Colpermin IBS Relief Capsules

1. Name Of The Medicinal Product

Colpermin IBS Relief Capsules

2. Qualitative And Quantitative Composition

Peppermint Oil BP 0.2ml

3. Pharmaceutical Form

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

4. Clinical Particulars

4.1 Therapeutic Indications

For the relief of the symptoms of Irritable Bowel Syndrome.

4.2 Posology And Method Of Administration

For oral use.

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.

4.3 Contraindications

None

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 Pregnancy And Lactation

There are no data available to establish the safety of Colpermin in pregnancy, therefore it should be used only if, in the opinion of the physician, the possible benefits of treatment outweighs the possible hazards. Levels of menthol were not detectable in plasma or saliva following administration of Colpermin indicating rapid first pass metabolism. Significant levels of menthol in breast milk are thought to be unlikely.

4.7 Effects On Ability To Drive And Use Machines

None

4.8 Undesirable Effects

Occasional heartburn, perianal irritation; allergic reactions to menthol, which are rare, include erythematous rash, headache, bradycardia, muscle tremor and ataxia, which may occur in conjunction with alcohol.

4.9 Overdose

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

Antispasmodic and carminative.

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

None

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 25°C, avoid direct sunlight.

6.5 Nature And Contents Of Container

Aluminium foil/PVC blister pack containing 10 capsules (250μm PVC, 20μm Al).

Pack sizes: 10, 20, 60 and 100 capsules.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire

SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0141

9. Date Of First Authorisation/Renewal Of The Authorisation

01^st May 2005

10. Date Of Revision Of The Text

7^th April 2010