GASTROPAN 90 MG/50 MG SOFT GASTRO-RESISTANT CAPSULES

Introduction

Patient Information Leaflet

Patient Information Leaflet: Information for the Patient

Gastropan 90 mg / 50 mg Gastro-Resistant Soft Capsules

Peppermint essential oil and caraway essential oil

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for this medication exactly as stated in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after two weeks.

You should consult a doctor or pharmacist if your symptoms persist or worsen during the use of this medication or if you experience side effects not mentioned in this leaflet.

Contents of the Leaflet

1. What is Gastropan and what is it used for
2. What you need to know before taking Gastropan
3. How to take Gastropan
4. Possible side effects
5. Storage of Gastropan
6. Package contents and additional information

1. What is Gastropan and what is it used for

It is a herbal medicine for the treatment of gastrointestinal discomfort, such as mild cramps, flatulence, bloating, and abdominal pain.

Gastropan is indicated for adults and adolescents over 12 years of age.

2. What you need to know before taking Gastropan

Do not take Gastropan:

• if you are allergic to peppermint oil, caraway oil, menthol, or any of the other components of this medication (listed in section 6).
• in case of liver disease, inflammatory diseases of the bile ducts (cholangitis), achlorhydria (absence of gastric acid), gallstones, and any other biliary disorder.
• Children under 8 years of age for safety reasons (since the content of pulegone and menthofuran can exceed the safety threshold in this age group).

Warnings and precautions

Consult your doctor or pharmacist before taking Gastropan.

The capsules should be swallowed whole, i.e., without breaking or chewing them, as this could release the peppermint oil prematurely, possibly causing local irritation of the mouth and esophagus.

Patients who already suffer from heartburn or hiatal hernia may sometimes experience an exacerbation of this symptom after taking peppermint oil. In this case, treatment should be discontinued.

In case of abdominal pain of unknown origin that persists for more than two weeks or worsens, or is accompanied by symptoms such as fever, jaundice, vomiting, or blood in the stool, you should consult your doctor immediately.

Children

The use of Gastropan in children between 8 and 11 years of age has not been established due to the lack of adequate information.

Other medications and Gastropan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

No interaction studies have been conducted.

Medications used to reduce stomach acid, such as histamine-2 blockers, proton pump inhibitors, or antacids, may cause premature dissolution of the enteric coating, which can lead to belching with a typical odor and/or gastrointestinal irritation. Therefore, concomitant use should be avoided.

If concomitant use is medically necessary, Gastropan should be taken at least 2 hours before antacids or other medications used to reduce stomach acid.

Gastropan with food and beverages

Since the gastro-resistant coating could dissolve prematurely if food is ingested simultaneously, Gastropan should be taken at least 30 minutes before meals.

Pregnancy and breastfeeding

Pregnancy

There are no data or limited data on the use of peppermint oil and caraway oil in pregnant women. Gastropan is not recommended during pregnancy.

Breastfeeding

Clinical data have shown that 1,8-cineole, a component of peppermint oil, can be excreted in human breast milk. The risk to newborns/children cannot be excluded. Gastropan is not recommended during breastfeeding.

Driving and using machines

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

Gastropan contains sorbitol and sodium

Gastropan contains 12.1 mg of sorbitol in each capsule.

This medication contains less than 1 mmol of sodium (23 mg) per capsule, i.e., it is considered essentially "sodium-free".

3. How to take Gastropan

Follow the administration instructions for this medication exactly as stated in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adolescents from 12 years of age, adults, and elderly patients:

1 gastro-resistant capsule twice a day.

Patient with renal and/or hepatic impairment:

No data are available for dosing instructions in case of impaired renal/hepatic function.

Method of administration

Oral use.

The capsules are taken whole with plenty of liquid (e.g., a glass of water) at least 30 minutes before meals (preferably in the morning and at noon). The capsules can also be taken without ingesting a subsequent meal.

The capsules should be swallowed whole; they should not be chewed, crushed, or broken before swallowing, so that the active ingredient is not released prematurely.

Duration of use

The gastro-resistant capsules should be taken until symptoms disappear, usually within 2 to 4 weeks. If symptoms persist or worsen after 2 weeks, you should seek medical advice. During periods when symptoms are more persistent, the intake of gastro-resistant capsules may continue for periods of up to 3 months per treatment period.

Use in children

The use of Gastropan in children from 8 to 11 years of age has not been established due to the lack of adequate data.

Gastropan is contraindicated in children under 8 years of age for safety reasons (since the content of pulegone and menthofuran can exceed the safety threshold in this age group).

If you take more Gastropan than you should

No symptoms of acute overdoses with Gastropan have been reported in multiple doses (up to 3 capsules together or 8 capsules per day).

Overdose may cause

1. severe gastrointestinal symptoms, diarrhea, rectal ulcers, nausea
2. epileptic seizures, loss of consciousness, apnea (interruption of breathing)
3. alterations in heart rhythm
4. lack of coordination and other problems with the central nervous system

If you take more Gastropan capsules than you should, inform your doctor, who will decide on the necessary measures.

If you forget to take Gastropan

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Gastrointestinal disorders

Heartburn, nausea, belching, perianal burning. The frequency of these effects is unknown.

Skin and subcutaneous tissue disorders / Immune system disorders

Allergic reactions (e.g., redness, swelling, itching).

The frequency is unknown.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Gastropan

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and/or blister pack. The expiration date is the last day of the month indicated.

Do not store above 30 °C.

Medications should not be disposed of via wastewater or household waste.Dispose of the packaging

and medications you no longer need at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Gastropan composition

Each gastro-resistant soft capsule contains as active ingredients:

90 mg of peppermint essential oil (Mentha x piperita L.) and 50 mg of caraway essential oil (Carum carvi L.).

The other ingredients are:

Succinylated gelatin; glycerol 85%; polysorbate 80; propylene glycol; glycerol monostearate 40-55; methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%; medium-chain triglycerides; sodium dodecyl sulfate; non-crystallizing liquid sorbitol.

Appearance of the product and package contents

Gastropan is a soft gelatin capsule of oval shape, with a transparent coating, containing a colorless to yellowish oil.

Gastropan is available in packs of 14, 42, and 84 gastro-resistant soft capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Str. 4

76227 Karlsruhe

Germany

Manufacturer

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Strasse 4

D-76227 Karlsruhe

Germany

Email: info@schwabepharma.com

Local representative:

SCHWABE FARMA IBÉRICA, S.A.U.

Avenida de la Industria, 4. Edificio 2, escalera 1, 2ª planta.

28108 Alcobendas, Madrid.

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

Belgium: Carmenthin 90 mg / 50 mg

Austria: Gaspan 90 mg / 50 mg magensaftresistente Weichkapseln

Slovakia: Gaspan 90 mg / 50 mg

Spain: Gastropan 90 mg / 50 mg gastro-resistant soft capsules

Czech Republic: Gaspan

Date of the last revision of this leaflet: March 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/.