Simoda 60 mg 28 gastro-resistant capsules — Made in Bulgaria — Free Delivery

Product description

Gastro-resistant solid capsules "Simoda " are used in the treatment of:

• major depressive disorder;
• peripheral neuropathic pain in diabetes;
• generalized anxiety disorder.

Compound

The active ingredient is duloxetine (one gastro-resistant solid capsule contains duloxetine hydrochloride, which is equivalent to 60 mg duloxetine).

Excipients: sugar spheres, hydroxypropyl cellulose, hypromellose, hypromellose phthalate, triethyl citrate, talc.

Contraindications

Contraindication for the use of the preparation is hypersensitivity to duloxetine or to any excipients of the preparation.

Duloxetine should not be administered together with non-selective irreversible MAO inhibitors (MAO) or for at least 14 days after stopping treatment with MAO inhibitors. Given the half-life of duloxetine, MAO inhibitors should not be prescribed for at least 5 days after discontinuation of duloxetine treatment.

"Simoda" should not be prescribed to patients with unstable hypertension, as it can provoke a hypertensive crisis.

The preparation should not be administered to patients with end-stage renal failure (creatinine clearance up to 30 ml / min).

"Simoda " should not be prescribed to patients with liver disease, it can lead to liver failure.

Duloxetine is not recommended for use in children due to insufficient data on the safety and efficacy of its use in this age group of patients.

The preparation should not be administered in combination with fluvoxamine, ciprofloxacin, or enoxacin (strong CYP1A2 inhibitors) due to an increase in plasma duloxetine concentration.

Mode of application

Major depressive disorder

The initial and recommended maintenance dose is 60 mg once a day. The preparation should be taken with or without food. Doses in excess of 60 mg once daily, up to a maximum of 120 mg daily, divided into 2 divided doses, have been evaluated for safety in clinical trials. However, there is no clinical evidence that patients do not respond to the initial recommended dose, which takes precedence over the higher titer dose.

A therapeutic response is usually observed after 2-4 weeks of treatment.

After a sustained antidepressant effect, it is recommended to continue treatment for several months to avoid relapse. In patients for whom treatment with duloxetine was effective and in whom repeated episodes of depressive disorders are observed, further long-term treatment can be carried out at a dose of 60 to 120 mg / day.

Generalized Anxiety Disorder

The recommended starting dose for patients with generalized anxiety disorder is 30 mg once daily. The preparation should be taken with or without food. For patients with insufficient response, the dose should be increased to 60 mg. In patients with concomitant major depressive disorders, the initial and maintenance doses are 60 mg 1 time per day. Doses up to 120 mg / day have been effective and have been evaluated for safety in clinical trials. For patients with insufficient response to the 60 mg dose, doses up to 90 mg or 120 mg per day may be considered. Dose escalation should be based on clinical response and tolerability.

After an increase in the response to the preparation, it is recommended to continue treatment for several months to prevent relapse.

Peripheral neuropathic pain in diabetes

The initial and recommended maintenance dose is 60 mg per day. The preparation is taken regardless of food intake. Doses exceeding 60 mg 1 time per day (up to a maximum of 120 mg per day) must be evenly divided into several doses. Plasma concentration of duloxetine reflects large individual variability. For patients who do not respond well to the 60 mg dose, higher doses may be effective.

The response to treatment should be assessed after 2 months. In patients with an inadequate initial response, an additional response after this period is unlikely.

The therapeutic effect should be regularly reviewed (at least once every 3 months).

Elderly patients

For elderly patients, the dose is not adjusted solely on the basis of age. However, as with any preparations, caution should be exercised in elderly patients, especially when prescribing Simoda  capsules at a dose of 120 mg per day for major depressive disorder, for which data are limited.

Liver failure

Simoda capsules should not be administered to patients with liver disease or liver failure.

Renal failure

No dose adjustment is required for patients with mild to moderate renal dysfunction (creatinine clearance 30 to 80 ml / minute). The preparation "Simoda " should not be prescribed to patients with severe renal impairment (creatinine clearance <30 ml / minute).

Termination of treatment

Abrupt discontinuation of treatment should be avoided. The dose should be gradually reduced over a period of at least one to two weeks to reduce the risk of withdrawal reactions. If withdrawal symptoms occur after dose reduction or after discontinuation of treatment, then you can restore the use of the preparation in the previously prescribed doses. Subsequently, the doctor may continue to reduce the dose, but more gradually.

Application features

Pregnant

There is insufficient data on the use of duloxetine in pregnant women.

Duloxetine very weakly penetrates into breast milk, which was confirmed by the example of 6 patients capable of breastfeeding, but who did not breastfeed. The estimated daily dose received by the child (mg / kg) was approximately 0.14% of the dose taken by the mother. The safety of duloxetine for infants is unknown, so taking Simoda  during breastfeeding is not recommended.

In animal studies, duloxetine did not affect male fertility, and the effects in women only appeared at doses that caused maternal toxicity.

Children

The preparation "Simoda " is not used to treat children and adolescents (under the age of 18).

Drivers

The study of the effect of duloxetine on the reaction rate when driving vehicles or other mechanisms was not carried out. The use of Simoda is associated with sedation and dizziness. Patients should refrain from potentially hazardous activities, such as driving vehicles or other machinery, if they feel sedated or dizzy.

Overdose

Symptoms

Overdose cases have been reported with duloxetine at a dose of 5400 mg as monotherapy or in combination with other preparations. Fatal cases have been recorded, primarily with a mixed overdose, as well as with the use of duloxetine at a dose of approximately 1000 mg. Signs and symptoms of overdose (duloxetine alone or in combination with other drugs): drowsiness, coma, serotonin syndrome, convulsions, vomiting and tachycardia.

Treatment

No specific antidotes are known. When serotonin syndrome occurs, specific treatment is necessary (cyproheptadine and / or temperature control). Check for airway patency. Cardiac monitoring and vital signs monitoring is recommended, together with appropriate symptomatic and supportive measures. Gastric lavage may be appropriate if it is performed immediately after taking the drug or for symptomatic therapy. Activated carbon reduces the absorption of the preparation. Duloxetine has a large volume of distribution in the body, and therefore forced diuresis, hemoperfusion and exchange perfusion are unlikely to be beneficial.

Side effects

Nausea, headache, dry mouth, drowsiness, and dizziness were most commonly reported. Most of the common adverse reactions were mild to moderate in intensity. They were usually noted at the beginning of therapy and decreased with continued therapy.

Storage conditions

Store in its original packaging at a temperature not exceeding 25 ° C, out of the reach of children.

Expiration date - 24 months.