0.05% ear drops, endospipette is
1. What Diprotite is and what it is used for
Diprotite contains the active substance betamethasone, which is a strong-acting cortisone preparation (strong steroid ) with a rapid and long-lasting effect on inflammatory, allergic, and itchy skin diseases.
Diprotite solution in endospipette is used to treat eczema in the external ear canals (external otitis ).
2. What you need to know before you use Diprotit
Do not use Diprotite
- if you are allergic to the active substance betamethasone or any of the other ingredients of this medicine (listed in section 6)
- in the ear at the hole on the eardrum (eardrum perforation).
Warnings and cautions
Intended for hearing aids only. Avoid getting Diprotit in your eyes.
Contact a doctor if you experience blurred vision or other visual disturbances.
Do not give to children without a doctor’s prescription.
Other medicines and Diprotitis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is a risk that the fetus is affected.
Goes into breast milk but probably does not affect breastfed babies. However, consult a physician in case of more than temporary use of Diprotit during breast-feeding.
Driving and using machines
Diprotitis does not affect the ability to drive or use machines.
3. How to use Diprotit
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Eczema of the external ear canals is treated according to a doctor’s prescription.
Instructions for use
See appendix to the package leaflet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon/rare: Secondary infection ( infection caused by the organism is not sensitive to the preparation). Contact allergic reactions in the form of increased skin irritation, if this occurs talk to a doctor.
No known frequency (cannot be calculated from the available data): Blurred vision.
5. How to store Diprotit
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Unopened pipette you should be stored in their envelopes.
Pipette in an opened envelope should be consumed within 4 weeks.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substance is betamethasone. 1 g of ear drops contains betamethasone dipropionate corresponding to betamethasone 0.5 mg.
- The other ingredients are carbomer, isopropanol, sodium hydroxide and purified water.
What the medicine looks like and contents of the pack
30 endospipets. One pipette contains 0.2 ml.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
182 12 Danderyd
Bobtail Nordic Pharma AB
182 33 Danderyd
IL-CSM Clinical Supplies Management GmbH