COLPERMIN IBS RELIEF CAPSULES - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Colpermin IBS Relief Capsules

2 Qualitative and Quantitative Composition

Peppermint Oil 0.2ml

Excipient: Arachis oil (peanut oil)

For the full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Sustained release enteric coated and gastro-resistant capsule, size 1. Body opaque light blue, cap opaque blue, with a dark blue band between body and cap.

4 CLINICAL PARTICULARS

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)

** 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 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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmaceutical group: Other therapeutics. ATC code:V03AX

The mode of action is local rather than systemic. The enteric coating delays opening of the capsule until it reaches the distal small bowel. Peppermint oil is then slowly released as the matrix passes along the gut. The oil exerts a local effect of colonic relaxation and a fall of intra-colonic pressure.

Pharmacological studies have demonstrated that peppermint oil exerts its inhibitory effect on gastrointestinal smooth muscle by interference with the mobilisation of calcium ions.

5.2 Pharmacokinetic properties

Not relevant

5.3 Preclinical safety data

Not relevant

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White beeswax

Arachis oil

Colloidal Silica

Gelatin

Titanium dioxide

Indigotine (E132)

Eudragit S100

Eudragit L30 D55

Triethyl citrate

Ammonia solution 10%

Monostearin

Polyethyleneglycol 4000

Talc

Purified Water

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 25°C; avoid direct sunlight

6.5 Nature and contents of container