VIBROCIL nasal spray 15ml
VIBROCIL spray 15 ml
Leaflet: user information
VIBROCIL 0.25%/0.025% Nasal spray, solution
Phenylephrine/Dimethindene Maleate
VIBROCIL 0.25%/0.025% Nasal spray, solution
Phenylephrine/Dimetindene maleate
Read all of this leaflet carefully before you start using 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 also includes any possible side effects not described in this leaflet. See point 4.
If after 7 days you or your child do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains
1. What VIBROCIL 0.25%/0.025% Nasal spray, solution is and what it is used for
2. What you need to know before you use VIBROCIL 0.25%/0.025% Nasal spray, solution
3. How to use VIBROCIL 0.25%/0.025% Nasal spray, solution
4. Possible side effects
5. How to store VIBROCIL 0.25%/0.025% Nasal spray, solution
6. Contents of the package and additional information
1. What VIBROCIL 0.25%/0.025% Nasal spray, solution is and what it is used for
VIBROCIL 0.25%/0.025% Nasal spray, solution contains a nasal decongestant (phenylephrine) and an antihistamine (dimethindene maleate). It provides quick and long-lasting relief of blocked and runny nose (runny nose) caused by a wide range of infectious or allergic disorders of the upper respiratory tract. Helps clear nasal passages, relieving runny nose and swelling. VIBROCIL 0.25%/0.025% Nasal spray, solution does not affect the activity of nasal cilia.
VIBROCIL 0.25%/0.025% Nasal spray, solution is used to relieve nasal congestion in case of cold, 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 spray, solution is used as an additional therapy in the treatment of inflammation of the ears (otitis).
VIBROCIL 0.25%/0.025% Nasal spray, solution can be prescribed by a doctor for pre- and post-operative care during nasal surgery.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
2. What you need to know before you use VIBROCIL 0.25%/0.025% Nasal spray solution
Do not use VIBROCIL 0.25%/0.025% Nasal spray, solution if you or your child are:
if you are allergic (hypersensitive) to the active substances phenylephrine and dimetindene maleate or to any of the other ingredients of VIBROCIL 0.25%/0.025% Nasal spray, solution (listed in point 6);
if you are taking or have taken in the last 14 days a prescription medicine containing a monoamine oxidase inhibitor (MAOIs are used to treat depression and other mental illnesses). Consult your doctor or pharmacist before using VIBROCIL 0.25%/0.025% Nasal spray, solution if you are not sure whether your prescribed medicine 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 eye).
Warnings and precautions
Talk to your doctor or pharmacist before using VIBROCIL 0.25%/0.025% Nasal Spray, Solution if you have any of the following medical problems:
heart disease;
high blood pressure;
thyroid disease;
diabetes;
an enlarged prostate, which can cause you to retain urine;
epilepsy.
If any of the problems listed above apply to you, do not use VIBROCIL 0.25%/0.025% Nasal Spray, Solution before consulting your doctor or pharmacist. Like other medicinal products for the treatment of nasal congestion, VIBROCIL 0.25%/0.025% Nasal Spray, solution may cause sleep disturbances, dizziness, tremors in very sensitive patients. Consult your doctor if such symptoms are bothersome.
VIBROCIL 0.25%/0.025% Nasal Spray, 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 Spray, 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 spray, solution is not intended for use in the eyes or mouth.
Children and adolescents
VIBROCIL 0.25%/0.025% Poe spray, solution is not recommended for children under 6 years of age. VIBROCIL 0.25%/0.025% Nasal spray, solution should be used under parental supervision in children from 6 to 12 years.
Other medicines and VIBROCIL 0.25%/0.025% Nasal spray, solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, in particular:
Monoamine oxidase inhibitors (MAO inhibitors) used to treat depression and Parkinson's disease: do not use VIBROCIL 0.25%/0.025% Nasal spray, solution if you are taking or have taken monoamine oxidase inhibitors (MAO inhibitors) in the previous 14 days.
Antidepressants used to treat depression, such as tri- and tetracyclic antidepressants.
Medicines used to treat high blood pressure such as beta-blockers. Please consult your doctor if you or your child are using or have recently used any other medicines, including those obtained without a prescription.
Pregnancy, lactation and fertility
VIBROCIL 0.25%/0.025% Nasal spray, solution should not be used during pregnancy and breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
There is no data available that the application of VIBROCIL 0.25%/0.025% Nasal Spray, solution affects the ability to drive and operate machines. However, VIBROCIL 0.25%/0.025% Nasal Spray, solution is unlikely to have such an effect.
3. How to use VIBROCIL 0>25%/0.025% Nasal spray, 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 spray, solution
Dosage
Children under 6 years: not recommended.
Children from 6 to 12 years (under parental supervision): 1 to 2 sprays in each nostril 3 to 4 times daily.
Adolescents over 12 years and adults: 1 to 2 sprays in each nostril 3 to 4 times daily.
Application method
Before initial application, remove the protective cap and perform several pumps until a spray appears in the air. At the next application, the dosing spray will be ready for immediate use. Insert the tip into the nostril and push the spray head sharply. Remove the tip from the nostril before the spray head returns to its original position. Breathing in a little air through the nose while spraying will ensure optimal distribution of the spray. After use, replace the protective cap.
The dosing spray ensures the good distribution of Vibrocil 0.25%/0.025% Nasal Spray, solution on the surface of the nasal mucosa. A standardized valve ensures precise dosing (140 micrograms per injection) and prevents the possibility of spontaneous overdose.
Use in children
VIBROCIL 0.25%/0.025% Nasal spray, solution is not recommended for children under 6 years of age. VIBROCIL 0.25%/0.025% Nasal spray, solution should be used under parental supervision in children from 6 to 12 years.
If you have taken more than the required dose of VIBROCIL 0.25%/0.025% Nasal spray, solution
If you put too much VIBROCIL 0.25%/0.025% Nasal Spray, solution or in case of accidental ingestion, contact your doctor or pharmacist immediately.
If you forget to use VIBROCIL 0.25%/0.025% Nasal spray, solution
Do not take a double dose to make up for a missed dose.
If you have any other questions about the use of this medicinal product, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, VIBROCIL 0.25%/0.025% Nasal spray, solution can cause side effects, although not everybody gets them.
Some side effects of VIBROCIL 0.25%/0.025% Nasal spray, solution are rare (may affect up to 1 in 1,000 patients):
Nasal discomfort, nasal dryness, nosebleeds and burning at the application site.
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system.
Medicines Executive Agency
St. "Damyan Gruev" No. 8
1303 Sofia
Phone: +35 928903417
Website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store VIBROCIL 0.25%/0.025% Nasal spray, solution
Keep out of the reach of children.
To be stored below 25°C.
Do not use VIBROCIL 0.25%/0.025% Nasal Spray, solution after the expiry date stated on the package. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container. 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 additional information
What VIBROCIL 0.25%/0.025% Nasal spray, solution contains
The active substances are: phenylephrine and dimethindene maleate.
The other ingredients (excipients) are: benzalkonium chloride, disodium phosphate, anhydrous, citric acid monohydrate, sorbitol, deterpentinated lavender essence, purified water.
What VIBROCIL 0.25%/0.025% Nasal spray, solution looks like and contents of the pack
Colorless to pale yellow, clear solution available in a 15 ml bottle equipped with a dosing pump and a tip with a safety cap.
Marketing Authorization Holder:
GlaxoSmithKline Dungarvan Limited, Ireland.
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG, Germany.
