Jewell 30mg Davipharm tablets treat severe severe depression (4 blisters x 7 tablets)

Dosage form Box of 4 blisters x 7 tablets
Specifications Mirtazapine

Ingredient

Composition information	Content
Mirtazapine	30mg

Uses

indications

Jewell drugs are indicated in the case of treatment of severe depression.

Pharmacokic

Mirtazapine is a four -round antidepressant, operating by α2 antagonistic Synap at the central level, increasing the neurotransmitter noradrenergic and central serotonergic. The enhancement of Serotonergic neurotransmitter is intermediaries of 5HT-1 receptors.

On the other hand, Mirtazapine also strongly opposes the 5HT-2 and 5HT-3 receptors of serotonin and antagonistic at the average level with the Muscarinic receptor. Mirtazapine has the effect of sleeping due to H-H-H-H-H-H-H-H-H-H-H-H-H-H-H-H-H-H-H-hypotension that causes posture hypotension due to α1-adrenergic receptor antagonist in the peripheral.

Dynamic pharmacokinetics

absorption

Mirtazapine absorbs fast and good through the gastrointestinal tract, oral bioavailability is about 50%. The peak concentration of the drug in plasma is about 2 hours after taking the drug.

Food affects the absorption of drugs. Stable concentration in plasma is achieved after 3-4 days of medication.

distribution

The ratio of cohesion with plasma proteins of mirtazapine is about 85%.

transformation

Mirtazapine is strongly metabolized in the liver, mainly according to the Demethylation and hydroxylation pathway then concluded with glucuronic acid. CYP2D6, CYP1A2 and CYP3A4 are the main isenzymes involved in the metabolism of mirtazapine.

In metabolic derivatives, N-Demethyl derivatives still retain antidepressant activity.

Elimination

mirtazapine excreted through urine (75%) and feces (15%). Selling time for plasma is from 20 - 40 hours.

Research on experimental animals shows that mirtazapine passes the placenta. The drug is also exported to breast milk.

Mirtazapine's clearance coefficient decreases in people with liver failure and kidney failure. In patients with hepatic failure when taking a single dose of 15 mg, Mirtazapine's clearance coefficient decreases by about 35% in patients with mild and moderate liver failure compared to patients with normal liver function; The average concentration of plasma Mirtazapine increased by about 55%.

In patients with renal failure, after taking the only dose of 15 mg of mirtazapine in medium renal impairment patients (CLCR

Before taking Jewell 30mg Davipharm tablets treat severe severe depression (4 blisters x 7 tablets)

How to use

oral medication, drink with water, no chewing tablets.

Take medicine at the same time of the day. Ideally, take a single dose before going to bed. However, the doctor can also tell you to divide the dose - take a dose in the morning and once in the evening before going to bed.

Normally, the drug will start working after 1-2 weeks of use and after 2-4 weeks, you can start to feel better.

In the first weeks of treatment, you must notify the doctor's effective doctor. After 2 - 4 weeks from the start of the drug, notify how the doctor has affected you.

If you still don't feel better, your doctor may give you a higher dosage. In this case, continue to notify the doctor after 2-4 weeks. Typically, you will have to continue taking the medicine until your depression symptoms disappear within 4-6 months.

Dosage

recommended starting dose is 15 or 30 mg/day.

After a few days, your doctor may give you the best dose to you (about 15 - 45 mg/day). The same dose is similar at all ages.

However, if you are an elderly or you have liver or kidney disease, your doctor can change the appropriate dose for you.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

do when using overdose? If you overdose or children swallow the drug, contact the nearest doctor and medical center immediately.

Stop taking medication and contact the nearest doctor or medical center.

Bring the tablet along with the packaging so that the doctor knows what medicine you take and takes timely measures.

What to do when you forget 1 dose? Do not drink twice as doses.

With a dose of 2 times/day:

If you forget to take the morning dose: Take this dose along with the evening dose

If you forget to take the evening dose, do not take this dose with the next morning dose. Continue to use the drug as normal doses in the morning and evening.

Side Effects

When using Jewell, you may experience unwanted effects (ADR).

is very common (can affect over 1 of 10 people)

Increase appetite, weight gain.

Sleep, sedation, headache.

dry mouth.

Common (can affect 1 in 10 people)

Unusual dream, confusion, anxiety, insomnia.

Sleep, dizziness, fatigue.

Dizziness or fainting when sudden standing up (posture hypotension).

Nausea, vomiting, diarrhea, constipation.

