Escitalopram bluefish

Escitalopram Bluefish, 10 mg, film-coated tablets
Escitalopram Bluefish, 20 mg, film-coated tablets
Escitalopram
Please read the entire package leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

The active substance in Escitalopram Bluefish is escitalopram. Escitalopram Bluefish belongs to
a group of antidepressant medicines known as selective serotonin reuptake inhibitors (SSRIs).
These medicines act on the serotonin system in the brain by increasing serotonin levels. Serotonin system disturbances
are considered a significant factor in the development of depression and related disorders.
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 only occur after several weeks of treatment. Treatment with Escitalopram Bluefish should be continued, even if it takes some time before the patient's well-being improves.
Inform the doctor if the patient does not feel better or feels worse.

2. Important information before using Escitalopram Bluefish

When not to use Escitalopram Bluefish:

• 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 of MAO inhibitors, including selegiline (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression), or linezolid (an antibiotic)
• if the patient has a congenital tendency to heart rhythm disorders or has previously experienced an episode of heart rhythm disturbances (detected on ECG, a test assessing heart function)
• if the patient is taking medicines used to treat heart rhythm disorders or that may affect heart function (see section 2 "Escitalopram Bluefish and other medicines")

Warnings and precautions
Before starting to take Escitalopram Bluefish, discuss this with your doctor or
pharmacist.
Inform your doctor if the patient has any other disorders or diseases, as these may need to be taken into account. In particular, inform the doctor:

• if the patient has epilepsy; treatment with Escitalopram Bluefish 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; the doctor may consider it necessary to adjust the dose;
• if the patient has diabetes; treatment with Escitalopram Bluefish may affect blood glucose control. Adjustment of insulin and/or oral antidiabetic drugs may be required;
• if the patient has low blood sodium levels;
• if the patient has a tendency to bleed or bruise easily, or if the patient is pregnant (see "Pregnancy, breastfeeding and fertility");
• if the patient is undergoing electroconvulsive therapy;
• if the patient has ischemic heart disease;
• if the patient has heart problems or has recently had a heart attack;
• if the patient has a slow resting heart rate and/or electrolyte deficiency is suspected due to prolonged severe diarrhoea, vomiting, or use of diuretics;
• if the patient has rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate heart rhythm disturbances;
• if the patient has or has previously had eye problems, such as certain types of glaucoma (increased eye pressure).

Note
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, consult a doctor.
During the first weeks of treatment, symptoms such as restlessness or difficulty sitting or standing still may also occur. If such symptoms appear, inform the doctor immediately.
Some medicines may worsen the side effects of Escitalopram Bluefish and sometimes cause very severe reactions. Inform the doctor if the patient is taking any other medicine (see section "Escitalopram Bluefish and other medicines").
If any of the following symptoms occur during treatment with Escitalopram Bluefish, contact a doctor immediately, as they may indicate serotonin syndrome, a potentially life-threatening condition. Symptoms include involuntary, rhythmic muscle contractions, including those affecting eye movement, agitation, hallucinations, coma, excessive sweating, tremor, increased reflexes, increased 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 beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working.
The occurrence of these symptoms is more likely in:

• patients who previously experienced thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient develops thoughts of self-harm or suicide, contact a doctor immediately or go to a hospital.
It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask them to inform him/her if they notice worsening depression or anxiety, or concerning changes in behavior.
Medicines such as Escitalopram Bluefish (so-called SSRIs or SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Escitalopram Bluefish should generally not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age taking medicines of this class are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviors, and manifestations of anger). Nevertheless, a doctor may prescribe Escitalopram Bluefish to patients under 18 years of age if he or she determines it is in their best interest. If a doctor has prescribed Escitalopram Bluefish to a patient under 18 years of age and there are any doubts, contact the doctor again. If the mentioned symptoms appear or worsen in patients under 18 years of age taking Escitalopram Bluefish, inform the doctor. There is currently no data on the long-term safety of escitalopram use in this age group regarding growth, maturation, and cognitive and behavioral development.
Escitalopram Bluefish and other medicines
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs), containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, they should wait 14 days before starting Escitalopram Bluefish. After stopping Escitalopram Bluefish, wait 7 days before taking any of these medicines;
• Reversible, selective monoamine oxidase A (MAO-A) inhibitors, containing moclobemide (used in the treatment of depression);
• Irreversible monoamine oxidase B (MAO-B) inhibitors, containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of adverse effects;
• The antibiotic linezolid;
• Lithium (used in the treatment of bipolar affective disorder) and tryptophan;
• Imipramine and desipramine (used in the treatment of depression);
• Sumatriptan and similar medicines (used in the treatment of migraine), tramadol (used for severe pain), and buprenorphine (used in the treatment of opioid addiction or moderate pain). These medicines increase the risk of adverse effects;
• Cimetidine, lansoprazole, and omeprazole (used in the treatment of stomach ulcers), fluconazole (an antifungal medicine), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These medicines may increase the blood concentration of escitalopram;
• St. John's wort (Hypericum perforatum) – a herbal medicine used for depression;
• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (painkillers or blood-thinning medicines, known as anticoagulants). These may increase the tendency to bleed;
• Warfarin, dipyridamole, and phenprocoumon (blood-thinning medicines, known as anticoagulants). The doctor will likely monitor blood clotting time before starting and after stopping Escitalopram Bluefish to ensure the dose of anticoagulant remains appropriate;
• Mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression), and tramadol (used for severe pain), due to the possible risk of lowering the seizure threshold;
• Neuroleptics (medicines used in the treatment of schizophrenia, psychosis) and antidepressants (tricyclic antidepressants or SSRIs) due to the possible risk of lowering the seizure threshold;
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A change in the dosage of Escitalopram Bluefish may be required;
• Medicines that reduce blood potassium or magnesium levels, due to an increased risk of life-threatening heart rhythm disturbances;

