Vividrin Nasal Spray
Package Leaflet: Information for the User
Vividrin® Nasal Spray
(sodium cromoglycate)
The name of your medicine is Vividrin® Nasal Spray
Please read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription, as an over the counter item only in a pharmacy. However, you still need to use Vividrin Nasal Spray carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Vividrin Nasal Spray is and what it is used for
2. Before you use Vividrin Nasal Spray
3. How to use Vividrin Nasal Spray
4. Possible side effects
5. How to store Vividrin Nasal Spray
6. Further information
1. What Vividrin Nasal Spray is and what it is used for
Your spray contains sodium cromoglycate as the active ingredient.
Your spray is used to prevent and treat perennial allergic rhinitis and hayfever (seasonal allergic rhinitis). The sodium cromoglycate in this spray works to prevent allergic reactions e.g. hayfever.
This spray works by preventing the itching, sneezing and runny nose often associated with hayfever.
2. Before you use Vividrin Nasal Spray DO NOT use this spray
• If you are allergic (hypersensitive) to any of its ingredients (see section 6) do not use the spray.
Take special care with this spray
• If you are using sodium cromoglycate or steroids to control asthma, you may find that the effects of that treatment may increase.
Using other medicines
• If you are using medicines called antihistamines, it may be possible that you may not need as much antihistamine.
• Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
• Use this spray only if necessary, and then only on your doctor's advice, if you are pregnant or breastfeeding.
Important information about some of the ingredients of Vividrin Nasal Spray
• This spray contains benzalkonium chloride which is an irritant and may cause skin reactions.
3. How to use Vividrin Nasal Spray
To work most effectively, Vividrin Nasal Spray should be used every day during the hayfever season, even when you are not suffering from any symptoms. If your symptoms are caused by pollen, you should continue to use your spray until the end of the hayfever season. If you have used sodium cromoglycate before, you may have to take it for several days before you obtain the maximum effect.
Always use your spray exactly as your doctor or pharmacist has told you to. You should check with your doctor or pharmacist if you are not sure. The medicine is to be used only as a spray applied into the nose.
Dosage
The usual dose is to apply one spray into each nostril, four to six times each day.
If you are using Vividrin Nasal Spray four times a day you may find it easier to remember to take it if you use it at meal times and when you go to bed.
Directions for use
- blow your nose to clear any mucus
- take the cap off the spray and check that the nozzle is clean
- hold the bottle with the spray nozzle pointing upwards, your fingers either side of the nozzle and your thumb on the base of the bottle
- press down with both fingers to ensure a fine spray is released
- holding the bottle upright, insert the spray nozzle into a nostril
- press the bottom of the bottle once with your thumb and a single spray of solution will be dispensed
- repeat the procedure for your other nostril
- after use wipe the nozzle with a clean tissue and replace the cap
Always read the label before using this medicine.
If you use more Vividrin Nasal Spray than you should
If you accidentally use too much do not worry, but if you accidentally swallow Vividrin Nasal Spray talk to your doctor.
If you forget to use Vividrin Nasal Spray
Use your spray as soon as you remember and then carry on in the usual way. Do not take a double dose to make up for a forgotten dose.
Make sure you know how and when to use your medicine. If you are not sure about using your spray, ask your pharmacist.
4. Possible side effects
Like all medicines, Vividrin Nasal Spray can cause some side effects, although not everybody gets them. If you experience any difficulty stop using your spray and talk to your doctor or pharmacist. Rarely, some people find the inside of their nose becomes irritated when they first use the spray. If this does happen it should not be a problem for long, but if it is or you are worried, then you should talk to your doctor or pharmacist about it.
If your spray makes you very breathless or causes an attack of coughing or wheezing, you should immediately contact your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Vividrin Nasal Spray
• Keep out of the sight and reach of children.
• Do not store above 25°C. Protect from light.
• Do not use Vividrin Nasal Spray after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month. Once opened, use within 6 weeks.
• If your medicine shows any sign of deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
6. Further Information
What Vividrin Nasal Spray contains
The active substance in Vividrin Nasal Spray is sodium cromoglycate 2.00% w/v.
The other ingredients are sodium edetate, polysorbate 80, sorbitol, sodium hydroxide and water for injections.
What Vividrin Nasal Spray looks like and contents of the pack
Nasal spray. Clear colourless solution contained in polyethylene bottle with integral nasal spray pump and cap, contained in a printed carton.
Vividrin Nasal Spray is available as 1 x 15ml bottle.
Manufacturer
Dr. Gerhard Mann, Chem-Pharm. Fabrik GmbH Brunsbutteler Damm 165-173, 13581 Berlin, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall WS9 8ER
Repackaged by XXXXXXXXXXXXXXXXXXXXXXXXXXXX
PLPI: 33532/0386
Leaflet dated 12th March 2015 Leaflet coded xxxxxxxxxxxx
Vividrin® is a registered trademark of xxxxxxxxxxxxxxxxxxxx