Escitalopram Bluefish

PATIENT INFORMATION LEAFLET: USER INFORMATION

Escitalopram Bluefish, 10 mg, film-coated tablets

Escitalopram Bluefish, 20 mg, film-coated tablets

Escitalopram

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Escitalopram Bluefish and what is it used for
• 2. Important information before taking Escitalopram Bluefish
• 3. How to take Escitalopram Bluefish
• 4. Possible side effects
• 5. How to store Escitalopram Bluefish
• 6. Contents of the pack and other information

1. What is Escitalopram Bluefish and what is it used for

The active substance of Escitalopram Bluefish is escitalopram. Escitalopram Bluefish 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 serotonin levels. Disruption of the serotonin system is thought to be a major factor in the development of depression and related diseases. Escitalopram Bluefish contains escitalopram and is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder). Improvement may occur only after several weeks of treatment. You should continue to take Escitalopram Bluefish even if it takes some time before you feel better. Tell your doctor if you do not feel better or feel worse.

2. Important information before taking Escitalopram Bluefish

When not to take Escitalopram Bluefish:

• if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6)
• if you are taking other medicines that belong to the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic)
• if you have a congenital condition that affects your heart rhythm or have had an episode of irregular heart rhythm (detected on an ECG)
• if you are taking medicines that affect your heart rhythm or may affect your heart (see section 2 "Escitalopram Bluefish and other medicines")

Warnings and precautions

Before taking Escitalopram Bluefish, discuss it with your doctor or pharmacist. Tell your doctor if you have other conditions or diseases, as they may need to be taken into account. In particular, inform your doctor:

• if you have epilepsy; treatment with Escitalopram Bluefish should be discontinued if seizures occur for the first time or if their frequency increases (see also section 4 "Possible side effects")
• if you have liver or kidney problems; your doctor may need to adjust the dose
• if you have diabetes; treatment with Escitalopram Bluefish may affect blood sugar control. It may be necessary to adjust the dose of insulin and/or oral antidiabetic medicines
• if you have low sodium levels in the blood
• if you have a tendency to bleed easily or have bruises, or if you are pregnant (see "Pregnancy, breastfeeding, and fertility")
• if you are receiving electroconvulsive therapy
• if you have coronary heart disease
• if you have or have had heart problems or have recently had a heart attack
• if you have a slow heart rate and/or suspected low levels of electrolytes due to prolonged severe diarrhea, vomiting, or taking diuretic medicines
• if you have a fast or irregular heartbeat, fainting, collapse, or dizziness when standing up, which may indicate heart rhythm disorders
• if you have or have had eye problems, such as certain types of glaucoma (increased pressure in the eye)

Caution

In some patients with bipolar 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, contact your doctor. In the first few weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform your doctor immediately. Some medicines can increase the side effects of Escitalopram Bluefish and sometimes cause very serious reactions. Tell your doctor if you are taking any other medicine (see section "Escitalopram Bluefish and other medicines"). If you experience any of the following symptoms while taking Escitalopram Bluefish, contact your doctor immediately, as it may indicate that you have developed a life-threatening condition called serotonin syndrome. Symptoms include involuntary, rhythmic muscle contractions, including those that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle stiffness, and body temperature above 38°C.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. These symptoms or behaviors may worsen at the start of treatment with antidepressant medicines, as they usually start working only after about 2 weeks, sometimes later. The occurrence of these symptoms is more likely in:

• patients who have had thoughts of self-harm or suicide before
• young adults. Clinical trial data show an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressant medicines.

If you experience thoughts of self-harm or suicide, contact your doctor immediatelyor go to the hospital. It may be helpful to inform your relatives or friendsabout your depression or anxiety disorder and ask them to read this leaflet. You may want to ask them to tell you if they notice that your depression or anxiety is getting worse or if you are behaving strangely.

Children and adolescents

Escitalopram Bluefish should not normally be used in children and adolescents under 18 years of age. It is also important to note that in patients under 18, treatment with this class of medicines may increase the risk of side effects, such as attempted suicide, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). Nevertheless, your doctor may prescribe Escitalopram Bluefish to patients under 18 if they consider it necessary. If your doctor has prescribed Escitalopram Bluefish to a patient under 18 and you have any concerns, contact your doctor again. If the above symptoms occur or worsen in patients under 18 taking Escitalopram Bluefish, inform your doctor. So far, there is no data on the long-term safety of escitalopram in this age group regarding growth, maturation, and cognitive and behavioral development.

