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 any side effects not mentioned in this information. See section 4.

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

What Escitalopram Mylan is and what it is used for

Escitalopram Mylan is an antidepressant drug that belongs to the group of SSRIs(selective serotonin reuptake inhibitors). 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 Mylan can be used to treat the following conditions:

  • depression
  • panic disorder with or without agoraphobia (square fear)
  • Social Phobia
  • general anxiety
  • obsessive-compulsive disorder

Escitalopram contained in Escitalopram Mylan may also be approved for the treatment of other conditions not mentioned in this product information. 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 Mylan

Do not take Escitalopram Mylan

  • 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 Mylan”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Escitalopram Mylan:

  • if you have impaired liver or kidney function. Your doctor may need to adjust someone
  • if you are older
  • if you have epilepsy or have had seizures. Treatment with Escitalopram Mylan should be discontinued if you experience seizures for the first time or if the seizures occur at more frequent intervals (see also section 4 “Possible side effects”)
  • if you are receiving electric shock treatment
  • if you tend to easily get bleeding or bruising
  • if you suffer from diabetes. Treatment with Escitalopram Mylan may affect glucose control (blood glucose). The dose of one of the insulin and/or blood sugar-lowering medicines may need to be changed.
  • if you have decreased levels of sodium in your blood
  • 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 may 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 that your heart is not functioning normally
  • if you suffer from 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.

Suicidal ideation and worsening of your depression or anxiety disorder
You who are depressed and/or suffering from anxiety/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for drugs of this type 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.

Drugs such as escitalopram (SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after the end of treatment.

Children and young people under 18 years of age

Escitalopram Mylan should not normally be used in the treatment of children and adolescents under 18 years of age. You should also be aware that the risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking this type of medicine. Nevertheless, Escitalopram Mylan may 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 tell your doctor if you notice any of the above symptoms or if they get worse with Escitalopram Mylan and you are under 18 years of age. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for this age group.

Other medicines and Escitalopram Mylan

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

Be especially careful to tell your doctor about the following medicines

  • “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substance (antidepressants). If you have taken any of these medicines, you must wait 14 days before starting Escitalopram Mylan. After stopping treatment with Escitalopram Mylan, you must wait 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant)
  • linezolid (an antibiotic )
  • “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.
  • sumatriptan and similar medicines (medicines for migraines ) or buprenorphine and tramadol (medicines for severe pain). These medicines can affect or be affected by Escitalopram Mylan and you may experience symptoms such as involuntary, rhythmic muscle twitching, even in the muscles that control eye movements, agitation, hallucinations, coma, heavy sweating, tremors, intensified reflexes, tense muscles, and body temperature above 38 °. C. Contact your doctor if you experience such symptoms.
  • cimetidine, omeprazole, and lansoprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections) fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke ). These can cause increased levels of escitalopram in the blood.
  • St. John’s wort ( Hypericum perforatum ) – an herbal remedy for depression
  • lithium or tryptophan (medicines for depression) as these may increase the effect of Escitalopram Mylan
  • acetylsalicylic acid (painkillers or blood thinners) and anti-inflammatory painkillers ( NSAIDs ). These may increase the tendency to bleed.
  • warfarin, dipyridamole, phenprocoumon, and other anticoagulants (blood thinners). When starting and stopping treatment with Escitalopram Mylan, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants appropriate.
  • mefloquine (an anti-malarial drug ), bupropion (an anti-smoking or anti-depressant drug), and tramadol (an anti-inflammatory drug) due to a possible risk of lowering the seizure threshold
  • neuroleptics (medicines for schizophrenia, psychosis ), antidepressants, and other SSRIs due to a possible risk of lowering the seizure threshold
  • flecainide, propafenone and metoprolol (used in various cardiovascular diseases), imipramine, desipramine, clomipramine and nortriptyline ( antidepressants ) and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Escitalopram Mylan may need to be adjusted.
  • drugs that cause low potassium levels in the blood ( hypokalaemia ) or low magnesium levels in the blood (hypomagnesemia).

Do not take  Escitalopram Mylan 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 (eg astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.

Escitalopram Mylan with food, drink, and alcohol

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

You should avoid alcohol while taking this medicine.

