5 mg, 10 mg, 15 mg, 20 mg film-coated tablets 
escitalopram

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. See section 4.

In this leaflet: 
1. What Escitalopram Bluefish is and what it is used for 
2. What you need to know before you take Escitalopram Bluefish 
3. How to take Escitalopram Bluefish 
4. Possible side effects 
5. How to store Escitalopram Bluefish 
6. Contents of the packaging and other information 

What Escitalopram Bluefish is and what it is used for

Escitalopram Bluefish contains the active substance escitalopram. Escitalopram Bluefish belongs to a group of antidepressant drugs called selective serotonin reuptake inhibitors ( SSRIs ). These drugs act on the serotonin system in the brain by increasing serotonin levels. Disorders of the serotonin system are considered an important factor in the development of depression and related diseases.

Escitalopram Bluefish contains escitalopram and is used to treat depression and anxiety disorders (such as panic disorder with or without market anxiety, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take a couple of weeks before you start to feel better. Continue to take Escitalopram Bluefish, even if it takes some time before you feel any improvement.

Talk to your doctor if you do not feel any improvement or if your condition worsens.

Escitalopram contained in Escitalopram Bluefish may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Escitalopram Bluefish

Do not take Escitalopram Bluefish

  • if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson’s disease ), moclobemide (used to treat depression), and linezolid (an antibiotic ).
  • if you have been born with or have had a period of abnormal heart rhythm (as observed with ECG, a method that examines how the heart works).
  • if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and Escitalopram Bluefish”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Escitalopram Bluefish.

Tell your doctor if you have other illnesses as your doctor may need to consider this. This is especially true:

  • if you have epilepsy. Treatment with escitalopram should be discontinued if you experience seizures for the first time or if the seizures occur at more frequent intervals (see section 4 “Possible side effects”).
  • if you have impaired liver or kidney function. Your doctor may need to adjust doseone.
  • if you have diabetes. Treatment with Escitalopram Bluefish may affect your blood sugar level. The dose of one of the insulin and/or blood sugar-lowering tablets may need to be changed.
  • if you have decreased levels of sodium in your blood.
  • if you have a tendency to bleed or bruise easily, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”).
  • if you receive electrical treatment.
  • if you have coronary heart disease.
  • if you suffer from or have suffered from heart problems or recently had a heart attack.
  • if you have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics ).
  • if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate the abnormal function of the heartbeat.
  • if you suffer from narrow-angle glaucoma or have had glaucoma (increased pressure in the eye).

Note

Some patients with manic-depressive illness may go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.

Symptoms such as restlessness and difficulty sitting or standing still can also occur during the first weeks of treatment. Contact your doctor immediately if you experience these symptoms.

If you start to feel worse and have thoughts of harming yourself

You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are a young adult. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Medicines such as Escitalopram Bluefish ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

Children and young people under 18 years of age

Escitalopram Bluefish should not normally be used in the treatment of children and adolescents under 18 years of age. You should also know the risk of side effects of suicidal ideation, suicidal ideation, and hostility (mainly aggression, defiance, and anger) are greater in patients under 18 years of age when taking this type of medicine. Despite this, Escitalopram Bluefish can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you received Escitalopram Bluefish, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse when patients under 18 take Escitalopram Bluefish. The long-term effects of Escitalopram Bluefish on growth, maturation, and intellectual and behavioral development have not yet been established in children and adolescents below 18 years of age.

Other medicines and Escitalopram Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking any of the following medicines:

  • “Non-selective monoamine oxidase inhibitors” ( MAOIs ) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substance. If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Bluefish. After stopping treatment with Escitalopram Bluefish, you must wait 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).
  • “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.
  • Linezolid, an antibiotic .
  • Lithium (medicine for manic-depressive illness) and tryptophan.
  • Imipramine and desipramine (antidepressants).
  • Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of blood clots). These can cause increased levels of Escitalopram Bluefish in the blood.
  • St. John’s wort (Hypericum perforatum) – an herbal remedy for depression.
  • Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
  • Warfarin, dipyridamole, and phenprocoumon (blood-thinning drugs, so-called anticoagulants ). When starting and stopping treatment with Escitalopram Bluefish, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants is appropriate.
  • Mefloquine (anti-malarial drug ), bupropion (anti-depressant drug), and tramadol (anti-severe pain medication) due to a possible risk of lowering the seizure threshold.
  • Neuroleptics (medicines for schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs ) due to a possible risk of lowering the seizure threshold.
  • Flecainide, propafenone and metoprolol (used in various cardiovascular diseases), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Escitalopram Bluefish may need to be adjusted.
  • Drugs that reduce the levels of potassium and magnesium in the blood as these conditions can increase the risk of life-threatening heart rhythm disturbance.

Do not take Escitalopram Bluefish if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class 1A and III antiarrhythmics, antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants, certain antimicrobial medicines (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions on the use of this product, 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, the use of alcohol during treatment with Escitalopram Bluefish is not recommended, although Escitalopram Bluefish is not expected to affect or be affected by alcohol.

