OLYNTH HA 0.05% (xylometazoline hydrochloride) nasal spray Read all of this leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, you must still use Olynth HA 0.05% carefully to get the best results. - Keep this leaflet. You may need to read it again. - If you need further information or advice, contact your pharmacist. - If your symptoms do not improve within 5 days or if they get worse, you must contact your doctor. - If you get any side effects that are serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet you will learn : 1. What Olynth HA 0.05% is and what it is used for 2. Before you use Olynth HA 0.05% 3. How to use Olynth HA 0.05% 4. Possible side effects 5. How to store Olynth HA 0.05% 6. Further information 1. WHAT Olynth HA 0.05% IS AND WHAT IT IS USED FOR The medicinal product Olynth HA 0.05%, xylometazoline hydrochloride, causes blood vessels to constrict at the site of its action, thereby reducing swelling of the mucous membrane and subsequently facilitating breathing through the nose and improving the release of mucus. The onset of action usually occurs in 5-10 minutes. Hyaluronic acid protects and moisturizes the nasal mucosa, thus creating an optimal environment for the healing process. The drug Olynth HA 0.05% is intended to reduce swelling of the nasal mucosa in acute rhinitis, in excessive mucus production caused by vasomotor rhinitis and in allergic rhinitis. The drug Olynth HA 0.05% is also intended to accelerate the release of mucus in inflammation of the paranasal sinuses and in inflammation of the auditory tube together with rhinitis. The drug is intended for children from 2 to 6 years of age. The drug does not contain preservatives. 2. BEFORE YOU USE OLYNTH HA 0.05% Do not use the drug Olynth HA 0.05% - if you are allergic (hypersensitive) to the drug or any of the other ingredients of the drug, - in case of dry inflammation of the nasal mucosa (rhinitis sicca), which is manifested by a feeling of dryness and itching in the nose, often accompanied by minor bleeding after peeling off the dried crusts, - in children under 2 years of age. Take special care with Olynth HA 0.05% - if you are being treated with certain antidepressants (monoamine oxidase inhibitors) or other medicines that may increase blood pressure, - if you have increased pressure in the eye, especially if you have narrow-angle glaucoma, - if you have a serious circulatory system disease (e.g. coronary heart disease, high blood pressure), - if you have phaeochromocytoma (a tumor of the adrenal medulla that causes an increase in blood pressure), - if you suffer from certain metabolic disorders (overactive thyroid, diabetes). In these cases, the medicine may only be used after a careful assessment of the benefits and risks by your doctor. Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of Olynth HA 0.05% and other medicines taken at the same time may interact. This applies to some medicines used to improve mood (tranylcypromine-type monoamine oxidase inhibitors or tricyclic antidepressants), which can act on the circulatory system by increasing blood pressure. Using Olynth HA 0.05% with food and drink Olynth HA 0.05% can be used independently of meals. Pregnancy and breast-feeding Before taking any medicine, consult your doctor or pharmacist. Olynth HA 0.05% must not be used during pregnancy, as there are no studies available on the effect of the medicine on the foetus. The medicine must not be used during breast-feeding, as it is not known whether the medicine is excreted in breast milk. Driving and using machines With long-term use and administration of higher doses of Olynth HA 0.05%, its effect on the circulatory or central nervous system cannot be excluded. This may impair your ability to drive and use machines. 3. HOW TO USE OLYNTH HA 0.05% Use Olynth HA 0.05% exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist. Unless otherwise prescribed by your doctor, children aged 2 to 6 years are given the medicine as needed, but not more than 3 times a day, 1 dose in each nostril. The dosage depends on the patient's sensitivity and the effect of the medicine. Do not use Olynth HA 0.05% for longer than 5 days without a doctor's recommendation. If the symptoms of the disease do not improve by this time or worsen, or if side effects or unusual reactions occur, consult your doctor about continuing to use the medicine. Use for longer than 5 days is possible only after consulting a doctor. Re-use of the medicine is possible only after a break of several days. The use of the drug in chronic