Package leaflet: information for the patient

Depremin 612 mg, 612 mg, coated tablets
Hyperici herbae extractum siccum quantificatum
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks of treatment, or if you feel worse, contact your doctor.

Leaflet contents

What Depremin 612 mg is and what it is used for
Important information before taking Depremin 612 mg
How to take Depremin 612 mg
Possible side effects
How to store Depremin 612 mg
Contents of the pack and other information

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

A herbal medicinal product intended for the short-term treatment of symptoms of mild
depressive disorders.
If there is no improvement after 4 weeks, or if the patient feels worse, medical advice should be sought.
If symptoms persist during treatment, consult a doctor.

2. Important information before taking Depremin 612 mg

When not to take Depremin 612 mg:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
if the patient is concurrently using anticoagulant drugs from the coumarin derivatives group, immunosuppressive drugs: cyclosporine, everolimus, sirolimus, tacrolimus for systemic use, drugs used in the treatment of HIV infection: fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors, anticancer drugs: irinotecan, imatinib and other cytostatic agents metabolized by CYP3A4, CYP2B6, CYP2C9, CYP2C19 enzymes or transported by P-glycoprotein.

Warnings and precautions
Before starting treatment with Depremin 612 mg, consult your doctor or pharmacist.
During treatment, avoid intense exposure to UV (ultraviolet) radiation.

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

Depremin 612 mg and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Patients taking other prescription medicines should consult their doctor or pharmacist before starting treatment with St. John's wort extract.

St. John's wort extracts induce the activity of CYP3A4, CYP2B6, CYP2C9, CYP2C19 enzymes and P-glycoprotein. Concomitant use is contraindicated with anticoagulant drugs from the coumarin derivatives group, cyclosporine, everolimus, sirolimus, tacrolimus for systemic use (immunosuppressive drugs), fosamprenavir, indinavir and other protease inhibitors, nucleoside reverse transcriptase inhibitors (drugs used in HIV infection), irinotecan, imatinib and other cytostatic agents metabolized by CYP3A4, CYP2B6, CYP2C9, CYP2C19 enzymes or transported by P-glycoprotein.

Particular caution is required when using concomitantly any medicinal substances metabolized by CYP3A4, CYP2B6, CYP2C9, CYP2C19 enzymes or P-glycoprotein, e.g.: amitriptyline (antidepressant), fexofenadine (antiallergic drug), alprazolam, diazepam, midazolam (anxiolytic drugs), methadone (analgesic), statins (drugs normalizing blood lipid levels), digoxin (used in heart failure), finasteride (used in benign prostatic hyperplasia), as their plasma concentrations may be reduced.

Reduced plasma concentrations of hormonal contraceptives may lead to intermenstrual bleeding and reduced efficacy of hormonal contraception. Women using hormonal contraceptives should use additional non-hormonal contraceptive methods.

Before a planned surgery, consider the possibility of interactions with medicinal products used for general and local anesthesia. If necessary, discontinue the medicine containing St. John's wort extract.

Increased enzyme activity returns to normal within 1 week after discontinuation of the medicine containing St. John's wort extract.

St. John's wort extract may enhance serotonergic effects such as nausea, vomiting, anxiety, agitation, and confusion when used concomitantly with antidepressant medicines such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine) or buspirone. Very rarely, when used concomitantly with serotonin reuptake inhibitors or other active substances with serotonergic activity, adverse reactions (serotonin syndrome) may occur, characterized by autonomic dysfunction (e.g. sweating, tachycardia, diarrhea, fever), mental changes (e.g. agitation, disorientation), and motor changes (e.g. tremor or involuntary muscle movements).

Taking Depremin 612 mg with food and drink
The tablet should be taken with sufficient liquid, preferably water.

Pregnancy, breastfeeding and fertility
Use during pregnancy and breastfeeding is not recommended.

Driving and operating machinery
There are no adequate studies on the effects on the ability to drive motor vehicles and operate mechanical equipment.

Depremin 612 mg contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to take Depremin 612 mg

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dose:
Adults: One tablet (corresponding to 612 mg of extract), once daily.

Method of administration:
Oral administration. The tablet should be taken with sufficient liquid, preferably water.

Duration of treatment:
6 weeks.
Therapeutic effect may be expected within 4 weeks of treatment. If symptoms persist during treatment, consult your doctor.

Use in children and adolescents
Due to insufficient available data, use in children and adolescents under 18 years of age is not recommended.

Overdose of Depremin 612 mg
After ingestion of up to 4.5 g of dry extract per day for a period of 2 weeks, and additionally 15 g of dry extract immediately before hospitalization, seizures and confusion occurred.
In case of overdose, the patient should be protected from exposure to sunlight and other sources of UV light for 1–2 weeks.

Missed dose of Depremin 612 mg
Do not take a double dose to make up for a missed dose.

Stopping treatment with Depremin 612 mg
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
Gastrointestinal disorders (such as nausea, abdominal pain and diarrhoea), allergic skin reactions, fatigue and restlessness may occur. The frequency of these is unknown.
During intense sun exposure, individuals with fair skin may experience dysesthesia symptoms (e.g. tingling, sensitivity to cold or pain, burning sensation) and intensified symptoms resembling sunburn.
If any adverse reactions not listed above occur, consult a physician or pharmacist.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Depremin 612 mg

Store below 25°C.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP (abbreviation used to describe the expiry date). The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Depremin 612 mg contains

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

What Depremin 612 mg looks like and contents of the packaging
Oblong, biconvex, film-coated tablet of light yellow colour.
Depremin 612 mg is available in packages containing: 30 or 60 tablets in PVC/PVDC/Aluminium blisters, packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne COLFARM S.A.
ul. Wojska Polskiego 3,
39-300 Mielec
Tel.: 17 788 58 11
E-mail: [email protected]