PACKAGE LEAFLET: INFORMATION FOR THE PATIENT • The use of corticosteroids can cause eye infections that may
not normally happen (opportunistic eye infections). In addition,
Softacort® 3.35 mg/ml eye drops, corticosteroids given to the eye may increase, make worse or hide
signs and symptoms of these eye infections.
solution in single-dose container • You should avoid wearing contact lenses during treament with this
Hydrocortisone sodium phosphate medicine.
• Contact your doctor if you experience blurred vision or other visual
disturbances.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you. Children
- Keep this leaflet. You may need to read it again. There are no data on safety and effectiveness in children.
- If you have any further questions, ask your doctor, pharmacist or Continuous long-term treatment with corticosteroids in children may
nurse. produce adrenal suppression.
- This medicine has been prescribed for you only. Do not pass it on The increase of the eye pressure in children occurs more frequently,
to others. It may harm them, even if their signs of illness are the more severely, and more quickly than in adults.
same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. Other medicines and Softacort
This includes any possible side effects not listed in this leaflet. See Please tell your doctor or pharmacist if you are using, have recently used
section 4. or might use any other medicines including medicines you have without
a prescription. Some medicines may increase the effects of Softacort
What is in this leaflet and your doctor may wish to monitor you carefully if you are taking
1. What Softacort is and what it is used for theses medicines (including some medicines for HIV such as ritonavir or
2. What you need to know before you use Softacort cobicistat).
3. How to use Softacort Pregnancy and breast-feeding
4. Possible side effects If you are pregnant or breast-feeding, think you may be pregnant or are
5. How to store Softacort planning to have a baby, ask your doctor or pharmacist for advice before
6. Contents of the pack and other information taking this medicine.
• The use of this medicine during pregnancy is not recommended
1. What Softacort is and what it is used for except when judged necessary by your doctor and under strict
supervision.
This medicine is an eye drops solution in single-dose containers, • It is not known whether this medicine passes into breast milk. Your
which contains a substance called hydrocortisone. This substance is a doctor will decide if you can use this medicine during breast-feeding
corticosteroid which reduces inflammatory symptoms. or not.
It is used to treat mild allergic or inflammation conditions that affect the Driving and using machines
clear lining that covers the whites of your eye(s) and the insides of your Temporary blurred vision or other sight problems may affect the ability
eyelids (your conjunctiva). to drive or use machines. Do not drive or use machines until normal
The eye should not be infected (see Do not use Softacort). vision has returned.
Softacort contains phosphates
2. What you need to know before you use Softacort This medicine contains 0.227 mg phosphates in each drop.
Do not use Softacort: 3. How to use Softacort
• If you are allergic to the active substance (hydrocortisone) or any of
the other ingredients of this medicine (listed in section 6). Dose
• If you have high pressure inside the eye (ocular hypertension), known Always use this medicine exactly as your doctor or pharmacist has told
to be due to glucosteroids (family of corticosteroid medicines) or to you. Check with your doctor or pharmacist if you are not sure.
other causes.
The recommended dose is 2 drops in the affected eye(s), 2 to 4 times
• If you have an eye infection caused by viruses (acute herpes or most
a day, depending on the prescription. Gradually reducing the dose is
other viruses while there are ulcers, unless the infection is being
recommended in order to avoid relapse. The duration of treatment
treated with an anti-infective treatment for herpes virus).
usually varies from a few days to a maximum of 14 days.
• If you have conjunctivitis with inflammation and ulcers on the clear
cornea surface of the eye (keratitis) even if it is at an early stage. The same dose is used for both adults and the elderly.
• If you have an eye infection caused by bacteria (acute purulent Use in children
infection, conjunctivitis, blepharitis, stye). The effectiveness and the safety in children have not been established
• If you have an eye infection caused by fungus (ocular mycosis). for this medicine.
• If you have a bacterial infection called tuberculosis which affects your
eye (ocular tuberculosis). How to use the drops
This medicine is to be used in the eye.
Warnings and precautions
• Talk to your doctor, pharmacist or nurse before using this medicine. Please follow these instructions to use the drops:
• If you have a red eye that has not been diagnosed, do not use this 1. Wash your hands and sit or stand comfortably.
medicine. 2. Open the sachet containing 10 single-dose containers. Write down
• If you have a viral eye infection (herpes), only use this medicine if the the date of first opening on the sachet.
infection is being treated with an anti-infective treatment and close
monitoring of your eyes is required. 3
• If you have a disease that causes thinning of the outer part of your
eye (cornea and sclera), there can be a higher risk of perforation
when topical corticosteroids are applied to the eye. 3. Break off one single-dose container
• If you have used or have been using a corticosteroid medicine for a from the strip.
long time and have an eye wound (corneal ulcer), a fungal infection
may be suspected.
