Cardo Mariano Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MILK THISTLE ARKOPHARMA

hard capsules

Silybum marianum L. Gaertner

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 the medicine contained in this leaflet or as indicated 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 adverse effects, consult your pharmacist, doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the 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

5. Contents of the pack and other information

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

A traditional herbal medicinal product for the symptomatic relief of digestive problems, such as heavy digestion, sensation of fullness, and to aid liver function, once a doctor has ruled out a serious clinical condition.

This product is a traditional herbal medicinal product for use in the specified indication, based exclusively on long-standing traditional use.

2. What you need to know before starting to take CARDO MARIANO ARKOPHARMA

Do not take CARDO MARIANO ARKOPHARMA

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to the plant family Asteraceae (Compositae).

If symptoms persist or worsen during use of the medicine, you should consult a doctor or qualified healthcare professional. If jaundice appears, or changes in the color of urine or stools occur, you should consult your doctor immediately.

Children and adolescents

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

Taking CARDO MARIANO ARKOPHARMA with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking CARDO MARIANO ARKOPHARMA with food and drink

Food and drink do not influence the effect of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

No studies have been conducted to establish the safety of using this medicine 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 advice.

Consult your pharmacist or doctor if you have any doubts.

The recommended dose is:

Adults: take 2 capsules, twice daily with the two main meals (lunch and dinner), accompanied by a glass of water.

This medicine is for oral use.

The recommended treatment duration is 14 days. However, if you notice that your symptoms have not improved 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

Cases of overdose with CARDO MARIANO ARKOPHARMA have not been reported.

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 CARDO MARIANO ARKOPHARMA

If you miss a dose, take the medicine as soon as possible and continue the treatment as prescribed. However, if the next dose is due soon, it is better not to take the missed dose and simply wait for the next scheduled dose. Never take a double dose to make up for a missed dose.

4. Possible adverse effects

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

Moderate gastrointestinal problems have been reported, such as dry mouth, nausea, stomach discomfort, gastric irritation, and diarrhea; headache; allergic reactions may occur (dermatitis, urticaria, rash, pruritus, anaphylaxis, asthma). The frequency with which these adverse effects may occur is unknown.

Reporting of adverse effects

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 CARDO MARIANO ARKOPHARMA

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine 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 drains or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of CARDO MARIANO ARKOPHARMA:

Each capsule contains as the active substance: 390 mg of cryomilled fruits of Silybum marianum L. Gaertner (Milk thistle).

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

Appearance of the product and contents of the container:

Two presentations are available 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 latest revision of this package leaflet: November 2019

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