5 mg, 10 mg, 15 mg and 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 Glenmark is and what it is used for 
2. What you need to know before you take Escitalopram Glenmark 
3. How to take Escitalopram Glenmark 
4. Possible side effects 
5. How to store Escitalopram Glenmark 
6. Package contents and other information 

What Escitalopram Glenmark is and what it is used for

Escitalopram Glenmark contains escitalopram and is used to treat depression (actual depressive episode) and anxiety disorders (such as panic disorder with or without agoraphobia which is fear of being in places where help is not available, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs act on the brain’s serotonin system 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 couple of weeks before you start to feel better. Continue to take Escitalopram Glenmark 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 Glenmark 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 Glenmark

Do not take Escitalopram Glenmark

  • 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; the MAOIs include drugs that selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of 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 medicines that may affect your heart rhythm (see section 2 “Other medicines and Escitalopram Glenmark”)

Warnings and cautions

Talk to your doctor or pharmacist before taking Escitalopram Glenmark.

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

  • if you have epilepsy; treatment with Escitalopram Glenmark should be discontinued if you experience seizures 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 the dose of Escitalopram Glenmark
  • if you have diabetes; treatment with Escitalopram Glenmark may affect blood sugar levels; dose one of 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 an increased tendency to bleed or to have bruises
  • if you are receiving treatment with electric shocks
  • 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 the use of diuretics ( diuretics )
  • if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up; it may indicate the abnormal function of the heart rhythm
  • have or have previously had problems with their eyes, such as certain types of glaucoma (increased pressure in the eye).
  • if you have a history of bleeding disorders, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”)

Drugs such as Escitalopram Glenmark (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

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 aggravated 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 taking antidepressants, as it takes time for this type of medicine to take effect; usually about 2 weeks, sometimes longer.

These thoughts may be more common in the following cases:

  • 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 antidepressants have an increased risk of suicidal behavior. 

Contact a doctor as soon as possible or see a 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

Escitalopram Glenmark 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, and anger) is greater in patients under 18 years of age when taking drugs of this type. Despite this, Escitalopram Glenmark 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 tell your doctor if you notice any of the above symptoms or if they get worse. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.

Other medicines and Escitalopram Glenmark

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 Glenmark; After stopping treatment with Escitalopram Glenmark, you must wait 7 days before taking any of these medicines
  • reversible, selective MAO-A inhibitors containing moclobemide (antidepressants)
  • irreversible MAO-B inhibitors containing selegiline (medicines for Parkinson’s disease ); increase the risk of side effect s
  • 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); increase the risk of side effect s
  • cimetidine, lansoprazole and omeprazole (medicines for heartburn and stomach ulcers ), fluconazole (used to treat fungal infections), fluvoxamine (medicines for depression), and ticlopidine (used to reduce the risk of stroke ); These may increase the levels of Escitalopram Glenmark in the blood
  • St. John’s wort (Hypericum perforatum) – (traditional) herbal medicine used to treat depression.
  • acetylsalicylic acid (magical, aspirin) and non-steroidal anti-inflammatory drugs (drugs used for pain relief or blood thinning, so-called anticoagulants ). These may increase the risk of bleeding.
  • warfarin, dipyridamole, and phenprocoumon (medicines used for blood thinning, so-called anticoagulants ); your doctor will probably measure your blood clotting time when you start or stop taking Escitalopram Glenmark to check that the dose of anticoagulant you are taking is still adequate
  • mefloquine (an anti-malarial drug), bupropion (an anti-depressant), and tramadol (an anti-severe drug) 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 (medicines for cardiovascular disease), clomipramine and nortriptyline (medicines for depression), and risperidone, thioridazine, and haloperidol (antipsychotic medicines); dose one of Escitalopram Glenmark 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.

DO NOT TAKE Escitalopram Glenmark if you are taking medicines for heart rhythm problems or medicines that may affect your heart rhythm, such as Class 1A and III antiarrhythmics, antipsychotics (eg phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, anti-malarial drugs, especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.

Escitalopram Glenmark with food, drink, and alcohol

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

As with many other medicines, the use of alcohol during treatment with Escitalopram Glenmark is not recommended, although Escitalopram Glenmark 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 take Escitalopram Glenmark if you are pregnant unless you have talked to your doctor about the risks and benefits of this medicine.

