3.35 mg/ml Eye Drops, Hydrocortisone Sodium Phosphate Solution
What Softacort Is And What Is Softacort Used For
What is softacort eye drops used for
Softacort is an eye drop solution, in single-dose containers, which contains a substance called hydrocortisone. This substance is a corticosteroid that inhibits inflammatory symptoms.
It is used to treat mild allergic or inflammatory conditions in the superficial part of the eye (conjunctiva).
The eye must not be infected (see Do not use Softacort).
The hydrocortisone contained in Softacort may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Softcore
Do Not Use Softacort:
- If you are allergic to hydrocortisone or any of the other ingredients of Softacort (listed in section 6).
- If you have high pressure in the eye ( ocular hypertension ), which is known to be due to neurosteroids (a type of corticosteroid ) or other causes.
- In case of acute infection in the eye caused by the herpes virus or other viral disease with ulceration in the eye (unless an infection is treated at the same time).
- If you have inflammation of the conjunctiva (conjunctivitis) with ulceration of the cornea (keratitis), even if the infection is in an early stage.
- If you have a bacterial eye infection
- Acute persistent infection
- Conjunctivitis
- Eyelid inflammation
- Vaginitis
- If you have a fungal infection in the eye (ocular mycosi).
- If you have a bacterial infection called tuberculosis that affects the eye (ocular tuberculosis).
Warnings And Precautions
- Talk to your doctor, pharmacist, or nurse before using this medicine.
- If you have an undiagnosed red eye, do not use this medicine.
- If you have a viral eye infection ( herpes ), use softacort eye drops only if the infection is treated with antiviral treatment. Careful monitoring of the eyes is required.
- If you have a disease that causes thinning of the outer part of the eye (cornea and sclera), there may be a higher risk of hole formation in the membranes of the eye due to the use of topical corticosteroids in the eye.
- If you have used corticosteroid drugs for a long time and have an eye injury (cornea ulcer), a fungal infection may be suspected.
- During treatment, the eyes need to be checked often and regularly. Especially in patients who already suffer from high eye pressure or are at risk of developing such a condition, long-term use of corticosteroids has been shown to cause an increase in eye pressure and the incidence of glaucoma (see Possible softacort eye drops side effects ). Long-term use of corticosteroids has also been shown to cause a clouding of the lens in the eye ( cataract ), especially in children and the elderly.
- The use of corticosteroids can cause eye inflammation in individuals with a weakened immune system. Corticosteroids used in the eye can also worsen or mask the signs and symptoms of this type of eye inflammation.
- You should not use contact lenses during treatment with this medicine.
- Contact a doctor if you experience blurred vision or other visual disturbances.
Children
- There is a lack of data regarding safety and efficacy in children.
- Continuous long-term treatment with corticosteroids in children can cause adrenal cortex suppression.
- The increase in eye pressure in children strikes more often, more severely, and faster than in adults.
Other Medicines And Softcore
Tell your doctor or pharmacist if you are using, have recently used, or might be using any other medicines, including non-prescription medicines.
Some medicines can increase the effect of Softacort and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
- The use of softacort eye drops during pregnancy is not recommended, except when deemed necessary by the doctor and under strict supervision.
- It is not known whether this drug is excreted in breast milk. Your doctor will decide whether or not you can use softacort eye drops while breastfeeding.
Driving Ability And Use Of Machinery
Transient blurred vision or other visual disturbances can affect the ability to drive or operate machinery. Do not drive or operate machinery until you have regained normal vision.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Softcore Contains Phosphates
Softacort eye drops contains 0.227 mg phosphate er per drop.
Softacort How To Use
Dosage
Always use softacort eye drops as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 2 drops in the affected eye(s), 2-4 times per day depending on the prescription. Gradual dose reduction is recommended to avoid relapse. The treatment time usually varies from a few days to a maximum of 14 days.
The same dose is used for both adults and the elderly.