rhinitis is permitted only under the supervision of a doctor due to the risk of thinning of the nasal mucosa. Instructions for use Remove the protective cap. Before first use, press the pump several times until a continuous dose of aerosol is released. The dispenser bottle containing the nasal spray solution is then ready for immediate use under all circumstances. When administering, inject only one dose into each nostril. Breathe easily through the corresponding nostril when injecting the dose. Hold the dosing bottle vertically, if possible. Do not inject the dose by holding the bottle horizontally or upside down. After use, put the protective cap back on the pump. If you use more Olynth HA 0.05% than you should In case of overdose or accidental oral ingestion, the following symptoms may occur: dilated pupils (mydriasis), nausea, vomiting, bluish discoloration of the lips (cyanosis), fever, convulsions, circulatory disorders (rapid heartbeat, heart rhythm disorders, circulatory failure, cardiac arrest, increased blood pressure), lung function disorders (pulmonary edema, respiratory disorders), mood disorders. Drowsiness, decreased body temperature, slowed heartbeat, decreased blood pressure, which mimics shock, respiratory arrest and unconsciousness may occur. In these cases, you should seek medical attention immediately! Charcoal can be given as first aid. If you forget to use Olynth HA 0.05% Do not take a double dose to make up for a missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Olynth HA 0.05% can cause side effects, although not everybody gets them. Respiratory system In sensitive patients, Olynth HA 0.05% may cause transient and mild symptoms of mucosal irritation, manifested as a burning sensation in the nose or a feeling of dryness of the mucous membrane. Swelling of the nasal mucosa may often occur after the effect of the medicine has worn off. Nervous system Headache, insomnia or fatigue may rarely occur. Circulatory system Undesirable effects on the heart and circulatory system occur less frequently, especially palpitations, rapid heartbeat and an increase in blood pressure. Long-term or frequent use of higher doses of Olynth HA 0.05% may lead to a burning sensation in the nose or dryness of the nasal mucosa, as well as congestion of the mucosa (swelling), which is worsened by excessive use of the medicine (so-called rhinitis medicamentosa). This effect may occur after just 5 days of treatment - long-term administration of the medicine may cause permanent damage to the mucosa, a feeling of dryness and itching in the nose with the formation of scabs and minor bleeding when they are peeled off (rhinitis sicca). If you start to experience any side effect as serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE OLYNTH HA 0.05% Keep out of the reach and sight of children. Store at a temperature not exceeding 25 ºC. Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. For hygiene reasons, the medicine should not be used after 12 months of first opening the package. Medicines must not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. These measures will help protect the environment. 6. FURTHER INFORMATION What Olynth HA 0.05% contains - The active substance is xylometazoline hydrochloride (xylometazoline chloride) 0.5 mg (0.05%) in 1 ml solution. - The other ingredients are: sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate dihydrate, glycerol, sodium chloride, sodium hyaluronate, sorbitol, water for injections. What Olynth HA 0.05% looks like and contents of the pack The medicine is produced in the dosage form of a nasal spray solution and is packaged in a glass bottle with a mechanical dispenser. Pack size: 10 ml Marketing Authorisation Holder McNeil Products Limited C/O Johnson & Johnson Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG United Kingdom Manufacturer URSAPHARM Arzneimittel GmbH Industriestrasse 35 D-66129 Saarbrücken Germany Local representative of the Marketing Authorisation Holder in the Slovak Republic: Johnson & Johnson, sro, Karadžičova 12, 821 08 Bratislava, tel. +421 232 408 400 This leaflet was last approved in November 2012.

Also try other products from the Olynth brand, which are in the categories Respiratory system, Runny nose, stuffy nose and Medicines. The product was rated by 8 customers and 88% of them would recommend it to others. Olynth HA 0.05% aer nao 10 ml is registered in the ŠUKL database under code 36096. If you are not sure about choosing this product, get inspired in the Runny nose, stuffy nose category.