CROM-OPHTAL sine eye drops EDB, 30X0.5 ml

Instructions for use for CROM-OPHTAL sine eye drops EDB, 30X0.5 ml

Application instructions

Children and adults

1 Drop

4 times a day

distributed throughout the day

Application areas

Mode of action

How does the ingredient of the medicine work?

The active ingredient protects against an allergic reaction in the mucous membranes by stabilizing the outer shell of certain cells, so-called mast cells. If foreign substances such as pollen or animal dander penetrate the body and accumulate on the shell of a mast cell, it opens and a variety of the body's own messenger substances emerge. These messenger substances activate the body's own defense mechanisms and as a result the affected mucous membranes become inflamed. Cromoglicic acid prevents this leakage.
However, the effect can only be used as a preventive measure; an acute attack cannot be treated with the substance.

Composition

Contraindications

What speaks against an application?

- Hypersensitivity to the ingredients

What about pregnancy and lactation?
- Pregnancy: Consult your doctor. Various considerations play a role in whether and how the medicine can be used during pregnancy.
- Breast-feeding: Consult your doctor or pharmacist. He will examine your particular situation and advise you accordingly as to whether and how you can continue breastfeeding.

If you have been prescribed this medicine despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit may be greater than the risk associated with use if there is a contraindication.

Side effects

What adverse effects may occur?

- Burning eyes
- Foreign body sensation in the eye
- Conjunctival swelling in the eye (chemosis)
- Feeling of warmth in the eye

If you notice any discomfort or change during treatment, contact your doctor or pharmacist.

The information provided here primarily takes into account side effects that occur in at least one in 1,000 treated patients.

Detailed instructions for CROM-OPHTAL sine eye drops EDB, 30X0.5 ml

Field of use

• The preparation is a medicine against allergic conjunctivitis.
• It is used for allergic, acute and chronic conjunctivitis (conjunctivitis), e.g. E.g. hay fever, conjunctivitis or spring catarrh ([Kerato-] conjunctivitis vernalis).

Active ingredients / ingredients / ingredients

10 mg cromoglicic acid, disodium salt
9.14 mg cromoglicic acid
Hypromellose excipient (+)
Hydrochloric acid, concentrated excipient (+)
Sorbitol excipient (+)
Water, purified excipient (+)

Contraindications

• The medicine must not be used,
  • if you are allergic to sodium cromoglicate or any of the other ingredients of this medicine.

dosage

• Always use the product as directed by your doctor or pharmacist. Please ask your doctor or pharmacist if you are not sure.
• Please adhere to the instructions for use, otherwise the medicine will not work properly.
• The recommended dose is
  • Children and adults instill 1 drop into the lower conjunctival sac of the affected eye 4 times a day.
  • The daily dose can be increased to 1 drop 6 times a day by increasing the frequency of application and can also be doubled to 1 drop 8 times a day.
  • The therapy effect must be monitored regularly. However, the dosing intervals can also be extended after the therapeutic effect has been achieved, as long as freedom from symptoms is maintained.

 

• Duration of application:
  • Regular daily use is necessary as the medicine does not have an immediate effect. Even after the symptoms have subsided, you should continue treatment with the product for as long as you are exposed to the allergenic substances (house dust, animal hair, fungal spores, pollen, etc.).
  • If you want to use the medicine for a longer period of time, you should have your doctor determine the need for treatment.
  • Please talk to your doctor or pharmacist if you have the impression that the effect of this medicine is too strong or too weak.

 

• If you use more than you should:
  • There are no specific overdose reactions known and not to be expected with this type of use.

 

• If you forget an application:
  • No special measures are required. Continue therapy at the same dosage at the next scheduled time. If necessary, you can also use the preparation between two scheduled times.
  • Do not use a double dose if you have forgotten the previous application.

 

• If you cancel the application:
  • If possible, treatment with the medicine should be carried out regularly for as long as you are exposed to the allergy-causing substances.
  • If you interrupt the use of the preparation, you must expect that the typical symptoms of your illness will soon appear again.

 

• If you have any further questions about using this medicine, talk to your doctor or pharmacist.

Intake

• For use on the eyes.
• Drop the eye drops into the conjunctival sac of the eye. To do this, bend your head slightly backwards, look up and pull your lower eyelid slightly away from your eye. By pressing on the container, you drip a drop into the lower conjunctival sac. Do not bring the drip opening into contact with the eye. After instillation, slowly close your eye.

Patient information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before using the product.
  • If an allergic reaction to the medication is suspected, renewed contact should be avoided at all costs.
  • After instilling the eye drops into the conjunctival sac of the eye, visual acuity may worsen for a few minutes. This is because there is a relatively large amount of fluid in the eye after the instillation, which can lead to blurred vision. Because of the reduction in visual acuity, we recommend that you do not work without a secure grip for a few minutes after instilling the medicine and that you do not drive.
  • In the case of inflammation, including allergic conjunctivitis, the ophthalmologist should be asked whether contact lenses can still be worn despite the symptoms. If your ophthalmologist allows you to wear contact lenses, please note the following: Remove the contact lenses before instillation and do not reinsert them until at least 15 minutes after instillation.

 

• Ability to drive and use machines:
  • Since this medicine causes a short-term impairment of visual performance immediately after use, you should not drive, work or operate machines without a secure footing during this time.

Pregnancy

• 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.
• Pregnancy
  • There is no evidence of a teratogenic effect of sodium cromoglicate either from animal studies or from previous experience with humans, but the existing experience is not sufficient for a final assessment of the risk. For safety reasons, the medicine should not be used in the first trimester of pregnancy or should only be used after careful benefit-risk assessment. Even during the further course of pregnancy, the eye drops may only be used after a careful risk-benefit assessment by the treating doctor.
• Lactation
  • The active ingredient is excreted in small amounts into breast milk. Therefore, you may only use the eye drops during breastfeeding after a careful risk-benefit assessment by the treating doctor.

Hints

Manufacturer:  Dr. Winzer Pharma GmbH, Brunsbütteler Damm 165-173