Arkopharma Vegetable Charcoal 225 Mg 45 Capsules

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

• Antidiarrheal: inactivating toxins and microorganisms in the digestive tract, through a physical process of adsorption.
• Antiflatulent: Relieving the symptoms of gas. Activated charcoal works by adsorbing gas particles and substances produced by fermentation that cause abdominal bloating and flatulence.

ARKOPHARMA VEGETABLE CHARCOAL is indicated for the symptomatic treatment of:

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

Do not take ARKOPHARMA CHARCOAL

- If you are allergic to the active ingredient or any of the other ingredients of this medicine,

included in section 6.1.

- If you are in a situation that presents absence of bowel 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 ARKOPHARMA CHARCOAL.

- It can modify intestinal motility (bowel movements).

- Do not administer at the same time as other medications to avoid loss of absorption or mutual cancellation of action (leave at least 2 hours).

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

- Tell your doctor if during treatment with this medicine your condition worsens, you develop new abdominal pain, constipation or severe diarrhea.

- Taking activated charcoal causes black stool coloration, but it is of no consequence.

Children

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

Taking ARKOPHARMA CHARCOAL with other medications

Tell your pharmacist or doctor if you are using, have recently used, or might use any other medicines.

Activated charcoal 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 analytical tests

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

Take ARKOPHARMA CHARCOAL with food and drinks

You should not eat anything until 2 hours have passed after taking ARKOPHARMA VEGETABLE CHARCOAL, as it reduces the action of this medicine.

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

Pregnancy and breastfeeding:

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

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

Driving and operating machinery

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

Follow the instructions for administering this medicine exactly as described in this leaflet or as directed by your pharmacist or doctor. If you are unsure, 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.

People over 65: consult your doctor.

ARKOPHARMA VEGETABLE CHARCOAL 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 beverages such as coffee, tea, wine, etc., nor ice cream or sorbet, as these reduce the effectiveness of the medication.

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

Use in children

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

If you take more ARKOPHARMA CHARCOAL than you should

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

Its use for long periods of time and its administration at high doses can decrease the absorption of enzymes, vitamins and minerals, which can lead to malnutrition.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Poison Control Center on 915620420, indicating the product and the amount ingested.

If you forgot to take ARKOPHARMA CHARCOAL

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the period of use of activated charcoal, the following adverse effects have been observed, the frequency of which could not be accurately established: nausea and vomiting.

Reporting of adverse effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

Keep the container properly closed.

Do not use this medicine after the expiry date shown on the carton after “EXP”. The expiry date refers to the last day of that month.

Medicines should not be disposed of down the drain or in the trash. Take any unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any questions, ask your pharmacist how to dispose of unused medicines and their packaging. By doing so, you will help protect the environment.

Composition of ARKOPHARMA VEGETABLE CHARCOAL:

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

Product appearance and package contents:

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

Marketing Authorisation Holder and Manufacturer :

Holder:

Arkopharma LABORATORIOS, SAU

C/ Amaltea N°9

28045 MADRID

Responsible for manufacturing:

ARKOPHARMA

PHARMACEUTICAL LABORATORIES

BP 28 – 06511 CEDEX TROLLEYS – France

Date of last revision of this leaflet: September 2016

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