Peppermint oil noventis

Patient Information Leaflet

Peppermint oil Noventis, 182 mg, enteric soft capsules
Menthae piperitae aetheroleum
Please read this leaflet carefully 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
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 10 days, or if the patient feels worse, consult a doctor.

Table of Contents

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

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

Peppermint oil Noventis is a herbal medicinal product containing peppermint oil.
Peppermint oil Noventis is used for symptomatic relief of mild gastrointestinal spasms (of moderate severity), bloating and abdominal pain, particularly in patients with irritable bowel syndrome (a chronic condition that impairs the emptying of the large intestine).
If there is no improvement after 10 days, or if the patient feels worse, consult a doctor.
This product is intended for elderly people, adults, adolescents, and children aged 8 to 11 years.

2. Important information before using Peppermint oil Noventis

When not to take Peppermint oil Noventis

• if the patient is allergic to peppermint oil or menthol, or to any of the other ingredients of this medicine (listed in section 6);
• if the patient has liver disease;
• if the patient has cholangitis (inflammation of the bile ducts);
• if the patient has gallstones or other disorders of the biliary tract;
• if the patient has reduced production of gastric hydrochloric acid (achlorhydria).

Warnings and precautions
Before starting treatment, discuss this with your doctor or pharmacist.
Discuss with your doctor or pharmacist if the patient has:

• heartburn;
• hiatal hernia (a condition where the upper part of the stomach moves into the chest cavity).

Symptoms of these conditions may sometimes worsen after taking Peppermint oil Noventis. In such cases, treatment with Peppermint oil Noventis should be discontinued.
The capsules must be swallowed whole; do not crush or chew them, as this would cause premature release of peppermint oil, potentially leading to local irritation of the mouth and esophagus.

Children
Use of Peppermint oil Noventis is not recommended in children under 8 years of age.

Peppermint oil Noventis and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including over-the-counter medicines and those planned for future use.
Concomitant use with other medicinal products that reduce gastric acid secretion, such as histamine H2-receptor antagonists, proton pump inhibitors, or antacids, may cause premature release of peppermint oil from the enteric-coated capsule. Concomitant use of these agents with Peppermint oil Noventis is not recommended.
Do not use Peppermint oil Noventis in combination with any other product containing peppermint oil.

Peppermint oil Noventis with food and drink
Concomitant intake with food may cause premature dissolution of the enteric-coated capsule contents.
Therefore, it is recommended to take Peppermint oil Noventis at least 30 minutes before meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Safety during pregnancy and lactation has not been adequately studied. Use of Peppermint oil Noventis is not recommended during pregnancy and breastfeeding, or in women of childbearing potential who are not using contraception.
It is unknown whether components of peppermint oil pass into human milk.

Driving and operating machinery
No studies have been conducted regarding the effect of this medicine on the ability to drive vehicles or operate machinery.

3. How to use Peppermint oil Noventis

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adolescents, adults and elderly
The recommended dose is 1–2 capsules. The daily dose is 3–6 capsules (this can be achieved by taking 1–2 capsules three times a day or 2 capsules twice a day).
Use in children aged 8 to 11 years
The recommended dose is 1 capsule three times a day.
Do not exceed the recommended dose.
Children under 8 years of age
This medicine is not recommended for children under 8 years of age.
Method of administration
Peppermint oil Noventis should be taken 30 minutes before a meal, swallowed whole (do not break or chew) with sufficient fluid (preferably a glass of cold water).
The duration of treatment depends on the duration of symptoms and usually lasts 1–2 weeks. The maximum duration of treatment is 3 months. Consult your doctor or pharmacist if symptoms do not improve or worsen after 10 days.
Accidental overdose of Peppermint oil Noventis
If more than the recommended dose has been taken, consult a doctor, pharmacist or healthcare professional immediately. Bring this leaflet with you.
Symptoms of overdose are likely due to the presence of menthol and may include:

• severe gastrointestinal symptoms affecting the stomach and small and large intestine, diarrhoea, rectal damage, nausea;
• epileptic-like seizures, loss of consciousness, respiratory arrest (cessation of breathing);
• heart rhythm disturbances;
• lack of muscle coordination and other nervous system problems.

Missed dose of Peppermint oil Noventis
If a dose is missed, take the next dose at the usual 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 everybody gets them.
Adverse reactions that may occur during treatment with this medicine include:
Very common (may affect more than 1 in 10 people)

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

Unknown frequency (cannot be estimated from the available data)

• allergic reactions, including anaphylactic shock (sudden, severe allergic reaction with symptoms such as low blood pressure and breathing difficulties) requiring immediate medical attention, headache, muscle tremor, lack of muscle coordination (ataxia), slow heart rate (bradycardia), erythematous skin rash
• urine and faeces with a menthol-like odour
• difficult and painful urination, balanitis.

Treatment should be discontinued if adverse reactions are troublesome to the patient.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your 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
PL-02 222 Warsaw
Tel.: + 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Peppermint oil Noventis

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines must 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 Peppermint oil Noventis contains

• The active substance is peppermint oil. Each capsule contains 182 mg (0.2 ml) of Menthae piperitae aetheroleum (peppermint oil).
• 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 pack
Peppermint oil Noventis is oval, translucent, matte soft capsules containing a colourless,
light yellow or pale greenish-yellow liquid.
The medicine is supplied in transparent, colourless blisters (PVC/PVDC/Aluminium), which are
packed in a cardboard box.
Pack sizes: 30, 60 or 90 gastro-resistant soft capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
ul. Ziębicka 40
50-507 Wrocław
Poland

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

This medicinal product is authorised 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