PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

Gastropan 90 mg / 50 mg Soft Gastric Resistant Capsules

Peppermint Essential Oil and Caraway Essential Oil

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions contained in this leaflet or those given 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 any 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 you worsen or do not improve after two weeks.

You should consult a doctor or pharmacist if the symptoms persist or worsen during the use of this medicine or if any side effects not mentioned in this leaflet occur.

1.What is Gastropan and what it is used for

2.What you need to know before starting to take Gastropan

3.How to take Gastropan

4.Possible side effects

5.Storage of Gastropan

6.Contents of the pack and additional information

It is a plant-based medication for the treatment of gastrointestinal discomforts, such as mild cramps, flatulence, fullness, and abdominal pain.

Gastropan is indicated for adults and adolescents over 12 years old.

Do not take Gastropan:

-if you are allergic to peppermint oil, caraway oil, menthol, or any other component of this medication (listed in section 6).

-if you have liver disease, inflammatory bile duct disease (colangitis), achlorhydria (absence of stomach acid), gallstones, or any other biliary disorder.

-children under 8 years old for safety reasons (see 3. Use in children).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gastropan.

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

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

In case of unknown abdominal pain 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 in children between 8 and 11 years old has not been established due to a lack of adequate information.

Other medications and Gastropan

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to 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, leading to characteristic eructation 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 gastric-resistant coating may dissolve prematurely if food is ingested simultaneously, Gastropan should be taken at least 30 minutes before meals.

Pregnancy and lactation

Pregnancy

No data, or limited data, are available regarding the use of peppermint oil and caraway oil in pregnant women. Gastropan should not be used during pregnancy.

Lactation

Clinical data have shown that 1,8 cineole, a component of peppermint oil, may be excreted in human breast milk. The risk to newborns/children cannot be excluded. Gastropan should not be used during lactation.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Gastropan contains sorbitol and sodium

Gastropan may contain up to 11 mg of sorbitol in each capsule.

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

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adolescents 12 years and older, adults, and elderly patients:

1 gastro-resistant capsule twice a day.

Patients with renal and/or hepatic insufficiency:

No data is available for dosage instructions in case of renal/hepatic function deterioration.

Administration form

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

Duration of use

Gastro-resistant capsules should be taken until symptoms disappear, usually within two to four weeks. If symptoms persist or worsen after two weeks, seek medical advice. In cases where symptoms are more persistent, the intake of gastro-resistant capsules may continue for periods of up to three months per treatment period.

Use in children

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

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

If you take more Gastropan than you should

No symptoms of acute intoxication 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 ulceration, nausea
2. epileptic seizures, loss of consciousness, apnea (respiratory interruption)
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 forgot to take Gastropan

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of thismedication, ask your doctororpharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Gastrointestinal Disorders

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

Skin and Subcutaneous Tissue Disorders / Immunological System Disorders

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

The frequency is unknown.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and/or on the packaging (blister). The expiration date is the last day of the month indicated.

Do not store above 86 °F (30 °C).

Medications should not be disposed of through drains or in the trash.Dispose of the packaging

and any unused medications at your local SIGRE collection point at your usual pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Gastropan

Each soft-gelatin capsule contains as active ingredient:

90 mg of essential oil ofMentha x piperitaL., (peppermint oil) and 50 mg of essential oil ofCarum carviL., (caraway oil).

The other components are:

Succinylated gelatin; 85% glycerol; polysorbate 80; propylene glycol; glycerol monostearate 40-55; copolymer of methacrylic acid and ethyl acrylate (1:1) dispersion 30%; medium-chain triglycerides; sodium dodecyl sulfate; liquid non-crystallized sorbitol; titanium dioxide (E 171); yellow iron oxide (E 172); patent blue V (E 131); quinoline yellow (E 104).

Appearance of the product and content of the container

Gastropan is a soft-gelatin oval capsule with a light green coating, containing a colorless to yellowish oil.

Gastropan is available in containers with 14, 42, and 84 soft-gelatin resistant capsules.

All containers may not be marketed.

Marketing authorization holder

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Str.4

76227 Karlsruhe

Germany

Responsible manufacturer

Dr. Willmar Schwabe GmbH & Co. KG

Willmar-Schwabe-Strasse 4

D-76227 Karlsruhe

Germany

Email: [email protected]

Local representative:

SCHWABE FARMA IBÉRICA, S.A.U.

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

28108 Alcobendas, Madrid.

Last review date of this leaflet: March 2020

For detailed and updated information on this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.