INTRODUCTION

CONSTICALO 2MG contains Prucalopride which belongs to the group of medicines called Gastrointestinal prokinetics. It is used to treat long standing/chronic constipation in adults in whom conventional medicines used to treat constipation (laxatives) are ineffective. Constipation is a condition that occurs when bowel movements become less frequent, and stools become difficult to pass which generally occurs due to changes in diet or inadequate intake of fibre food. It is characterized by symptoms such as hard, dry, or lumpy stools that are painful or difficult to pass; or having a feeling that stool has not passed at all.

Prucalopride is a gastrointestinal prokinetic agent that works by activating certain receptors in the intestinal walls that cause contractions in the walls resulting in increased frequency of passing stools in the constipated individuals, thereby providing relief from constipation.

CONSTICALO 2MG is not recommended for use in patients undergoing renal dialysis. It is also not recommended for use in patients suffering from perforation/obstruction of the gut wall, severe inflammation of the intestinal tract (such as crohn’s disease, ulcerative colitis or toxic megacolon/megarectum) and in patients who had recent bowel surgery. It should be used with caution in patients with heart disease, serious lung disease, severe kidney or liver disease.

CONSTICALO 2MG is not recommended for use in pregnant and breastfeeding women. It is also not recommended for use in children and adolescents (below 18 years of age). The common side effects associated with the use of CONSTICALO 2MG are headache, nausea, diarrhoea, abdominal pain, decreased appetite, dizziness, and vomiting. Contact your doctor or nearby hospital if any of the condition worsens.

USES OF CONSTICALO 2MG

• Treats chronic constipation in adults

HOW CONSTICALO 2MG WORKS

CONSTICALO 2MG helps in relieving constipation, where prucalopride works by activating certain receptors in the intestinal walls causing contractions which results in increased frequency of passing stools in constipated individuals, thereby providing relief from constipation.

DIRECTIONS FOR USE

Take CONSTICALO 2MG as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and severity of the condition.

SIDE EFFECTS OF CONSTICALO 2MG

HOW TO MANAGE SIDE EFFECTS

Diarrhoea:

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhoea and consult your doctor if the symptom gets worse.

Nausea or vomiting:

Try to take CONSTICALO 2MG with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

Decreased appetite:

Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Consult your doctor if the symptom gets worse.

Headache:

Take rest and drink plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching screen for long time. Consult your doctor if the condition persists for long or gets worsened.

Dizziness:

Lie down until dizziness passes away and get up slowly. Do not bend down suddenly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids. Avoid drinking alcohol or smoking. Consult your doctor if the condition persists for long or gets worsened.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions

Before taking CONSTICALO 2MG, inform your doctor, if you are taking any of the following medicines:

• medicines used to treat fungal infections Ex. ketoconazole
• medicines used to treat bacterial infections Ex. erythromycin
• atropine (used to treat symptoms of low heart rate)
• warfarin (medicine used for preventing blood clots)
• digoxin (medicine used to treat heart failure and abnormal heart rhythms)
• paroxetine (medicine used to treat depression, panic attacks, obsessive-compulsive disorder, anxiety disorders, and post-traumatic stress disorder)
• oral contraceptives such as ethinyl estradiol, norethindrone (used to prevent pregnancy)

Overdosage:

If you or anyone else accidentally takes too much of CONSTICALO 2MG, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are diarrhoea, headache and nausea.

SYNOPSIS

MORE INFORMATION

• Keep the medicine out of reach in children
• Store CONSTICALO 2MG at room temperature

FAQs ABOUT CONSTICALO 2MG

What is CONSTICALO 2MG used for?

CONSTICALO 2MG is used to treat chronic/long standing constipation in adults in whom other laxatives are ineffective. Constipation is a condition that occurs when bowel movements become less frequent, and stools become difficult to pass which generally occurs due to changes in diet or inadequate intake of fibre food. Consult your doctor before taking this medicine.

What happens if you take more CONSTICALO 2MG than your required dose?

If you or anyone else accidentally takes too much of CONSTICALO 2MG, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are diarrhoea, headache and/or nausea.

What side effects are seen with CONSTICALO 2MG?

The common side effects associated with the use of CONSTICALO 2MG are headache, nausea, diarrhoea, abdominal pain, decreased appetite, dizziness, and vomiting. Contact your doctor or visit the nearby hospital if any of the condition worsens.

Who should avoid taking CONSTICALO 2MG?

CONSTICALO 2MG is not recommended for use in patients undergoing renal dialysis and in patients suffering from perforation or obstruction of the gut wall, or severe inflammation of the intestinal tract such as crohn’s disease, ulcerative colitis or toxic megacolon/megarectum and who had recent bowel surgery. It is not indicated for use in pregnant and breastfeeding women. It is also not recommended for use in children and adolescents (below 18 years of age).

Is CONSTICALO 2MG safe to use in children or elderly patients?

CONSTICALO 2MG is not recommended for use in children and adolescents (below 18 years). It should be used cautiously in elderly patients (above 65 years of age). Consult your doctor before taking CONSTICALO 2MG.

How does CONSTICALO 2MG work?

CONSTICALO 2MG helps in relieving constipation, where prucalopride which is a gastrointestinal prokinetic that works by activating certain receptors in intestinal walls, causing contractions in the intestinal walls, thereby increasing the frequency of passing stools in constipated individuals.

Can I drive or use heavy machinery after taking CONSTICALO 2MG?

Do not drive or operate heavy machines if you feel dizziness or tiredness after taking CONSTICALO 2MG due to safety concerns. Consult your doctor before taking this medicine.

How to take CONSTICALO 2MG?

Take CONSTICALO 2MG as advised by your physician. It can be taken with or without food, at any time of the day. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and severity of the condition.

What if I forget to take a dose of CONSTICALO 2MG ?

You should take CONSTICALO 2MG immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

When to stop taking CONSTICALO 2MG ?

Do not stop taking CONSTICALO 2MG without discussing with your doctor. If you stop taking CONSTICALO 2MG without the doctor’s recommendation, constipation may recur and affects the regular bowel habits.

REFERENCES

1. KD. Tripathi. Drugs for Constipation and Diarrhea. Essentials of medical pharmacology. Seventh edition. 2013. Page – 675.

2. Anam Omer, Eamonn M.M. Quigley. An update on prucalopride in the treatment of chronic constipation. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. October 2017. [Assessed on 12th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5673021/#:~:text=Constipation%20may%20complicate%20several%20neurological,improving%20frequency%20of%20bowel%20movements

3. Movetis. Efficacy and Safety Study of Prucalopride for the Treatment of Chronic Constipation. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in April 2013] [Accessed on 12th July 2022] https://clinicaltrials.gov/ct2/show/NCT00483886

4. Sanico NV. Electronic Medicines Compendium (EMC). [Revised in June 2022] [Assessed on 12th July 2022] https://www.medicines.org.uk/emc/files/pil.584.pdf

5. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resotrans 1 mg and 2 mg tablets. [Revised in August 2021] [Assessed on 12th July 2022] https://www.medsafe.govt.nz/Consumers/cmi/r/resotrans.pdf