If you are taking Escitalopram Glenmark during the last three months before 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, difficulty breastfeeding, vomiting, low blood sugar, tension or slack muscles, overactive reflexes, tremors, jerky, 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 or doctor that you are taking Escitalopram Glenmark. When medicines similar to Escitalopram Glenmark 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 are taking Escitalopram Glenmark 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 be informed that you are taking Escitalopram Glenmark so that they can advise you on this.

The use of Escitalopram Glenmark should not be stopped abruptly if used during pregnancy.

Escitalopram Glenmark is likely to be excreted in human milk.

Do not take Escitalopram Glenmark if you are breast-feeding unless you have told your doctor about the risks and benefits of this medicine.

Citalopram, a drug similar to escitalopram, has been shown to reduce sperm quality in animal studies.

In theory, this could affect fertility, but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You should not drive or use machines until you know how Escitalopram Glenmark 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.

How to take Escitalopram Glenmark

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

Adults 

Depression 

The usual dose is 10 mg once a day. Your doctor may increase the dose to a maximum of 20 mg per day.

Panic disorder 

The starting dose is 5 mg once a day for the first week, after which the dose can be increased to 10 mg a day. Your doctor may increase the dose to a maximum of 20 mg per day.

Social Phobia 

The usual dose is 10 mg once a day. Your doctor may either reduce your dose to 5 mg per day or increase it to a maximum of 20 mg per day, depending on how you react to the medicine.

Generalized anxiety disorders 

The usual dose is 10 mg once a day. Your doctor may increase the dose to a maximum of 20 mg per day.

Obsessive-compulsive disorder 

The usual dose is 10 mg once a day. Your doctor may increase the dose to a maximum of 20 mg per day.

Elderly patients (over 65 years) 

The recommended starting dose is 5 mg once a day. Your doctor may increase the dose to a maximum of 10 mg per day.

Use for children and adolescents

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

How to take Escitalopram Glenmark

You can take Escitalopram Glenmark with or without food. Swallow the tablet with a little water. Do not chew the tablets; they have a bitter taste.

If you want, you can share the tablets. Place the tablet on an even surface with the notch facing up. Then press each tablet half using your index fingers.

Length of treatment

It may take a couple of weeks before you start to feel better. Continue to take Escitalopram Glenmark even if it takes a while before you feel better.

Do not change the dose of the medicine without talking to your doctor.

Continue to take Escitalopram Glenmark 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 use more Escitalopram Glenmark then you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, 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, agitation, cramps, nausea, coma, vomiting, irregular heartbeat, decreased blood pressure, and changes in the body’s fluid and salt balance. If you see a doctor or hospital, bring the Escitalopram Glenmark pack.

If you forget to take Escitalopram Glenmark

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 Glenmark

Do not stop taking Escitalopram Glenmark until your doctor tells you to. Once you have completed your treatment regimen, your doctor may recommend that you reduce the dose gradually over several weeks.

When you stop taking Escitalopram Glenmark, especially if it happens abruptly, you may experience withdrawal symptoms. They are common when treatment with Escitalopram Glenmark is stopped. The risk of withdrawal symptoms is higher when Escitalopram Glenmark has been used for a long time or in high doses or when the dose is reduced too quickly. In most people, these symptoms go away within two weeks. However, some patients may experience severe or prolonged (2-3 months) withdrawal symptoms. Contact a doctor if you experience severe withdrawal symptoms after stopping treatment. Your doctor may ask you to start taking the tablets again, then discontinue them more slowly.

Withdrawal symptoms include dizziness (feeling unsteady or unbalanced), sensory disturbances such as ant crawling, burning sensation and, less commonly, feeling of electric shock (including such feelings in the head), sleep disturbances (with vivid dreams, nightmares, inability to sleep), anxiety, headache, nausea, sweating (including night sweats), 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. Many of the effects can also be symptoms of your illness and will therefore get better as you start to get better.

