APERCAP

Route of administration:

Oral use Adults and elderly: One capsule to be taken three times a day, preferably before meals with a small quantity of water. The capsules must not be taken immediately after food. e. not broken or chewed, because this would release the peppermint oil prematurely, possibly causing local irritation of the mouth and oesophagus.

When symptoms are more severe, the dose may be increased to two capsules three times a day. Apercap capsules should be taken until the symptoms resolve, usually within one or two weeks. At times when the symptoms are more persistent, the intake of the gastro-resistant capsules can be continued for periods of no longer than 3 months per course.

Children under 12 years Not recommended for children.

Urine and stools with an odour to menthol were observed; dysuria and inflammation of the glans of the penis have been reported. The frequency is not known. Allergic reactions to menthol were reported, with headache, bradycardia, muscle tremor, ataxia, anaphylactic shock and erythematous skin rash.

The frequency is not known. Heartburn, perianal burning, blurred vision, nausea and vomiting were reported. The frequency is 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

If this is the first occurrence of these symptoms, a doctor should be consulted before self-medication begins, to confirm the suitability of the treatment. Before beginning self-medication, a doctor should be consulted if: • the patient is over 40 years old and it is some time since their last attack, or the symptoms have changed; • blood has been passed from the bowel; • the patient has experienced nausea or vomiting, loss of appetite or loss of weight, paleness and tiredness, severe constipation, fever, abnormal vaginal bleeding or discharge, difficulty or pain in passing urine.

• the patient has recently travelled abroad. • the patient is pregnant or possibly pregnant; they should consult their doctor prior to self-medication. If there are new symptoms or a deterioration of the condition or failure to improve over two weeks of treatment, the patient should consult their doctor.

Patients, who already suffer from heartburn or hiatal hernia, have sometimes an exacerbation of this symptom after taking peppermint oil. Treatment should be discontinued in these patients. Excipients Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

Hypersensitivity to peppermint oil or menthol. Patients with liver disease, cholangitis, achlorhydria, gallstones and any other biliary disorders.