Lactitol Monohydrate Syrup

Read all this information carefully before you start taking this medicine.
Sofitol Syrup contains lactitol monohydrate, which belongs to a group of medicines known as osmotic laxatives.
It is used for:
Lactitol works by reaching the colon where it is broken down by intestinal bacteria, increasing water content in the stool and helping to promote bowel movement.
Do not take Sofitol Syrup if you:
Warnings and precautions
Talk to your doctor or pharmacist before taking Sofitol Syrup if you:
Long-term use of laxatives should be avoided unless recommended by your doctor.
If watery diarrhea occurs, reduce the dose or stop treatment and consult your doctor.
During treatment, blood electrolytes may need to be monitored, particularly in elderly patients.
Hydrogen gas may accumulate in the bowel during treatment. Patients undergoing procedures such as electrocauterisation may require bowel cleansing with a non-fermentable solution.
Lifestyle measures such as adequate fluid intake, fibre-rich diet and physical activity should be followed in the management of constipation.
Other medicines and Sofitol Syrup
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Sofitol Syrup may interact with:
These medicines may increase potassium loss, which can increase the risk of digitalis toxicity.
Taking broad-spectrum antibiotics may reduce the therapeutic effect of lactitol by altering intestinal bacteria.
Taking neomycin together with lactitol may increase the activity of neomycin.
Pregnancy and breast-feeding
Pregnancy: Lactitol is minimally absorbed after oral administration. However, there is limited information regarding its use during pregnancy. Animal studies have shown no harmful effects on fetal development. Sofitol Syrup should be used during pregnancy only if clearly necessary and prescribed by your doctor.
Breast-feeding: It is not known whether lactitol passes into breast milk. Since the drug is minimally absorbed, exposure to the infant is expected to be low. Your doctor will decide whether you should continue breastfeeding or take Sofitol Syrup.
Driving and using machines
Sofitol Syrup has no or negligible effect on the ability to drive or operate machines.
Always take this medicine exactly as your doctor has told you.
For constipation
Take once daily, preferably in the morning or evening with meals.
Adults: 15 to 30 ml per day.
Children:
• 2–6 years: 10 ml daily
• Above 6 years: 10–15 ml daily
Hepatic encephalopathy
Prevention: 30 ml once daily in the evening.
Treatment: 45 to 90 ml per day divided into three doses with meals.
Important advice
If you take more Sofitol Syrup than you should
Overdose may cause:
If this happens, contact your doctor immediately. Monitoring of serum electrolytes may be required.
If you forget to take Sofitol Syrup
Take the missed dose as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common or common
These effects usually occur during the first 10 days of treatment and often decrease with continued use.
Less common
Rare
With excessive doses
If any side effect becomes serious, contact your doctor.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist.
You can also report side effects to: medico@zorvia.com
Reporting side effects helps provide more information about the safety of this medicine.
What Sofitol Syrup contains
Active substance:
Lactitol Monohydrate 10 g in 15 ml syrup
Other ingredients:
What Sofitol Syrup looks like and contents of the pack
Sofitol Syrup is supplied in a 200 ml bottle.
Marketing Authorization Holder
Zorvia Healthcare Limited
Suite 4, 10th Floor, Centaurus, Central Avenue,
Hiranandani Estate, Ghodbunder Road,
Thane West, Maharashtra, India—400607.