15 mg / g eye drops, solution in single-dose container azithromycin dihydrate

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 or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Azyter is and what it is used for 
2. What you need to know before you use Azyter 
3. How to use Azyter 
4. Possible side effects 
5. How to store Azyter 6. Contents of the pack 
and other ingredients information 

1. What Azyter is and what it is used for

Azytes contain azithromycin, an antibiotic belonging to the macrolide antibiotic class.

Azytes are used for the local treatment of certain eye infections caused by bacteria in adults (including the elderly) and in children from newborns to 17 years .

  • persistent bacterial infection of the conjunctiva ( conjunctivitis ).
  • trachoma conjunctivitis (special eye infection caused by bacteria called Chlamydia trachomatis which occurs in developing countries).

Azithromycin dihydrate contained in Azyter 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 you use Azyter

Do not use Azyter

  • if you are allergic to azithromycin, to any other antibiotic of the macrolide class or to a medium carbon chain triglyceride .

Warnings and cautions

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

  • If an allergic reaction occurs, stop using the medicine and consult your doctor.
  • If you do not experience improvement within three days of starting treatment or if you experience abnormal symptoms, consult your doctor.
  • Due to eye infection, the use of contact lenses is not recommended.

This medicine is for eye use only.

Do not inject or swallow.

Other drugs and Azytes

If you are using any other medicine to be applied to the eye, you should:

  1. apply for the other ophthalmic medicine first,
  2. wait 15 minutes,
  3. apply Azyter finally.

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

Pregnancy and breastfeeding

Pregnancy

Azytes can be used during pregnancy.

Your doctor may prescribe this medicine for you during pregnancy if your doctor considers it necessary.

Breast-feeding

There is only limited data on the excretion of azithromycin in breast milk. This medicine can be used during breast-feeding

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.

Driving and using machines

You may experience transient blurred vision after administering the medicine to the eye. Wait until you regain normal vision before driving or using machines.

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.

3. How to use Azyter

This medicine should be administered to the eye ( ocular use).

Always use this medicine exactly as your doctor or your doctor has told you. If you are not sure, talk to your or your child’s doctor or pharmacist.

Dosage

The recommended dose for adults (including the elderly) and children from newborns to 17 years is one drop twice daily in the eye / eyes to be treated: one drop in the morning and one drop in the evening.

The duration of treatment is three days.

Because the medicine has a long-lasting effect, it is not necessary to continue treatment for more than three days, even though you may still have signs of the bacterial infection.

Method of administration

Azytes should be administered as follows:

  • wash your hands thoroughly before and after applying the medicine,
  • drip a drop into the eye to be treated while looking upwards while pulling the lower eyelid slightly downwards,
  • avoid touching the eye and eyelids with the dropper tip of the single-dose container,
  • discard the single-dose container after use. You should not save it for later use.

DO NOT INJECT; DO NOT SWALLOW.

If you forget to use Azyter

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

If you stop using Azyter

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.

Tell your doctor immediately if you get any of the following symptoms after taking this medicine, as the symptoms may be severe.

Uncommon (affects up to 1 in 100 people):

  • severe allergic reaction that causes swelling of the face or throat ( angioedema ).

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

  • severe skin reactions: skin rash, sudden and severe skin reactions, blisters on skin, mouth, eyes and genitals ( Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN)), skin rash together with e.g. fever, swollen glands and an increase in a type of white blood cell ( eosinophils ), rash such as small, itchy, red lumps (drug reaction associated with an increase in the amount of eosinophilsand symptoms affecting the whole body (DRESS)), generalized redness of the skin with scaling over large parts of the body (exfoliative dermatitis), rash characterized by rapid appearance of areas of red skin full of small purulent blisters (small blisters filled with white / yellow fluid) ( acute generalized exanthematous pustulosis (AGEP)).

If you develop these skin symptoms, stop using azithromycin and contact your doctor or see a hospital immediately.

The following side effects were observed when the preparation was administered:

Very common (affects more than 1 user in 10):

  • transient discomfort in the eye ( itching, burning, tingling).

Common (affects up to 1 in 10 people):

  • dimsyn,
  • a sticky feeling in the eye,
  • the sensation of foreign objects in the eye.

Uncommon (affects 1 in 100 people):

  • allergic reaction (hypersensitivity),
  • inflammation of the white of the eye (may be due to infection or allergy ) ( conjunctivitis ),
  • allergic inflammation of the whites of the eyes (allergic conjunctivitis ),
  • inflammation of the cornea ( keratitis ),
  • itchy skin on the eyelids (eyelid eczema),
  • dryness, redness, swelling of the eyelids (eyelid edema),
  • eye allergy,
  • tear secretion.
  • red eyelids (eyelid erythema),
  • red eyes ( conjunctival hyperemia ).

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 Azyter

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 outer carton and disposable container. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

• Store single-dose containers in the outer carton . Sensitive to light.

Dispose of opened single-dose container and any remaining solution immediately after first use. Do not save it for later use.

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 azithromycin dihydrate. One gram of solution contains 15 mg of azithromycin dihydrate corresponding to 14.3 mg of azithromycin. A single-dose container of 250 mg solution contains 3.75 mg azithromycin dihydrate.
  • The other ingredients are triglycerides , medium carbon chain.

What the medicine looks like and the contents of the pack

Azytes are a solution for ocular use ( eye drops , solution) contained in single-dose containers , each container containing 0.25 g of the preparation. Azytes are a clear, colorless or yellowish, oily liquid.

The package contains six single-dose containers in one bag, which is sufficient for a treatment regimen.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Théa Laboratories

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Manufacturer

Théa Laboratories

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

or

Laboratory Unither

Zi de la Guérie

50200 Coutances

France

Muhammad Nadeem

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