Sofitol Syrup

Lactitol Monohydrate Syrup

Patient Information Leaflet: Information For the User
Patient Information Leaflet

Sofitol Syrup

Sofitol

Read all this information carefully before you start taking this medicine.

  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse.

What is there in this page?

  • What Sofitol Syrup is and what it is used for
    • What you need to know before you take Sofitol Syrup
    • How to take Sofitol Syrup
    • Possible side effects
    • How to store Sofitol Syrup
    • Contents of the pack and other information

1. What Sofitol Syrup is and what it is used for

Sofitol Syrup contains lactitol monohydrate, which belongs to a group of medicines known as osmotic laxatives.

It is used for:

  • Treatment of chronic constipation
  • Prevention and treatment of hepatic encephalopathy, a condition associated with liver disease where toxins such as ammonia accumulate in the body.

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.

2. What you need to know before you take Sofitol Syrup

Do not take Sofitol Syrup if you:

  • are allergic to lactitol or any of the other ingredients of this medicine
  • have appendicitis
  • have intestinal obstruction
  • have unexplained abdominal pain or intestinal bleeding
  • have galactosemia (a rare inherited disorder of galactose metabolism)

Warnings and precautions
Talk to your doctor or pharmacist before taking Sofitol Syrup if you:

  • have electrolyte imbalance or dehydration
  • are elderly or debilitated and require long-term treatment
  • have lactose intolerance or diabetes
  • are on a low-galactose diet
  • have faecal impaction, which should be treated before starting this medicine
  • have ileostomy

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:

  • Diuretics (e.g., thiazide diuretics)
  • Corticosteroids
  • Amphotericin B
  • Carbenoxolone

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.

3. How to take Sofitol Syrup

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

  • Drink adequate fluids during treatment.
  • The laxative effect may occur within a few hours, but in some patients it may take 2–3 days.

If you take more Sofitol Syrup than you should
Overdose may cause:

  • diarrhea
  • abdominal cramps
  • electrolyte imbalance

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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common or common

  • abdominal bloating
  • abdominal cramps
  • flatulence

These effects usually occur during the first 10 days of treatment and often decrease with continued use.

Less common

  • nausea
  • abdominal discomfort
  • dyspepsia
  • epigastric pain
  • urgent need to pass stool
  • stomach rumbling (borborygmi)
  • anal itching

Rare

  • vomiting

With excessive doses

  • diarrhea
  • electrolyte imbalance such as low potassium or high sodium levels
  • acid-base imbalance

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.

5. How to store Sofitol Syrup

  • Keep this medicine out of the sight and reach of children.
  • Store in a dry place at a temperature not exceeding 30°C.
  • Do not freeze.
  • Do not use this medicine after the expiry date printed on the pack.

6. Contents of the pack and other information

What Sofitol Syrup contains

Active substance:
Lactitol Monohydrate 10 g in 15 ml syrup

Other ingredients:

  • Benzoic Acid (preservative)
  • Aqueous base

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.

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