Cascara Sagrada Arkopharma hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

SACRED BARK ARKOPHARMA hard capsules

Rhamnus purshianus D.C.

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

• Follow exactly the instructions for use 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 more 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 after 4 days.

Contents of the leaflet

1. What CÁSCARA SAGRADA ARKOPHARMA is and what it is used for
2. What you need to know before taking CÁSCARA SAGRADA ARKOPHARMA
3. How to take CÁSCARA SAGRADA ARKOPHARMA
4. Possible side effects
5. How to store CÁSCARA SAGRADA ARKOPHARMA
6. Contents of the pack and other information

1. What is CÁSCARA SAGRADA ARKOPHARMA and what is it used for

A herbal medicine used for the short-term treatment of occasional constipation.

2. What you need to know before starting to take CÁSCARA SAGRADA ARKOPHARMA

Do not take CÁSCARA SAGRADA ARKOPHARMA

• If you are allergic to the active substances or to any of the other components.
• Do not use this medicine in children under 12 years of age.
• If you have abdominal pain of unknown origin.
• If you are experiencing or have recently experienced diarrhea or vomiting with significant loss of fluids and electrolytes.
• If you have intestinal obstruction or stenosis, atony, appendicitis, or inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis).

Take special care with CÁSCARA SAGRADA ARKOPHARMA

• If you are taking other medicines such as cardiac glycosides, antiarrhythmic drugs, drugs that induce QT interval prolongation, diuretics, corticosteroids, or licorice root.
• If you have acute or persistent gastrointestinal disorders that have not been diagnosed.
• If you need to take laxatives frequently, the cause of constipation should be investigated.
• Frequent use of this type of laxative should be avoided.
• If you have any kidney disease.

Use of other medicines

Inform your pharmacist or doctor if you are using or have recently used any other medicines, including those obtained without a prescription.

Prolonged use or abuse of laxatives may lead to decreased potassium levels, which could increase the effects of other medications used for heart conditions (antiarrhythmics, diuretics, corticosteroids, and licorice root).

The effect of this medicine on intestinal transit could alter the absorption and levels of other medicines taken simultaneously by the oral route.

Taking CÁSCARA SAGRADA ARKOPHARMA with food and drinks

Food and drinks do not influence the effect of this medicine.

Pregnancy and breastfeeding

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

Use during pregnancy and breastfeeding is not recommended.

Driving and use of machines

No effects on the ability to drive or operate machinery have been reported.

3. How to take CÁSCARA SAGRADA 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.

Recommended dose:

Adults and adolescents over 12 years of age: take 1 capsule daily before bedtime with a glass of water.

Dosage should be adjusted according to individual need. In general, it is sufficient to take the medicine two or three times, on consecutive days or not, to achieve the desired effect.

CÁSCARA SAGRADA ARKOPHARMA requires a certain amount of time for its effect to occur, typically between 6 and 12 hours after administration. Therefore, it is recommended to take the medicine at night so that the effect occurs the following morning.

If symptoms worsen or do not improve after 4 days, consult a doctor.

Use in children:

Do not use in children under 12 years of age without medical prescription.

Use in elderly patients:

Elderly patients may be more sensitive to the effects of this medicine and therefore may require a lower dose.

If you take more CÁSCARA SAGRADA ARKOPHARMA than you should

In case of overdose or accidental ingestion of large quantities, colicky-type pains and severe diarrhea may occur. It will therefore be necessary to restore fluids. In particular, elderly patients or individuals who have also taken cardiac glycosides, diuretics, corticosteroids, or licorice root should see a doctor to monitor potassium levels.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.

If you forget to take CÁSCARA SAGRADA ARKOPHARMA

If you miss a dose, do not take a double dose to make up for the missed dose.

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

This medicine may cause abdominal pain and loose stools, particularly in individuals with irritable bowel syndrome. However, these effects in many cases are due to having taken a higher dose than necessary, so in such cases it will be necessary to reduce the dose.

Bear in mind that prolonged use or abuse of laxatives may lead to imbalances that will be observed in a urine test (albuminuria and haematuria). The urine may appear dark (brownish) due to excreted compounds. This is not clinically significant and will disappear when treatment is discontinued.

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 CÁSCARA SAGRADA ARKOPHARMA

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

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the container, following the abbreviation “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 medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of CÁSCARA SAGRADA ARKOPHARMA:

Each capsule contains as the active substance: 250 mg of cryomilled bark of Rhamnus purshianus DC. (Cascara sagrada).

The other components are excipients: gelatin (capsule shell).

Appearance of the product and pack contents:

One presentation available in bottles containing 50 capsules.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Arkopharma LABORATORIOS, S.A.U

C/ Amaltea, 9

28045 MADRID

Manufacturer:

Laboratoires ARKOPHARMA

LID de Carros le Broc

Zone Industrielle lère Avenue 2709 m

06511 CARROS (France)

Date of the most recent review of this leaflet: September 2016

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