Carbon vegetable Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CARBON VÉGÉTAL ARKOPHARMA

hard capsules

Activated charcoal

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 this medicine provided in this leaflet or those given by your pharmacist, doctor, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your pharmacist, doctor, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve within 2 days.

Contents of the leaflet

1. What CARBON VÉGÉTAL ARKOPHARMA is and what it is used for
2. What you need to know before taking CARBON VÉGÉTAL ARKOPHARMA
3. How to take CARBON VÉGÉTAL ARKOPHARMA
4. Possible adverse effects
5. How to store CARBON VÉGÉTAL ARKOPHARMA
6. Contents of the pack and further information

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

Activated charcoal, the active ingredient in this medicine, works as:

• An antidiarrheal: by inactivating toxins and microorganisms in the digestive tract through a physical adsorption process.
• An anti-flatulence agent: relieving gas symptoms. Activated charcoal acts by adsorbing gas particles and substances produced by fermentations that cause abdominal distension and flatulence.

CARBÓN VEGETAL ARKOPHARMA is indicated for the symptomatic treatment of:

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

2. What you need to know before starting to take CARBÓN VEGETAL ARKOPHARMA

Do not take CARBÓN VEGETAL ARKOPHARMA

• If you are allergic to the active substance or to any of the other ingredients of this medicine,
  listed in section 6.1.

• If you have a condition characterized by absence of bowel sounds, intestinal perforation, have recently undergone gastrointestinal surgery, or are at risk of stomach or intestinal bleeding.

Warnings and precautions

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

• It may alter intestinal motility (intestinal movements).
• Do not administer at the same time as other medications to avoid reduced absorption of these medications or mutual cancellation of effects (allow at least 2 hours to elapse).
• Prolonged use is not recommended, as it may reduce the absorption of certain nutrients.
• Inform your doctor if, during treatment with this medicine, your symptoms worsen or you develop new abdominal pain, constipation, or severe diarrhea.
• Activated charcoal intake causes black discoloration of stools, which is harmless.

Children

Administration of this medicine is not recommended for children under 12 years of age without first consulting your pharmacist or doctor.

Taking CARBÓN VEGETAL ARKOPHARMA with other medicines

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

Activated charcoal interferes with the action of other oral medications; therefore, it is recommended to take other medicines either 2 hours before or 4–6 hours after taking this medicine.

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood or urine analyses, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking CARBÓN VEGETAL ARKOPHARMA with food and drinks

Do not consume any food within 2 hours after taking CARBÓN VEGETAL ARKOPHARMA, as food may reduce the effectiveness of this medicine.

Avoid using beverages such as coffee, tea, wine, etc., as well as ice creams or sorbets, as they may reduce the medicine’s effectiveness.

Pregnancy and breastfeeding

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

Activated charcoal is not absorbed systemically; therefore, it does not reach the placenta or breast milk.

Driving and using machines

Taking this medicine does not affect your ability to drive or operate machinery.

3. How to take CARBÓN VEGETAL ARKOPHARMA

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist or doctor. If in doubt, ask your pharmacist or doctor.

The recommended dose is:

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

Children under 12 years of age: consult your doctor.

Patients over 65 years of age: consult your doctor.

CARBÓN VEGETAL ARKOPHARMA is taken orally.

The capsules should be taken at least half an hour after finishing meals or at the onset of symptoms.

The capsules must be swallowed with a little water. Do not use other beverages such as coffee, tea, wine, etc., nor ice creams or sorbets, as these reduce the effectiveness of the medicine.

If symptoms worsen or persist for more than 2 days of treatment, or if you develop high fever, consult your doctor.

Use in children

Administration of this medicine is not recommended for children under 12 years of age without consulting your pharmacist or doctor.

If you take more CARBÓN VEGETAL ARKOPHARMA than you should

Activated charcoal is very well tolerated orally, so poisoning via this route is not expected.

Prolonged use and administration at high doses may reduce the absorption of enzymes, vitamins, and minerals, potentially leading to malnutrition.

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

If you forget to take CARBÓN VEGETAL ARKOPHARMA

If you forget to take CARBÓN VEGETAL ARKOPHARMA and symptoms persist, do not take a double dose to make up for the missed dose. If necessary, resume taking the medicine as indicated in section 3. How to take CARBÓN VEGETAL ARKOPHARMA.

4. Possible adverse effects

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

During the period of activated charcoal use, the following adverse effects have been observed, although their frequency cannot be precisely established: nausea and vomiting.

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 can 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 CARBÓN VEGETAL ARKOPHARMA

Keep this medicine out of sight and reach of children.

Keep the container properly closed.

Do not use this medicine after the expiry date stated on the packaging, following “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CARBÓN VEGETAL ARKOPHARMA:

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

Appearance of the medicine and contents of the pack:

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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 most recent revision of this leaflet: September 2016

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