ESSOBEL 10 mg. 28 tablets
ESSOBEL contains the active substance escitalopram and is used to treat depression (major depressive disorder) and anxiety disorders (e. Panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive compulsive disorder).
Escitalopram belongs to the group of antidepressants, known as selective inhibitors of serotonin reuptake. These drugs act on the serotonin system in the brain by increasing serotonin levels. Violations in the serotonin system are considered an important factor in development of depression and related diseases.
2. What you need to know before taking ESSOBEL
Do not take ESSOBEL:
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 the 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 QT-interval prolongation including congenital syndrome of QT-interval prolongation;
if you are taking other medicines that result in an extension of the QT-interval. If you are unsure, ask your doctor or pharmacist.
Take special care with ESSOBEL:
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 suffer from a disease of the liver or kidneys. Your doctor may decide that it is necessary to adjust your dose;
if you suffer from diabetes. ESSOBEL treatment may affect glycemic control. It may need a dose adjustment of insulin and / or oral antidiabetic drugs;
if you have decreased 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 symptoms suggestive of cardiac frequency, chest discomfort, dizziness or fainting, you should consult your doctor immediately.
Like other drugs used for the treatment of depression and related diseases, improvement in the condition is not achieved immediately. Following initiation of therapy with ESSOBEL may take several weeks before you feel better. At the beginning of treatment may experience increased anxiety, which will fade in the course of treatment. For this reason it is essential to carefully follow your doctor's advice and not interrupting treatment or change the dose without being consulted him.
Sometimes symptoms of depression or panic disorder may include thoughts of suicide or harming yourself. It is possible that these symptoms continue or worsen until the full antidepressant effect of the drug becomes obvious. This is more typical of young (under 30 years) people who previously did not use antidepressants.
In some patients with manic-depressive illness can 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 to stand still can also occur during the first weeks of treatment. Consult your doctor at once you experience 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 monitor the occurrence of similar signs of change in your behavior.
Consult your doctor immediately or go to the nearest hospital if you experience in sad thoughts or feeling, or some of the above symptoms occur during treatment.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have anxiety disorders 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 this way:
if you have previously had thoughts of suicide or self-harm;
if you are a young person. Data from clinical studies suggest an increased risk of behavior associated with suicide in people younger than 25 years with psychiatric conditions who were treated with an antidepressant.
If at any time there you have thoughts of harming or killing yourself, contact your doctor or go to hospital.
It 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 might 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
ESSOBEL 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 attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) when they take this class of drugs. However, your doctor may prescribe ESSOBEL patients aged under 18 years if it considers that it is in their interest. If your doctor has painted ESSOBEL a patient under the age of 18 years and want to discuss it, see your doctor again and consult. Tell your doctor if any of the above symptoms occur or worsen in patients aged under 18 who take ESSOBEL. There are no data on the safety of growth, maturation, and cognitive and behavioral development in long-term use of escitalopram in this age group.
Other medicines and ESSOBEL
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.
Consult your doctor if you are taking any of the following medications:
Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, izokarkoksazid, nialamide and tranylcypromine as active ingredients. If you are taking any of these medications, it needs to wait 14 days before taking ESSOBEL. After stopping use of ESSOBEL You must wait 7 days before taking any of these medicines;
Reversible selective MAO-A inhibitors, containing moclobemide (a medicine for treating depression);
Irreversible MAO-B inhibitors containing selegiline (a medicament for treating Parkinson's disease). Their use increases the risk of side effects;
Lithium (a medicine for the treatment of manic-depressive psychosis) and tryptophan;
Imipramine and desipramine (medicines to treat depression);
Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain). Their use increases the risk of side effects;
Cimetidine and omeprazole (medicines to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (a medicine for lowering the risk of stroke). Their use may increase the level of ESOBEL blood;
St. John's wort (Hypericum perforatum) - phyto used for depression;
Aspirin and nonsteroidal anti-inflammatory drugs (medicines to relieve pain or to thin the blood, so 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 ESSOBEL to check whether your assigned dose of anticoagulant is still adequate;
Mefloquine (used to treat malaria), bupropion (a 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). It may need dosage ESSOBEL be adapted.
ESSOBEL with food and drink
ESSOBEL can be taken with or without food (see "How to take ESSOBEL").
As with many other medicines, combining ESSOBEL alcohol should be avoided, although it is not expected ESSOBEL interact with alcohol.
Pregnancy and lactation
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before taking this medicine.
