DULCOLAX / Dulcolax 5mg x 30 tablets
DULCOLAX tablets 5 mg. * 30
PACKAGE 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 your doctor or pharmacist has told you.
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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 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 pack and other information
1. What DULCOLAX is and what it is used for:
DULCOLAX is a topical laxative that stimulates intestinal peristalsis and softens stools.
As a laxative that exerts its therapeutic effect on the large intestine, DULCOLAX specifically stimulates the natural process of emptying the lower gastrointestinal tract. Therefore, DULCOLAX does not affect digestion, nor does it lead to the accumulation of calories or other nutrients in the small intestine.
DULCOLAX is used for:
use in patients with constipation (difficulty defecation).
preparation for diagnostic procedures, before and after surgical treatment and in conditions where defecation is required to be facilitated.
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 intestinal obstruction;
if you have an acute surgical abdomen, including appendicitis or acute intestinal 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 taking DULCOLAX:
if you need laxatives every day or for a long period of time, you should contact your doctor to determine the cause of your constipation, as prolonged use of high doses can lead to a disturbance of 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 urination, which may be symptoms of dehydration due to fluid loss and may 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 associated with constipation (difficulty defecation, abdominal pain) and are not necessarily related to the use 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, concomitant use of diuretics (water tablets) or steroids may increase the risk of electrolyte imbalance. Electrolyte imbalance may lead to increased sensitivity to cardiac glycosides (a group of medicines used in heart failure and irregular heart rhythms, such as 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, lactation 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.
As with all medicines, DULCOLAX should only be taken during pregnancy on medical advice. 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 constipation-related colic may make you feel dizzy and/or faint. If you experience colic, you should avoid potentially dangerous activities, such as driving or operating machinery.
DULCOLAX contains lactose and sucrose:
One tablet contains 33.2 mg lactose, resulting in 66.4 mg 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 hereditary galactose intolerance, e.g. galactosemia, should not take this medicinal product.
One tablet contains 23.4 mg sucrose, resulting in 46.8 mg 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 hereditary fructose intolerance 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 may be increased to a maximum of 2 tablets to induce regular bowel movements. Do not exceed the maximum daily dose of 2 tablets.
Children and adolescents: Children aged 10 years and over - 1-2 tablets (5-10 mg) daily. Start with 1 tablet. The dose may be increased to a maximum of 2 tablets to induce regular bowel movements. 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 bowel emptying, the recommended dosage for adults is 2 tablets (10 mg) taken in the morning and 2 tablets (10 mg) taken the evening before the examination and administration of an immediate-acting laxative (e.g. suppositories) the following 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 (e.g. suppositories) the following morning.
Method of application:
You should take the tablets in the evening to cause a bowel movement the next morning. The tablets should be swallowed whole with an appropriate amount of liquid (but not milk, see section "Taking DULCOLAX with food and drink").
The tablets should not be taken with products that reduce the acidity of the upper gastrointestinal tract, such as milk, antacids or proton pump inhibitors, to avoid premature dissolution of the enteric coating of the tablets.
If you take 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, may cause chronic diarrhoea, abdominal pain, low blood potassium, secondary hyperaldosteronism (increased production of the hormone aldosterone, which controls the levels of sodium and potassium in the blood) and kidney stones. Cases of renal tubular damage (a type of kidney disorder), metabolic alkalosis (a disorder of acid-base balance) and muscle weakness due to low blood potassium have been described 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 one.
If you stop taking DULCOLAX:
DULCOLAX should be taken only when necessary, and use should be discontinued when symptoms resolve.
If you have any further questions on 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;
abdominal pain;
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;
swelling of the skin and mucous membranes, which may cause difficulty in breathing (angioedema);
rapidly progressive, life-threatening allergic (anaphylactic) reactions;
dehydration (water loss);
inflammation of the colon, which causes abdominal pain and diarrhea/constipation;
Dizziness and fainting may be due to constipation (pain during defecation, abdominal pain) and may not be related to the use of bisacodyl.
Reporting side effects:
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to:
Executive Agency for Medicines,
8 Damyan Gruev Street,
1303 Sofia,
Tel.: +359 2 8903417,
website: www.bda.bg.
By reporting side effects, you can help provide more information about the safety of this medicine.
5. How to store DULCOLAX:
This medicinal product does not require any 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Package contents and additional information:
What DULCOLAX contains:
The active substance is: 5 mg bisacodyl.
The other ingredients are: lactose, corn 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 what the pack contains:
White opaque blisters placed in a cardboard box.
The package contains 10 or 30 gastro-resistant tablets.
Not all types of packaging can be released for sale.
Marketing Authorisation Holder:
SANOFI BULGARIA EOOD, Bulgaria.
Manufacturer:
Delpharm Reims, France.
Date of last revision of the leaflet: January 2018
