Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hydrocortisone sodium phosphate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
This medicine is an eye drops solution in single-dose containers, which contains a substance called hydrocortisone. This substance is a corticosteroid which reduces inflammatory symptoms. It is used to treat mild allergic or inflammation conditions that affect the clear lining that covers the whites of your eye(s) and the insides of your eyelids (your conjunctiva). The eye should not be infected (see Do not use Softacort).
2.
What you need to know before you take it
e Softacort
Do not use Softacort: If you are allergic to the active substance (hydrocortisone) or any of the other ingredients of this medicine (listed in section 6). If you have high pressure inside the eye (ocular hypertension), known to be due to glucosteroids (family of corticosteroid medicines) or to other causes. If you have an eye infection caused by viruses (acute herpes or most other viruses while there are ulcers, unless the infection is being treated with an anti-infective treatment for herpes virus). 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. If you have an eye infection caused by bacteria (acute purulent infection, conjunctivitis, blepharitis, stye). If you have an eye infection caused by fungus (ocular mycosis). If you have a bacterial infection called tuberculosis which affects your eye (ocular tuberculosis). Warnings and precautions
- Talk to your doctor, pharmacist or nurse before using this medicine.
- If you have a red eye that has not been diagnosed, do not use this medicine.
2
• • • •
• • •
If you have a viral eye infection (herpes), only use this medicine if the infection is being treated with an anti-infective treatment and close monitoring of your eyes is required. 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. If you have used or have been using a corticosteroid medicine for a 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. The use of corticosteroids can cause eye infections that may not normally happen (opportunistic eye infections). In addition, corticosteroids given to the eye may increase, make worse or hide signs and symptoms of these eye infections. You should avoid wearing contact lenses during treament with this medicine. Contact your doctor if you experience blurred vision or other visual disturbances.
Children There are no data on safety and effectiveness in children. Continuous long-term treatment with corticosteroids in children may produce adrenal suppression. The increase of the eye pressure in children occurs more frequently, more severely, and more quickly than in adults. Other medicines and Softacort Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines including medicines you have without a prescription. Some medicines may increase the effects of Softacort and your doctor may wish to monitor you carefully if you are taking theses medicines (including some medicines for HIV such as ritonavir or cobicistat). Pregnancy and breast-feeding 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.
- The use of this medicine during pregnancy is not recommended except when judged necessary by your doctor and under strict supervision.
- It is not known whether this medicine passes into breast milk. Your doctor will decide if you can use this medicine during breast-feeding or not. Driving and using machines Temporary blurred vision or other sight problems may affect the ability to drive or use machines. Do not drive or use machines until normal vision has returned. Softacort contains phosphates This medicine contains 0.227 mg phosphates in each drop.
3.
How to use Softacort
Dose Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is 2 drops in the affected eye(s), 2 to 4 times a day, depending on the prescription. Gradually reducing the dose is recommended in order to avoid relapse. The duration of treatment usually varies from a few days to a maximum of 14 days. 3
The same dose is used for both adults and the elderly. Use in children The effectiveness and the safety in children have not been established for this medicine.
How to take it
the drops This medicine is to be used in the eye. Please follow these instructions to use the drops: 1. Wash your hands and sit or stand comfortably. 2. Open the sachet containing 10 single-dose containers. Write down the date of first opening on the sachet. 3. Break off one single-dose container from the strip.
4. Twist open the top of the single-dose container as shown. Do not touch the tip after opening the container.
5. Use your finger to gently pull down the lower eyelid of your affected eye. 6. Place the tip of the single-dose container close to, but not touching your eye. 7. Squeeze the single-dose container gently so that two drops go into your eye, then release the lower eyelid.
8. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute while keeping the eye closed.
