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

Read all of this leaflet carefully before you start using 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 may harm them, even if they show symptoms similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Escitalopram Krka is and what it is used for 
2. What you need to know before using Escitalopram Krka 
3. How to use Escitalopram Krka 
4. Possible side effects 
5. How to store Escitalopram Krka 
6. Contents of the pack and other information 

What Escitalopram Krka is and what it is used for

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

Escitalopram Krka belongs to a group of antidepressant medicines 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.

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

You need to talk to a doctor if you do not feel better or if you feel worse.

Escitalopram contained in Escitalopram Krka 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 use Escitalopram Krka

Do not use Escitalopram Krka

  • 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 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 Krka” ).

Warnings and cautions

Talk to your doctor or pharmacist before using Escitalopram Krka.

Tell your doctor if you have other diseases, as your doctor may need to consider them.

This is especially true if you:

  • have epilepsy. Treatment with Escitalopram Krka should be stopped if seizures for the first time or if the seizures were coming more frequently (see section 4 ” Possible side effects s “).
  • have impaired liver or kidney function (your doctor may need to adjust the dose of Escitalopram Krka).
  • have diabetes. Treatment with Escitalopram Krka may affect your blood sugar level. The dose of one of the insulin and/or blood sugar-lowering tablets may need to be changed.
  • have decreased levels of sodium in the blood.
  • tend to easily get bleeding or bruising.
  • receive treatment with electric shocks.
  • have coronary heart disease.
  • suffers from or has suffered from heart problems or recently had a heart attack.
  • 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 ).
  • experiencing a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal heart rhythm function.
  • have or have previously had problems with their eyes, such as certain types of 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.

Drugs such as Escitalopram Krka (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction. In some cases, these symptoms persist after discontinuation of treatment.

Suicidal ideation and worsening of your depression or anxiety disorder

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 younger than 25 years. 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.

Children and young people under 18 years of age

Escitalopram Krka should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance,e, and anger) is greater in patients under 18 years of age when taking drugs of this type. Despite this, Escitalopram Krka 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 were given this medicine, consult your doctor again. You should also inform your doctor if you notice any of the above symptoms or if they worsen when children and adolescents under the age of 18 use Escitalopram Krka. The long-term effects on growth, maturity,y, and cognitive and behavioral developmenhaveas not yet been established for children and adolescents in this age group.

Other medicines and Escitalopram Krka

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

Do not take Escitalopram Krka if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class IA 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.

Tell your doctor if you are taking the following medicines:

  • “Non-selective monoamine oxidase inhibitors” (MAOIs) (antidepressants) 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 treatment with Escitalopram Krka. After stopping treatment with Escitalopram Krka, 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 (medicine for depression).
  • 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 in the blood.
  • St. John’s wort ( Hypericum perforatum – an herbal remedy for depression).
  • Acetylsalicylic acid and non-steroidal anti-inflammatory drugs ( NSAIDs ) (painkillers or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
  • Warfarin, dipyridamole, and phenprocoumon (blood thinners, called anticoagulants). When starting and stopping treatment with Escitalopram Krka, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants 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) as well as risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Escitalopram Krka may need to be adjusted.
  • Drugs that lower blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.

Escitalopram Krka with food, drink, and alcohol

Escitalopram Krka can be taken with or without food (see section 3 “ How to use  Escitalopram Krka ”).

As with many other medicines, the use of alcohol during treatment with Escitalopram Krka is not recommended, although escitalopram is not expected to interact with alcohol.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Escitalopram Krka if you are pregnant unless you have discussed the benefits and possible risks of treatment with your doctor.

If you are taking Escitalopram Krka during the last three months until delivery, you should be aware that the following symptoms may be seen in your newborn baby: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, breastfeeding difficulties, vomiting, low blood sugar, tense or slack muscles, overactive reflexes, tremors, jerkiness, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor as soon as possible.

Tell your midwife and/or doctor that you are taking Escitalopram Krka. When drugs such as Escitalopram Krka 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 your midwife and / or doctor immediately.

If Escitalopram Krka is used during pregnancy, abrupt discontinuation of treatment should be avoided.

Escitalopram Krka is expected to be excreted in human milk. Do not use Escitalopram Krka if you are breast-feeding unless you have discussed the benefits and possible risks of treatment with your doctor.

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 on fertility has yet been demonstrated in humans.

Driving and using machines

Do not drive or use machines until you know how you are affected by Escitalopram Krka.

You are responsible for assessing whether you are fit to drive motor vehicles or perform risky work. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Escitalopram Krka contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Escitalopram Krka

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Adults

Depression

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

Panic syndrome

The starting dose is 5 mg Escitalopram Krka 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 is 10 mg Escitalopram Krka once a day. 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 is 10 mg Escitalopram Krka once a day. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Obsessive-compulsive disorder

The usual recommended dose is 10 mg Escitalopram Krka once a day. 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 is 5 mg Escitalopram Krka once daily. Your doctor may increase the dose one to 10 mg per day.

Method of administration

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

10 mg and 20 mg: The tablet can be divided into two equal doses.

Duration of treatment

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

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

Continue to take Escitalopram Krka 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.

