Chloramphenicol 0.5% w/v Eye Drops

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Chloramphenicol
Available from:
Martindale Pharmaceuticals Ltd
ATC code:
S01AA; S01AA01
INN (International Name):
Chloramphenicol
Dosage:
0.5 percent weight/volume
Pharmaceutical form:
Eye drops, solution
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
Antibiotics; chloramphenicol
Authorization status:
Not marketed
Authorization number:
PA0361/013/001
Authorization date:
2001-01-26

PACKAGE LEAFLET

Chloramphenicol 1.0% w/w Eye Ointment

Chloramphenicol

Read all of this leaflet carefully before you start this medicine because it contains

important information for you.

- 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.

What is in this leaflet

1. What Chloramphenicol Eye Ointment is and what it is used for

2. What you need to know before you use Chloramphenicol Eye Ointment

3. How to use Chloramphenicol Eye Ointment

4. Possible side effects

5. How to store Chloramphenicol Eye Ointment

6. Contents of the pack and other information

1. What Chloramphenicol Eye Ointment is and what it is 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 Eye Ointment are used in both adults and children for the treatment of a

wide

range of eye infections caused by bacteria.

2. What you need to know before you use Chloramphenicol Eye Ointment

Do not use the ointment if:

You are allergic to Chloramphenicol or any of the other ingredients of this medicine listed

in section 6

You or a member of your family has had problems with their blood or bone

marrow. These problems can include a severe reduction in red blood cells or

lower than normal blood count.

Warnings and precautions

Talk to your doctor or pharmacist before using Chloramphenicol Eye Ointment if:

you have visual disturbances

you have severe pain in the eye

you are sensitive to light

your eye is inflamed and you have a rash on the scalp or face

your eye looks cloudy

your black or coloured part of the eye looks unusual

you have a foreign body in the eye

you have an eye infection that keeps coming back

you have glaucoma (raised pressure in the eye)

you have dry eyes

you have eye injury or eye surgery

you are currently using any other eye drops or eye ointment

Other medicines and Chloramphenicol Eye Ointment

Tell your doctor or pharmacist if you are using, have recently used or might use 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 and breast-feeding

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, think you may be pregnant or are planning to have a

baby, ask your doctor or pharmacist for advice before using this medicine.

Chloramphenicol Eye Ointment

contains

This ointment contains wool fat. This may cause a skin reaction around the eyes such

as “contact dermatitis”.

Driving and using machines

The ointment may cause blurred vision due to smearing or stinging.

This will only happen for a short period after it is put in your eye.

If this happens do not drive or use machinery until you can see clearly.

3. How to use Chloramphenicol Eye Ointment

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

You should not wear contact lenses whilst you are using Chloramphenicol Eye Ointment.

If you usually wear contact lenses you should wait until you have completed your treatment

before you can use your lenses again.

You should wait 24 hours after you use your last dose of Chloramphenicol Eye Ointment

before starting to use your lenses again.

A small amount of ointment to be applied into the affected eye (every three hours or more

frequently if required), as directed by your doctor.

Instructions for use

1. Wash your hands well before use

2. Remove the outer cap. You may find it easier to apply your ointment in front of a mirror.

3. Tilt the head back and pull the lower lid of the eye out to form a pocket

4. Hold the tube between the thumb and middle finger of the other hand, turn the tube upside

down near to the eye, try not to touch the eye with the nozzle

5. Place about half an inch of the ointment into the pocket formed between the lid and the eye

6. Blink the eye a few times

7. Repeat in the other eye if you have been told to use Chloramphenicol Eye Ointment in both

eyes

8. Replace the outer cap on the tube, trying not to touch the applicator tip with anything,

including the eye or the fingers

9. Wash your hands

How much to use

Apply Chloramphenicol Eye Ointment every three hours or more frequently as advised by

your doctor.

OR

Chloramphenicol Eye Ointment can be applied at night with appropriate eye drops used

during the day.

Use in children:

Dosage adjustment may be necessary in new-born infants to reduce the risk of adverse

effects. The maximum duration of treatment is 10-14 days.

Prolonged use of Chloramphenicol Eye Ointment is not advisable. You should not use this

product for longer than 5 days at a time unless your doctor has told you otherwise.

If you use Chloramphenicol Eye Ointment for a long time, your doctor may want to take

blood samples to make sure the chloramphenicol has not affected

your blood in any way.

Seek further immediate medical advice any time if symptoms worsen.

Consult with your doctor if your eye infection does not start to improve within 48 hours.

If you use more chloramphenicol than you should

Chloramphenicol Eye Ointment is for external use only. If you suspect someone has

swallowed any Chloramphenicol, contact your doctor or go to the accident and emergency

department of your local hospital at once. Always take the container with you, if possible,

even if empty.

