Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.

1. What Buscomint Peppermint oil, capsules is and what it is used for
2. What you need to know before you take Buscomint Peppermint oil, capsules
3. How to take Buscomint Peppermint oil, capsules
4. Possible side effects
5. How to store Buscomint Peppermint oil, capsules
6. Contents of the pack and other information

If you are allergic to peppermint oil or menthol or any of the other ingredients of this medicine (listed in section 6)

If you suffer from liver disease, infection of the bile duct, reduced gastric acid production, gallstones or any other biliary disorders.

If you weigh less than 40 kg (6 stone) bodyweight, because of safety concerns.

Buscomint Peppermint oil, capsules must not be used in children under 12 years of age and adolescents with less than 40 kg (6 stone) bodyweight because of safety concerns.

Talk to your doctor or pharmacist before taking Buscomint Peppermint oil, capsules:

If you already suffer from heartburn (acid ingestion) or hiatus hernia (protrusion of the upper part of the stomach) symptoms can sometimes worsen after taking Buscomint Peppermint oil, capsules. In this case the treatment should be discontinued.

The capsules should be swallowed whole i.e. not broken or chewed because the peppermint oil inside the capsules can cause local irritation of the mouth and gullet (oesophagus).

Check with your doctor or pharmacist immediately if 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 your stools.

Buscomint Peppermint oil, capsules must not be used in children under 12 years of age and adolescents with less than 40 kg (6 stone) bodyweight because of safety concerns (see section “Do not take Buscomint Peppermint oil, capsules”).

No interaction studies have been performed.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines, including any obtained without a prescription.

Other medicinal products used to decrease stomach acid, like histamine-2 blockers, proton pump inhibitors or antacids which may cause the coating of the capsule to dissolve prematurely and should be avoided.

The capsules should be taken with liquid 30 minutes before a meal to avoid early release of the capsule content.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Safety during pregnancy has not been established. In the absence of sufficient human data, it is not recommended to take Buscomint Peppermint oil, capsules during pregnancy.

Breast-feeding

Clinical data have shown that 1,8 cineol, one constituent of peppermint oil, capsules can be excreted into human breast milk. The use of Buscomint Peppermint oil, capsules during lactation is not recommended.

No studies on the effect on the ability to drive and use machines have been performed.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially “sodium-free”.

Adults and adolescents over 12 years of age who weigh at least 40 kg (6 stone): One gastro-resistant capsule 3 times a day.

Use in children and adolescents:

Buscomint Peppermint oil, capsules must not be administered to children under 12 years of age and adolescents weighing less than 40 kg (6 stone) bodyweight (see “Do not take Buscomint Peppermint oil, capsules”).

For oral use.

The capsules must be swallowed whole with liquid ie. not broken, crushed or chewed.

They must be taken 30 minutes before a meal.

Buscomint Peppermint oil, capsules should be taken until symptoms resolve, usually within one or two weeks. You must talk to a doctor if you feel worse, or do not feel better after two weeks.

If your symptoms persist, the capsules can be continued for periods up to 3 months per treatment course.

Overdose may cause

• severe gastro-intestinal symptoms, diarrhoea, rectal ulceration, nausea
• epileptic convulsions, loss of consciousness, apnoea (cessation of breathing)
• disturbances in rhythms of the heartbeat
• lack of coordination and other problems with the central nervous system

If you take more Buscomint Peppermint oil, capsules than the recommended dose, talk to your doctor or go to a hospital straight away and take this leaflet with you.

Do not take a double dose to make up for a forgotten dose, take your usual dose at the usual time.

If you get any side effects, talk to your doctor, or pharmacist This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is peppermint oil.

Each gastro-resistant soft capsule contains 0.2 ml (=181.6 mg) of Mentha x piperita L., aetheroleum (peppermint oil)

The other ingredients are:

Capsule shell:

gelatin, glycerol, purified water, iron oxide yellow (E172), brilliant blue FCF (E133), medium chain triglycerides, sunflower lecithin.

Coating:

methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30 per cent, triethyl citrate, glycerol monostearate 40-55, polysorbate 80, sodium dodecyl sulfate

Buscomint Peppermint oil, capsules are dull, green-coloured, oval-shaped soft capsule containing a colourless, pale yellow or pale greenish-yellow liquid

Buscomint Peppermint oil, capsule is available in blister packs of 6, 12, 24 or 48 soft capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria: Buscomint 0,2 ml Reizdarmkapseln

Czech Republic: MINTAL

Germany: Buscomint bei Reizdarm 0,2 ml magensaftresistente Weichkapseln

Hungary: Entero-Spa 0,2 ml gyomornedv-ellenálló lágy kapszula

Ireland: Peppermint Oil Sanofi 0.2ml gastro-resistant soft capsules

Italy: BUSCOIBS 0,2 ml capsule molli gastroresistenti

Poland: Olejek miętowy NO-SPA

Portugal: Buscomint 0,2 ml cápsula mole gastroresistente

Slovakia: MINTAL

Spain: Buscadol 0,2 ml capsulas blandas gastrorresistentes

United Kingdom: Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft