BISACODYL SUPP 0.01G N10 (NIŽFARM) N40

ATC code: A06AB02 

Active substances: Bisacodylum

Vendor, principal: Nizhpharm Jsc. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

BISACODYL GSK 10MG N10

Package leaflet: Information for the user

BISACODYL GSK, 10 mg rectal suppositories

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 5 days.

What is in this leaflet:

1.   What BISACODYL GSK is and what it is used for
2.   What you need to know before you use BISACODYL GSK
3.   How to use BISACODYL GSK
4.   Possible side effects
5.   How to store BISACODYL GSK
6.   Contents of the pack and other information

1. What BISACODYL GSK is and what it is used for

Bisacodyl is used for short-term symptomatic treatment of constipation if the constipation is not corrected by diet, including habitual constipation and chronic constipation in bed-ridden and elderly patients.
Bisacodyl acts directly on the bowel mucosa, increasing peristaltic contractions and causing a laxative effect.
If you take the medicine during a day the effect will arrive in about 6 hours; if you take it before going to sleep, it will take 8-12 hours.

2. What you need to know before you use BISACODYL GSK Do not use BISACODYL GSK

-   if you are allergic to bisacodyl or any other ingredients of this medicine (listed in section 6) ;
-   if you have unclear abdominal pain, related to nausea or vomiting, appendicitis, ileus, inflammatory bowel disease, rectal diseases, acute peritoneal diseases (including peritonitis), severe dehydration, anal fissures and other conditions in which the use of laxatives is contraindicated.
Bisacodyl suppository use in children on contraindicated.

Warnings and precautions

Talk to your doctor or pharmacist before using BISACODYL GSK
Similarly to other laxatives bisacodyl may not be used for more than 5 days without investigating the cause of constipation. Long-term use of bisacodyl may lead to tolerance where defecation is only possible after the administration of a laxative.
Too frequent administration of bisacodyl can, especially in the elderly, cause increasing weakness and orthostatic hypotension (a drop in blood pressure after standing up) and coordination disorders due to fluid and electrolyte loss. Bisacodyl may decrease serum potassium content.
Vertigo and/or loss of consciousness have been reported during defecation that is due to defecation-related strain or reaction to abdominal pain.
Patients have experienced bloody stools, which is generally mild and disappears without treatment. Sporadic cases of abdominal pain and bloody stools have been reported.
Use of suppositories may cause pain and local irritation, especially in patients with anal fissures and ulcerative colitis.
Bisacodyl GSK should not be given to children under 10 years of age without consulting a doctor. This medication is not intended for losing weight.
Other medicines and BISACODYL GSK
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. Bisacodyl may decrease serum potassium content and increase the effect of cardiac glycosides. Bisacodyl increases the potassium-excreting effect of diuretics and corticosteroids.
BISACODYL GSK with food and drink
Bisacodyl is usually administered before going to sleep or before breakfast.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist for advice before taking this medicine.
This medicine should not be used during pregnancy or breast-feeding, unless directed by a physician.
Driving and using machines
Bisacodyl is considered safe and has no effect on the ability to drive and use machines.
3. HOW TO USE BISACODYL GSK
Always use this medicine exactly as described in this leaflet or as a doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Bisacodyl GSK suppositories are usually administered before breakfast.
The recommended dose is:
Adults and children over 10 years: 1 suppository (10 mg) once daily. The suppository should be inserted deep into the rectum.
If you feel that the effect of BISACODYL GSK is too strong or too weak, talk to your doctor or pharmacist.
If you use more BISACODYL GSK than you should
Large doses of bisacodyl can cause diarrhoea, abdominal cramps and loss of potassium and other electrolytes. Turn to the doctor immediately if you suspect overdose.
If you forget to use BISACODYL GSK
Do not use a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most often, abdominal pain and diarrhoea have been reported during treatment.
Side effects have been listed according to organ system and frequency: common (may occur in up to 1 patient of 10), uncommon (may occur in up to 1 patient of 100), rare (may occur in up to 1 patient of 1000).
Immune system disorders
Rare: anaphylactic reactions, tissue swelling (angioedema), hypersensitivity
Metabolism and nutrition disorders:
Rare: dehydration
Nervous system disorders Uncommon: vertigo Rare: fainting
Gastrointestinal disorders
Common: abdominal cramps, abdominal pain, diarrhoea, nausea
Uncommon: bloody stools, vomiting, unpleasant feeling in abdomen, unpleasant feeling in rectum Rare: colitis
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. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store BISACODYL GSK
Keep this medicine out of the sight and reach of children. Do not store above 25C.
Do not use this medicine after the expiry date, which is 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 GSK contains
-   The active substance is bisacodyl. One rectal suppository contains 10 mg of bisacodyl
-   The other ingredients are:
Microcrystal wax (Paracera M)
Inactive fat (Witepsol H 15)
What BISACODYL GSK looks like and contents of the pack
Torpedo-shaped suppository of an even white to creamy colour.
10 mg suppository, 5 or 10 pcs OVC/PE folium blister packaging with information leaflet Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GlaxoSmithKline Pharmaceuticals S.A., Grunwaldzka 189, Poznan, Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Estonia OÜ Löötsa 8a 11415 Tallinn Telephone: 6 676 900

This leaflet was last revised in February 2017.