If you accidentally apply too much ointment, you should wash your eye with plenty of water,

if any painful symptoms continue after this, you should tell your doctor immediately.

If you forget to use Chloramphenicol Eye Ointment

Try not to miss doses. If you do miss a dose, do not worry, just carry on as normal. Do not

use extra ointment to make up.

4. Possible side effects

Like all medicines, this medicine 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.

Disease of the blood with a reduced number of red or white blood cells or platelets.

Symptoms include tiredness, headaches, fever, severe chills, bleeding or bruising more easily

than normal, nosebleeds.

Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing

or breathing

Possible side effects include:

Not known (frequency cannot be estimated from the available data):

burning sensation

hives (urticaria)

pain (stinging sensation)

red raised or sac-like skin rashes

high temperature (pyrexia)

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 via

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail:

medsafety@hpra.ie

By reporting side effects you can help provide more information on the safety of this

medicine.

5. How to store Chloramphenicol Eye Ointment

Keep out of the sight and reach of children.

Do not use Chloramphenicol Eye Ointment after the expiry date printed on the crimp seal of

the tube. The expiry date refers to the last day of that month. Once the tube is open use within

28 days.

You are advised to dispose of the tube once you have finished your 5 day course of treatment.

This medicine needs to be stored below 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your

pharmacist how to dispose of medicines no longer required. The measures will help to protect

the environment.

6. Contents of the pack and other information

What Chloramphenicol Eye Ointment contains

The active substance is Chloramphenicol 1.0% w/w.

The other ingredients are Liquid Paraffin, Wool Fat and Yellow Soft Paraffin.

What Chloramphenicol Eye Ointment looks like and contents of the pack

Chloramphenicol Eye Ointment is supplied in plastic tubes, each tube containing 4 grams of

sterile eye ointment.

Marketing Authorisation Holder

Martindale Pharmaceuticals Ltd. Bampton Road,

Romford, RM3 8UG, England

Manufacturer

Farmigea S.p.A. Via G.B. 8 – 56121, Pisa, Italy

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:

PA 0361-013-002

This leaflet was last revised in

: June 2017

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Chloramphenicol 0.5% w/v Eye Drops.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1ml of the drops contains 5mg of chloramphenicol (0.5%w/v)

Excipients with known effect

Contains Phenylmercuric Nitrate 0.02mg/ml (0.002% w/v).

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Eye drops, solution.

Clear aqueous solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic Indications

Chloramphenicol is a broad spectrum antibiotic for the treatment of bacterial conjunctivitis caused by chloramphenicol

susceptible organisms including: Escherichia coli, Haemophilus influenzae, Staphylococcus aureus, Streptococcus,

haemolyticus, Morax-axenfeld, Klebsiella/Enterobacter species and others.

Chloramphenicol is indicated in both adults and children.

4.2 Posology and method of administration

Posology

Adults, including the elderly and children

One or two drops applied to each affected eye up to 6 times daily or more frequently if required.

Paediatric population

Dosage adjustment may be necessary in newborn infants because of reduced systemic elimination due to immature

metabolism and the risk of dose-related adverse effects. The maximum duration of treatment is 10-14 days.

Method of administration

Eye Drops for topical administration

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

a known personal or family history of blood dyscrasias including aplastic anaemia.

4.4 Special warnings and precautions for use

Chloramphenicol is absorbed systemically from the eye and toxicity has been reported following chronic exposure.

Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of

chloramphenicol. Whilst the hazard is a rare one, it should be borne in mind when assessing the benefits expected

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from the use of this compound. Where chloramphenicol is used on a long-term of intermittent basis, it may be

advisable to perform a routine blood profile before therapy and at appropriate intervals thereafter to detect

haemopoietic abnormalities.

In severe infections the topical use of chloramphenicol should be supplemented by appropriate systemic treatment.

The prolonged use of antibiotics can cause sensitisation and occasionally result in overgrowth of non-susceptible

organisms including fungi. If any new infection appears during treatment the antibiotic should be discontinued and

appropriate measures taken.

Chloramphenicol should be reserved for use only in infections for which it is specifically indicated. It is also

recommended that all types of contact lens are avoided during an ocular infection.

Chloramphenicol Eye Drops does not provide adequate coverage against Pseudomonas aeruginosa and Serratia

marcescens.

Do not use for more than 5 days without consulting a doctor.

Medical advice should be sought if there is no improvement in the condition after 2 days or if symptoms worsen at any

time.