If you experience any of the following symptoms, contact your doctor immediately or see a hospital:

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

  • unusual bleeding, including in the stomach or intestines

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

  • swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction ) 
  • high fever, agitation, confusion, tremors, and sudden muscle contractions; may be a sign 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”
  • yellowing of the skin and whites of the eyes; signs of hepatic impairment/hepatitis.
  • rapid, irregular heartbeat, fainting; can be a symptom of a life-threatening condition called Torsades de Pointes.
  • suicidal ideation or suicidal ideation, see also section 2 “Warnings and precautions”
  • sudden swelling of the skin or mucous membranes ( angioedema ).
  • severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

In addition to the above-mentioned side effects, 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):

  • nasal congestion or runny nose ( sinusitis )
  • decreased or increased appetite
  • anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, stinging sensation in the skin
  • diarrhea, constipation, vomiting, dry mouth
  • increased sweating
  • muscle and joint pain
  • sexual disorders (delayed ejaculation, erection problems, decreased sexual desire; women may experience difficulty having an orgasm)
  • fatigue, fever
  • weight gain

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

  • hives ( urticaria ), rash, itching ( pruritus )
  • gnashing of teeth, agitation, nervousness, panic attacks, confusion
  • sleep disorders, taste changes, fainting ( syncope )
  • enlarged pupils ( mydriasis ), visual disturbances, earrings ( tinnitus )
  • hair loss
  • abundant menstrual bleeding
  • irregular menstruation
  • weight loss
  • palpitation
  • swollen arms or legs
  • nosebleeds

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

  • aggression, depersonalization, hallucinations
  • slow heart rate

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

  • decreased levels of sodium in the blood (symptoms are general malaise with muscle weakness or confusion)
  • dizziness when standing up due to low blood pressure ( orthostatic hypotension )
  • abnormal liver function values ​​(increased amount of liver enzymes in the blood)
  • movement disorders (involuntary muscle movements)
  • painful erections (priapism)
  • signs of increased bleeding, eg from the skin and mucous membranes ( ecchymosis )
  • increased secretion of hormone et ADH, which causes fluid to accumulate in the body, and the blood-thinning and sodium content drops (abnormal ADHsecretion).
  • the flow of breast milk in men and in women who are not breastfeeding
  • mania
  • an increased risk of bone fractures has been seen in patients taking this type of drug
  • heart rhythm disturbances (so-called “prolonged QT interval”)

Also, several side effects are known for medicines that work in a similar way to escitalopram (the active substance in Escitalopram Glenmark). These side effects are:

  • motor restlessness ( akathisia )
  • anorexia

5. How to store Escitalopram Glenmark

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton or carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

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 of Escitalopram Glenmark contains 5 mg, 10 mg, 15 mg, or 20 mg of escitalopram (as oxalate).

Other ingredients are:

Tablet core:

Microcrystalline cellulose (E460), croscarmellose sodium (E468), magnesium stearate (E572), anhydrous colloidal silica, and talc

Drag:

Hypromellose (E464, titanium dioxide (E171), macrogol 400

What the medicine looks like and the contents of the pack

Escitalopram Glenmark 5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets. The tablets are described below.

5 mg: White to off-white, round, biconvex, film-coated tablet, marked with “E1” on one side.

10 mg: White to off-white, oblong, biconvex, film-coated tablet, marked with “E2” on one side and a breaker notch on the other. The tablet can be divided into two equal parts.

15 mg: White to off-white, oblong, biconvex, film-coated tablet, marked with “E3” on one side and a breaker notch on the other. The tablet can be divided into two equal parts.

20 mg: White to off-white, oblong, biconvex, film-coated tablet, marked with “E4” on one side and a breaker notch on the other. The tablet can be divided into two equal parts.

The tablets are packaged in aluminum/aluminum pressure packs or clear PVC-Aclar / aluminum pressure packs.

Escitalopram Glenmark is available in the following pack sizes:

5 mg film-coated tablets

Printing packaging: 14, 20, 28, 50, 100 and 200

10 mg film-coated tablets

Printing packaging: 14, 20, 28, 50, 56, 100 and 200

15 mg film-coated tablets

Printing packaging: 20, 28, 50, 56, 100 and 200

20 mg film-coated tablets

Printing packaging: 14, 20, 28, 50, 56, 100 and 200

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Arzneimittel GmbH

Industriestr. 31, 82194 Gröbenzell,

Germany

Manufacturer

Glenmark Pharmaceuticals Europe Limited.

Building 2, Croxley Green Business Park, Croxley Green, Hertfordshire, WD18 8YA

UK

Glenmark Pharmaceuticals sro

Hvězdova 1716 / 2b, 140 78 Prague 4,

Czech Republic

Glenmark Arzneimittel GmbH

Industriestr. 31, 82194 Gröbenzell,

Germany

Muhammad Nadeem

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