5 mg, 10 mg, 15 mg, 20 mg film-coated tablets 
escitalopram

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

What Escitalopram Actavis is and what it is used for

Escitalopram Actavis contains the active substance escitalopram. Escitalopram Actavis 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 Actavis is used to treat depression and anxiety disorders (such as panic disorder with or without market fear, 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 Actavis 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 Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. 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 take Escitalopram Actavis

Do not take Escitalopram Actavis:

  • 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 Actavis”).

Warnings and cautions

Talk to your doctor or pharmacist before taking Escitalopram Actavis.

Tell your doctor if you have other diseases. This is especially true if you:

  • have epilepsy. Treatment with Escitalopram Actavis 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 Actavis 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 easily bleed or bruise or if you are pregnant (see section Pregnancy).
  • 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 that your heartbeat is not functioning normally.
  • have or have previously had problems with the eyes, such as certain types of glaucoma (increased pressure in the eye.

Note

Some patients with manic-depressive illness may go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.

Symptoms such as restlessness and difficulty sitting or standing still can also occur during the first weeks of treatment. Contact your doctor immediately if you experience these symptoms.

Drugs such as Escitalopram Actavis ( SSRI / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.

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

If you are depressed and/or suffering from anxiety, you 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.

The above thoughts may be more 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

Escitalopram Actavis 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 Actavis 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 Actavis

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 Actavis. After stopping treatment with Escitalopram Actavis, 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.
  • Impipramine and desipramine (medicines for depression).
  • Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
  • Cimetidine, lansoprazole, omeprazole, and esomeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), 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 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 Actavis, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants is 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 cardiovascular diseases), desipramine, clomipramine, and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (drug against psychosis ). Dose one of Escitalopram Actavis 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 Actavis 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 Actavis with food, drink, and alcohol

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

As with many other medicines, the use of alcohol during treatment with Escitalopram Actavis is not recommended, although Escitalopram Actavis and alcohol are not expected to have any effect on each other.

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 Actavis if you are pregnant or breast-feeding without first discussing the risks and benefits of treatment with your doctor.

If you are taking Escitalopram Actavis during the last three months before delivery, you should be aware that the following symptoms may be seen in your newborn: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, breastfeeding difficulties, 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

you should contact your doctor or midwife as soon as possible for any of these symptoms.

Tell your midwife or doctor that you are taking Escitalopram Actavis. When drugs such as Escitalopram Actavis 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 Actavis is used during pregnancy, abrupt discontinuation of treatment should be avoided.

If you take Escitalopram Actavis 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 Actavis so that they can advise you on this.

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

Do not drive or use machines until you know how Escitalopram Actavis affects you.

You are responsible for assessing whether you are fit to drive motor vehicles or perform risky work. 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. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Escitalopram Actavis contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.

How to take Escitalopram Actavis

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

Adults

Depression

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

Panic syndrome

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

Use for children and adolescents

Escitalopram Actavis should not be given to children and adolescents under 18 years of age. For further information, see section 2 “Before taking Escitalopram Actavis”.

Take the tablet once a day, swallow with enough liquid (for example, a glass of water). Escitalopram Actavis can be taken with or without food.

Escitalopram Actavis 10 mg, 15 mg, 20 mg film-coated tablets

If needed, the tablets can be divided. Place the tablet on a flat surface with the notch facing up. Press each end of the tablet with your index fingers, as shown in the sketch.

Divide tablet

Duration of treatment

It may take a few weeks before you start to feel better. Continue to take Escitalopram Actavis 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 Actavis for as long as your doctor prescribes 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 Actavis 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 Actavis pack with you when contacting your doctor or hospital.

If you forget to take Escitalopram Actavis

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 Actavis

Do not stop taking Escitalopram Actavis 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 Actavis, and especially if it happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Actavis is stopped. The risk is higher if Escitalopram Actavis has been used for a long time or in higher doses, or if the dose is reduced too quickly. In most cases, these symptoms are mild and usually resolve within two weeks, although in some individuals they may be perceived as severe and persist for a longer period (2-3 months or more). Contact your doctor if you experience severe withdrawal symptoms after stopping treatment. He or she may ask you to start taking the tablets again, and then put them out more slowly.