4
9. Repeat in your other eye if your doctor has told you to do this. Each single-dose container contains enough solution for both eyes. 10. Discard the single-dose container after use. Do not keep it to use it again. 11. Put the unopened single-dose containers back in the sachet. Put the opened sachet in the carton. The unopened containers must be used within one month after opening the sachet. If you are using any other eye medicine, you should wait 5 minutes between using each medicine. If you use more Softacort than you should Rinse the eye with sterile water if you have used too much medicine in your eye and have irritation that lasts a long time. Immediately tell your doctor or pharmacist. If you forget to use Softacort Do not take a double dose to make up for a forgotten dose. If you stop using Softacort Do not suddenly stop using the medicine. Always tell your doctor if you are thinking about stopping the treatment. If you have any more questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Not known: frequency cannot be estimated from the available data transient (short-lived) eye discomfort (burning, stinging) after use. The following side effects were reported with medicines of the same group (corticosteroids) when used for treating eye conditions. Not known: frequency cannot be estimated from the available data allergic reactions (red, itchy eyes), delayed wound healing, clouding of the lens in the eye (posterior capsular cataract), eye infections that may not normally happen (opportunistic viral infections like herpes, fungal infection), increase of pressure in your eye (glaucoma), dilation of the pupil (mydriasis), drooping eyelids (ptosis), inflammation inside your eye (uveitis), changes in the thickness of the front of the eye (cornea). inflammation of the cornea (crystalline keratopathy). blurred vision. 5
If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This 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. By reporting side effects you can help provide more information on the safety of this medicine.
5.
How to store it
Softacort
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, sachet and single-dose container after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. After first opening of the sachet: use the single-dose containers within one month. 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 throw away the single-dose container after use. After the individual single-dose container is opened, the solution inside cannot stay sterile, so you must throw away any solution remaining in the container after each use. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6.
Contents of the pack and other information
What Softacort contains –
The active substance is hydrocortisone sodium phosphate. 1 ml eye drops, solution contains 3.35 mg of hydrocortisone sodium phosphate. The other ingredients are disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, disodium edetate, hydrochloric acid (for pH adjustment),water for injections.
What Softacort looks like and contents of the pack 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 container holding 0.4 ml of product. The pack size contains 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.
6
Marketing Authorisation Holder LABORATOIRES THEA 12, rue Louis Blériot 63017 CLERMONT-FERRAND Cedex 2 FRANCE Manufacturer LABORATOIRES UNITHER 1 rue de l'Arquerie 50200 Coutances FRANCE or LABORATOIRES THEA 12, rue Louis Blériot 63017 CLERMONT-FERRAND Cedex 2 FRANCE
This leaflet was last revised in August 2023
If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at THEA Pharmaceuticals Ltd, telephone number 0345 521 1290.
7
Frequently asked questions about SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container
How do I take SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container?
SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container comes as eye drops containing 3.35mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container?
The active substance in SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container is hydrocortisone sodium phosphate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: hydrocortisone sodium phosphate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of mild non-infectious allergic or inflammatory conjunctival diseases.
4.2. Posology and method of administration
Posology
The recommended dosage is 2 drops 2 to 4 times daily in the affected eye.
The duration of this dosing regimen will generally vary from a few days to a maximum of 14 days. Gradual tapering off up to one administration every other day may be recommended in order to avoid a relapse.
In case of insufficient response, a more potent corticosteroid should be used.
Paediatric population
The safety and efficacy have not been established in the paediatric population. See section 4.4.
Elderly
No dose adjustment is necessary in elderly patients.
Method of administration
Ocular use.
A single-dose container contains enough solution to treat both eyes.
For single use only.
This medicinal product is a sterile solution that does not contain a preservative. The solution from one individual single-dose container is to be used immediately after opening for administration to the affected eye(s) (see section 6.3).
Patients should be instructed:
- to avoid contact between the dropper tip and the eye or eyelids,
- to use the eye drops, solution immediately after first opening of the single-dose container and to discard the single-dose container after use.
Nasolacrimal occlusion by compression of lacrimal ducts for one minute may reduce systemic absorption.
In case of concomitant treatment with other eye drops, solution, instillations should be spaced out by 5 minutes.
4.3. Contraindications
▪ Hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
▪ Known glucocorticosteroid-induced ocular hypertension and other forms of ocular hypertension;
▪ Acute herpes simplex virus infection and most of the other corneal viral infections at the acute stage of ulceration (except when combined with specific chemiotherapeutic agents for herpes virus), conjunctivitis with ulcerative keratitis even at the initial stage (positive fluorescein test);
▪ Ocular tuberculosis;
▪ Ocular mycosis;
▪ Acute ocular purulent infection, purulent conjunctivitis and purulent blepharitis, stye and herpes infection that may be masked or aggravated by anti-inflammatory drugs.
4.4. Special warnings and precautions for use
Topical steroids should never be given for an undiagnosed red eye.
Use of this medicinal product is not recommended for the treatment of viral herpes keratitis, but it may be used if required only with a combined antiviral treatment and under close supervision of an ophthalmologist.
Thinning of the cornea and sclera (caused by diseases) may increase the risk of perforations with the use of topical steroids.
