Gaspan

PATIENT LEAFLET: INFORMATION FOR THE PATIENT

GASPAN gastro-resistant soft capsules

Peppermint essential oil and caraway essential oil
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist or doctor.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 2–4 weeks.

Contents of this leaflet:

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

What GASPAN is and what it is used for
GASPAN is a traditional herbal medicinal product derived from plants, containing peppermint essential oil and caraway essential oil.
GASPAN is indicated for the treatment of common gastrointestinal disorders, particularly mild cramps, flatulence, bloating, and abdominal pain, including in patients with dyspepsia and irritable bowel syndrome (IBS).
The use of this traditional herbal medicinal product for the specified therapeutic indications is based solely on long-standing use.
GASPAN is indicated for adults and adolescents over 12 years of age.
Consult your doctor if you do not feel better or if you feel worse after 2–4 weeks.

What you need to know before taking GASPAN
Do not take GASPAN

• if you are hypersensitive to peppermint, menthol, caraway, other umbelliferous plants (anise, fennel, celery, coriander, and dill), or to any of the other ingredients of this medicine (listed in section 6).
• if you have liver disease, gallstones, inflammatory bile duct diseases (cholangitis), or other biliary disorders.
• if you suffer from insufficient gastric acid secretion (achlorhydria).
• in children under 8 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking GASPAN.
Patients suffering from heartburn or hiatal hernia may experience worsening of symptoms after taking peppermint oil. In such cases, treatment should be discontinued.
Peppermint oil should be used with caution in cases of inflammation or ulceration of the gastrointestinal tract.
Avoid other medicines containing peppermint essential oil while using this product.
Seek immediate medical advice from a doctor or pharmacist if unexplained abdominal pain persists or worsens, or if it occurs together with symptoms such as fever, jaundice, vomiting, or blood in the stool.

Children
As adequate and well-documented studies on the use of this medicine in children aged 8 to 12 years are lacking, its use in this age group is not recommended.

Other medicines and GASPAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines have been observed.
To prevent premature dissolution of the gastro-resistant coating, GASPAN

• should be taken at least 30 minutes before meals
• should be taken at least one hour apart from other medicines used to reduce stomach acidity, such as antacids, proton pump inhibitors, or H2-receptor antagonists.

Pregnancy, breastfeeding, and fertility
Pregnancy
Data on the use of peppermint essential oil and/or caraway oil in pregnant women are limited. Animal studies are insufficient regarding reproductive toxicity. GASPAN is not recommended during pregnancy.
Breastfeeding
It is not known whether components of peppermint essential oil and/or caraway oil or their metabolites are excreted in breast milk. As a risk to the newborn/infant cannot be excluded, GASPAN should not be used during breastfeeding.
Fertility
No data are available on the effects of peppermint essential oil and/or caraway oil on fertility.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
No studies have been conducted to assess the effect on the ability to drive vehicles or operate machinery.

GASPAN contains sorbitol. This medicine contains 11.8 mg of sorbitol per capsule.

How to take GASPAN
Take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents over 12 years of age
The recommended dose is 1 capsule twice daily.
Method of administration
The capsule must be swallowed whole with water at least 30 minutes before meals (preferably in the morning and at noon). The capsules may also be taken without a subsequent meal.
The capsules must remain intact and must not be chewed, to ensure that the active substance is not released prematurely. Premature release of the active substance may cause local irritation in the mouth and esophagus.
Duration of treatment
If symptoms persist or worsen after 2–4 weeks of treatment, consult your doctor or pharmacist.
Use in children
GASPAN is not recommended for children under 12 years of age.

If you take more GASPAN than you should
The daily dose of GASPAN must not exceed the dose stated in this leaflet or prescribed by your doctor. Accidentally taking one or two extra capsules generally does not cause harmful effects.
Symptoms of overdose may include:

• fatigue
• severe gastrointestinal symptoms, nausea, diarrhea, rectal ulceration
• convulsions, loss of consciousness, respiratory arrest
• changes in heart rhythm
• lack of coordination and other central nervous system disorders.

If you have taken more GASPAN than recommended, inform your doctor or go to the nearest hospital, and bring this leaflet with you. This is particularly important if a young child has ingested a large amount of GASPAN.

If you forget to take GASPAN
Do not take a double dose to make up for the missed dose. Continue treatment as indicated in this leaflet.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Gastrointestinal disorders:
Gastric disorders (e.g. belching, heartburn, perianal burning, nausea). Frequency unknown.
Skin and subcutaneous tissue disorders / Immune system disorders:
Allergic reactions such as skin rash and itching. Frequency unknown.
If you experience any of the following effects, stop taking the capsules and consult a doctor immediately:
allergic reactions to menthol, e.g. anaphylactic shock, abnormally slow heartbeat (bradycardia), red skin eruptions (erythematous rash), tremor (muscle tremor), lack of coordination (ataxia), and headache.

Reporting of side effects
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps provide more information on the safety of this medicine.

How to store GASPAN
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). The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

Contents of the pack and other information
What GASPAN contains

• The active substances are peppermint essential oil and caraway essential oil.
• Each gastro-resistant soft capsule contains 90 mg of Mentha x piperita L., aetheroleum (peppermint essential oil) and 50 mg of Carum carvi L., aetheroleum (caraway essential oil).
• Other components are: Capsule contents: medium-chain triglycerides
  Capsule shell: succinylated gelatin, glycerol 85%, sorbitol (E-420), titanium dioxide (E 171), yellow iron oxide (E 172), patent blue V (E 131), quinoline yellow (E 104).
  Coating: methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30%, propylene glycol, polysorbate 80, glycerol monostearate 40-55, sodium dodecyl sulfate.

Description of the appearance of GASPAN and pack contents
GASPAN is an opaque, light green, oval-shaped soft capsule containing a yellowish transparent oil. GASPAN is available in blisters containing 14, 28, 42, and 84 gastro-resistant soft capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
D-76227 Karlsruhe (Germany)