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CHLORAMPHENICOL EAR DROPS BP 5% W/V - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - CHLORAMPHENICOL EAR DROPS BP 5% W/V

6. contents of the pack and other information

  • 1. What Chloramphenicol Ear Drops are and what they are used for

Chloramphenicol belongs to a group of medicines called antibiotics. An antibiotic is a medicine which is used for the treatment of a variety of infections caused by bacteria. Chloramphenicol Ear Drops are used in the treatment of a wide range of bacterial infections of the outer ear.

2. what you need to know before you use chloramphenicol ear drops

Do not use Chloramphenicol Ear Drops if:

  • you are allergic to Chloramphenicol, or any of the ingredients of this medicine (listed in section 6).
  • you have a hole in your ear drum.
  • you or someone in your family ever had a blood disorder or bone marrow disease including anemia (decrease in the number of red blood cells) when using chloramphenicol in the past.
  • you have a family history of"dyscrasias", a condition which can cause tiredness, bruising and an increased risk of infections.

Warningsand Precautions

Talk to your doctor, pharmacist or nurse before using Chloramphenicol Ear Drops if:

  • If you use chloramphenicol ear drops for a long time, your doctor may do some blood tests to check for any problems.

Other medicines and Chloramphenicol Ear Drops

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

In particular, tell your doctor if you are taking any of the following:

  • medicines for cancer such as methotrexate medicines for the immune system such as azathioprine
  • the dietary supplement chymotrypsin

Pregnancy, breast-feeding and fertility Chloramphenicol should not be used during pregnancy and breast-feeding unless considered essential by your doctor, as the effects are unknown. If you are a pregnant or breast-feeding, thinkyou may be pregnant or are planning to have a baby, askyour doctor or pharmacist for advice before using this medicine.

Driving and using machines

It is unlikely that after using Chloramphenicol Ear Drops your ability to drive and use machines will be affected. However, if you feel unwell you must speak to your doctor before driving or operating machinery.

Chloramphenicol Ear Drops contain propylene glycol.

This medicine contains 0.95g of propylene glycol in 1ml which is equivalent to 95% w/v.

3. how to use chloramphenicol ear drops

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Instructions for use

  • 1. Wash your hands well before use

  • 2. Remove the outer cap on the bottle

  • 3. Insert the nozzle into the affected ear and apply drops as advised by your doctor

  • 4. Repeat in the other ear if you have been told to use Chloramphenicol Ear Drops in both ears

  • 5. Replace the outer cap on the bottle, trying not to touch the applicator tip with anything, including the fingers

  • 6. Wash your hands.

How much to use

Three to four drops should be applied into the affected ear up to two to three times daily for up to one week.

Do not use Chloramphenicol Ear Drops for more than a one week period unless your doctor has told you otherwise.

f you use more chloramphenicol than fou should

Chloramphenicol Ear Drops are for external jse only. If you suspect someone has swallowed any Chloramphenicol Ear Drops, zontact your doctor or go to the accident snd emergency department of your local nospital at once. Always take the container with you, if possible, even if empty.

f you forget to use Chloramphenicol Ear Drops

Try not to miss doses. If you do miss a dose jo not worry, take your next dose at the lormal time. Do not use extra drops to nake up.

f you have any further questions on the jse of this medicine, askyour doctor, aharmacist or nurse.

i. possible side effects

.ike all medicines Chloramphenicol Ear Drops can cause side effects, although not everyone gets them.

Etop using your medicine and tell your doctor or pharmacist immediately if you experience the following side effects:

  • Wheeziness (shortness of breath), fever, swelling ofyourface, lips or tongue, itching or rash with swelling of skin (the rash could be puffy (swollen) or blotchy, or look like little blisters.
  • A sore throat, bruising or being unable to overcome an infection. On very rare occasions, patients using chloramphenicol have had changes in their blood cells causing severe tiredness or easy bruising.

’ossible side effects include:

  • inflammation of the skin (dermatitis).

}are side effects include:

  • bone marrow depression

(a condition where the marrow is unable to produce blood cells)

  • a reduced production and death of red blood cells (anaemia)

.ong term use of this product can stop it laving any effect.

Eerious side effects are possible if you sre pregnant. If you become pregnant during your course of treatment, stop mmediately and consult your doctor.

