COLPERMIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PEPPERMINT OIL (MENTHAE PIPERITAE AETHEROLEUM)

Available from:

TRADIS GAT LTD

ATC code:

A03AX

Pharmaceutical form:

CAPSULES

Composition:

PEPPERMINT OIL (MENTHAE PIPERITAE AETHEROLEUM) 187 MG

Administration route:

PER OS

Prescription type:

Not required

Manufactured by:

TILLOTTS PHARMA AG, SWITZERLAND

Therapeutic group:

OTHER DRUGS FOR FUNCTIONAL BOWEL DISORDERS

Therapeutic indications:

For the treatment of symptoms of discomfort abdominal colic and distension following irritable bowel syndrome

Authorization date:

2023-02-28

Patient Information leaflet

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed without a doctor’s prescription
COLPERMIN CAPSULES
Active ingredient: Peppermint oil 187 mg
For inactive ingredients and allergens in the medicine: see section 6
"Additional information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have any
further questions, consult your doctor or pharmacist.
You should take the medicine according to the instructions provided in
the
dose section of this leaflet. Consult the pharmacist if you need
further
information. Contact the doctor if the disease symptoms worsen or do
not
improve usually after 2 weeks.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Colpermin is used to treat symptoms of discomfort, abdominal pain and
bloating due to irritable bowel syndrome.
_ _
THERAPEUTIC GROUP: Gastrointestinal products
The active ingredient of Colpermin is natural peppermint oil extracted
from
the above-ground parts of the Mentha Piperita L. (peppermint).
Colpermin
capsules contain peppermint oil, the main ingredient of which is
menthol. In
order to enable local action of peppermint oil in the bowel, each
capsule is
coated with a gastric acid resistant protective film, which prevents
premature
release of peppermint oil in the stomach.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to the active ingredient peppermint oil,
menthol, peanuts and soya (possible cross-sensitivity) or to any of
the other ingredients in this medicine (see the list of excipients in
section 6: "Additional information").
•
you suffer from bile duct obstruction, gallbladder inflammation or
liver impairment.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
2
BEFORE USING COLPERMIN, TELL YOUR DOCTOR IF:
•
you suffer from deficiency of hydrochloric acid in the stomach,
heartburn (which may be also caused by diaphragmatic hernia). In
such cases, the symptoms may be exacerbat

Summary of Product characteristics

COLPERMIN®
PEPPERMINT OIL 187 MG CAPSULES
_TILLOTTS PHARMA AG _
_ _
_THERAPEUTIC INDICATIONS _
For the treatment of symptoms of discomfort abdominal colic and
distension following
irritable bowel syndrome.
_ _
_COMPOSITION _
_Active substance_: Menthae piperitae aetheroleum (peppermint oil)
_Excipient_s: arachis oil, gelatin, white beeswax, methacrylic
acid-ethyl acrylate copolymer
(1:1), triethyl citrate, water, colloidal anhydrous silica,
methacrylic acid-methyl methacrylate copolymer (1:2), titanium
dioxide, glycerol
monostearate 40-55, talc, macrogol 4000, indigotine (E 132) excip. pro
capsula q.s.
_PHARMACEUTICAL FORM AND QUANTITY OF ACTIVE SUBSTANCE PER UNIT _
capsules, hard, 187 mg (0.2 mL)
_DOSAGE / METHOD OF ADMINISTRATION _
_Adults and elderly patients: _
1 capsule three times daily, in case of severe symptoms the dosage may
be increased to 2
capsules three times daily (equivalent to 0.6
–
1.2 mL peppermint oil).
_Adolescents: _
_Adolescents aged 15 to 17 years:_
1 capsule three times daily (equivalent to 0.6 mL peppermint oil).
Colpermin is intended for use in adults and adolescents aged 15 years
and over.
_Correct method of administration _
The capsules must be taken whole with some liquid at least 2 hours
before or after meals.
The capsules must not be broken or chewed. Treatment should be
continued until symptoms
resolve, usually within 1 or 2 weeks, and no longer than 3 months.
_ _
_CONTRAINDICATIONS _
Hypersensitivity to the active substance or to any excipient listed in
the composition.
Achlorhydria.
Colpermin must not be taken in cases of biliary strictures,
cholecystitis or liver disease.
Children under 15 years of age.
_WARNINGS AND PRECAUTIONS _
Colpermin contains refined arachis oil.
Colpermin must not be taken in cases of known hypersensitivity to
peanuts and/or soya
(cross-allergy). Colpermin should not be given to children younger
than 15 years.
Colpermin should not be taken with food or with products used to
reduce stomach acid. This
may result in premature dissolution of the capsule