1 mg/ml, eye drops, solution in single-dose container 
dexamethasone phosphate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– 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. See section 4.

In this leaflet: 
1. What Baxil is and what it is used for 
2. What you need to know before you use Baxil 
3. How to use Baxil 
4. Possible side effects 
5. How to store Baxil 
6. Contents of the packaging and other information 

1. What Baxil is and what it is used for

Baxil is eye drops in disposable containers, which contain a substance called dexamethasone. The substance is a corticosteroid that inhibits inflammatory symptoms. Baxil is used to treat inflammation in the eye (s). The eye should not be infected (red eyes, secretions, tear flow). Upon infection should specific treatment for the infection a prescribed (see section 2).

Dexamethasone found in Baxil may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before using Baxil

DO NOT use Baxil

  • if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6),
  • if you have an eye infection that can be caused by a bacterial ( acute purulent infection ), a fungus, a virus (herpes virus, vaccinia virus, varicella zona – viruses ), or an amoeba,
  • if you have corneal damage (holes, wounds, or injuries due to incomplete healing),
  • if you have ocular hypertension (increased pressure in the eye) which is known to be caused by neurosteroids (a type of corticosteroid ).

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Baxil.

DO NOT INJECT OR SWALLOW

Avoid contact between the drip tip and the eye or eyelid.

  • Close eye checks are always required when using Baxil and especially :
    • in children and the elderly. More frequent eye examinations are recommended
    • if you have an eye infection. Only use Baxil if an infection is treated with antibiotics 
    • if you have corneal ulcers. Do not use topical dexamethasone treatment or Baxil, unless inflammation is the main cause of delayed wound healing.
    • if you have increased pressure in the eye. If you have already experienced side effects during treatment with local steroids that resulted in increased pressure in the eye, you run the risk of developing increased pressure in the eye if you are treated with Baxil,
    • if you have glaucoma ( glaucoma ).
  • Severe allergic conjunctivitis ( inflammation of the conjunctiva of the eye ): if you have severe allergic conjunctivitis that does not respond to standard treatment, use Baxil only for a short time.
  • Diabetes: If you are diabetic, tell your ophthalmologist.
  • Red-eye: if you have red-eye that has not been diagnosed, do not use Baxil.
  • Contact lenses: Avoid wearing contact lenses during treatment with Baxil.

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. The impaired adrenal function may develop after the completion of long-term or intensive treatment with Baxil. 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.

Contact a doctor if you experience blurred vision or other visual disturbances.

Other medicines and Baxil

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are using any other medicine to be applied to the eye, wait 15 minutes between each preparation.

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

Precipitation of calcium phosphate on the surface of the cornea has been observed during concomitant treatment with local steroids and beta-blockers.

Pregnancy and breastfeeding

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

  • There are insufficient data on the use of Baxil during pregnancy to evaluate the potential side effects. Therefore, the use of Baxil during pregnancy is not recommended.
  • It is not known whether Baxil is excreted in human milk. However, the total dose of dexamethasone is small. Therefore, Baxil can be used during breast-feeding.

Driving and using machines

As with all eye drops, transient blurred vision or other visual disturbances may affect the ability to drive or use machines. Do not drive or use machines until you have regained normal vision. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.

Baxil contains phosphate

This medicine contains 0.08 mg phosphate per drop equivalent to 1.68 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 Baxil

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

Dose

The recommended dose is one drop 4-6 times daily in the eye to be treated. In severe cases, treatment can begin with 1 drop every hour and dosage one can be reduced to 1 drop every 4 hours when a favorable response has been observed. Gradual reduction of dose one is recommended to prevent relapse.

Use for the elderly

No special dosage is required.

Use for children

Continuous long-term treatment should be avoided.

Instructions for use

Ocular use: This medicine is intended for use in the eyes.

  1. Wash your hands thoroughly before using this medicine.
  2. Drip one drop in the eye to be treated as you gaze upwards while pulling the lower eyelid down slightly.
  3. Immediately after application, press lightly with the finger in the corner of the eye on the treated eye for a few minutes (to reduce the risk of general reactions and to increase the penetration of the active substance into the eye).
  4. Dispose of the single-dose container after use. You should not save it for later use.

Repeated treatment

4-6 times daily.

Length of treatment

The duration of a treatment usually varies from a few days to a maximum of 14 days.

Rinse the eye with running sterile water if you have dropped too much of the medicine into your eye and you have been irritated for a long time. Contact a doctor or pharmacist immediately.

If you forget to use Baxil

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

If you stop using Baxil

Do not end the treatment suddenly. Always consult your doctor if you are considering stopping treatment.

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

4. Possible side effects

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

Very common (may affect more than 1 user in 10):

  • high pressure in the eye, after two weeks of treatment.

Common (may affect up to 1 in 10 people):

  • discomfort, irritation, burning, tingling, itching, and blurred vision. These side effects are usually short-lived and mild.

Uncommon (may affect up to 1 in 100 people):

  • allergic and hypersensitivity reaction to any of the ingredients in the eye drops,
  • delayed healing,
  • lens haze (cataracts, cataracts ),
  • infection is,
  • glaucoma ( glaucoma ).

Very rare (may affect up to 1 in 10,000 people):

  • inflammation of the conjunctiva of the eye ( conjunctivitis ),
  • dilated pupil ( mydriasis ),
  • facial swelling (facial edema),
  • drooping eyelids (ptosis),
  • inflammation of the iris ( uveitis ),
  • calcification of the cornea,
  • inflammation of the cornea (crystalline keratopathy ),
  • differences in corneal thickness,
  • corneal edema,
  • corneal ulcer,
  • holes in the cornea.

Has been reported (occurs in an unknown number of users):

  • 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”)
    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.

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Baxil

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 single-dose container after EXP.

The expiration date is the last day of the specified month.

After opening the protective bag containing the single-dose containers: use the single-dose containers within 60 days.

Use the single-dose container immediately after opening and discard it after use.

Store the single-dose containers in the protective bag. Sensitive to light.

Do not store above 30 ° 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 packaging and other information

Content declaration

  • The active substance is dexamethasone sodium phosphate. One milliliter solution contains dexamethasone sodium phosphate equivalent to 1 mg dexamethasone phosphate.
  • The other ingredients are disodium edetate, sodium chloride, disodium phosphate dodecahydrate, sodium hydroxide or hydrochloric acid (for adjustment), and water.

What the medicine looks like and the contents of the pack

Baxil is a clear colorless eye drop, solution in single-dose containers.

Each single-dose container contains 0.3 ml of solution. 5 single-dose containers are packed in a protective bag. Cartons containing 10, 20, 30, 50 or 100 single-dose containers .

Marketing Authorization Holder and Manufacturer

Orifarm Generics A / S

Energivej 15

5260 Odense S

Denmark

Local representative:

Orifarm Generics AB,

Box 56048

102 17 Stockholm

info@orifarm.com

Muhammad Nadeem

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