PATIENT INFORMATION LEAFLET

ARKOPHARMA Hypericum Capsules

Hypericum perforatumL.

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given by your pharmacist, doctor or nurse.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

- You should consult a doctor if your condition worsens or does not improve after 28 days of treatment.

1. What isARKOPHARMA Hypericumand what it is used for

2. What you need to know before takingARKOPHARMA Hypericum

3. How to takeARKOPHARMA Hypericum

4. Possible side effects

5. Storage ofARKOPHARMA Hypericum6. Contents of the pack and additional information.

A plant-based medication for the symptomatic treatment of states of decline characterized by disappointment, loss of interest, fatigue, and sleep disturbances.

Consult a doctor if symptoms worsen or do not improve after 28 days.

Do not take HIPÉRICO ARKOPHARMA

• If you are under 18 years old.
• If you are pregnant or breastfeeding.
• If you are allergic toHypericum perforatumL. or any of the components of the medication.
• If you are about to undergo any surgical intervention that requires treatment with other medications.
• If you are taking any of the medications listed in this prospectus. 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 HIPÉRICO ARKOPHARMA.

If you are taking HIPÉRICO ARKOPHARMA, avoid intense exposure to UV rays (long exposure to the sun or UVA baths).

Women using oral contraceptives should not use this medication simultaneously because it may cause bleeding between menstrual cycles and reduced effectiveness of contraceptive medications.

Avoid exposure to intense solar radiation or artificial ultraviolet radiation during the use of this medication. It is not recommended to use this medication during phototherapy (treatments with UVA rays) or if you are about to undergo any diagnostic 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 taking psychotropic medications or selective serotonin reuptake inhibitors or medications in the triptan group, do not use this medication.

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

Children and adolescents

Children and adolescents under 18 years old should not use this medication.

Use of HIPÉRICO ARKOPHARMA 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. This includes medications recommended by your doctor and those that you can purchase without a prescription.

Do not start using St. John's Wort preparations without consulting your doctor or pharmacist if you are taking the following medications:

• for HIV/AIDS (antiretrovirals)
• for transplant rejection (ciclosporina)
• for epilepsy
• for the heart (digoxina)
• for asthma or chronic bronchitis (teofilina)
• for migraines
• for depression
• oral anticoagulants
• oral contraceptives

For more information, see the following list:

Do not take this medication if you are taking any of the medications listed in this list:

•Agonists 5HT (Triptanes):such as almotriptan, eleptriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan;•Analgesics:such as tramadol;•Anesthetics/medications for surgical intervention preparation: such as fentanilo, propofol, midazolam, sevoflurano;•Anxiolytics: such as buspirona;•Antagonists hormones:such as exemestano;•Antiarrhythmics: such as amiodarona;Antibacterians: such as eritromicina, claritromicina, telitromicina;•Anticoagulants:such as warfarina, acenocumarol;•Anticonceptives Hormonales:oral contraceptives, emergency contraceptive pills, hormone implants, hormone injections, transdermal hormone patches, intrauterine devices with hormones;•Anticonvulsants (Antiepilépticos):such as carbamazepina, fenobarbital, fenitoína, primidona, valproato sódico;•Antidepressants Tricíclicos: such as amitriptilina, clomipramina;IMAO:such as moclobemida;ISRS(inhibidores selectivos de la recaptación de serotonina) such as citalopram, fluoxetina, fluvoxamina, paroxetina, sertralina;Other antidepressantssuch as duloxetina, venlafaxina;•Antifúngicos:such as itraconazol, voriconazol;•Antimaláricos:such as lumefantrina;•Antiparkinsonianos:such as rasagilina;•Antipsicóticos:such as aripiprazol;•All Antivirales:such asInhibidores de Proteasa(amprenavir, atazanavir, darunavir, fosamprenavir indinavir, lopinavir, nelfinavir, ritonavir, saquinavir, tipranavir);Inhibidores de transcriptasa inversa no nucleósidos(efavirenz, nevirapina, delavirdina);•Aprepitant(used to prevent vomiting after chemotherapy);•Barbituratossuch as butobarbital, fenobarbital;•Bloqueadores de los canales del Calcio:such as amlodipina, nifedipina, verapamilo, felodipina;•Citotóxicos:such as irinotecan, dasatinib, erlotinib, imatinib, sorafenib, sunitinib, etoposido, mitotano;•Diuréticos:such as eplerenona;•Estimulantes de SNC:such as metilfenidato;•Glucósidos cardiacos:such as digoxina;•Hipoglucemiantes orales(antidiabéticos orales): such as gliclazida;•Hipolipemiantes:such as simvastatina, atorvastatina;•Hormonas tiroideas:all medications of this class including Tiroxina;•Inhibidores de la bomba de protones:such as lansoprazol, omeprazol;•Inmunosupresores:such as ciclosporina, tacrolimus;•Litio; •Teofilina; •Terapia hormonal de remplazo:such as patches, gels, vaginal ring)