If you are pregnant or breast-feeding, do not take ESSOBEL unless you have discussed in advance with your doctor the risks and benefits of treatment.
If you take ESSOBEL during the last three months of your pregnancy it should know that in your newborn baby may experience the following symptoms: difficulty breathing, bluish skin, seizures, changes in body temperature, feeding difficulty, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, timidity, irritability, lethargy, constant crying, insomnia or difficulty sleeping. If your newborn baby has any of these symptoms, please inform your doctor immediately.
Make sure your midwife and / or doctor knows you are taking ESSOBEL. When taken during pregnancy, especially during the last three months of pregnancy, medicines like ESSOBEL 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 the baby is born. If this happens with your baby, you should immediately contact your midwife and / or doctor.
If you use ESSOBEL during pregnancy never use his suspension suddenly.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
It is recommended not to drive or operate machinery until you know how you affect the use of ESSOBEL.
Important information about some of the ingredients of ESSOBEL
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.
3. How to take ESSOBEL
Always take this medicine exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.
The recommended dose is ESSOBEL 10 mg once daily. The dose may be increased by the doctor to a maximum of 20 mg per day.
The starting dose is 5 mg once daily during the first week of treatment, then increased to 10 mg daily. The dose may be increased by the doctor to a maximum of 20 mg per day.
Social Anxiety Disorder
The usual recommended dose ESSOBEL is 10 mg once daily. Depending on your response to the drug, or your doctor may reduce your dose of 5 mg daily or to increase it to a maximum of 20 mg per day.
Generalised Anxiety Disorder
The usual recommended dose ESSOBEL is 10 mg once daily. The dose may be increased by your doctor to 20 mg daily.
Obsessive Compulsive Disorder
The usual recommended dose ESOBEL is 10 mg once daily. The dose may be increased by the doctor to a maximum of 20 mg per day.
Elderly (over 65 years)
The usual recommended starting dose ESOBEL is 5 mg once daily. The dose may be increased by the doctor to a maximum of 10 mg per day.
Children and adolescents (under 18 years)
ESSOBEL generally should not be given to children and adolescents. For additional information, please see section 2 "What you should know before taking ESOBEL."
It can take ESSOBEL with or without food. Swallow the tablets with a little water. Do not chew the tablets because their taste is bitter.
If necessary, you can split the tablet as first put it on a flat surface with the score line pointing upwards. Then the tablet can be broken by pressing down each of its edges with your index fingers.
Duration of treatment
It may take several weeks before you start 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 medicine without first you have consulted with your doctor.
Keep taking ESSOBEL as 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 dose ESSOBEL
If you take more than the prescribed dose ESSOBEL, immediately contact your doctor or visit the emergency department of the nearest hospital. Do this even if you feel any symptoms of discomfort. Some of the symptoms of overdose may be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, change in heart rhythm, decreased blood pressure and change in the balance of body fluids. Take the box / packaging ESSOBEL with you when you go to the doctor or hospital.
If you forget to take the tablets ESSOBEL
Do not take a double dose to make up the missed dose.
If you forget to take a dose and you remember before you go to bed, take it immediately. Next day proceed as usual. If you remember the night or the next day, skip the missed dose, then go on as usual.
If you stop taking ESSOBEL
Do not stop taking ESSOBEL until your doctor tells you to do. When you finish your course of treatment, the dose is recommended ESSOBEL be gradually reduced within a few weeks.
When stop taking ESSOBEL and especially if you do suddenly in you may experience withdrawal symptoms. These are common symptoms that occur in discontinuation of ESSOBEL. The risk is higher when ESSOBEL used for a long time or in high doses or when the dose is reduced too quickly. The majority of people find that the symptoms are mild and resolved within two weeks. However, in some patients it may be severe in intensity or continue longer (2-3 months or more). If you get severe withdrawal symptoms after discontinuation of ESSOBEL, please contact your doctor. He / she may advise you to start taking ESSOBEL again and stop taking slower.
Withdrawal symptoms include: dizziness (instability or imbalance), sensation of pins and needles, burning sensations and (less common) sense of shock, including in 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.
4. 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 may also be symptoms of your illness and will improve in the course of treatment.
Adverse reactions are evaluated depending on the frequency at which they meet. For this purpose, the following categories of frequency of adverse 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 per 1000 patient;
Very rare: Side effects that may occur in less than 1 person in 10,000 patients;
Isolated cases: Side effects that may occur in even smaller number of patients.
Visit your doctor if during the treatment you experience any of these side effects:
Unusual bleeding, including gastrointestinal bleeding;