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.

Pregnancy

Tell your doctor if you are pregnant or planning to become pregnant. Do not take Escitalopram Mylan if you are pregnant without first discussing the risks and benefits of treatment with your doctor. You should not suddenly stop taking Escitalopram Mylan.

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

Other symptoms that may occur if Escitalopram Mylan is used late in pregnancy include difficulty sleeping or eating properly, difficulty breathing, difficulty regulating body temperature, vomiting, persistent crying, low blood sugar, tense or relaxed muscles, overactive reflexes, irritability, increased sleepiness, tremors, tremors or seizures. If your newborn develops any of these symptoms, talk to your doctor right away and will be able to advise you.

Breast-feeding

Tell your doctor if you are breast-feeding. Escitalopram is likely to pass into breast milk. You should not breast-feed if you are taking Escitalopram Mylan. Your doctor will decide if you should stop/continue breast-feeding or stop/continue treatment with Escitalopram Mylan.

Fertility

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 Escitalopram Mylan 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. Descriptions 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.

Escitalopram Mylan contains lactose and sodium

This medicine 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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet and is essential ‘sodium-free’.

How to take Escitalopram Mylan

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

Remember that it may take two or more weeks of treatment with Escitalopram Mylan before you start to feel better.

Adults

Depression – The recommended dose of Escitalopram Mylan is 10 mg per day. Doseone can be increased by your doctor to a maximum of 20 mg daily. It can take 2 to 4 weeks before you start to feel better. You should continue treatment for at least 6 months after feeling well again.

Panic Syndrome – The recommended starting dose of Escitalopram Mylan is 5 mg per day for the first week, after which the doctor may increase the dose from one to 10 mg per day and, if necessary, to a maximum of 20 mg per day. The maximum effect will be achieved after 3 months.

Social phobia – The recommended dose of Escitalopram Mylan is 10 mg per day. It can take 2 to 4 weeks before you start to feel better. Thereafter, the dose may be reduced to 5 mg per day or increased to 20 mg per day, depending on how you respond to treatment. A treatment course of 12 weeks is normally recommended.

General Anxiety Disorder – The recommended dose of Escitalopram Mylan is 10 mg per day. Dose one can be increased by your doctor to a maximum of 20 mg daily. The doctor should regularly re-evaluate dose one.

Obsessive-compulsive disorder – The recommended dose of Escitalopram Mylan is 10 mg per day. Dose one can be increased by your doctor to a maximum of 20 mg daily. The doctor should regularly re-evaluate dose one.

Elderly patients (over 65 years)

Your doctor will give you a lower dose than the one mentioned above, as the elderly may be more sensitive to the effects of Escitalopram Mylan.

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

Use for children and adolescents (under 18 years)

Escitalopram 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 Mylan”.

If you have liver problems or severe kidney problems, your doctor will give you a smaller dose than the one mentioned above.

Escitalopram Mylan can be taken with or without food. Swallow the tablet with water. Do not chew the tablet, as the taste is bitter.

Keep taking the tablets for as long as your doctor recommends, even after you start to feel better.

You should continue treatment for at least three to six months after you feel well again so that the symptoms do not return.

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

If you take more Escitalopram Mylan then 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 (slower or faster pulse ), decreased blood pressure, and effects on the body’s salt and fluid balance. Take the pack and any remaining tablets with you to the doctor or hospital.

If you forget to take Escitalopram Mylan

Do not take a double dose to make up for a forgotten dose. 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 Mylan

Do not stop taking Escitalopram Mylan until your doctor tells you to. At the end of treatment, it is usually recommended that dose one of Escitalopram Mylan be phased out over a period of a few weeks.

When you stop taking Escitalopram Mylan, and especially if this happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Mylan is stopped. The risk is higher if Escitalopram Mylan 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 be severe and 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.