In the case of concomitant treatment of HIPÉRICO ARKOPHARMA with anticoagulant medications (such as fenprocumona, warfarina, clopidogrel, ácido acetilsalicílico and other non-steroidal anti-inflammatory drugs) it cannot be excluded that the effect of these preparations may be increased..

It cannot be excluded that HIPÉRICO ARKOPHARMA may act on the metabolism of other medications, which may affect the potency and/or duration of the effect of the medications listed. For this reason, consult your doctor or pharmacist before taking HIPÉRICO ARKOPHARMA 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 about any suspicion of a change in the effects of the medications you are taking simultaneously with HIPÉRICO ARKOPHARMA.

Intake of HIPÉRICO ARKOPHARMA with food and beverages

Foods and beverages have no influence on the effect of the medication.

Pregnancy, lactation, and fertility

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

Driving and use of machines

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your pharmacist, doctor, or nurse. If in 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 advisable to take the doses at the same hours every day.

This medication is taken orally.

The treatment duration is 6 weeks.

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

Once the packaging is opened, the absorbent bag will be removed, 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 HIPÉRICO ARKOPHARMA than you should

If an excessive dose of HIPÉRICO ARKOPHARMA has been taken, seizures or a state of confusion may appear.

In case of excessive intake of hypericum, protection from sunlight or any other source of UV radiation is recommended for 1-2 weeks.

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

If you forgot to take HIPÉRICO ARKOPHARMA

In case of forgotten dose, take the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one. Never take a double dose to compensate for the missed dose.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

In rare cases, with a frequency affecting less than one case per 1000 patients, digestive problems such as nausea, abdominal pain, diarrhea, loss of appetite; or skin reactions like itching, irritation, redness (urticaria) and very rarely, similar reactions to sunburns, on skin exposed to intense solar or artificial radiation, have been described.

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

Reporting Adverse Reactions:

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

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

Do not store at a temperature above 25°C.

Once opened, discard after 21 days.

Do not use HYPERICUM ARKOPHARMA after the expiration date that appears on the packaging, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of HIPÉRICO ARKOPHARMA

Each capsule contains as active ingredient:

175 mg of hydroalcoholic dry extract ofHypericum perforatumL. herb (flowering tops of St. John's Wort) (3.5-6:1) corresponding 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, colloidal hydrated silica, and maltodextrin.

Composition of thecapsule: hypromellose, titanium dioxide, and yellow iron oxide.

Appearance of the product and content of the packaging

There is 1 presentation in bottles containing 42 capsules, with an absorbent bag inside.

Once the packaging is opened, the absorbent bag will be removed, which is not suitable for human consumption and should not be ingested.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Arkopharma LABORATORIES, S.A.U,

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing

ARKOPHARMA

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS Cedex - FRANCE

Date of the last review of this leaflet: September 2016

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/