Chloramex Ophthalmic Ointment: Uses, Safety,Instructions

S4 – Prescription Only Medicine

It is classified under Schedule 4 (S4), meaning it is available by prescription only. Always consult a licensed healthcare professional before using this medication.

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1. Proprietary Name and Dosage Form
Dosage Form: Eye Ointment

CHLORAMEX is specifically formulated for ophthalmic use (application to the eye). It comes in a convenient ointment form designed to treat bacterial infections in and around the eyes.

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2. What CHLORAMEX Ophthalmic Ointment Contains

Each gram of CHLORAMEX ophthalmic ointment contains:

• Active ingredient: 10 mg chloramphenicol
• Inactive ingredients: Hard paraffin, liquid paraffin, wool fat, and yellow soft paraffin

Chloramphenicol is a broad-spectrum antibiotic effective in treating various eye infections caused by bacteria. The other ingredients serve as the ointment base, ensuring proper texture and stability.

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3. What CHLORAMEX Ophthalmic Ointment Is Used For

CHLORAMEX belongs to a group of medicines called antibiotics. It is prescribed for:

• Treating bacterial infections of the eye and eyelids
• Helping eliminate harmful bacteria and allowing the body to heal

It works by preventing bacterial growth and reproduction, thereby controlling the infection and supporting the body’s natural defenses.

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4. Before You Use CHLORAMEX Ophthalmic Ointment

Using any medicine safely begins with understanding when and how it should be used. Here’s what you need to know before starting CHLORAMEX.

You Should Not Use CHLORAMEX Ophthalmic Ointment If:

• You are allergic to chloramphenicol or any other ingredients in the ointment.
• You or a family member has a history of serious blood disorders, including aplastic anaemia or blood dyscrasias.

Take Special Care With CHLORAMEX Ophthalmic Ointment

While this ointment is generally safe when used correctly, caution is advised in the following scenarios:

Condition	Precaution or Reason for Concern
Allergic reactions	Discontinue use if symptoms like rash, fever, or difficulty breathing occur.
Ingestion	Can lead to nausea, vomiting, and diarrhoea. Meant for eye use only.
Prolonged use	May lead to bacterial resistance. Avoid long-term use unless advised by a doctor.
New or worsening symptoms	Stop using and consult your doctor.
Visual disturbances or eye pain	Could indicate a more serious condition. Seek medical advice.
Sensitivity to light or eye cloudiness	May require different treatment.
Use of contact lenses	Should not be worn while using this product.

Additional conditions to mention to your doctor:

• Glaucoma
• Dry eye syndrome
• Recent eye surgeries or injuries
• Other eye medications currently in use

Pregnancy and Breastfeeding

The safety of CHLORAMEX during pregnancy or breastfeeding has not been fully established. Therefore:

• Always consult your doctor before using this medicine if you’re pregnant or nursing.
• Chloramphenicol can cross the placenta and enter breast milk, which may affect your baby.

Driving and Using Machinery

Due to temporary blurred vision, burning, or stinging after application:

• Do not drive or operate machinery until your vision clears.
• Wait until you are sure the medication does not impair your focus or eyesight.

Using Other Medicines With CHLORAMEX Ophthalmic Ointment

Drug interactions may affect the efficacy or safety of your treatment. Inform your doctor if you are taking any of the following:

Medication Type	Examples	Interaction Risk
Anticoagulants	Warfarin	May increase bleeding risk
Diabetes medication	Chlorpropamide, tolbutamide	Can enhance effects
Antiepileptics	Phenytoin, phenobarbitone	May interfere with drug metabolism
Antibiotics	Rifampicin	Could alter effectiveness
Supplements	Iron, Vitamin B12	Reduced absorption/effect
Contraceptives	Oral birth control pills	Effectiveness may be decreased

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5. How to Use CHLORAMEX Ophthalmic Ointment

Using this medication correctly ensures optimal results and minimizes side effects.

General Instructions:

• Use only in the eye.
• Follow your doctor’s instructions precisely.
• Never share the ointment with others.

Dosage:

• Apply a small amount (about 1 cm strip) into the affected eye four times a day.

Step-by-Step Application:

1. Wash your hands thoroughly.
2. Open the tube carefully, avoiding contact with the tip.
3. Pull down your lower eyelid to expose the inner surface.
4. Apply the ointment gently without touching the eye or eyelid with the tube.
5. Repeat for the second eye if needed.
6. Recap the tube immediately after use.

For Eyelid Infections:

• Apply directly to the affected area of the eyelid with a clean fingertip four times daily.

Important Warnings:

• Do not swallow the ointment.
• If accidentally ingested, seek medical attention.

If You Use More Than Directed:

• Rinse your eyes with plenty of water.
• If symptoms persist, contact your doctor, pharmacist, or the nearest hospital.

If You Forget a Dose:

• Apply it as soon as you remember, provided it’s within a few hours.
• Do not double the dose to make up for missed applications.

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6. Possible Side Effects

While most people tolerate CHLORAMEX well, side effects can occur.

Serious Side Effects – Seek Immediate Help:

• Severe allergic reactions: Swelling of face or throat, rash, or breathing difficulty
• Signs of blood disorders: Fatigue, unusual bruising, or infections

These reactions may require urgent medical attention or hospitalisation.

Less Serious Side Effects – Report to Your Doctor:

• Burning or stinging in the eyes
• Mild skin inflammation
• Fever

If you notice any side effects not mentioned in this leaflet, inform your healthcare provider.

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7. Storage and Disposing of CHLORAMEX Ophthalmic Ointment

Storage Guidelines:

• Store in a cool place, at or below 25°C.
• Keep the tube tightly closed and in its original packaging.
• Protect from light.

Disposal Guidelines:

• Do not use after the expiry date on the label.
• Return unused medicine to your pharmacist.
• Do not dispose of via toilets or drains.
• Keep out of reach of children.

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8. Presentation of CHLORAMEX Ophthalmic Ointment

CHLORAMEX is presented in a:

• 3.5 g aluminium tube with an applicator nozzle
• Tube is sealed with a blue HDPE cap
• Packaged in a unit cardboard carton with the patient leaflet

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9. Identification of CHLORAMEX Ophthalmic Ointment

The ointment is:

• Translucent pale yellow
• Has a slightly greasy odour

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10. Registration Number

H1193 (Act 101/1965)
This registration number ensures that CHLORAMEX complies with South African Medicines Control Council (MCC) regulations.

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11. Name of Manufacturer

Pharmacare Limited
Healthcare Park
Woodlands Drive
Woodmead, 2191

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Final Thoughts

CHLORAMEX OPHTHALMIC OINTMENT is a reliable and effective treatment for bacterial eye infections when used properly under medical supervision. Its safety and efficacy depend on correct usage, awareness of side effects, and following storage instructions. Always consult your doctor or pharmacist if you experience symptoms or need advice.

Sources: SAHPRA

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