ESCITALON 10 mg. 28 tablets

SANDOZ
ESCITALON 10 mg. 28 tablets
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What Escitalon and what is it used?

Escitalon contains escitalopram and is used to treat depression (major depressive episodes).

Escitalopram belongs to the group of so-called selective inhibitors of serotonin reuptake (SSRI). These drugs act on the serotonin system in the brain by increasing the serotonin levels. Violations of the serotonin system are considered an important factor in development of depression and related diseases.

2. Before take Escitalon

Do not take Escitalon

• if you are allergic (hypersensitive) to escitalopram or any of the other ingredients of Escitalon(see. Section 6 "Further information").

• if you are taking medicines that belong to the group of MAO inhibitors, including selegiline (used to treat Parkinson's disease), mokpobemid (used to treat depression) and linezolid (an antibiotic).

Take special care with
Escitalon
Please tell your doctor if you have any of the following conditions or illnesses, as they should be taken into account.

Use in children and adolescents under 18 years of age

Escitalopram should not normally be used in children and adolescents under 18 years. You should know that patients under the age of 18 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. Despite this, your doctor may prescribe escitalopram in a patient under the age of 18 because he / she has chosen / and that it is in the interest of the patient. If your doctor has prescribed Estsitalon a patient under 18, please discuss this with him / her. If the patient is under the age of 18 years and accepts Estsitalon®, you should inform your doctor if any of the symptoms listed below or worsen. In addition, long-term effects Safety Estsitalon in terms of growth, maturation and cognitive and behavioral development in this age group have not yet been established.

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 harming yourself.

• If you are a young person. Data from clinical studies suggest an increased risk of behavior associated with suicide in young people (under 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. It might ask them to tell you if they think your depression or anxiety is getting worse, or are worried about changes in your behavior.

In particular, tell your doctor if:

• have epilepsy. Estsitalon treatment should be stopped if you have seizures or increased seizure frequency (see. Also section 4 "Possible Side Effects").

• suffer from impaired liver or kidney function. Your doctor may need to adjust your dose.

• have diabetes. Treatment with Estsitalon can change your blood sugar. You may need to adjust the dose of insulin and / or medication to lower blood sugar, which is taken orally.

• have reduced levels of sodium in the blood.

• have a tendency to bleed easily or bruise.

• conducts you to electroconvulsive therapy

• have coronary heart disease

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by unusual and rapid change of ideas, unjustified sense of happiness and excessive physical activity. It is important to consult your doctor if you develop symptoms similar to those described.

Symptoms such as anxiety, inability to remain calm in sitting or standing can also occur during the first weeks of treatment. Tell your doctor if you have these symptoms.

Taking other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you use any of the following medications:

• Non-selective MAO inhibitors (MAOIs)

containing active substances such as fennel-zine, iproniazid, isocarboxazid, and tranylcypromine nilamid. If you have used any of these medicinal products must wait 14 days before you start taking Estsitalon®. After stopping treatment with Estsitalon® must wait seven days before taking any of these medicines.

• Reversible selective MAO-A inhibitors, containing moclobemide (also used to treat depression).

• Irreversible MAO-B inhibitor, selegiline-containing (used to treat Parkinson's disease). These drugs increase the risk of side effects.

• The antibiotic linezolid

• Lithium (used in the treatment of manic-depressive disorder) and tryptophan.

• Imipramine and desipramine (both drugs are used to treat depression).

• Sumatriptan and similar drugs (for the treatment of migraine) and tramadol (to relieve severe pain). These drugs increase the risk of side effects.

• Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (drug used to treat depression) and ticlopidine (used to reduce the risk of stroke). These drugs can cause elevated blood escitalopram.

• St. John's wort (Hypericum perforatum) -bilkov preparation used for depression.

• Aspirin and nonsteroidal us potivovazpalitelni-inflammatory drugs (NSAIDs) (medicines used to relieve pain or reduce blood clotting, also called anticoagulants).

