Gastropan 90 mg/50 mg gastro-resistant soft capsules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET
Package leaflet: information for the patient
Gastropan 90 mg / 50 mg gastro-resistant soft capsules
Peppermint essential oil and caraway essential oil
Read all of this leaflet carefully before starting to take this medicine, because it contains important information for you.
Follow exactly the instructions for use provided 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 any adverse effects, consult your doctor or pharmacist, even if they are effects 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 symptoms persist or worsen during use of this medicine, or if adverse effects not mentioned in this leaflet occur.
Leaflet contents
- What Gastropan is and what it is used for
- What you need to know before taking Gastropan
- How to take Gastropan
- Possible adverse effects
- How to store Gastropan
- Contents of the pack and other information
1. What Gastropan is and what it is used for
It is a herbal medicinal product used for the treatment of gastrointestinal discomforts, 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 ingredients of this medicine (listed in section 6).
- if you have liver disease, inflammatory diseases of the bile ducts (cholangitis), achlorhydria (absence of gastric acid), gallstones, or any other biliary disorder.
- in children under 8 years of age for safety reasons (see section 3. Use in children).
Warnings and precautions
Talk to your doctor or pharmacist before taking Gastropan.
The capsules must be swallowed whole, without breaking or chewing them, as doing so would prematurely release the peppermint oil, possibly causing local irritation of the mouth and esophagus.
Patients who already suffer from heartburn or hiatal hernia may sometimes experience worsening of these symptoms after taking peppermint oil. In such cases, treatment should be discontinued.
If abdominal pain of unknown origin persists for more than two weeks, worsens, or occurs together with 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 lack of adequate information.
Other medicines and Gastropan
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interaction studies have been conducted.
Medicines used to reduce stomach acid, such as histamine-2 blockers, proton pump inhibitors, or antacids, may cause premature dissolution of the enteric coating, which could lead to burping with a characteristic 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 medicines used to reduce stomach acid.
Gastropan with food and drink
Since the gastro-resistant coating may dissolve prematurely if taken together with food, Gastropan should be taken at least 30 minutes before meals.
Pregnancy and breast-feeding
Pregnancy
There are no data or the data are limited regarding the use of peppermint oil and caraway oil in pregnant women. The use of Gastropan during pregnancy is not recommended.
Breast-feeding
Clinical data have shown that 1,8-cineole, a component of peppermint oil, may be excreted in human breast milk. Risk to newborns/infants cannot be excluded. The use of Gastropan during breast-feeding is not recommended.
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 per capsule.
This medicine 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 exactly the administration instructions for this medicine provided 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 daily.
Patients with renal and/or hepatic impairment:
There are no available data regarding dosage instructions in cases of impaired renal or hepatic function.
Method of administration
For oral use.
The capsules should be taken whole with plenty of liquid (e.g., a glass of water), at least 30 minutes before meals (preferably in the morning and at midday). The capsules may also be taken without subsequent food intake.
The capsules must be swallowed whole; they must not be chewed, crushed, or broken before swallowing, to prevent premature release of the active substance.
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, medical advice must be sought. During periods of more persistent symptoms, intake of gastro-resistant capsules may continue for treatment periods of up to 3 months.
Use in children
Use in children aged 8 to 11 years has not been established due to lack of adequate data.
Gastropan is contraindicated in children under 8 years of age for 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 have been reported with multiple doses of Gastropan (up to 3 capsules taken together or 8 capsules per day).
Overdose may cause:
- severe gastrointestinal symptoms, diarrhea, rectal ulceration, nausea
- epileptic seizures, loss of consciousness, apnea (cessation of breathing)
- disturbances in the heart beat rhythm
- 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 about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can produce adverse effects, although not everyone experiences them.
Gastrointestinal disorders
Heartburn, nausea, burping, anal burning. The frequency of occurrence of these effects is unknown.
Skin and subcutaneous tissue disorders / Immune system disorders
Allergic reactions (e.g., redness, swelling, itching).
Frequency is unknown.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Gastropan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and/or container (blister pack). The expiry date refers to the last day of the month indicated.
Do not store above 30 °C.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Gastropan
Each gastro-resistant soft capsule contains as the active substance:
90 mg of essential oil from Mentha x piperita L. (peppermint oil) and 50 mg of essential oil from Carum carvi L. (caraway oil).
The other components are:
Succinylated gelatin; glycerol 85%; polysorbate 80; propylene glycol; glycerol monostearate 40-55; copolymer of methacrylic acid and ethyl acrylate (1:1), 30% dispersion; medium-chain triglycerides; sodium dodecyl sulfate; liquid sorbitol (non-crystallizing).
Appearance of the product and contents of the pack
Gastropan is an oval-shaped, soft gelatin capsule with a transparent coating, containing a colorless to yellowish oil.
Gastropan is available in packs containing 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 responsible
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, Building 2, Staircase 1, 2nd floor
28108 Alcobendas, Madrid, Spain
This medicinal product 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 most recent review of this leaflet: March 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.