Patient info Open main menu
  1. Patient info
  2. » Patient leaflets
  3. » CHLORAMPHENICOL EAR DROPS BP 10% - Patient leaflet, side effects, dosage

CHLORAMPHENICOL EAR DROPS BP 10% - Patient leaflet, side effects, dosage

ATC code:

Dostupné balení:


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

Patient leaflet - CHLORAMPHENICOL EAR DROPS BP 10%

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.

If you use more chloramphenicol than /ou should

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

If you forget to use Chloramphenicol Ear Drops

fry not to miss doses. If you do miss a dose do not worry, take your next dose at the normal time. Do not use extra drops to make up.

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

4. possible side effects

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

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

  • Wheeziness (shortness of breath), fever, swelling of your face, 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.

Dossible side effects include:

  • inflammation of the skin (dermatitis).

Rare 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 naving any effect.

Serious side effects are possible if you are pregnant. If you become pregnant during your course of treatment, stop immediately 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. i/Vebsite: or search for MHRA Yellow Card in the Google Dlay 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

6. contents of the pack and other information what chloramphenicol ear drops contain the active ingredient is chloramphenicol 10% 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 00156/0051

This leaflet was last revised in: October 2021

Martindale

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

D05606

5606-F

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

The drug is classified in the ATC tree:

S SENSORY ORGAN DRUGS

S02 OTOLOGICALS

S02A ANTIINFECTIVE DRUGS, OTOLOGIC

S02AA Antiinfectives

S02AA01 chloramphenicol

Frequently Asked Questions

What is Chloramphenicol Ear Drops used for?

Chloramphenicol Ear Drops are primarily used to treat ear infections caused by bacteria. They help eliminate the infection and reduce symptoms like pain and swelling.

How do I use Chloramphenicol Ear Drops correctly?

To use Chloramphenicol Ear Drops, lie on your side and pull your outer ear slightly back to open the ear canal. Administer the prescribed number of drops into the ear, then remain in that position for a few minutes to allow the drops to penetrate.

Can I use Chloramphenicol Ear Drops if I have a perforated eardrum?

It's important to consult your healthcare provider before using Chloramphenicol Ear Drops if you have a perforated eardrum, as it may not be safe in such cases.

How often should I apply Chloramphenicol Ear Drops?

The frequency of use will depend on your doctor's instructions. Generally, it is applied two to three times a day, but always follow your healthcare provider’s advice.

Are there any side effects of using Chloramphenicol Ear Drops?

Some possible side effects include itching, irritation, or a burning sensation in the ear. If you experience severe reactions or signs of allergy, contact your doctor immediately.

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 nearly time for your next dose, skip the missed one and return to your regular schedule. Do not double up on doses.

Can children use Chloramphenicol Ear Drops safely?

Chloramphenicol Ear Drops can be used in children, but always consult with a pediatrician first to ensure it's safe and appropriate for their condition.

Should I avoid certain activities while using Chloramphenicol Ear Drops?

It is advisable to avoid getting water in your ear while using these drops. Swimming or showering might increase the risk of trapping moisture in the ear canal.

Is it safe to use Chloramphenicol Ear Drops during pregnancy or breastfeeding?

Chloramphenicol should only be used during pregnancy and breastfeeding if deemed necessary by your doctor. Discuss any concerns with your healthcare provider.

How should I store Chloramphenicol Ear Drops?

Store Chloramphenicol Ear Drops at room temperature, away from direct sunlight and moisture. Keep out of reach of children.

Can I buy Chloramphenicol Ear Drops over the counter?

Chloramphenicol Ear Drops require a prescription in most regions. Consult your healthcare provider for an evaluation and prescription if needed.

What should I do if my symptoms don't improve after using Chloramphenicol Ear Drops?

If symptoms persist or worsen after using the drops as directed for several days, contact your healthcare provider for further evaluation and alternative treatments.

Are there alternatives to Chloramphenicol Ear Drops for treating ear infections?

Yes, other antibiotic ear drops or oral antibiotics may be prescribed based on the type of infection. Your doctor will recommend the best alternative based on your specific condition.

Can I use other medications while taking Chloramphenicol Ear Drops?

Inform your doctor about all medications you are taking, including over-the-counter drugs and supplements. Some may interact with chloramphenicol.

Is there an age limit for using Chloramphenicol Ear Drops?

While there’s no strict age limit, young children should only use them under medical supervision. Always consult with a healthcare provider regarding its use in pediatrics.

How long should I continue using Chloramphenicol Ear Drops for optimal results?

Continue using the drops for the full duration prescribed by your doctor, even if symptoms improve before finishing the course.

Can I stop treatment early if my symptoms improve?

No, stopping treatment early can lead to incomplete eradication of the infection and potential recurrence. Always finish your prescribed course unless advised otherwise by a doctor.

What should I do in case of an overdose with Chloramphenicol Ear Drops?

If you suspect an overdose, seek immediate medical attention or contact Poison Control for guidance on what steps to take next.

Do chloramphenicol ear drops affect hearing?

When used correctly as directed by a healthcare provider, chloramphenicol ear drops are not expected to affect hearing negatively; however, inform your doctor if you experience any changes in hearing during treatment.