Azyter 15 mg/g, eye drops, solution in single-dose container
Generic Name: Azithromycin dihydrate
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What Azyter Is And What It Is Used For
Azyter contains azithromycin, which is an antibiotic (macrolide class). Azyter is used to treat some eye infections that are caused by bacteria, purulent bacterial conjunctivitis, trachoma conjunctivitis (a particular infection of the eye caused by bacteria called Chlamydia trachomatis, which is usually found in developing countries).
Before You Use Azyter
Do not use Azyter
- If you are allergic (hypersensitive) to azithromycin, to any other antibiotic from the macrolide class or to medium-chain triglycerides.
Take special care with Azyter
- If you have an allergic reaction, stop the treatment and tell your doctor.
- If your eye infection does not get better after three days using your drops, or if you notice anything unusual, tell your doctor.
- Do not wear contact lenses when you have your eye infection.
Use your drops only in your eyes. Do not inject or swallow your drops.
Using other medicines
If you are using any other eye medicine, you should:
- use the other eye medicine first,
- wait for 15 minutes,
- then use Azyter last.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy
If you are pregnant, tell your doctor before using Azyter. If he or she considers it to be necessary; he or she may still give this medicine to you.
Breast-feeding
You can use these drops if you are breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
You may have blurred vision for a short time after using your drops. Wait until your vision is normal before driving or using any machine.
How To Use Azyter
This medicine is only to be used in the eye (ocular use). Always use Azyter exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose is one drop twice a day in the eye(s) to be treated: one drop in the morning and one drop in the evening. The course of treatment is three days. Azyter eye drops have a prolonged action and will continue to work after the three day course. Do not use your drops for more than three days even if you still have some residual signs of your eye infection.
How to use Azyter
- wash your hands well before and after using your drops,
- look up and pull down the lower eyelid,
- apply one drop into each affected eye,
- take care not to touch the eye and eyelids with the dropper tip of the single-dose container,
- throw away the single-dose container after use. Do not keep it to use again.
Do Not Inject, Do Not Swallow
If you forget to use Azyter
Do not use a double dose to make up for a forgotten dose.
If you stop using Azyter
Always tell your doctor if you want to stop the treatment. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Azyter can cause side effects, although not everybody gets them. The following side effects have been observed upon administration of Azyter eye drops Very common (affects more than 1 person in 10)
- itching, burning or stinging when you use the drops. This will soon pass.
Common (affects 1 to 10 people in 100):
- blurred vision,
- a feeling of sticky eye,
- a feeling there is something in your eye.
Uncommon (affects 1 to 10 people in 1000):
- watering of the eyes.
Very rare: Signs of an allergic reaction (affects less than 1 person in 10.000). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How To Store Azyter
Before purchase Azithromycin, you must read how to store
Keep out of the reach and sight of children. Do not use Azyter after the expiry date which is stated on the single-dose container. The expiry date refers to the last day of that month.
- Do not store above 25°C.
- Keep the single-dose containers in the sachet to protect them from light.
Throw away the opened single-dose container immediately after you have used it, even if it has some solution left. Do not keep it to use again. 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.
Further Information
What Azyter contains
- The active substance is azithromycin dihydrate. Each gram of solution contains 15 mg of azithromycin dihydrate equivalent to 14.3 mg of azithromycin. Each single-dose container of 250 mg solution contains 3.75 mg of azithromycin dihydrate.
- The other ingredient is triglycerides, medium-chain.
What Azyter looks like and contents of the pack
Azyter is an eye drops solution supplied in single-dose containers, each containing 0.25 g of the product. It is a clear, colourless to slightly yellow, oily liquid. The pack contains six single-dose containers in a sachet, which are for one course of treatment.
Marketing Authorisation Holder
LABORATOIRES THEA 12, rue Louis Bleriot 63017 CLERMONT-FERRAND CEDEX 2 FRANCE
Manufacturer
LABORATOIRES THEA 1 2, rue Louis Bleriot 63017 CLERMONT-FERRAND CEDEX 2 FRANCE
This medicinal product is authorised in the Member States of the EEA under the following names:
| Country | Product Name |
|---|---|
| Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Norway, Poland, Portugal, Romania, Slovak Republic, Sweden, United Kingdom | AZYTER |
| Spain | AZYDROP |
| Slovenia | ZYDROP |