Pepelia gastro-resistant soft capsules

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PEPPERMINT OIL

Available from:

Florealis ehf. Síðumúla 25, 108 Reykjavík, Iceland

ATC code:

A03AX

INN (International Name):

PEPPERMINT OIL 182 mg

Pharmaceutical form:

GASTRO-RESISTANT SOFT CAPSULE

Composition:

PEPPERMINT OIL 182 mg

Prescription type:

OTC

Therapeutic area:

DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Withdrawn

Authorization date:

2020-07-16

Patient Information leaflet

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEPELIA GASTRO-RESISTANT SOFT CAPSULES
Peppermint oil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
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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 contact your doctor if you do not feel better or if you feel
worse after 3 months.
WHAT IS IN THIS LEAFLET
1.
What Pepelia is and what it is used for
2.
What you need to know before you take Pepelia
3.
How to take Pepelia
4.
Possible side effects
5.
How to store Pepelia
6.
Contents of the pack and other information
1.
WHAT PEPELIA IS AND WHAT IT IS USED FOR
Pepelia is a herbal medicinal product for the symptomatic relief of
irritable bowel syndrome (IBS),
such as minor spasms of the gastrointestinal tract, flatulence and
abdominal pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPELIA
DO NOT TAKE THIS MEDICINE:
-
If you are allergic to peppermint oil, menthol or any of the other
ingredients of this medicine
(listed in section 6).
-
If you have liver disease, cholangitis, achlorhydria, gallstones or
other biliary disorders
WARNINGS AND PRECAUTIONS
Pepelia should only be used after IBS has been diagnosed by a doctor.
Consult a doctor if the symptoms markedly change in character; if
blood passes from the bowel; or if
there is loss of appetite or weight for no obvious reason.
The capsules should be swallowed whole, i.e. not broken or chewed,
because this would release the
peppermint oil prematurely, possibly causing local irritation of mouth
and oesophagus.
Patients who already suffer from heartburn or hiatal hernia have
sometimes an exacerbation of this
symptoms after taking peppermint oil. T

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Pepelia gastro-resistant soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 182 mg of
_Mentha x piperita_
L., aetheroleum (peppermint oil).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant soft capsule.
Oval shaped, translucent, uncoloured, soft capsule (10x7 mm)
containing a clear liquid.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Herbal medicinal product for the symptomatic relief of irritable bowel
syndrome (IBS), such as minor
spasms of the gastrointestinal tract, flatulence and abdominal pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and elderly: _
1-2 capsules up to three times daily
_Children 8-12 years of age and adolescents over 12 years of age: _
1 capsule up to three times daily
_Paediatric population _
The use of Pepelia is not recommended in children under 8 years of
age, as safety and efficacy of
peppermint oil has not been established in this age group. No data are
available (see section 4.4).
_ _
Method of administration
Oral use.
The capsules must be taken with a full glass of water at least two
hours before meal or antacids; or at
least two hours after meal or antacids (see section 4.5). The capsules
should be swallowed whole, not
broken or chewed, to avoid premature release of peppermint oil from
the capsule (see section 4.4).
Duration of use
The gastro-resistant capsules should be taken until symptoms resolve,
usually within one or two
weeks. At times when the symptoms are more persistent, the intake can
be continued for periods of no
longer than 3 months per course.
If the symptoms persist after a continued use over three months, a
doctor or a qualified health care
practitioner should be consulted.
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4.3
CONTRAINDICATIONS
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Hypersensitivity to peppermint oil, menthol or to any of the
excipients listed in section 6.1.
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Patients with liver disease, cholangitis, achlorhydria, gallstones