Vibrocil Nasal drops x15 ml GlaxoSmithKline

VIBROCIL DROPS 15ML indications:
VIBROCIL 0.25%/0.025% Nasal drops, solution contains a nasal decongestant (phenylephrine) and an antihistamine (dimethindene maleate). It provides rapid and long-lasting relief of stuffy and runny nose (runny nose) caused by a wide range of infectious or allergic disorders of the upper respiratory tract. It helps to clear the nasal passages, relieving runny nose and swelling. VIBROCIL 0%/0.025% Nasal drops, solution does not affect the activity of nasal cilia. 
VIBROCIL 0.25%/0.025% Nasal drops, solution is used to relieve nasal congestion in case of colds, acute and chronic rhinitis, hay fever or other allergic rhinitis (allergy to house dust, animal fur, etc.), vasomotor rhinitis and sinusitis. VIBROCIL 0.25%/0.025% Nasal drops, solution is used as an additional therapy in the treatment of ear inflammation (otitis). 
VIBROCIL 0.25%/0.025% Nasal drops, solution may be prescribed by a doctor for pre- and postoperative care during nasal surgery. 
VIBROCIL DROPS 15ML dosage and administration:
Dosage 
• Children under 1 year: not recommended. 
• Children from 1 to 6 years (under parental supervision): 1 to 2 drops in each nostril 3 to 4 times daily. 
• Children from 6 to 12 years old (under parental supervision): 3-4 drops in each nostril 3-4 times daily. 
• Adolescents over 12 years of age and adults: 3-4 drops in each nostril 3-4 times daily. 
How to use: Tilt your head back while standing or sitting. If you are lying down, tilt your head to the side of the bed. Put the drops in each nostril and hold your head back for a few minutes so that the medicine is distributed in the nose. 
Use in children: VIBROCIL 25%/0.025% Nasal drops, solution is not recommended for children under 1 year of age. VIBROCIL 25%/0.025% Nasal drops, solution should be used under parental supervision in children from 1 to 12 years of age. 
VIBROCIL DROPS 15ML ingredients:
The active substances are: phenylephrine and dimethindene maleate. 
The other ingredients (excipients) are: benzalkonium chloride, disodium phosphate, anhydrous, citric acid monohydrate, sorbitol, deterpentated lavender essence, purified water. 
PACKAGE LEAFLET: INFORMATION FOR THE USER VIBROCIL 0.25%/0.025% Nasal drops, solution Phenylephrine/Dimetindene maleate VIBROCIL 0.25%/0.025% Nasal drops, solution Phenylephrine/Dimetindene maleate Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This medicine can be obtained without a prescription. 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 also includes any possible side effects not listed in this leaflet. • If after 7 days you or your child do not feel better or your condition worsens, you should seek medical attention. What this leaflet contains 1. What VIBROCIL 0.25%/0.025% Nasal drops, solution is and what it is used for 2. What you need to know before you use VIBROCIL 0.25%/0.025% Nasal drops, solution 3. How to use VIBROCIL 0.25%/0.025% Nasal drops, solution 4. Possible side effects 5. How to store VIBROCIL 0.25%/0.025% Nasal drops, solution 6. Contents of the pack and other information 1. What VIBROCIL 0.25%/0.025% Nasal drops, solution is and what VIBROCIL 0.25%/0.025% Nasal drops, solution is and what VIBROCIL 0.25%/0.025% is used for Nasal drops, solution contains a nasal decongestant (phenylephrine) and an antihistamine (dimethindene maleate). It provides fast and long-lasting relief of stuffy and runny nose (runny nose) caused by a wide range of infectious or allergic disorders of the upper respiratory tract. It helps to clear the nasal passages, relieving runny nose and swelling. VIBROCIL 0%/0.025% Nasal drops, solution does not affect the activity of nasal cilia. VIBROCIL 0.25%/0.025% Nasal drops, solution is used to relieve nasal congestion in case of colds, acute and chronic rhinitis, hay fever or other allergic rhinitis (allergy to house dust, animal fur, etc.), vasomotor rhinitis and sinusitis. VIBROCIL 0.25%/0.025% Nasal drops, solution is used as an additional therapy in the treatment of ear inflammation (otitis). VIBROCIL 0.25%/0.025% Nasal drops, solution may be prescribed by a doctor for pre- and postoperative care in nasal surgery. If you do not feel better after 7 days or your condition worsens, you should seek medical attention. 2. What you need to know before you use VIBROCIL 0.25 %/0.025% Nasal drops, solution Do not use VIBROCIL 0.25%/0.025% Nasal drops, solution • if you are allergic (hypersensitive) to the active substances phenylephrine and dimethindene maleate or to any of the other ingredients of VIBROCIL 0.25%/0.025% Nasal drops, solution (listed in section 6); • if you are taking or have taken in the last 14 days a prescription medicine containing a monoamine oxidase inhibitor (MAO inhibitors are used to treat depression and other mental illnesses). Consult your doctor or pharmacist before using VIBROCIL.25%/0.025% Nasal drops, solution, if you are not sure whether the medicine prescribed to you contains an MAO inhibitor; • if you suffer from atrophic rhinitis (a disease of the nasal mucosa with chronic inflammation and crusting); • if you suffer from narrow-angle glaucoma (increased pressure in the eyes). Warnings and precautions Talk to your doctor or pharmacist before using VIBROCIL 0.25%/0.025% Nasal drops, solution, if