Escitalopram Bluefish and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If you have taken any of these medicines, wait 14 days before starting to take Escitalopram Bluefish. After stopping treatment with Escitalopram Bluefish, wait 7 days before taking any of these medicines
• Reversible selective inhibitors of monoamine oxidase A (RIMAs) containing moclobemide (used to treat depression)
• Irreversible inhibitors of monoamine oxidase 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 (used to treat depression)
• Sumatriptan and similar medicines (used to treat migraines), tramadol (used to treat severe pain), and buprenorphine (used to treat opioid addiction or moderate pain). These medicines increase the risk of side effects
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (an antifungal medicine), 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
• Aspirin and non-steroidal anti-inflammatory medicines (used to relieve pain or thin the blood, known as anticoagulants). They may increase the risk of bleeding
• Warfarin, dipyridamole, and phenprocoumon (used to thin the blood, known as anticoagulants). Your doctor will probably check your blood clotting time before and after starting treatment with Escitalopram Bluefish to ensure that the dose of 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
• Antipsychotics (used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants or SSRIs) due to the possible risk of lowering the seizure threshold
• Flecainide, propafenone, and metoprolol (used to treat heart and blood vessel diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Bluefish may be necessary
• Medicines that lower potassium or magnesium levels in the blood, due to the increased risk of life-threatening heart rhythm disorders

Do not take Escitalopram Bluefish if you are taking medicines used to treat heart rhythm disorders or that may affect heart function, such as anti-arrhythmic medicines of class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozyd, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, mizolastine). If you have any further questions, ask your doctor.

Escitalopram Bluefish with food, drink, and alcohol

Escitalopram Bluefish can be taken with or without food (see section 3 "How to take Escitalopram Bluefish"). As with many other medicines, it is not recommended to take Escitalopram Bluefish with alcohol, although you do not need to expect an interaction between Escitalopram Bluefish and alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take Escitalopram Bluefish during pregnancy and breastfeeding unless you have discussed the risks and benefits with your doctor. If you take Escitalopram Bluefish during the last 3 months of pregnancy, be aware that your newborn may experience the following symptoms: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiffness or floppiness, increased reflexes, tremors, tremors, irritability, constant crying, sleepiness, and difficulty sleeping. If your newborn experiences any of these symptoms, contact your doctor immediately. Make sure your midwife and/or doctor know that you are taking Escitalopram Bluefish. Medicines like Escitalopram Bluefish, taken during pregnancy, especially during the last 3 months, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension, which causes the baby to breathe faster than normal and turn blue. These symptoms usually occur within the first 24 hours after birth. If your baby experiences these symptoms, tell your doctor or midwife immediately. Taking Escitalopram Bluefish at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you take Escitalopram Bluefish, inform your doctor or midwife so that they can give you appropriate advice. Never stop taking Escitalopram Bluefish during pregnancy without consulting your doctor. It is expected that Escitalopram Bluefish will pass into breast milk. Animal studies have shown that citalopram, a medicine similar to escitalopram, impairs sperm quality. This could theoretically affect fertility in men, but it has not been observed in humans so far.

Driving and using machines

Do not drive or operate machinery until you know how Escitalopram Bluefish affects you.

Escitalopram Bluefish contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per 10 mg and 20 mg tablet, which means it is essentially "sodium-free".

3. How to take Escitalopram Bluefish

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Adults

Depression

The recommended dose of Escitalopram Bluefish is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum dose of 20 mg per day.

Panic disorder

The initial dose of Escitalopram Bluefish is 5 mg once daily for the first week, then the dose is increased to 10 mg once daily. The dose may then be increased by your doctor to a maximum dose of 20 mg per day.

Social anxiety disorder

The recommended dose of Escitalopram Bluefish is 10 mg, taken as a single dose once daily. The dose may then be decreased by your doctor to 5 mg per day or increased to a maximum of 20 mg per day, depending on your response to the medicine.

Generalized anxiety disorder

The recommended dose of Escitalopram Bluefish is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum dose of 20 mg per day.

Obsessive-compulsive disorder

The recommended dose of Escitalopram Bluefish is 10 mg, taken as a single dose once daily. The dose may be increased by your doctor to a maximum dose of 20 mg per day.

Elderly patients (over 65 years)

The recommended initial dose of Escitalopram Bluefish is 5 mg, taken as a single dose once daily. The dose may be increased by your doctor to 10 mg per day.

Use in children and adolescents

Escitalopram Bluefish should not normally be used in children and adolescents under 18 years of age. Additional information is provided in section 2 "Important information before taking Escitalopram Bluefish".

Escitalopram Bluefish can be taken with or without food.

Swallow the tablets with water. Do not chew them, as they have a bitter taste.

If necessary, the tablet can be divided into two equal doses by placing it on a flat surface with the score line facing up and pressing the edges with your index fingers, as shown in the picture.

The 10 mg and 20 mg tablets can be divided into equal doses.

Duration of treatment

Improvement may occur only after several weeks of treatment. You should continue to take Escitalopram Bluefish even if it takes some time before you feel better. Do not change the dose without consulting your doctor. You should take Escitalopram Bluefish for as long as your doctor recommends. If you stop treatment too early, your symptoms may return. It is recommended to continue treatment for at least 6 months after you feel better.

