Do not take Escitalopram Actavis:<\/h2>\n\n\n\n- if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).<\/li>
- 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 ).<\/li>
- 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).<\/li>
- if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 \u201cOther medicines and Escitalopram Actavis\u201d).<\/li><\/ul>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before taking Escitalopram Actavis.
<\/p>\n\n\n\n
Tell your doctor if you have other diseases. This is especially true if you:<\/p>\n\n\n\n
- 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 \u201cPossible side effects\u201d).<\/li>
- have impaired liver or kidney function. Your doctor may need to adjust dose one.<\/li>
- 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.<\/li>
- have decreased levels of sodium in the blood.<\/li>
- tend to easily bleed or bruise or if you are pregnant (see section Pregnancy).<\/li>
- have coronary heart disease.<\/li>
- suffers from or has suffered from heart problems or recently had a heart attack.<\/li>
- 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 ).<\/li>
- experiencing a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate that your heartbeat is not functioning normally.<\/li>
- have or have previously had problems with the eyes, such as certain types of glaucoma (increased pressure in the eye.<\/li><\/ul>\n\n\n\n
Note<\/strong><\/p>\n\n\n\nSome 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.
<\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
If you start to feel worse and have thoughts of harming yourself<\/strong><\/p>\n\n\n\nIf 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.<\/p>\n\n\n\n
The above thoughts may be more common:<\/p>\n\n\n\n
- If you have previously had thoughts of harming yourself or committing suicide.<\/li>
- 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.<\/li><\/ul>\n\n\n\n
Contact a doctor as soon as possible or see the nearest hospital<\/strong> if you have thoughts of injuring yourself or committing suicide.
<\/p>\n\n\n\nIt may be helpful to tell a relative or close friend that<\/strong> 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.<\/p>\n\n\n\nChildren and young people<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Other medicines and Escitalopram Actavis<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
<\/p>\n\n\n\n
Tell your doctor if you are taking any of the following medicines:<\/p>\n\n\n\n
- “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine<\/a> 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.<\/li>
- “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).<\/li>
- “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.<\/li>
- Linezolid, an antibiotic .<\/li>
- Lithium (medicine for manic-depressive illness) and tryptophan.<\/li>
- Impipramine and desipramine (medicines for depression).<\/li>
- Sumatriptan and similar medicines (medicines for migraines ) and tramadol<\/a> (medicines for severe pain). These increase the risk of side effects.<\/li>
- 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.<\/li>
- St. John’s wort ( Hypericum perforatum<\/em> – an herbal remedy for depression).<\/li>
- Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.<\/li>
- 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.<\/li>
- Mefloquine (anti-malarial drug ), bupropion (anti-depressant drug), and tramadol (anti-severe pain medication) due to a possible risk of lowering the seizure threshold.<\/li>
- Neuroleptics (medicines for schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs) due to a possible risk of lowering the seizure threshold.<\/li>
- 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.<\/li>
- Drugs that lower blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.
<\/li><\/ul>\n\n\n\nDO NOT TAKE Escitalopram Actavis<\/strong> 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.<\/p>\n\n\n\nEscitalopram Actavis with food, drink, and alcohol<\/h2>\n\n\n\n
Escitalopram Actavis can be taken with or without food (see section 3 \u201cHow to take Escitalopram Actavis\u201d).
<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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.
<\/p>\n\n\n\n
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<\/p>\n\n\n\n
you should contact your doctor or midwife as soon as possible for any of these symptoms.
<\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
If Escitalopram Actavis is used during pregnancy, abrupt discontinuation of treatment should be avoided.
<\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
Escitalopram is expected to be excreted in human milk.
<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Do not drive or use machines until you know how Escitalopram Actavis affects you.
<\/p>\n\n\n\n
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.<\/p>\n\n\n\n
Escitalopram Actavis contains sodium<\/h2>\n\n\n\n
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
<\/p>\n\n\n\n
How to take Escitalopram Actavis<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\n
Adults<\/strong><\/p>\n\n\n\nDepression<\/em><\/p>\n\n\n\nThe 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.
<\/p>\n\n\n\n
Panic syndrome<\/em><\/p>\n\n\n\nThe 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.
<\/p>\n\n\n\n
Social Phobia<\/em><\/p>\n\n\n\nThe 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.
<\/p>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Talk to your doctor or pharmacist before taking Escitalopram Actavis.
