DULCOLAX 5mg x 30 tabl
DULCOLAX tablets 5 mg. * 30
LEAFLET: INFORMATION FOR THE USER
DULCOLAX 5 mg gastro-resistant tablets
DULCOLAX 5 mg gastro-resistant tablets
Bisacodyl (Bisacodyf)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine is available without a prescription. Always take this medicine exactly as described in this leaflet or as prescribed by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What DULCOLAX is and what it is used for
2. What you need to know before you take DULCOLAX
3. How to take DULCOLAX
4. Possible side effects
5. How to store DULCOLAX
6. Contents of the package and additional information
1. What DULCOLAX is and what it is used for:
DULCOLAX is a locally acting laxative that stimulates intestinal peristalsis and softens stools.
As a laxative that exhibits its therapeutic effect on the large intestine, DULCOLAX stimulates in a specific way the natural process of emptying the lower part of the gastrointestinal tract. Therefore, DULCOLAX does not affect digestion, and does not lead to the accumulation of calories or other nutrients in the small intestine.
DULCOLAX is used for:
application in patients with constipation (difficult bowel movements).
preparation for diagnostic procedures, before and after surgical treatment and for conditions that require the facilitation of defecation.
2. What you need to know before you take DULCOLAX:
Do not take DULCOLAX:
if you are allergic to bisacodyl or any of the other ingredients of this medicine (listed in section 6);
if you have a bowel obstruction or bowel obstruction;
if you have an acute surgical abdomen, including appendicitis or acute bowel inflammation;
if your body is severely dehydrated;
if you have acute abdominal pain accompanied by nausea and vomiting - this may be indicative of more serious conditions;
if you have rare congenital diseases that may lead to incompatibility with some of the excipients of the medicinal product (see section DULCOLAX contains lactose and sucrose).
Warnings and precautions:
Talk to your doctor or pharmacist before you start taking DULCOLAX:
if you need laxatives every day or for a long period of time, you should contact your doctor to find out the cause of the constipation, since the long-term administration of high doses can lead to a violation of the water and electrolyte balance and a decrease in the level of potassium in the blood (hypokalemia);
if you notice a feeling of thirst or increased urine output, which can be symptoms of dehydration due to fluid loss and can be harmful in elderly patients and in patients with kidney disorders - you should stop taking DULCOLAX and contact your doctor.
Blood may appear in the stool, but this is usually mild and resolves spontaneously.
Dizziness and/or fainting have been reported in patients treated with DULCOLAX.
These adverse events may be related to constipation (difficulty in defecation, abdominal pain) and are not necessarily related to the administration of bisacodyl.
DULCOLAX does not help with weight loss.
Other medicines and DULCOLAX:
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Concomitant use with other laxatives may increase the side effects of DULCOLAX.
When taking high doses of DULCOLAX, the simultaneous use of diuretics (drainage agents) or steroids may increase the risk of electrolyte imbalance. Electrolyte imbalance can lead to increased sensitivity to cardiac glycosides (a group of drugs used in heart failure and irregular heart rhythm, eg digoxin).
The tablets have a special coating and should not be taken with medicinal products that reduce the acidity of the upper gastrointestinal tract, such as antacids or proton pump inhibitors.
Taking DULCOLAX with food and drink
The tablets have a special coating and should not be taken with products that reduce the acidity of the upper gastrointestinal tract, such as milk.
Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Like all medicinal products, DULCOLAX should be taken during pregnancy only with a doctor's prescription. DULCOLAX can be taken during breastfeeding.
Driving and using machines:
No studies have been conducted on the effects of DULCOLAX on the ability to drive and use machines.
However, you should be aware that due to the colic associated with constipation, you may experience dizziness and/or fainting. If you develop colic, you should avoid potentially dangerous activities such as driving and operating machinery.
DULCOLAX contains lactose and sucrose:
One tablet contains 33.2 mg of lactose, resulting in 66.4 mg of lactose in the maximum recommended daily dose for the treatment of constipation in adults and children over 10 years of age. In preparation for radiographic examinations, this results in 132.8 mg in the maximum recommended daily dose. Patients with congenital intolerance to galactose, eg galactosemia, should not take this medicinal product.