Redders.

Muscle pain, joint pain, back pain.

Swelling (typically in the ankles or feet) due to water product (edema).

tired.

rarely (can affect 1 in 100 people)

Nightmares, manic, agitation, hallucinations, psychiatric insecurity (including restless sitting, hyperactivity). The feeling of abnormalities on the skin is like a burning, tingling, uncomfortable burning sensation on the skin (abnormal), restless, unconscious.

Hypotension.

Reducing sensation in the mouth.

rare (can affect 1 of 1000 people)

aggressively.

muscle vibration.

Increase serum transaminase.

Unknown frequency

Bone marrow inhibition (granulocytosis, leukopenia, property anemia, thrombocytopenia), eosinophilia.

Anti -hormone secretion is inappropriate.

Hypoglyc sodium.

Disorders of taste, disorder.

Mouth edema, increased secretion of saliva.

urinary retention.

sleepwalking.

Increase creatininsase.

Children under 18 years of age often have the following unwanted effects:

Significant weight gain.

urticaria.

Increase blood triglycerides.

Instructions on how to handle ADR

Discontinue the drug and contact the nearest medical center if you have the reactions that appear angioed symptoms such as skin rash, redness, edema (eyelids, face, lips, mouth and tongue), shortness of breath or difficulty swallowing. These are symptoms of hypersensitivity reactions.

Stop Mirtazapine and immediately notify your doctor if you encounter unwanted effects below:

Uncommon (can affect 1 of 100 drug users):

Feeling excited or strong emotions (manic)

Rare (can affect 1 of 1000 drug users):

Gold or skin or skin, this may be a sign of hinting liver dysfunction (jaundice)

Abdominal pain with nausea and vomiting (pancreatitis).

Unknown frequency:

Signs of infections such as sudden fever of unexplained cause, abdominal pain and mouth ulcer (grain leukemia).

seizures (convulsions).

The combination of many symptoms such as unexplained fever, sweating, increased heart rate, diarrhea, muscle contraction (uncontrolled), tremor, excessive activity reflexes, restlessness, mood change and coma. In very rare cases, these may be signs of serotonin syndrome.

There is a suicide thought or self -harm - contact the doctor immediately or go to the nearest hospital.

The reaction on the skin is called a variety of red pink patches (the red purple patches on the skin, especially in the palms or soles of the foot like honeycomb grow on the swollen skin areas, the software on the surface of the mouth, eyes and genitals, can be accompanied by fever and fatigue.

Heavy rash, with an burn (water -glossy dermatitis), peeling skin or other effects on the skin, eyes, mouth or genitals, itching or high fever (symptoms of a severe reaction on the skin called Stevens - Johnson syndrome or poisoned epidermal necrosis)

muscle pain or weakness, or swelling due to abnormal muscle destruction, sometimes accompanied by dark urine (muscle pattern).

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

contraindicated

Jewell drug is contraindicated in the following cases:

Mirtazapine's new hypersensitivity or any ingredient of the drug.

Used or recently used (within 14 days) Monoaminoxydase inhibitors (IMAO).

Be cautious when using

notify your doctor if you are having the following health problems:

Thinking of suicide and severe depression.

If you have depression, sometimes you may have the thought of harm yourself or suicide. This may increase when starting with antidepressants. Because these drugs all need time to promote the effect (usually takes about 2 weeks, sometimes longer).

You are more likely to have such thoughts:

If you had the thought before or kill yourself.

If you are an adult: Information from clinical trials shows the risk of increasing suicide behavior in adults under 25 years old with mental conditions treated with an antidepressant.

If you have suicidal thoughts or harm yourself at any time, contact your doctor immediately or go to medical centers.

You should notify relatives or friends that you are depressed. Ask them to tell you if they feel your depression worsen or worry about changes in your behavior.

Notice immediately to the doctor before taking Mirtazapine if you have or ever have one of the following conditions:

seizures (epilepsy). If you have convulsions or seizures occur more often, stop taking the drug and contact your doctor immediately. If the jaundice occurs, stop taking the drug and contact your doctor immediately. If psychotic symptoms such as paranoid thoughts occur more often or become worse, contact your doctor immediately. If you start to feel excited or overactive, stop taking the medication and contact your doctor immediately.

If you progress signs of infection such as: high fever for unknown reasons, sore throat or mouth ulcers, stop taking medication and contact your doctor immediately to conduct blood tests. In rare cases, these symptoms may be a sign of disorders in the production of blood cells from bone marrow. Although rare, these symptoms usually appear after 4-6 weeks of treatment.

