Peppermint Oil Sanofi 0.2 ml gastro-resistant soft capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Peppermint oil

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

A03AX

INN (International Name):

Peppermint oil

Dosage:

0.2 millilitre(s)

Pharmaceutical form:

Gastro-resistant capsule, soft

Therapeutic area:

Other drugs for functional gastrointestinal disorders

Authorization date:

2021-04-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PEPPERMINT OIL SANOFI 0.2 ML 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.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.
WHAT IS IN THIS LEAFLET
1.
What Peppermint Oil Sanofi, capsules is and what it is used for
2.
What you need to know before you take Peppermint Oil Sanofi, capsules
3.
How to take Peppermint Oil Sanofi, capsules
4.
Possible side effects
5.
How to store Peppermint Oil Sanofi, capsules
6.
Contents of the pack and other information
1.
WHAT PEPPERMINT OIL SANOFI, CAPSULES IS AND WHAT IT IS USED FOR
Peppermint Oil Sanofi, capsules is a herbal medicinal product which is
used to relieve the symptoms of
abdominal pain, minor spasms of the gastrointestinal tract (cramps),
and flatulance (bloating), especially
in patients with irritable bowel syndrome.
Peppermint Oil Sanofi is indicated for use in adults and adolescents
12 years of age and above (who weigh
at least 40 kg).
You must talk to a doctor if you do not feel better or if you feel
worse after two weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPPERMINT OIL SANOFI, CAPSULES
DO NOT TAKE PEPPERMINT OIL SANOFI, CAPSULES:
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.
Peppermint Oil S

Summary of Product characteristics

Health Products Regulatory Authority
17 May 2021
CRN009WZ8
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Peppermint Oil Sanofi 0.2 ml gastro-resistant soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 0.2 ml (= 181.6 mg) of _Mentha_ x _piperita_ L.,
aetheroleum (peppermint oil).
Excipients with known effect: less than 1mmol (23 mg) sodium per
dosage unit.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant capsule, soft.
Dull, green-coloured, oval-shaped soft capsule containing a
colourless, pale yellow or pale greenish-yellow liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Herbal medicinal product for the symptomatic relief of abdominal pain,
minor spasms of the gastrointestinal tract, and
flatulence, especially in patients with irritable bowel syndrome.
Peppermint Oil Sanofi is indicated for use in adults and adolescents
12 years of age and above (who weigh at least 40 kg).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One gastro-resistant capsule 3 times a day for patients who weigh at
least 40 kg.
_ _
_Paediatric population_
Peppermint Oil Sanofi is contraindicated in children under 12 years of
age and adolescents who weigh less than 40 kg because
of safety concerns (see 4.3 and 5.3).
_Renal impairment_
No data are available for a dosing instruction in case of impaired
renal function.
Duration of use
The gastro-resistant capsules should be taken until symptoms resolve,
usually within one or two weeks. After two weeks, the
patient is instructed to seek medical advice in case of persistent or
deteriorating symptoms. At times when the symptoms are
more persistent, the intake of gastro-resistant capsules can be
continued for periods up to 3 months per treatment course.
Method of administration
For oral use.
They must not be chewed, crushed or broken before swallowing (see
4.4).
To be taken 30 minutes before meal with plenty of liquid.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance, to