• Close regular monitoring of your eyes is required during your
treatment. Prolonged use of corticosteroids has shown to cause an
increase of the pressure inside the eye and the start of glaucoma,
especially in patients who already suffer from high pressure inside
the eye, or if you are known to be at risk of developing this condition
with local steroid treatment (see Possible side effects), and to cause a
clouding of the lens in the eye (cataract), in particular in children and
older people.
If you suffer from severe damage to the clear layer at the front of the
4
eye (the cornea), phosphates may cause in very rare cases cloudy
patches on the cornea due to calcium build-up during treatment.
4. Twist open the top of the single-dose Reporting of side effects
container as shown. Do not touch the If you get any side effects, talk to your doctor, pharmacist or nurse. This
tip after opening the container. includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme.
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card
in the Google Play or Apple App Store.
5. Use your finger to gently pull down the
lower eyelid of your affected eye. By reporting side effects you can help provide more information on the
6. Place the tip of the single-dose safety of this medicine.
container close to, but not touching
your eye. 5. How to store Softacort
7. Squeeze the single-dose container
gently so that two drops go into your Keep this medicine out of the sight and reach of children.
eye, then release the lower eyelid. Do not use this medicine after the expiry date which is stated on the
carton, sachet and single-dose container after EXP. The expiry date refers
to the last day of that month.
8. Press a finger against the corner of Do not store above 25°C.
the affected eye by the nose. Hold
After first opening of the sachet: use the single-dose containers within
for 1 minute while keeping the eye
one month.
closed.
Keep the single-dose containers in the sachet to protect them from light.
Write down the date of first opening on the sachet.
After first opening of the single-dose container: use immediately and
9. Repeat in your other eye if your doctor has told you to do this. Each
throw away the single-dose container after use.
single-dose container contains enough solution for both eyes.
10. Discard the single-dose container after use. Do not keep it to use it After the individual single-dose container is opened, the solution inside
again. cannot stay sterile, so you must throw away any solution remaining in
the container after each use.
11. Put the unopened single-dose containers back in the sachet. Put
the opened sachet in the carton. The unopened containers must be Do not throw away any medicines via wastewater or household waste.
used within one month after opening the sachet. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help to protect the environment.
If you are using any other eye medicine, you should wait 5 minutes
between using each medicine.
6. Contents of the pack and other information
If you use more Softacort than you should
Rinse the eye with sterile water if you have used too much medicine What Softacort contains
in your eye and have irritation that lasts a long time. - The active substance is hydrocortisone sodium phosphate.
Immediately tell your doctor or pharmacist. 1 ml eye drops, solution contains 3.35 mg of hydrocortisone sodium
If you forget to use Softacort phosphate.
Do not take a double dose to make up for a forgotten dose. - The other ingredients are disodium phosphate dodecahydrate,
sodium dihydrogen phosphate monohydrate, sodium chloride,
If you stop using Softacort
disodium edetate, hydrochloric acid (for pH adjustment),water for
Do not suddenly stop using the medicine. Always tell your doctor if you
injections.
are thinking about stopping the treatment.
If you have any more questions on the use of this medicine, ask your What Softacort looks like and contents of the pack
doctor, pharmacist or nurse. This medicine is an eye drops solution in single-dose containers.
The solution is practically clear, colourless to slightly yellow, practically
free from particles, packed in a sachet of 10 units, each single-dose
4. Possible side effects
container holding 0.4 ml of product.
Like all medicines, this medicine can cause side effects, although not The pack size contains 10 (1 x 10), 20 (2 x 10), 30 (3 x 10) or
everybody gets them. 60 (6 x 10) single-dose containers.
Not all pack sizes may be marketed.
Not known: frequency cannot be estimated from the available data
Marketing Authorisation Holder
• transient (short-lived) eye discomfort (burning, stinging) after use.
LABORATOIRES THEA
The following side effects were reported with medicines of the 12, rue Louis Blériot
same group (corticosteroids) when used for treating eye conditions. 63017 CLERMONT-FERRAND Cedex 2
Not known: frequency cannot be estimated from the available data FRANCE
• allergic reactions (red, itchy eyes),
• delayed wound healing, Manufacturer
• clouding of the lens in the eye (posterior capsular cataract), LABORATOIRES UNITHER
• eye infections that may not normally happen (opportunistic viral ZI de la Guérie
infections like herpes, fungal infection), 50 211 COUTANCES CEDEX
• increase of pressure in your eye (glaucoma), FRANCE
• dilation of the pupil (mydriasis), This leaflet was last revised in July 2018.
• drooping eyelids (ptosis),
If you would like any more information, or would like the leaflet
• inflammation inside your eye (uveitis),
in a different format, please contact Medical Information at
• changes in the thickness of the front of the eye (cornea),
THEA Pharmaceuticals Ltd, telephone number 0345 521 1290.
• inflammation of the cornea (crystalline keratopathy),
• blurred vision.
N1565U30ASP/0718
65NOTXXXX/X
