- 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
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.
PregnancyThere 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-feedingIt is not known whether peppermint oil or its metabolites are excreted in human milk.
|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.|
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.
SymptomsThe most commonly reported symptoms of overdose are severe nausea, vomiting, abdominal pain, vertigo, ataxia, drowsiness and coma.
ManagementIn the event of overdosage, the stomach should be emptied by gastric lavage. Observations should be carried out with symptomatic treatment if necessary.
McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG