Lactusoft Syrup 200ml

INTRODUCTION

LACTUSOFT contains Lactulose which belongs to the group of medicines called Laxatives. It is used to treat constipation (infrequent bowel movements, hard and dry stools) and hepatic encephalopathy. Hepatic encephalopathy is a decline in brain function due to liver disease that causes symptoms like confusion, tremor and decreased level of consciousness, also it can lead to hepatic coma.

LACTUSOFT is not recommended for use in patients with a serious genetic disorder where you cannot digest galactose (galactosaemia), acute inflammatory bowel disease, blockage in bowels (apart from normal constipation), gastro-intestinal perforation or risk of perforation or stomach pain due to an unknown cause.  During treatment with LACTUSOFT, you should drink enough fluids (about 6 - 8 glasses).

Before taking LACTUSOFT, inform your doctor if you are lactose intolerant or have diabetes or roemheld syndrome. LACTUSOFT should be used with caution in pregnant and breastfeeding women only if clearly advised by the doctor. LACTUSOFT is usually not recommended for use in infants and smaller children but your child’s doctor may prescribe it in certain circumstances.

It should be used with caution in elderly patients (aged 65 years and above) and your doctor may check your blood electrolytes when this medicine is taken for more than 6 months period or in patients with bad general conditions. The most common side effects of taking LACTUSOFT are flatulence, stomach pain, nausea, vomiting, or diarrhoea. Consult your doctor if any of the side effects worsen.

USES OF LACTUSOFT

Treats,

• constipation
• hepatic encephalopathy

HOW LACTUSOFT WORKS

LACTUSOFT works by making the stool softer and easier to pass, by drawing more water into the bowel. It also reduces the amount of ammonia in the blood by removing the toxin from the bloodstream which helps to improve cognitive functions.

DIRECTIONS FOR USE

Take LACTUSOFT as advised by your physician. Shake well before use. Use a measuring cup or spoon and swallow the medicine immediately, do not keep it in your mouth for long. You can mix this medicine with fruit juice or water. It is recommended that you drink plenty of fluids (6-8 glasses). Your doctor will decide the correct dose and duration for you according to your age, body weight and disease condition.

SIDE EFFECTS OF LACTUSOFT

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take LACTUSOFT with or just after meals. Stick to simple meals. Avoid eating oily, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.

Diarrhoea:

Drink lot of fluids such as water to keep yourself hydrated. Avoid eating high-fat or spicy foods. Do not take any medicine on your own to treat diarrhoea without consulting your doctor.

Stomach pain:

Try to rest and relax. Eat and drink slowly or try to eat smaller meals more frequently. Keep a heating pad on your stomach. If the stomach pain does not improve, consult your doctor.

Flatulence:

Eat smaller and frequent meals and exercise regularly (like walking). Limit the intake of carbonated drinks. Avoid eating foods such as beans and lentils. If the symptom does not show improvement, consult your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking LACTUSOFT, inform your doctor if you are taking any of the following medicines:

• medicines used to treat fluid retention (Ex. chlorthalidone, hydrochlorothiazide)
• medicines used to treat inflammatory conditions (Ex. hydrocortisone, prednisolone)
• amphotericin B (used to treat serious fungal infections)
• medicines used to treat heart insufficiency (Ex. digitalis, digoxin)
• 5-aminosalicylic acid (5-ASA) such as mesalamine (used to treat inflammatory bowel disease such as crohn’s disease)

Overdosage:

If you or anyone else accidentally take too much of LACTUSOFT, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of LACTUSOFT are diarrhoea, loss of electrolytes and abdominal pain.

SYNOPSIS

MORE INFORMATION

• Keep LACTUSOFT out of reach of children
• Store at room temperature

FAQs ABOUT LACTUSOFT

Can LACTUSOFT be given to infants?

LACTUSOFT is usually not recommended for use in infants and smaller children as it can disturb the normal reflexes for passing stools. Your child’s doctor will decide the correct dose or select a suitable alternative treatment for your child. In special situations, your doctor may prescribe it for your baby, and they will supervise the treatment closely.

Can LACTUSOFT cause diarrhoea?

LACTUSOFT may cause diarrhoea when you take a higher than the recommended dose of it. In such cases, drink a lot of fluids, such as water to keep yourself hydrated. Do not take any medicine on your own to treat diarrhoea without consulting your doctor. If diarrhoea does not improve, consult your doctor immediately.

Can LACTUSOFT be used during pregnancy?

LACTUSOFT should be used with caution in pregnant women only if clearly advised by your doctor. Consult your doctor before taking LACTUSOFT if you are pregnant or planning to get pregnant.

What if I forget to take a dose of LACTUSOFT?

If you forget to take a dose of LACTUSOFT, take it as soon as you remember. However, omit the missed dose if it is almost time for your next dose. Do not take LACTUSOFT twice to make up for the forgotten dose.

Can I stop taking LACTUSOFT on my own?

Continue taking LACTUSOFT until your doctor tells you to stop, unless you experience any unwanted effects, worsening of your condition or any new symptoms. In such a case, contact your doctor right away. If you stopped taking it suddenly, the expected benefit of the treatment may not be achieved.

REFERENCES

1. KD. Tripathi. Drugs for Constipation and Diarrhea. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 676.

2. Wesselius-De Casparis, A., Braadbaart, S., Bergh-Bohlken, G. E. and Mimica, M. Treatment of chronic constipation with lactulose syrup: results of a double-blind study. NIH National Library of Medicine, National centre for biotechnology information. PubMed Central. February 1968. [Accessed on 20th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1552607/pdf/gut00703-0098.pdf

3. Institute of Liver and Biliary Sciences, India. To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in February 2018] [Accessed on 20th July 2022] https://clinicaltrials.gov/ct2/show/NCT03448770

4. Abbott Biologicals B.V. Electronic Medicines Compendium (EMC). [Revised in April 2022] [Accessed on 20th July 2022] https://www.medicines.org.uk/emc/files/pil.5525.pdf

5. Braintree Laboratories, Inc. U.S. Food & Drug Administration. [Revised in February 2020] [Accessed on 20th July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211281s000lbl.pdf

6. Fresenius Kabi Austria GmbH. Health Products Regulatory Authority (HPRA). [Revised in May 2022] [Accessed on 20th July 2022] https://www.hpra.ie/img/uploaded/swedocuments/34c1e172-9c2b-4d3e-a53d-e021122ee5f9.pdf

USEFUL DIAGNOSTIC TESTS

• MRI defecography
• CT scan
• Electroencephalogram (EEG)