Use for children and adolescents (under 18 years)

Escitalopram Krka should not normally be given to children and adolescents. For further information, see section 2 “ Before using Escitalopram Krka ”.

If you use more Escitalopram Krka than you should 

If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, 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 Krka pack with you when contacting your doctor or hospital.

If you forget to use Escitalopram Krka

Do not take a double dose to make up for a forgotten dose . If you forget to take a dose and you come to this on the same day, 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 using Escitalopram Krka

Do not stop taking Escitalopram Krka until your doctor tells you to. When it is decided that treatment with Escitalopram Krka should be stopped, your doctor will usually advise you to slowly reduce your dose for a few weeks.

When you stop taking Escitalopram Krka, and especially if it happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Krka is stopped. The risk is higher if Escitalopram Krka 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. He or she may ask you to start taking the tablets again, and then put them out more slowly.

The symptoms of withdrawal include: dizziness (feeling of instability or balance difficulties), sensory disturbances such as ant crawling, burning sensation and (less common) feeling of electric shock (including such feelings 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, this medicine 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 or see a hospital immediately if you experience any of the following side effects during treatment:

Uncommon (affects up to 1 in 100 people):

  • Uncommon bleeding, including gastrointestinal bleeding.

Rare (affects up to 1 in 1,000 people):

  • Swelling of the skin, tongue, lips, throat or face, rash or difficulty breathing or swallowing (severe allergic reaction ).
  • High fever, anxiety, confusion, tremors and sudden muscle contractions; This may be a sign 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 .
  • Thoughts of self-harm or suicide, (see also section 2 “ Warnings and Precautions”).
  • Sudden swelling of the skin or mucous membranes ( angioedema ).

In addition, the following side effects have been reported:

Very common (affects more than 1 user in 10):

  • Nausea
  • Headache

Common (affects 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 (delayed ejaculation or erection problems, decreased sexual desire and for women difficulty in achieving orgasm)
  • Fatigue, fever
  • Weight gain

Uncommon (affects up to 1 in 100 people):

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

Rare (affects up to 1 in 1,000 people):

  • Aggression, personality changes, hallucinations
  • Slow heartbeat

No known frequency (cannot be calculated from the 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 ( orthostatichypotension )
  • Abnormal liver function values ​​(elevated levels of liver enzymes in the blood)
  • Movement disorders (involuntary muscle movements)
  • Painful erection (priapism)
  • Increased tendency to bleed in e.g. skin and mucous membranes ( ecchymosis ) and low platelet levels ( thrombocytopenia )
  • Increased secretion of a hormone called ADH , which causes the body to collect water and dilute the blood, which leads to a reduced amount of sodium(Inadequate ADH – secretion )
  • Flow of breast milk in men and women who are not breastfeeding
  • Mania
  • Changes in heart rate (” QT prolongation”, observed with ECG (measurement of electrical activity of the heart)) see sections 4.3, 4.4, 4.5, 4.8 and 4.9.

In addition to the above, a number of side effects have been observed with the use of drugs that act in a similar way to escitalopram. These are:

  • Motor restlessness ( akathisia )
  • Loss of appetite

5. How to store Escitalopram Krka

Keep out of 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.

Store in the original package. Moisture sensitive.

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 of escitalopram equivalent to 6.390 mg of escitalopram oxalate.Each tablet contains 10 mg of escitalopram equivalent to 12,780 mg of escitalopram oxalate.Each tablet contains 15 mg of escitalopram equivalent to 19.170 mg of escitalopram oxalate.Each tablet contains 20 mg of escitalopram equivalent to 25,560 mg of escitalopram oxalate.
  • The other ingredients are lactose monohydrate , crospovidone, povidone K30, microcrystalline cellulose, pregelatinised maize starch and magnesium stearate (E470b) in the tablet core, hypromellose 6cP (E464), titanium dioxide (E171), lactose monolithin , black4 iron oxide, (E172), propylene glycol (E1520)) in the film coating (see section 2).

What the medicine looks like and contents of the pack

5 mg film-coated tablets: white, round, biconvex film-coated tablets with bevelled edges and 5.5 mm in diameter, marked with “5” in black on one side of the tablet.

10 mg film-coated tablets: white, oval, biconvex film-coated tablets, with a scoreline on one side and dimensions 9 x 6 mm, marked with “10” in black on one side of the tablet. The tablet can be divided into two equal doses .

15 mg film-coated tablets: white, round, biconvex film-coated tablets with bevelled edges and 8.5 mm in diameter, marked with “15” in black on one side of the tablet.

20 mg film-coated tablets: white, oval, biconvex film-coated tablets, with a scoreline on one side and dimensions 12 x 7.5 mm, marked with “20” in black on one side of the tablet. The tablet can be divided into two equal doses .

Escitalopram Krka film-coated tablets are available in cartons of 14, 20, 28, 30, 50, 56, 60, 90 and 100 film-coated tablets in blisters (OPA / Alu / PVC-Alu).

Not all pack sizes may be marketed.

Manufacturer

KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

KRKA – FARMA doo, V. Holjevca 20 / E, 10450 Jastrebarsko, Croatia

Muhammad Nadeem

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