Opnol 1 mg/ml eye drops, solution, dexamethasone Phosphate single-dose container
What Opnol Is And What Opnol Used For
Opnol eye drops are a cortisone preparation with a strong anti-inflammatory effect.
Opnol is used to treat inflammation and allergies in the outer and front parts of the eye. Please note that your doctor may have prescribed Opnol for other uses or with a different dosage. Therefore, always follow your doctor’s prescription.
What You Need To Know Before Using Opnol
Do Not Use Opnol
- Have tuberculosis, acute herpes simplex, chickenpox, or any other viral disease of the eye
- Have a permanent eye infection or suspected fungal disease of the eyes if you do not receive treatment for this at the same time
- If you are allergic to dexamethasone phosphate or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
It is important to have regular contact with a doctor to check the pressure in the eye during long-term treatment.
Talk to your doctor if you experience swelling and weight gain around the torso and face, as these are usually the first signs of Cushing’s syndrome. An impaired adrenal function may develop after the completion of long-term or intensive treatment with Opnol. These risks are particularly important for children and patients treated with ritonavir or cobicistat. Therefore, talk to your doctor before stopping treatment yourself.
Contact a doctor if you experience blurred vision or other visual disturbances.
Other Medicines And Opnol Eye Drops
Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, always consult your doctor or pharmacist before using this medicine.
There is a risk that the fetus is affected.
A breastfed baby may be affected. Therefore, do not use Opnol eye drops during breastfeeding other than as directed by your doctor.
Driving And Using Machines
As with other eye drops, temporary blurred vision may occur after taking your eye drops. You should, therefore, not drive or operate machinery until your vision is completely clear.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Opnol Contains Phosphate Buffer
This medicinal product contains 0.35 mg of phosphate per unit dose equivalent to 2.3 mg/ml.
If you have severely damaged cornea, in rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How To Use Opnol
- Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Dosage
- Dose one is determined by the doctor, who adjusts it individually for you. The treatment time can range from a few days to several weeks, depending on the disease being treated and the effect of the treatment. The dosage for adults is 1-2 drops in the affected eye/eyes. How many times a day does the doctor talk about?
- Instructions for use
- Open the envelope at the line mark and pull out a single-dose container.
- Close the envelope by folding the edge.
- Shake the contents of the bottom of the single-dose container.
- Open the single-dose container by turning the wing (see picture).
- Drop 1-2 drops into the eye/eyes and then discard the single-dose container even if it is not empty. The contents of a single-dose container are sufficient for both eyes. Always take a new single-dose container at each dosing time. You can use drip support available at the pharmacy to make it easier to drip the eye drops into the eye.
If You Use More Opnol Than You Should
If you have used too much medicine or if, e.g., a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Possible Opnol Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
What side effects can Opnol cause?
Common (may affect more than 1 in 100 people):
- Local burning in the eyes
- Long-term treatment can damage the cornea
- The pressure in the eye can rise
Uncommon (may affect less than 1 in 100 people):
- A virus causes inflammatory corneal inflammation.
Rare Opnol side effects (may affect less than 1 in 1,000 people):
- With long-term treatment
- Corneal ulcers may occur, and in some cases, the lens may become cloudy
- Dimsyn
No known frequency (can not be calculated from the available data):
- Hormone disorders:
- Extra hair growth on the body (especially in women)
- Muscle weakness and loss
- Purple stretch marks on the skin
- High blood pressure
- Irregular or no menstruation
- Changes in protein and calcium levels in the body
- Growth retardation in children and adolescents and swelling and weight gain on the body and face (called Cushing’s syndrome, see section 2, “Warnings and precautions”).
- When Opnol is dropped into the eye for a long time, and in a high dose, a small amount of the active substance can be absorbed into the blood and give effects reminiscent of those you can get when using cortisone tablets, i.e., side effects that do not only affect the eye. Impaired wound healing has been observed.
- When using Opnol after surgery for lens haze (cataracts), so-called filtration blisters can rarely occur.
How To Store Opnol
- Opened single-dose containers are used immediately and then discarded even if empty.
- Single-dose containers in opened envelopes are stable for 3 months. The single-dose containers must be stored in a sealed foil envelope.
- An unopened envelope is used before the expiration date on the package.
- Keep out of sight and reach of children.
- Do not store above 25 ° C.
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.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is dexamethasone sodium phosphate, corresponding to dexamethasone phosphate.
- The other ingredients are disodium edetate, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose, and water for injections.
What The Medicine Looks Like And The Contents Of The Pack
- Single-dose container made of polyethylene, 30 pcs (3×10).
- The single-dose containers are packed in maps of 10-in aluminum foil envelopes.
Marketing Authorisation Holder:
Trump Healthcare AB
Box 16184
103 24 Stockholm
Tel: 08-12 13 52 00
Email: medical@trimb.se
Manufacturer:
Curia AS
Solbærvegen 5
2409 Elverum
Norway