BARDANA ARKOPHARMA hard capsules

Introduction

Package Leaflet: Information for the User.

BARDANAARKOPHARMA

Hard Capsules

Arctium lappaL.

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your pharmacist or doctor.

Siga exactamente las instrucciones de administración del medicamento contenidas en este prospecto o las indicadas por su farmacéutico o médico.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your pharmacist or doctor, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 14 days.

Contents of the Package Leaflet

1. What is BARDANA ARKOPHARMA and what is it used for
2. What you need to know before taking BARDANA ARKOPHARMA
3. How to take BARDANA ARKOPHARMA
4. Possible side effects
5. Storage of BARDANA ARKOPHARMA
6. Contents of the packaging and additional information

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

Traditional herbal medicinal product used:

• In seborrheic skin conditions such as skin eruptions, eczema, and/or acne-prone skin.
• To cleanse the body due to its urinary elimination functions.

Based exclusively on its traditional use.

2. What you need to know before taking BARDANA ARKOPHARMA

Do not take BARDANA ARKOPHARMA

If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).

Taking BARDANA ARKOPHARMA with other medications

Tell your pharmacist or doctor if you are taking, have recently taken, or may need to take any other medication.

Taking BARDANA ARKOPHARMA with food and drinks

The influence of food and drinks on the effect of the medication has not been described.

Use in Children

Do not use in children under 12 years old without consulting a doctor.

Pregnancy and Breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your pharmacist or doctor before using this medication. There is no clinical evidence demonstrating the safe use of the medication during pregnancy and breastfeeding; therefore, its use is not recommended in these circumstances.

Driving and Using Machines

No effects on the ability to drive or use machines have been reported.

3. How to Take BARDANA ARKOPHARMA

Follow these instructions unless your doctor has given you different instructions.

Consult your pharmacist or doctor if you have any doubts.

The recommended dose is:

Adults and adolescents over 12 years old: take 2 capsules with a glass of water 30 minutes before breakfast and 2 more capsules 30 minutes before dinner. The dose can be increased to 3 capsules per intake.

This medication is for oral use.

Use for a period of 14 to 28 days as needed.

If you take more BARDANA ARKOPHARMA than you should

No cases of overdose with BARDANA ARKOPHARMA have been reported.

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 BARDANA ARKOPHARMA

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 missed dose and wait for the next one. Never take a double dose to make up for the missed dose.

4. Possible Side Effects

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

At the recommended doses, BARDANA ARKOPHARMA does not present side effects.

Reporting Side Effects

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

5. Storage of BARDANA ARKOPHARMA

Keep this medication out of sight and reach of children.

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging, after the abbreviation "CAD". The expiration date is the last day of the month indicated.

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

6. Contents of the Packaging and Additional Information

Composition of BARDANA ARKOPHARMA

Each capsule contains as an active ingredient: 350 mg of cryomilled roots of Arctium lappaL.(Burdock).

The other components are the excipients: hypromellose (capsule coating), cornstarch, and magnesium stearate.

Appearance of the Product and Packaging Contents

There are 2 presentations in bottles containing 48 and 84 capsules.

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:November 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/