Nasivin Kids 0,25mg/ml preservative-free solution nasal spray 10ml

Nasivin Kids 0,25 mg/ml preservative-free nasal spray solution 10 ml

Classification type: non-prescription medicine Oxymetazoline hydrochloride-containing, non-prescription medicine for children aged 1-6 years. DOSAGE: For young children aged 1-6 years. From the age of 1 to 6 years, 1 spray into both nostrils 2-3 times a day Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution. A single dose of the product can be used up to three times a day. DISTRIBUTOR INFORMATION: P&G Hungary Kkt., 1082 Budapest, Kisfaludy utca 38., +36-1-451-1256, Patient information: Information for the user Nasivin Baby 0.1 mg/ml preservative-free nasal drops Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution oxymetazoline hydrochloride Before you start using this medicine, read the following patient information carefully as it contains important information for you. Always use this medicine exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. - Keep the patient information leaflet. You may need to read it again. - Ask your pharmacist for more information or advice. - If you experience any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this patient information leaflet. See section 4. - Be sure to tell your doctor if your symptoms do not improve within 5-7 days or if they get worse. Contents of the patient information leaflet: 1. What are Nasivin preservative-free products and what are they used for? 2. Things to know before using Nasivin preservative-free products 3. How to use Nasivin preservative-free products? 4. Possible side effects 5. How to store Nasivin preservative-free products? 6. Contents of the package and other information 1. What are Nasivin preservative-free products and what are they used for? Nasivin preservative-free products are for nasal use only. Nasivin preservative-free products contain the active ingredient oxymetazoline. This active ingredient has vasoconstrictor properties and thus causes a reduction in swelling of the mucous membrane. Nasivin preservative-free products can be used for the following conditions: - common cold (acute rhinitis), - allergic rhinitis (allergic rhinitis), - episodic hay fever (vasomotor rhinitis), - to facilitate the discharge of secretions in the event of inflammation of the nose and/or sinuses, - otitis media and otitis media associated with a cold, - diagnostic reduction of mucosal swelling during medical examinations. Treatment with Nasivin Classic preservative-free 0.5 mg/ml nasal spray solution reduces the duration of the common cold from an average of 6 days to 4 days compared to physiological saline. 2. Things to know before using Nasivin preservative-free products Do not use Nasivin preservative-free products: - if you are allergic to oxymetazoline or any of the other ingredients of this medicine (listed in section 6). - if you suffer from rhinitis sicca (a certain type of chronic rhinitis with drying out of the nasal mucosa and crust formation). Warnings and Precautions Talk to your doctor or pharmacist before using Nasivin preservative-free products if any of the following conditions apply to you: - if the pressure in your eye is elevated or if you have closed-angle glaucoma (a type of glaucoma), - if you suffer from severe cardiovascular disease (e.g. coronary artery disease), - if you have high blood pressure, - if you are being treated with an MAO inhibitor (a medicine used to treat depression) or another medicine that may increase blood pressure, - if you have a tumor of the adrenal gland (so-called pheochromocytoma), - if you suffer from a metabolic disorder such as hyperthyroidism (hyperthyroidism) and diabetes mellitus (diabetes mellitus). Prolonged use of nasal drops or nasal spray to reduce swelling of the mucous membrane can lead to chronic swelling and eventually to atrophy of the nasal mucosa. Prolonged use and overdose should be avoided. Other medicines and Nasivin preservative-free products Always tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take, including medicines obtained without a prescription. Medicines can affect each other. Ask your doctor for advice before using nasal drops or nasal spray if you are currently or have recently taken mood-elevating medicines (tricyclic antidepressants or MAO inhibitors) or medicines that raise blood pressure. If you are taking Nasivin preservative-free products at the same time as any of the above medicines, you may experience an increase in blood pressure due to their effect on heart and circulatory function. Taking Nasivin preservative-free products with food, drink and alcohol No such interaction is to be expected. Pregnancy, breastfeeding and fertility If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. There are no clinical data on the safety of using Nasivin preservative-free products during pregnancy. Nasivin preservative-free products should only be used during pregnancy and breastfeeding after careful consideration. The recommended dosage should not be exceeded. Effects of the product on the ability to drive and use machines When used as directed, the ability to drive and use machines is not expected to be affected. In the case of prolonged use or use of higher doses than prescribed, any oxymetazoline preparation used to treat the common cold may cause side effects affecting the cardiovascular system. In such cases, the ability to drive and use machines may be impaired. 