Cipralex 10 Mg 28 Tablets ingredient Escitalopram

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• Excipients: Tablet core: microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate Film coat: hypromellose, macrogol 400, titanium dioxide (E171)

Before using this drug you are reading this USE INSTRUCTION carefully because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, do not give it to others.

• When using this medicine, tell your doctor if you go to a doctor or to a hospital.

• We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for medication.

In this Instructions for Use:

1. What is CIPRALEX and what is it used for? 2. What to look out for before using CIPRALEX 3. How to use CIPRALEX? 4. What are the possible side effects? 5. CIPRALEX hiding

titles are included.

1. What is CIPRALEX and what is it used for?

• CIPRALEX 10 mg film tablets each contain 10 mg of escitalopram.

• CIPRALEX is offered to the market in 28, 56 and 84 tablets.

• CIPRALEX contains escitalopram. This drug is used in depression (major depressive states) and anxiety disorders (agoraphobia (open field fear) or agoraphobic panic disorder, social anxiety disorder and generalized anxiety disorder and obsessive-compulsive disorder).

• escitalopram is an antidepressant group called selective serotonin reuptake inhibitors (SSRIs). These drugs increase serotonin levels by affecting the serotonin system in the brain. The disorder in the serotonin system is considered to be an important factor in the development of depression and similar diseases.

2. CAREFULLY

BEFORE USING CIPRALEXDo not use CIPRALEX in the following situations:

••have allergies (other ingredients in Essentialopram or CIPRALEX

If youhypersensitivity) to(see "Supplementary substances").

• You are using selejil (used in the treatment of Parkinson's disease), moclobemide (used in the treatment of depression) and linezolid (antibiotic) in the group of MAO (monoamine oxidase) inhibitors.

• If you are using pimozide (antipsychotic).

• If you have a birth or an abnormal heart rhythm (a picture of how ECG looks (a study evaluating how the heart works)).

• If you are using medications for your heart rhythm problems or if you are using medications that can affect your heart rhythm (see Chapter 2 "Use with other medicines").

CIPRALEX is used in the following situations: D Please use caution Please inform your doctor if you have any other condition or illness to consider. In particular,should tell your doctor:

youif• You have epilepsy (sara). If first-time seizures occur or epileptic seizures occur more frequently, use of CIPRALEX should be discontinued (see chapter 4 "What are the possible side effects?").

• If your liver or kidney function is impaired, your doctor may need to adjust the dosage.

• If you have diabetes, CIPRALEX treatment can disrupt blood sugar control. it may be necessary to adjust the dose of the insulin and / or oral blood-reducing drugs.

• If your level of sodium is low.

• If you tend to develop bleeding or morrow.

• If you are receiving electroconvulsive therapy (electroshock therapy).

• If you have coronary heart disease.

• If you have recently had a heart attack or if you have a problem with your heart or have lived in the past.

• If you have low heart rate while you are resting and / or if you have severe diarrhea and vomiting after long periods of time (loss of salt) or diuretic (diuretic drug) use.

• If you are experiencing conditions that indicate anomalies in your heart rate function, such as fainting, falling, or dizziness, while you are standing fast or with irregular heartbeat.

• Patients with a high risk of developing Torsade de Pointes, such as those with congestive heart failure, those with a recent heart attack, those with slow heart rate, or those with hypokalemia due to co-morbid illness or medication use ) or hypomagnesemia (low levels of magnesium in the blood).

Please note Some patients with manic-depressive illness may develop manic faza. This is characterized by the appearance of strange and rapidly changing ideas, undue happiness and extreme physical activity. If you experience such a situation, go with your doctor.

During the first weeks of treatment, symptoms such as restlessness, constant movement, or lack of fit may occur. If you have any of these types of symptoms, tell your doctor immediately.

worsening of thought, depression and anxiety disorder: If you are depressed and / or have an anxiety disorder, sometimes you may be thinking about harming yourself or killing yourself. These symptoms may increase when the antidepressant is first used. Because it usually takes about 2 weeks, but sometimes longer, to start showing the effectiveness of these drugs. This is more likely in the following situations:

• If you have previously thought of suicide or harm yourself.

