5 mg, 10 mg, 20 mg film-coated tablets 
escitlopram

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 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.

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

1. What Escitalopram Accord is and what it is used for

Escitalopram Accord 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).

Escitalopram belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs affect the serotonin system in the brain by increasing serotonin levels. Disorders of the serotonin system are considered to be an important factor in the development of depression and related diseases.

Escitalopram contained in Escitalopram Accord 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.

It may take a few weeks before you start to feel better. Continue to take Escitalopram Accord 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.

2. What you need to know before using Escitalopram Accord

Do not use Escitalopram Accord

  • If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (see 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), or linezolid (an antibiotic ).
  • If you were 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).

Warnings and cautions

Tell your doctor if you have any other symptoms or illness, as your doctor may need to consider this. Tell your doctor in particular:

  • If you have epilepsy. Treatment with Escitalopram Accord 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 have impaired liver or kidney function. Your doctor may need to adjust someone.
  • If you have diabetes. Treatment with Escitalopram Accord may affect your blood sugar. The dose of one of the insulin and/or blood sugar-lowering medicines taken by mouth may need to be adjusted.
  • If you have lowered your blood sodium levels.
  • If you tend to bleed or bruise easily
  • 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 if you know 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, which may indicate the abnormal function of the heartbeat.
  • If you have or have ever had eye problems, such as certain types of glaucoma(increased pressure in the eye).
  • Drugs such as Escitalopram Accord ( SSRI / 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 or difficulty sitting or standing still may 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 anxiety/worry can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor immediately or go to 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.

Use in children and adolescents under 18 years of age

Escitalopram Accord 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. Nevertheless, Escitalopram Accord 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 determined for children and adolescents under 18 years of age.

Other medicines and Escitalopram Accord

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking:

  • Non-selective monoamine oxidase inhibitors (MAOIs) ‘, which contain phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substance. If you have taken any of these medicines, you must wait 14 days before taking Escitalopram Accord. After stopping Escitalopram Accord, you must wait 7 days before taking any of these medicines.
  • “Reversible, selective MAO-A inhibitors”, containing moclobemide (used to treat depression).
  • “Irreversible MAO-B inhibitors”, which contain selegiline (used to treat Parkinson’s disease ). These increase the risk of side effects.
  • Buprenorphine (a type of opioid drug). Concomitant use increases the risk of the serotonergic syndrome, which can be a life-threatening condition. The symptoms can be involuntary rhythmic muscle contractions, even in the muscles that control the movements of the eye; restlessness, hallucinations, coma, heavy sweating, tremors, excessive reflexes, increased muscle tension, body temperature exceeding 38 ° C. Contact a doctor if you get these symptoms.
  • Linezolid, an antibiotic .
  • Lithium (used to treat manic-depressive illness) and tryptophan.
  • Imipramine and desipramine (both used to treat depression).
  • Sumatriptan and similar medicines (used to treat migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, and omeprazole (medicines used to treat stomach ulcers, fluconazole (used to treat fungal infections), fluvoxamine (antidepressants), and ticlopidine (used to reduce the risk of stroke ) may cause increased levels of escitalopram in the blood.
  • St. John’s wort ( Hypericum perforatum ) – herbal medicine used for depression.
  • Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (drugs used as painkillers or as blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
  • Warfarin, dipyridamole, and phenprocoumon (blood thinners, called anticoagulants). Your doctor will probably check how fast your blood coagulates when you start and stop taking Escitalopram Accord to make sure that the dose of one of the anticoagulants you have been prescribed is still right.
  • Mefloquine (used to treat malaria ), bupropion (used to treat depression), and tramadol (medicines for severe pain) due to possible decreased seizure threshold (increases the risk of epileptic seizures).
  • Neuroleptics (medicines used to treat schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs ) due to the possible risk of reduced seizure threshold, and antidepressants.
  • Flecainide, propafenone, and metoprolol (used to treat cardiovascular disease) and clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). The dosage of Escitalopram Accord may need to be adjusted.