One tablet contains 23.4 mg of sucrose (sucrose), resulting in 46.8 mg of sucrose (sucrose), in the maximum recommended daily dose for the treatment of constipation in adults and children over 10 years of age. In preparation for radiographic examinations, this results in 93.6 mg in the maximum recommended daily dose. Patients with congenital intolerance to fructose should not take this medicinal product.
3. How to take DULCOLAX
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is:
For constipation:
Adults: 1-2 tablets (5-10 mg) daily. Start with 1 tablet. The dose can be increased to a maximum of 2 tablets to induce regular defecation. Do not exceed the maximum daily dose of 2 tablets.
Children and adolescents: Children aged 10 years and older - 1-2 tablets (5-10 mg) daily. Start with 1 tablet. The dose can be increased to a maximum of 2 tablets to induce regular defecation. Do not exceed the maximum daily dose of 2 tablets.
In preparation for examinations and before surgery: In preparation for examinations and before surgery, the administration of DULCOLAX should be carried out under medical supervision.
Adults: To achieve complete emptying of the intestinal tract, the recommended dosage for adults is 2 tablets (10 mg) taken in the morning and 2 tablets (10 mg) taken in the evening before the examination and administration of an immediate-acting laxative (e.g. suppositories) on the next morning.
Children and adolescents: The recommended dosage for children 4 years of age and older is 1 tablet (5 mg) taken in the evening and administration of an immediate-acting laxative for children (eg suppositories) the next morning.
Application method:
You should take the tablets in the evening to induce a bowel movement the next morning. The tablets should be swallowed whole, with the appropriate amount of liquid (but not milk, see section "Taking DULKOLAX with food and drink").
The tablets should not be taken with products reducing the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, in order not to prematurely dissolve the gastro-resistant coating of the tablets.
If you have taken more DULCOLAX than you should:
If you take more DULCOLAX than you should, you should seek advice from your doctor or pharmacist.
If high doses are taken, watery stools, abdominal cramps, and loss of fluid, potassium, and other electrolytes may occur.
Chronic overdose with DULCOLAX, as with all medicinal products, can cause chronic diarrhea, abdominal pain, low blood potassium, secondary hyperaldosteronism (increased production of the hormone aldosterone, which controls sodium and potassium levels in the blood), and kidney stone disease. Cases of renal tubule damage (a type of kidney failure), metabolic alkalosis (acid-base imbalance) and muscle weakness due to low blood potassium have been reported as a result of chronic laxative abuse.
If you forget to take DULCOLAX:
If you miss a dose, take it as soon as you remember, but do not take a double dose to make up for the missed dose.
If you stop taking DULCOLAX:
DULCOLAX should be taken only when needed and should be discontinued when symptoms subside.
If you have any further questions related to the use of this product, please ask your doctor or pharmacist.
4. Possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people):
abdominal cramps;
stomach ache;
diarrhea;
nausea
Uncommon (may affect up to 1 in 100 people):
dizziness;
abdominal discomfort;
vomiting;
blood in the stool;
discomfort in the anus and rectum.
Rare (may affect up to 1 in 1,000 people):
hypersensitivity;
edema (swelling) of the skin and mucous membranes, which may cause difficulty in breathing (angioedema);
rapidly progressing, life-threatening allergic (anaphylactic) reactions;
dehydration (loss of water);
inflammation of the colon that causes abdominal pain and diarrhea/constipation;
Dizziness and fainting may be due to constipation (pain during defecation, abdominal pain) and not related to the use of bisacodyl.
Reporting Adverse Reactions:
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report side effects directly to:
Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
Tel.: +359 2 8903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store DULCOLAX:
This medicinal product does not require special storage conditions. Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information:
What DULCOLAX contains:
The active substance is: 5 mg bisacodyl.
The other ingredients are: lactose, maize starch, soluble starch, glycerol, magnesium stearate, sucrose, talc, gum arabic, titanium dioxide, eudragit L100 and S100, castor oil, macrogol 6000, yellow iron oxide (E172), white beeswax, carnauba wax, shellac.
What DULCOLAX looks like and contents of the pack:
White opaque blisters placed in a cardboard package.
The package contains 10 or 30 gastro-resistant tablets.
Not all types of packaging can be put on sale.
Marketing Authorization Holder:
SANOFI BULGARIA EOOD, Bulgaria.
Manufacturer:
Delpharm Reims, France.
Date of last revision of leaflet: January 2018
