MERSINOL 10 mg. 30 tablets

WHAT MERSINOL AND WHAT IT IS USED
MERSINOL belongs to a group of antidepressants called selective serotonin reuptake inhibitors of serotonin (SSRIs, SSRIs). These drugs act on the serotonin system in the brain by increasing serotonin levels. Violations of the serotonin system are considered an important factor in development of depression and related diseases.
MERSINOL contains escitalopram and is used to treat depression (major depressive disorder) and anxiety disorders (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder and obsessive compulsive disorder).

2. WHAT YOU SHOULD KNOW BEFORE YOU TAKE MERSINOL
Do not take MERSINOL:
if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6);
if you take other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson's disease), moclobemide (used to treat depression) and linezolid (an antibiotic);
if you are born with or have had an episode of abnormal heart rhythm (ECG monitor, study for the evaluation of cardiac function);
if you are taking medicines for heart rhythm problems or that may affect heart rhythm (see section 2, "Other medicines and MERSINOL").
Warnings and Precautions
Talk to your doctor or pharmacist before taking MERSINOL if you suffer from any other condition or illness, as may be necessary for your doctor to take this into account.
It is particularly important to tell your doctor if:
suffer from epilepsy. MERSINOL treatment should be discontinued at the first appearance of seizures or increasing seizure frequency (see also section 4 "Possible Side Effects");
have impaired liver or kidney function. You may need your doctor may adjust your dose;
suffer from diabetes. Treatment with MERSINOL may alter glycemic control. It may need a dose adjustment of insulin and / or oral hypoglycemic agents;
you have a decreased level of sodium in the blood;
You have a tendency to bleed easily or bruise;
You are subjected to electroconvulsive treatment;
suffer from coronary heart disease;
suffer or have suffered from heart problems or have recently had a heart attack;
have a low resting heart rate and / or know that you can be a loss of salt in the body due to severe diarrhea or vomiting or the use of diuretics (water tablets);
you feel that your heart rate is rapid or irregular if you have seizures, feel faint or feel dizzy when standing up, which can indicate abnormal heart rhythm.
Please note:
Some patients suffering from manic-depressive illness may enter a manic phase. It is characterized by unusual and rapidly changing ideas, inappropriate happiness and excessive physical activity. If you experience this, contact your doctor.
Symptoms such as restlessness or difficulty to sit or stand in one place may occur during the first weeks of treatment. Tell your doctor immediately if you experience these symptoms.

Thoughts of suicide and worsening of your depression or anxiety disorder
If you suffer from depression and / or anxiety disorder may sometimes have thoughts of harming or killing themselves. They may be increased when taking antidepressants for the first time since these medicines all take time until AFFF, usually about two weeks, but possibly longer.

You may be more likely to think like this if:
you had previous thoughts of harming or killing;
if you are a young person. Information from clinical trials has shown an increased risk of suicidal behavior in adults under the age of 25 suffering from psychiatric conditions who were treated with antidepressants.
If you have thoughts of harming or killing yourself, contact your doctor or visit the nearest hospital immediately.

You can tell a relative or close friend that you are depressed or suffer from 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 if they are worried about changes in your behavior.

Children and adolescents
Usually MERSINOL should not be used in children and adolescents under 18 years of age. In addition, you should be aware that patients under 18 years of age have a greater risk of side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, oppositional behavior and anger) when they take this class of medicines. However, your doctor may prescribe MERSINOL for patients under the age of 18 because he / she is considered that it is in their interest. If your doctor has prescribed MERSINOL a patient under the age of 18 and you want to discuss this, please go back to your doctor. You should tell your doctor if any of the symptoms listed above appear or worsen when patients under 18 years of age receive MERSINOL. In addition, long-term safety effects concerning growth, maturation and cognitive and behavioral development of MERSINOL use in this age group have not yet been proven.

Other medicines and MERSINOL
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

It is particularly important to tell your doctor if you are taking any of the following medications:
Non-selective monoamine oxidase inhibitors (MAOIs) containing active ingredients such as phenelzine, iproniazid, isocarboxazid, and tranylcypromine nialamide. If you take any of these medicines will need to wait 14 days before you start taking MERSINOL. After discontinuation of MERSINOL must pass at least 7 days to administration of any of these drugs;
Reversible selective MAO-A inhibitors, containing moclobemide (used to treat depression);
Irreversible MOA-B inhibitors containing selegiline (used to treat Parkinson's disease). They can increase the risk of side effects;
Antibiotic linezolid;
Lithium (used in the treatment of manic-depressive disorder) and tryptophan;
Imipramine and desipramine (used to treat depression);
Sumatriptan and similar drugs (used to treat migraine) and tramadol (used in the acute pain). They can increase the risk of side effects;
Cimetidine and omeprazole (used to treat stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). They can increase the levels of blood MERSINOL;
St. John's wort (hypericum perforatum) - a herbal product used for depression;
Aspirin and nonsteroidal anti-inflammatory drugs (medicines used to relieve pain or thin the blood, so called anticoagulants). They can increase the likelihood of bleeding;
Warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulants). In all likelihood, your doctor will monitor blood clotting time you start and stop taking MERSINOL to establish whether anti-coagulant dose you are taking is still appropriate;
Melflokin (used to treat malaria), bupropion (used to treat 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 a possible 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 a dose adjustment of MERSINOL.
DO NOT TAKE MERSINOL if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treat malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have further questions, you should talk to your doctor.

MERSINOL with food, drink and alcohol
MERSINOL can be taken with or without food (see section 3 "How to take MERSINOL").
As with many other medicines, combining MERSINOL alcohol it is not advisable, although not expected MERSINOL interact with alcohol.