Patients should be referred to their doctor if any of the following apply:

Disturbed vision

Severe pain within the eye

Photophobia

Eye inflammation associated with a rash on the scalp or face

The eye looks cloudy

The pupil looks unusual

Suspected foreign body in the eye

Patients should also be referred to their doctor if any of the following in his/her medical history apply:

Previous conjunctivitis in the recent past

Glaucoma

Dry eye syndrome

Eye surgery or laser treatment in the last 6 months

Eye injury

Current use of other eye drops or eye ointment

Contact lens use

Soft contact lenses should not be worn during treatment with chloramphenicol eye drops due to absorption of the

preservative onto the lens which may cause damage to the lens. It is recommended that all types of contact lenses be

avoided during ocular infections. If you wear soft contact lenses do not start wearing them for at least 24 hours after

you have finished using the eye drops.

The packaging will convey the following information:

If symptoms do not improve within 48 hours talk to your doctor

Seek further immediate medical advice at any time if symptoms worsen

Do not use if you are allergic to chloramphenicol or any of the ingredients

Phenylmercuric nitrate is irritating to the skin. Topical application to eyes has been associated with mercurialentis and

atypical band keratopathy.

4.5 Interaction with other medicinal products and other forms of interaction

The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should

be avoided.

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4.6 Fertility, pregnancy and lactation

Safety for use in pregnancy and lactation has not been established. Chloramphenicol may be absorbed systemically

following the use of eye drops and may cross the placenta and appear in breast milk. Therefore this product is not

recommended for use during pregnancy and lactation

4.7 Effects on ability to drive and use machines

Chloramphenicol has a minor influence on the ability to drive and use machines. Blurring of vision can occur with the

drops and patients should be warned not to drive or operate machinery unless their vision is clear.

4.8 Undesirable effects

Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below. The

frequencies correspond with:

Not known (cannot be estimated from the available data)

*Causes for discontinuation

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued

monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any

suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2;Tel: +353 16764971; Fax:

+353 1 6762517;Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

4.9 Overdose

Accidental ingestion of chloramphenicol eye drops is unlikely to cause systemic toxicity due to the low content of

antibiotic. If irritation, pain, swelling, lacrimation or photophobia occur after undesired eye contact, the exposed eye(s)

should be irrigated for at least 15 minutes. If symptoms persist after this, an ophthalmological examination should be

considered.

Blood & lymphatic system disorders

Not known

Aplastic anaemia*, bone marrow failure*

Immune system disorders

Not known

Anaphylactic reaction*

Nervous system disorders

Not known

Burning sensation

Skin and subcutaneous tissue disorders

Not known

Angioedema*, dermatitis* (including

vesicular & maculopapular dermatitis)

urticaria

General disorders and administration

site conditions

Not known

Pain (stinging sensation), pyrexia*

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5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Antibiotics

ATC code: S01AA01

Chloramphenicol is a broad spectrum antibiotic with bacteriostatic activity and is effective against a wide range of

Gram-negative and Gram-positive organisms, including Haemophilus influenzae, Streptococcus pneumoniae,

Staphylococcus aureus, Streptococcus viridans, Moraxella species and Enterobacteriaceae, the main pathogens

responsible for acute bacterial conjunctivitis. Chloramphenicol exerts its antibacterial effect by reversibly binding to

bacterial ribosomes thereby inhibiting bacterial protein synthesis.

5.2 Pharmacokinetic properties

Evidence suggests that chloramphenicol is absorbed systemically via topical ocular administration. Any

chloramphenicol that is absorbed will be widely distributed in the body tissues and fluids. It is found in cerebrospinal

fluid, is secreted in saliva, with the highest concentrations occurring in the kidneys and liver.

Chloramphenicol also diffuses across the placenta into the foetal circulation and into breast milk.

Chloramphenicol is excreted chiefly in the urine as the glucuronide with small amounts being excreted via the bile and

faeces. It has a reported half life of 1.5 to 5 hours which is increased in patients with liver impairment and neonates to

between 24 and 28 hours.

5.3 Preclinical safety data

No additional data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Borax

Boric acid

Phenylmercuric nitrate

Purified water

6.2 Incompatibilities

None known.

6.3 Shelf life

2 years unopened.

28 days once opened.

6.4 Special precautions for storage

Store at 2-8ºC. Protect from light.

Once opened do not store above 25°C.

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6.5 Nature and contents of container

White polyethylene eye dropper bottle with integral

eye drop insert.

Fitted with tamper evident

white polyethylene

cap.

Pack size 10 ml.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

Sterile until opened.

Discard 28 days after opening.

7 MARKETING AUTHORISATION HOLDER

Martindale Pharmaceuticals Ltd

Bampton Road

Harold Hill

Romford RM3 8UG

England

8 MARKETING AUTHORISATION NUMBER

PA 0361/013/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation:

26 January 2001

Date of last renewal:

26 January 2006

10 DATE OF REVISION OF THE TEXT

August 2017

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