GASPAN * 28CPS MOLLI GASTRORES

GASPAN * 28CPS MOLLI GASTRORES

Therapeutic indications

Traditional herbal medicine indicated for the treatment of the most common gastrointestinal disorders, in particular mild cramps, flatulence, fullness and abdominal pain, also in patients with dyspepsia and irritable bowel syndrome (IBS). The use of this traditional medicinal product of plant origin, for the indicated therapeutic indications, is based exclusively on the experience of many years of use. GASPAN is indicated in adults and adolescents over 12 years of age.

Dosage and method of use

DosageAdults and adolescents over 12 years of age: 1 capsule 2 times a day (corresponding to 180 mg of peppermint essential oil and 100 mg of cumin essential oil per day).Pediatric population:GASPAN is not recommended in children below 12 years (see section 4.4).Method of administrationThe capsule should be swallowed whole with water at least 30 minutes before meals (preferably in the morning and at noon). The capsules can also be taken without a subsequent meal (see section 4.5). The capsules must be intact and must not be chewed to ensure that the active substance is not released prematurely. Premature release of the active substance could cause local irritation in the mouth and esophagus. If symptoms persist after 2 - 4 weeks of using the medicine, a doctor or pharmacist should be consulted.

Contraindications

- Hypersensitivity to peppermint, menthol, caraway, other plants of the Apiacea family (Umbrelliferae) (anise, fennel, celery, coriander and dill), to the active substances or to any of the excipients listed in section 6.1. - Patients with liver disease, achlorhydria, gallstones and inflammatory diseases of the bile ducts (cholangitis) or other biliary disorders. - Children under the age of 8.

Side effects

There are no verified data on the frequency of undesirable effects, as they are disclosed through individual reports from patients, doctors or pharmacists. Assessment of adverse reactions is based on the following frequency information:

Gastrointestinal disorders

: Gastric disturbances (eg belching, heartburn, perianal burning, nausea). The frequency is unknown.Skin and subcutaneous tissue disorders / Immune system disorders: Allergic reactions such as rash and itching. The frequency is unknown. Allergic reactions to menthol, with headache, bradycardia, muscle tremor, ataxia, anaphylactic shock, mucosal contact sensitivity and erythematous skin rash have been reported. The frequency is unknown.Reporting of suspected adverse reactionsReporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Since therapeutic experience is not sufficiently documented in children aged 8 to 12 years, use in this age group is not recommended. Patients suffering from heartburn or hiatal hernia may experience an exacerbation of these symptoms after taking peppermint oil. In these patients, treatment with this medicinal product should be discontinued. Peppermint oil should be used with caution in conditions of inflammation and ulceration of the gastrointestinal tract. Avoid other medicines containing peppermint oil while using this medicine. If you experience unexplained abdominal pain that persists for more than two weeks or worse, or occurs alongside symptoms such as fever, jaundice, vomiting, or blood in the stool, seek immediate medical attention.Important information about some of the ingredientsGASPAN contains 11.8 mg of sorbitol per capsule.

Pregnancy and breastfeeding

PregnancyThere are limited data on the use of peppermint and / or cumin essential oil in pregnant women. Animal studies are insufficient with respect to reproductive toxicity (see section 5.3). GASPAN is not recommended during pregnancy.Feeding timeIt is not known whether the components of peppermint and / or cumin essential oil or their metabolites are secreted in breast milk. As a risk to the newborn / infant cannot be excluded, GASPAN should not be used in breastfeeding.FertilityThere are no data on the effects of peppermint essential oil and / or cumin oil on fertility.

Expiration and retention

Do not store above 30 ° C.

Interactions with other drugs

No interaction studies have been performed. In order to prevent premature dissolution of the gastro-resistant lining, GASPAN - must be taken at least 30 minutes before meals - must be taken with an interval of at least one hour after taking other medicines used to reduce stomach acid such as antacids, proton pump inhibitors or histamine H2 antagonists.

Overdose

No symptoms of acute intoxication have been reported with GASPAN at multiple doses (up to 3 capsules at once or 8 capsules per day). Overdose can cause fatigue, severe gastrointestinal symptoms, nausea and diarrhea, rectal ulceration, seizures, loss of consciousness, respiratory arrest, cardiac arrhythmia, ataxia and other central nervous system disorders possibly due to the presence of menthol. Treatment In the event of an overdose, the stomach should be freed by gastric lavage. Observation should be conducted with symptomatic treatment if necessary.

Active principles

One gastro-resistant soft capsule contains: 90 mg ofMentha x piperita L.,aetheroleum (peppermint essential oil) and 50 mg ofCarum carvi L., aetheroleum (cumin essential oil). Excipient with known effect: sorbitol. For the full list of excipients, see section 6.1.

Excipients

Capsule contents:medium chain triglyceridesCapsule 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.