1 mg/ml eye drops, suspension
dexamethasone

1. What Isopto-Maxidex is and what it is used for

Isopto-Maxidex is used to suppress inflammation in the outer and front parts of the eye.

Isopto-Maxidex contains a substance called dexamethasone, which is a so-called corticosteroid. Corticosteroids help prevent or reduce inflammation, redness, swelling, and soreness in the eye.

Please note that your doctor may have prescribed the medicine for a different indication and/or at a different dose than the one given in the package leaflet. Always follow your doctor’s prescription and the instructions on the dose label.

2. What you need to know before using Isopto-Maxidex

Do not use Isopto-Maxidex

  • if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6).
  • If you have or think you have:
    • an acute untreated bacterial infection in the eye
    • corneal infection ( keratitis ) caused by herpes simplex, smallpox, chickenpox / shingles or any other viral infection of the eye
    • tuberculosis of the eye
    • fungal disease of the eye or an untreated parasitic infection of the eye

Warnings and cautions

  • Talk to your doctor before using Isopto-Maxidex.
  • Use Isopto-Maxidex only to drip into the eye (s).
  • If you already have glaucoma or high pressure in your eye (s), you need to have your eye pressure checked regularly while using Isopto-Maxidex. Consult your doctor. This is especially important in children, as the risk of increased pressure in the eye due to corticosteroids may be greater in children and may occur earlier than in adults. Isopto-Maxidex is not approved for use in children. The risk of increased pressure in the eye and / or cataracts due to corticosteroids increases in susceptible patients (eg diabetics).
  • Contact a doctor if you experience blurred vision or other visual disturbances.
  • If you use Isopto-Maxidex for a long time, you can:
    • get an elevated pressure in the eye (s)
    • develop cataracts. You should see your doctor regularly if you use Isopto-Maxidex eye drops for a long time.
  • Talk to your doctor if you experience swelling and weight gain around the torso and face, as these are usually the first signs of a syndrome called Cushing’s syndrome. Impaired adrenal function may develop after discontinuation of long-term or intensive treatment with Isopto-Maxidex. These risks are particularly important for children and patients treated with medicines called ritonavir or cobicistat. Therefore, talk to your doctor before stopping treatment yourself.
  • If your symptoms worsen or come back suddenly, contact your doctor. You may have become more susceptible to eye infection when using this product.
  • If you have an infection , your doctor will prescribe another medicine to treat that infection .
  • If you have previously been treated for, or are currently being treated for, an herpes infection in your eye, the use of Isopto-Maxidex may make your infection worse . Your eyes must be examined regularly by your doctor. 
  • Steroids that are applied to the eye can make it take longer for the wound in the eye to heal. It is also known that topical NSAIDs (“non-steroidal anti-inflammatory drugs”) slow down healing or delay healing. Concomitant use of topical NSAIDs -preparat and topical steroid you can increase the potential for healing problems.
  • If you have a disease that causes the tissue of the eye to thin out, consult your doctor or pharmacist before using this medicine.
  • If you wear contact lenses:– You should not wear contact lenses (hard or soft) during the treatment of an eye inflammation.

Other medicines and Isopto-Maxidex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Tell your doctor if you are using NSAIDs.

Tell your doctor if you are taking ritonavir or cobicistat, as this may increase the amount of dexamethasone in your blood.

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Isopto-Maxidex is not recommended during pregnancy and lactation.

Driving and using machines

You may notice blurred vision for a while after using Isopto-Maxidex. In this case, avoid driving or using machines until your vision has cleared again.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Isopto-Maxidex contains benzalkonium chloride and phosphates

Isopto-Maxidex contains benzalkonium chloride

This medicine contains 0.5 mg benzalkonium chloride per 5 ml, equivalent to 0.1 mg / ml. Benzalkonium chloride can be absorbed by soft contact lenses and can discolor the contact lenses. Remove contact lenses before using the medicine and wait at least 15 minutes before re-inserting the contact lenses.

Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.

Isopto Maxidex-containing phosphate s

This medicine contains 6.5 mg phosphate per 5 ml equivalent to 1.3 mg / ml.

If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment.

3. How to use Isopto-Maxidex

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Adults, including the elderly

Dose one is determined by the doctor who adjusts the dose individually for you.

Recommended dose

The recommended dose for chronic inflammation is 1 or 2 drops in the eye (s) at 3 to 6-hour intervals.

