Bisacodyl 10 mg (6 suppositories)

• Adults and children over 10 years: 1 suppository of 10 mg daily for immediate effect.
• Children from 2 to 10 years: 1 suppository of 5 mg daily for immediate effect.
• Children 10 years of age and younger children with chronic constipation can only be treated with bisacodyl on prescription.

Bisacodyl should not be used in children under 2 years of age.

BISACODYL suppositories 10 mg * 6 FOR ADULTS SOPHARMA

PACKAGE LEAFLET: USER
INFORMATION BISACODYL SOPHARMA 5 mg suppositories BISACODYL SOPHARMA 10 mg suppositories BISACODYL SOPHARMA 5 mg suppositories
BISACODYL SOPHARMA 10 mg suppositories

bisacodyl

Read all of this leaflet carefully as it contains important information for you.

This medicine can only be obtained without a doctor’s prescription. However, to get the best results from treatment. You must carefully follow the instructions for use of the medicinal product.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• You should seek medical attention if your symptoms worsen or do not improve after 5 days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Bisacodyl Sopharma suppositories are and what it is used
for 2. Before using Bisacodyl Sopharma suppositories
3. How to use Bisacodyl Sopharma Suppositories
4. Possible side effects
5. How to store Bisacodyl Sopharma suppositories
6. Further information

1. WHAT BISACODYL SOPHARMA SUPPOSITORIES ARE AND WHAT IT IS USED FOR

Bisacodyl in the form of suppositories is a laxative, purgative medicinal product. Bisacodyl stimulates colonic peristalsis by direct action on the nerve endings of the intestinal mucosa.
The product is used for short-term symptomatic treatment of constipation (constipation) in weakened tone and peristalsis of the colon, for cleansing the intestine before surgical or diagnostic procedures.

2. BEFORE USING BISACODYL SOPHARMA SUPPOSITORIES

Do not use Bisacodyl Sopharma suppositories

• if you are allergic (hypersensitive) to the active substance or any of the other ingredients of the product;
• if you have acute abdominal pain (it may be symptoms of a condition called an “acute abdomen” that requires surgery);
• if you have bleeding from the rectum (fissures, ragadi, hemorrhoids);
• in acute enterocolitis (inflammation of the small and large intestine);
• in intestinal obstruction;
• if you are dehydrated (dehydrated);
• if you have a colon tumor.

Pay special attention to the use of Bisacodyl Sopharma suppositories

• Do not administer for a long time (more than 5 days) for an unknown reason for constipation.
• Prolonged and unjustified use of the product should be avoided.
• Suppositories should be used with caution in elderly patients, patients with cardiovascular disease (low blood pressure, chronic heart failure), debilitated and patients with fever.
• The product should be used with caution in case of diagnostically unexplained abdominal pain, nausea and vomiting.
• Indefinite gastrointestinal discomfort lasting more than 2 weeks requires prior consultation with a doctor before using Bisacodyl Sopharma.
• Administration of higher doses can lead to the development of abdominal pain, mucus secretion and significant water loss.
• The product is used in cases where the hygienic and dietary measures taken (food rich in vegetables and fruits and increased physical activity) have not shown effectiveness.
• To be used under medical supervision in children under 10 years of age.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking cardiac glycosides (medicines to treat heart failure), diuretics (medicines for drainage), glachocorticoids (hormonal products), local anesthetics (painkillers), opiates.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy
Bisacodyl should not be used during pregnancy, especially during the first trimester, unless the benefit of its use for the mother outweighs the risk to the fetus.

Breast-feeding It is not recommended to use it during breast-feeding
. If treatment of the mother with Bisacodyl is necessary, it is recommended to consult a doctor.

Driving and using machines

Bisacodyl has no influence on the ability to drive and use machines.

3. HOW TO USE BISACODYL SOPHARMA SUPPOSITORIES

Always use Bisacodyl Sopharma suppositories exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.

Dosage

Short-term treatment of constipation (constipation)
Adults and children over 10 years: 1 suppository of 10 mg per day for immediate effect.
Children from 2 to 10 years: 1 suppository of 5 mg daily for immediate effect.
Children 10 years and younger children with chronic constipation can be treated with Bisacodyl after consulting the attending physician.
Bisacodyl should not be used in children under 2 years of age.

Preparation for diagnostic procedures or preoperative preparation
Should only be used under medical supervision.
Adults and children over 10 years
Each 2 tablets of bisacodyl (10 mg) in the morning and evening, followed by 1 suppository (10 mg) the next morning.
Children from 4 to 10 years 1 tablet of bisacodyl (5 mg) in the evening, followed by 1
suppository (5 mg) the next morning.

Route of administration

Bisacodyl Sopharma suppositories are administered rectally. They usually occur 30 minutes after administration.
The duration of treatment of constipation with the product should not be more than 7 days.

If you feel that the effect of the drug is very strong or too weak, please consult your doctor.

If you use more Bisacodyl Sopharma suppositories than you should

Abdominal colic, diarrhea with loss of a large amount of fluid and electrolytes (muscle weakness, low blood pressure, cardiac impairment) may be observed. If you have given a higher dose than prescribed, contact your doctor or the nearest medical institution.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Bisacodyl Sopharma suppositories can cause side effects, although not everybody gets them.
Side effects are mainly gastrointestinal tract.

Immune system
disorders Rare: hypersensitivity (allergic reactions);
Not known: anaphylactoid reactions, angioedema.

Metabolism and nutrition
disorders Not known: dehydration.

Gastrointestinal disorders
Common: abdominal pain, abdominal cramps; nausea and diarrhea;
Uncommon: vomiting, haematochezia (blood in the stool), abdominal dyscomforg, anorectal discomfort;
Not known: colitis.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE BISACODYL SOPHARMA SUPPOSITORIES

Store in the original package.
Store below 25°C.Keep out of the reach of children.

Do not use Bisacodyl Sopharma after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION

What Bisacodyl Sopharma suppositories contains

• The active substance is bisacodyl 5 mg or 10 mg.
• The other ingredients are: triglycerides, medium chain; solid mass.

What Bisacodyl Sopharma suppositories looks like and contents of the pack

Suppositories of regular torpedo shape and smooth surface, with white to pale yellow color. 6 suppositories of 5 or 10 mg in a blister of double-layer PVC/PE film, 1 blister per carton, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD,Bulgaria