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Escitacon 10 mg. 28 tablets

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What Escitacon is and what it is used for
Escirtacon contains the active substance escitalopram. Escitacon belongs to a group of antidepressants called selective serotonin reuptake inhibitors. These drugs act on the serotonin system in the brain by increasing serotonin levels. Disorders of the serotonin system are considered an important factor in the development of depression and related diseases.

Escitacon is used to treat depression (major depressive episode) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder).

It may take several weeks before you start to feel better. Keep taking Escitacon even if it takes some time for you to feel an improvement in your condition.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Escitacon
Do not take Escitacon
If you are allergic (hypersensitive) to escitalopram or any of the other ingredients of this medicine (listed in section 6).
If you are taking other medicines that belong to a group called MLO inhibitors. including selegiline (used to treat Parkinson's disease), moclobemil (used to treat depression), and linezolid (an antibiotic).
If you were born with or have had an episode of an irregular heart rhythm (seen on an E CT scan to assess how the heart is functioning).
If you are taking medicines for heart rhythm problems or which may affect the heart's rhythm (see section 2).
Warnings and precautions
Talk to your doctor before taking Escitacon. Tell your doctor if you suffer from any other condition or illness, as your doctor may take this into account. In particular, notify your decare:

if you suffer from epilepsy. Treatment with Escitacon should be stopped if seizures occur or an increase in seizure frequency is observed (see section 4);
if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dose;
if you have diabetes. Treatment with Escitacon may alter blood sugar control. Adjustment of insulin and/or dose of oral hypoglycemic agents may be required;
if you have a low level of sodium in your blood;
if you tend to bleed or bruise easily;
if you are undergoing electroconvulsive therapy;
if you have coronary heart disease;
if you suffer or have suffered from heart problems or have recently had a heart attack;
if you have a slow resting heart rate and/or know you may be salt depleted as a result of prolonged severe diarrhea and vomiting or use of diuretics (water tablets);
if you get fast or irregular heartbeats, fainting, collapse or lightheadedness when you stand up, which may signal an abnormally functioning heart rhythm;
if you have or have had eye problems such as certain types of glaucoma (increased pressure in the eye).
Please, have in mind
Some patients with manic-depressive illness could enter a manic phase. This is characterized by unusual and frequently changing ideas, an inadequate sense of happiness and excessive physical activity. If you experience similar sensations, contact your doctor. Symptoms such as restlessness or difficulty sitting or standing still may also occur during the first weeks of treatment. Tell your doctor immediately if you experience these symptoms.

Suicidal thoughts and worsening of your depression or anxiety disorder.
If you are depressed and/or have an anxiety disorder you may sometimes have thoughts of harming or killing yourself. These thoughts may be heightened when you first take antidepressants, as all these medications take time to work, usually about two weeks, but sometimes longer.
You may be more inclined to think this way:

if you have had thoughts of suicide or self-harm before;
if you are a young person. Data from clinical trials show an increased risk of suicidal behavior in young people (under 25 years) with mental illness who are treated with an antidepressant.
If at any time you have thoughts of harming or killing yourself, contact your doctor or go to hospital immediately. 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 if they are worried about changes in your behaviour.

Children and adolescents
Escitacon should not usually be used in children and adolescents under the age of 18 years. It is also necessary to know that at
Escitacon with food, drink and alcohol
Escitacon can be taken with or without food (see section 3).

As with many medications, combining Escitacon with alcohol is not recommended, although Escitacon is not expected to interact with alcohol.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Do not take Escitacon if you are pregnant or breast-feeding unless you have discussed the risks and benefits with your doctor.
If you take Escitacon during the last 3 months of your pregnancy, you need to know that the following side effects could be observed in your newborn; difficulty breathing, bluish skin, fainting, changes in body temperature, difficulty eating, vomiting, low blood sugar, stiff or relaxed muscles, lively reflexes, tremors, nervousness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your baby has any of these symptoms, please contact your doctor immediately.

Make sure your midwife and/or doctor know you are taking Escitacon. When taken during pregnancy, especially in the last 3 months of pregnancy, medicines like Escitacon could increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes fast and turns blue . These symptoms usually start within the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or GP immediately.

If Escitacon is used during pregnancy, it should never be stopped suddenly.

Escitalopram is expected to be excreted in breast milk.

Citalopram, a drug like escitalopram, has been shown to reduce sperm quality in animal studies. Theoretically, it may affect fertility, but an effect on human fertility has not yet been observed.

Driving and using machines
It is not recommended to drive or operate machinery before you find out how lin works Escitacon.

Escitacon contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Escitacon
Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Adults

Depression

The usual recommended dose of Escitacon is 10 mg taken as a single daily dose. The dose may be increased by your doctor to a maximum of 20 mg daily.

Panic disorder

The starting dose of Escitacon is 5 mg once daily for the first week before being increased to 10 mg daily. Your doctor may increase the maximum dose to 20 mg daily.

Social anxiety disorder

The usual recommended dose of Escitacon is 10 mg taken as a single daily dose. Depending on how you respond to treatment with this medicine. Your doctor may either reduce your dose to 5 mg or increase it to a maximum of 20 mg daily,

Generalized anxiety disorder

The usual recommended dose of Escitacon is 10 mg taken as a single daily dose. The dose can be increased by your doctor to a maximum of 20 mg daily.

Obsessive-compulsive disorder

The usual recommended dose of Escitacon is 10 mg taken as a single daily dose. The dose can be increased by your doctor to a maximum of 20 mg daily.

Elderly patients (over 65 years)
The recommended starting dose of Escitacon is 5 mg taken as a single daily dose. The dose could be increased by your doctor to 10 mg daily.