Pregnancy, lactation and fertility
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.
MERSINOL Do not take if you are pregnant or breast-feeding unless you have discussed the potential benefits and risks with your doctor.
If you take MERSINOL during the last trimester of pregnancy should be aware that the newborn may occur following side effects: difficulty breathing, bluish skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles, increased reflexes, tremor, jitteriness, irritability, lethargy, constant crying, sleepiness and sleep problems. If the infant has any of these symptoms, please contact your doctor immediately.
Make sure your midwife and doctor know that you are taking MERSINOL. When taken during pregnancy, especially during the last trimester, drugs such as MERSINOL may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), leading to more frequent breathing baby and bruising. These symptoms usually begin during the first 24 hours after birth. If this happens to your baby you should contact your midwife and / or your doctor.
If taken during pregnancy, MERSINOL should never be interrupted suddenly.
Consult your doctor or pharmacist before taking any medicine.
In animal studies, it was shown that citalopram, a drug similar to escitalopram decreased semen quality. Theoretically, this can affect fertility, but has not been observed effect on human fertility.

Driving and using machines
It is not recommended to drive or operate machinery until you know how you affect MERSINOL.

MERSINOL contains lactose. If your doctor has said that you have an intolerance to some sugars, contact him before to sweep this product.

3. HOW TO TAKE MERSINOL
Always take this medicine exactly as you have been told by your doctor. If you are not sure, always ask your doctor or pharmacist.

The recommended dose for adults is as follows:
Depression, generalized anxiety disorder, obsessive-compulsive disorder:
The usual recommended dose MERSINOL 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:
MERSINOL starting dose is 5 mg as a single daily dose for the first week before increasing the dose to 10 mg daily. The dose may be increased by your doctor up to an additional maximum of 20 mg daily.

Social Anxiety Disorder:
The usual recommended dose MERSINOL is 10 mg, taken as a single daily dose. Your doctor will either decrease your dose to 5 mg per day, will increase to a maximum of 20 mg daily, depending on your response to the drug.

Elderly (over 65 years):
The usual recommended starting dose MERSINOL is 5 mg, taken as a single daily dose.
The dose may be increased by your doctor to 10 mg daily.

Use in children and adolescents
MERSINOL generally should not be given to children and adolescents. For further information see section 2 "Before you take MERSINOL."
It can take MERSINOL with or without food. Swallow the tablet with some water. Do not chew the tablet as it is bitter.
If necessary, it can divide MERSINOL 10 mg tablets in half.

Duration of treatment
It may take several weeks before you start to feel better. Continue to take MERSINOL even take some time before you feel any improvement in your condition.
Do not change your dose without first discussing it with your doctor.
Continue to take MERSINOL long as your doctor recommends. If you stop treatment too soon, your symptoms may return. It is recommended to continue treatment for at least 6 months after you feel well again.

If you take more dose MERSINOL
If you take more than the prescribed dose MERSINOL, immediately contact your doctor or the emergency department of the nearest hospital. Do this even if you do not feel any discomfort. Some of the symptoms of overdose can be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, change in heart rate, decreased blood pressure and change in the balance of body fluids and salt balance. Take the cardboard box / container MERSINOL with you when you visit your doctor or hospital.

If you forget to take MERSINOL
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 the dose immediately. Keep taking your regular schedule the next day. If you remember the night or the next day, skip the missed dose and continue your regular schedule.

If you stop taking MERSINOL
Do not stop taking MERSINOL until your doctor tells you to do. When you have completed the course of treatment is usually recommended dose MERSINOL be reduced gradually over a few weeks.
When stop taking MERSINOL, especially if suddenly, you may experience withdrawal symptoms. They are common when treatment is discontinued MERSINOL. The risk is higher when MERSINOL is administered for a long period of time or at high doses, or when the dose is reduced too quickly. Most people identify these symptoms as mild and resolving itself within two weeks. However, in some patients, they may be severe in intensity or longer (2-3 months or more). If you experience serious withdrawal symptoms if you stop taking MERSINOL, please contact your doctor. He or she may ask you to start taking the tablets again and stop them more slowly.

Withdrawal symptoms include: Feeling dizzy (unsteady or off-balance), sensation of pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head, sleep disturbances (vivid dreams, nightmares inability to sleep), feeling anxious, headaches, nausea, sweating (including night sweats), feeling restless or agitated, tremor (shaking), confusion or disorientation, emotional or irritable, diarrhea (loose stools), 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 a few weeks after starting treatment. Please note that some of the side effects may also be symptoms of your illness and therefore will improve when your general condition started to improve.

If any of these side effects immediately visit your doctor or nearest hospital:
Swelling of the skin, tongue, lips or face or difficulty breathing or swallowing (allergic reaction);
Problems with urination;
Seizures (convulsions), see also section 2 "Warnings and precautions;
Yellowing of the skin or whites of the eyes are symptoms of hepatic impairment / hepatitis;
Rapid, irregular heartbeat, fainting, which can be symptoms of a life-threatening condition known as torsades de pointes (polymorphic ventricular tachycardia).
Visit your doctor if during the treatment you experience any of these side effects:
Uncommon (affects 1 to 10 patients in 1000):
Unusual bleeding, including gastrointestinal bleeding.
Rare (affects 1 to 10 patients in 10,000):
If you have a fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome. If you experience any of these, contact your doctor.
In addition to the above reported the following adverse reactions:
Very common (affects more than 1 patient in 10):