Olint 0.05% Nasal spray for children x10 ml

OLINT spray 0.05% 10 ml
Leaflet: Patient InformationOlynth 0.05% nasal spray, solutionOlynth 0.05% nasal spray, solutionXylometazoline hydrochloride (xylometazotine hydrochloride)Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. If you need further information or advice, ask your pharmacist. If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. If you do not feel better after 7 days or if your condition worsens, you should seek medical advice.
What this leaflet contains 1. What Olint is and what it is used for 2. What you need to know before you use Olint 3. How to use Olint 4. Possible side effects 5. How to store Olint 6. Contents of the pack and other information
1. What Olint is and what it is used for
Olint nasal spray belongs to a group of drugs called sympathomimetics. It has a vasoconstrictor effect, thereby reducing swelling of the mucous membrane and leading to improved drainage of secretions.
Symptomatic relief of nasal congestion and swelling associated with upper respiratory tract infections or rhinitis of various aetiologies, such as allergic rhinitis, vasomotor rhinitis or rhinitis associated with upper respiratory tract infections.
Indicated to facilitate the discharge of secretions in cases of sinusitis and Eustachian tube congestion in combination with a cold.
Suitable for preparing patients for diagnostic procedures in the nasal passages.
2. What you need to know before you use Olint
Do not use Olint

if you are allergic to xylometazoline or any of the other ingredients of Olint;
in children under 2 years of age.

Warnings and precautions Talk to your doctor or pharmacist before using Olint if you have a heart condition (e.g. long QT syndrome)
Other medicines and Olint Please tell your pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding Ask your doctor or pharmacist before using any medicine.
Olint should not be used during pregnancy, as the effects of the drug on the fetus are unknown. The drug should not be used during breastfeeding, as it is not known whether it passes into breast milk.
Driving and using machines It is not known whether xylometazoline has an effect on the ability to drive and use machines.
Olint contains benzalkonium chloride. This medicine contains 0.2 mg benzalkonium chloride per 1 ml, which is equivalent to 0.014 mg/0.070 ml spray. If used long-term, it may cause irritation and swelling inside the nose.
3. How to use Olint
Unless otherwise prescribed, for children from 2 to 6 years of age, 1 spray of Olint is administered as needed in each nostril up to 3 times daily. The dosage depends on the individual sensitivity of the patient and the clinical effect.
Olint nasal spray should not be used for more than 5 to 7 days unless otherwise prescribed by a doctor.
If you take more Olint than you should If you take more Olint than you should or accidentally swallow Olint, contact your doctor or pharmacist immediately. Keep out of the reach of children. In case of overdose, emergency medical attention should be sought immediately.
If you forget to use Olint Do not take a double dose to make up for a missed dose.
If you have stopped using OlintRe-use should only be done if treatment has been interrupted for a few days. Always consult a doctor about the duration of use in children.
4. Possible side effects
Like all medicines, Olint can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or you notice any other side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common (> 1/10); common (> 1/100, 1/1,000, 1/10,000, < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data). Nervous system disorders Very rare Burning sensation of the mucous membrane Respiratory, thoracic and mediastinal disorders Very rare Dry nose General disorders and administration site conditions Very rare Rebound effect If symptoms persist or worsen, or new symptoms appear, then contact a doctor immediately. Reporting of side effects If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: Executive Agency for Medicines, ul. „Damyan Gruev” № 81303 Sofia Tel.: +359 2 8903417 website: www.bda.bg. By reporting side effects, you can contribute to obtaining more information about the safety of this medicine. 5. How to store Olint Keep out of the reach of children. Do not use Olint after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. For hygiene reasons, Olint should not be used 24 weeks after first use. Medicines should not be thrown away via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment. 6. Contents of the pack and other information What Olint contains The active substance is xylometazoline hydrochloride. The other ingredients are: benzalkonium chloride, sorbitol, sodium chloride, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, disodium edetate, purified water. What Olint looks like and contents of the pack Olint is available in a pack containing 1 bottle of 10 ml nasal spray (metered) Marketing Authorisation Holder McNeil Healthcare (Ireland) Ltd., Ireland. Manufacturer Famar Orleans, France. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Johnson & Johnson Bulgaria EOOD zh.k. Mladost 4, Business Park Sofia, building 4 Sofia 1766 Tel.: 02 489 94 00 Date of last approval of this leaflet: 11/2019.