Any fungal infection should be suspected in cases of corneal ulceration where a steroid has or had been used for a long period.
Patients should be monitored at frequent intervals during treatment with hydrocortisone eye drops. Prolonged use of corticosteroid treatment has shown to cause ocular hypertension/glaucoma especially for patients with previous IOP increase induced by steroids or with pre-existing high IOP or glaucoma, (see sections 4.3 and 4.8) and also cataract formation, especially in children and elderly population.
The use of corticosteroids may also result in opportunistic ocular infections due to the suppression of host response or to the delay of their healing. In addition, topical ocular corticosteroids may promote, aggravate or mask signs and symptoms of opportunistic eye infections.
Wearing of contact lenses during treatment with corticosteroid eye drops should be avoided.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
This medicine contains 0.227 mg phosphates in each drop (see also section 4.8).
Paediatric population
In children, long-term continuous corticosteroid therapy may produce adrenal suppression (see section 4.2).
The ocular hypertensive response to topical corticosteroids in children occurs more frequently, more severely, and more rapidly than that reported in adults.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited data from the use of SOFTACORT in pregnant women. Corticosteroids cross the placenta. Studies in animals have shown reproductive toxicity including formation of cleft palates (see section 5.3). The clinical relevance of this observation is unknown. After systemic administration of higher doses of corticosteroids, effects on the unborn/neonate (intra-uterine growth inhibition, inhibition of the function of the adrenal cortex) have been reported. However, these effects have not been observed after ocular use.
SOFTACORT is not recommended during pregnancy, unless clearly necessary.
Breastfeeding
Systemically administered glucocorticoids are excreted in breast milk and may cause suppression of growth or of endogenous corticosteroid production or may have other undesirable effects.
It is unknown whether SOFTACORT is excreted in human milk.
A risk to the newborns/infants cannot be excluded.
Fertility
There are no data on potential effects of hydrocortisone sodium phosphate 3.35 mg/ml on fertility.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs, the patient must wait until the vision is clear before driving or using machines.
4.8. Undesirable effects
List of adverse reactions:
Adverse events are categorised by frequency as follows: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from available data).
Hydrocortisone
Eye disorders:
- Not known:
Burning*, stinging*.
Corticoid class effects
The following adverse drug reactions have not been observed with hydrocortisone, but are known with other topical corticosteroids.
Eye disorders:
- Not known:
Allergic and hypersensitivity reactions, delayed wound healing, posterior capsular cataract*, opportunistic infections (herpes simplex infection, fungal infection, see Section 4.4), glaucoma*, mydriasis, ptosis, corticosteroid-induced uveitis, changes in corneal thickness*, crystalline keratopathy, blurred vision (see also section 4.4).
* see section Description of selected adverse reactions
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Description of selected adverse reactions
Burning and stinging may occur immediately after instillation. These events are usually mild and transient and have no consequences.
Prolonged use of corticosteroid treatment has shown to cause ocular hypertension/glaucoma (especially for patient with previous IOP increase induced by steroids or with pre-existing high IOP or glaucoma, or family history of high IOP or glaucoma) and also cataract formation. Children and elderly patients may be particularly susceptible to steroid-induced IOP rise (see section 4.4).
Increase of intra-ocular pressure induced by corticosteroid topical treatment has been generally observed within 2 weeks of treatment (see section 4.4.).
Diabetics are also more prone to develop subcapsular cataracts following topical steroid administration.
In diseases causing thinning of the cornea, topical use of steroids could lead to perforation in some cases (see section 4.4).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions 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.
4.9. Overdose
In the case of topical overdosage associated with prolonged eye irritation, the eye(s) should be rinsed with sterile water.
Prolonged overdosages could produce ocular hypertension. In this case, it is necessary to discontinue treatment.
The symptomatology due to accidental ingestion is not known. As with other corticosteroids however, the physician may consider gastric lavage or emesis.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- SOFTACORT 3,35 mg/ml prescriptionHYDROCORTISONUM · eye / ear / nose
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- Hydrocortisonum JelfaHydrocortisonum · taken by mouth
- Hydrocortison VUABHydrocortisonum · injection / infusion
- Hydrocortisonum AflofarmHydrocortisoni acetas
- Hydrocort CHEMAHydrocortisoni acetas · skin / topical
- Corhydron 25Hydrocortisonum · injection / infusion
- Corhydron 100Hydrocortisonum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about SOFTACORT 3.35 mg/ml eye drops, solution in single-dose container. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.