3. How to use Nasivin preservative-free products? Always use these medicines exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure about the dosage, ask your doctor or pharmacist. Recommended dosage of the product Newborns and infants up to 1 year of age: Up to 4 weeks of age, 1 drop of Nasivin Baby 0.1 mg/ml preservative-free nasal drops into both nostrils 2-3 times a day - From 5 weeks of age to one year of age, 1-2 drops of Nasivin Baby 0.1 mg/ml preservative-free nasal drops into both nostrils 2-3 times a day. A single dose of the product can be used up to three times a day. Blow your nose thoroughly or use a nasal aspirator before instilling the drops. Since the nasal drops can only be used vertically, upside down, the child should lie on their back or with their head tilted back and their head tilted slightly to the side when using Nasivin Baby 0.1 mg/ml preservative-free nasal drops. In this position, instill the drops into the nostril, then after a short time, turn the head in the other direction and repeat the instillation into the other nostril. It is advisable to keep your head tilted back for a few minutes after instillation. How to use Nasivin Baby 0.1 mg/ml preservative-free nasal drops in infants? Before first use, the pump mechanism must be used until a so-called "jump drop" appears. Remove the protective cap. Hold the container as shown in Figure 1 (the dispensing head facing down!). By pumping several times (pulling the dispensing head towards you), the dispensing head fills up and the first drop ("jump drop") appears at the opening of the dispensing head. Instill one dose (Figure 2) into the infant's nostril by pressing the pump once (pulling the dispensing head towards you). Clean the dispensing head with a clean cloth after use and replace the protective cap. The "jump drop" can be used as shown in the picture for both raised and lying infants. By pressing the dispensing head once, a precisely measured amount is dispensed. It takes a few minutes for the effect to set in and it lasts for up to 12 hours. Young children aged 1-6 years: From the age of 1 to 6 years, 1 spray into both nostrils 2-3 times a day Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution. A single dose of the product can be used up to three times a day. How to use Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution in young children? When used for the first time, pull off the protective cap, hold it in your hand and fill the dispensing head with the appropriate spray by pumping several times. The spray mechanism can be operated by pressing the dispensing head. Spray one dose into the young child's nostril by pressing the pump once. Clean the dispensing head with a clean cloth after use and replace the protective cap. By pressing the dispensing head once, a precisely measured amount is dispensed. It takes a few minutes for the effect to set in and it lasts for up to 12 hours. Adults and children over 6 years of age: From the age of 6 years, 1 spray into both nostrils 2-3 times a day Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution A single dose of the product can be used up to three times a day. How to use Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution in adults and children over 6 years of age? When used for the first time, pull off the protective cap, hold it in your hand and fill the dispensing head with the appropriate spray by pumping several times. The spray mechanism can be operated by pressing the dispensing head. Spray one dose into the young child's nostril by pressing the pump once. Clean the dispensing head with a clean cloth after use and replace the protective cap. By pressing the dispensing head once, a precisely measured amount is dispensed. The effect occurs very quickly (the onset of effect was observed 25 seconds after first use in one study) and lasts for up to 12 hours. Duration of use Unless your doctor specifically directs otherwise, do not use Nasivin preservative-free products for more than 5-7 days. Only continue using Nasivin preservative-free products after a break of several days. In the case of chronic rhinitis, Nasivin preservative-free products should only be used under medical supervision. Prolonged use can lead to atrophy of the nasal mucosa. If you find that Nasivin preservative-free nasal drops/nasal sprays are too strong or if the products are not effective enough, consult your doctor or pharmacist. Method of administration Instill (Nasivin preservative-free nasal drops) or spray (Nasivin preservative-free nasal sprays) into both nostrils as directed. If you have used more Nasivin preservative-free products than you should See a doctor immediately! Poisoning can occur as a result of significant overdose or accidental ingestion of Nasivin preservative-free products. Overdose occurs primarily in children. The symptoms of poisoning can vary greatly. Anxiety, agitation, hallucinations and seizures may occur. Decreased body temperature, drowsiness, drowsiness and unconsciousness are also possible. Other symptoms may include: pupillary constriction, pupillary dilation, fever, sweating, pallor, bluish discoloration of the skin due to decreased oxygen content of the blood, palpitations, inadequate gas exchange and respiratory arrest, nausea, vomiting, mental disorders, increased or decreased blood pressure, irregular heartbeat, excessively fast or slow heartbeat. In case of suspected poisoning, a doctor should be consulted immediately so that he can decide on further action. Hospital treatment and medical supervision may be necessary. If you forget to use Nasivin preservative-free products If you forget to use the product, continue treatment with the next dose. Do not use a double dose to make up for the missed dose, as this will not make up for the missed dose but may put you at risk of overdose. 