Use in children and adolescents
Escitacon should not usually be given to children or adolescents. For further information see point 2.

How to take the tablets
Escitacon can be taken with or without the tap. Swallow the tablets with water. Do not chew them as the taste is bitter.

If necessary, the tablet can be split by placing it on a flat surface with the score line up. It can then be broken by pushing down on both ends using your index fingers.

Duration of treatment
It may take several weeks before you feel an improvement. Keep taking Escitacon even if it takes some time before you feel an improvement in your condition. Never change the dose before talking to your doctor. Keep taking Escitacon for as long as your doctor tells you. If you stop treatment too soon, symptoms may return. It is recommended that treatment continue for at least 6 months after you feel well again.

If you have taken more Escitacon than you should
If you have taken more than your prescribed dose of Escitacon, contact your doctor or the nearest emergency center immediately.
If you have stopped taking Escitacon
Do not stop taking Escitacon until your doctor tells you to. When you finish the course of treatment, it is usually recommended that the dose of Escitacon be reduced gradually over several weeks.

When you stop taking Escitacon, especially if it happens suddenly, you may experience withdrawal symptoms. These are common when Escitacon treatment is stopped. The risk of this is greater when Escitacon has been used for a longer time or in higher doses or when the dose is reduced too quickly. Most people find these symptoms mild and resolve on their own within two weeks. However, in some patients they may be severe in intensity or more prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Escitacon, please contact your doctor. He or she may ask you to start taking your tablets again and stop them more slowly.

Withdrawal symptoms include: feeling dizzy (unsteadiness or loss of balance), pins and needles, burning and (less commonly) electric shock, including in the head, sleep disturbances (excessively vivid dreams, nightmares, inability to sleep), feeling restless, headaches, feeling sick (nausea), sweating (including night sweats), feeling nervous and agitated (agitation), tremors (shaking), feeling confused and disoriented, overemotional or irritable, diarrhea (rare stools), visual disturbances, fluctuating or heavy pulse (palliations).

If you have any further questions related to 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.

Adverse drug reactions usually disappear after a few weeks of treatment. Please note that some of the reactions may also be symptoms of your illness and therefore disappear when you start to get better.

Contact your doctor or go to hospital immediately if you experience any of the following symptoms.
Uncommon (may affect up to 1 in 100 people):

Abnormal bleeding, including from the gastrointestinal tract.
Rare (may affect up to 1 in 1,000 people):

Swelling of the skin, tongue, lips, throat or face, rash (hives) or you have difficulty breathing or swallowing (severe allergic reaction).
High fever, agitation, confusion, tremors and sudden muscle contractions can be signs of a rare condition called serotonin syndrome.
Not known (frequency cannot be estimated from the available data):

Difficulty urinating.
Seizures (seizures, convulsions), see also subsection "Warnings and precautions".
Yellowing of the skin and whites of the eyes are signs of impaired function/hepatitis.
Fast, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition known as Torsade de Pointes.
Thoughts of self-harm or suicide, see also subsection "Warnings and precautions".
Sudden swelling of the skin or mucous membranes (angioedema).
In addition to the above, the following side effects have been reported.

Very common (may affect more than 1 in 10 people):

Lifting (nausea).
Headache.
Common (may affect up to 1 in 10 people):

Stuffy nose or nasal discharge (sinusitis),
Decreased or increased appetite.
Anxiety, restlessness, unusual dreams, difficulty falling asleep, feeling sleepy, dizziness, yawning, tremors, goosebumps.
Diarrhea, constipation, vomiting, dry mouth.
Increased sweating.
Muscle and joint pain (arthralgia and myalgia).
Sexual disturbances (delayed ejaculation, erection problems, decreased sexual desire, women may have difficulty reaching orgasm).
Fatigue, fever.
Increased weight.
Uncommon (may affect up to 1 in 100 people):

Hives (urticaria), rash, itching (pruritus).
Grinding teeth, agitation, nervousness, panic attack, confusion.
Sleep disturbances, taste abnormalities, seizures (synchon).
Dilated pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus).
Hair loss.
Heavy menstrual bleeding.
Irregular menstruation.
Reduced weight.
Fast heart rate,
Swelling (edema) of the hands or feet.
Bleeding from the nose.
Rare (may affect up to 1 in 1,000 people):

Aggression, depersonalization, hallucinations.
Slow heartbeat.
Not known (frequency cannot be estimated from the available data):

Decreased levels of sodium in the blood (symptoms are feeling sick π discomfort with muscle weakness or confusion).
Dizziness when standing up due to low blood pressure (orthostatic hypotension).
Abnormal liver function test values (increased amounts of liver enzymes in the blood).
Motor disorders (unconscious muscle movements).
Painful erections (priapism).
Acknowledgment
5. How to store Escitacon
Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the label or carton after "EXP:" The expiry date corresponds to the last day of the specified month. It does not require special storage conditions.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Escitacon contains
The active substance is escitalopram. Each Escitacon tablet contains 10 mg of escitalopram (as oxalate).
The other ingredients are:
Core: lactose monohydrate, colloidal anhydrous silica, croscarmellose sodium, carmellose, propyl gallate, talc, magnesium stearate.
Coating: hypromellose 6cP (E 464), titanium dioxide (E 171), macrogol (PEG 400).

What Escitacon looks like and contents of the pack
White to off-white, round, biconvex, film-coated tablet debossed with "ML 60" on one side and scored on the other, scored on both sides of the score. Escitacon 10 mg film-coated tablets are supplied in Alu/Alu blisters containing 28 or 30 tablets placed in a cardboard box with a leaflet.

Not all types of packaging can be put on sale.

 

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