Reporting of side effects

f you get any side effects, talk to your doctor or pharmacist or nurse.This ncludes any possible side effects not listed n this leaflet. You can also report side effects directly via Yellow Card Scheme. /Vebsite: or search for MHRA Yellow Card in the Google ’lay or Apple App Store. By reporting side effects you can help provide more nformation on the safety of this medicine.

  • 5. Howto store Chloramphenicol Ear Drops Keep out of the sight and reach of children. Do not use Chloramphenicol Ear Drops after the expiry date printed on the bottle label. The expiry date refers to the last day of that month.

6. contents of the pack and other information what chloramphenicol ear drops contain

The active ingredient is Chloramphenicol 5% w/v.

The other ingredient is Propylene Glycol (95%).

What Chloramphenicol Ear Drops look like and contents of the pack

Chloramphenicol Ear Drops are supplied in plastic bottles, each bottle containing 10mi of solution.

Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd.

Bampton Road,

Romford, RM3 8UG, England

Manufacturer

Famar A.V.E Alimos Plant

63, Agiou Dimitriou str, Alimos, Attiki 17456, Greece

If you would like any more information, or would like the leaflet in a different format, please contact Medical Information at the above address.

Product Licence Number:

PL 00156/0050

This leaflet was last revised in: October 2021

Martindale

Bampton Road, Harold Hill Romford, RM3 8UG United Kingdom

D05604

5604-E

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Chloramphenicol ear drops used for?

Chloramphenicol ear drops are used to treat bacterial infections in the ear, helping to reduce inflammation and pain.

How does Chloramphenicol work in the ear?

Chloramphenicol works by stopping the growth of bacteria, which helps to clear up the infection and alleviate symptoms.

Are Chloramphenicol ear drops safe for children?

Yes, Chloramphenicol ear drops can be used in children, but it's important to follow your doctor’s instructions regarding dosage and frequency.

Can I use Chloramphenicol ear drops if I am pregnant or breastfeeding?

Consult your doctor before using Chloramphenicol ear drops if you are pregnant or breastfeeding to ensure safety for you and your baby.

How do I properly apply Chloramphenicol ear drops?

To apply the drops, lie on your side with the affected ear facing up, pull the earlobe gently to straighten the ear canal, and instill the prescribed number of drops.

What should I do if I miss a dose of Chloramphenicol ear drops?

If you miss a dose, apply it as soon as you remember. If it's close to the time of your next dose, skip the missed dose and continue with your regular schedule.

Can Chloramphenicol ear drops cause side effects?

Yes, some patients may experience side effects such as irritation, itching, or allergic reactions. If you notice any unusual symptoms, contact your healthcare provider.

How long should I use Chloramphenicol ear drops?

Typically, treatment lasts for 5-7 days. Always follow your doctor’s advice on how long to use the medication.

Can I wear a hearing aid while using Chloramphenicol ear drops?

It's best to avoid using hearing aids while applying the drops until they are fully absorbed. Consult with your audiologist for specific advice.

Is it safe to use Chloramphenicol ear drops with other medications?

While many medications can be safely used together, always inform your doctor about all other medications you are taking to avoid interactions.

What should I do if my symptoms do not improve after using Chloramphenicol ear drops?

If symptoms do not improve within a few days or worsen, contact your healthcare provider for further evaluation and possible alternative treatment.

Can I share my Chloramphenicol ear drops with someone else?

No, you should not share medication as it may not be appropriate for others and could lead to complications or ineffective treatment.

How should I store Chloramphenicol ear drops?

Store the eye/ear drops at room temperature away from light and moisture. Keep it out of reach of children.

Are there any special precautions before using Chloramphenicol ear drops?

Make sure to inform your doctor about any allergies or previous reactions you’ve had to medications before starting treatment.

What if I experience an allergic reaction to Chloramphenicol?

If you experience symptoms such as rash, itching, swelling, or difficulty breathing after using these drops, seek immediate medical attention.

Can I use other treatments alongside Chloramphenicol ear drops?

Always consult with your healthcare provider before combining other treatments with Chloramphenicol to ensure they are safe together.

Is there an age limit for using Chloramphenicol ear drops?

Chloramphenicol can be administered at various ages; however, always consult a healthcare professional for appropriate use in young children or infants.

Does Chloramphenicol have any effect on my hearing?

When used as directed, Chloramphenicol should not affect your hearing. However, consult your doctor if you have concerns about changes in hearing during treatment.

What should I do if my bottle of Chloramphenicol ear drops expires before I use it all?

Do not use expired medication. Dispose of any unused or expired medication safely and consult your pharmacist for disposal instructions.