Oftaquix 5 mg/ml eye drops, solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Oftaquix is and what it is used for
2. What you need to know before you use Oftaquix
3. How to use Oftaquix
4. Possible side effects
5. How to store Oftaquix
6. Contents of the pack and other information

• if you are allergic to levofloxacin or other quinolones or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, ask your doctor or pharmacist first.

Talk to your doctor, pharmacist or nurse before using Oftaquix

• if an allergic reaction occurs even after a single dose stop using the medicine
• if you observe worsening of your eye symptoms during treatment, please contact your doctor as soon as possible
• if you do not see any sign of recovery within a certain treatment period agreed with your doctor, please contact your doctor as soon as possible
• generally, no types of contact lenses should be worn when the eye is infected.
• Oftaquix contains the preservative benzalkonium chloride, which may cause eye irritation.

Tendon swelling and rupture have happened in people taking oral or intravenous fluoroquinolones, particularly in older patients and in those treated concurrently with corticosteroids. Stop taking Oftaquix if you develop pain or swelling of the tendons (tendinitis).

The special warnings and precautions for using this medicine are the same in adults, adolescents and children aged ≥1 year.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist if you are applying any other type of eye drop or eye ointment before you start to use Oftaquix.

If you are using other eye drops, you should wait at least 15 minutes between applying Oftaquix and any other type of eye drop.

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.

Oftaquix eye drops should be used during pregnancy only if the potential benefit justifies the potential risk to the growing baby.

Although very small amounts of levofloxacin reach the blood and the breast milk, respectively, after instilling eye drops it is very unlikely that the eye drops would harm the growing baby. Your doctor is informed about the potential risk and will advise you whether to take Oftaquix eye drops in this case.

Your fertility (ability to become pregnant or to father a child) is not impaired when you apply Oftaquix following its instructions for use.

Oftaquix has minor influence on the ability to drive and use machines.

If the eye drops cause blurring of your sight when you use them, you should wait until this clears before driving or operating machinery.

This medicine contains approximately 0.002 mg benzalkonium chloride in each drop which is equivalent to 0.05 mg/ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses. You should remove contact lenses before using this medicine and put them back 15 minutes afterwards.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.

No dosage modification is required in children ≥ 1 year old and in adolescents. Oftaquix is not recommended to be used in children aged below 1 year.

If possible, ask someone else to apply the drops for you. Ask them to read these instructions with you before applying the drops.

1) Wash your hands.

2) Open the bottle. Take special care that the tip of the dropper bottle does not touch your eye, the skin around your eye or your fingers.

3) Tilt your head backwards and hold the bottle upside down over the eye.

4) Pull the lower eyelid downwards and look up. Gently squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye.

5) Close the eye and press the inner corner of the eye with your finger for about one minute. Thus you can prevent the eye drop from draining down the tear duct.

6) Wipe off any excess solution from the skin around the eye.

7) Put the cap back on and close the bottle tightly.

If another drop is needed, and when both eyes are to be treated, repeat steps 3 to 7.

Oftaquix eye drops should not be injected into the interior part of the eyeball.

If you use more Oftaquix than you should, flush the eye(s) with water and tell your doctor or pharmacist.

If you forget to use the eye drops, put in the next dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.

The amount of levofloxacin in the provided bottle is too small to cause side-effects. However, if you are concerned, tell your doctor or pharmacist who will advise you on any necessary measures.

If you stop using Oftaquix earlier than instructed, it may delay the healing process.

Frequency, type and severity of side effects in children and adolescents are expected to be the same as in adults.

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 at: 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.

• The active substance is levofloxacin.
  1 ml contains 5.12 mg of levofloxacin hemihydrate equivalent to 5 mg of levofloxacin.
• The other ingredients are benzalkonium chloride (0.05 mg in 1 ml eye drops, solution; preservative), sodium chloride, sodium hydroxide or hydrochloric acid and water for injections.

• Oftaquix is a clear, light yellow to light greenish-yellow solution, free of visible particulate matter.
• It is supplied in a pack containing 1 white plastic bottle with 5 ml solution. The plastic bottle is closed with a screw cap.

Marketing Authorisation Holder

Manufacturer