<\/p>\n\n\n\n
Tell your doctor if you have other diseases. This is especially true if you:<\/p>\n\n\n\n
- 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 \u201cPossible side effects\u201d).<\/li>
- have impaired liver or kidney function. Your doctor may need to adjust dose one.<\/li>
- 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.<\/li>
- have decreased levels of sodium in the blood.<\/li>
- tend to easily bleed or bruise or if you are pregnant (see section Pregnancy).<\/li>
- have coronary heart disease.<\/li>
- suffers from or has suffered from heart problems or recently had a heart attack.<\/li>
- 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 ).<\/li>
- experiencing a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate that your heartbeat is not functioning normally.<\/li>
- have or have previously had problems with the eyes, such as certain types of glaucoma (increased pressure in the eye.<\/li><\/ul>\n\n\n\n
Note<\/strong><\/p>\n\n\n\n
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.
<\/p>\n\n\n\nSymptoms 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.
<\/p>\n\n\n\nDrugs 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.
<\/p>\n\n\n\nIf you start to feel worse and have thoughts of harming yourself<\/strong><\/p>\n\n\n\n
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.<\/p>\n\n\n\n
The above thoughts may be more common:<\/p>\n\n\n\n
- If you have previously had thoughts of harming yourself or committing suicide.<\/li>
- 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.<\/li><\/ul>\n\n\n\n
Contact a doctor as soon as possible or see the nearest hospital<\/strong> if you have thoughts of injuring yourself or committing suicide.
<\/p>\n\n\n\nIt may be helpful to tell a relative or close friend that<\/strong> 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.<\/p>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
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.<\/p>\n\n\n\n
Other medicines and Escitalopram Actavis<\/h2>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
<\/p>\n\n\n\nTell your doctor if you are taking any of the following medicines:<\/p>\n\n\n\n
- “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine<\/a> 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.<\/li>
- “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).<\/li>
- “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.<\/li>
- Linezolid, an antibiotic .<\/li>
- Lithium (medicine for manic-depressive illness) and tryptophan.<\/li>
- Impipramine and desipramine (medicines for depression).<\/li>
- Sumatriptan and similar medicines (medicines for migraines ) and tramadol<\/a> (medicines for severe pain). These increase the risk of side effects.<\/li>
- 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.<\/li>
- St. John’s wort ( Hypericum perforatum<\/em> – an herbal remedy for depression).<\/li>
- Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.<\/li>
- 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.<\/li>
- Mefloquine (anti-malarial drug ), bupropion (anti-depressant drug), and tramadol (anti-severe pain medication) due to a possible risk of lowering the seizure threshold.<\/li>
- Neuroleptics (medicines for schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs) due to a possible risk of lowering the seizure threshold.<\/li>
- 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.<\/li>
- Drugs that lower blood levels of potassium or magnesium, as these conditions increase the risk of life-threatening heart rhythm disorders.
<\/li><\/ul>\n\n\n\nDO NOT TAKE Escitalopram Actavis<\/strong> 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.<\/p>\n\n\n\n
Escitalopram Actavis with food, drink, and alcohol<\/h2>\n\n\n\n
Escitalopram Actavis can be taken with or without food (see section 3 \u201cHow to take Escitalopram Actavis\u201d).
<\/p>\n\n\n\nAs 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.<\/p>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
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.
<\/p>\n\n\n\nIf 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<\/p>\n\n\n\n
you should contact your doctor or midwife as soon as possible for any of these symptoms.
<\/p>\n\n\n\nTell 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.
<\/p>\n\n\n\nIf Escitalopram Actavis is used during pregnancy, abrupt discontinuation of treatment should be avoided.
<\/p>\n\n\n\nIf 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.
<\/p>\n\n\n\nEscitalopram is expected to be excreted in human milk.
<\/p>\n\n\n\nIn 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.<\/p>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Do not drive or use machines until you know how Escitalopram Actavis affects you.
<\/p>\n\n\n\nYou 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.<\/p>\n\n\n\n
Escitalopram Actavis contains sodium<\/h2>\n\n\n\n
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
<\/p>\n\n\n\nHow to take Escitalopram Actavis<\/h2>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
<\/p>\n\n\n\nAdults<\/strong><\/p>\n\n\n\n
Depression<\/em><\/p>\n\n\n\n
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.
<\/p>\n\n\n\nPanic syndrome<\/em><\/p>\n\n\n\n
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.
<\/p>\n\n\n\nSocial Phobia<\/em><\/p>\n\n\n\n
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.
<\/p>\n\n\n\n
- “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine<\/a> 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.<\/li>