Contents of the leaflet

1. What HYPERICUM ARKOPHARMA is and what it is used for

2. What you need to know before you start taking HYPERICUM ARKOPHARMA

3. How to take HYPERICUM ARKOPHARMA

4. Possible side effects

5. Storage of HYPERICUM ARKOPHARMA 6. Package contents and additional information.

Do not take HYPERICUM ARKOPHARMA

• If you are under 18 years old.
• If you are pregnant or breastfeeding.
• If you are allergic to Hypericum perforatum L. or any of the components of the medicine.
• If you are undergoing surgery requiring treatment with other medications.
• If you are being treated with any of the medicines listed in this leaflet. Some components of hypericum (Hypericum perforatum L.) can cause pharmacokinetic interactions with numerous medicines, potentially reducing their effectiveness (see information on taking other medicines).

Warnings and precautions

Consult your pharmacist, doctor, or nurse before starting HYPERICUM ARKOPHARMA.

If you are taking HYPERICUM ARKOPHARMA, avoid intense UV exposure (prolonged sun exposure or tanning beds).

Women using oral contraceptives should not use this medicine simultaneously, as it may cause intermenstrual bleeding and reduce the effectiveness of contraceptives.

Avoid intense solar radiation or artificial ultraviolet radiation while taking this medicine. Its use is not recommended during phototherapy treatments (UVA light therapy) or if undergoing any photodiagnostic tests, particularly in light-skinned individuals, as it may cause sunburn-like reactions on exposed skin.

If you have been diagnosed with depression and are being treated with psychotropic drugs, selective serotonin reuptake inhibitors, or triptans, do not use this medicine.

Stop taking this medicine 10 days before surgery or any planned clinical intervention to avoid potential interactions with other medicines during general or local anesthesia.

Children and adolescents

Children and adolescents under 18 years should not use this medicine.

Use of HYPERICUM ARKOPHARMA with other medicines

Some components of hypericum (Hypericum perforatum L.) may reduce the therapeutic effects of other medicines when taken simultaneously. These include medicines recommended by your doctor and over-the-counter medications.

Patients taking the following medicines should not start hypericum preparations without consulting their doctor or pharmacist:

• For AIDS (antiretrovirals)
• For transplant rejection (cyclosporine)
• For epilepsy
• For the heart (digoxin)
• For asthma or chronic bronchitis (theophylline)
• For migraines
• For depression
• Oral anticoagulants
• Oral contraceptives

For more information, consult the following list:

Do not take this medicine if you are being treated with any of the medicines listed below:

• 5HT agonists (Triptans): such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan;
• Analgesics: such as tramadol;
• Anesthetics/medications for surgical preparation: such as fentanyl, propofol, midazolam, sevoflurane;
• Anxiolytics: such as buspirone;
• Hormonal antagonists: such as exemestane;
• Antianginal drugs: such as ivabradine;
• Antiarrhythmics: such as amiodarone; Antibiotics: such as erythromycin, clarithromycin, telithromycin;
• Anticoagulants: such as warfarin, acenocoumarol;
• Hormonal contraceptives: oral contraceptives, emergency hormonal contraceptives (morning-after pill), implants and hormonal injections, transdermal patches, intrauterine devices with hormones;
• Anticonvulsants (antiepileptics): such as carbamazepine, phenobarbital, phenytoin, primidone, sodium valproate;
• Tricyclic antidepressants: such as amitriptyline, clomipramine; MAOIs: such as moclobemide; SSRIs: such as citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline; Other antidepressants: such as duloxetine, venlafaxine;
• Antifungals: such as itraconazole, voriconazole;
• Antimalarials: such as lumefantrine;
• Antiparkinsonian drugs: such as rasagiline;
• Antipsychotics: such as aripiprazole;
• All antivirals: such as Protease Inhibitors (amprenavir, atazanavir, darunavir, fosamprenavir, indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir); Non-nucleoside reverse transcriptase inhibitors (efavirenz, nevirapine, delavirdine);
• Aprepitant (used to prevent vomiting after chemotherapy treatment);
• Barbiturates: such as butobarbital, phenobarbital;
• Calcium channel blockers: such as amlodipine, nifedipine, verapamil, felodipine;
• Cytotoxic drugs: such as irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposide, mitotane;
• Diuretics: such as eplerenone;
• CNS stimulants: such as methylphenidate;
• Cardiac glycosides: such as digoxin;
• Oral hypoglycemics (antidiabetics): such as gliclazide;
• Lipid-lowering agents: such as simvastatin, atorvastatin;
• Thyroid hormones: all drugs in this class, including thyroxine;
• Proton pump inhibitors: such as lansoprazole, omeprazole;
• Immunosuppressants: such as cyclosporine, tacrolimus;
• Lithium;
• Theophylline;
• Hormone replacement therapy: such as patches, gels, vaginal ring.

Concomitant treatment of HYPERICUM ARKOPHARMA with anticoagulants (such as phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory drugs) may increase their effect.

HYPERICUM ARKOPHARMA may affect the metabolism of other medicines, potentially altering their potency and/or duration of effect. Therefore, consult your doctor or pharmacist before taking HYPERICUM ARKOPHARMA with other treatments.

Inform your doctor or pharmacist if you are taking or have recently taken any other medication, including those obtained without a prescription.

Also inform your doctor or pharmacist about any suspected changes in the effects of medications you are taking alongside HYPERICUM ARKOPHARMA.

Taking HYPERICUM ARKOPHARMA with food and drinks

Food and beverages have no influence on the effect of the medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your pharmacist or doctor before using this medicine. Its use is not recommended in these circumstances.

Driving and using machines

No studies have been conducted on the ability to drive and use machines.