Consumer medicine information

Siguent Hycor 1% Eye ointment

Hydrocortisone acetate

BRAND INFORMATION

Brand name

Siguent Hycor 1%

Active ingredient

Hydrocortisone acetate

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Siguent Hycor 1% Eye ointment.

What is in this leaflet

This leaflet answers some common questions about Siguent Hycor 1% eye ointment.

It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this against the benefits they expect it will have for you.

Ask your doctor or pharmacist if you have any concerns about using this medicine.

Keep this leaflet with the medicine. You may need to read it again.

What Siguent Hycor 1% is used for

Siguent Hycor 1% eye ointment contains 1% hydrocortisone (as the acetate) as the active ingredient.

This medicine is a type of glucocorticoid and belongs to the group of medicines called corticosteroids.

It is used in inflammatory (red, swollen) conditions of the eye including:

  • allergic conjunctivitis
  • nonpurulent (non-pus producing) conjunctivitis or swollen eyelids
  • herpes zoster ophthalmicus
  • recurrent marginal ulceration (recurring eye ulcers).

Siguent Hycor 1% is for use in the eyes only. It should not be taken by mouth.

Ask your doctor if you have any questions about why it has been prescribed for you. Your doctor may have prescribed this medicine for another purpose.

It is available only on a doctor’s prescription.

Before you use it

When you must not use it

Do not use it if you are allergic to:

  • hydrocortisone or any of the ingredients listed at the end of this leaflet.

Do not use Siguent Hycor 1% eye ointment if you have an acute herpes infection of the eye (herpes simplex), vaccinia (a special form of chicken pox), varicella or other viral infections of the eye, ocular tuberculosis, fungal diseases of the eye or pus-producing infections of the eye.

Do not wear contact lenses while using Siguent Hycor 1% eye ointment as it may increase the risk of infection.

Do not use it after the expiry date printed on the pack. If you use it after the expiry date has passed, it may have no effect at all, or worse, there may be an entirely unexpected effect.

Do not purchase or use this ointment if the packaging is torn or shows signs of tampering.

Before you start to use it

You must tell your doctor if you:

  • are allergic to any other medicines or any foods, dyes or preservatives
  • have glaucoma or a family history of glaucoma
  • wear contact lenses
  • have cataracts
  • are diabetic
  • have a disease where the cornea is thinned (perforation may occur).

Taking other medicines

Tell your doctor if you are taking any other medication, including medicines, creams, ointments or lotions that you buy without a prescription from a pharmacy, supermarket or health food shop.

Do not use in children unless specifically directed to by your doctor.

Some medicines may interfere with Siguent Hycor 1% eye ointment.

These include:

  • drugs used to treat glaucoma
  • atropine and related compounds, these include medicines used to relieve stomach cramps or spasms, to prevent travel sickness and to treat parkinson’s disease.

The above medicines may either reduce the effectiveness of this medicine, reduce their own effectiveness and/or react with it resulting in untoward or sometimes dangerous side effects.

This list is not exhaustive. Your doctor or pharmacist have more information on medicines to be careful with or avoid while using it.

How to use it

How to use it

Gently pull out the lower eyelid to form a sac. Run the ointment into the sac, then allow the eye to close. Apply gentle pressure on the closed eye for about one minute.

Try not to let the nozzle of the tube contact the eye when applying. If handled incorrectly, eye ointments such as Siguent Hycor 1% can become contaminated by bacteria which can cause, when applied to the eye, further infections.

How much to use

Siguent Hycor 1% should be applied two to four times a day or as directed by your doctor.

Do not use more than the amount advised or use this medicine more frequently than directed. It is important to use the ointment exactly as directed. If you use less than you should, it may not work as well and your medical condition may not improve. Using it more frequently than you should may not improve your condition any faster and may cause or increase side effects.

How long to use it

Siguent Hycor 1% eye ointment should be used as long as your doctor thinks it is necessary.

If you forget to use it

Use it as soon as you remember and then return to your normal dosing time. If your next dose is almost due, leave using it until that time.

Do not try to make up for missed doses by using more than one dose at a time. This may increase the chance of getting an unwanted side effect.

If you accidentally swallow it

Immediately phone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital, if you think you or anyone else may have swallowed Siguent Hycor 1%. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention.

While you are using it

Things you must do

Tell your doctor if you feel it is not helping your condition.

Tell your doctor if, for any reason, you have not used this medicine as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.

Always discuss with your doctor any problems or difficulties during or after using Siguent Hycor 1% eye ointment.