Do not take Escitalopram Bluefish if the patient is taking medicines used to treat
heart rhythm disorders or that may affect heart function, such as class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If in doubt, consult a 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 consume alcohol while taking Escitalopram Bluefish, although interaction between Escitalopram Bluefish and alcohol is not expected.
Pregnancy, breastfeeding, and 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 Escitalopram Bluefish during pregnancy or breastfeeding without first discussing the risks and benefits with a doctor.
If the patient has taken Escitalopram Bluefish during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, bluish skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, persistent crying, drowsiness, and difficulty sleeping. If the newborn shows any of these symptoms, seek medical advice immediately.
Ensure that the midwife and/or doctor know that the patient is taking Escitalopram Bluefish. Medicines such as Escitalopram Bluefish, when used 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 appear blue. These symptoms usually occur within the first 24 hours after birth. If the baby shows such symptoms, inform the doctor or midwife immediately.
Taking Escitalopram Bluefish towards the end of pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Escitalopram Bluefish, she should inform her doctor or midwife so they can provide appropriate advice.
When taking Escitalopram Bluefish during pregnancy, do not stop treatment suddenly.
Escitalopram Bluefish is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, worsens semen quality. Theoretically, this may affect male fertility, but such an effect on human fertility has not been observed so far.
Driving and operating machinery
Do not drive or operate machinery until the effect of Escitalopram Bluefish on the individual is known.
Escitalopram Bluefish contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 10 mg and 20 mg tablet, meaning the medicine is considered "sodium-free".

3. How to use Escitalopram Bluefish

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

Depression
The usual recommended dose of Escitalopram Bluefish is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to the maximum dose of 20 mg per day.

Panic disorder
The initial dose of Escitalopram Bluefish is 5 mg once daily during the first week of treatment. The dose is then increased to 10 mg per day. Your doctor may further increase the dose up to the maximum dose of 20 mg per day.

Social phobia
The usual recommended dose of Escitalopram Bluefish is 10 mg taken once daily as a single dose. Depending on the patient's response to the medicine, the dose may then be reduced by the doctor to 5 mg per day or increased up to a maximum of 20 mg per day.

Generalised anxiety disorder
The usual recommended dose of Escitalopram Bluefish is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to the maximum dose of 20 mg per day.

Obsessive-compulsive disorder
The usual recommended dose of Escitalopram Bluefish is 10 mg taken once daily as a single dose. Your doctor may increase the dose up to the maximum dose of 20 mg per day.

Elderly patients (over 65 years)
The recommended initial dose of Escitalopram Bluefish is 5 mg taken once daily as a single dose. Your doctor may increase the dose 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 may be taken with or without food.
Tablets should be swallowed with water. Do not chew the tablets, as they have a bitter taste.
If necessary, the tablet can be divided into two equal parts by placing it on a flat surface with the groove facing upwards, then pressing the edges with the index fingers of both hands, as shown in the illustration.

Tablets of 10 mg and 20 mg strength can be divided into equal doses.

Duration of treatment
Improvement may occur only after several weeks of treatment. Continue taking Escitalopram Bluefish even if it takes some time before your well-being improves.
Do not change the dosage without consulting your doctor.
Take Escitalopram Bluefish for as long as your doctor recommends. If treatment is stopped too early, symptoms may return. Therefore, treatment should be continued for at least 6 months after regaining good well-being.

Taking more Escitalopram Bluefish than prescribed
If you take more Escitalopram Bluefish than prescribed, contact your doctor immediately or go to the nearest hospital emergency department. This should be done even if you do not feel any discomfort. Symptoms of overdose include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, cardiac arrhythmias, low blood pressure, and disturbances in water and electrolyte balance. Bring the medicine pack of Escitalopram Bluefish with you to the doctor's visit or hospital.

