Akantior 0.8 mg/ml eye drops solution in single-dose container
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
AKANTIOR 0.8 mg/ml eye drops solution in single-dose container
polihexanide
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What AKANTIOR is and what it is used for
- What you need to know before using AKANTIOR
- How to use AKANTIOR
- Possible adverse effects
- How to store AKANTIOR
- Contents of the pack and other information
1. What AKANTIOR is and what it is used for
AKANTIOR contains the active substance polihexanide.
AKANTIOR is used in adults and children aged 12 years and older to treat Acanthamoeba keratitis. Acanthamoeba is a parasite (a tiny organism that lives within humans and can cause disease) that may cause an infection leading to keratitis (inflammation of the cornea, the transparent layer at the front of the eye). Acanthamoeba keratitis can cause serious defects on the corneal surface, including ulcers (open sores).
AKANTIOR damages the membrane (outer "skin") of the Acanthamoeba parasite, causing the cellular contents to leak out, thereby destroying the cell. AKANTIOR also prevents the Acanthamoeba parasite from copying its DNA by interfering with enzymes (proteins) responsible for the replication process, thus disrupting the parasite's growth and reproduction in humans.
2. What AKANTIOR is and what it is used for
Do not use AKANTIOR
If you are allergic to polihexanide or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use AKANTIOR.
Treatment with AKANTIOR may cause mild to moderate eye discomfort (such as eye pain) and red eye. If you experience a severe eye reaction, contact your doctor.
Children and adolescents
The use of AKANTIOR is not recommended in children under 12 years of age, as it has not been studied in this age group.
Other medicines and AKANTIOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are using another eye drop, wait at least 5 minutes between applying AKANTIOR and the other eye drop. AKANTIOR should be administered last.
Pregnancy and breastfeeding
There is no experience with the use of AKANTIOR in pregnant women. The use of AKANTIOR during pregnancy is not recommended. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
It is unknown whether AKANTIOR is excreted in breast milk. Consult your doctor or pharmacist before starting treatment with AKANTIOR.
Driving and using machines
Your vision may become temporarily blurred after using AKANTIOR. Do not drive or operate machinery until your vision is clear again.
AKANTIOR contains phosphates
This medicine contains 0.37 mg of phosphates per drop, equivalent to 10.66 mg/ml. If you suffer from severe damage to the transparent layer at the front of the eye (cornea), treatment with phosphates may, in very rare cases, lead to cloudy patches in the cornea due to calcium deposition.
3. How to use AKANTIOR
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor again.
The treatment consists of two parts: an initial intensive treatment for the first 19 days and a continuation treatment starting from day 20.
The recommended dose is 1 drop of AKANTIOR in the affected eye as indicated below:
Initial intensive treatment (19 days)
- Apply one drop every hour (16 times a day) during the first five days (days 1 to 5)
- Apply one drop every 2 hours (8 times a day) during the following seven days (days 6 to 12)
- Apply one drop every 3 hours (6 times a day) during the following seven days (days 13 to 19)
Continuation treatment
- Apply one drop every 4 hours (4 times a day) until there is no corneal inflammation or signs of infection (the eye is healed).
Your doctor will tell you when to stop the treatment.
Instructions for use
- Wash your hands.
- Open the aluminum pouch containing the single-dose containers.
- Remove one single-dose container from the strip and place the unused containers back into the pouch.
- Open the single-dose container by twisting the top off—do not pull it. Do not touch the tip after opening.
- Tilt your head backward. The container is now open. Hold the single-dose container in an upright position and do not press it yet.
- Use a finger to gently pull down the lower eyelid of the affected eye.
- Turn the single-dose container upside down and bring its tip close to your eye. Do not let the tip touch the eye or eyelid.
- Squeeze the single-dose container to release one single drop, then release the lower eyelid.
- Close your eye and press a finger against the inner (nasal) corner of the affected eye. Maintain pressure for 2 minutes.
- Discard the single-dose container after use.
If you use more AKANTIOR than you should
Apply the next dose at the usual time, as it is unlikely to cause serious harm.
If you forget to use AKANTIOR
Apply the next dose at the usual time. Do not use a double dose to make up for forgotten doses.
If you stop using AKANTIOR
Use AKANTIOR exactly as your doctor has instructed to achieve the best effect. Always inform your doctor if you plan to stop the treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Most adverse effects usually occur in the treated eye.
Contact your doctor if you experience a serious eye reaction.
The following adverse effects have been reported:
Very common (may affect more than 1 in 10 people)
- eye pain
- ocular hyperemia (red eye)
Common (may affect up to 1 in 10 people)
- corneal perforation (damage to the corneal surface)
- visual impairment
- ulcerative keratitis (inflammation or infection of the cornea)
- corneal epithelial defects (damage to the outermost layer of the cornea)
- corneal infiltrates (immune response to corneal injury)
- punctate keratitis (small tears on the eye surface)
- lacrimation (watery eyes)
- conjunctival hyperemia (redness of the conjunctiva)
- eye inflammation
- eye irritation
- photophobia (eye discomfort due to light sensitivity)
- conjunctival papillae (redness, swelling, and irritation of the inner surface of the eyelid)
- ocular pruritus (itchy eyes)
- eye discharge
- eye swelling
- sensation of foreign body in the eye
- eye discomfort
- dry eye
- conjunctivitis (inflammation of the outermost layer of the eye)
- eye infection
- worsening of condition (deterioration of the disease)
- product intolerance (hypersensitivity to the medicine)
- reactions at the application site such as pain
- reactions at the application site such as discomfort
- reactions at the application site such as pruritus (itching)
- persistent epithelial defect (persistent loss of the outermost layer of the cornea after injury)
- toxicity to various agents
- need for corneal transplant
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of AKANTIOR
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated for the unopened product.
This medicine does not require any special storage conditions.
After opening the sachet, the single-dose containers must be used within 28 days. After this period, unused single-dose containers must be discarded.
The contents of a single-dose container should be used immediately after opening, and any remaining contents must be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines that are no longer needed. This will help protect the environment.
6. Contents of the container and other information
Composition of AKANTIOR
- The active substance is polyhexanide. Each millilitre of solution contains 0.8 mg of polyhexanide.
- The other components are monohydrate sodium dihydrogen phosphate, dodecahydrate disodium phosphate, sodium chloride and purified water.
AKANTIOR contains phosphates (see section 2).
Appearance of the product and contents of the container
AKANTIOR eye drops solution in single-dose containers (eye drops) is a clear, colourless solution in a single-dose container.
The single-dose containers are packed in sealed strips of 5 units, which in turn are enclosed in a polyester/aluminum/polyethylene pouch and placed in a carton box.
Pack sizes:
- 20 single-dose containers
- 30 single-dose containers
- multiple pack containing 120 (4 packs of 30) single-dose containers.
Only some pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti, 36
95025 Aci Sant'Antonio (CT)
Italy
Date of the most recent revision of this leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) or device the QR code included in the leaflet and on the carton. You can also access this information at the following internet address: https://qr.sifigroup.com/akantior/.
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