Patient information leaflet

BUSCOIBS 0.2 ml gastro-resistant soft capsules

peppermint oil
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor. See section 4. Contact your doctor if you do not notice improvement or if your symptoms worsen after 2 weeks.

Contents of this leaflet

What BUSCOIBS capsules are and what they are used for
What you need to know before taking BUSCOIBS capsules
How to take BUSCOIBS capsules
Possible side effects
How to store BUSCOIBS capsules
Contents of the pack and other information

1. What BUSCOIBS capsules are and what they are used for

BUSCOIBS capsules are a herbal medicinal product used to relieve symptoms of abdominal pain, mild spasms of the gastrointestinal tract (cramps), and flatulence (bloating), particularly in patients with irritable bowel syndrome.
BUSCOIBS is indicated for use in adults and adolescents aged 12 years and older (weighing at least 40 kg).
Consult your doctor if you do not feel better or if you feel worse after two weeks.

2. What you need to know before taking BUSCOIBS capsules

Do not take BUSCOIBS capsules:

if you are allergic to peppermint oil or menthol or to any of the other ingredients of this medicine (listed in section 6)
if you have liver disease, biliary tract infection, reduced gastric acid production, gallstones, or any other biliary disorder.
if your body weight is less than 40 kg, for safety reasons.
BUSCOIBS must not be used in children under 12 years of age and adolescents with body weight below 40 kg due to safety concerns.

Warnings and precautions
Talk to your doctor or pharmacist before taking BUSCOIBS capsules:
if you already suffer from heartburn (acid regurgitation) or hiatal hernia (protrusion of the upper part
of the stomach), symptoms may sometimes worsen after taking BUSCOIBS capsules. In this
case, treatment must be discontinued.
The capsules must be swallowed whole, i.e. not broken or chewed, as the peppermint oil
contained in the capsules may cause local irritation of the mouth and oesophagus.
Consult your doctor or pharmacist immediately if unexplained abdominal pain persists or
worsens or occurs together with symptoms such as fever, jaundice, vomiting, changes in bowel
frequency, severe constipation, unintentional weight loss, or blood in the stool.
Children and adolescents
BUSCOIBS must not be used in children under 12 years of age and adolescents with body weight
below 40 kg due to safety concerns (see section “Do not take BUSCOIBS capsules”).
Other medicines and BUSCOIBS capsules
No interaction studies have been conducted.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Other medicines used to reduce gastric acid, such as histamine-2 blockers, proton pump inhibitors, and antacids, may cause premature dissolution of the enteric coating and should be avoided.
BUSCOIBS capsules with food
The capsules should be taken with liquid, 30 minutes before meals, to avoid premature release of the capsule contents.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine.
Pregnancy
Safety during pregnancy has not been established. In the absence of sufficient data in humans, the use of BUSCOIBS capsules during pregnancy is not recommended.
Breastfeeding
Clinical data have shown that 1,8-cineole, a constituent of peppermint oil, may be excreted in breast milk. The use of BUSCOIBS during breastfeeding is not recommended.
Driving and using machines
No studies have been performed to evaluate the effect on the ability to drive vehicles or operate machinery.
BUSCOIBS contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit, i.e. essentially “sodium-free”.

3. How to take BUSCOIBS capsules

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents over 12 years of age weighing at least 40 kg:
One gastro-resistant capsule three times a day.
Use in children and adolescents
BUSCOIBS capsules must not be given to children under 12 years of age or to adolescents weighing less than 40 kg (see "Do not take BUSCOIBS capsules").
Method of administration
For oral use.
The capsules must be swallowed whole with liquid; do not break, crush, or chew them. They should be taken 30 minutes before meals.
Duration of use
BUSCOIBS should be taken until symptoms resolve, usually within one or two weeks. Contact your doctor if symptoms worsen or do not improve after two weeks.
If symptoms persist, the capsules may be continued for treatment cycles of up to 3 months.
Special populations
Dosage instructions in patients with impaired renal function are not available.
If you take more BUSCOIBS capsules than you should
Overdose may cause:
* severe gastrointestinal symptoms, diarrhoea, rectal ulcer, nausea
* epileptic seizures, loss of consciousness, apnoea (cessation of breathing)
* disturbances in heart rhythm
* lack of coordination and other central nervous system problems
If you take more BUSCOIBS capsules than recommended, contact your doctor or go immediately to hospital, and bring this leaflet with you.
If you forget to take BUSCOIBS capsules
Do not take a double dose to make up for a missed dose. Take your usual dose at the regular time.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
If you experience the following effects, stop taking the capsules and consult a doctor immediately:
* allergic reactions to menthol, such as anaphylactic shock, abnormally slow heart rate (bradycardia), red skin rash (erythematous skin eruption), tremor (muscular tremor), lack of coordination (ataxia), and headache

Other possible side effects include:
* blurred vision
* acid indigestion (heartburn), perianal burning
* nausea and vomiting
* smell of menthol in faeces and urine
* inflammation of the glans
* painful urination (dysuria)

The frequency of occurrence of these side effects is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BUSCOIBS capsules

Keep this medicine out of the sight and reach of children.
Store the blister packs in the outer cardboard package to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.

6. Package contents and other information

What BUSCOIBS capsules contain
The active substance is peppermint oil.
Each gastro-resistant soft capsule contains 0.2 ml (=181.6 mg) of Menta x piperita L., aetheroleum
(peppermint oil).
The other components are:
Capsule shell:
gelatine
glycerol
purified water
yellow iron oxide (E172)
brilliant blue FCF (E133)
medium-chain triglycerides
sunflower lecithin
Coating:
methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30%
triethyl citrate
glycerol monostearate 40-55
polysorbate 80
sodium dodecyl sulfate

Description of the appearance of BUSCOIBS capsules and pack contents
BUSCOIBS capsules are gastro-resistant soft capsules, oval-shaped, opaque, green in colour, containing a colourless, pale yellow or light yellowish-green liquid.
BUSCOIBS is available in blisters containing 6, 12, 24 or 48 soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Opella Healthcare Italy S.r.l
Viale L. Bodio 37/b
20158 Milan, Italy

Manufacturer
Dragenopharm Apotheker Pueschl GmbH
Göllstraße 1
84529 Tittmoning, Germany
Or
Swiss Caps GmbH, Grassingerstraße 9
83043 Bad Aibling, Germany

This medicinal product is authorised in the EEA Member States under the following names:
Austria: Buscomint 0.2 ml Reizdarmkapseln
Germany: Buscomint bei Reizdarm 0.2 ml magensaftresistente Weichkapseln
Portugal: Buscomint 0.2 ml cápsula mole gastroresistente
Spain: Buscadol 0.2 ml capsulas blandas gastrorresistentes
United Kingdom: Buscomint Peppermint oil 0.2ml gastro-resistant capsule, soft
Czech Republic: MINTAL
Hungary: Entero-Spa 0.2 ml gyomornedv-ellenálló lágy kapszula
Ireland: Buscomint 0.2ml gastro-resistant soft capsules
Italy: BUSCOIBS 0.2 ml capsule molli gastroresistenti
Poland: Olejek miętowy NO-SPA
Slovakia: MINTAL