Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft

Gastro-resistant capsule, soft Dull, green-coloured, oval-shaped soft capsule containing a colourless, pale yellow or pale greenish-yellow liquid.

4.1 Therapeutic indications Herbal medicinal product for the symptomatic relief of abdominal pain, minor spasms of the gastrointestinal tract, and flatulence, especially in patients with irritable bowel syndrome. Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft is indicated for use in adults and adolescents 12 years of age and above (who weigh at least 40 kg).4.2 Posology and method of administration Posology One gastro-resistant capsule 3 times a day for patients who weigh at least 40 kg. *Paediatric population* Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft is contraindicated in children under 12 years of age and adolescents who weigh less than 40 kg because of safety concerns (see 4.3 and 5.3). *Renal impairment* No data are available for a dosing instruction in case of impaired renal function. Duration of use The gastro-resistant capsules should be taken until symptoms resolve, usually within one or two weeks. After two weeks, the patient is instructed to seek medical advice in case of persistent or deteriorating symptoms. At times when the symptoms are more persistent, the intake of gastro-resistant capsules can be continued for periods up to 3 months per treatment course. Method of administration For oral use. They must not be chewed, crushed or broken before swallowing (see 4.4). To be taken 30 minutes before meal with plenty of liquid.4.3 Contraindications Hypersensitivity to the active substance, to menthol or to any of the excipients listed in section 6.1. Patients with liver disease, cholangitis, achlorhydria, gallstones and any other biliary disorders. Patients with less than 40 kg bodyweight because of safety concerns (see 5.3). Children under 12 years of age and adolescents with less than 40 kg bodyweight due to safety reasons (see 5.3).4.4 Special warnings and precautions for use The capsules should be swallowed whole, i.e. not broken or chewed, because this would release the peppermint oil prematurely, possibly causing local irritation of the mouth and oesophagus. Patients, who already suffer from heartburn or hiatus hernia have sometimes an exacerbation of this symptom after taking peppermint oil. Treatment should be discontinued in these patients. In case unexplained abdominal pain persists or worsens, or occurs together with symptoms like fever, jaundice, vomiting, changes in bowel movement frequency, severe constipation, unintended weight loss or blood in stool medical advice should immediately be sought. This medicine contains less than 1 mmol sodium (23 mg) per dosage unit.4.5 Interaction with other medicinal products and other forms of interaction No interaction studies have been performed. Use of food or antacids administered at the same time could cause early release of capsule content. Other medicinal products used to decrease stomach acid, like histamine-2 blockers and proton pump inhibitors may cause premature dissolution of the enteric coating and should be avoided.4.6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of peppermint oil in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). In the absence of sufficient data, the use during pregnancy is not recommended. Breast-feeding Clinical data have shown that 1,8 cineol, one constituent of peppermint oil, can be excreted into human breast milk. Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft is not recommended during lactation. Fertility Data on human fertility have not been established.4.7 Effects on ability to drive and use machines No studies on the effect on the ability to drive and use machines have been performed.4.8 Undesirable effects Undesirable effects are classified into the following groups in order of frequency: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data) *Table of undesirable effects per organ system* | | | | --- | --- | | **Organ Class** | **Frequency** | | Immune system disorder | | | Allergic reaction to menthol with anaphylactic shock | Not known | | Nervous system disorders | | | Muscle tremor, ataxia, and headache | Not known | | Eye disorders | | | Blurred vision | Not known | | Cardiac disorders | | | Bradycardia | Not known | | Gastrointestinal disorders | | | Heartburn, perianal burning, nausea and vomiting, abnormal smell of feces (odour of menthol) | Not known | | Skin and subcutaneous tissue disorders | | | Inflammation of the glans of the penis, erythematous skin rash | Not known | | Renal and urinary disorders | | | Urine odour abnormal of menthol, dysuria | Not known | If other adverse reactions not mentioned above occur, a doctor or a pharmacist should be consulted. 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 website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store4.9 Overdose Symptoms Overdose may cause severe gastro-intestinal symptoms, diarrhoea, rectal ulceration, epileptic convulsions, loss of consciousness, apnoea, nausea, disturbances in cardiac rhythms, ataxia and other CNS problems, probably due to the presence of menthol. Management In the event of overdose, the stomach should be emptied by gastric lavage. Observation should be carried out with symptomatic treatment if necessary.

5.1 Pharmacodynamic properties Pharmacotherapeutic group: *Other drugs for functional gastrointestinal disorders* ATC code: A03 AX Mechanism of action The enteric coating delays the release of the peppermint oil until it reaches the distal small bowel, exerting local effects of colonic relaxation. Pharmacodynamic effects *In vivo* studies Several studies in healthy subjects or patients, who underwent exposure to peppermint oil either by topical intraluminal (stomach or colon) or oral administration by single doses, result in effects, indicating a substantial spasmolytic action of peppermint oil on the smooth muscles of the gastrointestinal tract. Peppermint oil appears to enhance production of bile. The choleretic and antifoaming effects of peppermint oil play an additional role to the antispasmodic action, decreasing the abdominal distension, as the discomfort and abdominal pain.5.2 Pharmacokinetic properties Absorption Menthol and other terpene constituents of peppermint oil are fat soluble and rapidly absorbed at the proximal small intestinal tract. Distribution No data on distribution are available. Biotransformation Menthol, the main constituent of peppermint oil, is metabolized by glucuronidation. Elimination To some extent, they are excreted in the form of glucoronide. The peak menthol urinary excretion levels were lower and secretion delayed with the modified-release preparations, than with the immediate release preparations. In one clinical study with peppermint oil and one clinical study with menthol, some inhibition of CYP3A4 activity has been described.5.3 Preclinical safety data Preclinical data concerning repeated dose toxicity are incomplete and therefore of limited informative value. Based on the long standing clinical use there is a sufficiently established safety of the usage of peppermint oil in the given posology (up to 0.6 mL daily) in humans. A standard battery of genotoxicity studies (in-vitro bacterial reverse mutation assay, in-vitro mouse lymphoma assay, in-vivo bone marrow micronucleus assay) showed that peppermint oil has no genotoxic potential. The recommended maximum daily intake of pulegone and menthofuran for a life-long exposure is 0.75 mg/kg bodyweight per day. For a person with at least 40 kg bodyweight the daily intake of 3 capsules of this medicinal product does not exceed this recommendation. No cases of liver damage caused by peppermint oil or mint oil were reported under this posology. Tests on reproductive toxicity and carcinogenicity have not been performed

6.1 List of excipients Capsule shell: Gelatin Glycerol Water, purified Iron oxide yellow (E172) Brilliant blue FCF (E133) Triglycerides, medium chain Sunflower lecithin Coating: Methacrylic acid – Ethyl acrylate copolymer (1:1) dispersion 30 per cent Triethyl citrate Glycerol monostearate 40-55 Polysorbate 80 Sodium dodecyl sulfate6.2 Incompatibilities Not applicable.6.3 Shelf life 36 months6.4 Special precautions for storage Keep blisters in the outer carton in order to protect from light.6.5 Nature and contents of container The gastro-resistant soft capsules are packaged in blister packs. Folding boxes with blisters (PVC/PCTFE-aluminium) containing 6, 12, 24 or 48 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