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Cipralex 20 Mg 28 Tablets ingredient Escitalopram

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Cipralex 20 Mg 28 Tablets ingredient Escitalopram

CIPRALEX 20 mg film tablet is taken orally.

Active ingredient
20 mg escitalopram (as oxalate)

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Tablet core: Microcrystalline cellulose, colloidal anhydride silica, talc, croscarmellose sodium, magnesium stearate

Film coating: Hypromellose, macrogol 400, titanium dioxide (E171)

You should read this USE INSTRUCTION carefully before you start using this medicine, because it contains important information for you.

Save 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 or doctor if you go to the hospital.

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

In this Instructions for Use:

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

2. Things to watch out for before using CIPRALEX

3. How to use CIPRALEX?

4. What are the possible side effects?

5. CIPRALEX hiding

Their headlines are in place.

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

• CIPRALEX 20 mg film tablets each contain 20 mg of escitalopram.

• CIPRALEX is presented on the market in 28 tablets packages.

• CIPRALEX depression (major depressive states) and anxiety disorders (agoraphobia or non-agoraphobic panic disorder, social anxiety disorder and generalized anxiety disorder and obsessive-compulsive disorder) are used.

• 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.

3. How to use CIPRALEX?

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.

Panic disorder

The initial dose of CIPRALEX is 5 mg once daily for one week, before 10 mg of doxa 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. Depending on the coin you give your doctor, your doctor may reduce the dose to 5 mg / day or up to a maximum of 20 mg / day.

Common anxiety disorder

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

Application path and method

You can get CIPRALEX on your stomach or hungry. 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.

Use in children

CIPRALEX should not be used in children and adolescents. For more information

please see chapter 2 "What to look out for before using CIPRALEX".

Use in the elderly

The recommended initial dose of CIPRALEX is 5 mg per day. Treatment duration:

You can find yourself a few weeks before you feel better. Continue to use CIPRALEX if it will take some time to notice 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 and talk to a doctor or pharmacist if you have used too much.

Some signs of overdose include: dizziness, tremors, agitation, seizures (convulsions), coma, nausea, vomiting, normal slow or rapid heartbeat, decreased 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 forgot 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 night at a time 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 have your doctor. The duration of treatment

If you have completed it, you should usually leave within a few weeks, gradually reducing the recommended dose of CIPRALEX.

If you have abandoned CIPRALEX abruptly, you can experience the interruption indication. These symptoms can be 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. According to many people, symptoms are mild and go away in two weeks. However, in some patients, it may be more severe or may last longer (23 months or longer). If you discontinue CIPRALEX, please tell your doctor if the cessation is severe. You may want to start using the tablets again and leave it slower.

Discontinuation statements include: electrical shock sensations (more rarely), dizziness (dizziness or imbalance), tingling sensation, burning sensation and head area, sleep disorders (live dreams, nightmares, sleepiness), anxiety, headache, nausea, sweating night sweats), fuzzy or agitated feelings, trembling, confusion or confusion, sensuality 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 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.

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

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

• Abnormal bleeding, including stomach-intestinal bleeding

Sparse (more than 1 in 10,000 and less than 1 in 1000):

• Tell your doctor or go to the hospital immediately if you experience difficulties with swelling of the bottom, on the skin, on the lips or on the face or when breathing or swallowing (allergic reaction).

• 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, tell your doctor immediately or go to the hospital:

• Difficulty in urinating

• Seizures, see also section "Use CIPRALEX with caution in the following situations".

