Prospect: information for the user

ARKOPHARMA VEGETABLE CHARCOAL

Hard capsules

Activated charcoal

Read this prospect carefully before starting to take this medicine, because

it contains important information for you.

Follow exactly the medication administration instructions contained in this prospect or those indicated by your pharmacist, doctor, or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your pharmacist, doctor, or nurse, even if they are not listed in this prospect. See section 4
• You should consult a doctor if it worsens or does not improve after 2 days.

1. What isARKOPHARMA VEGETABLE CHARCOALand for what it is used

2. What you need to know before starting to takeARKOPHARMA VEGETABLE CHARCOAL

3. How to takeARKOPHARMA VEGETABLE CHARCOAL

4. Possible adverse effects

5. Storage ofARKOPHARMA VEGETABLE CHARCOAL

6. Contents of the package and additional information

The activated charcoal, active ingredient of this medication, acts as:

• Antidiarrheal: inactivating toxins and microorganisms in the digestive tract, through a physical adsorption process.
• Antiflatulent: alleviating symptoms of gas. Activated charcoal acts by adsorbing gas particles and substances due to 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).

Do not take CARBÓN VEGETAL ARKOPHARMA

- If you are allergic to the active ingredient or to any of the other components of this medication, as 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 have a risk of stomach or intestinal bleeding.

Warnings and precautions

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

- 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 reciprocal cancellation of action (allow at least 2 hours to pass).

- Prolonged use is not recommended as it may decrease the absorption of some nutrients.

- Inform your doctor if during treatment with this medication worsens, a new abdominal pain, constipation, or severe diarrhea occurs.

- The intake of activated charcoal produces black stool coloration, but without any importance.

Children

Administration of this medication is not recommended in children under 12 years, without consulting your pharmacist or doctor.

Taking CARBÓN VEGETAL ARKOPHARMA with other medications

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

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

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Taking CARBÓN VEGETAL ARKOPHARMA with food and beverages

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

Do not use beverages such as coffee, tea, wine, etc., or ice cream or sorbet because they reduce the action of the medication.

Pregnancy and lactation:

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

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

Driving and operating machines

The intake of this medication does not affect the ability to drive or operate machines.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your pharmacist or doctor. If in 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 with the doctor.

Over 65 years:consult with the doctor.

CARBÓN VEGETAL ARKOPHARMA is taken orally.

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

The capsules must be swallowed with the help of a little water. Do not use other beverages such as coffee, tea, wine, etc., or ice cream or sorbet that reduce the action of the medication.

If symptoms worsen or persist after 2 days of treatment or have high fever, consult the doctor.

Use in children

It is not recommended to administer this medication to children under 12 years, without consulting your pharmacist or doctor.

If you take more CARBÓN VEGETAL ARKOPHARMA than you should

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

Its use over long periods of time and its administration at high doses, may decrease the absorption of enzymes, vitamins, and minerals, which may cause malnutrition.

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

If you forgot to take CARBÓN VEGETAL ARKOPHARMA

If you forgot to take CARBÓN VEGETAL ARKOPHARMA and symptoms continue, do not take a double dose to compensate for the missed dose. If necessary, take the medication again in the same way as indicated in section 3. How to take CARBÓN VEGETAL ARKOPHARMA.

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

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines 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.

Keep the container properly closed.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of CARBÓN VEGETAL ARKOPHARMA:

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

Appearance of the product and content of the packaging:

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

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea N°9

28045 MADRID

Responsible for manufacturing:

ARKOPHARMA

Laboratoires Pharmaceutiques

BP 28 – 06511 CARROS CEDEX – France

Date of the last review of this leaflet: September 2016

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