Source: Medicines Authority (MT) Revision Year: 2021 Publisher: A. Menarini Industrie Farmaceutiche Riunite Srl, Via Sette Santi 3, 50131 Florence, Italy
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
To be used with caution in subjects with glaucoma, prostatic hypertrophy and pyloric stenosis. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
No interaction studies of otilonium bromide with other products were performed.
At the recommended dose of 40 mg 2 or 3 times daily, the effect of Otilonium bromide on total time of gastrointestinal transit seems to be not significant.
There are no or limited amount of data from the use of Otilonium Bromide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of Spasmomen during pregnancy, unless absolutely necessary and under close medical supervision.
It is unknown whether Otilonium Bromide is excreted in human milk.
A risk to the newborns/infants cannot be excluded.
Spasmomen should only be recommended to breast-feeding mothers if absolutely necessary and under close medical supervision.
There are no data on the effect of Otilonium Bromide on human fertility. No effects on fertility have been observed in animal studies with female and male rats (see section 5.3).
Spasmomen has no or negligible influence on the ability to drive and use machines.
Undesirable effects are described in accordance with their system organ class and based on their estimated frequency from post-authorisation studies and spontaneous reporting.
Frequencies are defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
| System organ classification | Frequency | Undesirable effects |
|---|---|---|
| Skin and subcutaneous tissue disorders | Not known | Angioedema* Urticaria* |
| Gastrointestinal disorders | Not known | Dry mouth Nausea |
* Undesirable effects coming from post-marketing experience
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
