Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Summary of Safety Profile
Many of the listed undesirable effects can be assigned to the anticholinergic properties of SPIRIVA.

Tabulated summary of adverse reactions

The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse drug reactions (i.e. events attributed to tiotropium) observed in the tiotropium group (9,647 patients) from 28 pooled placebo-controlled clinical trials with treatment periods ranging from four weeks to four years.

Frequency is defined using the following convention:
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 (cannot be estimated from the available data).

System Organ Class/MedDRA Preferred                Frequency
Term

Metabolism and nutrition disorders
Dehydration                                        Not known
Nervous system disorders
Dizziness                                          Uncommon
Headache                                           Uncommon
Taste disorders                                    Uncommon
Insomnia                                           Rare

Eye disorders
Vision blurred                                     Uncommon
Glaucoma                                           Rare
Intraocular pressure increased                     Rare

Cardiac disorders
Atrial fibrillation                                Uncommon
Supraventricular tachycardia                       Rare
Tachycardia                                        Rare
Palpitations                                       Rare
Respiratory, thoracic and mediastinal disorders
Pharyngitis                                        Uncommon
Dysphonia                                          Uncommon
Cough                                              Uncommon
Bronchospasm                                        Rare
Epistaxis                                           Rare
Laryngitis                                          Rare
Sinusitis                                           Rare

Gastrointestinal disorders
Dry Mouth                                           Common
Gastrooesophageal reflux disease                    Uncommon
Constipation                                        Uncommon
Oropharyngeal Candidiasis                           Uncommon
Intestinal obstruction, including ileus paralytic   Rare
Gingivitis                                          Rare
Glossitis                                           Rare
Dysphagia                                           Rare
Stomatitis                                          Rare
Nausea                                              Rare
Dental caries                                       Not known

Skin and subcutaneous tissue disorders,
immune system disorders:
Rash                                                Uncommon
Urticaria                                           Rare
System Organ Class/MedDRA Preferred                 Frequency
Term
Pruritus                                            Rare
Hypersensitivity (including immediate               Rare reactions)
Angioedema                                          Rare
Anaphylactic reaction                               Not known
Skin infection, skin ulcer                          Not known
Dry skin                                            Not known

Musculoskeletal and connective tissue disorders
Joint swelling                                      Not known

Renal and urinary disorders
Dysuria                                             Uncommon
Urinary retention                                   Uncommon
Urinary tract infection                             Rare
Description of selected adverse reactions

In controlled clinical studies, the commonly observed undesirable effects were anticholinergic undesirable effects such as dry mouth which occurred in approximately 4% of patients.
In 28 clinical trials, dry mouth led to discontinuation in 18 of 9,647 tiotropium treated patients (0.2%).

Serious undesirable effects consistent with anticholinergic effects include glaucoma, constipation and intestinal obstruction including ileus paralytic as well as urinary retention.
Other special population

An increase in anticholinergic effects may occur with increasing age.
Reporting of suspected adverse reactions
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. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectM edic@moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL).