Package Leaflet: Information for the User

HepaMed, Tablets

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

This medicine can be purchased without a prescription for the treatment of minor ailments, without the intervention of a doctor. Nevertheless, for the best results it should be used properly.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

-Keep this leaflet, as you may need to read it again.
-If you need advice or more information, consult your pharmacist.

-Ifyou experience adverse effects, consultyour doctor or pharmacist, even if it is for adverse effects that do not appear in this leaflet. See section 4.

-You should consult a doctor if you worsen or do not improve after 15 days of treatment.

1. What isHepaMed tabletsand for what it is used

2. What you need to know before starting to takeHepaMed tablets

3. How to takeHepaMed tablets

4. Possible adverse effects

5. Storage ofHepaMed tablets

6. Contents of the pack and additional information

HepaMed tablets, is a traditional herbal medicine used to treat the symptoms of dyspepsia, such as indigestion, stomach burning, abdominal distension, flatulence and nausea,based exclusively on its traditional use.

Do not take HepaMed tablets:

• If you are allergic to artichoke, lion's tooth, boldo, or any other component of this medication (listed in section 6).

of the other components of this medication.

• If you are allergic to plants of the Compositae family (Asteraceae). Artichoke, lion's tooth, and cardo mariano belong to this family
• If you are under 18 years of age.
• If you are pregnant or breastfeeding.
• Suffering from 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

• Patients with renal insufficiency, heart failure, or diabetes should avoid using this medication due to possible complications caused by hypercalcemia.
• Patients 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 treatment, discontinue treatment and consult a doctor.
• If symptoms worsen or no improvement is observed after 2 weeks of treatment, consult a doctor.

tratamiento, consult a doctor.

Children and adolescents

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

Other medications and HepaMed

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

No interactions with other medications have been described.

Pregnancy and lactation

As a precaution and in the absence of sufficient data, use during pregnancy and lactation is not recommended.

If you are pregnant or believe you may be pregnant, consult your doctor before taking this medication. The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery:

No studies have been conducted on the influence of the medication on the ability to drive vehicles and operate machinery.

Follow the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist

The recommended dose is:

Adults (over 18 years old), 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 old.

If symptoms worsen or no improvement is observed after 2 weeks of treatment, consult a doctor.

If you take more HepaMed tablets than you should:

It is unlikely that symptoms or toxicity will manifest.

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

If you forgot to take HepaMed tablets

Do not take a double dose to compensate for the missed doses.

Make sure you have read section 2 of this prospectus.

Do not take HepaMed tablets if you are allergic to artichoke, lion's tooth, boldo, cardoon or any of the other components of this medication.

Like all medicationsHepaMed tabletsmay have adverse effects, although not everyone will experience them.

Adverse reactions are generally mild.

In some cases, they may causegastrointestinal discomfortsuch as nausea, stomach discomfort, diarrhea, cramps, abdominal pain, hyperacidity and heartburn, and skin allergic reactions (urticaria, rash, pruritus, anaphylactic reactions). The frequency of occurrence is unknown.

If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.

By 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 use HepaMed tablets after the expiration date indicated on the packaging.

Use it within 5 months after opening.

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

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

Medications 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. By doing so, you will help protect the environment.

Composition of HepaMed

HepaMed tablets contain as active ingredient:

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

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

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

0.7 mg of extract(as dry extract) from the leaf ofPeumus boldusMolina

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

3.2 mg of extract(as dry extract) from the fruit ofSilybum 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 contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Phone 93 201 99 22

Fax 93 209 03 19

Responsible for Manufacturing

A. VOGEL B.V.

J.P. Broekhovenstraat 16

ELBURG - Netherlands

Last review date of this leaflet: January 2020

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