Withdrawal symptoms: dizziness (feeling unsteady or balance), 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 restless or upset, tremor (tremors), feeling confused or disoriented, emotional instability or irritability, diarrhea, visual disturbances, palpitations.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Contact your doctor 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):

  • Uncommon bleeding, including gastrointestinal bleeding.

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

  • Swelling of the skin, tongue, lips, throat, or face, rash or difficulty breathing or swallowing (severe allergic reaction ), contact your doctor, or go to the hospital immediately.
  • High fever, anxiety, feeling confused, trembling, and having sudden muscle contractions, can be signs of a rare condition called serotonergic syndrome.

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

  • Difficulty urinating
  • Seizures
  • 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”).
  • Sudden swelling of the skin or mucous membranes ( angioedema ).

Also, 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, 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 delayed ejaculation or erection problems while women may experience decreased sexual desire and difficulty reaching 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
  • Taste change, sleep disturbance, fainting ( syncope )
  • Enlarged pupils ( mydriasis ), visual disturbances, earrings ( 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

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)
  • 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)
  • Signs of abnormal bleeding e.g. from the skin and mucous membranes ( Eskimos er)
  • Low platelet levels ( thrombocytopenia )
  • Increased secretion of a hormone called ADH, which causes the body to collect water and dilute the blood, which leads to a reduced amount of sodium(Inadequate ADH – secretion )
  • The flow of breast milk in men and women who are not breastfeeding
  • Severe vaginal bleeding shortly after delivery ( postpartum hemorrhage), see section Pregnancy for more information
  • Mania
  • An increased risk of bone fractures has been seen in patients taking this type of drug
  • Changes in heart rate (“prolongation of QT interval”, observed with ECG(a measurement of the electrical activity of the heart)

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

  • Motor restlessness ( akathisia )
  • Loss of appetite

5. How to store Escitalopram Actavis

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 blister, label, or carton after EXP. The expiration date is the last day of the specified month.

Blister packs: Do not store above 25 ° C.

Jar: 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 film-coated tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).

Other ingredients are:

Tablet core: microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, talc, magnesium stearate.

Film coating : hypromellose 6cP, titanium dioxide (E 171), macrogol 6000.

What the medicine looks like and the contents of the pack

Escitalopram Actavis 5 mg: Round, biconvex, white, film-coated tablet (6 mm diameter) marked with “E” on one side.

Escitalopram Actavis 10 mg: Oval, biconvex, white, film-coated tablet (6.4 mm x 9.25 mm diameter) with a notch on one side, side notches, and marked with “E” on the other side of the tablet. The tablet can be divided into two equal doses.

Escitalopram Actavis 15 mg: Oval, biconvex, white, film-coated tablet (7.3 mm x 10.6 mm diameter) with a notch on one side, side notches, and marked with “E” on the other side of the tablet. The tablet can be divided into two equal doses.

Escitalopram Actavis 20 mg: Oval, biconvex, white, film-coated tablet (8 mm x 11.7 mm diameter) with a notch on one side, side notches, and marked with “E” on the other side of the tablet. The tablet can be divided into two equal doses.

Escitalopram Actavis is available in blister packs of 14, 20, 28, 30, 50, 56, 60, 98, 100 and 200 tablets.

Escitalopram Actavis 5 mg / 10 mg is available in cans of 100 or 200 tablets.

Escitalopram Actavis 15 mg / 20 mg is available in bottles of 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf

220 Hafnarfjörður

Reykjavikurvegur 76-78

Iceland

Manufacturer

Actavis Ltd

BLB016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Actavis hf.

Reykjavikurvegur 76-78,

220 Hafnarfjordur,

Iceland.

Balkanpharma-Dupnitsa AD,

3 Samokovsko Shosse Str., Dupnitza 2600

Bulgaria

TjoaPack Netherlands BV

New Donk 9

4879 AC in Etten-Leur

Netherlands

Muhammad Nadeem

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