BEKUNIS 5 mg GASTRO-RESISTANT TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Bekunis 5 mg gastro-resistant tablets

Bisacodyl

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

This medicine can be obtained without a prescription. Nevertheless, to get 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 think any of the side effects that you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the package leaflet:

1. What is Bekunis and what is it used for
2. Before taking Bekunis
3. How to take Bekunis
4. Possible side effects
5. Storage of Bekunis
6. Further information

1. What is Bekunis and what is it used for

Bisacodyl belongs to the group of so-called stimulant laxatives, which act by direct contact with the intestinal mucosa, stimulating the nerve endings of the intestinal wall, increasing its motility.

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

2. Before taking Bekunis

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 gastrointestinal bleeding or inflammatory intestinal diseases (ulcerative colitis, Crohn's disease).
• If the patient is a child under 2 years of age.
• If you have water or electrolyte metabolism disorders.

Be careful with Bekunis

• Prolonged use of bisacodyl can cause dependence on laxatives, so it is recommended that this medicine be used for short periods of time.
• If you have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to consult a doctor to rule out the presence or absence of appendicitis.
• If you are over 65 years old or in debilitated patients, adequate intake of fluids and mineral salts is recommended, and periodic monitoring of electrolyte levels is necessary to avoid dehydration problems.
• If you have gastrointestinal obstruction or suffer from chronic constipation, it is recommended to consult a doctor, as the cause of constipation should be investigated in that case.

Use of other medicines

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

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

• Antiarrhythmics (quinidine).
• Anti-inflammatory drugs (corticosteroids).
• Thiazide diuretics (used to increase urine elimination).
• Cardiac glycosides such as digoxin, used for the heart.
• Antacid and anti-ulcer medications (proton pump inhibitors, H2 antihistamines), which should be taken at least 2 hours apart.
• Medicines based on licorice.

Interference with diagnostic tests:

• It can increase blood glucose levels, so it should be taken into account in diabetic patients.
• It can interfere with the results of analytical tests, due to the fact that prolonged use of laxatives can lead to hypokalemia (decrease in potassium in the blood).

Taking Bekunis with food and drinks

Do not take licorice while being treated with this medicine.

It should be avoided to take Bekunis simultaneously with milk, or at least to space out its administration by 2 hours, since the absorption of this medicine may increase if they are administered at the same time.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Bisacodyl can pass into breast milk, so breastfeeding women should not take this medicine without first consulting their doctor.

Driving and using machines

No effect on the ability to drive or use machines has been described due to the use of this medicine.

Important information about some of the components of Bekunis

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

3. How to take Bekunis

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

The normal dose is:

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

Use in children

• Children under 2 years: Do not use this medicine.
• Children from 2 to 6 years: this medicine should only be used under medical advice.
• Children from 6 to 12 years: maximum 1 tablet per day. Do not take 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. Nighttime intake will produce defecation approximately in 10 hours. If intake is in the morning, on an empty stomach, defecation will occur approximately in 6 hours.

If symptoms worsen, if no stool or defecation occurs within 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 diarrhea 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, fluids, and administration of mineral salts.

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

If you forget to take Bekunis

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Bekunis can cause side effects, although not everyone gets them.

During the period of use of bisacodyl medicines, the following side effects have been observed, whose frequency has not been established with precision.

The most frequent side effects have been digestive disorders such as abdominal pain or cramps, flatulence, abdominal distension, and slower intestinal movement.

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

The administration of bisacodyl for long periods of time can cause increased water loss, potassium salts, and other salts. This can lead to alterations in cardiac function, muscle weakness, and fatigue, particularly if diuretic and corticosteroid medications are administered at the same time.

If you think any of the side effects that you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Bekunis

Keep out of the reach and sight of children.

No special storage conditions are required.

Do not use BEKUNIS after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

6. Further information

Composition of Bekunis

• 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, methacrylic acid and ethyl acrylate copolymer (1:1), sucrose, gum arabic, calcium carbonate, polysorbate 80, titanium dioxide (E 171), stearic acid, liquid glucose, purified water, white wax, and montan wax.

Appearance of the product and packaging content

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

Marketing authorization holder

ROHA ARZNEIMITTEL GmbH

Am Tabakquartier 50 (Loft 20)

28197 Bremen

Germany

Manufacturer

Artesan Pharma GmbH & Co. KG

Wendlandstraße 1

29439 Lüchow

Germany

This leaflet was approved in October 2007

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/