Patient Leaflet Updated 02-Dec-2025 | Alcon Eye Care UK Limited
ANATERA 100mg/ml solution for injection
ANATERA™ 100 mg/ml solution for injection
Fluorescein
Keep this leaflet.
You may need to read it again. If you have any further questions, please ask your doctor. If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.
See section 4.
1. What ANATERA™ 100 mg/ml solution for injection is and what it is used for
2. What you need to know before you are given ANATERA™ 100 mg/ml solution for injection
3. How ANATERA™ 100 mg/ml solution for injection is given
4. Possible side effects
5. How to store ANATERA™ 100 mg/ml solution for injection
6. Contents of the pack and other information
7. Information for the Health care professional
ANATERA™ 100 mg/ml solution for injection is a dye solution that makes the blood vessels at the back of your eye visible during an eye examination (this procedure is known as fluorescein angiography). This medicine is for diagnostic use only. It is not used to treat any condition.
Tell your doctor before you are given ANATERA™ 100 mg/ml solution for injection:
If any of the above applies to you, or if you are not sure, please tell your doctor before you are given ANATERA™ 100 mg/ ml solution for injection.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This medicinal product must not be mixed with other medicinal products.
Pregnancy and fertility
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you are pregnant, ANATERA™ 100 mg/ml solution for injection should only be used after your doctor has prescribed it. Due to limited experience, caution should be exercised when considering the use of ANATERA™ 100 mg/ml solution for injection during pregnancy.
Breast feeding
Tell your doctor if you are breast feeding.
Fluorescein, the active substance in ANATERA™ 100 mg/ml solution for injection, passes into the mother’s milk where it is slowly eliminated. Therefore, after using ANATERA™ 100 mg/ ml solution for injection, you should not breast feed for 7 days. During this period, breast milk should be expressed and thrown away.
As part of your eye examination, you may be given eye drops which increase the size of the pupil of your eye. This can temporarily affect your vision and your ability to drive or use machines. Do not drive or use machinery until your vision has returned to normal.
This medicinal product contains 72.45 mg sodium (main component of cooking/table salt) in each 5ml. This is equivalent to 3.7% of the recommended maximum daily dietary intake of sodium for an adult.
ANATERA™ 100 mg/ml solution for injection will be administered by your doctor. Depending on your condition your doctor may modify the dose. However, since this product has not been studied in children, dose-adaptation data for children are not available. Therefore, ANATERA™ 100 mg/ml solution for injection should not be used in patients below 18 years as efficacy and safety in this group have not been established.
By injection:
Usually one vial of ANATERA™ 100 mg/ml solution for injection is given by injection into a vein in the arm. ANATERA™ 100 mg/ml solution for injection should not be injected intrathecally (into the spinal canal) or intra-arterially (into the arteries).
If you have any further questions about how ANATERA™ 100 mg/ml solution for injection is given, ask your doctor.
Like all medicines, ANATERA™ 100 mg/ml solution for injection can cause side effects, although not everybody gets them. The following side effects have been reported:
Very common side effects
May affect more than 1 in 10 people
Nausea
Common side effects
May affect up to 1 in 10 people
Vomiting, stomach problems, fainting, itching, escape of blood or fluid into the tissue.
Uncommon side effects
May affect up to 1 in 100 people
Headache, dizziness, sensation of pins and needles, cough, throat tightness, abdominal pain, hives, impaired speech, pain, feeling hot, hypersensitivity, inflammation of the veins
Rare side effects
May affect up to 1 in 1,000 people
Severe allergic reaction, cardiac arrest, low blood pressure, shock, difficulty in breathing or wheezing (bronchospasm)
Very rare side effects
May affect up to 1 in 10,000 people
Anaphylactic shock, convulsion, angina pectoris, slow heart rate, fast heart rate, high blood pressure, cramp of blood vessels, cramp in the calf muscles, poor circulation, skin flushing, pallor, hot flush, stopping breathing, fluid on the lungs, asthma, decreased breathing function, swelling of the larynx, shortness of breath, swelling of the nose, sneezing.
Not known (frequency cannot be estimated from the available data)
Stroke, chest pain, loss of consciousness, shaking, abnormal or decreased skin sensation, rash, cold sweat, skin inflammation, sweating, oedema, generalised weakness, myocardial infarction, throat irritation, skin discolouration, abnormal sense of taste and chills, diarrhoea.
After receiving ANATERA™ 100 mg/ml solution for injection, you may experience a change in the way things taste. Your skin may appear yellowish; this discoloration usually disappears after 6-12 hours. Your urine also may appear bright yellow; this may take 24-36 hours to return to normal.
After injection, inflammation of the vein and blood clots in the vein may occur. If during injection the solution leaks from the vein into the surrounding tissues, it can cause damage to the skin and inflammation of the veins, nerves and tissues close to the injection site; this can lead to severe pain. If you notice any pain or other problems at the injection site, tell your doctor; you may need to be given pain medication or other treatment to help with this.
As listed previously, fluorescein can have unexpectedly severe side effects.
These are more likely if you have suffered a reaction to fluorescein before or if you suffer from allergies (food or drug allergies), eczema, asthma or hay fever.
If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor.
It is possible that fluorescein may affect certain blood and urine tests for 3 to 4 days after you are given it. If you have any blood or urine tests or further X-rays during this period, tell your doctor that you have been given fluorescein.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
These measures will help protect the environment.
The active substance is fluorescein.
1 ml of solution contains 100 mg fluorescein (as 113.2 mg fluorescein sodium).
One vial with 5 ml contains 500 mg fluorescein (as 566 mg fluorescein sodium).
The other ingredients are sodium hydroxide and / or hydrochloric acid (used to adjust the pH of the solution) and water for injections.
ANATERA™ 100 mg/ml solution for injection is a clear red-orange solution for injection.
ANATERA™ 100 mg/ml solution for injection is available in packages containing 12 vials of 5 ml solution for injection.
PL 41809/0001
This product is also authorised in the EU under the following names:
Fluorescein ALCON™ 10% and FLUORESCITE™ 100 mg/ml solution for injection
This leaflet was last revised in 07/2025
The complete SmPC is provided as a separate document in the medicinal pack.
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