HIPÉRICO ARKOPHARMA hard capsules

2. What you need to know before taking ARKOPHARMA HYPERICUM

Do not take ARKOPHARMA HYPERICUM

• If you are under 18 years old.
• If you are pregnant or breastfeeding.
• If you are allergic to Hypericum perforatumL. or any of the components of the medication.
• If you are going to undergo surgery that requires treatment with other medications.
• If you are being treated with any of the medications listed in this package leaflet. Some components of St. John's Wort (Hypericum perforatumL.) may produce pharmacokinetic interactions with a large number of medications, resulting in a possible decrease in their effectiveness (see information on taking other medications).

Warnings and precautions

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

If you are taking ARKOPHARMA HYPERICUM, avoid intense exposure to UV rays (prolonged sun exposure or UVA radiation).

Women using oral contraceptives should not use this medication simultaneously, as it may cause bleeding between menstrual cycles and a lack of effectiveness of contraceptive medications.

Avoid exposure to intense solar radiation or artificial ultraviolet radiation during treatment with this medication. The use of this medication is not recommended during phototherapy treatments (UVA radiation) or if you are going to undergo a photodiagnostic study, particularly in people with fair skin, as it may cause reactions similar to sunburn on exposed skin.

If you have been diagnosed with depression and are being treated with psychotropic medications or selective serotonin reuptake inhibitors or triptan medications, you should not use this medication.

You should stop taking this medication 10 days before a scheduled surgical operation or other clinical intervention to avoid potential interactions with other medications during the use of general or local anesthesia.

Children and adolescents

This medication should not be used in children and adolescents under 18 years old.

Using ARKOPHARMA HYPERICUM with other medications

Some components of St. John's Wort (Hypericum perforatumL.) may reduce the therapeutic effects of other medications when taken simultaneously with St. John's Wort. The treatments that may be affected by this medication include medications prescribed by your doctor and those that you can purchase without a prescription.

Patients who are taking the following medications should not start using St. John's Wort preparations without consulting their doctor or pharmacist:

• for HIV (antiretrovirals)
• for transplant rejection (cyclosporine)
• for epilepsy
• for the heart (digoxin)
• for the treatment of asthma or chronic bronchitis (theophylline)
• for migraines
• for depression
• oral anticoagulants
• oral contraceptives

For more information, consult the following list:

Do not take this medication if you are being treated with any medication listed in this list:

•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; •Anti-anginal medications:such as ivabradine; •Anti-arrhythmics: such as amiodarone; Antibacterials: such as erythromycin, clarithromycin, telithromycin; •Anticoagulants:such as warfarin, acenocoumarol; •Hormonal contraceptives:oral contraceptives, emergency hormonal contraceptives (morning-after pill), hormonal implants and 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(selective serotonin reuptake inhibitors) such as citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline; Other antidepressantssuch as duloxetine, venlafaxine; •Antifungals:such as itraconazole, voriconazole; •Antimalarials:such as lumefantrine; •Antiparkinsonian medications: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); •Barbituratessuch as butobarbital, phenobarbital; •Calcium channel blockers:such as amlodipine, nifedipine, verapamil, felodipine; •Cytotoxics: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(oral antidiabetics): such as gliclazide; •Lipid-lowering medications:such as simvastatin, atorvastatin; •Thyroid hormones:all medications 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 rings)

In the event of concomitant treatment with ARKOPHARMA HYPERICUM and anticoagulant medications (such as fenprocoumon, warfarin, clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory medications), it cannot be ruled out that the effect of these preparations may be increased.

It cannot be ruled out that ARKOPHARMA HYPERICUM may affect the metabolism of other medications, which may affect the potency and/or duration of the effect of the medications in question. For this reason, consult your doctor or pharmacist before taking ARKOPHARMA HYPERICUM with other treatments.

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

Also, inform your doctor or pharmacist of any suspected change in the effects of the medications you are taking while taking ARKOPHARMA HYPERICUM.

Taking ARKOPHARMA HYPERICUM with food and beverages

Food and beverages do not affect the effect of the medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your pharmacist or doctor before using this medication. Its administration is not recommended in these circumstances.

Driving and using machines

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

3. How to take ARKOPHARMA HYPERICUM

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your pharmacist, doctor, or nurse. In case of doubt, ask your pharmacist, doctor, or nurse.

The recommended dose is:

Adults: take 2 capsules, 2 or 3 times a day with a glass of water.

It is recommended that the doses be taken at the same time every day.

This medication is for oral use.

The duration of treatment is 6 weeks.

The effect of the medication usually appears after 4 weeks. If symptoms persist, you should consult a healthcare professional.

Once the package is opened, remove the desiccant bag, which is not suitable for human consumption and should not be ingested.

Use in children and adolescents

Do not use in children and adolescents under 18 years old.

If you take more ARKOPHARMA HYPERICUM than you should

If you have taken an excessive dose of ARKOPHARMA HYPERICUM, convulsions or confusion may occur.

In the event of an overdose of St. John's Wort, you should be protected from solar radiation or any other source of UV rays for 1-2 weeks.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to take ARKOPHARMA HYPERICUM

In case of forgetting a dose, take the medication as soon as possible, continuing the treatment as prescribed. However, if the next dose is near, it is best not to take the forgotten dose and wait for the next one. In no case should you take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In rare cases, with a frequency that affects less than one case per 1000 patients, gastrointestinal problems such as nausea, abdominal pain, diarrhea, loss of appetite; or skin reactions such as itching, irritation, redness (urticaria) and very rarely could occur reactions similar to sunburn on exposed skin.

Headache, neuropathy, anxiety, dizziness, fatigue, mania, or allergies have also been described, for which the frequency of occurrence is unknown.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of ARKOPHARMA HYPERICUM

Keep this medication out of the sight and reach of children.

Do not store above 25°C.

Once opened, discard after 21 days.

Do not use ARKOPHARMA HYPERICUM after the expiration date shown on the package, after the abbreviation "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of ARKOPHARMA HYPERICUM

Each capsule contains as an active ingredient:

175 mg of dry hydroalcoholic extract of Hypericum perforatumL. herb (flowering tops of St. John's Wort) (3.5-6:1) which corresponds to: 0.27 mg to 0.46 mg of total hypericins, ≥ 10.5 mg of flavonoids, and 2.71 mg to 4.63 mg of hyperforin.

Extraction solvent: ethanol 60% m/m

The other components are the excipients: microcrystalline cellulose, magnesium stearate, hydrophobic colloidal silica, and maltodextrin.

Capsule composition: hypromellose, titanium dioxide, and yellow iron oxide.

Appearance of the product and package contents

There is one presentation in bottles containing 42 capsules, with a desiccant bag inside.

Once the package is opened, remove the desiccant bag, which is not suitable for human consumption and should not be ingested.

Marketing authorization holder and manufacturer:

Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturer

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

Date of the last revision of this package leaflet: September 2016

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/