ColperIBS®

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content_paste General Specifications

ColperIBS® 

Peppermint oil

content_paste Packaging and dosage form

It contains 2 blister of 10 oral enteric ColperIBS capsules and a patient information leaflet.

content_paste Composition

Active substance of each capsule: 187 mg peppermint oil

content_paste Indications

Symptomatic relief of bowel cramps, bloating, abdominal pain and modulating bowel movements in patients with irritable bowel syndrome.

content_paste How to use

For irritable bowel syndrome (IBS):

Adults: 1-2 capsules orally 3 times daily or as prescribed by the physician.

Children 8 years old and older: 1 capsules orally 3 times daily or as prescribed by the physician.

The ColperIBS capsules should be swallowed whole with aglass of water , 30 to 60 minutes before meals on an empty stomach.

content_paste Pharmacological and clinical effects

Peppermint oil has antispasmodic (anti-cramp-ing) effect on the smooth muscles of the gastrointestinal tract and bile ducts. In the irritable bowel syndrome, it slows peristaltic movement which appears to be result of its effects on calcium and potassium channels of the gastrointestinal tract's smooth muscles. 

Peppermint oil also reduce bloating and abdominal pain by facilitating  the excretion of bowel gases which has a combined mechanism including anti-foam effect. In addition, in a study peppermint oil increased bile secretion by 33% and reduced bilirubin concentrations by 63% Since peppermint oil is rapidly absorbed in the proximal intestine, it has some effects on upper gastrointestinal tract such as relaxation of the lower esophageal sphincter. For peppermint oil to exert effects on the lower intestine, it must pass through the upper gastrointestinal tract unmetabolized, so the enteric capsules are suitable for this problem.

content_paste Side Effects

This product is safe when used orally at the recommended dos and no cases of poisoninf are reported.

Peppermint oil can cause heartburn, nausea and vomiting, anal or perianal burning, and rarely allergic reactions and hypersensitivity (due to menthol) including erythematosus skin reactions, flushing, headache, bradycardia (decreased heart rate), muscle tremor and inconsistency in muscle movement (Ataxia).

Because of enteric capsules, less heartburn happens.

content_paste Interaction

Antacids, H2 blockers, and proton pump inhabitors: Since they raise gastric pH, they can cuase enteric capsules to dissolve sooner so separate administration times by at least 2 hours.

Metabolism of cyclosporine and a series of drugs metabolized by the P450 cytochromes (including Amitriptyline, Haloperidol, Ondansetron, Propranolol, Theophylline, Verapamil, proton pump inhabitors, Diazepam, non-steroidal anti-inflammatory drugs (NSAIDs), Warfarin, Losartan, Lovastatin, Ketoconazole, Itraconazole and Fexofenadine) may be inhibited by peppermint oil, so far this interaction has not been reported in humans.

However it is recommended to avoid using peppermint oil in patients taking these drugs or it should be taken with caution along with monitoring levels of mentioned medications.

content_paste Precaution and Warning

Remove the product slowly from the blister, so the capsule shell doesn't get damaged, swallow whole and avoid chewing and crushing it.

As this product has enteric capsules, it should not be consumed during meal or immediately afterward.

Diarrhea, due to greatly increase intestinal motility, interferes in the absorption of enteric formulation of peppermint oil which causes insufficient absorption  of it and results in high concentrations of unabsorbed menthol in anal mucosa and anal burning.

Using peppermint oil is usually not recommended for those prone to reflux: althogh this product because of enteric capsules is less likely to cause a physician before taking the ColperIBS.

If you have anemia hiatus hernia (a condidition in which a part of stomach slips upward through the diaphragm into the chest) consult a physician before the consumption of this product.

In case of hypersensitivity reactions, discontinue the use of the product.

If the symptoms persist or worsen after taking the product, inform your physician or pharmacist.

Do not take the product over the recommended dose and consult a physician if you need to take it more than 2 weeks.

Do not use product after expiration date on the packaging.

Due to the lack of sufficient data, consumption of this product in children under 8 years old is not recommended.

content_paste Contraindication

History of hypersensitivity to peppermint oil or menthol, history of allergy to peanut oil or soybean oil (due to the use of arachis oil in the formulation components, Achlorhydria, occlusion of the biliary ducts, bile ducts inflammation (cholangities), gallstones or any other biliary disorder and severe liver damage.

content_paste Pregnancy and lactation

There is insufficient reliable information about the safety of taking this product during pregnancy and lactation, therfore, it shold be avoided.

content_paste Storage

Store the product in the original packaging below 25 C, in a dry place and away from direct sunlight.

keep out of the sight and reach of children.