4. Possible side effects Like all medicines, these medicines can cause side effects, although not everybody gets them. The side effects are listed according to the following frequency classification: Very common: occurs in at least 10 in 100 patients. Common: occurs in 1 to 10 in 100 patients. Uncommon: occurs in 1 to 10 in 1000 patients. Rare: occurs in 1 to 10 in 10,000 patients. Very rare: occurs in less than 1 in 100,000 patients, including isolated cases and cases of unknown frequency. Nervous system disorders and symptoms Very rare: restlessness, insomnia, fatigue (drowsiness, calmness), headache, hallucinations (especially in children), seizures (especially in children) Heart disease and symptoms related to the heart Rare: palpitations, rapid heart rate (tachycardia), increased blood pressure Very rare: Heart rhythm disturbances Respiratory, thoracic and mediastinal disorders and symptoms Common: burning or dry nasal mucosa, sneezing Uncommon: nasal congestion, nosebleeds after loss of effectiveness Immune system disorders and symptoms Uncommon: hypersensitivity reactions (redness, itching, swelling of the skin and mucous membranes) If you experience any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this patient information leaflet. 5. How to store Nasivin preservative-free products? This medicine does not require any special storage conditions. Keep this medicine out of the reach of children! Do not use these medicines after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of that month. Do not use this medicine if you notice any clouding. Shelf life after opening: Can be used for 1 year after opening. Do not throw any medicines into wastewater or 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 Nasivin preservative-free products contain The active ingredient in the products is oxymetazoline hydrochloride. Nasivin Baby 0.1 mg/ml preservative-free nasal drops 0.10 mg oxymetazoline hydrochloride per milliliter. 1 drop (28 microliters) contains 2.8 micrograms of oxymetazoline hydrochloride. Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution 0.25 mg oxymetazoline hydrochloride per milliliter. 1 spray (45 microliters) contains 11.25 micrograms of oxymetazoline hydrochloride. Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution 0.5 mg oxymetazoline hydrochloride per milliliter. 1 spray (45 microliters) contains 22.5 micrograms of oxymetazoline hydrochloride. Other ingredients: citric acid monohydrate, sodium citrate, glycerol (85%), purified water. What Nasivin preservative-free products look like and contents of the pack Appearance Nasivin Baby 0.1 mg/ml preservative-free nasal drops: Clear, aqueous solution. Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution and Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution: Clear, yellowish-green aqueous solution. Packaging Nasivin Baby 0.1 mg/ml preservative-free nasal drops Approximately 5 ml of filling volume, clear, aqueous solution filled into an opaque white PE container with a blue, green or mint green protective cap and a PE/PP/stainless steel dosing pump (3K). 1×5 ml container in a box. Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution Approximately 10 or 15 ml of solution filled into an opaque white PE container with a blue, green or mint green protective cap and a PE/PP/stainless steel dosing pump (3K system). 1×10 ml or 1×15 ml container in a box. Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution Approximately 15 ml of solution filled into an opaque white PE/PP container with a blue protective cap and a PP/PE/stainless steel dosing pump (Comod system). Approximately 10 ml of solution filled into an opaque white PE container with a blue or mint green protective cap and a PE/PP/stainless steel dosing pump (3K system). 1×15 ml or 1×10 ml container in a box. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Merck Selbstmedikation GmbH, 64293 Darmstadt, Frankfurter Strasse 250, Germany Manufacturers Merck KGaA & Co. Werk Spittal, Hösslgasse 20, 9800 Spittal/Drau, Austria OGYI-T-7882/05 (Nasivin Baby 0.1 mg/ml preservative-free nasal drops) 1×5 ml OGYI-T-7882/06 (Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution) 1×10 ml OGYI-T-7882/07 (Nasivin Kids 0.25 mg/ml preservative-free nasal spray solution) 1×15 ml OGYI-T-7882/08 (Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution) 1×10 ml OGYI-T-7882/09 (Nasivin Classic 0.5 mg/ml preservative-free nasal spray solution) 1×15 ml Date of last revision of the patient information leaflet: November 2016