If you miss 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 going to bed, take the missed dose immediately and take the next dose the following day at the usual time. If you remember about the missed dose during 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 unless your doctor advises you to do so. When stopping treatment, your doctor will usually recommend gradually reducing the dose of Escitalopram Bluefish over several weeks.

After stopping Escitalopram Bluefish, especially if 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, 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 Escitalopram Bluefish, contact your doctor. Your doctor may recommend restarting the medicine and tapering it more slowly.

Withdrawal symptoms include dizziness (unsteady gait, balance disturbances), tingling sensations, burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep disturbances (vivid dreams, nightmares, insomnia), feelings of anxiety, headache, nausea, sweating (including night sweats), psychomotor agitation or restlessness, tremors, feelings of disorientation, emotional instability or irritability, diarrhoea (loose stools), visual disturbances, strong or rapid heartbeat, or palpitations.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects usually resolve within a few weeks of treatment. Remember that some of these
effects may also be symptoms of the illness itself and will improve as your condition gets better.
If any of the following adverse effects occur during treatment, contact your doctor immediately or go to the nearest hospital.

Not very common (may occur in up to 1 in 100 people):

• Unusual bleeding, including gastrointestinal bleeding.

Rare (may occur in up to 1 in 1000 people):

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

Frequency unknown (cannot be estimated from available data):

• Difficulty passing urine;
• Seizures; see also section “Warnings and precautions”;
• Yellowing of the skin and whites of the eyes, indicating liver dysfunction and/or hepatitis;
• Rapid, irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders called torsade de pointes;
• Suicidal thoughts and behaviour; see also section “Warnings and precautions”.

In addition, the following adverse effects have also been reported:
Very common (may occur in more than 1 in 10 people):

• Nausea;
• Headache.

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

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

Not very common (may occur in up to 1 in 100 people):

• Urticaria, rash, itching;
• Teeth grinding, agitation, restlessness, panic attack, confusion (disorientation);
• Sleep disturbances, taste disturbances, fainting;
• Pupil dilation, visual disturbances, ringing in the ears (tinnitus);
• Hair loss;
• Heavy menstrual bleeding;
• Irregular menstruation;
• Weight loss;
• Rapid heartbeat;
• Swelling of the upper or lower limbs;
• Nosebleeds.

Rare (may occur in up to 1 in 1000 people):

• Aggression, depersonalisation (feeling of loss of self-identity), hallucinations;
• Slow heartbeat.

Frequency unknown (cannot be estimated from available data):

• Decreased sodium concentration in the blood (manifesting as nausea and malaise, with muscle weakness or confusion);
• Dizziness upon standing due to low blood pressure (orthostatic hypotension);
• Abnormal liver function tests (increased liver enzyme activity in the blood);
• Movement disorders (involuntary muscle movements);
• Painful penile erection (priapism);
• Signs of increased bleeding, e.g. under the skin or from mucous membranes (petechiae);
• Sudden swelling of the skin or mucous membranes (angioedema);
• Increased urine production (inappropriate antidiuretic hormone secretion + vasopressin);
• Milk production in women who are not breastfeeding (galactorrhea);
• Mania;
• Changes in heart rhythm (known as “QT interval prolongation”, observed on ECG, the recording of the heart's electrical activity);
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage); see additional information in subsection “Pregnancy, breastfeeding and fertility” in section 2.

In addition, adverse effects are known from medicines with a similar mechanism of action to escitalopram
(active substance in Escitalopram Bluefish). These include:

• Psychomotor restlessness (akathisia);
• Loss of appetite.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the responsible entity.
By reporting adverse effects, more information on the safety of this medicine can be collected.

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 the carton under “Expiry date” or “EXP”. The expiry date refers to the last day of the specified month.
Store below 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Escitalopram Bluefish contains

• The active substance is escitalopram. Each tablet contains 10 mg or 20 mg of escitalopram (equivalent to 12.775 mg or 25.550 mg escitalopram oxalate).
• The other ingredients are:
  Tablet core: microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium croscarmellose, 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 central break line and engraved with the code "J" on one side and "2" on the other.
20 mg: White or almost white, oval, biconvex film-coated tablets, approximately 11.4 x 6.9 mm in size, with a central break line and engraved with the code "J" on one side and "4" on the other.
The 10 mg and 20 mg tablets can be divided into equal doses.
Escitalopram Bluefish is available in the following pack sizes:
Clear blisters (PVC/PE/PVDC/Aluminium):
10 mg and 20 mg: 28 film-coated tablets

Marketing Authorisation 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 authorised in the European Economic Area countries under the following names: