Escitalopram bluefish

Escitalopram Bluefish, 10 mg, film-coated tablets
Escitalopram Bluefish, 20 mg, film-coated tablets
Escitalopram
Please read this 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 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. What you need to know 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. It is important to continue taking Escitalopram Bluefish even if it takes some time before the patient feels better.
Tell your 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 predisposition 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 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 considered. 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 adjusting the dose;
• if the patient has diabetes; treatment with Escitalopram Bluefish may affect blood glucose control. Adjustment of insulin and/or oral antidiabetic medicines may be necessary;
• if the patient has low sodium levels in the blood;
• if the patient has a tendency to bleed more easily or bruise, or if the patient is pregnant (see "Pregnancy, breastfeeding and effect on 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 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 characterised 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 increase 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 behaviours 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 had thoughts of self-harm or suicide;
• young adult patients. Clinical trial data show an increased risk of suicidal behaviour 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 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 behaviour.
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, oppositional behaviours, and manifestations of anger). Nevertheless, a doctor may prescribe Escitalopram Bluefish to patients under 18 years of age if he/she considers it to be 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. To date, there is no data on the long-term safety of escitalopram use in this age group regarding growth, maturation, cognitive development, and behavioural development.
Escitalopram Bluefish and other medicines
Inform the doctor about all medicines currently or recently taken, 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 (MAO), containing active substances such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine. If the patient has taken any of these medicines, a 14-day interval should be observed 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 concentration of escitalopram in the blood;
• 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 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 in cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). A dose adjustment of Escitalopram Bluefish may be required;
• Medicines that reduce potassium or magnesium levels in the blood, 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 agents (e.g., sparfloxacin,
moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines,
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 no interaction between Escitalopram Bluefish and alcohol is expected.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. Do not use Escitalopram Bluefish during pregnancy or breastfeeding unless discussed with a doctor regarding the risks and benefits of treatment.
If the patient takes Escitalopram Bluefish during the last 3 months of pregnancy, she should be aware that the newborn may experience the following symptoms: breathing difficulties, blue skin, seizures, temperature fluctuations, feeding difficulties, vomiting, low blood glucose levels, muscle stiffness or floppiness, increased reflexes, tremors, jitteriness, irritability, lethargy, constant crying, drowsiness, and sleep disturbances. If any of these symptoms occur in the newborn, seek medical advice immediately.
Ensure that the midwife and/or doctor are aware that the patient is taking Escitalopram Bluefish. Medicines such as Escitalopram Bluefish, when used during pregnancy, particularly during the last 3 months, may increase the risk in the newborn of a serious condition called persistent pulmonary hypertension, which causes the baby to breathe faster than normal and have cyanosis. 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 severe 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, never stop treatment abruptly.
Escitalopram Bluefish is expected to pass into breast milk.
Animal studies have shown that citalopram, a medicine similar to escitalopram, impairs semen quality. Theoretically, this may affect male fertility, but such an effect on human fertility has not been observed to date.
Driving and operating machinery
Do not drive or operate machinery until it is known how Escitalopram Bluefish affects the individual.
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 take Escitalopram Bluefish

This medicine should always be taken exactly as directed by your doctor. If you are unsure, 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 your response to the medicine, your doctor may reduce the dose to 5 mg per day or
increase it 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 starting 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 usually 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.
Swallow the tablets with water. Do not chew them, as they have a bitter taste.
If necessary, the tablet can be split into two 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.

Duration of treatment
Improvement may take several weeks to occur. Continue taking Escitalopram Bluefish even if it takes
some time before you feel better. Do not change the dose 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 recovery
to maintain 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. Do this even if you do not feel unwell. Symptoms of
overdose may include dizziness, tremors, agitation, seizures, coma, nausea, vomiting, irregular
heartbeat, low blood pressure, and disturbances in water and electrolyte balance. Bring the
Escitalopram Bluefish packaging with you to the doctor's office 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 going to bed, take the missed dose immediately and take the next dose at the usual time. If
you remember 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 tells you to. When stopping treatment,
your doctor will usually recommend gradually reducing the dose of Escitalopram Bluefish over a
period of several weeks.
After stopping Escitalopram Bluefish, especially if stopped abruptly, you may experience withdrawal
symptoms. These symptoms are common and the risk is greater 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 on their own 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 reducing the dose more slowly.
Withdrawal symptoms may include dizziness (unsteadiness, loss of balance), tingling sensations,
burning sensations, and (less commonly) electric shock-like sensations, including in the head, sleep
disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea, sweating (including
night sweats), psychomotor agitation or activation, tremors, feelings of disorientation, emotional
instability or irritability, diarrhoea (loose stools), visual disturbances, and palpitations (rapid or
pounding heartbeat).
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product can cause adverse reactions, although not everybody will experience them.
Adverse reactions usually subside after a few weeks of treatment. It is important to remember that some
of these reactions may also be symptoms of the illness itself and may resolve as the patient's condition improves.
If any of the following adverse reactions occur during treatment, the patient should immediately contact a doctor 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 (allergic reaction);
• High fever, agitation, confusion (disorientation), tremors and violent muscle contractions, which may be symptoms of a rare condition called serotonin syndrome.

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

• Difficulty in 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 or irregular heartbeat, fainting, which may be symptoms of life-threatening heart rhythm disorders known as torsade de pointes;
• Suicidal thoughts and behaviour, see also section “Warnings and precautions”.

In addition, the following adverse reactions 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 runny nose (sinusitis);
• Decreased or increased appetite;
• Anxiety, psychomotor agitation, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensations 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, nervousness, 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 not known (cannot be estimated from available data):

• Decreased sodium concentration in blood (manifested by nausea, malaise, muscle weakness or confusion);
• Dizziness upon standing due to low blood pressure (orthostatic hypotension);
• Abnormal liver function tests (increased liver enzyme activity in blood);
• Movement disorders (involuntary muscle movements);
• Painful penile erection (priapism);
• Signs of increased bleeding, e.g. under the skin or from mucous membranes (petechiae);
• Sudden swelling of the skin or mucous membranes (angioedema);
• Increased urine output (inappropriate antidiuretic hormone [vasopressin] secretion);
• Lactation in women who are not breastfeeding;
• Mania;
• Changes in heart rhythm (known as “QT interval prolongation”, observed in ECG, the recording of electrical heart 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 reactions associated with medicines having a similar mechanism of action to escitalopram
(active substance in Escitalopram Bluefish) are known. These include:

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can
be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Escitalopram Bluefish

Keep the 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 "Expiry date" or "EXP". The expiry date refers to the last day of the stated 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. 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 are:
  Tablet core: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, and magnesium stearate.
  Coating: titanium dioxide (E 171), hypromellose, polyethylene glycol 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 provided 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:
Transparent 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 Member States of the European Economic Area under the following names: