Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile
The most commonly reported adverse reactions are epistaxis occurring in 14.8% and nasal dryness occurring in 11.3 % of patients.
Many of the adverse reactions reported are also symptoms of a common cold.

Tabulated list of adverse reactions
The adverse reactions are listed by system organ class and by frequency. Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from available data)

Xylometazoline and Ipratropium
The following adverse reactions for the combination of xylometazoline and ipratropium were reported in two randomized clinical studies and one non-interventional post-marketing study with the product as well as from post-marketing surveillance.


MeDRA SOC                            Adverse Reactions                   Frequency Immune system disorders              Hypersensitivity reaction           Very rare (angioedema, rash, pruritis)

Psychiatric disorders                Insomnia                            Uncommon Nervous system disorders             Dysgeusia                           Common Parosmia, Tremor                    Uncommon
Eye disorders                        Eye irritation, dry eye             Uncommon Photopsia                             Not known
Cardiac disorders                    Palpitations, tachycardia             Uncommon Respiratory, thoracic and            Epistaxis                             Very common mediastinal disorders
Nasal congestion, rhinalgia           Common
Nasal ulcer, dysphonia,               Uncommon oropharyngeal pain, sneezing
Rhinorrhea                            Rare
Paranasal sinus discomfort            Not known
Gastrointestinal disorder            Dyspepsia                             Uncommon Dysphagia                             Not known
General disorders and                Fatigue, discomfort                   Uncommon administration site                  Chest discomfort, thirst              Not Known conditions

Xylometazoline
The following adverse reactions have been reported in clinical trials and post- marketing surveillance with xylometazoline.


MeDRA SOC                            Adverse Reactions                        Frequency 
Nervous system disorders             Headache                                 Common Eye disorders                        Visual impairment                        Very rare Respiratory, thoracic and            Nasal dryness, nasal discomfort          Common mediastinal disorders                Epistaxis                                Uncommon Gastrointestinal disorders           Nausea                                   Common 
General disorders and                Application site burn                    Common administration site conditions

Ipratropium bromide
The following adverse reactions were identified from data obtained in clinical trials and pharmacovigilance during post approval use of the drug.

MeDRA SOC                        Adverse Reactions                              Frequency Immune system                    Anaphylactic reaction, hypersensitivity        Not known disorders
Nervous system                   Dizziness, headache                            Common disorders
Eye disorders                    Corneal oedema, conjunctival                   Uncommon hyperaemia
Glaucoma, intraocular pressure increased,      Not known accommodation disorder, blurred vision,
halo vision, mydriasis, eye pain
Cardiac disorders                Supraventricular tachycardia, palpitations     Uncommon Atrial fibrillation                            Not known
Respiratory, thoracic and       Throat irritation, dry throat                  Common mediastinal disorders           Cough                                          Uncommon Laryngospasm, pharyngeal                       Not known oedema
Gastrointestinal                Dry mouth                                      Common disorders
Nausea                                         Uncommon
Skin and subcutaneous           Rash, urticaria pruritis                       Not known tissue disorders
Renal and urinary               Urinary retention                              Not Known disorders


Description of selected adverse reactions
Several of the adverse reactions listed under "Not known" have only been reported once for the product in clinical trials or are reported during postmarketing surveillance only, thus, an estimate of the frequency based on the present number of patients treated with Otrivin Complete cannot be given.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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
/https://sideeffects.health.gov.il
Additionally, please also report to GSK Israel (il.safety@gsk.com).