• Warfarin, dipyridamole, and phenprocoumon (medicines used to reduce blood clotting, called anticoagulants). Your doctor will probably check your blood clotting when starting or stopping treatment with Estsitalon® to make sure that your dose of anticoagulant is still adequate.

• Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to the potential risk of lowering the seizure threshold.

• Antipsychotic drugs (medicines used to treat schizophrenia, psychosis) are associated with a risk of lowering the seizure threshold and antidepressants (medicines used to treat depression).

• flecainide, propafenone and metoprolol (used in cardiovascular diseases) and desipramine, nortriptyline and clomipramine (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). It may be necessary to adjust the dose of Escitalon

Taking Escitalon with food and drink

Escitalopram may be taken with or without food (see. Section 3 "How to take Estsitalon"). Like many medicines, combining Estsitalon® alcohol is not recommended, although no interaction is expected.

Pregnancy and lactation

Pregnancy

Tell your doctor if you are pregnant or trying to become pregnant. Estsitalon® Do not take if you are pregnant unless you have discussed with your doctor include risks and benefits.

If you take Escitalon in the last three months of pregnancy, you need to be aware that these symptoms can be seen in your newborn baby: trouble breathing, bluish skin color, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, stiff or floppy muscles, vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness or difficulty sleeping. If your newborn child has any of these symptoms, please contact your doctor immediately.

If during pregnancy using Estsitalon, this treatment should not be stopped suddenly.

Breastfeeding

Estsitalon Do not use if you are breast feeding, unless you have discussed this with your doctor the benefits and risks involved.

Driving and using machines

It is recommended not to drive or operate machinery until you know how you affect Escitalon

Important information about some of the ingredients of Estsitalon®

This medicinal product contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking Estsitalon®.

H. How to take Escitalon?

Always take Estsitalon exactly as your doctor has told you. If you're not sure, ask your doctor or pharmacist.

You can take Estsitalon with or without food. Take the tablets with a glass of water.

Only Escitalon 10 mg: If necessary, you can divide the tablet into two equal halves.

Only Estsitalon 20 mg: If necessary, you can divide the tablets into four equal parts and two identical halves. Only Estsitalon® 15 mg: If necessary, you can divide the tablet into three equal parts.

Mature

The usual dose is 10 mg once daily. The dose may be increased by your doctor to a maximum dose of 20 mg once daily.

Elderly (over 65 years) The usual starting dose is 5 mg once daily. It should use a lower maximum dose. Please discuss this with your doctor.



Children and adolescents (under 18 years)

Estsitalon® should not be used in children and adolescents (see section 2 "Before you take Estsitalon).



Duration of treatment

• It may take several weeks before you start to feel better. Therefore, you should continue taking Estsitalon even take some time before you feel better.

• Do not change the dose of your medicine before you discuss this with your doctor.

• Keep taking the tablets for as long as your doctor recommends you. If you stop your treatment too soon, your symptoms may reappear. It is recommended that treatment be continued for at least 6 months after you feel well again.


If you take more dose
Escitalon
If you take too much Estsitalon, contact your doctor or the nearest emergency department immediately. Do this even if you have no symptoms of discomfort. Some of the symptoms that you have are: dizziness, tremor, agitation, seizures, coma, nausea, vomiting, abnormal heart rhythm, decreased blood pressure and change in body fluid / salt balance. Take your box / packaging Estsitalon® with you when you go to the doctor or hospital.


If you forget to take Estsitalon

Do not take a double dose to make up the missed dose. If you really miss a dose and you remember it before you go to bed immediately accept it. The next day, resume your usual dosing schedule. If you remember the night or the next day, skip the missed dose and continue with your regular dosing schedule.

If you stop taking Escitalon

Do not stop taking Estsitalon until your doctor tells you to do. Upon completion of the course of treatment is recommended dose Estsitalon® be reduced over several weeks.

