Hypericum Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

HYPERICUM ARKOPHARMA hard capsules

Hypericum perforatum L.

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as advised by your pharmacist, doctor, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.
• You must consult a doctor if you worsen or do not improve after 28 days of treatment.

Contents of the leaflet

1. What HYPERICUM ARKOPHARMA is and what it is used for
2. What you need to know before taking HYPERICUM ARKOPHARMA
3. How to take HYPERICUM ARKOPHARMA
4. Possible adverse effects
5. How to store HYPERICUM ARKOPHARMA
6. Contents of the pack and other information

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

A herbal medicinal product used for the symptomatic treatment of states of exhaustion accompanied by low mood, loss of interest, fatigue, and sleep disturbances.

You should consult a doctor if symptoms worsen or do not improve after 28 days.

2. What you need to know before starting to take HIPERICO ARKOPHARMA

Do not take HIPERICO ARKOPHARMA

• If you are under 18 years of age.
• 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 scheduled for a surgical procedure requiring treatment with other medications.
• If you are currently taking any of the medicines listed in this leaflet. Some components of St. John's wort (Hypericum perforatum L.) may cause pharmacokinetic interactions with many drugs, potentially reducing their effectiveness (see information about taking other medicines).

Warnings and precautions

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

If you are taking HIPERICO ARKOPHARMA, avoid intense exposure to UV rays (prolonged sun exposure or UVA tanning sessions).

Women using oral contraceptives should not take this medicine concurrently, as it may cause breakthrough bleeding and reduce the effectiveness of contraceptive drugs.

Avoid intense exposure to sunlight or artificial ultraviolet radiation while taking this medicine. Its use is not recommended during phototherapy treatments (UVA light treatments) or if you are undergoing photodiagnostic procedures, especially if you have fair skin, as skin reactions similar to sunburn may occur on exposed areas.

If you have been diagnosed with depression and are being treated with psychotropic medicines or with selective serotonin reuptake inhibitors (SSRIs) or triptans, you should not use this medicine.

This medicine should be discontinued at least 10 days before any planned surgery or other clinical intervention to avoid potential interactions with other medicines used during general or local anesthesia.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Use of HIPERICO ARKOPHARMA with other medicines

Some components of St. John's wort (Hypericum perforatum L.) may reduce the therapeutic effects of other medicines when taken simultaneously. Treatments that may be affected include those prescribed by your doctor as well as those available without a prescription.

Patients taking any of the following medicines should not start taking St. John's wort preparations without first consulting their doctor or pharmacist:

• for AIDS (antiretrovirals)
• for transplant rejection (cyclosporine)
• for epilepsy
• for heart conditions (digoxin)
• for treatment of asthma or chronic bronchitis (theophylline)
• for migraine
• for depression
• oral anticoagulants
• oral contraceptives

For further information, refer to the list below:

Do not take this medicine if you are currently taking any of the following medicines:

•5HT agonists (Triptans): such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan; •Analgesics: such as tramadol; •Anesthetics / medicines used in preparation for surgery: such as fentanyl, propofol, midazolam, sevoflurane; •Anxiolytics: such as buspirone; •Hormonal antagonists: such as exemestane; •Anti-anginal agents: such as ivabradine; •Antiarrhythmics: 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, hormonal intrauterine devices; •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 antidepressants such as duloxetine, venlafaxine; •Antifungals: such as itraconazole, voriconazole; •Antimalarials: such as lumefantrine; •Antiparkinson agents: 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); •Barbiturates such 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 agents: such as simvastatin, atorvastatin; •Thyroid hormones: all medicines 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.

When HIPERICO ARKOPHARMA is taken concomitantly with anticoagulant medicines (such as phenprocoumon, warfarin, clopidogrel, acetylsalicylic acid, and other non-steroidal anti-inflammatory drugs), it cannot be ruled out that the effect of these preparations may be increased.

It cannot be excluded that HIPERICO ARKOPHARMA may affect the metabolism of other medicines, thereby influencing the potency and/or duration of action of the medicines concerned. For this reason, consult your doctor or pharmacist before taking HIPERICO ARKOPHARMA with other treatments.

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

Also inform your doctor or pharmacist about any suspected changes in the effects of the medicines you are taking concurrently with HIPERICO ARKOPHARMA.

Taking HIPERICO ARKOPHARMA with food and drink

Food and drink do not affect the action of the medicine.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

No studies have been conducted on the ability to drive or use machinery.

3. How to take HIPERICO ARKOPHARMA

Follow exactly the instructions for use provided in this leaflet or those indicated by your pharmacist, doctor, or nurse. In case of doubt, ask your pharmacist, doctor, or nurse.

Recommended dose:

Adults: Take 2 capsules, 2 or 3 times daily with a glass of water.

It is advisable to take the doses at the same times each day.

This medicine is for oral use.

The treatment duration is 6 weeks.

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

Once the container has been opened, remove the desiccant sachet, which is not suitable for human consumption and must not be ingested.

Use in children and adolescents

Do not use in children and adolescents under 18 years of age.

If you take more HIPERICO ARKOPHARMA than you should

If an excessive dose of HIPERICO ARKOPHARMA has been taken, seizures or confusion may occur.

In case of excessive intake of St. John's wort, protect yourself from solar radiation or any other source of UV rays for 1–2 weeks.

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

If you forget to take HIPERICO ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue treatment as prescribed. However, if the next dose is due soon, it is better to skip the missed dose and wait for the next scheduled dose. Never take a double dose to make up for a missed one.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Rarely, affecting less than 1 in 1,000 patients, gastrointestinal problems such as nausea, abdominal pain, diarrhoea, and loss of appetite have been reported; or skin reactions such as itching, irritation, redness (urticaria), and very rarely, reactions resembling sunburn may occur in skin exposed to intense natural or artificial sunlight.

Headache, neuropathy, anxiety, dizziness, fatigue, mania, or allergic reactions have also been reported, although the frequency of these is unknown.

Reporting of adverse reactions:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ST. JOHN'S WORT ARKOPHARMA

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

Do not store above 25°C.

After opening, discard after 21 days.

Do not use ST. JOHN'S WORT ARKOPHARMA after the expiry date stated on the packaging, following the abbreviation “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of HYPERICUM ARKOPHARMA

Each capsule contains as the active substance:

175 mg of dry hydroalcoholic extract of Hypericum perforatum L. herba (flowering tops of St. John's wort) (3.5-6:1), corresponding to: 0.19 mg - 0.56 mg of total hypericins, ≥ 11.10 mg of flavonoids and ≤ 11.10 mg of hyperforin.

Extraction solvent: ethanol 60% m/m

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

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

Nature of the product and pack contents

One presentation available in bottles containing 42 capsules, with a desiccant sachet inside.

After opening the container, remove the desiccant sachet, which is not suitable for human consumption and must not be ingested.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Arkopharma LABORATORIOS, S.A.U.,

C/ Amaltea, 9

28045 MADRID

Manufacturer

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

Date of the most recent review of this leaflet: September 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/