Depremin 612 mg, 60 tablets polish -Depremin 612 mg, 60 tabl. powl.

• Important information about the medicine

This is a medicine. For safety, use it according to the leaflet enclosed in the package. Do not exceed the maximum dose of the medicine. If in doubt, consult your doctor or pharmacist.

Leaflet enclosed in the package: information for the patient

Depremin 612mg, 612 mg, film-coated tablets

• Hyperici herbae extractum siccum quantificatum

1. What is Depremin 612mg and what is it used for

A herbal medicinal product intended for the short-term treatment of symptoms of mild depressive disorders.

If after 4 weeks there is no improvement or the patient feels worse, talk to your doctor.

2. Important information before taking Depremin 612mg

When not to take Depremin 612mg:

– if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

– if the patient is simultaneously taking medicines that reduce the rejection reaction of the transplant: cyclosporine, tacrolimus for systemic use, medicines used to treat HIV infection: amprenavir, indinavir and other protease inhibitors, anticancer medicines: irinotecan and anticoagulant medicines: warfarin.

Warnings and precautions

Before starting to use Depremin 612mg, talk to your doctor or pharmacist.

During treatment, exposure to intense UV (ultraviolet) radiation should be avoided.

Children and adolescents

Due to the lack of sufficient data, use in children and adolescents under 18 years of age is not recommended.

Depremin 612mg and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or are planning to take.

St. John’s wort extract induces the activity of CYP3A4, CYP2C9, CYP2C19 enzymes and P-glycoprotein. Concomitant use of cyclosporine, tacrolimus for systemic use (drugs reducing the reaction of transplant rejection), amprenavir, indinavir and other protease inhibitors (drugs used in HIV infection), irinotecan (anticancer drug) and warfarin (anticoagulant drug) is contraindicated.

Particular caution should be exercised when simultaneously using drugs that are metabolized by CYP3A4, CYP2C9, CYP2C19 enzymes or P-glycoprotein, e.g. amitriptyline (antidepressant), fexofenadine (antiallergic drug), benzodiazepines (anti-anxiety drugs), methadone (painkiller), simvastatin (drugs that normalize blood lipid levels), digoxin (drug used in heart failure), finasteride (drug used in benign prostatic hyperplasia), because it is possible to reduce their plasma concentration.

A decrease in the plasma concentration of oral contraceptives may lead to intermenstrual bleeding and reduce the effectiveness of hormonal contraception. Women using oral hormonal contraceptives should use additional non-hormonal contraceptives.

Before a planned surgery, the possibility of interactions with medicinal products used for general and local anesthesia should be considered. If necessary, discontinue the drug containing St. John’s wort extract.

Increased enzyme activity returns to normal levels within 1 week after discontinuing the drug containing St. John’s wort extract.

St. John’s wort extract may contribute to the intensification of serotonergic effects such as nausea, vomiting, anxiety, agitation and confusion when used in combination with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine, nefazodone) or triptans and buspirone.

In patients taking other prescription drugs, it is recommended to consult a doctor or pharmacist before starting treatment with St. John’s wort extract.

Using Depremin 612mg with food and drink

The drug should be taken with a sufficient amount of fluid, preferably water.

Pregnancy, breastfeeding and effects on fertility

Use during pregnancy and breastfeeding is not recommended.

Driving and operating machinery

There are no adequate studies on the effect on the ability to drive and operate machinery.

3. How to take Depremin 612mg

Always take this medicine exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

Adults: one tablet (612 mg), once a day.

Method of administration:

Use orally.

Duration of use:

6 weeks.

The therapeutic effect can be expected within 4 weeks of treatment. If symptoms persist during the use of the drug, consult a doctor.

Use in children and adolescents

Due to the lack of sufficient data, use in children and adolescents under 18 years of age is not

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