Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Summary of the safety profile
In clinical studies involving 2,170 patients treated with DuoTrav the most frequently reported treatment-related adverse reaction was ocular hyperaemia (12.0%).
Tabulated summary of adverse reactions
The adverse reactions listed in the table below were observed in clinical studies or with post-marketing experience. They are ranked according to system organ class and classified according to 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), or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in decreasing order of seriousness.


System Organ Class               Frequency        Adverse reactions
Immune system disorders          Uncommon         Hypersensitivity

Rare             Nervousness
Psychiatric disorders
Not known        Hallucinations*,Depression
Uncommon         Dizziness, headache
Nervous system disorders                          Cerebrovascular accident, syncope, Not known paraesthesia
Very
Ocular hyperaemia common
Punctate keratitis, eye pain, visual disturbance,
Common           vision blurred, dry eye, eye pruritus, ocular
Eye disorders                                     discomfort, eye irritation Keratitis, iritis, conjunctivitis, anterior
Uncommon         chamber inflammation, blepharitis,
photophobia, visual acuity reduced,
asthenopia, eye swelling, lacrimation increased, erythema of eyelid, growth of eyelashes, eye allergy, conjunctival oedema,
eyelid oedema


DUO API DEC20 V3                                                                                 EU SmPC Oct2020 Corneal erosion, meibomianitis, conjunctival
Rare        haemorrhage, eyelid margin crusting, trichiasis,
distichiasis.
Macular oedema, eyelid ptosis, lid sulcus
Not known deepened, iris hyperpigmentation, corneal disorder.

Uncommon    Bradycardia.

Cardiac disorders                   Rare        Arrhythmia, heart rate irregular.
Cardiac failure, tachycardia, chest pain,
Not known palpitations.

Uncommon    Hypertension, hypotension.
Vascular disorders
Not known   Oedema peripheral

Uncommon    Dyspnoea, postnasal drip.
Respiratory, thoracic and                       Dysphonia, bronchospasm, cough, throat mediastinal disorders               Rare        irritation, oropharyngeal pain, nasal discomfort.

Not known   Asthma.
Gastrointestinal disorders          Not known   Dysgeusia.
Alanine aminotransferase increased,
Hepatobiliary disorders             Rare aspartate aminotransferase increased.

Uncommon    Dermatitis contact, hypertrichosis, skin
Skin and subcutaneous                           hyperpigmentation (periocular).
tissue disorders
Urticaria, skin discolouration, alopecia.
Rare


Not known   Rash.
Musculoskeletal and
Rare        Pain in extremity.
connective tissue disorders
Renal and urinary disorders         Rare        Chromaturia.
General disorders and administration site                 Rare        Thirst, fatigue.
conditions
* adverse reactions observed with timolol.
Additional adverse reactions that have been seen with one of the active substances and may potentially occur with DuoTrav:



DUO API DEC20 V3                                                                             EU SmPC Oct2020 Travoprost
System organ class                                MedDRA preferred term Immune system disorders                           Seasonal allergy
Psychiatric disorders                             Anxiety, insomnia
Eye disorders                                     Uveitis, conjunctival follicles, eye discharge, periorbital oedema, eyelids pruritus, ectropion,
cataract, iridocyclitis, ophthalmic herpes simplex,
eye inflammation, photopsia, eczema eyelids,
halo vision, hypoaesthesia eye, anterior chamber pigmentation, mydriasis, eyelash hyperpigmentation, eyelash thickening, visual field defect
Ear and labyrinth disorders                       Vertigo, tinnitus
Vascular disorders                                Blood pressure diastolic decreased, blood pressure systolic increased
Respiratory, thoracic and mediastinal disorders   Asthma aggravated, rhinitis allergic, epistaxis, respiratory disorder, nasal congestion, nasal dryness
Gastrointestinal disorders                        Peptic ulcer reactivated, gastrointestinal disorder, diarrhoea, constipation, dry mouth,
abdominal pain, nausea, vomiting
Skin and subcutaneous tissue disorders            Skin exfoliation, hair texture abnormal, dermatitis allergic, hair colour changes,
madarosis, pruritus, hair growth abnormal,
erythema
Musculoskeletal and connective tissue disorders   Musculoskeletal pain, arthralgia Renal and urinary disorders                       Dysuria, urinary incontinence General disorders and administration site         Asthenia conditions
Investigations                                    Prostatic specific antigen increased 


DUO API DEC20 V3                                                                             EU SmPC Oct2020 Timolol
Like other topically applied ophthalmic medicinal products, timolol is absorbed into the systemic circulation. This may cause undesirable effects similar to those seen with systemic beta-blocking agents.
Additional listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. The incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. For information on how to reduce systemic absorption, see section 4.2.


System organ class                                       MedDRA preferred term Systemic allergic reactions including angioedema,
Immune system disorders                                  urticaria, localized and generalized rash, pruritus, anaphylaxis.
Metabolism and nutrition disorders                       Hypoglycaemia.
Psychiatric disorders                                    Hallucinations,insomnia, nightmares, Cerebral lischaemia, increases in signs and
Nervous system disorders symptoms of myasthenia gravis.
Signs and symptoms of ocular irritation (e.g.
burning, stinging, itching, tearing, redness),
choroidal detachment following filtration surgery
Eye disorders
(see section 4.4), decreased corneal sensitivity,
diplopia.

Oedema, congestive heart failure,
Cardiac disorders                                        atrioventricular block, cardiac arrest.

Vascular disorders                                       Raynaud's phenomenon, cold hands and feet.


Nausea, dyspepsia, diarrhea, dry mouth,
Gastrointestinal disorders abdominal pain, vomiting.
Skin and subcutaneous tissue disorders                   Psoriasiform rash or exacerbation of psoriasis.
Musculoskeletal and connective tissue disorders          Myalgia.
Reproductive system and breast disorders                 Sexual dysfunction, decreased libido.
General disorders and administration site
Asthenia.
conditions
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 https://sideeffects.health.gov.il/