If you suddenly stop taking Estsitalon, it may have withdrawal symptoms. These symptoms are common when discontinue Estsitalon®. The risk is higher when Estsitalon® has been used for a long period of time or at high doses, or when the dose is reduced too quickly. In most people these symptoms are mild and disappear by themselves within 2 weeks. However, in some patients, these symptoms may be severe or continue long (2-3 months or longer). If you have severe withdrawal symptoms when you stop taking Estsitalon®, please contact your doctor. Your doctor ask you to temporarily continue to take their dose and then gradually reduce the dose slowly.

Withdrawal symptoms include: dizziness (imbalances, instability), numbness and tingling, burning sensations and (less commonly) the passage of electricity, including in the head, sleep disturbances (vivid dreams, nightmares or difficulty sleeping), anxiety , headache, nausea, sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientation, emotional instability or irritability, diarrhea, visual disturbances, rapid or intense heartbeat.

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

4. Possible side effects

Like all medicines, Estsitalon® can cause side effects, although not everybody gets them.

These side effects are generally mild and usually disappear after a few weeks of treatment. You should know that many of these effects can also be symptoms of your illness and therefore will improve in the course of treatment.

See your doctor or go to hospital if during treatment, have any of the following side effects:

Uncommon (more than 1 in 1000 and less than 1 in 100 patients)

• increased bleeding, including bleeding from stomach and intestines (bleeding from the gastrointestinal tract)

Rare (more than 1 in 10 000 and less than 1 in 1000 patients)

• swelling of the skin, tongue, lips or face or difficulty breathing or swallowing (allergic)

• fever, agitation, confusion, trembling and abrupt contractions of muscles, these side effects may be signs of a rare condition known as serotonin syndrome.

Not known

• difficulty in urination

• seizures (seizures, see. Also section 2 "Take special care with Estsitalon®"

• yellow coloring of the skin and whites of the eyes is a sign of liver function impairment / hepatitis

In addition to the items noted above are reported the following adverse reactions:

Very common

(affecting more than 1 in 10 patients)

• nausea

Common (affecting more than 1 in 100 and less than 1 in 10 patients)

• stuffy or runny nose (sinusitis)

• decreased or increased appetite

• anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, yawning, shaking, chills skin

• diarrhea, constipation, vomiting, dry mouth

• increased sweating

• pain in muscles and joints (arthralgia and myalgia)

• sexual dysfunction (late ejaculation, erectile dysfunction, decreased libido, women may have difficulty reaching orgasm)

• fatigue, fever

• increased body weight

Uncommon (affecting more than 1 in 1000 and less than 1 in 100 patients)

• hives (urticaria), skin rash, itching (pruritus)

• gnashing of teeth, agitation / restlessness, nervousness, panic attack, confusion

• taste disturbances, disturbed sleep, fainting (syncope)

• dilated pupils (mydriasis), visual disturbances, ringing in the ears

- Hair loss

• vaginal bleeding

• underweight

• rapid heartbeat

• swelling of the hands or feet

• bleeding from the nose.

Rare (more than 1 in 10 000 and less than 1 in 1000 patients)

• aggression, alienation from themselves or from their own feelings (depersonalization), seeing unreal things (hallucinations)

• slow heartbeat

Not known

In some patients the following adverse reactions:

• thoughts of harming or killing yourself, see. also section "Take special care with Estsitalon"

• reduced levels of sodium in the blood (the symptoms are nausea and feeling unwell with muscle weakness or confusion)

• dizziness when standing due to low blood pressure (orthostatic hypotension)

• violated tests for liver function tests (increased liver enzymes in the blood)

• movement disorders (involuntary movements)

• painful erection (priapism)

• coagulation disorders including bleeding from the skin and mucous membranes (ecchymosis) and low levels of platelets (thrombocytopenia)

• sudden swelling of skin or mucosa (angioedema)

• increased urine output (syndrome of inappropriate secretion of antidote-uretichen hormone)

• separation of milk from women who do not breastfeed

• periods of elevated mood, accompanied by the presence of a lot of energy (mania)

In addition, it is known that a number of adverse reactions occur with drugs which act in a similar way to escitalopram (the active substance of Estsitalon). These are:

• Inability to remain calm in a sitting or standing (akathisia)
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