Mintec or 0.2ml gastro-resistant capsules

Each capsule contains 0.2ml peppermint oil.

For a full list of excipients, see section 6.1.

Gastro-resistant capsules, soft (for oral use).

Size no. 4, one half of capsule is green, the other half is ivory.

Symptomatic relief of irritable bowel or spastic colon syndrome.

Adults: one capsule orally three times a day, preferably before meals with a small quantity of water, but not immediately after food. The capsules must not be broken or chewed.

When symptoms are more severe, the dose may be increased to two capsules three times a day.

Mintec should be taken until symptoms resolve, but may be continued for up to 2 to 3 months.

Elderly: Dose as for adults.

Paediatric patients: Mintec is not recommended for children.

Hypersensitivity to peppermint oil, salicylates or to any other excipients of Mintec.

If this is the first occurrence of these symptoms, a doctor should be consulted before self medication begins, to confirm the appropriateness 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 the last attack of irritable bowel or spastic colon syndrome, 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.

If the patient has recently travelled abroad, or is pregnant or possibly pregnant, they should consult their doctor prior to self medication.

If there are new symptoms or worsening of the condition or failure to improve over two weeks of treatment, the patient should consult their doctor.

In patients with pre-existing heartburn, symptoms may be exacerbated.

None known.

The usual precautions concerning the administration of any drug during pregnancy should be observed.

Mintec has no known influence on the ability to drive and use machines.

Heartburn, and rarely allergic reactions including erythematous skin rash, bradycardia, muscle tremor and ataxia, which may also occur in association with alcohol.

Treatment consists of gastric lavage, together with symptomatic and supportive measures.

Pharmacotherapeutic group: Drugs for function bowel disorders.

ATC Code: A03A Drugs for functional bowel disorders; A02D (Antiflatulents).

Mintec (peppermint oil) is an aromatic carminative which acts locally to relax gastro intestinal smooth muscle and relieve gastro-intestinal flatulence and colic. The enteric coating of the capsules is designed to delay release of the peppermint oil beyond the stomach and upper small bowel.

An open cross-over study was conducted in eight healthy volunteers, to compare the excretion pattern of menthol (the major constituent of peppermint,oil) from peppermint oil contained in gastro-resistant soft gelatin capsules (Mintec), and similar, uncoated capsules. In each leg of the study, each volunteer received 0.4 ml of peppermint oil as two capsules of one of the preparations. The excretion of the oil in the urine (as the glucuronide) was followed over a 24 hour period.

Mintec capsules significantly delayed the rate of excretion of menthol compared with the non-coated capsules.

The maximum amounts of menthol were excreted within 0 to 2 hours following administration of uncoated capsules and between 2 to 4 hours following Mintec administration. There were no significant differences between treatments in terms of the maximum or total amounts of menthol excreted over the 24 hour post-dose period.

No additional data available.

Capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Chlorophyll KK (E141)

Enteric coat:

Hydroxypropylmethyl cellulose phthalate

Dibutyl phthalate

Not applicable.

30 months.

Do not store above 25ºC.

In order to protect from light, store in the original package.

Aluminium/PVC/PVDC blister strips in packs of 2, 3 (sample), 4, 6, 12, 24, 25, 84 and 100.

Not all pack sizes may be marketed.

None.

Almirall S.A

General Mitre 151

08022 Barcelona

Spain

PL 16973/0020

17/06/2008

3 September 2010