constipation, vomiting, dry mouth.
• Increased sweating.
• Muscle and joint pain.
• Sexual dysfunction (delayed ejaculation, erectile dysfunction, decreased libido, and difficulty achieving orgasm in women).
• Feeling tired, fever.
• Weight gain.

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

• Hives, rash, itching.
• Grinding of the teeth, agitation, nervousness, panic attacks, confusion.
• Sleep disturbances, taste disturbances, fainting.
• Dilated pupils, vision disturbances, ringing in the ears (tinnitus).
• Hair loss.
• Excessive menstrual bleeding.
• Irregular menstrual bleeding.
• Weight loss.
• Rapid heartbeat.
• Swelling of the arms or legs.
• Nosebleeds.

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

• Aggression, depersonalization (feeling detached from one's body and mind), hallucinations.
• Slow heartbeat.

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

• Decreased sodium levels in the blood (manifested as nausea and malaise with muscle weakness or confusion).
• Dizziness when standing up due to low blood pressure (orthostatic hypotension).
• Abnormal liver function test results (increased liver enzyme activity in the blood).
• Movement disorders (involuntary muscle movements).
• Painful erection of the penis (priapism).
• Symptoms of unusual bleeding, e.g., from the skin and mucous membranes.
• Increased secretion of a hormone called ADH, which causes water retention in the body, dilution of the blood, and low sodium levels in the blood (inappropriate antidiuretic hormone secretion).
• Milk secretion in men and women who are not breastfeeding.
• Mania.
• Increased risk of bone fractures, which is observed in patients taking medicines of this type.
• Heart rhythm disorders (called QT interval prolongation, observed in an ECG that images the heart's electrical activity).

In addition, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Betesda):

• Restlessness (akathisia).
• Loss of appetite.

Reporting side effects

If any side effects occur, including any 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 Monitoring of Adverse Reactions to Medicinal Products 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 gathered on the safety of the medicine.

5. How to store Betesda

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the blister or carton after "EXP". The expiry date refers to the last day of that month. Store in a temperature below 30°C. 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 pack and other information

What Betesda contains

The active substance of Betesda is escitalopram. Each Betesda coated tablet contains 10 mg of escitalopram (which corresponds to 12.775 mg of escitalopram oxalate). The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, and magnesium stearate. Coating: titanium dioxide (E 171), hypromellose 3 cP, hypromellose 6 cP, macrogol 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, coated tablets with a score line, with "J" embossed on one side and "2" on the other side. Betesda is available in the following pack sizes: Blister packs (white) in a carton: 28 coated tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

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

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 more detailed information on this medicine and its names in the Member States of the European Economic Area, the patient should contact the marketing authorization holder.

Date of last revision of the leaflet: June 2021