MILK THISTLE ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

CARDO MARIANO ARKOPHARMA Hard Capsules

Silybum marianumL. Gaertner

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, doctor, or nurse.

• 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, doctor, or nurse, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Package Leaflet Contents

1. What CARDO MARIANO ARKOPHARMA is and what it is used for
2. What you need to know before taking CARDO MARIANO ARKOPHARMA
3. How to take CARDO MARIANO ARKOPHARMA
4. Possible side effects
5. Storage of CARDO MARIANO ARKOPHARMA
6. Package Contents and Additional Information

1. What CARDO MARIANO ARKOPHARMA is and what it is used for

Traditional herbal medicinal product used in cases of heavy digestion or dyspepsia due to liver disorders, based exclusively on its traditional use.

2. What you need to know before taking CARDO MARIANO ARKOPHARMA

Do not take CARDO MARIANO ARKOPHARMA

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

Children and Adolescents

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

Taking CARDO MARIANO ARKOPHARMA with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Taking CARDO MARIANO ARKOPHARMA with food and beverages

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medication.

No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so its administration is not recommended.

Driving and Using Machines

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

3. How to take CARDO MARIANO ARKOPHARMA

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

Consult your pharmacist or doctor if you have doubts.

The recommended dose is:

Adults: Take 2 or 3 capsules with meals and dinner with a glass of water.

This medication is for oral use.

The recommended treatment is 14 days; however, if you observe that your symptoms do not improve or worsen within 7 days, you should consult your pharmacist or doctor.

Use in Children and Adolescents:

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

If you take more CARDO MARIANO ARKOPHARMA than you should

No cases of overdose with CARDO MARIANO 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 CARDO MARIANO 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 better 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 experiences them.

At the recommended doses, CARDO MARIANO 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 CARDO MARIANO ARKOPHARMA

Keep this medication out of sight and reach of children.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date shown on the package, 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 packages and medications you no longer need at the Sigre Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of CARDO MARIANO ARKOPHARMA:

Each capsule contains as the active ingredient: 300 mg of cryomilled fruit of Silybum marianumL. Gaertner (Milk Thistle).

The other components are the excipients: gelatin (capsule shell).

Appearance of the Product and Package Contents:

There are 2 presentations in bottles containing 50 and 100 capsules.

Marketing Authorization Holder and Manufacturer:

Holder

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea 9

28045 MADRID

Manufacturers

Arkopharma

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - FRANCE

This package leaflet was approved in: 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.es/).