If you develop any other eye condition such as injury, eye surgery or infections while using this medicine, seek your doctor’s advice concerning the continued use.

Things you must not do

Do not give it to anyone else even though their symptoms seem similar to yours.

Do not use it for other conditions unless your doctor tells you. Siguent Hycor 1% eye ointment has been prescribed for you for a specific condition. If you use it for another reason, it may not work or may make the condition worse.

Do not give this ointment to small children.

Things to be careful of

Do not use Siguent Hycor 1% eye ointment for a long time. If you use it for longer than recommended or use more than the prescribed dose, the chances of absorption of the drug into the body and the chance of side effects increases.

Ask your doctor or pharmacist if you are concerned about the length of time you have been using it.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while using Siguent Hycor 1% eye ointment.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

The most common side effect is temporary blurred vision (especially after application of the eye ointment).

Uncommon to rare side effects include:

  • burning, stinging, redness or watering of the eyes
  • corneal thinning (resulting in decreased vision, watering of the eyes)
  • cataracts
  • glaucoma
  • blurred vision.

There is a possibility of absorption into the body of hydrocortisone, especially if this ointment is used for a long time. This may result in effects to the organs that regulate and maintain hormone levels in the body. Your doctor will decide if there is a need for a test to monitor the hormone levels in the blood.

Check with your doctor as soon as possible if you have any other problems while using this ointment even if you do not think the problems are connected with this medicine or are not listed in this leaflet.

Do not be alarmed by this list of side effects or their discussion. You may not experience any of them.

After using it

Storage

Discard any of the ointment still left after 4 weeks from first using it.

Store below 25°C.

Keep it where children cannot reach it. A locked cupboard at least one and a half metres above the floor is a good place to store medicines.

Do not store it or any other medicines in a bathroom or near a sink. Do not leave it in the car or on windowsills.

Disposal

If your doctor tells you to stop using Siguent Hycor 1% eye ointment or it has passed its expiry date, ask your pharmacist what to do with any left over.

Product description

What it looks like

Siguent Hycor 1% eye ointment is a soft, yellowish-white sterile ointment with a faint odour of paraffin and lanolin. It is packed in a special eye ointment tube with an elongated nozzle.

Ingredients

Active ingredient:
Each gram of Siguent Hycor 1% eye ointment contains 10 mg of hydrocortisone (as the acetate).

Other ingredients:

  • white soft paraffin
  • liquid paraffin
  • wool fat.

Siguent Hycor 1% eye ointment does not contain any preservatives.

Sponsor

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

Australian Registration Number: AUST R 139082

This information was revised in February 2020.

Published by MIMS April 2020

BRAND INFORMATION

Brand name

Siguent Hycor 1%

Active ingredient

Hydrocortisone acetate

Schedule

S4

 

1 Name of Medicine

Hydrocortisone acetate.

2 Qualitative and Quantitative Composition

Siguent Hycor eye ointment contains 1% hydrocortisone acetate as the active ingredient in a sterile oculentum base. It is a preservative-free preparation.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

A soft, yellowish-white, clear eye ointment with an odour faintly of paraffin and lanolin.

4 Clinical Particulars

4.1 Therapeutic Indications

Inflammatory conditions of the eye, including allergic conjunctivitis, nonpurulent conjunctivitis and/or blepharitis, iritis, herpes zoster ophthalmicus, recurrent marginal ulceration.

4.2 Dose and Method of Administration

Apply two to four times daily.

4.3 Contraindications

Hypersensitivity to any ingredient including excipients.
Acute herpes simplex, vaccinia, varicella and most other viral diseases of the cornea and conjunctiva; ocular tuberculosis; fungal diseases of the eye; purulent conjunctivitis and blepharitis and other acute purulent untreated infections of the eye which may be masked or enhanced by the presence of a steroid.

4.4 Special Warnings and Precautions for Use

Extended use of the topical steroid therapy may cause increased intraocular pressure in certain individuals. Ophthalmologic examinations, especially tonometry and slit lamp examinations should be performed 2 to 3 weeks following onset of chronic therapy; subsequent examinations should be performed at intervals as determined by patient status or risk factors.
Risk/ benefit should be considered when the following medical problems exist: cataracts (may be exacerbated); diabetes mellitus (patient may be predisposed toward increase in intraocular pressure and/or cataract formation); diseases causing thinning of the cornea or sclera (use may result in perforation); glaucoma, chronic open angle or family history of glaucoma (may be precipitated or exacerbated); infections of the cornea or conjunctiva (risk of exacerbation or development of secondary infections).
There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or the surrounding structures.
Patients should be instructed that ocular solutions, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Patients should also be advised that if they develop an intercurrent ocular condition (e.g. trauma, ocular surgery or infection) or any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician's advice concerning the continued use of the product.
If more than one topical ophthalmic drug is being utilised, the drugs should be administered at least 10 minutes apart.
To minimise systemic absorption of the active ingredient, pressure should be applied to the tear duct for one minute immediately after application.

