Xamflam Eye Suspension

XAMFLAM is a sterile eye drop, suspension. XAMFLAM contains the active substances dexamethasone which is a corticosteroid and tobramycin which is an antibiotic active against a wide range of bacteria that may infect the eye. It is used to reduce inflammation and to prevent infection of the eye following surgery to the eye.

Do not use XAMFLAM

• if you are hypersensitive (allergic) to dexamethasone and/or tobramycin or any of the other ingredients of XAMFLAM (listed in section 6)
• if you suffer from a herpes infection of the eye
• if you suffer from any viral or fungal infection of the eye
• if you require treatment for injury to the cornea or surface of the eye
• XAMFLAM is not recommended for use whilst soft contact lenses are being worn.

If you are not sure whether you should use XAMFLAM, contact your health care provider.

Warnings and precautions

Take special care with XAMFLAM

• if you suffer from diabetes mellitus (sugar diabetes) you may be more likely to develop blurred vision (cataracts) or increased pressure inside the eye (glaucoma)
• if you have a family history of increased eye pressure the risk of developing it may be increased
• if you experience allergic reactions with XAMFLAM, discontinue use and consult your health care provider. Allergic reactions may vary from localized itching or skin redness to severe allergic reactions (anaphylactic reaction) or serious skin reactions. These allergic reactions may occur with other topical or systemic antibiotics of the same family (aminoglycoside type)
• if you experience swelling and weight gain around the trunk and in the face as these are usually the first manifestations of a syndrome called Cushing’s syndrome
• if you have or if you have ever had conditions such as myasthenia gravis or Parkinson’s disease, ask your health care provider for advice as antibiotics of this kind may worsen muscle weakness
• if you experience blurred vision or other visual disturbances, contact your health care provider
• if you have a disorder causing a thinning of the eye tissues, such as rheumatoid arthritis, Fuch’s dystrophy or following a corneal (the clear layer at the front of the eye) transplant. Corticosteroids may cause further thinning and possible perforation and may delay the healing of your eye wound. Topical non-steroidal anti-inflammatory drugs (NSAIDs) are also known to slow or delay healing. If you use topical NSAIDs and corticosteroids together, it may increase the potential for healing problems
• if you have ulcers or infection of the eye, XAMFLAM may aggravate the condition or worsen the infection
• secondary eye infection may develop after prolonged use
• if you are using XAMFLAM for a long period of time, you may become more susceptible to eye infections, have increased pressure in your eye(s) or develop cataracts. It is important that you have regular eye examinations by your ophthalmologist. This is especially important in children as the risk is greater.

Other medicines and XAMFLAM

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your health care provider about all medicines, including other eye drops, that you are using or plan to use, including those obtained without a prescription. Especially tell your health care provider if you are using topical NSAIDs. If you use topical steroids and topical NSAIDs together, it may increase corneal healing problems. Tell your health care provider if you are using ritonavir or cobicistat, as this may increase the amount of dexamethasone in the blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your health care provider for advice before taking this medicine. The safe use of XAMFLAM during pregnancy is not known. If you are breastfeeding, caution should be observed when taking XAMFLAM because it is not known if the medicine is passed into breast milk.

Do not share medicines prescribed for you with any other person. Always use XAMFLAM exactly as your health care provider has told you. Check with your health care provider if you are not sure. SHAKE WELL BEFORE USE. STORE BOTTLE UPRIGHT.

When you first open the bottle and remove the cap, remove the tamper evident ring and throw it away. This will prevent the ring falling into the eye and causing injuries.

The usual dose is one drop into the eye to be operated on every 4 hours whilst awake, for three days before surgery. After surgery put in two drops every two hours for two days beginning with the first dressing change. From the third day put in one drop four times a day for one week. Thereafter put in one drop once daily for ten days. No further treatment should be used.

Duration of administration

Your health care provider will tell you how long your treatment with XAMFLAM will last. Do not change the dose of the medicine without consulting your health care provider. If you must stop treatment, contact your health care provider immediately. If you have the impression that the effect of XAMFLAM is too strong or too weak, talk to your health care provider.