• If you are a young adult. The information obtained from clinical trials has shown that suicidal behavior increases the risk for adults under the age of 25, who are psychiatric disorders treated with an antidepressant. If, at any time, you are thinking of harming yourself or killing yourself, contact your doctor immediately or go to the hospital.

The use of antidepressants, especially in children and young people up to 24 years, is likely to increase suicidal thoughts or behaviors. This is why it is imperative that the patient closely watch for the patient, either the family or the caregivers, especially at the beginning and the first months of treatment, the unexpected behavioral changes such as uneasiness the patient may show during the period of increasing / decreasing or discontinuing treatment, extreme mobility, or the possibility of suicide.

Use in children and adolescents under the age of 18 CIPRALEX should not normally be used in children and adolescents under the age of 18. It should also be known that patients under the age of 18 have a higher risk of developing side effects such as suicide attempt, suicide tendency and hostility (mostly aggression, opposing behavior and resentment) when using such drugs. Nevertheless, your doctor may start CIPRALEX, considering that it is the best option for a patient under 18 years of age. If your doctor has given CIPRALEX to a patient under the age of 18, and you want to talk about it, please contact your doctor. If a patient under the age of 18 is using CIPRALEX, you should tell your doctor if any of the above-mentioned findings occur or becomes worse. In addition, the long-term safety effects of CIPRALEX on the growth, maturation and cognitive and behavioral development of this age group have not yet been demonstrated.

Please consult your doctor if these warnings apply to you, even at a time in the past.

Use of CIPRALEX with food and drink You can open CIPRALEX on your stomach (see chapter 3 "How to use CIPRALEX"). CIPRALEX is not expected to interact with alcohol. However, as with many medicines, taking CIPRALEX with alcohol is not recommended.

pregnancy.

Please consult your doctor or pharmacist before using lac

If you are pregnant or have pregnancy plans, tell your doctor. If you are pregnant, do not use CIPRALEX with your doctor without discussing its risks and benefits.

If you have used CIPRALEX in the last 3 months of pregnancy, you should know that the following effects can occur in your newborn baby: difficulty breathing, bluish skin, seizures, changes in body temperature, difficulties in feeding, vomiting, low blood sugar, hard or loose muscles, excessive vigorous reflexes, trembling, , nervousness, numbness, constant crying, drowsiness and sleep disorders. If you have any of these findings in your baby, contact your doctor immediately.

Be sure to tell your doctor you are using CIPRALEX. During your pregnancy, especially during the last 3 months of your pregnancy, medications such as CIPRALEX may increase the risk of a serious condition called newborn stubborn pulmonary hypertension in your newborn baby. This will cause your baby to breathe more often and look bluish. These symptoms usually start within the first 24 hours after the birth of the baby. If this happens to your baby, contact your doctor immediately.

If you are using CIPRALEX during pregnancy, the medication should never be abruptly cut off.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

breastfeeding

Consult your doctor or pharmacist before using thelady.

If you are breastfeeding, do not use CIPRALEX, but discuss with your doctor about the risks and benefits and use it if your doctor finds it appropriate.

Using the machine and the machine It is not advisable to use the machine or the machine until you understand how CIPRALEX is affecting you.

Important information about some of the auxiliary substances contained in CIPRALEX is not valid.

Concomitant use with other medicines

If you are using any of these medicines, tell your doctor:

• "Non-selective monoamine oxidase inhibitors (MAOIs)" a group of drugs called (phenelzine as the active ingredient, iproniazid, isocarboxazid, including nialamide and tranylcypromine). If you have used one of these medicines, you must wait 14 days before taking CIPRALEX. After curing CIPRALEX, you should wait 7 days before taking these medicines.

• "Recycled, selective MAO-A inhibitors" containing moclobemide (used in the treatment of depression).

• "Reversible MAO-B inhibitors" containing selegiline (used in the treatment of Parkinson's disease). These medicines increase the risk of side effects.

• Linezolid, an antibiotic.

