Hiperis

Package Leaflet: Information for the Patient

Hyperis, 612 mg, Coated Tablets

Hyperici herbae extractum siccum quantificatum

Please Read This Leaflet Carefully Before Taking This Medicine, as It Contains

Important Information for the Patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet

• 1. What is Hyperis and What is it Used For
• 2. Important Information Before Taking Hyperis
• 3. How to Take Hyperis
• 4. Possible Side Effects
• 5. How to Store Hyperis
• 6. Package Contents and Other Information

1. What is Hyperis and What is it Used For

A herbal medicinal product for the short-term treatment of mild depressive symptoms.
If there is no improvement or the patient feels worse after 4 weeks, they should consult a doctor.

2. Important Information Before Taking Hyperis

When Not to Take Hyperis:

• 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 to take Hyperis, 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 Hyperis in children and adolescents under 18 years of age is not recommended.

Hyperis and Other Medicines

The patient should inform their doctor or pharmacist about all medicines they are 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 (immunosuppressants), amprenavir, indinavir, and other protease inhibitors (HIV medicines), irinotecan (anticancer medicine), and warfarin (anticoagulant) is contraindicated.
Special caution is advised when taking medicines that are metabolized by CYP3A4, CYP2C9, CYP2C19, or P-glycoprotein enzymes, such as amitriptyline (antidepressant), fexofenadine (antihistamine), benzodiazepines (anxiolytics), methadone (analgesic), simvastatin (lipid-lowering agent), digoxin (heart medicine), finasteride (prostate medicine), as their plasma levels may be reduced.
A decrease in the plasma level 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 interaction with medicines used for general and local anesthesia should be considered. If necessary, the medicine containing St. John's Wort extract should be discontinued. The increased enzyme activity returns to normal within 1 week after stopping the treatment with the St. John's Wort extract-containing medicine.
St. John's Wort extract may contribute to the enhancement of serotonergic effects such as nausea, vomiting, anxiety, agitation, and confusion when used in combination with antidepressant medicines, such as selective serotonin reuptake inhibitors (e.g., sertraline, paroxetine, nefazodone) or triptans and buspirone.
Patients taking other prescription medicines before starting treatment with St. John's Wort extract are advised to consult their doctor or pharmacist.

Taking Hyperis with Food and Drink

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

Pregnancy, Breast-feeding, and Fertility

Use during pregnancy and breast-feeding is not recommended.

Driving and Using Machines

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

3. How to Take Hyperis

This medicine should always be taken exactly as described in the patient leaflet or as directed by a 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 Hyperis in children and adolescents under 18 years of age is not recommended.

Taking More Than the Recommended Dose of Hyperis

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. In case of overdose, the patient should be protected from sunlight and other UV sources for 1-2 weeks.

Missing a Dose of Hyperis

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

Stopping Treatment with Hyperis

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, Hyperis can cause side effects, although not everybody gets them.
Gastrointestinal disorders, allergic skin reactions, fatigue, and restlessness may occur. The frequency of these side effects is not known.
During intense sun exposure, people with fair skin may experience enhanced symptoms, such as sunburn.
In case of other side effects 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 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 this medicine.

5. How to Store Hyperis

Store below 25°C.
The medicine should be kept 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. Package Contents and Other Information

What Hyperis Contains

The active substance of Hyperis 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)
The 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 Hyperis Looks Like and What the Package Contains

Oval, biconvex, coated tablet, light yellow in color.
Hyperis is available in packages containing: 20 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 the last update of the leaflet: