0.05% ear drops, endospipette is 
betamethasone

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Diprotit is and what it is used for 
2. What you need to know before you use Diprotit 
3. How to use Diprotit 
4. Possible side effects 
5. How to store Diprotit 
6. Contents of the packaging and other information 

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.

Children

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

Content declaration

  • 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

Box 120

182 12 Danderyd

Manufacturer

Bobtail Nordic Pharma AB

Svärdvägen 21

182 33 Danderyd

IL-CSM Clinical Supplies Management GmbH

Marie-Curie-Str. 8,

79539 Lörrach

Germany

Muhammad Nadeem

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