Patient leaflet - Akantior 0.8 mg/ml eye drops, solution in single-dose Container
1. What AKANTIOR is and what it is used for
AKANTIOR contains the active substance
polihexanide.
AKANTIOR is used in adults and children
from 12 years of age to treat Acanthamoeba
keratitis, Acanthamoeba is a parasite (tiny
organism that lives inside humans and
can cause disease) which can cause an
infection resulting in keratitis (inflammation
of the cornea, the clear layer in front of the
eye). Acanthamoeba keratitis can cause
severe defects on the surface of the cornea,
including ulcers (open sores).
AKANTIOR damages the membrane
(outer skin) of the Acanthamoeba parasite
resulting in leakage of the cellular contents
which destroys the cell. AKANTIOR also
prevents the Acanthamoeba parasite from
making copies of its DNA by interfering
with enzymes (proteins) responsible for the
replication process, which stops the growth
and reproduction of the parasite in humans.
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Package leaflet: Information for the patient
1G156221R1 AKANTIOR 0.8 mg/mL eye drops, solution in single-dose container polihexanide
1911
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Package Leaflet: Information for the patient AKANTIOR 0.8 mg/mL
eye drops, solution in single-dose container
polihexanide 1G156221R1
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2. What you need to know before you use AKANTIOR
Do not use AKANTIOR
If you are allergic to polihexanide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using AKANTIOR.
Treatment with AKANTIOR may cause you mild to moderate eye discomfort (such as eye pain) and eye redness. In the case you are experiencing a severe eye reaction, contact your doctor.
Children and adolescents
AKANTIOR is not recommended in children under 12 years, as it has not been tested in this age group.
Other medicines and AKANTIOR
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are using other eye drops, wait at least 5 minutes between applying AKANTIOR and the other drops. AKANTIOR should be administered last.
Pregnancy and breast-feeding
There is no experience of using AKANTIOR in pregnant women. AKANTIOR is not recommended during pregnancy. 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.
It is unknown whether AKANTIOR passes into breast-milk. Ask your doctor or pharmacist for advice before AKANTIOR treatment.
Driving and using machines
Your sight may become temporarily blurred after using AKANTIOR. Avoid driving or using machines until your sight is clear again.
AKANTIOR contains phosphates
This medicine contains approximately 0.4 mg phosphates in each drop which is equivalent to 11 mg/mL. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.
3. How to use AKANTIOR
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The treatment consists of two parts: intensive treatment that lasts for the first 19 days and continuation treatment that lasts from day 20.
The recommended dose is 1 drop of AKANTIOR in the affected eye as follows:
Starting intensive treatment (19 days)
Apply one drop every hour (16 times a
day), for the first five days (days 1 to 5)
Apply one drop every 2 hours (8 times a
day), for a further seven days (days 6 to 12)
Apply one drop every 3 hours (6 times a
day) , for a further 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 no evidence of infection (cured)
Your doctor will advise you when to stop treatment.
Instructions for use
- 1) Wash your hands.
- 2)
Open the aluminium sachet containing
the single-dose containers.
- 3)
Separate the single-dose container
from the strip and put the unopened containers back into the sachet.
- 4)
Open the single-dose container by
twisting the upper part without pulling. Do not touch the tip after opening the container.
- 5)
Tilt the head back. The single-dose
container is now open. Keep the single dose container upright, and do not squeeze.
- 6)
Use your finger to gently pull down the
lower eyelid of your affected eye.
- 7)
Invert the single-dose container and
place the tip of the container close to your eye. Do not touch your eye or eyelid with the container tip.
- 8)
Squeeze the single-dose container in
order to administer only one drop, then release the lower eyelid.
- 9)
Close your eye and press a finger
against the corner of the affected eye by the side of your nose. Hold for 2 minutes.
- 10)
Discard the single dose container after
use.
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If you use more AKANTIOR than you should
Put your next dose in at the usual time, as it is unlikely to cause you any serious harm.
If you forget to use AKANTIOR
Apply the next dose as usual. Do not use a double dose to make up for a forgotten dose.
If you stop using AKANTIOR
Use AKANTIOR as prescribed for best effect. Always tell your doctor if you are thinking about stopping the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The majority of side effects generally occur at the treated eye.
Contact your doctor if you have a severe eye reaction.
The following side effects have been reported:
Very common (may affect more than 1 in 10 people)
- eye pain
- ocular hyperaemia (eye redness)
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 epithelium defects (defects of
outermost corneal layer)
corneal infiltrates (immune response to
corneal insult)
punctuate keratitis (small breaks in the
surface of the eye)
- tearing (watery eyes)
conjunctival hyperaemia (redness of the
conjunctiva)
- eye inflammation
- eye irritation
photophobia (unpleasant eye sensitivity
to light)
- conjunctival papillae (inside of eyelid gets red, swollen and irritated)
- eye pruritus (itchy eyes)
- eye discharge
- eye swelling
- foreign body sensation in the eye
- discomfort in the eye
- dry eye
- conjunctivitis (inflammation of the outermost layer of the eye)
- eye infection
- condition aggravated (disease worsening)
- product intolerance (hypersensitivity to the medicine)
- application site reactions such as pain
- application site reactions such as discomfort
- application site reactions such as pruritus (itching)
- persistent epithelial defect (persistent loss of outermost corneal layer after injury)
- toxicity to various agents
- corneal transplant required
Reporting of side effects
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 Yellow Card Scheme (Website: www.mhra. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store AKANTIOR
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 packaging after EXP. The expiry date refers to the last day of that month of the unopened product.
This medicine does not require any special storage conditions.
After opening the sachet, the single-dose containers have to be used within 28 days. After this period, the unused single-dose containers must be discarded.
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The contents of the single dose container must be used immediately after opening and any remaining content should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What AKANTIOR contains
The active substance is polihexanide.
Each mL of solution contains 0.8 mg of polihexanide.
The other ingredients are sodium
dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, sodium chloride and purified water.
AKANTIOR contains phosphates (see section 2).
What AKANTIOR looks like and contents of the pack
AKANTIOR eye drops, solution in single-dose container (eye drops) is a clear and colourless solution in a single-dose container.
The single-dose containers are moulded in 5 sealed units strip, which in turn are wrapped in a polyester/aluminium/ polyethylene sachet and packaged inside a carton box.
Pack sizes:
- 20 single-dose containers
- 30 single-dose containers
multipack containing 120 (4 packs of 30)
single-dose containers.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
SIFI S.p.A.
Via Ercole Patti, 36
95025 Aci Sant’Antonio (CT)
Italy
This leaflet was last revised in 04/2025
Detailed information on this medicine is available on the website:
www.mhra.gov.uk
Detailed and updated information on this product is available by scanning the QR code included below or on the outer packaging with a smartphone/device. The same information is also available on the following URL:
https://qr.sifigroup.com/akantior/