SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT <Invented name> 0.5 mg/ml eye drops, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of eye drops, solution contains 0.5 mg of tetryzoline hydrochloride. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Eye drops, solution. Clear, colourless solution (pH 6.2 – 6.5; osmolality 0.265 – 0.306 osmol/kg). 4. CLINICAL PARTICULARS 4.1 Therapeutic indications For conjunctival decongestion in patients with non-infectious irritation of the eye induced by e.g. smoke, dust, wind, chlorinated water, light or due to allergic reaction (e.g. hay fever). 4.2 Posology and method of administration Posology Adults and adolescents older than 12 years If not otherwise prescribed, the dose is one drop in each affected eye 2-3 times daily. Children aged 2 to 12 years The use of this medicine is not recommended in children aged 2 to 12 years without previously consulting a doctor. <Invented name> is contraindicated in children younger than 2 years (see section 4.3). Elderly No data on the need of dose reduction in the elderly are available. Renal impairment No data on the need of dose reduction in patients with renal impairment are available. Hepatic impairment No data on the need of dose reduction in patients with hepatic impairment are available. Method of administration Ocular use. Use of the medicine longer than 72 hours is allowed only under medical supervision. Information for contact lens users In case of eye disease, contact lenses should not be worn. If, in special situations, it is allowed to wear contact lenses, they must be removed before application of the medicine. Lenses can be reinserted 15 minutes after application of the medicine. Instructions for use: 1. Wash your hands. 2. Remove the protection cap from the bottle (picture 1). 3. Grasp the bottle with your hand (picture 2). 4. Turn the bottle upside down and activate the pump until the first drop appears (picture 3). Before first application of the medicine after the first drop appears it is necessary to discard at least another 5 drops. Before each subsequent application it is necessary to discard 2 drops. If the medicine has not been used for more than 15 days, it is necessary to discard 5 drops before the application. 5. Tilt your head backwards and gently pull down your lower eyelid to form a pocket between lower eyelid and eye and holding the bottle upside down by pressing the pump instill one drop in the eye (picture 4). Do not touch anything with a dropper tip in order to avoid contamination of the solution. 6. Immediately after instillation press a finger into the corner of your eye, by the nose, or close your eyelids for 1-2 minutes. This helps to stop the medicine from getting into the rest of the body. 7. If you are using the medicine in the other eye as well, repeat the steps 5 and 6. 8. Close the bottle with the protection cap immediately after use. 4.3 Contraindications <Invented name> 0.5 mg/ml eye drops, solution must not be used in patients: - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - with narrow angle-glaucoma - with severe cardiovascular diseases (e.g. coronary heart disease, hypertension) - with pheochromocytoma - with prostatic hyperplasia - with metabolic disorders (e.g. hyperthyroidism, diabetes, porphyria) - who are being treated with monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants or other medicines that may increase blood pressure (see section 4.5). - in children younger than 2 years. 4.4 Special warnings and precautions for use Use in children as well as use of higher doses is allowed only under medical supervision. Apart from narrow angle glaucoma, where its use is contraindicated, use of this medicine in patients with other types of glaucoma is allowed only with special caution and under medical supervision. Use of this medicine is not recommended in patients with dry rhinitis (rhinitis sicca) and dry keratoconjunctivitis. Patients with a history of contact hypersensitivity to silver should not use this product as dispensed drops may contain traces of silver. Patients who are using <Invented name> must know that inflammation or redness of eyes is often a sign of serious eye disease and should therefore consult an ophthalmologist. <Invented name> should be used only for minor eye irritation. If there is no improvement within 48 hours, or if irritation and redness persist or increase, use of this drops should be discontinued and a doctor should be consulted. Irritation or redness caused by serious eye diseases such as infection, foreign body in the eye or chemical damage to the cornea also requires urgent visit to the doctor. In case of severe eye pain, headache, loss of vision, occurrence of specks in the visual field, strong, acute or unilateral redness of the eyes, feeling pain when exposed to light or occurrence of double vision, a medical advice should be sought immediately. As a result of prolonged and improper administration of higher doses than recommended (or abuse) reactive hyperaemia (redness) of the conjunctiva and mucous membrane of the nose (rhinitis medicamentosa) may occur. Long-term use should be avoided, especially in children. Use of the <Invented name> may result in transient pupil dilatation. If, in special situations, it is allowed to wear contact lenses, they must be removed before application of the medicine. Lenses can be reinserted 15 minutes after application of the medicine (see section 4.2). 