OTRIVINE EXTRA DUAL RELIEF

Posology Adults: 1 puff in each nostril up to 3 times daily. At least 6 hours should elapse between two doses. Do not exceed 3 applications daily into each nostril. 4). Do not exceed the stated dose. The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.

8). Paediatric population Otrivine Extra Dual Relief is not recommended for use in children and adolescents below 18 years of age due to lack of sufficient documentation. Geriatrics There is only limited experience of use in patients above 70 years of age.

Method of administration Vertically actuated pump:

Before the first application, prime the pump by actuating 4 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. 1. Clear the nose. 2. Hold the bottle upright with thumb under base and nozzle between two fingers.

3. Lean forward slightly and insert the nozzle into a nostril. 4. Spray and breathe in gently through the nose at the same time. 5. Repeat this procedure in the other nostril. 6. Clean and dry the nozzle before replacing back the cap right after use.

Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 6 days, the pump will need to be reprimed with 4 actuations as initially performed. If the full spray is not administered, the dose should not be repeated.

Thumb laterally actuated pump:

Before the first use Prime the pump by actuating 5 times. Once primed the pump will normally remain charged throughout regular daily treatment periods. Remove the cap. 1. Clear the nose. 2. Hold the bottle upright with thumb on the actuation button.

3. For a no dripping effect, stay upright and insert the nozzle into a nostril. 4. Press on the button to spray and breath in gently through the nose at the same time. Repeat this procedure (step 2 to 4) in the other nostril. 5. After each use, clean and dry the nozzle.

6. Put the protective cap back on until an audible “click” is heard. Should the spray not be ejected during the full actuation stroke, or if the product has not been used for longer than 7 days, the pump will need to be re-primed with 2 actuations.

If the full spray is not administered, the dose should not be repeated. To avoid possible spread of infection, the spray should only be used by one person. Be careful not to spray in the eyes.

3% of patients. Many of the adverse events reported are also symptoms of common cold. Tabulated list of adverse reactions The adverse reactions are presented by system organ class and frequency.

Frequencies are defined as:

Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10000 and <1/1000); Very rare (< 1/10,000); Not known (can not be estimated from the available data) Xylometazoline and Ipratropium The following adverse reactions for the combination of xylometazoline and ipratropium were reported in two randomised 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 (angioedema, rash, pruritis) Very rare Psychiatric disorders Insomnia Uncommon Dysgeusia CommonNervous system disorders Parosmia, Tremor Uncommon Eye disorders Eye irritation, dry eye Uncommon Photopsia Not known Cardiac disorders Palpitations, tachycardia Uncommon Epistaxis Very common Nasal congestion, rhinalgia Common Nasal ulcer, dysphonia, oropharyngeal pain, sneezing Uncommon Rhinorrhea Rare Respiratory, thoracic and mediastinal disorders Paranasal sinus discomfort Not known Dyspepsia UncommonGastrointestinal disorder Dysphagia Not known Fatigue, discomfort UncommonGeneral disorders and administration site conditions Chest discomfort, thirst Not Known 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 Nasal dryness, nasal discomfort CommonRespiratory, thoracic and mediastinal disorders Epistaxis Uncommon Gastrointestinal disorders Nausea Common General disorders and administration site conditions Application site burn Common 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 disorders Anaphylactic reaction, hypersensitivity Not known Nervous system disorders Dizziness, headache Common Corneal oedema, conjunctival hyperaemia UncommonEye disorders Glaucoma, intraocular pressure increased, accommodation disorder, blurred vision, halo vision, mydriasis, eye pain Not known Supraventricular tachycardia, palpitations UncommonCardiac disorders Atrial fibrillation Not known Throat irritation, dry throat Common Cough Uncommon Respiratory, thoracic and mediastinal disorders Laryngospasm, pharyngeal oedema Not known Dry mouth CommonGastrointestinal disorders Nausea Uncommon Skin and subcutaneous tissue disorders Rash, urticaria pruritis Not known Renal and urinary disorders Urinary retention Not Known 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 from postmarketing surveillance only, thus an estimate of the frequency based on the present number of patient treated with Otrivine Extra Dual Relief cannot be given.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

The medicinal product must be used with caution in patients who are sensitive to adrenergic substances, which may give symptoms such as sleeping disturbances, dizziness, tremor, cardiac arrythmias or elevated blood pressure. The medicinal product must be administered with caution to patients with: - hypertension, cardiovascular diseases.

Patients with long QT syndrome treated with xylometazoline may be at increased risk of serious ventricular arrhythmias - hyperthyroidism, diabetes mellitus - hypertrophy of the prostate, stenosis of the bladder bar - pheochromocytoma - cystic fibrosis - monoamine oxidase inhibitor (MAOI) treatment or who have received them in the last two weeks (see section

Otrivine Extra Dual Relief should not be given to children under the age of 18 due to lack of sufficient documentation. 1. Hypersensitivity to atropine or atropine like substances such as, hyoscyamine and scopolamine. g. trans- sphenoidal hypophysectomy or other trans-nasal operations.

Glaucoma. Rhinitis sicca or atrophic rhinitis.