Active ingredient
- betamethasone sodium phosphate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 36301/0003 .
Betnesol Eye, Ear and Nose Drops Solution 0.1% w/v
Patient information Leaflet:
Betnesol Eye, Ear & Nose Drops Solution 0.1% w/v Bethamethasone sodium phosphate
Read all of this leaflet carefully before you start using this medicine.
In this leaflet:
1. What Betnesol Drops are for
2. Before you use Betnesol Drops
3. How to use Betnesol Drops
4. Possible side effects
5. How to store Betnesol Drops
6. Further information.
1. What Betnesol Drops are for
Betnesol Drops belong to a group of medicines called corticosteroids (‘steroids’ for short).
Betnesol Drops work by reducing inflammation (redness, itching and soreness). Betnesol Drops are used to treat inflammation of the eye, ear or nose where there is no infection.
It is important to use this medicine to prevent any damage to the delicate tissues of your eyes, ear or nose and to prevent any infection developing.
2. Before you use Betnesol Drops
Important: Never use this medicine in your eye without first checking with your doctor. If it is used for the wrong condition, it could lead to blindness.
Do not use Betnesol Drops if:
If any of the above applies to you talk to your doctor or pharmacist.
Check with your doctor before using Betnesol Drops if:
If any of the above applies to you, talk to your doctor or pharmacist.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Betnesol Drops and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat)
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant or breast-feeding ask your doctor or pharmacist for advice before using Betnesol Drops. If you use this medicine while pregnant, there may be a small risk of cleft palate or retarded growth in the foetus.
Driving and using machines
Betnesol Drops may cause temporary blurred vision and lightheadedness. If this happens to you, do not drive or use machinery until you return to normal.
Warnings about the ingredients in Betnesol Drops
This medicine contains benzalkonium chloride as a preservative which may cause skin reactions or eye irritation.
Avoid contact with soft contact lenses. Remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses.
Warnings about visual problems when using Betnesol Drops
Contact your doctor if you experience blurred vision or other visual disturbances.
3. How to use Betnesol Drops
Important: Your doctor will choose the dose that is right for you. Your dose will be shown clearly on the label that your pharmacist puts on your medicine. If it does not, or you are not sure, ask your doctor or pharmacist.
Things to remember about your dose:
Getting ready to use your medicine
Check that the seal on the bottle is not broken before using Betnesol Drops for the first time. Wash and dry your hands. Do not breathe on or touch the dropper nozzle.
Using your medicine
If there is no improvement in your symptoms after 7 days, stop using the drops and see your doctor again.
Eyes
1. Tilt the head back
2. Gently pull lower eyelid downwards and outwards
3. Place drops in the gap between the lid and eye (squeeze bottle very gently if necessary)
4. Blink a few times to spread out the drops
5. Repeat for the other eye if needed.
Medical check-ups
If you are using this medicine for your eyes and you use it for a number of weeks, your doctor may ask you to have check-ups.
These are to make sure that your medicine is working properly and that the dose you are taking is right for you. Your doctor will check your eyes for:
Ears
1. Tilt the head to one side
2. Place drops in the ear canal (squeeze bottle gently if necessary)
3. Keep head tilted for a minute or two to let the drops soak in
4. Repeat for the other ear if needed.
Nose
The usual dose is 2 or 3 drops put into each nostril two or three times each day.
1. Tilt head backwards
2. Place drops in nostril (squeeze bottle gently if necessary)
3. Keep head tilted and sniff gently to let the drops soak in
4. Repeat for other nostril if needed.
Medical check-ups
Your doctor will regularly check the growth of children who are taking Betnesol by nose over a long period of time.
If you use more Betnesol Drops than you should
If you accidentally use too much Betnesol Drops it is unlikely to lead to any serious side effects. However, if you are concerned, contact the nearest hospital casualty department or your doctor.
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should use only as much as your doctor recommends; using more or less may make your symptoms worse.
If you forget to use Betnesol
Do not use a double dose to make up for a missed dose. Simply use the next dose as planned.
How to stop using Betnesol Drops
Do not stop using Betnesol Drops without first talking to your doctor.
If you have been using Betnesol Drops for a long period of time (around 6 to 8 weeks), then you should stop using it gradually, to avoid the inflammation coming back.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines Betnesol Drops can cause side effects, although not everybody gets them. These may include:
If you are using Betnesol Drops for your nose, you may also experience some of the following side effects:
Using too much of this medicine for a long time can prevent your adrenal gland from working properly and producing your body’s own natural steroids (known as adrenal suppression). This means that when you stop using Betnesol Drops, you could experience the following effects:
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme on the MHRA website (www.mhra. gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Betnesol Drops
Keep this medicine out of the sight and reach of children. Do not use Betnesol Drops after the expiry date on the label. The expiry date refers to the last day of that month.
The bottle should be disposed of 28 days after first opening, even if there is solution remaining
Store Betnesol Drops below 25°C and in the original carton to protect it from light. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.
6. Further information
What Betnesol Drops contain
The active substance is betamethasone sodium phosphate at a concentration of 0.1%.
The other ingredients are bezalkonium chloride solution, disodium hydrogen phosphate anhydrous, sodium chloride, disodium edetate, sodium hydroxide (E524), phosphoric acid and water for injections.
What Betnesol Drops look like
Betnesol Drops is an eye, ear and nose drops solution. It is a clear, colourless liquid.
Betnesol Drops come in 5 ml or 10 ml plastic bottles with a built-in nozzle and a tamper-evident plastic cap.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in June 2018.
If this leaflet is difficult to see or read or you would like it in a different format, please contact
23292703
Lagervagen 7, Jordbro, Sweden
+44 (0)845 023 0467
+44 207 862 1716
+44(0)845 023 0467
+44(0)845 023 0467