Escitalopram
Escitalopram LEK-AM belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors (SSRIs). These medicines work on the serotonin system in the brain by increasing the level of serotonin. Disturbances in the serotonin system in the brain are believed to play a key role in the development of depression and related disorders.
Escitalopram LEK-AM contains the active substance escitalopram, which is used to treat depression (major depressive episodes) and anxiety disorders (such as panic disorder with or without agoraphobia, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks of treatment before you feel better. You should continue to take Escitalopram LEK-AM even if it takes some time before your condition improves.
If you do not feel better or feel worse, you should consult your doctor.
Before starting treatment with Escitalopram LEK-AM, you should discuss it with your doctor.
You should tell your doctor if you have other disorders or diseases, as your doctor should take this information into account. In particular, you should inform your doctor:
In some patients with bipolar affective disorder, a manic phase may occur. It is characterized by unusual and rapidly changing ideas, unjustified feelings of happiness, and excessive physical activity. If these symptoms occur, you should consult your doctor.
In the first few weeks of treatment, restlessness or inability to sit or stand still may also occur. If such symptoms appear, you should immediately inform your doctor.
If you have depression and/or anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These symptoms may worsen when starting treatment with an antidepressant, as the medicine starts to work with some delay. It usually takes about 2 weeks, but sometimes it may take longer.
The likelihood of such thoughts occurring is higher if:
If you experience thoughts of self-harm or suicidal thoughts, you should immediately contact your doctor or go to the hospital.
It may be helpful to tell someone from your family or a close person about your depression or anxiety disorder; you can ask this person to read this leaflet. You can ask them to inform you if they notice that your depression or anxiety disorder is worsening or if worrying changes in your behavior occur.
Escitalopram LEK-AM should not be used in children and adolescents under 18 years of age. It should also be emphasized that in the case of taking medicines from this group, patients under 18 years of age are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (including aggression, rebellious behavior, and manifestations of anger). Nevertheless, your doctor may prescribe Escitalopram LEK-AM to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Escitalopram LEK-AM to a patient under 18 years of age, and you have any doubts, please contact your doctor. If the above-mentioned symptoms develop or worsen in patients under 18 years of age taking Escitalopram LEK-AM, you should inform your doctor.
Additionally, there is a lack of data on the long-term safety of using Escitalopram LEK-AM in this age group, regarding growth, maturation, and cognitive and behavioral development.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you are taking any of the following medicines:
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Do not take Escitalopram LEK-AMat the same time as medicines used to treat heart rhythm disorders or medicines that may affect heart rhythm, such as: antiarrhythmic medicines of class IA and class III, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antibacterial medicines (e.g. sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine), and certain antihistamines (astemizole, mizolastine). You should consult your doctor if you have any further questions.
Escitalopram LEK-AM can be taken with or without food (see section 3 "How to take Escitalopram LEK-AM").
As with other medicines, it is not recommended to take Escitalopram LEK-AM at the same time as drinking alcohol, although interactions (effects) of Escitalopram LEK-AM with alcohol are not expected.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before taking this medicine. You should not take Escitalopram LEK-AM during pregnancy and while breastfeeding, unless you have discussed the risks and benefits with your doctor.
Taking Escitalopram LEK-AM in the last 3 months of pregnancy may cause the following symptoms in the newborn: breathing difficulties, blue discoloration of the skin, seizures, fluctuations in body temperature, difficulty sucking, vomiting, low blood sugar, muscle stiffness or floppiness, increased reflexes, trembling, jittering, irritability, lethargy, constant crying, or sleepiness. If the newborn experiences any of these symptoms, you should immediately consult your doctor.
You should inform your doctor and/or midwife about taking Escitalopram LEK-AM.
Taking medicines like Escitalopram LEK-AM, especially in the last 3 months of pregnancy, may increase the risk of the newborn developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue discoloration, and usually appears in the first day after birth. If such symptoms occur in the newborn, you should immediately consult your doctor and/or midwife.
Taking Escitalopram LEK-AM at the end of pregnancy may increase the risk of severe bleeding from the vagina, occurring shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Escitalopram LEK-AM, you should inform your doctor or midwife so that they can provide you with appropriate advice.
It is assumed that escitalopram passes into breast milk.
In animal studies, it has been shown that citalopram, a medicine similar to escitalopram, reduces sperm quality. This may theoretically affect fertility, although no effect on fertility has been observed in humans so far.
Medicines like Escitalopram LEK-AM (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.
You should not drive or operate machinery until you know how Escitalopram LEK-AM affects you.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Escitalopram LEK-AM can be taken with or without food.
The tablet should be swallowed with water. The tablets should not be chewed.
The tablet with a score line can be divided into equal doses.
Adults
Depression
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg once daily.