you have any of the following medical problems: • heart disease; • high blood pressure; • thyroid disease; • diabetes; • an enlarged prostate, which may cause you to retain urine; • epilepsy. If any of the above apply to you, do not use VIBROCIL 0.25%/0.025% Nasal Drops, solution before consulting your doctor or pharmacist. Like other medicinal products for the treatment of nasal congestion, VIBROCIL 0.25/0.025% Nasal Drops, solution may cause sleep disturbances, dizziness, restlessness and tremor in very sensitive patients. Consult your doctor if such symptoms are bothersome. VIBROCIL 0.25%/0.025% Nasal Drops, solution should not be used for more than 7 consecutive days. If symptoms persist, consult your doctor. Prolonged or excessive use of VIBROCIL 0.25%/0.025% Nasal Drops, solution may cause nasal congestion again or worsen the condition. Do not exceed the recommended dose, especially in children and elderly patients. VIBROCIL 0.25%/0.025% Nasal Drops, solution is not intended for use in the eyes or mouth. Children and adolescents VIBROCIL 0.25%/0.025% Nasal Drops, solution is not recommended for children under 1 year of age. VIBROCIL 0.25%/0.025% Nasal Drops, solution should be used under parental supervision in children from 1 to 12 years of age. Other medicines and VIBROCIL 0.25%/0.025% Nasal drops, solution Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, in particular: • Monoamine oxidase inhibitors (MAOIs), used to treat depression and Parkinson's disease: do not use VIBROCIL 0.25%/0.025% Nasal drops, solution, if you are taking or have taken monoamine oxidase inhibitors (MAOIs) in the previous 14 days. • Antidepressants used to treat depression, such as tri- and tetracyclic antidepressants. • Medicinal products used to treat high blood pressure, such as beta-blockers. Please consult your doctor if you or your child are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding VIBROCIL 0.25%/0.025% Nasal drops, solution should not be used during pregnancy and breast-feeding. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist before using this medicine. Driving and using machines There is no data available on the effect of VIBROCIL 0.25%/0.025% Nasal drops, solution on your ability to drive and use machines. However, it is unlikely that VIBROCIL 0.25%/0.025% Nasal drops, solution will have such an effect. 3. How to use VIBROCIL 0.25%/0.025% Nasal drops, solution Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. VIBROCIL.0.25%/0.025% Nasal drops, solution Dosage • Children under 1 year: not recommended. • Children from 1 to 6 years (under parental supervision): 1 to 2 drops in each nostril 3 to 4 times daily. • Children from 6 to 12 years (under parental supervision): 3-4 drops in each nostril 3-4 times daily. • Adolescents over 12 years and adults: 3-4 drops in each nostril 3-4 times daily. Method of administration Tilt your head back while standing or sitting. If you are lying down, you should tilt your head to the side of the bed. Put the drops in each nostril and hold your head back for a few minutes so that the medicinal product is distributed in the nose. Use in children VIBROCIL 25%/0.025% Nasal drops, solution is not recommended for children under 1 year. VIBROCIL 25%/0.025% Nasal drops, solution should be used under parental supervision in children from 1 to 12 years of age. If you take more than the required dose of VIBROCIL 0.25%/0.025% Nasal drops, solution If you have used too much VIBROCIL 0.25%/0.025% Nasal drops, solution or in case of accidental ingestion, contact your doctor or pharmacist immediately. If you forget to use VIBROCIL 0.25%/0.025% Nasal drops, solution Do not take a double dose to make up for a forgotten 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 VIBROCIL 0.25%/0.025% Nasal drops, solution can cause side effects, although not everybody gets them. Some side effects of VIBROCIL 0.25%/0.025% Nasal drops, solution are rare (may affect up to 1 in 1,000 patients): - Nasal discomfort, dry nose, nosebleeds and burning at the application site If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 5. How to store VIBROCIL 0.25%/0.025% Nasal drops, solution • Keep out of the reach of children. • Store below 30 °C, in the original packaging. • Do not use VIBROCIL after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month. • Use within 24 days of opening the package. • Do not throw away any medicines via 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 pack and other information What VIBROCIL 0.25%/0.025% Nasal drops, solution contains The active substances are: phenylephrine and dimethindene maleate. The other ingredients (excipients) are: benzalkonium chloride, disodium phosphate, anhydrous, citric acid monohydrate, sorbitol, deterpentated lavender essence, purified water. What VIBROCIL 0.25%/0.025% Nasal drops, solution looks like and contents of the pack Colorless to pale yellow, clear solution, available in a 15 ml dark glass bottle with a dropper. Marketing Authorization Holder and Manufacturer Novartis Consumer Health GmbH, Zielstattstrasse 40, 81379 Mtinchen, Germany For any information about this medicine, please contact the local representative of the Marketing Authorization Holder: Sap vie Pharma OOD 1528 Sofia, 5 Dimitar Peshev Str. Tel.: +359 882 532 901