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.

Use in the elderly.

No geriatric specific problems have been documented.

Paediatric use.

Corticosteroids should be used with caution in children 2 years of age or younger because the different dose/weight ratio for children increases the risk of adrenal suppression. This risk increases with the length of therapy, which, therefore, should be limited to the shortest possible time (preferably less than 5 days).

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Anti-glaucoma agents.

Chronic or prolonged use of corticosteroids may raise intraocular pressure and decrease the efficiency of the anti-glaucoma agents.

Anticholinergics (especially atropine and related compounds).

Prolonged corticosteroid therapy may increase risk of intraocular hypertension which may be more likely to occur during treatment with anticholinergics in patients predisposed to acute angle closure.

Interactions with therapeutic devices.

Contact lenses: risk of infection is increased.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Systemically absorbed hydrocortisone is classified category A in Australia. Problems in humans have not been documented with ophthalmologically applied hydrocortisone, however, well controlled studies have not been performed. Studies in pregnant mice have shown that hydrocortisone drops, when applied to both eyes five times a day on days 10-13 of gestation, caused a significant increase in foetal cleft palate. Studies in rabbits have shown that corticosteroids produce foetal resorptions and multiple abnormalities, including those of the head, ears, limbs and palate. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Problems in humans have not been documented.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.
Frequent or intensive use of ophthalmic corticosteroids may retard corneal healing.

Common.

Ophthalmological.

Temporary blurred vision (particularly after application of the eye ointment).

Uncommon to rare.

Ophthalmological.

Burning, stinging, redness or watering of the eyes; corneal thinning and/or globe perforation (decreased vision, watering of the eyes); glaucoma; ocular hypertension; optic nerve damage; posterior subcapsular cataract; visual acuity and field defects (gradual blurring or loss of vision, eye pain, nausea, vomiting); secondary ocular infection.

Post marketing.

Eye disorders.

Blurred vision.

4.9 Overdose

Dilution with water and other fluids is the usual response to accidental or deliberate overdose.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Hydrocortisone is the main glucocorticoid secreted by the adrenal cortex. It is an anti-inflammatory hormone. Hydrocortisone acetate is the acetate salt of hydrocortisone.

Mechanism of action.

Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These then enter the cell nucleus, bind to DNA and stimulate transcription of mRNA and subsequent protein synthesis of enzymes ultimately responsible for anti-inflammatory effects of topical applications of corticosteroids to the eye.
In high concentrations, which may be achieved after topical application, corticosteroids may exert direct membrane effects. Corticosteroids decrease cellular and fibrinous exudation and tissue infiltration, inhibit fibroblastic and collagen-forming activity, retard epithelial regeneration, diminish postinflammatory neovascularization and reduce toward normal levels the excessive permeability of inflamed capillaries.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Hydrocortisone and its acetate salt are absorbed into the aqueous humour, cornea, iris, choroid, ciliary body and retina. Systemic absorption occurs, but may be significant only at higher dosages or in extended paediatric delivery. The biological half-life is about 100 minutes.

Distribution.

It is more than 90% bound to plasma proteins.

Metabolism.

Hydrocortisone is metabolised in the liver and most body tissues to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol.

Excretion.

These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids. Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results.

6 Pharmaceutical Particulars

6.1 List of Excipients

White soft paraffin, liquid paraffin and wool fat.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Discard 4 weeks after opening.

6.5 Nature and Contents of Container

Aluminium tube with a HDPE nozzle. Pack sizes of 2.5 g or 5 g.
(Note: not all pack sizes are available.)

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Hydrocortisone acetate is a white or almost white, odourless crystalline powder. 112 mg of hydrocortisone acetate is approximately equivalent to 100 mg of hydrocortisone. It is insoluble in water, soluble 1 in 230 of alcohol, 1 in 200 in chloroform. Formula: C23H32O6. Molecular weight: 404.5.

Chemical structure.


CAS number.

50-03-3.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes