Leaflet: information for the user

CARDU MARIANUM ARKOPHARMA

Hard capsules

Silybum marianumL. Gaertner

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your pharmacist, doctor or nurse, even if they are not listed in this leaflet. See section 4
• You should consult a doctor if you get worse or do not improve after 7 days.

1.What isCARDU MARIANUM ARKOPHARMAand what it is used for

2.What you need to knowbefore starting to takeCARDU MARIANUM ARKOPHARMA

3.How to takeCARDU MARIANUM ARKOPHARMA

4.Possible side effects

1. Storage ofCARDU MARIANUM ARKOPHARMA

6.Contents of the pack and additional informationl

Traditional plant-based medication for symptomatic relief of digestive problems, such as heavy digestions, feeling of fullness, and to facilitate liver function, once a serious clinical situation has been ruled out by a doctor.

This product is a traditional plant-based medication for use in the specified indication, based exclusively on its long-standing use.

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)or to the plant familyAsteraceae (Compositae).

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

Children and adolescents

Do not use in children or adolescents under 18 years old.

Use of CARDO MARIANO ARKOPHARMA with other medications

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

Use of CARDO MARIANO ARKOPHARMA with food and drinks

Foods and drinks have no influence on the effect of the medication.

Pregnancy and breastfeeding

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

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

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

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: take 2 capsules, 2 times a day with the two main meals (lunch and dinner) with a glass of water.

This medication is taken orally.

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

Use in children and adolescents:

Do not use in children or adolescents under 18 years old.

If you take more CARDO MARIANO ARKOPHARMA than you should

No cases of overdose withCARDO MARIANO ARKOPHARMA have been described.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to take CARDO MARIANO ARKOPHARMA

In case of forgotten 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 take a double dose to compensate for the forgotten dose.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.esBy reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition of CARDO MARIANO ARKOPHARMA:

Each capsule contains as active ingredient: 390 mg of cryomolded fruits ofSilybum marianumL. Gaertner(Milk Thistle).

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

Appearance of the product and content of the container:

There are 2 presentations in brown polyvinyl chloride bottles, closed with a low-density polyethylene stopperthat contain 45 and 84 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder

Arkopharma LABORATORIES, S.A.U

C/ Amaltea 9

28045 MADRID

Manufacturing responsible parties

Arkopharma

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS Cedex - FRANCE

Last review date of this leaflet: November 2019

Detailed and updated information on this medication is available on the website ofthe Spanish Agencyof Medicines and Medical Devices (AEMPS) (http://www.aemps.es/).