Do not take Escitalopram Accord if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class 1A and III antiarrhythmics (medicines for irregular heart activity), antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (medicines depression), certain antimicrobial drugs (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 Accord with food, drink, and alcohol

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

As with many other medicines, the use of alcohol during treatment with Escitalopram Accord is not recommended, although Escitalopram Accord 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 Accord if you are pregnant or breast-feeding without first discussing the risks with your doctor. and the benefits of the treatment. If you are taking Escitalopram Accord during the last three months of pregnancy, 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, tense or slack muscles, overactive reflexes, tremors, jerkiness, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor or midwife immediately.

Tell your midwife or doctor that you are using Escitalopram Accord. When medicines like Escitalopram Accord 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 Escitalopram Accord is used during pregnancy, treatment should never be stopped abruptly. Escitalopram Accord is expected to be excreted in human milk.

Do not take Escitalopram Accord if you are breast-feeding without first discussing the risks and benefits of treatment with your doctor.

In animal studies, citalopram, a drug similar to Escitalopram Accord, 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

You are advised not to drive or use machines until you know how you are affected by Escitalopram Accord.

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.

3. How to use Escitalopram Accord

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

Adults:

Depression

The 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 10 mg daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Social Phobia

The recommended dose is 10 mg once daily. Your doctor may either reduce the doseone 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 recommended dose 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 is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.

Elderly patients (> 65 years of age)

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

Use in children and adolescents (under 18 years)

Escitalopram Accord should not normally be given to children and adolescents. For further information, see section 2.

You can take Escitalopram Accord with or without food. The tablet is swallowed whole with water. Do not chew it because the taste is bitter.

If needed, the tablet can be shared. Place the tablet on a flat surface with the notch facing up. Press both ends of the tablet with your index fingers, as shown in the illustration.

Only 10 mg and 20 mg tablets can be divided into two equal doses 

10 mg and 20 mg can be divided.

Treatment time

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

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

Continue to take Escitalopram Accord 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 you feel well again.

If you take more Escitalopram Accord 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. Symptoms of overdose may include dizziness, tremors, anxiety, seizures, coma, nausea, vomiting, changes in heart rate, decreased blood pressure, and changes in the body’s salt and fluid balance. Take the pack/jar of Escitalopram Accord to your doctor or hospital.

If you forget to take Escitalopram Accord

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and remember it before going to bed, take it immediately. Continue as usual the following day. If you remember it at night or the next day, do not take the missed dose but continue as usual.

If you stop taking Escitalopram Accord

Do not stop using Escitalopram Accord until your doctor tells you to. Once treatment is complete, it is generally recommended that the dose be gradually reduced over a period of several weeks.

When you stop taking Escitalopram Accord, especially if it happens suddenly, withdrawal symptoms may occur. These symptoms are common when treatment with Escitalopram Accord is stopped. The risk is greater if Escitalopram Accord has been used for a long time or in high doses, or if dose one is reduced too quickly. In most people, the symptoms are mild and go away on their own within two weeks. In some patients, however, the symptoms can be very strong or long-lasting (2-3 months or longer). If you experience severe withdrawal symptoms when you stop using Escitalopram Accord, contact your doctor. Your doctor may ask you to start taking the tablets again and then slow down the use more slowly.

Withdrawal symptoms include Dizziness (feeling of instability and balance), tingling and crawling, burning sensation and (less common) feeling of electric shock, including in the head, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats), feeling of restlessness or anxiety, tremor (tremors), feeling of confusion or disorientation, sensitivity or irritability, diarrhea, visual disturbances, fluttering or throbbing heartbeat ( palpitation ).

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

4. Possible side effects

Like all medicines, Escitalopram Accord can cause side effects, although not everybody gets them.

The side effects usually stop after a few weeks of treatment. Be aware that several of the following effects can also be symptoms of your illness and therefore will subside as you begin to feel better.

