INTRODUCTION

COLISPAS PAED 10/40MG DROPS is a combination of Dicyclomine and Dimethicone which belongs to the group of medicines called Antispasmodic agents and Anti-foaming agents respectively. It is used for the treatment of functional bowel/irritable bowel syndrome, gastric distension, functional digestive disorders and stomach pain in children.

Before giving COLISPAS PAED 10/40MG DROPS inform your doctor if your child have diarrhea, ulcerative colitis, thyroid problems, hypertension, liver problems, kidney problems or heart problems, history of allergy, intolerance to any food products and abdominal obstruction.

Your doctor will decide the right dose depends on your child’s age, body weight and disease condition. COLISPAS PAED 10/40MG DROPS may cause your child to sweat less, increasing his or her risk of heatstroke. Avoid overheating by avoiding strenuous work or exercise in hot weather and using hot baths.

Give the prescribed dose to your child orally before a meal or as directed by the doctor. Do not abruptly stop the medicine by yourself as it may bring back the symptoms or worsen your child’s condition.

The most common side effects of this medicine are dryness in the mouth, dizziness, weakness, sleepiness, nervousness, blurred vision and nausea. Contact your physician if any of the above symptoms worsen or persists for a longer duration.

If these side effects occur, they will subside once your child’s body adapts to the medicine. In case these side effects do not improve or become bothersome for your child, contact your doctor immediately.

USES OF COLISPAS PAED 10/40MG DROPS

It is used to treat:

• functional bowel/irritable bowel syndrome
• gastric distension
• functional digestive disorders
• stomach pain

HOW COLISPAS PAED 10/40MG DROPS WORKS

COLISPAS PAED 10/40MG DROPS is a combination of Dicyclomine and Dimethicone. Dicyclomine works by relaxing the muscles in the stomach and gut (intestine). It stops sudden contractions of the muscle (spasms), thereby relieving abdominal cramps and pain. Dimethicone works by disintegrating the gas bubbles and allowing easy passage of gas. Hence it helps to reduce the abdominal pain caused due to cramps, spasms and gas formation.

DIRECTIONS FOR USE

Give COLISPAS PAED 10/40MG DROPS to your child as advised by your physician. Shake well before use. Your physician will decide the correct dose and duration depending on your child’s age, body weight and disease condition.

SIDE EFFECTS OF COLISPAS PAED 10/40MG DROPS

HOW TO MANAGE SIDE EFFECTS

Nausea or Vomiting:

Give this medicine with or just after meals. Stick to simple meals. Avoid eating oily or spicy foods.

Dizziness:

Lie down until dizziness goes away and then move slowly and carefully. Give more amount of rest and drink more of fluids. Consult your physician if your symptom worsens.

Dry Mouth:

Give plenty of water frequently, do regular mouth rinses and use sugarless candy. Consult your doctor for advice.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Inform your physician if your child is taking any of the following medicine:

• medicines used as antiarrhythmics (prevent and treat a heart rhythm that's too fast or irregular)
• medicine used to treat allergies (Ex. chlorpheniramine)
• medicines used as antipsychotic (Ex. phenothiazines)
• medicines used as a sympathomimetic (Ex. amphetamine)
• medicines used to treat nausea and vomiting (Ex. metoclopramide)

Overdosage:

If your child accidentally took too much of COLISPAS PAED 10/40MG DROPS, consult your doctor immediately. Symptoms of overdose may include headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation including convulsion.

SYNOPSIS

MORE INFORMATION

• Keep out of reach of children
• Store COLISPAS PAED 10/40MG DROPS at room temperature

FAQs ABOUT COLISPAS PAED 10/40MG DROPS

Q: Is COLISPAS PAED 10/40MG DROPS can be used in patients with heart problems?

A: COLISPAS PAED 10/40MG DROPS should be used with caution if your child have heart problems. Contact your doctor before giving COLISPAS PAED 10/40MG DROPS.

Q: What are the symptoms of overdosage of COLISPAS PAED 10/40MG DROPS?

A: If your child accidentally took too much of COLISPAS PAED 10/40MG DROPS, consult your doctor immediately. Symptoms of overdose may include headache, nausea, vomiting, blurred vision, dilated pupils, hot dry skin, dizziness, dryness of the mouth, difficulty in swallowing and CNS stimulation including convulsion.

Q: When to seek medical emergency while giving COLISPAS PAED 10/40MG DROPS?

A: Stop giving COLISPAS PAED 10/40MG DROPS and contact your physician immediately if your child experience fever and heat stroke (due to decreased sweating) and experience high and long-lasting pain in the abdomen.

Q: How to give COLISPAS PAED 10/40MG DROPS?

A: Give COLISPAS PAED 10/40MG DROPS as advised by your physician. Shake well before use. The correct dose and duration will be decided by your physician for you depending on your age, body weight and disease condition.

Q: When not to use COLISPAS PAED 10/40MG DROPS?

A: Before giving COLISPAS PAED 10/40MG DROPS inform your doctor if your child have diarrhea, ulcerative colitis, thyroid problems, hypertension, liver problems, kidney problems or heart problems, history of allergy, intolerance to any food products and abdominal obstruction.

REFERENCES

1. K.D. Tripathi. Antiemetic, Prokinetic and Digestant Drugs and Anticholinergic Drugs and Drugs Acting on Autonomic Ganglia. Essentials of medical pharmacology. Seventh edition. 2013. Page – 663, 117.

2. P L B J Lucassen, W J J Assendelft, J W Gubbels, J T M van Eijk, W J van Geldrop and A Knuistingh Neven. Effectiveness of treatments for infantile colic: systematic review. National Library of Medicine. May 1998, [Accessed on 4th July 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC28556/

3. Dicyclomine and Dimethicone. [Accessed on 4th July 2022] https://www.leeford.in/product/327/spastone

4. Dicyclomine and Dimethicone. [Accessed on 4th July 2022] https://www.unibytekids.com/goncid-kid

5. Dicyclomine and Dimethicone. [Accessed on 4th July 2022] https://www.dmpharma.co.in/Dicyclomine%20+%20Activated%20Dimethicone%20Drops.html

6. Dicyclomine and Dimethicone. [Accessed on 4th July 2022] https://www.biotichealthcare.com/pharma-products/Kidomine10-Drops

7. Axcan Pharma US, Inc. U.S. Food & Drug Administration. [Revised on July 2011] [Accessed on 4th July 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/007409s041lbl.pdf