If you are elderly, you may be more sensitive to the unwanted effects of antidepressants.

Jewell contains lactose. Notify the doctor if you are not able to tolerate a certain type of sugar.

Jewell contains polysorbat 80 that can cause allergies, castor oil can cause nausea, vomiting, abdominal pain, diarrhea.

To be out of reach of children.

Use drugs for children and adolescents

Do not use this drug for children and minors under 18 years of age because of the effectiveness of the drug on this group has not been proven.

In addition, you should also know that patients under the age of 18 when taking drugs of this group of drugs will increase the risk of unwanted effects such as trying to kill suicide, suicide thoughts and opposition behaviors (mostly aggressive, opposing behaviors and anger). However, doctors can also give patients using mirtazapine when this is the best choice for them.

If the doctor prescribes Mirtazapine for patients under the age of 18 and you want to talk about this, see your doctor. You should notify your doctor if you have any symptoms above progress or get worse in patients under 18 years of age who are taking Mirtazapine.Mirtazapine's long -term safety effects related to development, maturity and cognitive development, behavior in this age group have not been proven. In addition, significant weight gain in this age group when treated with Mirtazapine is also reported more often than adults.

The ability to drive and operate machinery

mirtazapine may affect your ability to focus or alert. Therefore, you should not perform high concentration such as driving or operating machinery, until you are sure whether you are affected or not.

Pregnancy

If you are pregnant or breastfeeding, think that you are pregnant or intend to get pregnant, consult your doctor before taking the medication.

Some information about drug use for pregnant women do not see increased risks. However, caution when taking the drug during pregnancy.

If you use mirtazapine until or right before birth, your child needs to be monitored unwanted effects.

Make sure your midwifery and/ or your doctor know you're using Mirtazapine. During pregnancy, taking similar drugs (SSRI) may increase the risk of a serious condition in children called persistent pulmonary hypertension in infants (PPHN), causing children to breathe fast and green, these symptoms usually start within the first 24 hours after the child is born.

If this happens to your child, please contact your midwife and/or your doctor.

Breastfeeding period

If you are breastfeeding, consult your doctor before taking the medication.

Drug interaction

should not be used in combination with mirtazapine with the following drugs:

Monoaminoxydase inhibitors (IMAO). Also, do not take Mirtazapine within 2 weeks after stopping using imao. If you stop taking Mirtazapine, you must not use imao for 2 weeks later. Imao drugs such as moclobemide, tranylcypromin (both antidepressants) and Selegilin (Parkinson's treatment).

Be cautious when using mirtazapine in combination with:

Antidepressants such as selective Serotonin reabsorption inhibitors (SSRI), Venlafaxin and L - Tryptophan or triptan derivatives (migraine treatment), tramadol (painkillers), linezolid (antibiotics), lithium (treatment of psychotic disorders) and preparations of St. John - Hypericum Perfolatum (an herb to treat depression).

Some symptoms of this syndrome are: unexplained fever, sweat, heart rate, diarrhea, muscle contraction (uncontrollable), tremor, excessive activity reflexes, restlessness, mood change and unconscious. If you experience these symptoms, notify your doctor. Notify your doctor if you are taking these medications as you may need to reduce the dose of mirtazapine or increase the dose again when stopping nefazodon. Mirtazapine may increase the drowsiness caused by these drugs when used in combination. Mirtazapine combination with these drugs can increase the amount of mirtazapine in your blood. Notify your doctor if you are taking these medications because you need to reduce the dose of mirtazapine or increase the dose of mirtazapine again when stopping using the above drugs. Mirtazapine combination with these drugs can reduce the amount of mirtazapine in your blood. Notify your doctor if you are taking these medications because you need to increase the dose of mirtazapine or reduce the dose of mirtazapine again when stopping the use of the above drugs. Mirtazapine may increase the effect of warfarin in the blood. Notify your doctor if you are using these medications. In case of need to be shared, your doctor will monitor your blood closely.

Use JWELL with food and drink:

You may be drowsy if you drink alcohol while being treated with Mirtazapine. Therefore, you should not take alcohol while taking the medication.

Storage

Keep the drug in the packaging of the manufacturer, covered.

Put the drug in a dry place, avoid light, the temperature does not exceed 30 ° C and out of the reach of children.

Do not use the drug after the expiry date on the packaging (box and blister box).

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