• Lithium (used in the treatment of manic-depressive disorder) and tryptophan (an amino acid and used as nutritional support).

• mipramine and desipramine (both used in the treatment of depression).

• Sumatriptan and similar drugs (used in migraine treatment) and tramadol (used in severe pain). These medicines increase the risk of side effects.

• Simethidine and omeprazole (used in stomach ulcers), fluvoxamine (antidepressant) and ticlopidine (used to reduce stroke risk). These medicines may increase the level of CIPRALEX.

• St. John's Wort; (Yellow wort: Hypericum perforatum) - a herbal product used in depression.

• Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (drugs used as pain relievers or blood thinners, another name used as an antiagregan). These medications can increase the tendency to bleed.

• Warfarin, dipyridamole and fenproquimone (blood-thinning drugs, called anticoagulants). Your doctor may want to check the time of clotting when starting CIPRALEX or cutting the drug to confirm that the anticoagulant dose you are using is still at an appropriate level.

• mefloquine (used in the treatment of malaria), bupropion (used in the treatment of depression) and tramadol (used in severe pain) due to the risk of lowering the seizure threshold.

• Neuroleptics (drugs used in the treatment of schizophrenia and psychosis) and antidepressants due to the risk of lowering seizure threshold.

• When taken in combination with flecainide, propafenone and metoprolol (used in cardiovascular disease), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics), a dose adjustment of CIPRALEX may be required.

• medications that may affect your heart rhythm if you are taking medication for your heart rhythm problems or cardiac rhythm problems such as Class IA and III antiarrhythmics, antipsychotics (eg phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial compounds (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, especially halofantrin), some medicines that are effective against allergic diseases (astemizole, mizolastine), do not use CIPRALEX if you are taking medicines that can affect the heart rhythm.

Please inform your doctor or pharmacist if you are using or have recently used any medicine with or without a prescription.

3. How to use CIPRALEX?

• Instructions for proper use and dose / application frequency: Always use CIPRALEX as prescribed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Adults Depression The recommended dose of CIPRALEX is 10 mg per day. Your dose may be increased to a maximum of 20 mg / day.

The initial intake of panic disorder CIPRALEX is 5 mg once daily for one week, before 10 mg of doozzole emerges per day. The dose can be increased by your doctor to a maximum of 20 mg / day later.

Social anxiety disorder The recommended dose of CIPRALEX is 10 mg per day. According to your response to lacrosse, your doctor may reduce the dose to 5 mg / day or up to a maximum of 20 mg / day.

Common anxiety disorder CIPRALEX is the recommended dose of 10 mg per day. The dose can be increased up to a maximum of 20 mg per day by your doctor.

Obsessive-compulsive disorder The recommended dose of CIPRALEX is 10 mg once daily. The dose can be increased up to a maximum of 20 mg per day by your doctor.

• Application route and method: You can take CIPRALEX on a stomach or on a stomach. Drink the tablets with water. Do not chew, the taste is painful.

If necessary, the tablets may be divided into two, put on a flat surface, notched up. The tablet, as seen, can be divided into two parts by pressing with the index finger from both ends.

• Different age groups: Children and adolescents (under 18 years): CIPRALEX should not be used in children and adolescents. For more information, please see chapter 2 "What to watch out for before using CIPRALEX".

Elderly patients (over 65 years): The recommended initial dose of CIPRALEX is 5 mg per day. The dose can be increased up to a maximum of 10 mg per day by your doctor.

The duration of treatment: You can find a few weeks to feel better. Continue to use CIPRALEX even if it takes some time to feel your improvement.

Do not change the dose of your medication without talking to your doctor.

Use CIPRALEX for the time recommended by your doctor. If the treatment is terminated early, the disease may repeat the indication. It is advisable to continue treatment until at least 6 months after you feel well.

If you have an impression that the effect of CIPRALEX is too strong or weak, talk to your doctor or pharmacist.

If you use more CIPRALEX than you need, use CIPRALEX. If you have used too much, talk to a doctor or pharmacist or contact the emergency department of your nearest hospital. Even if you do not feel any discomfort, do it.

