4.1. Therapeutic indications

Colpermin is indicated for the relief of the symptoms of Irritable Bowel Syndrome.

4.2. Posology and method of administration

Posology:

Adults:

One capsule three times a day. This dosage may be increased to two capsules three times a day if discomfort is severe.

The capsules should be taken until symptoms resolve which would normally be within one or two weeks. The treatment can be continued for longer periods of between 2 to 3 months, when symptoms are more persistent.

Elderly:

As adult dose.

Children:

There is no experience in the use of these capsules in children under the age of 15.

Method of administration:

For oral use. Do not chew or break the capsule.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

The capsules should be swallowed whole, ie not broken or chewed. Patients who already suffer from heartburn sometimes have an exacerbation of this symptom after taking Colpermin. Treatment should be discontinued in these patients.

Colpermin contains Arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to Soya, patients with Soya allergy should also avoid Colpermin.

The patient should be advised to consult a doctor before use in the following circumstances:

• first presentation of these symptoms for confirmation of IBS

• aged 40 years or over and it is some time since the last attack, or the symptoms have changed

• blood has been passed from the bowel

• there is a feeling of sickness or there is vomiting

• loss of appetite or loss of weight

• paleness and tiredness

• severe constipation

• fever

• recent foreign travel

• pregnancy or planning a pregnancy or possibly pregnant

• abnormal vaginal bleeding or discharge

• difficulty or pain in passing urine

If there are new symptoms or worsening of the condition or failure to improve over two weeks, the patient should consult their doctor.

4.5. Interaction with other medicinal products and other forms of interaction

The capsules should not be taken immediately after food. Indigestion remedies should not be taken at the same time as Colpermin.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women. This product should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus.

Breast-feeding

It is not known whether peppermint oil or its metabolites are excreted in human milk.

4.7. Effects on ability to drive and use machines

Peppermint Oil has no influence on the ability to drive and use machines.

4.8. Undesirable effects

Adverse drug reactions (ADRs) identified during post-marketing experience with Peppermint Oil are included in the following table. The frequencies are provided according to the following convention:

Very common ≥1/10

Common ≥1/100 and <1/10

Uncommon ≥1/1,000 and <1/100

Rare ≥1/10,000, and <1/1,000

Very rare <1/10,000

Not known (cannot be estimated from the available data)

Adverse Drug Reactions Identified During Post-Marketing Experience with Peppermint Oil Frequency Category Estimated from adequately designed clinical trials or epidemiology studies

SOC

Frequency category

Adverse Event Preferred Term

Immune System Disorders

Not known

Hypersensitivity**

Nervous System Disorders

Not known

Burning sensation mucosal

Gastrointestinal System Disorders

Not known

Anorectal discomfort

Not known

Dyspepsia

Not known

Gastrooesophageal reflux

Not known

Nausea

Not known

Vomiting

** Individual intolerance as well as allergic reactions may occur. Includes erythematous rash, headache, bradycardia, muscle tremor and ataxia which may occur in conjunction with alcohol.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Symptoms

The most commonly reported symptoms of overdose are severe nausea, vomiting, abdominal pain, vertigo, ataxia, drowsiness and coma.

Management

In the event of overdosage, the stomach should be emptied by gastric lavage. Observations should be carried out with symptomatic treatment if necessary.