Pregnancy, breastfeeding, and fertility

Tell your doctor if you are pregnant or planning to become pregnant.

Do not take Escitalopram Bluefish if you are pregnant or breast-feeding without first discussing the risks and benefits of treatment with your doctor.

If you are taking Escitalopram Bluefish during the last three months of pregnancy, be aware that the following effects may be seen in your newborn baby: difficulty breathing, dark blue or violet skin discoloration, cramps, difficulty regulating body temperature, breastfeeding difficulties, vomiting, low blood sugar, tense or slack muscles, lively reflexes, tremors, tremors, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor as soon as possible.

Tell your midwife or doctor that you are taking Escitalopram Bluefish. When drugs such as Escitalopram Bluefish are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.

If you take Escitalopram Bluefish at the end of your pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should tell you to take Escitalopram Bluefish so that they can advise you on this.

If Escitalopram Bluefish is used during pregnancy, treatment should never be stopped abruptly.

Escitalopram Bluefish is expected to be excreted in human milk.

In animal studies, citalopram, a drug similar to escitalopram, has been shown to reduce sperm quality. In theory, this could affect fertility, but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.

Driving and using machines

It is recommended that you do not drive or use machines until you know how Escitalopram Bluefish affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. The description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to take Escitalopram Bluefish

Always take Escitalopram Bluefish exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults

Depression

The usual recommended dose of Escitalopram Bluefish is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Panic syndrome

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

Social Phobia

The usual recommended dose of Escitalopram Bluefish is 10 mg once daily. Your doctor may either reduce the dose one to 5 mg per day or increase the dose one to a maximum of 20 mg per day, depending on how you respond to treatment.

Anxiety

The usual recommended dose of Escitalopram Bluefish is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The usual recommended dose of Escitalopram Bluefish is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (over 65 years)

The recommended starting dose of Escitalopram Bluefish is 5 mg once daily. Your doctor may increase the dose one to 10 mg per day.

Children and adolescents (under 18 years)

Escitalopram Bluefish should not normally be given to children and adolescents under 18 years of age. For more information, see section 2 “What you need to know before you take Escitalopram Bluefish”.

Escitalopram Bluefish can be taken with or without food. Swallow the tablet with water. Do not chew the tablet due to its bitter taste.

If necessary, the tablets can be divided by first placing the tablet on a flat surface with the notch upwards. The tablets can then be broken by pressing down on each end of the tablet, using both index fingers shown in the drawing.

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Duration of treatment

It may take a few weeks before you start to feel better. Continue to take Escitalopram Bluefish even if it takes time before you experience any improvement in your condition.

Do not change the dosage without first talking to your doctor.

Keep taking Escitalopram Bluefish for as long as your doctor recommends it. If you stop treatment too soon, the symptoms may return. It is recommended that you continue treatment for at least 6 months after feeling well again.

If you take more Escitalopram Bluefish then you should

If you have ingested too much medicine or if e.g. a child inhaled the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if you / the child does not notice any symptoms.

Signs of overdose can include dizziness, tremors, anxiety, seizures, unconsciousness, nausea, vomiting, disturbed heart rhythm, decreased blood pressure, and effects on the body’s salt and fluid balance.

Take the Escitalopram Bluefish pack with you when contacting your doctor or hospital.

If you forget to take Escitalopram Bluefish

Do not take a double dose to make up for a forgotten tablet. Take the next dose as usual. If you forget to take a dose and you remember this before going to bed, take one dose at a time. Continue as usual the next day. If you forget during the night or the next day that you have missed a dose, do not miss the dose and continue as usual.

If you stop taking Escitalopram Bluefish

Do not stop taking Escitalopram Bluefish until your doctor tells you to. Usually, your doctor will advise you to slowly reduce your dose for a few weeks.

When you stop taking Escitalopram Bluefish, and especially if this happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Bluefish is stopped. The risk is higher if Escitalopram Bluefish has been used for a long time or in higher doses, or if dose one is reduced too quickly. In most cases, these symptoms are mild and usually resolve within two weeks, although in some individuals they may persist for a longer period (2-3 months or more). Contact your doctor if you experience severe withdrawal symptoms after stopping treatment with Escitalopram Bluefish. He or she may ask you to start taking the tablets again, and then put them out more slowly.

Withdrawal symptoms: dizziness (feeling unsteady or balance), sensory disturbances such as ant crawling, burning sensation and, less commonly, feeling of electric shock including such sensations in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats), feeling of restlessness or agitation, tremor (tremors), feeling confused or disoriented, emotional instability or irritability, diarrhea, visual disturbances, palpitations.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Escitalopram Bluefish can cause side effects, although not everybody gets them.

The side effects usually disappear after a few weeks of treatment. Be aware that several of the effects described below can be symptoms of your illness and will therefore subside as you begin to feel better.

Contact your doctor if you experience any of the following side effects during treatment:

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

  • Uncommon bleeding, including gastrointestinal bleeding.

