Peppermint oil Noventis

Package Leaflet: Information for the Patient

Peppermint oil Noventis, 182 mg, gastro-resistant soft capsules

Menthae piperitae aetheroleum

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

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

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 10 days, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Peppermint oil Noventis and what is it used for
• 2. Important information before taking Peppermint oil Noventis
• 3. How to take Peppermint oil Noventis
• 4. Possible side effects
• 5. How to store Peppermint oil Noventis
• 6. Contents of the package and other information

1. What is Peppermint oil Noventis and what is it used for

Peppermint oil Noventis is a herbal medicinal product containing peppermint oil. Peppermint oil Noventis is used for the symptomatic relief of minor spasms of the gastrointestinal tract (of moderate severity), bloating, and abdominal pain, especially in patients with irritable bowel syndrome (a chronic disease that makes it difficult to empty the large intestine). If there is no improvement or the patient feels worse after 10 days, they should consult their doctor. The product is intended for the elderly, adults, adolescents, and children from 8 to 11 years old.

2. Important information before taking Peppermint oil Noventis

When not to take Peppermint oil Noventis

• if the patient is allergic to peppermint oil or menthol or any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver disease;
• if the patient has bile duct inflammation;
• if the patient has gallstones and other bile duct disorders;
• if the patient has reduced production of stomach acid (achlorhydria).

Warnings and precautions

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

• heartburn;
• hiatus hernia (a condition where the upper part of the stomach slides up into the chest).

Symptoms of these diseases may worsen after taking Peppermint oil Noventis. In such cases, the patient should stop taking Peppermint oil Noventis. The capsules should be swallowed whole, i.e., not broken or chewed, as this could cause premature release of peppermint oil, which could cause local irritation of the mouth and throat.

Children

Peppermint oil Noventis is not recommended for children under 8 years old.

Peppermint oil Noventis with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription. Concomitant use with other medicinal products that reduce stomach acid secretion, such as histamine type 2 receptor blockers, proton pump inhibitors, or antacids, may cause premature release of peppermint oil from the gastro-resistant capsule. Concomitant use of these medicines with Peppermint oil Noventis is not recommended. Peppermint oil Noventis should not be taken in combination with any other product containing peppermint oil.

Peppermint oil Noventis with food and drink

Taking food at the same time may cause premature dissolution of the capsule contents. Therefore, it is recommended to take Peppermint oil Noventis at least 30 minutes before a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Safety during pregnancy and lactation has not been sufficiently investigated. Peppermint oil Noventis is not recommended during pregnancy and lactation, as well as in women of childbearing age not using contraception. It is not known whether the components of peppermint oil can pass into human milk.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

3. How to take Peppermint oil Noventis

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

Use in adolescents, adults, and the elderly

The recommended dose is 1-2 capsules. The daily dose is 3-6 capsules (which can be achieved by taking 1-2 capsules 3 times a day or 2 capsules 2 times a day).

Use in children from 8 to 11 years old

The recommended dose is 1 capsule three times a day. A higher dose should not be taken.

Children under 8 years old

This medicine is not recommended for children under 8 years old. Method of administration: Peppermint oil Noventis should be taken 30 minutes before a meal, swallowing the capsule whole (i.e., not breaking or chewing), with a sufficient amount of liquid (preferably a glass of cold water). The duration of treatment depends on the duration of symptoms and usually lasts 1-2 weeks. The maximum treatment duration is 3 months. If the patient does not feel better or feels worse after 10 days, they should consult their doctor or pharmacist.

Overdose of Peppermint oil Noventis

In case of overdose, the patient should consult their doctor, pharmacist, or a healthcare professional. They should bring this package leaflet with them. Overdose symptoms are likely to be caused by the presence of menthol and may include:

• severe gastrointestinal symptoms, diarrhea, rectal damage, nausea;
• seizures, loss of consciousness, apnea (cessation of breathing);
• heart rhythm disorders;
• lack of muscle coordination and other nervous system problems.

Missed dose of Peppermint oil Noventis

In case of a missed dose, the patient should take the usual dose at the usual time. They 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, Peppermint oil Noventis can cause side effects, although not everybody gets them.

Side effects that may occur when taking this medicine are:

Very common(may affect more than 1 in 10 people)

• heartburn (acid reflux), anal burning, nausea, dry mouth, vomiting
• blurred vision

Unknown(frequency cannot be estimated from the available data)

• allergic reactions, including anaphylactic shock (a sudden, severe allergic reaction with symptoms such as low blood pressure and breathing problems) requiring immediate medical attention, headache, muscle tremors, lack of muscle coordination (ataxia), slow heart rate (bradycardia), flushing of the skin
• urine and feces with a menthol smell
• difficult and painful urination, inflammation of the glans penis.

The patient should stop taking the medicine if the side effects are troubling them.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-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 gathered on the safety of the medicine.

5. How to store Peppermint oil Noventis

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store in the original package to protect from light. 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. Contents of the package and other information

What Peppermint oil Noventis contains

• The active substance is peppermint oil. Each capsule contains 182 mg (0.2 ml) of Menthae piperitae aetheroleum(peppermint oil).
• The other ingredients are: gelatin; glycerol; purified water; ethylcellulose; sodium alginate; medium-chain triglycerides; purified stearic acid; oleic acid.

What Peppermint oil Noventis looks like and contents of the package

Peppermint oil Noventisare oval, transparent, matte, soft capsules containing a colorless, pale yellow or pale greenish-yellow liquid. The medicine is provided in transparent, colorless blisters (PVC/PVDC/Aluminum) that are packaged in a cardboard box. Pack size: 30, 60, or 90 gastro-resistant soft capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

US Pharmacia Sp. z o.o., ul. Ziębicka 40, 50-507 Wrocław

Manufacturer:

Noventis s.r.o., Filmová 174, Kudlov, 760 01 Zlín, Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic - Permisan, Poland - Peppermint oil Noventis, Slovakia - Permisan 182 mg soft gastro-resistant capsules

Date of last revision of the package leaflet: