HEPAMED COMPRESSES

Introduction

Package Leaflet: Information for the User

HepaMed, Tablets

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

This medication can be obtained without a prescription for the treatment of minor conditions, without the intervention of a doctor. However, to obtain the best results, it should be used properly.

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

-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 doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

-You should consult a doctor if your condition worsens or does not improve after 15 days of treatment.

Contents of the Package Leaflet

1. What HepaMed tablets are and what they are used for
2. What you need to know before taking HepaMed tablets
3. How to take HepaMed tablets
4. Possible side effects
5. Storage of HepaMed tablets
6. Package contents and additional information

1. What HepaMed tablets are and what they are used for

HepaMed tablets are a traditional herbal medicinal product used to treat symptoms of dyspepsia, such as indigestion, heartburn, abdominal distension, flatulence, and nausea, based exclusively on traditional use.

2. What you need to know before taking HepaMed tablets

Do not take HepaMed tablets:

• If you are allergic to artichoke, dandelion, boldo, or milk thistle, or to any

of the other components of this medication (listed in section 6).

• If you are allergic to plants of the Compositae (Asteraceae) family. Artichoke, dandelion, and milk thistle belong to this family
• If you are under 18 years of age.
• If you are pregnant or breastfeeding.
• If you have a bile duct obstruction, gallstones, cholangitis (inflammation of the bile ducts), or other biliary disorders.
• Intestinal obstruction
• Liver disorders, including hepatitis
• Active peptic ulcer.

Warnings and precautions

• Patient with renal insufficiency, heart failure, or diabetes should avoid using this medication due to possible complications from hyperkalemia.
• Patient with liver problems should consult their doctor before taking this medication.
• If symptoms such as fever, dysuria, spasms, or blood in the urine appear during medication use, treatment should be discontinued and a doctor consulted.
• If symptoms worsen or do not improve after 2 weeks of

treatment, a doctor should be consulted.

Children and adolescents

This product is not indicated for patients under 18 years of age.

Other medications and HepaMed

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

No interactions with other medications have been reported.

Pregnancy and breastfeeding

As a precautionary measure and in the absence of sufficient data, use during pregnancy and breastfeeding is not recommended.

If you are pregnant or think you might be, consult your doctor before taking this medication. Medication use during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machinery:

The influence of the medication on the ability to drive vehicles and use machinery has not been studied.

3. How to take HepaMed tablets

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

The recommended dose is:

Adults (over 18 years), take one tablet twice a day.

HepaMed tablets are an oral medication.

Use in children

This product is not indicated for patients under 18 years of age.

If symptoms worsen or do not improve after 2 weeks of treatment, a doctor should be consulted.

If you take more HepaMed tablets than you should:

It is unlikely that symptoms or toxicity will occur.

In case of overdose or accidental ingestion, go to a medical center or consult the Toxicology Information Service, phone 91 562 0420, indicating the medication and the amount ingested.

If you forget to take HepaMed tablets

Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Make sure you have read section 2 of this package leaflet.

Do not take HepaMed tablets if you are allergic to artichoke, dandelion, boldo, or milk thistle, or to any of the other components of this medication.

Like all medications, HepaMed tablets can have side effects, although not everyone will experience them.

Adverse reactions are generally mild.

On some occasions, gastrointestinal disorders such as nausea, stomach discomfort, diarrhea, cramps, abdominal pain, hyperacidity, and heartburn, as well as allergic skin reactions (hives, rash, pruritus, anaphylactic reactions), may occur. The frequency of occurrence is unknown.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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 HepaMed tablets

Keep this medication out of sight and reach of children

Do not use HepaMed tablets after the expiration date indicated on the packaging.

Use it within 5 months after opening.

This medication should be stored at a temperature below 30°C

Do not use the medication if you notice changes in its appearance. HepaMed tablets are round, biconvex, beige-colored tablets.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. 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. Package contents and additional information

HepaMed composition

One HepaMed tablet contains as the active ingredient:

4.6 mg of extract (as dry extract) of the fresh leaf of Cynara scolymusL.

(1:30-31) extraction solvent: ethanol 65% v/v

1.2 mg of extract (as dry extract) of the aerial part and fresh root of Taraxacum officinaleWeber ex Wigg.. (1:17-18) Solvent of extraction: ethanol 51% v/v

0.7 mg of extract (as dry extract) of the leaf of Peumus boldusMolina

(1:10-11) Solvent of extraction: ethanol 70% v/v

3.2 mg of extract (as dry extract) of the fruit of Silybum marianum(L.) Gaertn.

(1:2.0- 2.1) Solvent of extraction: ethanol 58% v/v

The other components are excipients:

Microcrystalline cellulose

Glycerol distearate

Appearance of the product and package contents

HepaMed is presented in the form of round, biconvex, beige-colored tablets, packaged in an amber glass bottle with 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

Manufacturer

• VOGEL B.V.

J.P. Broekhovenstraat 16

ELBURG - Netherlands

Date of the last revision of this package leaflet: January 2020

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/