ESOBEL table. 10 mg. 28 tablets
ESOBEL table. 10 mg. 28 tablets
What ESOBEL and what it is used
ESOBEL contains the active ingredient escitalopram and is used to treat depression (major depressive disorder) and anxiety disorders (eg, panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive-compulsive disorder).
Escitalopram belongs to a group of antidepressants called selective serotonin reuptake. These drugs act on the serotonin system in the brain by increasing serotonin levels. Disturbances of serotonin system is considered an important factor in the development of depression and related disorders.
What you should know before taking ESOBEL
Do not take ESOBEL:
if you are allergic to escitalopram or any of the other ingredients of this product listed in paragraph 6;
if you are taking other medicines that belong to a group called monoamine oxidase inhibitors (MAOIs) including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression) and linezolid (an antibiotic);
if you have QT-interval prolongation, including congenital long QT-interval;
if you are taking other medicines that cause prolongation of the QT-interval. If you are not sure, ask your doctor or pharmacist.
Take special care with ESOBEL:
Consult your doctor if you suffer from any other condition or illness, as your doctor may decide to take this into account.
In particular, tell your doctor:
if you have epilepsy. Treatment should be discontinued if the first seizures occur or seizure frequency increased (see also section 4 "Possible side effects");
if you have liver disease or kidney disease. Your doctor may decide that it is necessary to adjust your dose;
If you suffer from diabetes. ESOBEL treatment may affect glycemic control. You may need a dose adjustment of insulin and / or oral antidiabetic agents;
if you have low levels of sodium in the blood;
if you have a tendency to easy bruising or bleeding;
If you are receiving electroconvulsive therapy;
If you suffer from coronary heart disease;
If during treatment with escitalopram experience symptoms suggestive of heart rate, and chest discomfort, dizziness or fainting, you should consult your doctor immediately.
Like other medicines used to treat depression and related disorders, improvement in the condition is not achieved immediately. After starting treatment with ESOBEL may take several weeks before you feel better. Early treatment may experience increased anxiety, which will go away during treatment. For this reason it is important to carefully follow your doctor's advice and not interrupting treatment or change the dose without consulting you with it.
Sometimes symptoms of depression or panic disorder may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent. This is more typical of young (under 30 years) people who previously did not use antidepressants.
Some patients with manic-depressive illness may manifest manic phase. It is characterized by unusual and rapidly changing ideas, gratuitous happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty standing in one place can also occur during the first weeks of treatment. Consult your doctor immediately if you experience at these symptoms.
It is free to you to decide whether you have the above symptoms, so ask a friend or relative to help you as you watch for the appearance of these signs of change in your behavior.
Consult your doctor immediately or go to the nearest hospital, if you get any distressing thoughts or feelings, or some of the above symptoms occur during therapy.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have anxiety disorders you can sometimes have thoughts of harming or killing themselves. These may be increased when first starting antidepressants, since these medicines all take time to start running - usually about two weeks but sometimes longer.
You may be more likely to think like this:
if you have previously had thoughts about killing or harming yourself;
If you are a young person. Clinical studies have shown an increased risk of behavior associated with suicide in people under the age of 25 years with psychiatric conditions who were treated with an antidepressant.
If at any time you get any thoughts of harming or killing yourself, contact your doctor or go to hospital.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse, or are worried about changes in your behavior.
Use in children and adolescents under the age of 18
ESOBEL not recommended for use in children and adolescents under 18 years. Patients under 18 years of age are at increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) when they take this class of drugs. However, your doctor may prescribe ESOBEL patients aged under 18 years, if it considers that it is in their interest. If your doctor has painted ESOBEL a patient under the age of 18 years and want to discuss it, visit your doctor again and consult. Tell your doctor if any of the above symptoms occur or worsen in patients under the age of 18 years, taking ESOBEL. There are no data on safety in growth, maturation and cognitive and behavioral development in the long-term use of escitalopram in this age group.
Other medicines and ESOBEL
Tell your doctor or pharmacist if you are taking, have recently taken or may take other medicines.
Check with your doctor if any of the following:
Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, izokarkoksazid, nialamide and tranylcypromine as active substances. If you are taking any of these medicines, you need to wait 14 days before taking ESOBEL. After stopping use of ESOBEL You must wait seven days before taking any of these drugs;
Reversible, selective MAO-A inhibitors, containing moclobemide (medicine for depression);
Irreversible MAO-B inhibitors, containing selegiline (a medicine used to treat Parkinson's disease). Their use increases the risk of side effects;
Lithium (a medicine used to treat manic-depressive psychosis) and tryptophan;
Imipramine and desipramine (medicine for depression);
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain). Their use increases the risk of side effects;
Cimetidine and omeprazole (medicines to treat stomach ulcers), fluvoxamine (an antidepressant) and ticlopidine (medication to reduce the risk of stroke). Their use may increase the level of blood ESOBEL;
St. John's Wort (Hypericum perforatum) - phyto used for depression;
Aspirin and nonsteroidal anti-inflammatory drugs (drugs to relieve pain or to thin the blood, called anticoagulants). These drugs may increase the tendency to bleed;
Warfarin, dipyridamole, and phenprocoumon (medicines used against blood clotting, called. Anticoagulants). Your doctor will probably check your clotting time at the beginning and discontinuation of ESOBEL to check whether your prescribed dose of anticoagulant is still relevant;
Mefloquine (used to treat malaria), bupropion (medicine for depression) and tramadol (used to treat severe pain) due to the risk of lowering the seizure threshold;
Neuroleptics (medicines to treat schizophrenia, psychosis) due to the risk of lowering the seizure threshold, and antidepressants;
Flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). You may need a dosage ESOBEL be adapted.
