BISACODYL DRG 5MG N30 N40

ATC code: A06AB02 

Active substances: Bisacodylum

Vendor, principal: Icn Polfa Rzeszow S.a.. 

 Prescription drug (℞) 

BISACODYL-GRINDEKS 5MG N40

Package leaflet: information for the user

BISACODYL-GRINDEKS, 5 mg gastroresistant tablets

Bisacodyl

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use 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.
•   Ask your pharmacist if you need more information or advice.
•   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
•   You must talk to a doctor if you do not feel better or if you feel worse after five days.
What is in this leaflet
1.   What Bisacodyl-Grindeks is and what it is used for
2.   What you need to know before you use Bisacodyl-Grindeks
3.   How to use Bisacodyl-Grindeks
4.   Possible side effects
6.   5. How to store Bisacodyl-Grindeks Contents of the pack and other information

1.   What Bisacodyl-Grindeks is and what it is used for

Bisacodyl-Grindeks contains the active ingredient bisacodyl. It is a synthetic laxative that acts directly on the colonic mucosa, which increases the colonic smooth muscle peristaltic contractions and causes colonic emptying.
If you take the medicine during daytime, the laxative effect will arrive in about 6 hours; if you take it before going to sleep it will take 8-12 hours.

Bisacodyl-Grindeks is used:

•   for short-term treatment of constipation not correctable with diet.
•   prior to surgical or diagnostic procedures (e.g. colonoscopy, radiological studies)

2.   What you need to know before you use Bisacodyl-Grindeks

Do not use Bisacodyl-Grindeks if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6),
•   if you have bowel emptying problems due to bowel obstruction or ileus,
•   if you have an acute surgical abdominal condition such as appendicitis or rectal bleeding;
•   if you are dehydrated;
•   if you have acute inflammatory bowel disease;
•   in children under the age of 6.

Warnings and precautions

Talk to your doctor or pharmacist before using Bisacodyl-Grindeks
-   if you are using any alkaline products or medicines. These products or medicines should also not be used for 1 hour before and after taking Bisacodyl-Grindeks;
-   if you have abdominal pain, nausea and you are vomiting.
As with other laxatives, long-term use of Bisacodyl-Grindeks should be avoided, so do not use Bisacodyl-Grindeks for longer than 5 days.
Your doctor will determine your need for Bisacodyl-Grindeks prior to a surgical or diagnostic procedure.

Children

Bisacodyl-Grindeks should not be used in children under the age of 6, as it is difficult for a child to swallow the pill without chewing it.

Other medicines and Bisacodyl-Grindeks

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Concomitant use of antacids, H₂-histamine receptor blockers (i.e. cimetidine, ranitidine, famotidine) or medicines called proton pump inhibitors may decrease the resistance of the tablet cover and cause overly rapid release of the active substance, which causes gastric and duodenal irritation.
Bisacodyl-Grindeks with food and drink
Concomitant use of Bisacodyl-Grindeks with alkaline products that decrease gastric acid levels (sodium hydrogen carbonate, alkaline mineral waters, milk) may cause gastrointestinal mucosal irritation.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Bisacodyl-Grindeks must only be used according to the doctor’s instructions during pregnancy and breast-feeding.

Driving and using machines

Bisacodyl-Grindeks has no effect on the ability to drive and use machines.
Bisacodyl-Grindeks contains sucrose, lactose and the dye sunset yellow (E110).
One Bisacodyl-Grindeks tablet contains 19.3 mg of sucrose and 81 mg of lactose monohydrate. Patients with rare hereditary disorders, such as fructose or galactose intolerance, lactase deficit, glucose-galactose malabsorption or sucrase-isomaltase deficiency must not use this medicine.
The polymer coating of the tablets contains the dye sunset yellow (E 110), which may cause allergic reactions.
3. How to use Bisacodyl-Grindeks Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Bisacodyl-Grindeks is taken before going to sleep.
The tablets should be swallowed whole without chewing.
Food has no effect on the absorption.
Adults and children over the age of 12
Constipation: the daily dose is 5-15 mg (1-3 tablets) as a single dose.

nights before or diagnostic

Prior to surgical or diagnostic procedures: 10 mg (2 tablets) before going to sleep for 2 the procedure.
Children aged 6-12
Constipation: the daily dose is 5-10 mg (1-2 tablets) as a single dose. Prior to surgical procedures: 5 mg (1 tablet) before going to sleep for 2 nights before the procedure.
Bisacodyl-Grindeks may not be used over 5 days without talking to a doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you take more Bisacodyl-Grindeks than you should

Bisacodyl overdose may cause severe diarrhoea, significant water and electrolyte (especially potassium) loss, and the development of small bowel or colonic inflammation or large bowel atony.
In case of bisacodyl overdose, please contact your doctor immediately!

4. Possible side effects OSSIBLE SIDE EFFECTS

Like all medicines, Bisacodyl-Grindeks can cause side effects, although not everybody gets them. Bisacodyl-Grindeks is usually well tolerated. However, you may experience the following side effects:
Rarely occurring side effects (less than 1 user in 10.000):
-   allergic reactions, including rare cases of angioedema and anaphylactic reactions;
-   abdominal pain
-   stomach cramps
Long term use of this medicine can cause:
-   weakness and impaired coordination;
-   a drop in blood pressure;
-   diarrhoea;
-   extensive loss of water and electrolytes
-   large bowel atony
-   hypokalaemia (low blood potassium)
Side effects are seen more frequently in elderly patients.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee/en. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Bisacodyl-Grindeks

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Bisacodyl-Grindeks contains

-   The active substance is bisacodyl.
Each gastroresistant tablet contains 5 mg of bisacodyl.
-   The other ingredients are:
Tablet contents: sucrose, lactose monohydrate, potato starch, talc, calcium stearate, methyl cellulose, polysorbate 80;
Polymer coating of the tablet: metacyl acid-ethyl acryolatecopolymer, talc, titanium dioxide (E 171), triethyl citrate, colouring sunset yellow (E 110).

What Bisacodyl-Grindeks looks like and contents of the pack

Bright orange round covered double-hollowed tablets. Tablet fold surface is white.
PVC and aluminium foil blisters 10 tablets in each blister pack.
4 blister packs (40 tablets) in the cardboard packaging.

Marketing Authorisation Holder and Manufacturer:

AS GRINDEKS.
Krustpils iela 53, Rīga, LV-1057, Latvia Tel.: +371 67083205 Fax: +371 67083505 E-mail: grindeks@ grindeks.lv
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
AS Grindeks Estonian branch Tondi 33.11316, 11316, Tallinn, Estonia Telephone: 612 02 24 Fax: 612 0331

This leaflet was last revised in September 2017.