Depremin 612 mg

Package Leaflet: Information for the Patient

Depremin 612mg, 612 mg, Coated Tablets

Hyperici herbae extractum siccum quantificatum

Read the package leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.

• The package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 4 weeks or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Depremin 612mg and what is it used for
• 2. Important information before taking Depremin 612mg
• 3. How to take Depremin 612mg
• 4. Possible side effects
• 5. How to store Depremin 612mg
• 6. Contents of the pack and other information

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

A herbal medicinal product for the short-term treatment of mild depressive symptoms.
If there is no improvement after 4 weeks or the patient feels worse, they should consult their 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 taking medicines that reduce the rejection of transplanted organs: cyclosporine, systemic tacrolimus, medicines used to treat HIV infection: amprenavir, indinavir, and other protease inhibitors, anticancer medicines: irinotecan, and anticoagulant medicines: warfarin.

Warnings and precautions

Before starting treatment with Depremin 612mg, the patient should discuss it with their doctor or pharmacist.
During treatment, the patient should avoid exposure to intense UV radiation (ultraviolet).

Children and adolescents

Due to the lack of sufficient data, the use of Depremin 612mg in children and adolescents under 18 years of age is not recommended.

Depremin 612mg and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
St. John's Wort extract induces the activity of CYP3A4, CYP2C9, CYP2C19, and P-glycoprotein enzymes.
Concomitant use of cyclosporine, systemic tacrolimus (medicines that reduce the rejection of transplanted organs), amprenavir, indinavir, and other protease inhibitors (medicines used to treat HIV infection), irinotecan (anticancer medicine), and warfarin (anticoagulant medicine) is contraindicated.
Special caution is advised when using medicines that are metabolized by CYP3A4, CYP2C9, CYP2C19, or P-glycoprotein enzymes, such as amitriptyline (antidepressant), fexofenadine (antihistamine), benzodiazepines (anxiolytic medicines), methadone (pain reliever), simvastatin (lipid-lowering medicine), digoxin (medicine used to treat heart failure), finasteride (medicine used to treat benign prostatic hyperplasia), as their plasma concentrations may be reduced.
A decrease in the plasma concentration of oral contraceptives may lead to intermenstrual bleeding and reduced efficacy of hormonal contraception.
Women taking oral hormonal contraceptives should use additional non-hormonal contraceptive methods.
Before planned surgery, the possibility of interactions with medicines used for general and local anesthesia should be considered. If necessary, the medicine containing St. John's Wort extract should be discontinued.
Increased enzyme activity returns to normal within 1 week after stopping the medicine 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, if used in combination with antidepressant medicines, such as selective serotonin reuptake inhibitors (e.g., sertraline, paroxetine, nefazodone) or triptans and buspirone.
In patients taking other prescription medicines before starting treatment with St. John's Wort extract, consultation with a doctor or pharmacist is recommended.

Using Depremin 612mg with food and drink

The medicine should be taken with a sufficient amount of liquid, preferably water.

Pregnancy, breastfeeding, and fertility

Use during pregnancy and breastfeeding is not recommended.

Driving and using machines

There are no adequate studies on the effect on the ability to drive and use machines.

3. How to take Depremin 612mg

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose:
Adults: one tablet (612 mg), once a day.
Method of administration:
Oral use.
Duration of treatment:
6 weeks.
Therapeutic effect can be expected within 4 weeks of treatment. If symptoms persist during treatment, the patient should consult their doctor.

Use in children and adolescents

Due to the lack of sufficient data, the use of Depremin 612mg in children and adolescents under 18 years of age is not recommended.

Taking a higher dose of Depremin 612mg than recommended

After ingestion of up to 4.5 g of dry extract per day for 2 weeks and an additional 15 g of dry extract before hospitalization, seizures and confusion occurred.
After overdose, the patient should be protected from sunlight and other sources of UV radiation for 1-2 weeks.

Missing a dose of Depremin 612mg

A double dose should not be taken to make up for a missed dose (1 tablet).

Stopping treatment with Depremin 612mg

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Depremin 612mg can cause side effects, although not everybody gets them.
Gastrointestinal disorders, allergic skin reactions, fatigue, and anxiety may occur.
The frequency of these side effects is not known.
During intense sun exposure, people with fair skin may experience intensified symptoms, such as sunburn.
If other side effects occur, not listed above, the patient should consult their doctor or pharmacist.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the package leaflet, the patient should inform their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Depremin 612mg

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP (abbreviation used to describe the expiry date). The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Depremin 612mg contains

The active substance is dry extract of St. John's Wort ( Hyperici herbae extractum siccum quantificatum)
One coated tablet contains 612 mg of extract (in the form of dry extract, quantified) from Hypericum perforatumL., herba (St. John's Wort) (DER 3-6:1), which corresponds to: 0.6 mg - 1.8 mg of hypericin, 36.72 mg - 91.80 mg of flavonoids in terms of rutin, not more than 36.72 mg of hyperforin.
Extraction solvent: ethanol 60% (V/V)
Other excipients are: colloidal anhydrous silica, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, magnesium stearate, coating mixture Opadry II 85F32410 yellow (polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, yellow iron oxide (E 172)).

What Depremin 612mg looks like and contents of the pack

Oblong, biconvex, coated tablet, yellow in color.
Depremin 612mg is available in packs containing: 20, 30, or 60 tablets in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne „COLFARM” S.A.
ul. Wojska Polskiego 3

• 39 - 300 Mielec Tel.: 17 788 58 11 E-mail: [email protected]

Date of last revision of the package leaflet: July 2024