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).

They should 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 must 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 that is to say essentially “sodium-free”.

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

Data suggest excretion of peppermint constituents / metabolites like 1,8 cineol in human milk. A risk to the newborns/infants cannot be excluded. Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft should not be used during breast-feeding.

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), dry mouth

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 Store

4.9. 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.