Consumer medicine information

Bleph-10 Eye Drops

Sulfacetamide sodium

BRAND INFORMATION

Brand name

Bleph-10 Eye Drops

Active ingredient

Sulfacetamide sodium

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Bleph-10 Eye Drops.

What is in this leaflet

This leaflet answers some common questions about BLEPH®-10 eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks of you using BLEPH®-10 eye drops against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What BLEPH®-10 eye drops are used for

BLEPH®-10 eye drops contain the antibiotic sulfacetamide and are used to treat bacterial infections in the eye.

BLEPH®-10 eye drops work by stopping the growth of the bacteria causing the eye infection.

This medicine is available via a doctor’s prescription or can be supplied by a pharmacist without a prescription. If you have any questions about why this medicine has been prescribed for you, ask your doctor or pharmacist.

Before you use BLEPH®-10 eye drops

When you must not use it

Do not use BLEPH®-10 eye drops:

  • if you are allergic to sulfacetamide (or other sulfur medicines) or any of the other ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
  • if the seal around the cap is broken.
  • if the bottle/packaging shows signs of tampering.
  • if the solution is discoloured dark brown.
  • if the expiry date on the bottle has passed. If you use this medicine after the expiry date has passed, it may not work effectively.
  • 4 weeks after opening the bottle.
  • if you are wearing contact lenses. The preservative in BLEPH®-10 eye drops may be deposited in soft contact lenses. Also, contact lenses should not be worn while you have an eye infection.

BLEPH®-10 eye drops should not be used in children less than two months old.

These drops are for topical use only.

Before you start to use it

Tell your doctor or pharmacist if:

  • you are allergic to any other medicines, foods, preservatives or dyes.
  • you are pregnant or intend to become pregnant. BLEPH®-10 should not be used during pregnancy unless clearly necessary.
  • you are breast feeding. Your doctor or pharmacist can discuss with you the risks and benefits involved.
  • you are scheduled to have surgery using a general anaesthetic.
  • you wear contact lenses. Contact lenses should not be worn while you have an eye infection or while using BLEPH®-10 eye drops.

Taking other medicines

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

Some medicines and BLEPH®-10 eye drops may interfere with each other. Your doctor or pharmacist has more information on medicines to be careful with or avoid while using BLEPH®-10 eye drops.

How to use BLEPH®-10 eye drops

How much to use

The usual dose is one or two drops in the affected eye(s) every two to three hours during the day, less often at night.

If your eye(s) does not feel better after using BLEPH®-10 eye drops for two to three days consult your doctor or pharmacist.

Follow all directions given to you by your doctor or pharmacist carefully. The directions may differ from the information contained in this leaflet.

Ask your doctor or pharmacist before using other eye drops during treatment with BLEPH®-10 eye drops.

If you are using more than one eye drop product, wait 5 minutes before using the second product.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

To open a new bottle of BLEPH®-10 eye drops first tear off the protective seal from the bottle. The contents are sterile if the seal is intact.

The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Shake the bottle.
  3. Remove the lid/cap.
  4. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor or pharmacist for more specific instructions on this technique.
  11. Replace the lid/cap, sealing it tightly.
  12. Wash your hands again with soap and water to remove any residue.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

How long to use it

Your doctor or pharmacist will tell you how long you should continue to use BLEPH®-10.

If your eye(s) does not feel better after using BLEPH®-10 eye drops for two to three days consult your doctor or pharmacist.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you have missed several doses, consult your doctor or pharmacist.

If you use too much

(overdose)

If you accidentally put several drops in your eye(s), you may have burning, redness or stinging of the eye(s). You should immediately rinse your eye(s) with warm water or normal saline.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of BLEPH®-10 eye drops, immediately telephone your doctor or Poisons Information Centre (Australia : telephone 13  11  26; New Zealand: telephone 0800 POISON or 0800  764  766) for advice, or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using BLEPH®-10 eye drops

Things you must do

Use BLEPH®-10 eye drops only as recommended by your doctor or pharmacist.

If you become pregnant while using BLEPH®-10 eye drops tell your doctor or pharmacist immediately.

Tell your doctor or pharmacist if your condition gets worse or does not get better while using BLEPH®-10 eye drops.

Tell any doctors, dentists or pharmacists who treat you that you are using this medicine. If you are about to start any new medicine tell your doctor and pharmacist that you are using BLEPH®-10 eye drops.

Things you must not do

Do not give BLEPH®-10 eye drops to anyone else, even if they have the same condition as you.

Do not use BLEP®H-10 eye drops for any other condition unless your doctor tells you to.

Things to be careful of

BLEPH®-10 eye drops generally should not cause any problems with your ability to drive or operate machinery. However, you should make sure you know how you react to BLEPH®-10 eye drops or that your vision is clear before driving or operating machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using BLEPH®-10 eye drops.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. Some patients may experience unwanted effects during treatment with BLEPH®-10 eye drops. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • Burning, stinging and itching These may also be due to the eye infection.

If the burning, stinging or itching continues or gets worse after using BLEPH®-10 for two or three days, consult your doctor or pharmacist as soon as possible.

Tell your doctor or pharmacist immediately or go to Accident and Emergency at your nearest hospital if you experience symptoms of an allergic reaction to BLEPH®-10. Symptoms of an allergic reaction include: shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using BLEPH®-10 eye drops

Storage

Keep your BLEPH®-10 eye drops in a cool, dry place away from direct light where the temperature stays below 25°C.

Do not store BLEPH®-10 eye drops or any other medicines in the bathroom or near a sink. Do not leave them on a windowsill or in a car. Heat and dampness can destroy some medicines.

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

Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you first open the eye drops and throw out any remaining solution after four weeks from the date of opening. Eye drops contain a preservative which helps prevent germs growing in the solution for the first 4 weeks after opening the bottle. After this time, there is a greater risk that the drops may become contaminated

If your doctor or pharmacist tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What BLEPH®-10 eye drops look like:
BLEPH®-10 eye drops are in a 15 mL plastic bottle with a tamper evident seal. The drops are a clear, colourless solution.

Ingredients

Active ingredient :
Sulfacetamide sodium 100 mg/mL.

Preservative:
Benzalkonium chloride

Inactive ingredients:
Polyvinyl alcohol
Polysorbate 80
Sodium thiosulfate
Sodium phosphate monobasic
Sodium phosphate dibasic
Disodium edetate
Sodium hydroxide
Purified water

Manufacturer/Supplier

Allergan Australia Pty Ltd
810 Pacific Highway
Gordon NSW 2072
ABN 85 000 612 831
Toll free: 1800 252 224 (Australia)

Allergan New Zealand Limited
Cnr. Manu Tapu Drive and Joseph Hammond Place
Auckland International Airport
New Zealand
Freephone: 0800 659 912 (NZ)

Australian registration number: AUST R 69835

Date of preparation:

September, 2008

® marks owned by Allergan, Inc.

BRAND INFORMATION

Brand name

Bleph-10 Eye Drops

Active ingredient

Sulfacetamide sodium

Schedule

S3