PATIENT INFORMATION LEAFLET

Bekunis 5 mg gastro-resistant tablets

Bisacodyl

Read this leaflet carefully because it contains important information for you.

This medicine can be obtained without a prescription. However, for the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, you should consult your doctor.
• If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Bisacodyl belongs to the group of laxatives known as stimulants, which act by direct contact with the intestinal mucosa, stimulating the intestinal wall nerve endings, increasing its motility.

This medication is indicated for adults and children over 6 years old for symptomatic relief of occasional constipation, such as that caused by prolonged bed rest and travel, It can also be used in cases where defecation needs to be facilitated, such as in the case of hemorrhoids or anal fissures.

Do not take Bekunis

• If you are allergic (hypersensitive) to bisacodyl or any of the other components of Bekunis.
• If you have abdominal pain of unknown origin.
• If you have intestinal obstruction or paralytic ileus (a disease of the intestine).
• If you have appendicitis or intestinal perforation.
• If you have digestive bleeding or inflammatory intestinal diseases (ulcerative colitis, Crohn's disease).
• If the patient is a child under 2 years old.
• If you have disorders of water and electrolyte metabolism.

Be especially careful with Bekunis

• The continued use of bisacodyl may cause dependence on laxatives, so it is recommended that this medication be used for short periods of time.
• If you have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out the presence or absence of appendicitis.
• If you are over 65 years old or in debilitated patients, it is recommended to have an adequate intake of liquids and mineral salts, and to monitor electrolyte levels periodically to avoid dehydration problems.
• If you have gastrointestinal obstruction or chronic constipation, it is recommended to see a doctor, as in that case the cause of constipation should be investigated.

Use of other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of one of them, or interrupt treatment:

• Antiarrhythmics (quinidine).
• Anti-inflammatory (corticosteroids).
• Diuretic thiazides (used to increase urine elimination).
• Cardiac glycosides such as digoxin, used for the heart.
• Antacid and antiulcer medications (proton pump inhibitors, H2 antihistamines), and should be taken at least 2 hours apart.
• Medications based on licorice root.

Interference with diagnostic tests:

• It may elevate blood glucose levels, so it should be taken into account in diabetic patients.
• It may interfere with analytical test results, due to the prolonged use of laxatives, which can lead to hypokalemia (decreased potassium in the blood).

Taking Bekunis with food and drinks

Do not take licorice root while taking this medication.

Avoid taking Bekunis with milk, or at least delay its administration by 2 hours, as it may increase the absorption of this medication if taken at the same time.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Bisacodyl may pass into breast milk, so women in the lactation period should not take this medication without first consulting with their doctor.

Driving and operating machines

No effects on the ability to drive or operate machines have been described due to the use of this medication.

Important information about some of the components of Bekunis

This medication contains lactose, glucose, and sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow the administration instructions for Bekunis indicated in this leaflet or those indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and children over 12 years:1 to 3 tablets per day. Do not administer more than 3 tablets per day.

Use in children

• Children under 2 years:Do not use this medication.
• Children from 2 to 6 years:This medication should only be used under medical advice.
• Children from 6 to 12 years:Maximum 1 tablet per day. Do not administer more than 1 tablet per day (corresponding to 5 mg of bisacodyl per day).

It is recommended to swallow the tablet whole, without chewing and with plenty of liquid, at night or in the morning on an empty stomach. Ingestion at night will produce defecation approximately in 10 hours. If ingestion is in the morning, on an empty stomach, defecation will occur approximately in 6 hours.

If symptoms worsen, if no bowel movement or defecation occurs in 12 hours, or if symptoms persist for more than 7 days, you should consult your doctor.

If you take more Bekunis than you should

If you have taken more Bekunis than you should, consult your doctor or pharmacist immediately.

The most frequent symptoms of overdose are: abdominal cramps, vomiting, mucous and diarrheal stools, and loss of potassium and other electrolytes.

Treatment in these cases will consist of suspending the administration of the laxative and subsequent rehydration with saline solution, liquids, and administration of mineral salts.

If you have taken more Bekunis Instant than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take Bekunis

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Bekunis may produce adverse effects, although not all people will experience them.

During the period of use of medications with bisacodilo, the following adverse effects have been observed, whose frequency has not been established with exactness.

The adverse effects produced most frequently have been digestive alterations such as abdominal pain or cramps, flatulence, abdominal distension, and slower intestinal movement.

Rarely, allergic reactions, skin eruptions, and angioedema (swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing) may also appear.

The administration of bisacodilo over long periods of time may cause an increase in water loss, potassium salts, and other salts. This may lead to cardiac function alterations, muscle weakness, and fatigue, particularly if administered at the same time as diuretic and corticosteroid medications.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

No special storage conditions are required.

Do not use BEKUNIS after the expiration date appearing on the packaging after 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 at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

Bekunis Composition

• The active ingredient is bisacodyl. Each tablet contains 5 milligrams of bisacodyl.
• The other components (excipients) are: magnesium stearate, talc, microcrystalline cellulose (E-460), Macrogol 6000, lactose monohydrate, copolymer of methacrylic acid and ethyl acrylate (1:1), saccharose, arabic gum, calcium carbonate, polisorbate 80, titanium dioxide (E 171), stearic acid, liquid glucose, purified water, white wax, and montan wax

Product Appearance and Packaging Contents

Bekunis are gastro-resistant tablets, in polypropylene bottles with polyethylene caps or in blister packs (PVC/PVDC/AL) containing 30 gastro-resistant tablets.

Marketing Authorization Holder

ROHA ARZNEIMITTEL GmbH

Rockwinkeler Heerstrasse 100

28355 Bremen

Germany

Responsible Manufacturer

ROHA ARZNEIMITTEL GmbH

Rockwinkeler Heerstrasse 100

28355 Bremen

Germany

O

Artesan Pharma GmbH & Co. KG

Wendlandstraße 1

29439 Lüchow

Germany

This leaflet was approved in October/2007

The 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/