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, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

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

What Estitalopram STADA is and what it is used for

Escitalopram 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 Stada contains escitalopram and is used to treat depression (actual 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 Stada 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 Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you use Estitalopram STADA

Do not take Escitalopram STADA

  • 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 Stada”).
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Warnings and cautions

Talk to your doctor or pharmacist before taking Escitalopram Stada. This is especially true:

  • if you have epilepsy. Treatment with Escitalopram Stada should be discontinued if you experience seizures for the first time or if the seizures occur at more frequent intervals (see section 4 “Possible side effects”)
  • if you have impaired liver or kidney function (your doctor may need to adjust the dose of Escitalopram Stada)
  • if you have diabetes. Treatment with Escitalopram Stada may affect your blood sugar level. The dose of one of the insulin and/or blood sugar-lowering tablets may need to be changed
  • if you have decreased levels of sodium in your blood
  • if you tend to easily get bleeding or bruising
  • have previously had bleeding disorders or if you are pregnant (see “Pregnancy, breast-feeding and fertility”)
  • if you are receiving treatment with electric shocks
  • if you have coronary heart disease
  • if you have or have had heart problems or have recently had a heart attack
  • if you have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics )
  • if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal heart rhythm function
  • have or have previously had problems with their eyes, such as certain types of glaucoma (increased pressure in the eye).

Drugs such as Escitalopram Stada (so-called SSRIs ) 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.

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

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

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are a young adult. Studies have shown that adults under the age of 25 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

Escitalopram Stada 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 Stada 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 Estitalopram STADA

Tell your doctor or pharmacist if you are taking, have recently taken, nor 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 Stada. After stopping treatment with Escitalopram Stada, you must wait 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).
  • “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.
  • Linezolid, an antibiotic .
  • Lithium (medicine for manic-depressive illness) and tryptophan.
  • Imipramine and desipramine (antidepressants).
  • Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections) and fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of blood clots). These may cause increased levels of Escitalopram Stada in the blood.
  • St. John’s wort ( Hypericum perforatum – an herbal remedy for depression).
  • Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
  • Warfarin, dipyridamole, and phenprocoumon (blood thinners, called anticoagulants). When starting and stopping treatment with Escitalopram Stada, 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), desipramine, clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Escitalopram Stada 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 Stada 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 phenothiazines, pimozide, haloperidol )
  • tricyclic antidepressants
  • certain antimicrobial drugs (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, especially halofantrine)
  • some antihistamines (astemizole, mizolastine).

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

Estitalopram STADA with food, drink, and alcohol

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

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

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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 Stada if you are pregnant without first discussing the risks and benefits of treatment with your doctor.

If you are taking Escitalopram Stada during the last 3 months of pregnancy, you should be aware that the following symptoms may be seen in your newborn baby: difficulty breathing, dark blue or violet skin discoloration, seizures, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, jerky, trembling, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor as soon as possible.

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

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

Escitalopram Stada 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.

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

Driving and using machines

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

Estitalopram STADA contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Estitalopram STADA

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 of Escitalopram Stada 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 Escitalopram Stada once daily for the first week, then 10 mg daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Social Phobia

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

Older

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

Children and young people

Escitalopram Stada should not be given to children and adolescents under 18 years of age. For further information see section 2 “What you need to know before taking Escitalopram Stada”.

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

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

For 10 mg, 15 mg, and 20 mg film-coated tablets only:

If necessary, the tablets can be divided by placing the tablet on a flat surface with the breaker notched upwards. The tablets can then be divided by pressing each end of the tablet with your index fingers.

Duration of treatment

It may take a few weeks before you start to feel better. Continue to take Escitalopram Stada 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 Stada 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 STADA 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 Stada pack with you when contacting your doctor or hospital.

If you forget to take Escitalopram STADA

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 STADA

Do not stop taking Escitalopram Stada 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 Stada, and especially if this happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Stada is stopped. The risk is higher if Escitalopram Stada 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: dizziness (feeling unsteady or balance), sensory disturbances such as ant crawling, burning sensation and (less common) feeling of electric shock, including such sensations in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache , nausea, sweating (including night sweats) feeling of restlessness or agitation, tremor (tremors), feeling 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 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 if you experience any of the following side effects during treatment:

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

  • Uncommon bleeding, including gastrointestinal bleeding.

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

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

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

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

  • 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”.

In addition, the following side effects have been reported:

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

  • Nausea
  • Headache.

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

  • Clogged or runny nose ( sinusitis )
  • Decreased or increased appetite
  • Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
  • Diarrhea, constipation, vomiting, dry mouth
  • Increased sweating
  • Pain in muscles and joints ( arthralgia and myalgia )
  • Sexual disorders (men may experience problems with delayed ejaculation, erection problems, decreased sexual desire and women may experience 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 1,000 people)

  • Aggression, personality changes, hallucinations
  • Slow heartbeat

Some patients have reported (occurs in unknown number of users)

  • 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 erection (priapism)
  • Bleeding disorders including skin and mucous membrane 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 women who are not breastfeeding
  • Mania
  • An increased risk of bone fractures has been seen in patients taking this type of drug
  • Changes in heart rate (” QT prolongation”, observed with ECG , electrical activity in the heart)
  • Severe vaginal bleeding shortly after delivery ( postpartum haemorrhage ), see Pregnancy, breast-feeding and fertility in section 2 for more information.

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 Stada. These are:

  • Motor restlessness ( akathisia )
  • Anorexia.

5. How to store Estitalopram STADA

Keep this medicine out of the sight and reach of children.

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

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

Other ingredients are:

  • Core : Microcrystalline cellulose (E460), croscarmellose sodium (E468), colloidal anhydrous silica, magnesium stearate (E470b)
  • Coating : Hypromellose (E464), titanium dioxide (E 171) and macrogol 400.

What the medicine looks like and the contents of the pack

Escitalopram Stada is available as 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. The tablets have the following appearance:

Escitalopram Stada 5 mg: round, white, film-coated tablet.

Escitalopram Stada 10 mg: oval (approximately 8.1 x 5.6 mm), white, film-coated tablet with a notch on one side.

The tablet can be divided into two equal doses .

Escitalopram Stada 15 mg: oval (approximately 10.4 x 5.6 mm), white, film-coated tablet with a notch on one side.

The breaker is not for dividing the tablet into equal doses but only for easier swallowing.

Escitalopram Stada 20 mg: oval (approximately 11.5 x 7.1 mm), white, film-coated tablet with a notch on one side.

The tablet can be divided into two equal doses .

Escitalopram Stada is available in the following pack sizes:

10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 120, 200 tablets (blister map).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Other manufacturers

HBM Pharma s ro, Sklabinská 30, 036 80 Martin, Slovakia

STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Vienna, Austria

Sanico NV, Veedijk 59, 2300 Turnhout, Belgium

Centrafarm Services BV, Nieuwe Donk 9, 4879 AC Etten-Leur, The Netherlands

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary, Ireland

LAMP SAN PROSPERO SPA, Via della Pace, 25 / A, 41030 San Prospero (Modena), Italy

PharmacCoDane ApS, Marielundvej 46 A, 2750 Herlev, Denmark

ITC Farma SRL, Via Pontina KM 29, 00071 Pomezia (RM), Italy

Local representative

STADA Nordic ApS

Marielundvej 46ª

2730 Herlev

Denmark

Muhammad Nadeem

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