Mintec or 0.2ml gastro-resistant capsules

1. Name Of The Medicinal Product

Mintec or 0.2ml gastro-resistant capsules

2. Qualitative And Quantitative Composition

Each capsule contains 0.2ml peppermint oil.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

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

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

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of irritable bowel or spastic colon syndrome.

4.2 Posology And Method Of Administration

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.

4.3 Contraindications

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

4.4 Special Warnings And Precautions For Use

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.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

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

4.8 Undesirable Effects

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

4.9 Overdose

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

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

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.

5.2 Pharmacokinetic Properties

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.

5.3 Preclinical Safety Data

No additional data available.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Capsule shell:

Gelatin

Glycerol

Titanium dioxide (E171)

Chlorophyll KK (E141)

Enteric coat:

Hydroxypropylmethyl cellulose phthalate

Dibutyl phthalate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

30 months.

6.4 Special Precautions For Storage

Do not store above 25ºC.

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

6.5 Nature And Contents Of Container

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.

6.6 Special Precautions For Disposal And Other Handling

None.

Administrative Data

7. Marketing Authorisation Holder

Almirall S.A

General Mitre 151

08022 Barcelona

Spain

8. Marketing Authorisation Number(S)

PL 16973/0020

9. Date Of First Authorisation/Renewal Of The Authorisation

17/06/2008

10. Date Of Revision Of The Text

3 September 2010