Description

How Supplied:

Bisacodyl F.C. tablets are presented as forms containing 5 mg Bisacodyl; every 10 tablets are packed in a blister and also every 10 blisters with a leaflet are packed in a box.

Category:

Bisacodyl is a laxative medicine used to treat: Constipation and bowel clearance before radiological procedures and surgery.

Administration:

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Administer with water and swallow whole tablet; do not break, chew, or crush; do not administer within 1 hour of antacids, milk, or dairy products.

Dosage and Administration:

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Constipation:

Usual adult dose:

• Take 5 to 15 mg once daily before bedtime. If you have not taken Bisacodyl 5mg laxative tablets before, start with one tablet and increase to two if necessary. When the bowel regularity has returned to normal, the dose can usually be stopped.

Bowel cleansing:

 Bowel cleansing prior to rectal examination:

Adults: 2 tablets (10 mg) twice a day, morning and evening before imaging or surgery.

Pediatrics:

The usual dose for children is:

• Children 3 to under 10 years: Limited data available in ages under 6 years: 5 mg once daily.
• Children 10 to under 12 years: 5 to 10 mg once daily.
• Children over 12 years and adolescents: 5 to 15 mg once daily.
• Children under 3 years: Bisacodyl tablets are not recommended for children under 3 years.

Adverse reactions:

Bisacodyl as like as other medicines, can cause side effects; although it doesn’t appear for everybody.

If you get any side effects, including not listed in this leaflet, talk to your doctor or pharmacist.

It should also be noted that there are no adverse reactions listed in the manufacturer’s labeling. But also there are some post marketing adverse reactions that have been reported like: Gastrointestinal abdominal pain, diarrhea, flatulence, ischemic colitis and headache.

Precautions:

• Do not chew or crush; do not use if you can’t swallow without chewing. Do not administer within 1 hour after taking an antacid, milk, or any dairy products.
• Consult a health care provider prior to use if stomach pain, nausea, vomiting, or a sudden change in bowel movements lasting more than 2 weeks occurs, or if you have already used a laxative, including Bisacodyl.
• Using more than 1 week may cause stomach discomfort, faintness, rectal burning, and mild cramps.
• Discontinue use and consult a health care provider if use of this tablet is needed more than 1 week.

 Do not take Bisacodyl 5mg tablets if you have: Bowel condition called “ileus” (blockage in the intestine), allergy to Bisacodyl, severe dehydration, intolerant to or cannot digest lactose, serious abdominal condition such as appendicitis or severe abdominal pain with nausea and vomiting, blocked bowel (intestinal obstruction) and inflammation of the bowel (small or large intestine).

Drug interactions:

Antacids should not be used within 1 hour before Bisacodyl administration because of possible diminishing of the therapeutic effect of Bisacodyl.

Inform your doctor if you are taking any of the following medicines: Furosemide, Prednisolone, other laxative medicines.

Pregnancy and breast feeding:

If you are pregnant, breast-feeding or there is possibility of being pregnant or there is a planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Use of Bisacodyl should be limited during pregnancy due to an increased risk of adverse events, such as electrolyte abnormalities. When dietary changes and lifestyle modifications are insufficient, agents other than Bisacodyl are recommended for the treatment of constipation in pregnant women.

Storage:

Store below 30^ºC. Protect from light and moisture.

Keep out of the reach of children.

Manufactured by Pursina Pharmaceutical Co.   

 Tehran-Iran