Colicure Sus

COLICURE SUS by EMPIAI PHARMACEUTICALS LTD

COLICURE SUS is an oral suspension primarily used to manage gastrointestinal disorders. It is also available in syrup and drop forms, such as Colicure Syrup and Colicure Drops.

Composition

COLICURE SUS contains two main active ingredients:

• Dicyclomine (10 mg): An antispasmodic agent that relaxes smooth muscles in the gastrointestinal tract, reducing abdominal pain, cramping, and bowel spasms by decreasing acetylcholine activity.
• Simethicone (40 mg) / Dimethicone: An anti-foaming agent that works by breaking down gas bubbles in the stomach and intestines, facilitating the easy passage of gas and reducing bloating and flatulence.

Uses

COLICURE SUS is prescribed for the management of various gastrointestinal conditions, including:

• Irritable Bowel Syndrome (IBS), relieving symptoms like abdominal pain, cramps, and spasms.
• Excess gas in the stomach and intestines, addressing discomfort, bloating, and flatulence.
• Abdominal pain, cramps, and digestive spasms.
• Acid Peptic Disease, by reducing gastrointestinal spasms and controlling excessive GI secretions.

Dosage and Administration

COLICURE SUS is administered orally. The exact dosage and duration should be prescribed by a doctor, as it varies based on the severity of symptoms and the patient's response.

• It can generally be taken with or without food, though taking it with meals may help reduce stomach upset.
• For infants older than 6 months, a typical dose might be 5 mg orally every 6-8 hours, not exceeding 20 mg/day. For older children, 10 mg orally every 6-8 hours, not exceeding 40 mg/day, may be prescribed.
• The medicine bottle should be shaken well before use, and the exact quantity measured with a spoon or cup.
• It is important to adhere to the prescribed dosage and complete the full course of treatment.

Side Effects

Common side effects of COLICURE SUS may include:

• Dry mouth, nose, and throat
• Constipation
• Nausea and vomiting
• Headache
• Weakness
• Dizziness and drowsiness
• Blurred vision
• Nervousness Most side effects are temporary and usually resolve with time. If any side effects persist or worsen, medical consultation is advised.

Precautions

• Allergies: Do not use if allergic to dicyclomine, simethicone, or any other ingredients.
• Age Restrictions: While designed for children, its safety and effectiveness have not been established for children below 12 years of age for some formulations, and it is not recommended for children younger than six months of age.
• Medical Conditions: Exercise caution and consult a doctor if the patient has liver or kidney health issues, glaucoma (dicyclomine can increase eye pressure), myasthenia gravis (may worsen muscle weakness), severe ulcerative colitis (can cause complications like toxic megacolon), enlarged prostate, or heart diseases.
• Pregnancy and Breastfeeding: Use during pregnancy only if clearly needed and prescribed by a doctor. It is generally not recommended during breastfeeding as it can pass into breast milk and potentially cause adverse effects in infants.
• Alcohol: Avoid consuming alcohol while taking this medicine as it can worsen sleepiness and increase the risk of liver damage.
• Driving and Operating Machinery: COLICURE SUS may cause dizziness, drowsiness, or blurred vision. Avoid activities requiring mental alertness until you know how the medicine affects you.
• Drug Interactions: Dicyclomine can interact with antidepressants (e.g., fluoxetine) and antihistamines (e.g., loratadine, cetirizine), potentially increasing side effects like dry mouth, constipation, drowsiness, or blurred vision.

Storage

Store COLICURE SUS at room temperature (between 10ºC to 25ºC or below 30ºC) in its original container. Protect it from light and heat, and keep it out of the sight and reach of children.

Here are frequently asked questions about COLICURE SUS by EMPIAI PHARMACEUTICALS LTD, along with concise answers:

What is COLICURE SUS used for?

COLICURE SUS is primarily used to manage gastrointestinal disorders such as abdominal pain, cramps, and digestive spasms. It is effective in treating Irritable Bowel Syndrome (IBS) and alleviating symptoms like bloating, discomfort, and excess gas, particularly in children.

How does COLICURE SUS work?

COLICURE SUS contains two main active ingredients: Dicyclomine (an antispasmodic) and Simethicone (an anti-foaming agent). Dicyclomine works by relaxing the smooth muscles in the gastrointestinal tract, which helps to reduce muscle contractions and spasms. Simethicone acts by breaking down gas bubbles in the stomach and intestines, allowing for easier expulsion and relieving discomfort caused by gas.

What is the usual dosage for COLICURE SUS?

The appropriate dosage of COLICURE SUS should be determined by a doctor, as it varies based on the severity of symptoms and the patient's response to the medicine. It is crucial to always adhere to the prescribed dosage and never increase it without consulting a doctor. Shake the bottle well before each use and measure the exact quantity recommended by your doctor. COLICURE SUS is generally not recommended for infants younger than six months of age.

What are the possible side effects of COLICURE SUS?

Common side effects may include dry mouth, constipation, nausea, vomiting, headache, weakness, dizziness, blurred vision, nervousness, and sleepiness. Most of these side effects are temporary and usually resolve on their own. If any side effects persist or worsen, it is advisable to consult a doctor.

Is COLICURE SUS safe during pregnancy or breastfeeding?

During pregnancy, COLICURE SUS should be used only if clearly needed and specifically prescribed by a doctor, as its safety is not well-established, and animal studies suggest potential risks. It is generally not recommended during breastfeeding because its components can pass into breast milk and potentially cause adverse effects such as drowsiness or breathing problems in the infant. Always consult your doctor if you are pregnant, planning to conceive, or breastfeeding.

Can COLICURE SUS be taken with other medications?

COLICURE SUS can interact with certain medications, including antidepressants (such as fluoxetine), antihistamines (like loratadine or cetirizine), digoxin, and some painkillers like ibuprofen or naproxen. Antacids may also reduce its absorption. It is essential to inform your doctor about all other medicines, supplements, or herbal preparations you are currently taking to avoid potential interactions.

What precautions should be taken while using COLICURE SUS?

Do not use COLICURE SUS if you are allergic to dicyclomine, simethicone, or any other ingredients. Exercise caution if you have pre-existing conditions such as liver, kidney, or heart diseases, glaucoma, myasthenia gravis, an enlarged prostate, urinary retention, or severe ulcerative colitis. This medicine may cause dizziness, drowsiness, or blurred vision, so it is advisable to avoid driving or operating heavy machinery until you know how it affects you. Alcohol consumption should be limited as it can worsen drowsiness.

What should I do if I miss a dose of COLICURE SUS?

If you miss a dose of COLICURE SUS, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should COLICURE SUS be stored?

COLICURE SUS should be stored at room temperature, ideally between 20-25°C or below 30°C. Keep it in its original container, away from direct sunlight, heat, and moisture. Ensure the bottle is tightly closed after each use and keep it out of the reach and sight of children.