Ciprofloxacin/dexamethasone 3mg/ml + 1mg/ml ear drops, suspension

• Keep this leaflet. 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

Talk to your doctor or pharmacist before using this medicine.

• This preparation should only be applied to the ear. It is not for use in the eye and should not be swallowed, injected or inhaled.
• Once treatment has begun, if you notice the first signs of a skin rash or any other allergic symptoms (e.g. urticaria (hives), sudden swelling of face, throat or eyelids, breathing problems), you must stop treatment immediately and you should consult with your doctor. Serious allergic reactions may need immediate emergency treatment.
• Tell the doctor if the symptoms do not improve within one week of starting treatment, get worse or suddenly return. As with all antibiotics, sometimes additional infections may occur caused by organisms which are not affected by ciprofloxacin. In case of such infection appropriate treatment should be started by your doctor.
• If you feel pain, swelling or inflammation of the tendons while, or soon after taking this medicine, stop treatment and contact your doctor. Pay special attention if you are over 65 years old or being treated with corticosteroids.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• Use in children: There is insufficient clinical experience available on the use of this medicine in children younger than 1 year in the treatment of outer ear infections, so talk to your doctor before giving this medicine to your child if they fall into this age group.

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

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

There are no known effects of this medicine on the ability to drive or use machines.

This medicine contains 0.004mg benzalkonium chloride in each drop which is equivalent to 0.1 mg per millilitre suspension.

Benzalkonium chloride may irritate the skin.

It is best if another person can put the drops in for you. Children should never be allowed to put the drops in themselves.

1. Wash hands

The person giving this medicine should wash their hands with soap and water.

2. Warm & shake the bottle

The person giving this medicine should hold the bottle in their hands for several minutes to warm the ear drops (picture 1) to avoid the dizziness that may result from the instillation of a cold solution into the ear canal, then shake the bottle well before use.

3. Give drops

Lie with the infected ear upward (picture 2).

The person administering the medicine should put 4 drops into the infected ear (picture 3). They must not touch the tip of the bottle against the ear, their fingers or any other surface, as it could infect the drops.

After putting in the drops follow the instructions below.

4. For patients with outer ear infection.

While the patient lies on their side, the person giving this medicine should gently pull the outer ear lobe upward and backward (picture 4). This will allow the ear drops to flow down into the ear canal.

5. Stay on your side

You should remain on your side for 5 minutes to facilitate penetration of the drops into the ear.

When you raise your head up again, some drops can run out. You can dry them with a non-sterile absorbent paper.

6. Repeat Steps 2-5 for the other ear if both ears are infected.

It is of the utmost importance to follow these instructions to allow the drug to work effectively in your ear. When you use ear drops, keeping your head vertical or moving your head too rapidly can cause the drops to move from the ear and run down onto your face. This can result in the drops not reaching the depths of the auditory canal, where they are needed.

Keep the bottle tightly closed when not in use.

The bottle should be used until the completion of the course of treatment. Do not keep it for subsequent use.

When applying the medicine, be careful that the dropper does not come into contact with your ear or your fingers so as to avoid contamination.

If you use more medicine than you should, please tell your doctor or pharmacist.

If you forget to use this medicine do not worry, just continue with your next dose. Do not use a double dose to make up for a forgotten dose.

Do not stop using this medicine without telling your doctor or pharmacist. If the affected ear does not feel better after 1 week of treatment go back to your doctor.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (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 substances are ciprofloxacin hydrochloride and dexamethasone.

Each 1ml of suspension contains 3mg ciprofloxacin as hydrochloride and 1mg dexamethasone.

The other ingredients are Hydroxyethyl cellulose (Natrosol 250 HX), Benzalkonium chloride as 50% aqueous solution, Tyloxapol, Edetate disodium dehydrate, Sodium chloride, Sodium acetate trihydrate, Acetic acid (glacial), Boric acid, Sodium hydroxide pellets, Hydrochloric acid (1M), Water for injection.

Ciprofloxacin/dexamethasone is a white to off-white homogeneous suspension free from visible foreign matter supplied as a 5ml suspension in a pack containing a 10ml bottle (LDPE) with a (LDPE) dropper and a (HDPE) cap.