Package leaflet: Information for the patient

OLEOMINT, 182 mg, enteric soft capsules
Menthae piperitae aetheroleum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse after 7 to 14 days of treatment, consult your doctor.

Table of contents of the leaflet

What Oleomint is and what it is used for
Important information before taking Oleomint
How to take Oleomint
Possible side effects
How to store Oleomint
Contents of the pack and other information

1. What Oleomint is and what it is used for

Oleomint is a herbal medicinal product containing peppermint oil. The medicine helps restore normal intestinal function by reducing intestinal smooth muscle spasms.
Oleomint is used for symptomatic treatment of moderate gastrointestinal spasms, bloating (gas), and abdominal pain, particularly in patients with irritable bowel syndrome.
Oleomint capsules are enteric-coated, which protects them from gastric juice, allowing the capsules to pass intact through the stomach and the initial part of the intestine. This enables the capsules to reach the lower parts of the intestine, where the therapeutic effect is desired. Only then is the peppermint oil released from the capsule.
If there is no improvement or if you feel worse after 7 to 14 days of treatment, consult your doctor.

2. Important information before taking Oleomint

When not to take Oleomint:

if the patient is allergic to peppermint oil, menthol, or any of the other ingredients of this medicine (listed in section 6);
if the patient has liver diseases, biliary tract inflammation, gallstones, or other biliary disorders;
in the condition known as "achlorhydria" (lack of hydrochloric acid in gastric juice), which prevents proper digestion of food.

Warnings and precautions
Before starting treatment with Oleomint, consult a doctor or pharmacist if:

the patient already suffers from heartburn or a condition known as "hiatal hernia", as these conditions may worsen during treatment with Oleomint. If symptoms of heartburn or hiatal hernia worsen, treatment with Oleomint should be discontinued;
the patient experiences for the first time any of the following symptoms: bloating, difficulty passing gas, or discomfort and pain in the intestinal area;
the patient is over 40 years of age and has not had symptoms of irritable bowel syndrome for a long time, or if symptoms are different from previous ones;
the patient has experienced gastrointestinal bleeding;
the patient has nausea or vomiting;
the patient has decreased appetite or weight loss;
the patient appears pale and fatigued;
the patient has severe constipation;
the patient has a high fever;
the female patient has abnormal vaginal bleeding or discharge;
the patient experiences pain or difficulty when urinating;
the patient has recently travelled abroad;
the patient is pregnant, suspects she might be pregnant, or is planning pregnancy.

The capsules should be swallowed whole, not chewed, crushed, or taken with food,
as this could lead to premature release of peppermint oil, causing local irritation of the oral cavity and oesophagus.
Children
Oleomint is not recommended for children under 8 years of age.
Oleomint and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use, especially:

medicines used to reduce gastric acidity (antacids, H-\receptor antagonists such as ranitidine, famotidine, or proton pump inhibitors such as omeprazole, pantoprazole), as they may cause premature release of the capsule contents;
medicines metabolized by the hepatic enzyme system called cytochrome P450 CYP3A4, for example: cyclosporine (used to prevent organ rejection after transplantation), felodipine (used to treat high blood pressure), lovastatin (used to reduce blood cholesterol levels), ketoconazole (used to treat fungal infections), triazolam (used to treat insomnia). This interaction may lead to uncontrolled increases in blood concentration of the drug and potentially serious adverse effects.

Oleomint with food, drink, and alcohol
No specific studies have been conducted on the interaction between peppermint oil and alcohol.
Concomitant use of Oleomint with alcohol may increase adverse effects.
See also section 3.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Use of Oleomint is not recommended during pregnancy and breastfeeding.
There is no data available regarding the effect on fertility.
Driving and operating machinery
No studies have been performed on the effect of the medicine on the ability to drive or operate machinery.
Oleomint contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to take Oleomint

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
Adolescents over 12 years of age, adults, elderly people
1-2 capsules up to three times daily, depending on the severity of symptoms.
Children
Children aged 8–12 years
1 capsule up to three times daily.
Children under 8 years of age
Oleomint is not recommended for children under 8 years of age.
Renal impairment
Dosage has not been established in patients with renal impairment.
Hepatic impairment
Oleomint should not be used in patients with liver disease.
Method of administration
The medicine is for oral use. Capsules should be taken before meals (30–60 minutes before eating) with a small amount of water. Do not take capsules immediately after a meal.
Capsules must be swallowed whole. Do not chew or break them, as this would damage the special protective layer designed to resist gastric juice, which enables the capsules to reach the appropriate part of the intestine.
Duration of treatment
Oleomint should be taken until symptoms resolve.
However, if there is no improvement after 1 to 2 weeks, consult a doctor, who may decide to continue treatment for up to three months.
Overdose of Oleomint
In case of overdose, seek immediate medical attention from a doctor or hospital emergency department.
Overdose may lead to severe gastrointestinal symptoms, diarrhea, perianal skin lesions (anal ulceration), epileptic seizures, loss of consciousness, respiratory arrest, nausea, and cardiac arrhythmias.
Missed dose of Oleomint
If a dose is missed, take the next dose at the usual scheduled time.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur:

allergic reactions (rash, itching or shortness of breath), anaphylactic shock (severe allergic reaction causing shortness of breath, dizziness, a significant drop in blood pressure and loss of consciousness);
headache;
muscle tremor;
movement coordination disturbances;
blurred vision;
slow heartbeat;
urine and faeces with a menthol odour;
heartburn;
anal burning;
nausea;
vomiting;
skin rash;
pain or difficulty when passing urine;
balanitis.

The frequency of adverse reactions is unknown (cannot be estimated from the available data).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, consult a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions enables continued monitoring of the medicine's safety.

5. How to store Oleomint

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date (EXP) stated on the carton and blister pack.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oleomint contains

The active substance is peppermint oil. Each capsule contains 182 mg of peppermint essential oil (Mentha x piperita L., aetheroleum).
The other ingredients are: capsule shell: gelatin, glycerol, titanium dioxide (E 171), copper chlorophyllin sodium (E 141), purified water; enteric coating layer: copolymer of methacrylic acid and methyl acrylate (1:1), sodium carboxymethylcellulose, talc, medium-chain saturated triglycerides, triethyl citrate.

What Oleomint looks like and contents of the pack
Light green soft capsule with a seam in the middle, matte surface, approximately 7 mm x 11 mm in size, filled with oily liquid.
Aluminum/PVC/PVDC blisters in a cardboard box containing 30, 60 or 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz