10 mg, 20 mg film-coated tablets 
escitalopram (as oxalate)

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, pharmacist, or nurse.

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

What Escitalopram SUN is and what it is used for

Escitalopram SUN contains the active substance escitalopram. Escitalopram SUN 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.

Escitalopram SUN 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 few weeks before you start to feel better. Continue to take Escitalopram SUN 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.

What you need to know before you take Escitalopram SUN

Do not take Escitalopram SUN

  • 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 the heart rhythm (see section 2, ” A Change medicines and Escitalopram SUN “).

Warnings and cautions

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

Talk to your doctor, pharmacist, or nurse before taking Escitalopram SUN. Tell your doctor if you have any other illnesses that your doctor may need to consider. This is especially true if you:

  • have epilepsy. Treatment with Escitalopram SUN 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”).
  • have impaired liver or kidney function (your doctor may need to adjust dose one).
  • have diabetes. Treatment with Escitalopram SUN 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 bleed or bruise easily, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”).
  • receive electrical treatment.
  • 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).
  • if you have low levels of potassium or magnesium in your blood ( hypokalemia/hypomagnesemia
  • if you suffer from a heart disease called “QT prolongation” or if the disease is present in your family.

Caution is advised if Escitalopram SUN is taken concomitantly with drugs with a serotonergic effect, such as sumatriptan, other triptans, tramadol, or tryptophan. In rare cases, a so-called serotonergic syndrome may occur, not only in combination with other serotonergic drugs but has also been reported in rare cases in patients using SSRIs. If you have symptoms such as high fever, muscle twitching, confusion, restlessness, tremors, or chills with this combination, treatment with Escitalopram SUN and serotonergic drugs should be stopped immediately and a doctor called to start symptomatic 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 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 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.

Children and young people under 18 years of age

Escitalopram SUN 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 SUN 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 inform your doctor if you notice any of the above symptoms or if they worsen during treatment with Escitalopram SUN and you are under 18 years of age. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been determined for this age group.

Other medicines and Escitalopram SUN

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 SUN. After stopping treatment with Escitalopram SUN, 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 (both are antidepressants).
  • Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, esomeprazole, and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant drug), 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 (aspirin) and NSAIDs (analgesics 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 SUN, 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). The dose of Escitalopram SUN 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 SUN 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 SUN with food, drink, and alcohol

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

As with many other medicines, the use of alcohol during treatment with Escitalopram SUN is not recommended, although Escitalopram SUN 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.

If you take Escitalopram SUN during the last three months of pregnancy until delivery, you should be aware that the following effects may be seen in your newborn baby: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, difficulty feeding, vomiting, low blood sugar, tension or slack muscles, lively reflexes, tremors, tremors, irritability, lethargy, persistent crying, increased sleepiness, or difficulty sleeping. If your newborn has any of these symptoms, contact your doctor or midwife as soon as possible.

Tell your midwife or doctor that you are taking Escitalopram SUN. When drugs such as Escitalopram SUN 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 SUN 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 SUN so that they can advise you on this.

If Escitalopram SUN is used during pregnancy, treatment should not be interrupted abruptly.

Escitalopram 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

You should not drive or use machines until you know how Escitalopram SUN 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 SUN 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 take Escitalopram SUN

Always take 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 once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Panic syndrome

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

Social Phobia

The usual recommended dose 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 SUN 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 Ranbaxy is 10 mg once daily. Doseone 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 SUN is 5 mg once daily. Dose one can be increased by your doctor to a maximum of 10 mg per day.

Use for children and adolescents (under 18 years)

Escitalopram SUN should not normally be given to children and adolescents. For further information see section 2 “What you need to know before taking Escitalopram SUN”.

Escitalopram SUN 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 breaker notched upwards. The tablet can then be split with a jerk at each end of the tablet with your index fingers, as shown in the sketch.

Divide the tablet on a flat surface.

Duration of treatment

It may take a few weeks before you start to feel better. Continue to take Escitalopram SUN 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 SUN 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 SUN 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, decreased blood pressure and effects on the body’s salt and fluid balance. Take the Escitalopram SUN pack with you when contacting your doctor or hospital.

If you forget to take Escitalopram SUN

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 SUN

Do not stop taking Escitalopram SUN 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 SUN, and especially if this happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram SUN is stopped. The risk is higher if Escitalopram SUN 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.

