3 mg / ml, eye drops , solution

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Ciloxan is and what it is used for 
2. What you need to know before you use Ciloxan 
3. How to use Ciloxan 
4. Possible side effects 
5. How to store Ciloxan 
6. Contents of the packaging and other information 

1. What Ciloxan is and what it is used for

Eye drops for the treatment of bacterial infection in the conjunctiva and cornea of both children and adults.

Ciprofloxacin contained in Ciloxan may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Ciloxan

Do not use Ciloxan

  • if you are allergic to ciprofloxacin , to other antibiotics belonging to the quinolonegroup or to any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor or pharmacist before using Ciloxan.

  • If your symptoms worsen or return, you should consult your doctor. You may become more susceptible to other infections when you use this medicine, especially after prolonged use.
  • At the first signs of a skin rash or other hypersensitivity reaction , including hives, itching or difficulty breathing, you should stop treatment and contact a doctor immediately. If you have a severe allergic reaction , you may need urgenttreatment.
  • If you experience pain, swelling or inflammation of the tendons during or shortly after taking this medicine, you should stop treatment and contact your doctor.
  • If you are elderly or taking medicines called corticosteroids (which are used to treat eg pain and inflammation , asthma or skin problems), you may be at greater risk of developing tendon problems during treatment with Ciloxan. If you get an inflammation or an inflammatory disease, stop treatment and see a doctor immediately.
  • Do not wear contact lenses (hard or soft) while you are being treated with Ciloxan.

In patients with corneal ulcers and frequent administration of Ciloxan, white drug residues have been observed in the eye, which disappeared after continued application of Ciloxan. These drug precipitates do not prevent further treatment with Ciloxan, nor do they affect healing.

Children and young people

Do not use Ciloxan in children under 1 year of age unless expressly prescribed by your doctor.

Other medicines and Ciloxan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ciloxan is not expected to affect or be affected by other drugs.

Pregnancy and breastfeeding

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.

Driving and using machines

As with all eye drops , temporary blurred vision may occur after administration of Ciloxan. You should therefore not drive or use machines until your vision is completely clear.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Ciloxane contains benzalkonium chloride

This medicine contains 0.3 mg benzalkonium chloride per 5 ml corresponding to 0.06 mg / ml.

Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses. Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling or pain in the eye after using the medicine, consult a doctor.

However, you should not wear contact lenses (hard or soft) during the treatment of an eye inflammation.

3. How to use Ciloxan

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Ciloxan should only be used in the eyes.

The recommended dose is

For infection of the cornea ( corneal ulcer ):

First day: 2 drops in the affected eye every 15 minutes for the first 6 hours, then 2 drops every 30 minutes for the rest of the day. Second day: 2 drops every hour in the affected eye. Third – fourteenth day: 2 drops every 4 hours. If treatment is required for more than 14 days, the dosage is determined on a case-by-case basis by the attending physician. The above dosing intervals must also be observed during the night.

For infection of the conjunctiva ( conjunctivitis ):

During the first 2 days, 1-2 drops are given in the affected eye every two hours during the waking part of the day, then 1-2 drops every 4 hours until the infection subsides.

How to use Ciloxan correctly:

If the safety collar is loose when the cover has been removed, it must be removed before using the product.

Use
  1. Bring out the bottle of Ciloxan.
  2. Wash your hands and sit in front of a mirror.
  3. Unscrew the bottle cap.
  4. Hold the bottle with the tip facing down between your thumb and forefinger (Fig. 1).
  5. Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should be placed .
  6. Push the drip tip of the bottle towards the eye. Use a mirror if it helps.
  7. The drip tip must not touch the eye, eyelid, surrounding areas or anything else. It may contaminate the eye drops in the bottle.
  8. Do not squeeze the bottle: it is designed so that a light pressure on the bottom is sufficient (Fig. 2).
  9. Gently press on the bottom of the bottle to release one drop of Ciloxan at a time (Figure 3).
  10. After using Ciloxan, close your eyes and gently press with your finger in the corner of your eye at your nose for 2 minutes (Fig. 4). This prevents Ciloxan from reaching other parts of the body.
  11. If you are using Ciloxan in both eyes, repeat steps 4-10 for the other eye.
  12. Tighten the bottle cap carefully immediately after use.

If a drop misses the eye, try again.

If you use other eye drops or ointments, wait at least 5 minutes between using the medicines. Eye ointments should be used last.

If you forget to use Ciloxan

If you forget to take a dose , take it as soon as you remember. However, if it is almost time for your next dose , skip the missed dose .

Do not take a double dose to make up for a forgotten dose .

If you stop using Ciloxan

Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using the medicine too soon, the symptoms may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Common (may affect up to 1 in 10 people):

Effects in the eye: white deposits on the surface of the eye (cornea) and on the edges of the eyelids, discomfort in the eye, red eye, temporary burning in the eye when dripping, photosensitivity.

General side effects: bad taste in the mouth.

Uncommon (may affect up to 1 in 100 people):

Effects in the eye: damage to or staining of the surface of the eye ( cornea ), impaired vision or blurred vision, swollen eye or eyelid, eye pain, dry eye, itchy eye, increased tear production, discharge from the eye, crusts on the eyelid, scaly eyelids, red eyelids.

General side effects: allergic reactions, headache, nausea.

Rare (may affect up to 1 in 1,000 people):

Effects in the eye: damage to the eye, eye inflammation, double vision, impaired sensation in the eye, tired eyes, vagel , eye irritation, ulceration of the cornea.

General side effects: dizziness, earache, inflammation inside the nose, secretion from the sinuses of the nose, diarrhea, abdominal pain, dermatitis.

No known frequency (cannot be calculated from the available data):

General side effects: effects on the tendons.

If you accidentally swallow Ciloxan eye drops , consult your doctor. However, no serious complications are expected.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Ciloxan

Keep this medicine out of the sight and reach of children.

Store in a cold place. Do not freeze. The bottle is discarded 4 weeks after opening.

Do not use this medicine after the expiry date which is stated on the label and carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is ciprofloxacin . 1 ml solution contains 3 mg ciprofloxacin .
  • The other ingredients are benzalkonium chloride ( preservative ), disodium edetate, mannitol, acetic acid, sodium acetate, hydrochloric acid and / or sodium hydroxide (to control acidity) and purified water.

What the medicine looks like and the contents of the pack

Ciloxan is a clear, colorless to pale yellow solution supplied in a 5 ml plastic bottle (DROPTAINER) with a screw cap.

Marketing Authorisation Holder

Novartis Sverige AB

Box 1218

164 28 Kista

Manufacturer

SA Alcon-Couvreur NVRijksweg 142870 PuursBelgium or Alcon Cusi SACamil Fabra 5808320 El Masnou BarcelonaSpain

Muhammad Nadeem

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