MILK THISTLE ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

CARDO MARIANO ARKOPHARMA

Hard Capsules

Silybum marianumL. Gaertner

Read the 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.

Contents of the Package Leaflet

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
   1. Storage of CARDO MARIANO ARKOPHARMA

1. Package Contents and Additional Information

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

Traditional herbal medicinal product for the symptomatic relief of digestive problems, such as heavy digestions, feeling of fullness, and to facilitate liver function, once a serious clinical condition has been ruled out by a doctor.

This product is a traditional herbal medicinal product for use in the specified indication, based exclusively on long-standing 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 any of the other components of this medication (listed in section 6) or to the Asteraceae (Compositae) plant family.

If symptoms persist or worsen during medication use, you should consult a doctor or qualified healthcare professional. If jaundice or changes in urine or stool color appear, you should consult a doctor immediately.

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 using this medication.

No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding; therefore, 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 capsules, 2 times a day, at the two main meals (lunch and dinner), with a glass of water.

This medication is for oral use.

The recommended treatment duration 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 a missed 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.

Moderate gastrointestinal problems, such as dry mouth, nausea, stomach discomfort, gastric irritation, and diarrhea, have been reported; headache; allergic reactions (dermatitis, urticaria, rash, pruritus, anaphylaxis, asthma) may occur. The frequency of these side effects is not known.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects 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 the sight and reach of children.

Do not store above 25°C.

Do not use this medication after the expiration date stated 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 any unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of CARDO MARIANO ARKOPHARMA:

Each capsule contains as an active ingredient: 390 mg of cryomilled fruit of Silybum marianumL. Gaertner (Milk Thistle).

The other components are the excipients: hypromellose (capsule coating).

Appearance of the Product and Package Contents:

There are 2 presentations in brown polyvinyl bottles, closed with a low-density polyethylene cap, containing 45 and 84 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

Date of the Last Revision of this Package Leaflet: November 2019

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/).