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

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

Very common (more than 1 person in 10):

• Nausea

Common (more than 1 in 100 and less than 1 in 10):

• Congestion or flow (sinusitis)

• Decreased or increased appetite

• Anxiety, restlessness, abnormal dreams, difficulty sleeping, drowsiness, dizziness, stretching, trembling, deep tingling

• Diarrhea, constipation, vomiting, mouth instability

• Sweating increase

• Pain in muscles and joints (arthralgia and myalgia)

• Sexual disorders (delayed ejaculation, erectile problems, decreased urination and orgasmic disorders in women)

• Fatigue, fever

• Weight gain

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

• Hives (urticaria), rash, itching (prurit)

• Tooth grinding, agitation, nervousness, panic attack, dizziness, confusion status

• Sleep disturbance, impaired taste, fainting (syncope)

• Growth in the pups (mydriasis), visual disturbances, tinnitus (tinnitus)

• Hair loss

• Vaginal bleeding

• Weight loss

• Heart rate acceleration

• Swelling in arms and legs

• Nose bleeding

Sparse (more than 1 in 10,000 and less than 1 in 1000):

• Aggression, depersonalization, hallucination

• Deceleration in heart rate

Reported by some patients (frequency unknown):

• Thinking about harming yourself or killing yourself, see also

"Use CIPRALEX with caution in the following situations" section.

• Decrease in blood sodium levels (symptoms: nausea, feeling sick, weak muscles or confusion)

• When the leg is raised, dizziness due to low blood pressure (orthostatic hypotension)

• Abnormal liver function tests (elevated liver enzymes)

• Movement disorders (involuntary movements in the muscles)

• Painful erection (priapism)

• Bleeding disorders (ecchymosis) including skin and mucosal bleeds and low platelet level (thrombocytopenia)

• Sudden swelling of the skin or mucous membranes (angioedema)

• Increased urine output (inappropriate ADH release)

• Milk coming in women who do not breastfeed

• Mani

In addition, escitalopram (the active ingredient of CIPRALEX) has some side effects that are found in drugs that act in a similar way. These:

• Motor unrest (akatizi)

• Anorexia (anorexia)

Inform your doctor or pharmacist if you encounter any side effects not mentioned in these instructions for use.

2. Things to consider before using CIPRALEX
DO NOT USE CIPRALEX in the following situations

• If you are allergic to other ingredients in Essitalopram or CIPRALEX (see "Helps").

• If 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 inhibitors.

• If you are using pimozide.

Use CIPRALEX CAREFULLY in the following situations

Please let your doctor know if you have any other condition or illness to consider.

Especially what you need to tell your doctor:

• If epilepsy (epilepsy) is present, seizures occur or an increase in seizure frequency

, CIPRALEX treatment should be terminated (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 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 taking electroconvulsive therapy.

• If you have coronary heart disease.

Please be carefull

Some patients with manic-depressive illness may have a manic episode. 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 inability to sit or not standing can be seen. If you have any of these types of symptoms, tell your doctor immediately.

Suicidal 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 probability is higher in the following situations:

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

• If you are a young adult. Information from clinical trials has shown that suicidal behavior may be increased in adults under 25 years of age with psychiatric disorders treated with antidepressants.

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. For this reason, it is necessary to closely monitor the patient, the family, and the caretakers, especially at the beginning and the first months of treatment, either due to unexpected behavior changes such as uneasiness that the patient may show during the period of increasing / decreasing or discontinuing the drug, extreme mobility, or the possibility of suicide.

Children and adolescents under the age of 18

CIPRALEX should not normally be used in children and adolescents under 18 years of age. In addition, patients under the age of 18 should be aware that side effects such as suicide attempts, suicide tendency and hostility (mostly aggression, antagonism and anger) are more frequent when using such drugs. Nevertheless, your doctor may start CIPRALEX, thinking that I will be of use to patients under the age of 18 years. If your doctor has given CIPRALEX to a patient under the age of 18, and you want to talk about it, please contact him. Patients under the age of 18 using CIPRALEX, above

you should tell your doctor if any of the above mentioned symptoms will appear or become worse.

At the same time, the long-term safety implications of CIPRALEX's growth, development, cognitive and behavioral development in 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

4.1. Therapeutic indications

Major depressive states,

Panic disorder without agoraphobia or agoraphobia,

Social anxiety disorder (social phobia)

Common anxiety disorder,
4.2. Posology and application form

Posology / application frequency and duration:

No safety has been demonstrated at daily doses above 20 mg.