4.5 Interaction with other medicinal products and other forms of interaction Concomitant use of this medicine with MAO inhibitors e.g. tranylcypromine or tricyclic antidepressants, as well as with medicines that increase blood pressure can intensify vasoconstriction and increase the blood pressure. Therefore, concomitant treatment with these medicines should be avoided. 4.6 Fertility, pregnancy and lactation Fertility No data are available on the effect on fertility. Pregnancy No data are available on the passage of the medicine through the placenta. Use of the medicine in pregnancy should be avoided due to possible systemic side effects. Lactation No data are available on the excretion of the medicine in breast milk. Use of the medicine during breast-feeding should be avoided due to possible systemic side effects. 4.7 Effects on ability to drive and use machines The ability to drive and use machines may be reduced after administration of this medicine due to occurrence of blurred vision and light induced blindness (a consequence of mydriasis). 4.8 Undesirable effects The adverse reactions in table are 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). Eye disorders rare: mydriasis very rare: keratinization of the epithelium (xerosis) of the conjunctiva with occlusion of the tear ducts and epiphora ("watery eyes") after prolonged use of tetryzoline not known: irritation of the conjunctiva, blurred vision General disorders and common: increased swelling of the mucous membrane of the administration site conditions eye (reactive hyperaemia), burning of the mucous membrane of the eye, dryness of the mucous membrane of the eye, systemic effects (e.g. palpitations, headache, tremor, weakness, sweating, blood pressure increased, heart rate increased) not known: ocular and periocular burning, erythema, irritation, oedema, pain, pruritus Paediatric population The risk of occurrence of overdose symptoms is particularly pronounced in infants and small children due to absorption as the result of ingestion of the medicine. The main symptoms are manifested through central nervous system disorders such as increase in blood pressure, arrhythmia, tachycardia, tachyarrhythmia, and reactive bradycardia. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 4.9 Overdose Excessive systemic absorption of imidazole alpha-sympathomimetic derivatives can lead to central nervous system depression. This fact should be particularly kept in mind when it comes to children. Symptoms of overdose are mydriasis, cyanosis, fever, convulsions, tachycardia, cardiac arrhythmia, cardiac arrest, hypertension, pulmonary oedema, respiratory and mental disorders. Furthermore, in certain cases, overdose can lead to inhibition of central nervous system functions, and consequently to sleepiness, decrease in body temperature, bradycardia, marked hypotension which resembles a state of shock, apnoea and coma. The risk of occurrence of overdose symptoms is particularly pronounced due to absorption as the result of ingestion of the medicine, wherein the central nervous system disorders, depression of respiratory system and circulatory collapse may occur. Already 0.01 mg of tetryzoline per kilogram of bodyweight must be considered as toxic dose. Therapeutic measures in case of overdose Administration of medical charcoal, gastric lavage, administration of oxygen, lowering of body temperature and anticonvulsant therapy. Use of vasoconstrictors is contraindicated in patients with hypotension. In case of anticholinergic symptoms, an antidote should be administered, e.g. physostigmine. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: ophtalmologicals; sympathomimetics used as decongestants, ATC code: S01GA02. Mechanism of action: Tetryzoline is a sympathomimetic that directly stimulates alpha-adrenergic receptors of the sympathetic nervous system. It has minimal or no effect on beta-adrenergic receptors. As a sympathomimetic, it has vasoconstrictor and decongestant properties. 5.2 Pharmacokinetic properties Vasoconstrictor and decongestant activity of tetryzoline starts within few minutes after local application and lasts for 4 to 8 hours.