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

  • If you experience swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing ( allergic reaction ).
  • If you have a high fever, anxiety, feel confused, tremble, and have sudden muscle contractions, these may be signs of a rare condition called serotonergic syndrome.

No known frequency (cannot be calculated from the available data):

  • Difficulty urinating
  • Seizures, see also section “Warnings and precautions”
  • Yellowish skin and yellowish whites of the eyes (signs of hepatic impairment/hepatitis).
  • Rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition known as Torsade de Pointes.
  • Suicide-related behavior, see also section “Take special care with Escitalopram Bluefish”.

Also, the following side effects have been reported:

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

  • Nausea
  • Headache

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

  • Clogged or runny nose ( sinusitis )
  • Decreased or increased appetite
  • Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
  • Diarrhea, constipation, vomiting, dry mouth
  • Increased sweating
  • Pain in muscles and joints ( arthralgia and myalgia )
  • Sexual disorders (men may experience delayed ejaculation or erection problems while women may experience decreased sexual desire and difficulty reaching orgasm)
  • Fatigue, fever
  • Weight gain

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

  • Hives ( urticaria ), rash, itching
  • Tooth grinding, anxiety, nervousness, panic attacks, states of confusion
  • Sleep disturbance, taste change, fainting ( syncope )
  • Enlarged pupils ( mydriasis ), visual disturbances, earrings ( tinnitus )
  • Hair loss
  • Vaginal bleeding
  • Weight loss
  • Palpitation
  • Swollen arms and legs
  • Nasal blood

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

  • Aggression, personality changes, hallucinations
  • Slow heartbeat

Some patients have reported (frequency can not be calculated from available data):

  • Decreased sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion)
  • Dizziness in a standing position due to low blood pressure ( orthostatic hypotension )
  • Abnormal liver function values ​​(elevated levels of liver enzymes in the blood)
  • Movement disorders (involuntary muscle movements)
  • A painful erection (priapism)
  • Bleeding diseases including skin and mucous membrane bleeding ( ecchymosis )
  • Sudden swelling of the skin and mucous membranes ( angioedema )
  • Increased urine output (poorly functioning ADH secretion (anti-diuretic hormone))
  • The flow of breast milk in women who are not breastfeeding
  • Mania
  • An increased risk of bone fractures has been seen in patients taking this type of drug
  • Changes in heart rate (called ” QT prolongation”, observed with ECG, the electrical activity of the heart)
  • Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

Apart from the above, a plurality of side effects is observed with the use of drugs that act similarly as Escitalopram Blue Fish. These are:

  • Motor restlessness ( akathisia )
  • Loss of appetite ( anorexia )

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is escitalopram. Each tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (as oxalate).

Other ingredients are:

Core: microcrystalline cellulose, anhydrous colloidal silica, croscarmellose sodium, talc, and magnesium stearate.

Coating: titanium dioxide (E171), hypromellose, macrogol 400 (E1521), and polysorbate 80 (E433).

What the medicine looks like andthe contents of the pack

Escitalopram Bluefish is available in strengths of 5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets. The tablets are described below.

5 mg: White to off-white, round, beveled edges, biconvex film-coated tablet, approx. 5.2 mm. Marked with “J” on one side and “1” on the other side.

10 mg: White to off-white, oval, biconvex film-coated tablet with a notch. Approx. 7.9 x 5.4 mm. Marked with “J” on one side and “2” on the other side.

15 mg: White to off-white, oval, biconvex film-coated tablet with a notch. About 9.8 x 6.2 mm. Marked with “J” on one side and “3” on the other side.

20 mg: White to off-white, oval, biconvex film-coated tablet with a notch. Approx. 11.4 x 6.9 mm. Marked with “J” on one side and “4” on the other side.

The 10 mg, 15 mg, and 20 mg tablets can be divided into two equal doses.

Escitalopram Bluefish is available in the following pack sizes:

Transparent triplex blisters (PVC / PE / PVdC-Aluminum): 14, 28, 56 and 98 tablets.

HDPE cans:

5 mg: 100 tablets

10 mg: 200 tablets

Single-dose packaging:

Transparent triplex blisters (PVC / PE / PVdC-Aluminum): 28 x 1 tablets.

Not all pack sizes may be marketed.

Pharmadox Healthcare Ltd.

KW20A Corradino Industrial Estate,

Paola, PLA 3000

Malta

This medicinal product is authorized under the European Economic Area under the names:

Austria Escitalopram Bluefish 5 mg / 10 mg film tablets
Denmark Escitalopram Bluefish
Spain Escitalopram Bluefish 10mg / 15mg / 20mg compressed drugs with EFG film
Ireland Escitalopram Bluefish 5 mg / 10 mg / 15 mg / 20 mg film-coated tablets
Iceland Escitalopram Bluefish 5 mg / 10 mg / 15 mg / 20 mg film-coated tablets
Poland Escitalopram Bluefish
Portugal Escitalopram Bluefish

Muhammad Nadeem

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