Major depressive states

It is taken as 10 mg once a day. According to the individual patient response, the dose can be increased to a maximum of 20 mg per day.

Generally 2-4 weeks are required for antidepressant response. After the symptoms have been corrected, at least 6 months of treatment is required for the consolidation of the response to be received.

Panic disorder without agoraphobia or agoraphobia

Initial daily dose of 5 mg is recommended for the first week before the 10 mg daily dose is passed. The dose can then be increased to a maximum of 20 mg per day, depending on the individual patient response to be taken.

The maximum effect is obtained after about 3 months. Treatment lasts a few months.

Social anxiety disorder (social phobia)

It is taken as 10 mg once a day. It usually takes 2-4 weeks to relieve symptoms. The dose can be reduced to 5 mg or up to 20 mg per day depending on the individual's disease.

Social anxiety disorder is a chronic illness and 12 weeks of treatment is recommended for the consolidation of the response. When the 6-month long-term treatment of the responders was examined, it was seen that the response should be assessed in relation to the individual in order to prevent relapse. Benefits from the treatment need to be reevaluated at regular intervals.

Social anxiety disorder is a well-defined definitive terminology of a specific disorder and should not be shuddered with extreme hesitation. If this disorder only affects professional and social activities significantly, medication should be started.

This treatment has not been compared with cognitive behavioral therapy. Drug therapy is part of the overall treatment strategy.

Common anxiety disorder

The initial dose is 10 mg once daily. According to the individual patient response, the dose may be increased to a maximum of 20 mg per day.

Long-term therapy (20 mg / day) was evaluated with at least 6-month studies in patients responding to treatment. Benefits and dosages from treatment should be reassessed at regular intervals (see section 5.1).

Obsessive Compulsive Disorder (OCD)

The initial dose is 10 mg once daily. According to the individual patient response, the dose can be increased to a maximum of 20 mg per day.

Because OCD is a chronic disease, patients should be treated for a sufficient period of time to ensure that symptoms are relieved.

Benefits and dosages from the treatment should be re-evaluated at regular intervals (see Chapter

5.1).

Method of Application:

Cipralex can be used as a single daily dose, with or without meals.

Additional information on special populations:

Kidney failure

Dose adjustment is not required for patients with mild or moderate renal insufficiency. Patients with severe renal insufficiency (CLR <30 mL / min) should be cautious (see Section 5.2).

Liver failure

In patients with mild or moderate hepatic insufficiency, it is recommended that 5 mg be administered as an initial dose for the first two weeks of treatment. Depending on the individual patient response, the dose can be increased to 10 mg per day. In patients with severe hepatic insufficiency, particularly careful dose titration is recommended (see section 5.2).

Pediatric population (under the age of 18)

Cipralex should not be used in children and in the treatment of adolescents under the age of 18 (see section 4.4).

Geriatric population (over 65 years)

For initial treatment, the recommended dose should be half and the lower maximum dose should be applied (see Section 5.2). The efficacy of Cipralex in social anxiety disorder in elderly patients has not been investigated.

Patients with poor metabolism due to CYP2C19:

In patients with poor metabolism towards CYP2C19, it is recommended to use 5 mg as the initial dose in the first two weeks of treatment. Depending on the individual patient response, the dose can be increased to 10 mg per day (see section 5.2).

Discontinuation indication when treatment is terminated
4.3. contraindications

It is contraindicated in those with hypersensitivity to any of the escitalopram or its adjuncts.

Use of non-selective irreversible monoamine oxidase inhibitors (MAO-inhibitors) in combination with agitation, tremor, hyperthermia, etc. is contraindicated because of the risk of serotonin syndrome in which the symptoms are seen (see Section 4.5).