Panic disorder
The initial dose of Escitalopram LEK-AM is 5 mg once daily in the first week of treatment, then the dose is increased to 10 mg once daily. The dose may be further increased by your doctor to a maximum of 20 mg once daily.
Social phobia
The recommended dose of Escitalopram LEK-AM is 10 mg once daily. The dose may then be decreased by your doctor to 5 mg once daily or increased to a maximum of 20 mg once daily, depending on your response to the medicine.
Generalized anxiety disorder
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg once daily.
Obsessive-compulsive disorder
The usual dose of Escitalopram LEK-AM is 10 mg once daily. The dose may be increased by your doctor to a maximum of 20 mg once daily.
Elderly patients (over 65 years of age)
The recommended initial dose of Escitalopram LEK-AM is 5 mg once daily. Your doctor may recommend increasing the dose to 10 mg once daily.
Escitalopram LEK-AM should not normally be used in children and adolescents. Additional information is provided in section 2 "Important information before taking Escitalopram LEK-AM.”
You may feel better after a few weeks of treatment. You should therefore continue to take Escitalopram LEK-AM even if it takes some time before your condition improves.
You should not change the dose without consulting your doctor.
The medicine should be taken for as long as your doctor has prescribed it. If you stop treatment too early, your symptoms may return. It is therefore recommended to continue treatment for at least 6 months after you have felt better.
If you have taken more Escitalopram LEK-AM than prescribed, you should immediately contact your doctor or go to the emergency department of the nearest hospital.
This should be done even if you do not feel any discomfort. Symptoms of overdose include: dizziness, trembling, restlessness, seizures, coma, nausea, vomiting, heart rhythm disorders, low blood pressure, and electrolyte disturbances. When visiting your doctor or the hospital, you should bring the packaging of Escitalopram LEK-AM with you.
You should not take a double dose to make up for a missed dose. If you have missed a dose and remember before bedtime, you should take the missed dose immediately. You should take the next dose at the usual time the next day. If you remember that you have missed a dose in the night or the next day, you should skip the missed dose and take the next dose as usual.
You should not stop taking Escitalopram LEK-AM unless your doctor tells you to do so.
When you stop treatment, it is usually recommended to gradually reduce the dose of Escitalopram LEK-AM over a period of several weeks.
After stopping treatment with Escitalopram LEK-AM, especially if it is stopped abruptly, you may experience withdrawal symptoms. These symptoms are common. The risk is higher if Escitalopram LEK-AM has been taken for a long time, in high doses, or if the dose has been reduced too quickly. In most patients, the symptoms are mild and disappear on their own within two weeks. However, in some patients, their course may be more severe or may last longer (2-3 months or longer). If you experience severe withdrawal symptoms after stopping treatment with Escitalopram LEK-AM, you should contact your doctor. Your doctor may recommend restarting treatment with the medicine and reducing the dose more slowly.
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The withdrawal symptoms include: dizziness (unsteady gait, balance disorders), tingling sensation, burning sensation, and (less often) a sensation of electric shock, also in the head, sleep disturbances (vivid dreams, nightmares, insomnia), restlessness, headache, nausea (feeling sick), sweating (including night sweats), restlessness or agitation, trembling, disorientation, emotional instability or irritability, diarrhea (loose stools), vision disturbances, heart palpitations or rapid heartbeat.
If you have any further doubts about taking the medicine, you should consult your doctor or pharmacist.
Like all medicines, Escitalopram LEK-AM can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should remember that some of these side effects may also be symptoms of the treated disease and will disappear as your condition improves.
You should contact your doctor or go to the hospital if you experience any of the following side effects during treatment:
Rare(affecting up to 1 in 1,000 people):
Frequency not known(frequency cannot be estimated from the available data):
In addition to the above-mentioned information, the following side effects have also been reported:
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Common(affecting up to 1 in 10 people):
Uncommon(affecting up to 1 in 100 people):
Rare(affecting up to 1 in 1,000 people):
Frequency not known- cannot be estimated from the available data:
In addition to the above-mentioned information, the following side effects are known for medicines with a similar mechanism of action to escitalopram (the active substance of Escitalopram LEK-AM):
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Reporting side effects
If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.
The medicine should be stored out of the sight and reach of children.
Do not take this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
Escitalopram LEK-AM, 5 mg is a white, round, biconvex, film-coated tablet.
Escitalopram LEK-AM, 10 mg is a white, oval, biconvex, film-coated tablet with a score line in the middle.
Escitalopram LEK-AM, 15 mg is a white, oval, biconvex, film-coated tablet.
Escitalopram LEK-AM, 20 mg is a white, oval, biconvex, film-coated tablet with a score line in the middle and the letter "E" engraved on both sides of the score line on one side of the tablet.
Escitalopram LEK-AM is available in blisters containing 7 or 14 tablets, packed in a cardboard box.
The cardboard box contains: 28 or 56 tablets.
Not all pack sizes may be marketed.
LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
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