ESOBEL with food and drink
ESOBEL can be taken with or without food (see section "How to take ESOBEL").
As with many other drugs combined ESOBEL alcohol should be avoided, although it is not expected to interact with ESOBEL alcohol.
Pregnancy and lactation
If you are pregnant or nursing, you think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist before taking this medicine.
If you are pregnant or nursing, do not take ESOBEL unless you have talked to your doctor the benefits and risks of treatment.
If you take ESOBEL during the last three months of your pregnancy you need to know about your newborn baby may experience the following symptoms: difficulty in breathing, bluish skin, seizures, changes in body temperature, feeding difficulty, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, fear, irritability, lethargy, constant crying, insomnia or difficulty sleeping. If your newborn baby has any of these symptoms, tell your doctor immediately.
Make sure your midwife and / or doctor know that you are taking ESOBEL. When taken during pregnancy, especially during the last three months of pregnancy, medicines like ESOBEL could increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathe faster and turning blue . These symptoms usually begin during the first 24 hours after birth of the baby. If this happens to your baby, you should immediately contact your midwife and / or doctor.
If ESOBEL use during pregnancy, never use a sudden cessation.
Ask your doctor or pharmacist before taking any medicine.
Driving and operating machinery
It is advisable not to drive or operate machinery until you know how you affect the use of ESOBEL.
Important information about some of the ingredients of ESOBEL
This medicinal product contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.
How to take ESOBEL
Always take this medicine exactly as your doctor tells you. If you're not sure, ask your doctor or pharmacist.
The recommended dose is 10 mg ESOBEL daily. The dose may be increased by your doctor to a maximum of 20 mg daily.
The starting dose is 5 mg once daily during the first week of treatment and then increased to 10 mg daily. The dose may be increased by your doctor to a maximum of 20 mg daily.
Social Anxiety Disorder
The usual recommended dose is 10 mg ESOBEL daily. Depending on your response to the medicine, or your doctor may reduce your dose of 5 mg or increased to a maximum of 20 mg per day.
The usual recommended dose is 10 mg ESOBEL daily. The dose may be increased by your doctor to 20 mg daily.
The usual recommended dose is 10 mg ESOBEL daily. The dose may be increased by your doctor to a maximum of 20 mg daily.
Elderly (over 65 years)
The usual recommended starting dose is 5 mg ESOBEL daily. The dose may be increased by your doctor to a maximum of 10 mg daily.
Children and adolescents (under 18 years)
Usually ESOBEL should not be given to children and adolescents. For more information, please refer to section 2 "What you should know before taking ESOBEL."
You can take ESOBEL with or without food. Swallow the tablets with a drink of water. Do not chew the tablets, because the taste is bitter.
If necessary, you can split the tablet as the first place it on a flat surface with the score upwards. Then the tablet can be broken down by pressing each of the ends with the index finger.
Duration of treatment
It may take several weeks before you begin to feel better. Continue to take ESOBEL even take some time before you feel any improvement in your condition.
Do not change the dose of your medication without first consulting you doctor.
Continue to take ESOBEL so long as your doctor recommends. If you stop using too soon, your symptoms may return. Recommended intake ESOBEL last at least 6 months after you feel better.
If you take more than the dose ESOBEL
If you take more than the prescribed dose ESOBEL, contact your doctor or visit the emergency room of the nearest hospital. Do this even if you feel any symptoms of discomfort. Some of the symptoms of overdose could be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, change in heart rate, decreased blood pressure and change in the balance of body fluids. Take the box / packaging ESOBEL with you when you go to the doctor or hospital.
If you forget to take your tablets ESOBEL
Do not take a double dose to make up for a missed dose.
If you forget to take a dose and you remember before going to bed, take it immediately. Over the next day continue as usual. If you remember the night or the next day, skip the missed dose, then go on as usual.
If you stop taking ESOBEL
Do not stop using ESOBEL as your doctor tells you to do so. When you have finished your course of treatment, the dose ESOBEL is recommended to be reduced gradually over several weeks.
When you stop taking ESOBEL especially if you do suddenly in you may experience withdrawal symptoms. These are common symptoms seen on discontinuation of therapy ESOBEL. The risk is higher when ESOBEL used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away within two weeks. However, in some patients they may be severe in intensity or continue longer (2-3 months or more). If you experience severe withdrawal symptoms after discontinuation of ESOBEL, please contact your doctor. He / she may advise you to start taking ESOBEL again and stop taking slower.
Withdrawal symptoms include: dizziness (instability or imbalance), pins and needles, burning sensations and (less common) sense of shock, including the head, sleep disturbances (vivid dreams, nightmares, lack of sleep), anxiety headache, nausea, sweating (including night sweats), anxiety, tremors, confusion, or being not increased, emotional or irritable, diarrhea (loose stool), visual disturbances, fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects usually disappear after a few weeks of treatment. You should know that many of the effects can also be symptoms of your illness and will improve with continued treatment.
Adverse reactions were evaluated according to the frequency with which they occur. For this purpose, the following categories of frequency of adverse drug reactions:
Common: Side effects that may occur in less than 1 person in every 10;
Uncommon: Side effects that may occur in less than one in 100 patients;
Rare: Side effects that may occur in less than one in 1,000 patients;
Very rare: Side effects that may occur in less than 1 person in 10,000 patients;
Isolated cases: Side effects that may occur with even small numbers of patients.
Visit your doctor if during treatment any of the following side effects:
Unusual bleeding, including gastrointestinal bleeding;
Swelling of the skin, tongue, lips or face or have difficulty breathing or swallowing (allergic reaction). In these cases, immediately contact your doctor or go to the nearest hospital;
Fever, agitation, confusion, trembling and abrupt contractions of muscles. This can be symptoms of serotonin syndrome rarest. If you feel so, contact your doctor.