Oleomint

Leaflet attached to the packaging: patient information

OLEOMINT, 182 mg, enteric-coated soft capsules

Menthae piperitae aetheroleum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 to 14 days of use, there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Oleomint and what is it used for
• 2. Important information before taking Oleomint
• 3. How to take Oleomint
• 4. Possible side effects
• 5. How to store Oleomint
• 6. Package contents and other information

1. What is Oleomint and what is it used for

Oleomint is a herbal medicine containing peppermint oil. The medicine helps restore normal bowel function by reducing muscle spasms in the intestinal wall. Oleomint is used for symptomatic treatment of moderate spasms of the gastrointestinal tract, bloating (gas) and abdominal pain, especially in patients with irritable bowel syndrome. The capsules of Oleomint have a protective coating that protects them from stomach acid, allowing the capsules to pass through the entire stomach and the initial part of the intestine. This enables the capsules to reach the further parts of the intestine, where the action of the medicine is desired. Only then is the peppermint oil released from the capsule. If after 7 to 14 days, there is no improvement or the patient feels worse, they should contact their 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 disease, bile duct inflammation, gallstones, and other bile duct disorders;
• in cases of a condition called "achlorhydria" (lack of stomach acid), which prevents proper digestion of food.

Warnings and precautions

Before starting to take the medicine, the patient should discuss it with their doctor or pharmacist if:

• the patient already suffers from heartburn or a hiatal hernia, as these conditions may worsen when taking Oleomint. If symptoms of heartburn or hernia worsen, the patient should stop taking Oleomint;
• the patient experiences any of the following symptoms for the first time: bloating, difficulty passing gas, or discomfort and pain in the intestinal area;
• the patient is over 40 years old and has not had symptoms of irritable bowel syndrome for a long time or has different symptoms than before;
• the patient has had gastrointestinal bleeding;
• the patient has nausea or vomiting;
• the patient has a decreased appetite or weight loss;
• the patient is pale and tired;
• the patient has severe constipation;
• the patient has a high fever;
• the patient has unusual vaginal bleeding or discharge;
• the patient experiences pain or difficulty urinating;
• the patient has recently traveled abroad;
• the patient is pregnant or suspects they may be pregnant.

Capsules should be swallowed whole, not chewed, crushed, or taken with food, as this may cause premature release of peppermint oil, leading to local irritation of the mouth and throat.

Children

Oleomint is not recommended for children under 8 years old.

Oleomint and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, especially:

• medicines used to reduce stomach acid (antacids, H2 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 that are metabolized by the liver enzyme system called cytochrome P450 CYP3A4, such as: cyclosporine(used to prevent organ rejection after transplantation), felodipine(used to treat high blood pressure), lovastatin(used to lower cholesterol levels), ketoconazole(used to treat fungal infections), triazolam(used to treat insomnia). This interaction may lead to uncontrolled increased levels of the medicine in the blood and potentially serious side effects.

Oleomint with food, drink, and alcohol

No special studies have been conducted on the interaction of peppermint oil with alcohol. When taking Oleomint with alcohol, side effects may worsen. See also section 3.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or suspects they may be pregnant, they should consult their doctor or pharmacist before taking this medicine. Oleomint is not recommended during pregnancy and breastfeeding. There is no data on the effect on fertility.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

Oleomint contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Oleomint

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adolescents over 12 years old, adults, elderly

1-2 capsules up to three times a day, depending on the severity of symptoms.

Children 8-12 years old

1 capsule up to three times a day.

Children under 8 years old

Oleomint is not recommended for children under 8 years old.

Renal impairment

Dosing has not been established in patients with renal failure.

Hepatic impairment

Oleomint should not be used in patients with liver disease.

Method of administration

The medicine is taken orally. Capsules should be taken before meals (30-60 minutes before a meal) with a small amount of water. Capsules should not be taken immediately after a meal. Capsules should be swallowed whole, not chewed or broken, as this may damage the special protective coating that prevents stomach acid from affecting the capsules, allowing them to reach the desired part of the intestine.

Duration of treatment

Oleomint should be used until symptoms disappear. However, if after 1 to 2 weeks, there is no improvement, the patient should consult their doctor, who may decide to continue treatment for up to three months.

Taking a higher dose of Oleomint than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or the hospital emergency department. Overdose may lead to severe gastrointestinal symptoms, diarrhea, skin changes around the anus (anal ulceration), seizures, loss of consciousness, respiratory failure, nausea, and heart rhythm disturbances.

Missing a dose of Oleomint

In case of missing a dose, the patient should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oleomint can cause side effects, although not everybody gets them. The following side effects may occur:

• allergic reactions (rash, itching, or shortness of breath), anaphylactic shock (a severe allergic reaction causing shortness of breath, dizziness, significant decrease in blood pressure, and loss of consciousness);
• headache;
• muscle tremors;
• coordination disorders;
• blurred vision;
• slow heart rate;
• urine and stool with a menthol smell;
• heartburn;
• burning sensation around the anus;
• nausea;
• vomiting;
• skin rash;
• pain or difficulty urinating;
• inflammation of the glans penis.

The frequency of side effects is unknown (cannot be determined from available data).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should consult their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oleomint

The medicine should be stored out of 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. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Oleomint contains

• The active substance of the medicine is peppermint oil. Each capsule contains 182 mg of peppermint essential oil (Menthax piperitaL., aetheroleum).
• Other ingredients are: capsule shell: gelatin, glycerol, titanium dioxide (E 171), chlorophyllin sodium-copper (E 141), purified water; protective coating: methacrylic acid copolymer, sodium carboxymethylcellulose, talc, saturated fatty acid triglycerides, triethyl citrate.

What Oleomint looks like and what the package contains

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

Marketing authorization holder and manufacturer

Marketing authorization 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., Oddział Medana w Sieradzu, ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: