Package leaflet: Information for the patient

Hyperis, 612 mg, coated tablets
Hyperici herbae extractum siccum quantificatum
Please read all of 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 the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 4 weeks, or if your condition worsens, contact your doctor.

Contents of the leaflet

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

1. What Hyperis is and what it is used for

Hyperis is a herbal medicinal product indicated for the short-term treatment of symptoms of mild depressive disorders.
If there is no improvement after 4 weeks, or if your condition worsens, consult your doctor.

2. Important information before taking Hyperis

When not to take Hyperis:

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 medicines that suppress transplant rejection reactions: cyclosporine, systemic tacrolimus, drugs used in the treatment of HIV infection: amprenavir, indinavir and other protease inhibitors, anticancer drugs: irinotecan, and anticoagulants: warfarin.

Warnings and precautions
Before starting treatment with Hyperis, discuss this with your doctor or pharmacist.
During treatment, avoid exposure to intense UV (ultraviolet) radiation.
Children and adolescents
Due to insufficient data, use in children and adolescents under 18 years of age is not recommended.
Hyperis and other medicines
You should inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
St. John's wort extract induces the activity of CYP3A4, CYP2C9, CYP2C19 enzymes and P-glycoprotein. Concomitant use of cyclosporine, systemic tacrolimus (immunosuppressive drugs), amprenavir, indinavir and other protease inhibitors (drugs used in HIV infection), irinotecan (anticancer drug), and warfarin (anticoagulant) is contraindicated.
Particular caution is required when using concomitantly drugs metabolized by CYP3A4, CYP2C9, CYP2C19 enzymes or P-glycoprotein, e.g.: amitriptyline (antidepressant), fexofenadine (antiallergic drug), benzodiazepines (anxiolytics), methadone (analgesic), statins (lipid-lowering drugs), digoxin (used in heart failure), finasteride (used in benign prostatic hyperplasia), as their plasma concentrations may be reduced.
Reduced plasma concentrations of oral contraceptives may lead to intermenstrual bleeding and reduced efficacy of hormonal contraception. Women using oral hormonal contraceptives should use additional non-hormonal contraceptive methods.
Prior to 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 contribute to enhanced serotonergic effects such as nausea, vomiting, anxiety, agitation, and confusion when used concomitantly with antidepressants such as serotonin reuptake inhibitors (e.g. sertraline, paroxetine, nefazodone) or triptans and buspirone.
Patients taking other prescription medicines should consult their doctor or pharmacist before starting treatment with St. John's wort extract.
Taking Hyperis with food and drink
The medicine should be taken with sufficient fluid, 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 effect on the ability to drive motor vehicles and operate mechanical equipment.

3. How to take Hyperis

This medicine should always be taken exactly as described in the patient information leaflet or
as advised by the doctor or pharmacist. If in doubt, consult your doctor
or pharmacist.
Recommended dose
Adults: one tablet (612 mg) once daily.
Method of administration
For oral use.
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.
Taking more Hyperis than recommended
Seizures and confusion occurred after ingestion of up to 4.5 g of dry extract per day
for 2 weeks, and additionally 15 g of dry extract immediately before hospitalization.
In case of overdose, the patient should be protected from exposure to sunlight and
other UV light sources for 1–2 weeks.
If you miss a dose of Hyperis
Do not take a double dose to make up for a missed dose (1 tablet).
Stopping Hyperis
If you have any further doubts regarding the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody
will experience them.
Gastrointestinal disorders, allergic skin reactions, fatigue and restlessness may occur.
Their frequency is unknown.
During intense sun exposure, intensified symptoms similar to sunburn may occur in
individuals with fair complexion.
If any other adverse reactions occur, not listed above, medical advice should be sought
from a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
inform a 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, phone: +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 the medicine Hyperis

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP
(the 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 will help protect the environment.

6. Contents of the package and other information

What Hyperis contains
The active substance in Hyperis 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 quantified dry extract) from Hypericum perforatum L., herba (St. John's wort herb)
(DER 3-6:1), corresponding to: 0.6 mg – 1.8 mg of total hypericins expressed as hypericin, 36.72 mg – 91.80 mg of total flavonoids expressed as rutin, and not more than 36.72 mg of hyperforin.
Extraction solvent: ethanol 60% (V/V).
The other ingredients are: anhydrous colloidal silicon dioxide, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silicon dioxide, magnesium stearate, and coating mixture Opadry II 85F32410 yellow (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, yellow iron oxide (E 172)).

What Hyperis looks like and contents of the pack
Oblong, biconvex, coated tablet of light yellow colour.
Hyperis is available in packages containing: 20 or 60 tablets in PVC/PVDC/Aluminium blisters 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]