Method of administration

Insert the recommended dose into the affected eye(s). XAMFLAM is for ocular use only. Multi-dose eye drops: Do not allow the tip of the container to touch the eye or areas around the eye. It may become contaminated with bacteria that can cause eye infections leading to serious damage of the eye, even loss of vision. To avoid possible contamination of the container, wash your hands before using this medicine and keep the tip of the container away from contact with any surface. If you think your medicine may be contaminated, or if you develop an eye infection, contact your health care provider immediately concerning continued use of this bottle.

Instructions for use

1. First wash your hands.
2. Shake the bottle well.
3. To open the bottle, unscrew the cap by turning it to the left. Do not pull the cap directly up and away from the bottle. Pulling the cap directly up will prevent your dispenser from operating properly.
4. Tilt your head back and use your finger to gently pull down your lower eyelid to form a pouch between your eye and eyelid.
5. Invert the bottle and press lightly with the thumb or index finger until a single drop is dispensed into the eye as directed by your health care provider. DO NOT LET YOUR EYE OR EYELID TOUCH THE DROPPER TIP.
6. After using XAMFLAM press a finger into the corner of your eye, by the nose, or close your eyelids for 2 minutes. This helps to stop the medicine from getting into the rest of the body.
7. Repeat steps 4 and 5 in the other eye if instructed to do so by your health care provider.
8. Replace the cap by turning until it is firmly touching the bottle. Do not overtighten or you may damage the bottle and cap.

If you wear soft contact lenses Do not use the drops with your soft contact lenses in. After using the drops wait 15 minutes before putting your lenses back in.

If you are using other eye drops If you are using XAMFLAM with another eye drop, the drops should be instilled at least 5 minutes apart.

If you use more XAMFLAM than you should In the event of overdosage, consult your health care provider. If not available, contact the nearest hospital or poison centre. If you put too much XAMFLAM into your eye(s) it can be washed out of your eye(s) with warm tap water.

If you forget to use XAMFLAM Do not use a double dose to make up for forgotten individual doses. It is important to use XAMFLAM as prescribed by your health care provider. If you miss a dose, apply the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not double the dose to make up for the forgotten individual dose.

XAMFLAM can have side effects. Not all side effects reported for XAMFLAM are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using XAMFLAM, please consult your health care provider for advice. If any of the following happens, stop using XAMFLAM and tell your doctor immediately or go to the casualty department at your nearest hospital:

• itchy rash or hives
• swelling of the face, lips, tongue or other parts of the body
• shortness of breath/wheezing
• severe skin reactions such as blistering which may be accompanied by sore throat, fever or headache.

Tell your doctor if you notice any of the following:

Less frequent side effects:

• eye pain, eye itching, eye discomfort, increase pressure in the eye, eye irritation, eye infection, eye allergy, blurred vision, dry eye, eye redness
• runny nose, tightness of the throat
• bad taste.

Side effects with frequency unknown:

• allergic reaction, hypersensitivity, dizziness, headache, eyelid swelling, eyelid redness, increase in pupil size, increase tears production, nausea, stomach discomfort, rash, face swelling, itching.

Side effects with dexamethasone:

• headache
• eye redness, eyelid redness, abnormal feeling in the eye
• secretions from the nose that drain into the throat causing congestion and cough.

• eye infection
• decrease hormone (such as cortisol) secretion
• reduced sharpness of vision, increased eye pressure, visual field defects
• slow healing
• damage to the cornea (white part of the eye).

Side effects with tobramycin:

• eye redness, eye pain.

• eye infection, eye itching, eye irritation (burning and stinging upon instillation), blurred vision, eye redness, eyelid swelling, eyelid itching, increase tears production, eye pain, inflammation of the clear tissue on the front of the eye (cornea)
• reddening of the skin around the eye.

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

Reporting of side effects

If you get side effects, talk to your health care provider. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of XAMFLAM. Suspected side effects can also be reported directly to the Holder of the Certificate of Registration via [email protected].

• Store all medicines out of reach of children.
• Store at or below 25 °C.
• Keep in the original container to protect from light.
• Do not use more than 28 days after opening. Once opened, the suspension may become contaminated, which can cause eye infections. Therefore, you must throw away the bottle 4 weeks (28 days) after you first opened it.
• Do not use this medicine after the expiry date which is printed on the carton and bottle after EXP. The expiry date refers to the last day of that month.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).