Use For Children
Efficacy and safety in children have not been established.
How to use the drops
Softacort eye drops is intended for use in the eye.
Follow these instructions to use the drops:
- Wash your hands and sit or stand comfortably.
- Open the bag containing 10 single-dose containers. Write the date of the first opening on the bag.
- Break off a single-dose container from the strip.
- Twist off the top of the single-dose container, as shown in the picture. Do not touch the tip after opening the single-dose container.
- Use your finger to gently pull down the lower eyelid of the affected eye.
- Place the tip of the single-dose container close to the eye, without touching it.
- Gently squeeze the single-dose container so that two drops enter the eye, then release the lower eyelid.
- Press a finger against the corner of the eye, near the nose, on the affected eye. Hold for 1 minute while closing your eyes.
- Repeat in the other eye if your doctor has told you to do this. Each single-dose container contains enough solution for both eyes.
- Throw away the single-dose container after use. Do not save it to use again.
- Put the unopened single-dose containers back into the bag. Place the opened bag in the carton. The unopened single-dose containers must be used within one month of opening the pouch.
If you are using any other medicine to be applied to the eye, you should wait 5 minutes between each application.
If You Have Used Too Much Softcore
Rinse the eye with sterile water if you have dropped too much of the medicine in the eye and you experience irritation in the eye that does not go away.
Contact a doctor or pharmacist immediately.
If you have used too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
If you Forget To Use Softcore
Do not take a double dose to make up for a missed dose.
If You Stop Using Softcore
Do not end treatment abruptly. Always consult your doctor if you are considering stopping treatment.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
Possible Softacort Side Effects
Like all medicines, Softacort eye drops can cause side effects, although not everybody gets them.
Has been reported softacort side effects (occurring in an unknown number of users):
- Transient eye discomfort (burning, stinging sensation) after application.
The following side effects have been reported for drugs in the same group ( corticosteroids ) when used to treat eye diseases.
Has been reported softacort side effects (occurring in an unknown number of users):
- Allergic reactions
- Delayed wound healing
- Clouding of the lens in the eye (posterior capsular cataract)
- Infection in patients with a weakened immune system (caused by herpes virus, fungal infection)
- Increase in pressure in the eye (glaucoma)
- Dilation of pupil one (mydriasis)
- Drooping eyelids ( ptosis )
- Inflammation inside the eye (uveitis)
- Changes in the thickness of the front part of the eye (cornea),
- Inflammation of the cornea (crystalline keratopathy),
- Blurred vision
If you have a severely damaged cornea, phosphate can in very rare cases cause cloudy spots on the cornea due to the accumulation of calcium during treatment.
How To Store Softcore
- Keep softacort eye drops out of the sight and reach of children.
- Use before the expiry date which is stated on the carton, sachet, and single-dose container after EXP. The expiration date is the last day of the specified month.
- Store at a maximum of 25 °C.
- After first opening the bag: use the single-dose containers within one month.
- Store the single-dose containers in the bag. Light sensitive.
- Write the date of the first opening on the bag.
- After first opening the single-dose container: use it immediately and discard the single-dose container after use.
Since sterility cannot be maintained after opening the single-dose container, any remaining contents should be discarded immediately after administration.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substance is hydrocortisone sodium phosphate.1 ml softacort eye drops, the solution contains 3.35 mg hydrocortisone sodium phosphate.
- Other ingredients are disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment), and water for injections.
Appearance And Package Sizes Of The Medicine
- Softacort is an eye drop solution in a single-dose container.
- The solution is almost clear, colorless to slightly yellow, and practically free from particles, packaged in a bag of 10 single-dose containers, each single-dose container contains 0.4 ml of solution.
- Pack sizes: 10 (1 x 10), 20 (2 x 10), 30 (3 x 10) or 60 (6 x 10) single-dose containers.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
Laboratoires UNITHER
ZI de la Guérie
50211 Coutances Cedex
France
or
Laboratoires THEA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France