Taking a higher dose of Escitalopram Bluefish than recommended

If you have taken more Escitalopram Bluefish than prescribed, contact your doctor or go to the emergency room immediately. Do this even if you do not feel any symptoms. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. Take the Escitalopram Bluefish packaging with you to the doctor or hospital.

Missing a dose of Escitalopram Bluefish

Do not take a double dose to make up for a missed dose. If you forget to take a dose and remember before bedtime, take the missed dose immediately. Take the next dose at the usual time the next day. If you remember that you missed a dose in the night or the next day, skip the missed dose and take the next dose at the usual time.

Stopping treatment with Escitalopram Bluefish

Do not stop taking Escitalopram Bluefish without consulting your doctor. When you stop treatment, it is usually recommended to gradually reduce the dose of Escitalopram Bluefish over a few weeks. After stopping treatment with Escitalopram Bluefish, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common, and the risk is higher if Escitalopram Bluefish has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, symptoms are mild and disappear on their own within two weeks. However, in some patients, they may be more severe or last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping Escitalopram Bluefish, contact your doctor. Your doctor may recommend restarting treatment with Escitalopram Bluefish and reducing the dose more slowly. Withdrawal symptoms include dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less often) electric shock sensation, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), agitation or excitement, tremors, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, rapid heartbeat or palpitations. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects usually disappear after a few weeks of treatment. Remember that some of these side effects may also be symptoms of your illness and will improve as you get better. If you experience any of the following side effects during treatment, contact your doctor or go to the emergency room immediately.

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

• Unusual bleeding, including bleeding from the gastrointestinal tract.

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

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

Unknown (frequency cannot be estimated from the available data):

• Difficulty urinating
• Seizures, see also section "Warnings and precautions"
• Yellowing of the skin and whites of the eyes, which is a sign of liver dysfunction and/or hepatitis
• Rapid or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsades de pointes
• Suicidal thoughts and behaviors, see also section "Warnings and precautions"

In addition, the following side effects have been reported:

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

• Nausea (feeling sick)
• Headache

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

• Nasal congestion or sinusitis (sinus infection)
• Decreased or increased appetite
• Anxiety, restlessness, vivid dreams, difficulty sleeping, drowsiness, dizziness, yawning, tremors, tingling sensation, and numbness
• Diarrhea, constipation, vomiting, dry mouth
• Increased sweating
• Muscle and joint pain
• Sexual disturbances (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
• Teeth grinding, agitation, nervousness, panic attacks, confusion (disorientation)
• Sleep disturbances, taste disturbances, fainting
• Dilated pupils, vision disturbances, ringing in the ears (tinnitus)
• Hair loss
• Excessive menstrual bleeding
• Irregular menstrual periods
• Weight loss
• Rapid heartbeat
• Swelling of the arms or legs
• Nosebleeds

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

• Aggression, depersonalization (feeling of losing one's identity), hallucinations
• Slow heartbeat

Unknown (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 increased bleeding, such as bruising or bleeding from mucous membranes (ecchymoses)
• Sudden swelling of the skin or mucous membranes (angioedema)
• Increased urine production (inappropriate secretion of antidiuretic hormone, vasopressin)
• Milk secretion in women who are not breastfeeding
• Mania
• Changes in heart rhythm (called "QT interval prolongation", which is observed in an ECG, a record of the electrical activity of the heart)
• Severe bleeding from the vagina, occurring shortly after delivery (postpartum hemorrhage), see additional information in section "Pregnancy, breastfeeding, and fertility"

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

• Restlessness (akathisia)
• Anorexia

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety Monitoring, 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escitalopram Bluefish

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month. Store in a temperature below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Escitalopram Bluefish contains

• The active substance is escitalopram. Each tablet contains 10 mg or 20 mg of escitalopram (corresponding to 12.775 mg or 25.550 mg of escitalopram oxalate).
• The other ingredients of the medicine are: Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sodium carboxymethylcellulose, talc, and magnesium stearate. Coating: titanium dioxide (E 171), hypromellose, macrogol 400, and polysorbate 80.

What Escitalopram Bluefish looks like and contents of the pack

Escitalopram Bluefish is available as film-coated tablets in strengths of 10 mg and 20 mg. The description of the tablets is given below. 10 mg: White or almost white, oval, biconvex film-coated tablets, approximately 7.9 x 5.4 mm in size, with a score line, with the inscription "J" on one side and "2" on the other side. 20 mg: White or almost white, oval, biconvex film-coated tablets, approximately 11.4 x 6.9 mm in size, with a score line, with the inscription "J" on one side and "4" on the other side. The 10 mg and 20 mg tablets can be divided into equal doses. Escitalopram Bluefish is available in the following pack sizes: Transparent blisters (PVC/PE/PVDC/Aluminum): 10 mg and 20 mg: 28 film-coated tablets

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden

Manufacturer/Importer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden, Pharmadox Healthcare Ltd., KW20A Corradino Industrial Estate, Paola, PLA 3000, Malta

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

Date of last revision of the leaflet:20.05.2021