- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Colpermin IBS Relief Capsules
2. Qualitative and quantitative composition
Peppermint Oil BP 0.2ml Excipient: Arachis oil (peanut oil) BPFor 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 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. Do not chew or break the capsule.
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.
Hypersensitivity to the active substance or to any of the excipients.
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 urineIf 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
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. 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)
Reporting of suspected adverse reactionsReporting 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.
|Adverse Drug Reactions Identified During Post-Marketing Experience with Peppermint Oil Frequency Category Estimated from adequately designed clinical trials or epidemiology studies|
|Frequency category||Adverse Event Preferred Term|
|Immune System Disorders|
|Nervous System Disorders|
|Not known||Burning sensation mucosal|
|Gastrointestinal System Disorders|
|Not known||Anorectal discomfort|
|Not known||Gastrooesophageal reflux|
|** 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.|
The most commonly reported symptoms of overdose are severe nausea, vomiting, abdominal pain, vertigo, ataxia, drowsiness and coma. 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
5.3 Preclinical safety data
6. Pharmaceutical particulars
6.1 List of excipients
White beeswax Arachis oilColloidal SilicaGelatin, Titanium dioxideIndigotine (E132)Eudragit S100Eudragit L30 D55Triethyl citrate, Ammonia solution 10%MonostearinPolyethyleneglycol 4000TalcPurified Water
6.3 Shelf life
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
No special requirements.Any unused medicinal product or waste material should be disposed of in accordance with local requirements
7. Marketing authorisation holder
McNeil Products LimitedFoundation ParkRoxborough WayMaidenheadBerkshireSL6 3UGUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
01st May 2005
10. Date of revision of the text
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
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