The combined use of escitalopram with reversible MAO-A inhibitors (eg moclobemide) or with the reversible non-selective MAO-inhibitor linezolid is contraindicated due to the risk of causing serotonin syndrome (see section 4.5).
4.4. Special use warnings and precautions

The following special precautions and precautions are applied for the selective serotonin reuptake inhibitors (SSRI)

all medicines in its class.

The use of antidepressants, especially in children and adolescents up to 24 years, is likely to increase suicidal thoughts or behaviord. For this reason, it is necessary to closely monitor the patient, either the patient or the family, for the reasons such as unexpected behavioral changes such as uneasiness, excessive mobility, or the possibility of suicide in the beginning and the first months of treatment, during the increase / decrease or withdrawal period of the drug dose. The use of Cipralex should not be used in the treatment of children and adolescents under 18 years of age. In clinical trials, children and adolescents treated with antidepressants, suicide-related behaviors (suicide attempt and suicidal ideation) and hostility (mostly aggression, antagonism and nervousness) were more frequently observed compared to placebo-treated patients. , the patient should be carefully monitored for the occurrence of suicidal symptoms. In addition, there is no long-term safety data for growth, maturation, cognitive and behavioral development for children and adolescents. Paradoxical anxiety Some patients with panic disorder may exhibit increased anxiety symptoms at the beginning of antidepressant treatment. This paradoxical reaction usually disappeared within the first two weeks after the start of treatment. Low initial doses are recommended to reduce potential anxiogenic effects (see section 4.2). Seizures Drugs should be discontinued in all seizure cases. Unstable epilepsy patients should not be given SSRI and should be monitored carefully in controlled epileptic patients. SSRIs should be used with caution in patients with mania / hypomania at the onset of menstruation. If the patient enters the manic episode, the SSRI should be interrupted. SSRI treatment in diabetic patients may change glycemic control (hypoglycemia or hyperglycaemia). Suicidal / suicidal ideation or clinical deterioration Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until a significant improvement occurs. Patients should be closely monitored until an improvement has occurred as treatment may not improve in the first few weeks or more. According to general clinical experience, the risk of suicide may increase in the early stages of recovery. In other psychiatric conditions prescribing escitalopram, the risk of suicide-related events may be increased. Major depressive disorder may also be present with these conditions. Patients with major depressive disorder should be treated in the same manner as patients treated with other psychiatric disorders. It is known that patients presenting with suicide-related events or those who exhibit significant suicidal ideation prior to the beginning of treatment have a risk of suicidal ideation or attempted suicide. . A placebo-controlled meta-analysis of antidepressants in adult patients with psychiatric disorders showed that the risk of suicidal behavior in patients under 25 years of age increased when antidepressants were compared to placebo. Patients at high risk should be monitored closely, especially in the early stages of treatment and after the dose changes. Patients (and patients) should be monitored for any clinical deterioration, suicidal behavior, or unusual changes in thought and behavior, The use of SSRI / SNRI has been associated with akathisia development (characteristically with unfavorable or distressed restlessness, often with lack of ability to sit or with motionless accompaniment) with psychomotor disturbances. This often occurs within the first few weeks of treatment. In patients with these symptoms, increasing doses can be harmful. SSRI has rarely been reported to cause hyponatremia because of the often ending and possibly inappropriate Antidiuretic Hormone Secretion (SIADH) following termination of the hyponatremia. SSRIs should be used with caution in patients at risk such as elderly patients, patients with cirrhosis, or patients who are using known medicines known to cause hyponatremia. Superficial hemorrhagic disorders such as ecchymosis, purpura, etc. have been reported in patients treated with SSRIs. Particular attention should be given to using oral anticoagulants and certain medications known to affect platelet function (eg, atypical antipsychotics and phenothiazines, most of the tricyclic antidepressants, acetylsalicylic acid and nonsteroidal anti-inflammatory drugs (NSAIDs), ticlopidine and dipyridamole) (ECT) with SSRIs and EK

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