Medicinal Products

ELMIRON 100 mg

Generic drug of the therapeutic class: Urology nephrology
active ingredients: Pentosane sodium polysulfate
laboratory: Cevidra

capsule
box of 1 bottle of 90
All forms

Indication

Elmiron® is indicated for the treatment of painful bladder syndrome characterized by glomerular or Hunner lesions in the bladder wall in adults with moderate to severe pain, urgency and voiding frequency (see chapter Warnings and precautions for use ).

Dosage ELMIRON 100 mg capsule box of 1 bottle of 90

Elmiron® is indicated for the treatment of painful bladder syndrome characterized by glomerular or Hunner lesions in the bladder wall in adults with moderate to severe pain, urgency and voiding frequency (see chapter Warnings and precautions for use ).

Against indications

Hypersensitivity to the active substance or to any of the excipients listed in section List of excipients.

Due to the low anticoagulant effect of Pentosane polysulfate sodium, elmiron® should not be used in patients who experience bleeding. Menstruation is not a contraindication.

Elmiron side effects

This section lists the adverse reactions reported in the literature in patients treated with pentosane polysulfate sodium in clinical studies. The potential causality between the occurrence of these adverse effects and the intake of pentosane polysulfate sodium has not been discussed in the various publications.

The most common adverse reactions reported in clinical studies are headache, dizziness, and gastrointestinal disorders such as diarrhea, nausea, abdominal pain, and rectal bleeding.

The adverse reactions reported in patients treated with pentosane polysulfate sodium are comparable to those reported during placebo treatment both qualitatively and quantitatively.

Table of adverse effects

The list of adverse reactions is presented by organ system according to the MedDRA classification and by frequency: very common (≥1 / 10); frequent (≥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); indeterminate (can not be estimated from the available data).

Infections and infestations

Frequent

Infections, Influenza

Blood and lymphatic system disorders

Rare

Anemia, bruising, haemorrhage, leukopenia,

thrombocytopenia,

Undetermined

Coagulation disorders

Immune system disorders

Rare

Photosensitivity

Undetermined

Allergic reactions

Metabolism and nutrition disorders

Rare

Anorexia, taking or losing weight

Psychiatric disorders

Rare

Severe mood disorders /

Depression

Nervous system disorders

Frequent

Headache, dizziness

Rare

Increased perspiration, insomnia,

hyperkinesia, paresthesia

Eye disorders

Rare

Breathing, amblyopia

Affection of the ear and labyrinth

Rare

tinnitus

Respiratory, thoracic and

mediastinal

Rare

Dyspnea

Gastrointestinal disorders

Frequent

Nausea, diarrhea, dyspepsia, abdominal pain, dilated abdomen, hemorrhage

rectal,

Rare

Indigestion, vomiting,

mouth ulcer, flatulence, constipation


Skin and subcutaneous tissue disorders

Frequent

Peripheral edema, alopecia

Rare

Eruption, increase in

size of moles

Musculoskeletal disorders

and systemic

Frequent

Low back pain

Rare

Myalgia, arthralgia

Kidney disorders and

urinary tract

Frequent

Frequent urination

General disorders and site abnormalities

administration

Frequent

Asthenia, pelvic pain

Investigation

Undetermined

Functional anomaly

liver

Reporting of suspected adverse reactions

It is essential to report any suspected adverse reactions following the authorization of the drug. This allows continuous monitoring of the benefit / risk ratio of the drug. Healthcare professionals are advised to report suspected adverse reactions using the appropriate form available in the Therapeutic Use and Information Collection Protocol (see Annex D4 of the PUT).

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