Withdrawal symptoms include dizziness (feeling unsteady or unbalanced), 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 anxious, 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 immediately or see your nearest hospital if you experience any of the following side effects:

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

  • Uncommon bleeding, including gastrointestinal bleeding

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

  • Swelling of the skin, tongue, lips, or face, or having difficulty breathing or swallowing (severe allergic reaction )
  • High fever, anxiety, feeling confused, trembling, and having sudden muscle contractions, can be signs of a rare condition called serotonergic syndrome

Has been reported (occurs in an unknown number of users):

  • difficulty urinating
  • seizures, see also section 2 “Warnings and precautions”
  • yellowish skin and yellowish whites of the eyes are signs of impaired liver function
  • rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsades de Pointes
  • Thoughts of self-harm or suicide (see also section 2 “Warnings and Precautions”).

Also, the following side effects have been reported:

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

  • headache
  • nausea

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

  • loss of appetite
  • increased appetite
  • weight gain
  • anxiety or restlessness
  • difficulty falling asleep
  • somnolence
  • unusual dreams
  • tingling or numbness in the hands or feet
  • tremor ( tremor )
  • dizziness
  • yawn
  • inflamed swollen sinuses that cause pain, high fever, tenderness ( sinusitis )
  • diarrhea
  • constipation
  • vomiting
  • dry mouth
  • increased sweating
  • fever
  • muscle or joint pain
  • fatigue
  • sexual disorders (delayed ejaculation, erection problems, or decreased sexual desire, and women may experience difficulty reaching orgasm)

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

  • weight loss
  • confusion
  • concern
  • nervousness
  • gnashing of teeth in sleep
  • panic attack
  • taste changes
  • changes in sleep patterns
  • fainting
  • enlarged pupils ( mydriasis ), visual disturbances
  • ringing in the ears ( tinnitus )
  • fast heart rate
  • nosebleeds
  • hair loss
  • hives or hives
  • rash
  • itching
  • heavy menstruation or intermittent bleeding
  • a lot of fluid in the body

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

  • aggression or a feeling of unreality (depersonalization)
  • hallucinations
  • slow heart rate

Has been reported (occurs in an unknown number of users):

  • thrombocytopenia (decreased platelet count that increases the risk of bleeding and bruising)
  • increased content of a hormone ( ADH ) that leads to the accumulation of fluid or water in the body
  • abnormally low sodium content in the blood, which causes you to become weak and confused and have pain
  • mania (feeling of elation or excessive arousal that causes unusual behavior)
  • abnormal muscle movements
  • dizziness in a standing position due to low blood pressure ( orthostatic hypotension )
  • changes in liver enzyme tests
  • persistent painful erection of the penis
  • abnormal production of breast milk in men and women
  • an increased risk of bone fractures has been seen in patients taking this type of drug

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

  • restlessness or difficulty sitting still ( psychomotor restlessness/akathisia)
  • loss of appetite

5. How to store Escitalopram Mylan

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 tablet/blister and carton.

The expiration date is the last day of the specified month.

Do not store above 25 ° C. Jars: Close the jar tightly. Blister: Store in the original package.

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).

The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate, lactose monohydrate, macrogol 4000, titanium dioxide (E171), and hypromellose. See section 2, “Escitalopram contains lactose and sodium”.

What the medicine looks like and the contents of the pack

Escitalopram Mylan is a film-coated tablet.

One 5 mg film-coated tablet is a white, round tablet marked with “EC 5” on one side and “G” on the other.

One 10 mg film-coated tablet is a white, oval, scored tablet marked with “EC | 10” on one side and “G” on the other. The tablet can be divided into two equal doses.

One 15 mg film-coated tablet is a white, oval, scored tablet marked with “EC | 15” on one side and “G” on the other. The tablet can be divided into two equal doses.

One 20 mg film-coated tablet white, oval, scored tablet marked with “EC | 20” on one side and “G” on the other. The tablet can be divided into two equal doses.

Escitalopram Mylan is available in tablet cans of 28, 49, 100, 200, 250 and 500 film-coated tablets, in blister packs of 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 100, 180 and 200 film-coated tablets and in perforated single-dose blister packs of 28 x 1 and 56 x 1 film-coated tablets.

Not all pack sizes may be marketed.

Manufacturer

McDermott Lab. Ltd. (t / a Gerard)

35/36 Baldoyle Industrial Estate

13 Dublin Ireland

Mylan Hungary Kft

Mylan utca 1

H-2900 Komárom,

Hungary

Muhammad Nadeem

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