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 (vivid dreams, nightmares, inability to sleep), feeling of anxiety , headache, nausea, sweating (including night sweats) feeling of restlessness or agitation, tremor (tremors), feeling of being 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, pharmacist or nurse.

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.

If you experience the following side effects , contact your doctor or go to hospital immediately:

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

  • Uncommon bleeding, including gastrointestinal bleeding.

Rare (may affect up to 1 in 1000 people):

  • Swelling of the skin, tongue, lips or face, or difficulty breathing or swallowing ( allergic reaction ).
  • High fever, anxiety, feeling confused, trembling and having sudden muscle contractions, these can 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.
  • Thoughts about harming yourself or committing suicide, see also section 2 “Warnings and precautions”.
  • Severe vaginal bleeding shortly after delivery ( postpartum haemorrhage ), see “Pregnancy, breast-feeding and fertility” in section 2 for more information.

In addition, 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 users): 

  • 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 problems with delayed ejaculation, erection problems or decreased sexual desire while women may experience decreased sexual desire and difficulty achieving 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, ear rings ( tinnitus )
  • Hair loss
  • Abundant menstrual bleeding
  • Irregular menstruation
  • Weight loss
  • Palpitation
  • Swollen arms and legs
  • Nasal blood

Rare (may affect up to 1 in 1000 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 (orthostatic hypotension)
  • Abnormal liver function values ​​(elevated levels of liver enzymes in the blood)
  • Movement disorders (involuntary muscle movements)
  • Painful erections (priapism)
  • Increased bleeding diseases in e.g. skin and mucosal bleeding ( ecchymosis ) and low platelet levels ( thrombocytopenia )
  • Sudden swelling of the skin and mucous membranes ( angioedema )
  • Increased urine output (poorly functioning ADH secretion)
  • Flow of breast milk in men and women who are not breastfeeding
  • Feeling of being unusually elated, overactive and uninhibited (mania)
  • Changes in heart rate (” QT prolongation”, as measured by ECG measurement of electrical activity in the heart)

In addition to the above, a number of side effects have been observed with the use of medicines that act in a similar way to escitalopram (the active substance in Escitalopram Ranbaxy). These are:

  • Motor restlessness ( akathisia )
  • Loss of appetite

An increased risk of bone fractures has been seen in patients taking this type of drug.

5. How to store Escitalopram SUN

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 or blister after EXP. or 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 (as oxalate). Each tablet contains escitalopram 10 mg or 20 mg.
  • The other ingredients are: microcrystalline cellulose, lactose monohydrate , copovidone (K 90-100), maize starch, silicon modified microcrystalline cellulose, croscarmellose sodium, talc, colloidal anhydrous silica, magnesium stearate.
  • Tablet coating: Opadry OY-S-58910 consisting of hypromellose, titanium dioxide (E171), macrogol 400, talc.

What the medicine looks like and contents of the pack

Escitalopram SUN is available as 10 mg and 20 mg film-coated tablets.

The tablets have the following appearance:

10 mg: White to off-white, oval biconvex, film-coated tablets approximately 8,10 ± 0,40 mm long, 5,60 ± 0,40 mm wide marked with “E” and “8” on each side of the breaker notch on one tablet page. The other side is smooth.

20 mg: White to off-white, oval biconvex, film-coated tablets approximately 11.60 ± 0.40 mm long, 7.10 ± 0.40 mm wide marked with “E” and “9” on each side of the break notch on one tablet page. The other side is smooth.

Escitalopram SUN 10 mg film-coated tablets are supplied in packs of 14, 20, 28, 30, 50, 56 and 100 tablets, packaged in polyamide / Alu / PVC / Alublister.

Escitalopram SUN 20 mg film-coated tablets are supplied in packs of 14, 20, 28, 30, 50, 56 and 100 tablets, packaged in polyamide / Alu / PVC / Alublister.

Marketing Authorisation Holder

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH, Hoofddorp

Netherlands

Manufacturer

Therapy S. A. , St. Fabricii no. 124, Cluj Napoca, Romania

Sun Pharmaceutical Industries Europe BV , Polarisavenue 87, 2132JH, Hoofddorp, The Netherlands

Muhammad Nadeem

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