Description
CLINICAL PARTICULARS
1.1 Therapeutic indications
Symptomatic relief of irritable bowel or spastic colon syndrome.
1.2 Posology and method of administration
Adults: 1 softgel daily or preferably before meals with a small quantity of water, but not immediately after food. The capsules must not be broken or chewed.
Or as prescribed by Physician
When symptoms are more severe, the dose may be increased to one-two capsule three times a day.
IBMint should be taken until symptoms resolve, but may be continued for up to 2 to 3 months.
Elderly: Dose as for adults.
Pediatric Patients: Not recommended for children.
1.3 Contraindications
Hypersensitivity to peppermint oil, or to any other excipients of IBMint.
1.4 Special warnings and precautions for use
If this is the first occurrence of these symptoms, a doctor should be consulted before self medication begins, to confirm the appropriateness of the treatment.
Before beginning self medication, a doctor should be consulted if:
The patient is over 40 years old and it is some time since the last attack of irritable bowel or spastic colon syndrome, or the symptoms have changed; blood has been passed from the bowel; the patient has experienced nausea or vomiting, loss of appetite or loss of weight, paleness and tiredness, severe constipation, fever, abnormal vaginal bleeding or discharge, difficulty or pain in passing urine.
If the patient has recently travelled abroad, or is pregnant or possibly pregnant, they should consult their doctor prior to self medication.
If there are new symptoms or worsening of the condition or failure to improve over two weeks of treatment, the patient should consult their doctor.
In patients with pre-existing heartburn, symptoms may be exacerbated.
1.5 Interaction with other medicinal products and other forms of interaction
None known.
1.6. Pregnancy and lactation
The usual precautions concerning the administration of any drug during pregnancy should be observed.
1.7 Effects on ability to drive and use machines
IBMint has no known influence on the ability to drive and use machines.
1.8 Undesirable effects
Heartburn, and rarely allergic reactions including erythematous skin rash, bradycardia, muscle tremor and ataxia, which may also occur in association with alcohol.
1.9 Overdose
Treatment consists of gastric lavage, together with symptomatic and supportive measures.
2. PHARMACOLOGICAL PROPERTIES
2.1 Pharmacodynamic properties
Pharmacotherapeutic group:
Drugs for function bowel disorders.
IBMint is an aromatic carminative which acts locally to relax gastro intestinal smooth muscle and relieve gastro-intestinal flatulence and colic.
2.2 Pharmacokinetic properties
An open cross-over study was conducted in eight healthy volunteers, to compare the excretion pattern of menthol (the major constituent of peppermint oil) from peppermint oil contained in gastro-resistant soft gelatin capsules , and similar, uncoated capsules. In each leg of the study, each volunteer received 300 mg of peppermint oil as one capsules of one of the preparations.
The excretion of the oil in the urine (as the glucuronide) was followed over a 24 hour period.
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