VEGETABLE CHARCOAL ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

VEGETAL CARBON ARKOPHARMA

Hard Capsules

Activated Carbon

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

It contains important information for you.

Follow the administration instructions of 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 2 days.

Contents of the Package Leaflet

1. What is VEGETAL CARBON ARKOPHARMA and what is it used for
2. What you need to know before taking VEGETAL CARBON ARKOPHARMA
3. How to take VEGETAL CARBON ARKOPHARMA
4. Possible side effects
5. Storage of VEGETAL CARBON ARKOPHARMA
6. Package Contents and Additional Information

1. What is VEGETAL CARBON ARKOPHARMA and what is it used for

Activated carbon, the active ingredient of this medication, acts as:

• Antidiarrheal: inactivating toxins and microorganisms in the digestive tract through a physical process of adsorption.
• Antiflatulent: relieving symptoms of gas. Activated carbon acts by adsorbing gas particles and substances due to fermentations that cause abdominal distension and flatulence.

VEGETAL CARBON ARKOPHARMA is indicated for the symptomatic treatment of:

• Occasional diarrhea
• Symptomatic relief of gas (aerophagia, meteorism, flatulence).

2. What you need to know before taking VEGETAL CARBON ARKOPHARMA

Do not take VEGETAL CARBON ARKOPHARMA

• If you are allergic to the active ingredient or any of the other components of this medication, included in section 6.1.

including those listed in section 6.1.

• If you are in a situation that presents absence of intestinal sounds, intestinal perforation, have recently undergone digestive surgery, or are at risk of stomach or intestinal bleeding.

Warnings and Precautions

Consult your pharmacist, doctor, or nurse before starting to take VEGETAL CARBON ARKOPHARMA.

• It may modify intestinal motility (intestinal movements).
• Do not administer at the same time as other medications to avoid loss of absorption of the same or mutual cancellation of action (wait at least 2 hours).
• Prolonged use is not recommended as it may decrease the absorption of some nutrients.
• Inform your doctor if during treatment with this medication your symptoms worsen, or if you experience new abdominal pain, constipation, or severe diarrhea.
• Taking activated carbon causes black discoloration of the stool, but this is of no importance.

Children

This medication is not recommended for children under 12 years old without consulting a pharmacist or doctor.

Taking VEGETAL CARBON ARKOPHARMA with other medications

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

Activated carbon interferes with the action of other medications taken orally, so it is recommended to take them 2 hours before or 4-6 hours after taking this medication.

Interference with Laboratory Tests

If you are going to have any laboratory tests (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking VEGETAL CARBON ARKOPHARMA with Food and Drinks

Do not take any food until 2 hours after taking VEGETAL CARBON ARKOPHARMA, as it reduces the action of this medication.

Do not use drinks like coffee, tea, wine, etc., or ice cream or sorbets because they reduce the action 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.

Activated carbon is not absorbed, so it does not reach the placenta or breast milk.

Driving and Using Machines

Taking this medication does not affect your ability to drive or use machines.

3. How to Take VEGETAL CARBON ARKOPHARMA

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your pharmacist or doctor. In case of doubt, ask your pharmacist or doctor.

The recommended dose is:

Adults and adolescents over 12 years: 2 capsules, 3 or 4 times a day, if necessary.

Children under 12 years: consult a doctor.

Over 65 years: consult a doctor.

VEGETAL CARBON ARKOPHARMA is taken orally.

The capsules are administered at least half an hour after finishing meals or at the onset of symptoms.

The capsules should be swallowed with a little water. Do not use other drinks like coffee, tea, wine, etc., or ice cream or sorbets that reduce the action of the medication.

If your symptoms worsen or persist after 2 days of treatment or you have a high fever, you should consult a doctor.

Use in Children

This medication is not recommended for children under 12 years old without consulting a pharmacist or doctor.

If you take more VEGETAL CARBON ARKOPHARMA than you should

Activated carbon is very well tolerated orally, so it should not cause intoxication by this route.

Long-term use and administration at high doses may decrease the absorption of enzymes, vitamins, and minerals, which can cause malnutrition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at 915620420, indicating the product and the amount ingested.

If you forget to take VEGETAL CARBON ARKOPHARMA

If you forget to take VEGETAL CARBON ARKOPHARMA and your symptoms continue, do not take a double dose to make up for the forgotten dose. If necessary, take the medication again as indicated in section 3. How to take VEGETAL CARBON ARKOPHARMA.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

During the use of activated carbon, the following side effects have been observed, whose frequency has not been established with precision: nausea and vomiting.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 VEGETAL CARBON ARKOPHARMA

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

Keep the package properly closed.

Do not use this medication after the expiration date that appears on the package, after "EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown away in drains or in the trash. Deposit the packages and medications you no longer need in the Sigre Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of VEGETAL CARBON ARKOPHARMA:

Each capsule contains 225 mg of activated carbon as the active ingredient. The other components (excipients) are: hypromellose and magnesium stearate.

Appearance of the Product and Package Contents:

This medication is presented in hard capsules, packaged in brown polyvinyl bottles, closed with a low-density polyethylene cap. Each bottle contains 45 capsules.

Marketing Authorization Holder and Manufacturer:

Holder:

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea N°9

28045 MADRID

Manufacturer:

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS CEDEX – France

Date of the Last Revision of this Package Leaflet: September 2016

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/