Some signs of overdose include: dizziness, tremors, agitation, seizures (convulsions), coma, nausea, vomiting, normal or slow heartbeat, drop in blood pressure, and changes in the body's water / salt balance. When you go to the doctor or the hospital, you have the CIPRALEX box next to you.

If you forget to use CIPRALEX, do not take double doses to compensate for forgotten doses.

If you forget to take a dose and remember before you go to bed, you are taken immediately. Continue normally the next day. If you remember the same day at night or the next day, skip that dose and continue with normal treatment.

Effects that may occur when treatment with CIPRALEX is terminated Do not interrupt CIPRALEX unless you are taking your medicine. If you have completed the course of the treatment, you should usually leave the CIPRALEX dose within a few weeks, gradually reducing it.

If you suddenly have stopped using CIPRALEX, you may experience the interruption indication. These symptoms are frequent when CIPRALEX treatment is abruptly terminated. This risk is higher when CIPRALEX is used for a long period of time or when it is used in high doses, or when the dosage is reduced very quickly. Symptoms in many patients are mild and go away in two weeks. However, in some patients, it may be more severe or may last longer (2- 3 months or longer). If you discontinue CIPRALEX, please tell your doctor if the cessation is severe. Your doctor may want you to start using your medicine again and leave it at a slower rate.

Intermittent symptoms include: dizziness or dizziness, tingling sensation, burning sensation, electric shock sensation (less common) including head area, sleep disturbances (live dreams, nightmares, sleepiness), anxiety, headaches, nausea , sweating (including night sweats), fuzzy or agitated feeling, trembling, confusion, emotionality or nervousness, diarrhea (soft stool), visual disturbances, palpitations or excessive heartbeat.

If you have any questions about the use of this medicine, your doctor or pharmacist is ok.

4. What are the possible side effects?

As with all medicines, there may be side effects in people sensitive to the ingredients in the CIPRALEX. Side effects usually disappear after a few weeks of treatment. Please bear in mind that most influenza may be linked to your illness and you may pass it if you start to recover. The side effects are listed as shown in the following categories: Very common: affecting more than 1 user in 10. Common: affecting 1-10 users in 100. Uncommon: affecting 1-10 users in 1000. Rare: Affects 1-10 users at 10000. Unknown: the frequency at hand is unpredictable.

If you experience any of the following side effects during your treatment, contact your doctor: Uncommon:

• Abdominal bleeds, including stomach-intestinal bleeding

Rare:

• Tell your doctor if you have an overdose, swollen skin, lips or face, or if you feel difficulty breathing or swallowing (allergic reaction) Go to the hospital.

• If high fever, agitation, dizziness, chills, and sudden contractions occur in the muscles, these may be a rare occurrence, the so-called serotonin syndrome. If you feel this way, tell your doctor.

If you notice any of the following, report to your doctor or go to the hospital:

• Difficulty in

drilling • Seizures (see also "Use CIPRALEX with caution in the following situations")

• Liver dysfunction / hepatitis symptoms in the white part of the liver and eyes.

• Fast, irregular heartbeat, fainting: these can be life-threatening and indicate a condition known as Torsades de Pointes.

In addition to the above, the following side effects have been reported: Very common:

• Nausea

Common:

• Congestion or(sinusitis)

sneezing• Decreased or increased appetite

• Anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, skin tingling

• diarrhea, constipation, vomiting, dry mouth

• Sweating increases

•Muscle and pain in the joints (arthralgia and myalgia)

• sexual disorders (delay ejaculation, erection problems, libido decrease and women orgasm disorders)

• Fatigue, fever

• Weight gain

Uncommon:

• Hives, rash, itching (pruritus)

• Gum creaking, agitation, nervousness, panic attacks, dizziness, confusion status

• Sleep disturbance, tardiness, fainting (syncope)

• Growth in moles (mydriasis) visual disturbance, tinnitus

• Hair loss

• Vaginal bleeding

• Weight loss

• Heart rate hi Acceleration

• swelling in the arms and legs

• Nosebleeds

Rare:

• Aggression, depersonalisation, hallucination

• Heart inslowdown