If the inflammation is severe or acute, the doctor may initially increase the dose by one to 1 or 2 drops in the eye (s) at 30 to 60-minute intervals, until a favorable reaction can be observed. The frequency of administration is then gradually reduced until the drug is discontinued.

In case of allergies or mild inflammation, the usual dose is 1 or 2 drops in the eye (s) at 3 to 4-hour intervals.

In all situations, the doctor talks about how long your treatment should last.

How to use Isopto-Maxidex correctly:

Remove the loose collar from the lid when opening the bottle for the first time.

Instructions for use
  1. Bring out the bottle of Isopto-Maxidex.
  2. Wash your hands and sit in front of a mirror.
  3. Shake the bottle well before use.
  4. Turn off the bottle cap.
  5. Hold the bottle between your thumb and forefinger so that it is facing downwards (Fig. 1).
  6. Tilt your head back. Pull down the lower eyelid with a clean finger until a “pocket” is formed between the lower eyelid and the eye. This is where the drop should end up.
  7. Move the bottle tip close to the eye. Use a mirror if it helps.
  8. Avoid touching the eye or eyelid, surrounding areas or other surfaces with the drip tip. Then the drops can become infected.
  9. Do not squeeze the bottle. It is designed so that only a light pressure on the bottom is needed (Fig. 2).
  10. Gently press on the bottom of the bottle to release one drop of Isopto-Maxidex at a time (Figure 3).
  11. After using Isopto-Maxidex, close the eyelid and gently press with one finger in the corner of the eye for at least 1 minute. It helps prevent Isopto-Maxidex from entering the rest of the body (Figure 4).
  12. If you are using Isopto-Maxidex in both eyes, repeat steps 6 through 11 for the other eye.
  13. Close the bottle cap carefully immediately after use.

If a drop misses the eye, try again.

If you use other eye drops or ointments, wait at least 5 minutes between each medicine. Eye ointments should be used last.

If you use more Isopto-Maxidex than you should

Rinse everything with lukewarm water. Do not drip in more drops until it is time for your next regular dose.

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Isopto-Maxidex

Continue with the next dose as planned. If it is almost time for your next dose, you can skip the missed dose and continue with your usual dosing schedule.

Do not take a double dose to make up for a forgotten dose.

If you stop using Isopto-Maxidex

Do not stop using this medicine prematurely, even if your symptoms have disappeared. If you stop using this medicine too soon, your symptoms may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You may experience the following reactions:

  • Common side effects (may affect up to 1 in 10 people): discomfort in the eyes and increased pressure in the eye (eyes)
  • Uncommon side effects (may affect up to 1 in 100 people): inflammation of the surface of the eye, discoloration of the cornea from the color, dry eyes, photosensitivity, blurred vision, abnormal sensation in the eye, foreign body sensation in the eyes, increased tear production, crust formation on the eyelids, eye itching, irritation or redness , viral inflammation of the cornea .
  • Rare (may affect up to 1 in 1,000 people): cataracts with long-term treatment, corneal ulcers.
  • No known frequency (can not be calculated from the available data): impaired vision, corneal disease, drooping eyelids, eye pain and increased pupil size, glaucoma (increased pressure in the eye), ulcers on the cornea.

Reactions in other parts of the body:

  • Uncommon side effects (may affect up to 1 in 100 people): change in taste
  • No known frequency (can not be calculated from the available data): allergy , dizziness and headache. Hormone disorders: extra hair growth on the body (especially in women), muscle weakness and loss, purple stretch marks in the skin, high blood pressure , irregular or no menstruation, changes in protein and calcium levels in the body, growth inhibition in children and adolescents and swelling and weight gain on the body and in the face (called Cushing’s syndrome, see section 2 “Warnings and Precautions”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Isopto-Maxidex

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

The bottle is discarded 4 weeks after opening.

Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

Content declaration

  • The active substance is dexamethasone 1 mg / ml.
  • The other ingredients are benzalkonium chloride ( preservative ), hypromellose, sodium chloride, disodium phosphate, disodium edetate, polysorbate 80, citric acid monohydrate and / or sodium hydroxide and purified water.

What the medicine looks like and contents of the pack

Isopto-Maxidex is a white to light yellow suspension supplied in a 5 ml polyethylene plastic bottle (DROPTAINER) with a screw cap.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Novartis Sverige AB

Box 1218

164 28 Kista

Manufacturer

SA Alcon-Couvreur NV

Rijksweg 14

2870 Puurs

Belgium

or

Alcon Cusi SA

Camil Fabra 58

08320 El Masnou, Barcelona

Spain

Muhammad Nadeem

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