GASPAN 28CPS MOLLI GASTRORES

GASPAN CAPSULE GASTRORESISTANCE

active ingredients

A gastro-resistant soft capsule contains: 90 mg of Mentha x piperita L., aetheroleum (essential peppermint oil) and 50 mg of Carriage L., aetheroleum (essential cumin oil). Excipient with known effects: sorbitol. For the full list of excipients, see paragraph 6.1.

Excellent

Content of the capsule: medium chain triglycerides Capsule envelope: succiniated gelatin, glycerol 85%, sorbitol (E 420), titanium dioxide (E 171), yellow iron oxide (E 172), patented blue V (E 131), chinolin yellow (E 104). Coating: metacrilic acid - copolymer of ethyl-acrylate (1:1) 30% dispersion, propylene glycol, 80 polysorbate, 40-55 monostearate glycerol, sodium dodecylsulfate.

Therapeutic indications

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

Contraindications

- Hypersensitivity to peppermint, menthol, meadow cumin, other plants of the Apiacee family (Ombrellifere) (anise, fennel, celery, coriander and aneto), active substances or any of the excipients listed in the paragraph 6.1. - Patients with liver disease, achloride, gallstones and inflammatory diseases of bile ducts (colangitis) or other biliary disorders. - Children under 8.

Population

Population Adults and teenagers over 12 years: 1 capsule 2 times a day (corresponding to 180 mg of essential peppermint oil and 100 mg of essential cumin oil per day). Pediatric population: GASPAN is not recommended in children under 12 years (see paragraph 4.4). 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 can also be taken in the absence of a subsequent meal (see paragraph 4.5). The capsules must be intact and should not be chewed, to make sure that the active substance is not released prematurely. A premature release of the active substance could cause local irritation in the mouth and esophagus. If symptoms persist after 2 to 4 weeks of use of the medicinal product, consult a doctor or pharmacist.

Conservation

Do not store at temperature above 30°C.

Warnings

Since therapeutic experience is not sufficiently documented in children aged 8 to 12, use in this age group is not recommended. Patients suffering from heartburn or iatal hernia may charge an exacerbation of such symptoms after taking peppermint oil. In these patients treatment with this medicine must be stopped. Mint 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. In case of abdominal pain not otherwise explainable that it persists for more than two weeks or worse, or manifests itself along with symptoms such as fever, jaundice, vomiting or blood in the stools, immediately consult a doctor. Important information about some excipients GASPAN contains 11.8 mg of sorbitol per capsule.

Interactions

Interaction studies have not been carried out. In order to prevent premature dissolution of the gastro-resistant coating, GASPAN - must be taken at least 30 minutes before meals - must be taken with a range of at least one hour from taking other medicines used to reduce stomach acid such as antacids, protonic pump inhibitors or antagonists H2 of histamine.

Effects

There are no verified data on the frequency of unwanted effects, since they are made known through individual reports of patients, physicians or pharmacists. The evaluation of adverse reactions is based on the following frequency information:

Gastrointestinal disorders: Gastric disorders (e.g. eruption, heartburn, perianal burning, nausea). The frequency is not known. Skin and subcutaneous tissue disorders / Immune system disorders: Allergic reactions such as skin rash and itching. The frequency is not known. Allergic reactions to menthol have been reported, with headache, bradycardia, muscle tremor, ataxia, anaphylactic shock, contact sensitivity on mucosa and erythematous skin rash. The frequency is not known. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No symptoms of acute intoxication with GASPAN have been reported to multiple dosages (up to 3 capsules at once or 8 capsules per day). Overdose can cause fatigue, severe gastrointestinal symptoms, nausea and diarrhea, ulcerations of the rectum, seizures, loss of consciousness, respiratory arrest, cardiac arrhythmia, ataxia and other central nervous system disorders probably due to the presence of menthol. Treatment In case of overdose, the stomach must be released by gastric lavender. Observation must be conducted with symptomatic treatment if necessary.

Pregnancy

Data on the use of the essential oil of peppermint and/or cumin in pregnant women are limited. Animal studies are insufficient in reproductive toxicity (see paragraph 5.3). GASPAN is not recommended during pregnancy.

Food

It is not known whether the components of the essential oil of peppermint and/or cumin or their metabolites are secreted in breast milk. Since a risk for infant/child cannot be excluded, GASPAN should not be used in nursing.

Fertility

Data on the effects of peppermint essential oil and/or sewing oil on fertility are not available.

Source: Farmadati