Gastropret

Package leaflet: Information for the user

Gastropret, 182 mg, enteric soft capsules
Menthae piperitae aetheroleum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See: section 4.
• If there is no improvement after 2 weeks, or if you feel worse, you should consult your doctor.

Contents of the leaflet

1. What Gastropret is and what it is used for
2. What you need to know before taking Gastropret
3. How to take Gastropret
4. Possible side effects
5. How to store Gastropret
6. Contents of the pack and other information

1. What Gastropret is and what it is used for

A herbal medicinal product used for symptomatic relief of mild gastrointestinal spasms, bloating and abdominal pain, particularly in patients with irritable bowel syndrome.
Gastropret is indicated for use in adults, adolescents and children aged 8 years and older.

2. Important information before using Gastropret

When not to use Gastropret:

• 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, biliary tract inflammation, reduced gastric acid production (achlorhydria), gallstones, or any other biliary tract disorders,
• in children under 8 years of age and children with body weight below 19 kg.

Warnings and precautions
Before starting to use Gastropret, discuss this with your doctor or pharmacist:

• if the patient has heartburn (acid reflux) or a hiatal hernia (a displacement of the upper part of the stomach), symptoms may worsen after taking Gastropret. In such cases, treatment with Gastropret should be discontinued.
• avoid taking Gastropret together with other products containing peppermint oil. The enteric-coated soft capsules (referred to as "capsules" in the remainder of this leaflet) must be swallowed whole; do not break or chew them, as this could cause premature

release of peppermint oil, which may lead to local irritation of the oral cavity and
oesophagus.
Children
Use of Gastropret is contraindicated in children under 8 years of age and in children with body weight
below 19 kg.
Gastropret and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Avoid using other medicines intended to reduce gastric acidity, such as histamine H2-receptor antagonists and proton pump inhibitors, as they may cause premature dissolution of the enteric coating of the capsule.
No studies on interactions with other medicines have been conducted.
Taking Gastropret with food and drink
Taking Gastropret together with food may cause premature dissolution of the enteric-coated capsule.
Therefore, it is recommended to take Gastropret 30 minutes before meals.
Pregnancy and breastfeeding
Due to insufficient data, use of Gastropret is not recommended during pregnancy, breastfeeding, and in women of childbearing age who are not using contraception.
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
No studies on the effect on the ability to drive and operate machinery have been conducted.
Gastropret contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, this medicine is considered "sodium-free."

3. How to use Gastropret

This medicine should always be used exactly as described in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a physician or pharmacist.
The recommended dose is:

Method of administration
For oral use. Gastropret should be taken 30 minutes before a meal, accompanied by an adequate amount of cool liquid (preferably a glass of cool water).
The capsules should be swallowed whole; do not break or chew them.
Duration of use:
Gastropret should be taken until symptoms subside, usually from one to two weeks. In cases of more persistent symptoms, treatment with this medicine may be continued without interruption for a period not exceeding 3 months.
Taking a higher than recommended dose of Gastropret
If a higher than recommended dose is taken, consult a doctor or pharmacist and bring this leaflet with you.
Overdose may cause severe gastrointestinal symptoms, diarrhea, anal ulceration, seizures, loss of consciousness, respiratory arrest, nausea, cardiac arrhythmias, impaired motor coordination, and other nervous system disorders, probably due to the presence of menthol in the medicine.
Missed dose of Gastropret
Take the usual dose at the regular time. A missed dose is not significant.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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 have been reported:

Common (may occur in up to 1 in 10 people):

• Hyperacidity (heartburn), anal burning, blurred vision, dry mouth, nausea and vomiting.

Frequency unknown (frequency cannot be estimated from the available data):

• Urine and faeces with a menthol odour;
• Painful urination (dysuria) and balanitis (inflammation of the glans penis);
• Allergic reactions to menthol have been reported, including headache, slowing of the heart rate (bradycardia), muscle tremor, lack of muscle coordination (ataxia), anaphylactic shock (sudden severe allergic reaction with symptoms such as low blood pressure and breathing difficulties), and red skin rash (erythematous skin eruption).

In the event of severe allergic reactions, including anaphylactic shock requiring immediate treatment, the medicine must be discontinued and urgent medical assistance sought.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 .
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 Gastropret

Keep this medicine out of 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 specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Gastropret contains

• The active substance is Menthae piperitae aetheroleum (peppermint oil). Each capsule contains 182 mg (corresponding to 0.2 ml) of peppermint oil (Menthae piperitae aetheroleum).
• Other ingredients: Capsule shell: gelatin, glycerol (E 422), purified water
  Enteric coating layer: sodium alginate, stearic acid, ethylcellulose, medium-chain triglycerides, oleic acid

What Gastropret looks like and contents of the pack
Oval, translucent-matte capsules containing a clear, slightly sticky liquid.
Capsule length is approximately 10 mm and width approximately 7 mm.
Gastropret is available in blister packs contained in cardboard boxes of 15 or 45 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
BIONORICA SE
Kerschensteinerstraße 11-15
92318 Neumarkt, Germany
Tel.: +49 (0)9181 231-90
Fax: +49 (0)9181 231-265
E-mail: [email protected]

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Bionorica Polska Sp. z o.o.
ul. Hrubieszowska 6B
01-209 Warsaw
Poland
Tel/Fax: +48 22 886 46 06
e-mail: [email protected]

This medicinal product is authorised for marketing in the European Economic Area countries under the following names:
AUSTRIA: Intestipret magensaftresistente Weichkapseln
BELGIUM:
BULGARIA: Интестипрет, 182 mg стомашно-устойчиви капсули, меки
Intestipret, 182 mg gastro-resistant soft capsule
CROATIA: Intestipret meke želučanootporne kapsule
FRANCE:
GREECE: Digestopret
SPAIN: Digestopret
NETHERLANDS: Digestopret
GERMANY: Digestopret
POLAND: Gastropret
CZECH REPUBLIC: Digelib
ROMANIA: Digestopret 182 mg capsule moi gastrorezistente
SLOVAKIA: Digelib
SLOVENIA: Gastropret
SWEDEN: Gastopret
HUNGARY: Digelib
ITALY: Gastopret