Leaflet: information for the user

ARKOPHARMA SAGRADA SHELLhard capsules

Rhamnus purshianusD.C.

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

• Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated 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 side effects, consult your pharmacist, doctor or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

1. What isARKOPHARMA SAGRADA SHELLand what it is used for

2. What you need to know before starting to takeARKOPHARMA SAGRADA SHELL

3. How to takeARKOPHARMA SAGRADA SHELL

4. Possible side effects

5. Storage ofARKOPHARMA SAGRADA SHELL

6. Contents of the pack and additional information

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

Do not takeCÁSCARA SAGRADA ARKOPHARMA

- If you are allergic to the active ingredients or any of the other components.

- Do not use this medication in children under 12 years old.

- If you have unknown abdominal pain.

- If you are experiencing or have recently experienced diarrhea or vomiting with significant loss of liquids 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, antiarrhythmics, medications that induce prolongation of the QT interval, 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.

- Frequent use of this type of laxative should be avoided.

- If you have any kidney disease.

Use of other medications

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

The prolonged or abuse of laxatives may cause a decrease in potassium levels that may increase the action of other medications administered for the heart (antiarrhythmics, diuretics, corticosteroids and licorice root).

The action of this medication on intestinal transit could modify the levels of other medications taken simultaneously by oral route.

TakingCÁSCARA SAGRADA ARKOPHARMAwith food and beverages

Foods and beverages have no influence on the effect of the medication.

Pregnancy and lactation:

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

Use during pregnancy and lactation is not recommended.

Driving and operating machines

No effects have been registered on the ability to drive and operate machines.

Follow exactly the administration instructions 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 old: 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 requires 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 old, without a doctor's prescription.

Use in the elderly:

Elderly patients may be more sensitive to the effects 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, abdominal pain and severe diarrhea may appear, and it will be necessary to replenish fluids. In the case of elderly patients or individuals who have taken it at the same time, glucosides, diuretics, corticosteroids, or licorice root, they should consult a doctor to control their potassium levels.

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

If you forgot to take CASCARA SAGRADA ARKOPHARMA

In case of forgotten dose, do not take a double dose to compensate for the missed dose.

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

This medication may produce 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, it will be necessary to reduce the dose.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication..

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

Do not store at a temperature above30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of CÁSCARA SAGRADA ARKOPHARMA:

Each capsule contains as active ingredient: 250 mg of cryomilled cortex ofRhamnus purshianusDC. (Sacred bark).

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

Appearance of the product and content of the packaging:

There is 1 presentation in bottles containing 50 capsules.

Holder of the marketing authorization and responsible for manufacturing:

Holder:

Arkopharma LABORATORIES, S.A.U

C/ Amaltea, 9

28045 MADRID

Responsible for manufacturing:

Laboratoires ARKOPHARMA

LID de Carros le Broc

Zone Industrielle lère Avenue2709 m

06511 CARROS (France)

Last review date of this leaflet: September 2016

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/