SEN ARKOPHARMA hard capsules

Introduction

Package Leaflet: Information for the User

SEN ARKOPHARMA

Hard Capsules

Cassia angustifoliaVahl.

Read the package leaflet carefully before starting to take this medication, because it

contains important information for you.

Follow the administration instructions of 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 is SEN ARKOPHARMA and what is it used for
2. What you need to know before taking SEN ARKOPHARMA
3. How to take SEN ARKOPHARMA
4. Possible side effects
5. Storage of SEN ARKOPHARMA
6. Package contents and additional information

1. What is SEN ARKOPHARMA and what is it used for

Herbal medicine for the short-term treatment of occasional constipation.

2. What you need to know before taking SEN ARKOPHARMA

Do not take SEN ARKOPHARMA

If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

Do not use this medication in children under 12 years of age.

If you have abdominal pain of unknown origin.

If you are suffering 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 bowel diseases (such as Crohn's disease, ulcerative colitis).

Warnings and precautions

Consult your pharmacist or doctor before starting to take SEN ARKOPHARMA.

Be particularly careful 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.

Children

This medication is not recommended for children under 12 years of age.

Taking SEN ARKOPHARMA with other medications

Inform your pharmacist or doctor if you are taking, have recently taken, or may need to take any other medication.

The prolonged use or abuse of laxatives can lead to a decrease in potassium levels, which can increase the effect of other medications administered for the heart (anti-arrhythmics, diuretics, corticosteroids, and/or licorice root). The action of this medication on intestinal transit could modify the levels of other medications taken orally at the same time.

Taking SEN ARKOPHARMA with food and beverages

Food and beverages 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. No studies have been conducted to establish the safety of using this medication during pregnancy or breastfeeding, so its administration is not recommended in these circumstances.

The 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 SEN ARKOPHARMA

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

The recommended dose is:

Adolescents over 12 years of age, adults, and the elderly: 2 to 4 capsules per day.

Adjust the dosage as needed.

It is usually sufficient to take the medication for 2 or 3 days to achieve the desired effect.

It is recommended to take the medication before bedtime with a glass of water.

The laxative effect of SEN ARKOPHARMA usually occurs between 8-12 hours after administration, so it is recommended to take it at night for the effect to occur the next morning.

If your symptoms worsen or persist after 4 days, you should consult a doctor.

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 SEN ARKOPHARMA than you should

In case of overdose or accidental ingestion of large quantities, colic pain and severe diarrhea may occur, and it will be necessary to replenish fluids. In the case of elderly patients or those who have taken, at the same time, cardiac glycosides, diuretics, corticosteroids, or licorice root, they should consult a doctor to have their potassium levels checked.

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

If you forget to take SEN ARKOPHARMA

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

4. Possible Side Effects

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

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

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 the compounds being eliminated. This has no clinical significance and will disappear when treatment is stopped.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of SEN ARKOPHARMA

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

Do not store above 30°C.

Do not use this medication after the expiration date stated 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 any unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of SEN ARKOPHARMA:

Each capsule contains as the active ingredient: 300 mg of cryomilled leaves of Cassia angustifoliaVahl. (Sen) with a content of 6.25 mg of hydroxyanthracene heterosides expressed as sennoside B.

The other components are the excipients: microcrystalline cellulose and hypromellose (capsule coating).

Appearance of the Product and Package Contents:

There is one presentation in bottles containing 48 capsules.

Marketing Authorization Holder and Manufacturer:

Holder:

Arkopharma LABORATORIOS, S.A.U.

C/ Amaltea, 9

28045 MADRID

Manufacturer:

ARKOPHARMA

LABORATOIRES PHARMACEUTIQUES

BP 28 – 06511 CARROS Cedex - 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/