Contact your doctor or see a hospital immediately if you experience any of the following side effects during treatment:

Uncommon (may affect up to 1 in 100 people)

  • unusual bleeding, including gastrointestinal bleeding

Rarely intact (may affect up to 1 in 1,000 users)

  • swelling of the skin, tongue, lips, or face, or difficulty breathing or swallowing (allergic reaction fever, anxiety, confusion, tremors, or sudden muscle contractions may be signs of a rare condition called serotonergic syndrome.

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

  • Difficulty urinating.
  • Rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition known as Torsade de Pointes.
  • Seizures, see also section 2 “Warnings and precautions”.
  • Yellowish skin and yellow whites of the eyes are signs of hepatic impairment/hepatitis.
  • Thoughts about harming yourself or committing suicide, see also section 2 “Warnings and precautions”.

In addition to the above 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)

  • Clogged or runny nose ( sinusitis )
  • Decreased or increased appetite
  • Anxiety, restlessness, abnormal dreams, difficulty falling asleep, feeling drowsy, dizziness, yawning, tremors, tingling in the skin
  • Diarrhea, constipation, vomiting, dry mouth
  • Increased sweating
  • Muscle and joint pain ( myalgia and arthralgia )
  • Sexual disorders (men may experience problems with delayed ejaculation, erection problems, or decreased sexual desire, while 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, altered sense of taste, fainting ( syncope )
  • Enlarged pupil s ( mydriasis ), visual disturbance, ringing in the ears ( tinnitus )
  • Hair loss
  • Abundant menstrual bleeding
  • Irregular menstruation
  • Weight loss
  • Fast heart rate
  • Swelling in arms or legs
  • Nasal blood

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

  • Aggression, personality changes, hallucinations
  • Slow heartbeat

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

  • Decreased sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion)
  • Changes in heart rhythm (“prolongation of QT interval”, observed with ECG, measurement of the electrical activity of the heart).
  • 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)
  • A painful erection (priapism)
  • Increased tendency to bleed in e.g. skin and mucous membranes ( ecchymosis )
  • Sudden swelling of the skin and mucous membranes ( angioedema )
  • Increased urine output (poorly functioning ADH secretion)
  • The flow of breast milk in men and women who are not breastfeeding
  • Mania
  • An increased risk of bone fractures has been seen in patients taking this type of drug

Also, there are several side effects observed with the use of medicines that act in a similar way to escitalopram (the active substance in Escitalopram Accord film-coated tablets). These are:

  • Motor restlessness ( akathisia )
  • Loss of appetite

5. How to store Escitalopram Accord

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, label, or carton after EXP.

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

Do not store above 30 ° C.

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 Accord contains 5 mg, 10 mg, or 20 mg escitalopram (as oxalate).

Other ingredients are:

Tablet core: microcrystalline cellulose ( PH 101) (E460), croscarmellose sodium (E468), hypromellose E5 (E464), talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E470b).

Coating: hypromellose E-15 (E464), titanium dioxide (E171), macrogol 400

What the medicine looks like and the contents of the pack

Escitalopram Accord is available in strengths of 5 mg, 10 mg, and 20 mg. The tablets are described below.

5 mg: White to off-white, round biconvex, film-coated tablet approximately 5.65 mm in diameter, unmarked on both sides.

10 mg: White to off-white, oval, biconvex film-coated tablet approximately 8.10 mm long, 5.60 mm wide, marked “1” and “0” on one side of the incision and unmarked on the other side.

20 mg: White to off-white, oval, biconvex film-coated tablet approximately 11.60 mm long, 7.10 mm wide, with a scoreline on one side and unmarked on the other side.

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

Escitalopram Accord is available in the following pack sizes:

Blister in outer carton: 14, 28, 56, and 98 tablets

HDPE jar with 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

Netherlands

Manufacturer

Accord Healthcare Ltd, Sage House, 319 Pinner Road, NorthHarrow, Middlesex

HA1 4HF, UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Muhammad Nadeem

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