Properties
What is it?
Naphthyzin 0.1% Nasal Drops, Solution Naphazoline Nitrate Read this entire leaflet carefully before you start using this medicine, as it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. - Keep these instructions! You may need to read them again later. - If you need more information or advice, ask your pharmacist. - If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any possible side effects not listed in this leaflet. See section 4. - If you feel better or your condition worsens after 5-7 days, in children after 3 days, you should consult a doctor. With this leaflet you can learn: 1. What Naphthyzin is and what it is used for 2. What you need to know before using Naphthyzin 3. How to use Naphthyzin 4. Possible side effects 5. How to store Naphthyzin 6. Contents of the package and other information 1. What Naphthyzin is and what it is used for Naphthyzin is a topical nasal decongestant that causes vasoconstriction, reduces swelling, hyperemia, and secretion. It facilitates nasal breathing. Naphthyzin is used to treat acute rhinitis (runny nose) and sinusitis (inflammation of the sinuses). Naphthyzin can be used to reduce swelling during diagnostic procedures. If you feel better or your condition worsens after 5-7 days, in children after 3 days, you should consult a doctor. 2. What you need to know before using Naphthyzin Do not use Naphthyzin if: - you are allergic to the active substance of this medicine or any of the other ingredients (listed in section 6); - you have inflammation and dryness of the nasal mucosa (Rhinitis sicca); - you have angle-closure glaucoma; - arterial hypertension; - tachycardia; - severe atherosclerosis; - chronic rhinitis; - atrophic rhinitis; - hyperthyroidism; - pheochromocytoma; - diabetes mellitus; - coronary heart disease Safety and precautions for use Talk to your doctor, pharmacist, or nurse before using Naphthyzin. The preparation should be used with caution if you have cardiovascular disorders, metabolic disorders, or bronchial asthma. It is necessary to avoid prolonged use and overdose of the preparation. Prolonged use of this medicine can cause chronic nasal congestion and atrophy of the nasal mucosa. Children and adolescents Naphthyzin should not be used in children under 15 years of age. Other medicines and Naphthyzin Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Caution is advised when using MAO inhibitors (preparations that inhibit the activity of the enzyme monoamine oxidase) and other preparations that can increase blood pressure, as well as anesthetics that enhance the myocardial response to sympathomimetic substances (e.g., halothane). It should not be combined with MAO inhibitor antidepressants (nialamide), the administration of the preparation is possible no earlier than 14 days after their discontinuation. Pregnancy, lactation and fertility If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. To date, there is insufficient information on naphazoline's ability to cross the placental barrier or be excreted in breast milk. This medicine should be used only when necessary. Driving and operating machinery When used at therapeutic doses, this medicine does not affect the ability to drive or operate machinery. Naphthyzin contains excipients boric acid and water for injection. 3. How to use Naphthyzin Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist, or nurse has told you. If you are unsure, ask your doctor, pharmacist, or nurse. Before using the drops for the first time, open the cap as much as possible, do not twist the bottle and do not make a hole with foreign objects, as this may cause damage. The wedge inserted into it will cause it to open. Do not cut the bottle and do not make a hole with foreign objects, as in this case you may use more Naphthyzin drops than necessary (as one drop will be too large). Open the cap, remove it, and instill the solution into the nose by gently pressing the bottle body. Before use, hold the bottle in your hand to warm it to body temperature. After instillation, close the cap tightly and store the medicine according to the storage recommendations. Instill Naphthyzin into each nostril, tilting your head slightly back and to the right to instill the medicine into the left nostril, and to the left to instill into the right nostril. The recommended dose is: For adults and adolescents from 15 years of age, Naphthyzin 0.1% is used 1-3 drops in each nostril 2-3 times a day. Naphthyzin should be taken 2-3 times a day, but not more often than every 6 hours. The medicine should be taken for a short period. Naphthyzin should not be used for more than 5-7 days in adults and adolescents over 15 years of age, and for more than 3 days in children. If the nasal passage has recovered, treatment can be discontinued earlier. Naphthyzin can be repeated after 7-14 days. Use in children and adolescents - Naphthyzin is not used in children under 15 years of age. - From 15 years of age, adolescents can use Naphthyzin 0.1%. Caution is advised when using Naphthyzin. - Elderly patients. - Patients with liver and kidney problems. It is recommended to consult a doctor before using the preparation. When symptoms disappear, the course of treatment can be shortened. If you take more Naphthyzin than you should, stop taking this medicine. If necessary, symptomatic treatment should be carried out as directed by a doctor. If you forget to take Naphthyzin Do not take a double dose to make up for a missed dose. If you stop taking Naphthyzin If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Local reaction Respiratory, thoracic and mediastinal disorders: Rare (≥1/1000 to <1/100) - swelling of the larynx caused by drops, swelling of the nasal mucosa with prolonged use, reactive hyperemia (prolonged congestion of the nasal mucosa). Systemic reactions Nervous system disorders: Rarely (≥1/1000 to <1/100) - weakness, tremor, nausea, headache, irritability, excessive sweating. Cardiac dysfunction: Very rarely (<1/10000) - in isolated cases, increased blood pressure, tachycardia and arrhythmia (in predisposed patients with a tendency to cardiovascular diseases). Immune system disorders: Rare (≥1/1000 to <1/100) allergic reactions, Very rarely (<1/10000) angioneurotic edema (urticaria, swelling of the face, tongue, respiratory tract). If you take this medicine for more than a week, you may become dependent. Prolonged use of this medicine can cause atrophic rhinitis. These side effects can develop after overdose. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Naphthyzin Keep this medicine out of the reach of children. Store at a temperature not exceeding 25°C. Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month. Use within 28 days of the first opening of the bottle. Do not dispose of medicines down the drain or into household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the package and other information What Naphthyzin contains - The active substance is Naphazoline Nitrate (Naphazolini nitras) - 1 ml of Naphthyzin 0.1% solution contains 1 mg of Naphazoline Nitrate; - 1 drop of Naphthyzin 0.1% solution contains 0.032 mg of Naphazoline Nitrate. Other ingredients are boric acid and water for injection. What Naphthyzin looks like and contents of the package A clear, colorless or slightly yellowish liquid. 10 ml LDPE bottles with a PP tamper-evident cap. The bottle and instructions for use are placed in a cardboard box.
