CÁSCARA SAGRADA ARKOPHARMA HARD CAPSULES

Introduction

Package Leaflet: Information for the User

CÁSCARA SAGRADA ARKOPHARMAhard capsules

Rhamnus purshianusD.C.

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

• Follow the administration instructions for 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 4 days.

Contents of the Package 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. Storage of CÁSCARA SAGRADA ARKOPHARMA
6. Package Contents and Additional Information

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

Plant-based medication for the short-term treatment of occasional constipation.

2. What you need to know before taking CÁSCARA SAGRADA ARKOPHARMA

Do not takeCÁSCARA SAGRADA ARKOPHARMA

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

Be especially careful withCÁSCARA SAGRADA ARKOPHARMA

• If you are taking other medications such as cardiac glycosides, anti-arrhythmic medications, medications that induce QT interval prolongation, diuretics, corticosteroids, or licorice root.
• If you have acute or persistent undiagnosed gastrointestinal disorders.
• If you need to take laxatives frequently, the cause of constipation should be investigated.
• The frequent use of this type of laxative should be avoided.
• If you have kidney disease.

Use of other medications

Tell your pharmacist or doctor if you are using or have recently used other medications, including those purchased without a prescription.

Prolonged use or abuse of laxatives can lead to a decrease in potassium levels, which can increase the action of other medications administered for the heart (anti-arrhythmics, diuretics, corticosteroids, and licorice root).

The action of this medication on intestinal transit could modify the levels of other medications taken orally at the same time.

TakingCÁSCARA SAGRADA ARKOPHARMAwith food and drinks

Food and drinks do not affect the effect of the medication.

Pregnancy and breastfeeding:

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

Use during pregnancy and breastfeeding is not recommended.

Driving and using machines

No effects on the ability to drive and use machines have been reported.

3. How to take CÁSCARA SAGRADA ARKOPHARMA

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

The recommended dose is:

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

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

CÁSCARA SAGRADA ARKOPHARMA needs some time to take effect, between 6 and 12 hours after administration, so it is recommended to take it at night for the effect to occur the next morning.

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

Use in children:

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

Use in the elderly:

Elderly patients may be more sensitive to the action of this medication 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, colic pain and severe diarrhea may occur, making it necessary to replenish fluids, and in the particular case of elderly patients or those who have taken cardiac glycosides, diuretics, corticosteroids, or licorice root at the same time, they should consult a doctor to monitor potassium levels.

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

If you forget to take CÁSCARA SAGRADA ARKOPHARMA

In case of forgetting a dose, do not take a double dose to make up for the forgotten dose.

4. Possible side effects

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

This medication can cause abdominal pain and liquid stools, particularly in people with irritable colon. However, these effects are often due to taking a higher dose than necessary, so in these cases, the dose should be reduced.

Note that prolonged use or abuse of laxatives can lead to imbalances that will be observed in a urine analysis (albuminuria and hematuria). The urine may appear dark (brownish) due to compounds being eliminated. This has no clinical significance and will disappear when treatment is stopped.

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 CÁSCARA SAGRADA ARKOPHARMA

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

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging, after the abbreviation "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of CÁSCARA SAGRADA ARKOPHARMA:

Each capsule contains as the active ingredient: 250 mg of cryomilled bark of Rhamnus purshianusDC. (Sacred Bark).

The other components are the excipients: gelatin (capsule coating).

Appearance of the product and package contents:

There is one presentation in bottles containing 50 capsules.

Marketing Authorization Holder and Manufacturer:

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 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/