Kinofta

Package leaflet: Information for the user

KIN Ofta 5 mg/ml eye drops, solution
Levofloxacin (as hemihydrate)
Equivalent medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse.

Contents of this leaflet:

1. What KIN Ofta is and what it is used for
2. What you need to know before using KIN Ofta
3. How to use KIN Ofta
4. Possible side effects
5. How to store KIN Ofta
6. Contents of the pack and other information

1. What KIN Ofta is and what it is used for

One bottle of KIN Ofta contains 5 ml of solution with levofloxacin as the active substance.
For the theoretical volume of one drop, equivalent to 0.05 ml, the amount of active substance is 0.256 mg of levofloxacin hemihydrate, equivalent to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic belonging to the fluoroquinolone group (also commonly referred to simply as quinolones). The antibiotic works by killing certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is indicated for the treatment of bacterial infections affecting the front surface of the eye in children aged 1 year and older, and in adults. One type of infection affecting this part of the eye is bacterial conjunctivitis, an infection of the front lining of the eye (conjunctiva).
Levofloxacin is not recommended in children under 1 year of age.
Contact your doctor if you do not feel better or if you feel worse after 5 days.

2. What you should know before using KIN Ofta

Do not use KIN Ofta

• if you are allergic to levofloxacin, to other quinolones, or to any of the other ingredients of this medicine (listed in section 6).

If you have any doubts, consult your doctor or pharmacist.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using KIN Ofta

• if you experience an allergic reaction, even after a single dose, do not use this medicine any longer
• if during treatment your eye symptoms worsen, contact your doctor as soon as possible
• if you do not notice any improvement within the treatment period agreed with your doctor, contact your doctor as soon as possible
• in general, wearing any type of contact lens is not recommended while an eye infection is present
• KIN Ofta contains benzalkonium chloride as a preservative, which may cause eye irritation.

As with all products containing the preservative benzalkonium chloride, soft contact lenses
should not be worn during use of this medicine, as this may cause
irritation of the ocular surface.
Children and adolescents
The special warnings and precautions for use of this medicine are the same for adults,
adolescents, and children aged 1 year and older.
Other medicines and KIN Ofta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines – including those not requiring a prescription.
In particular, inform your doctor or pharmacist if you are using any other type of eye drops or
ophthalmic ointment before starting to use KIN Ofta.
If you are using other eye drops, you must wait at least 15 minutes between the application of KIN Ofta and any
other type of eye drops.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning a pregnancy, consult
your doctor or pharmacist before using this medicine.
KIN Ofta should be used during pregnancy only if the potential benefit justifies the potential
risk to the fetus.
Although very small amounts of levofloxacin may pass into the bloodstream and breast milk,
respectively, after instillation of the eye drops, it is very unlikely that this could cause
harm to the infant.
Your doctor is aware of the potential risks and will advise you whether you can use KIN Ofta.
Fertility (ability to become pregnant or conceive a child) is not impaired when
levofloxacin is used as directed.
Driving and using machines
Levofloxacin may slightly affect the ability to drive and use machines.
If use of the eye drops causes blurred vision, you must wait until this effect has passed
before driving or using machines.
KIN Ofta contains Benzalkonium chloride
This medicine contains 0.250 mg of benzalkonium chloride per container, equivalent to
0.050 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause a change in their color. Remove your contact lenses before using this medicine and wait
15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or
corneal disorders (the transparent outer layer of the eye). If you experience any unusual eye sensation, burning, or pain after using this medicine, speak with your doctor.

3. How to use KIN Ofta

Use this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
KIN Ofta is for ophthalmic use and must be applied to the outer surface of the eye.
For patients over 1 year of age, the recommended dose is as follows:
DAYS 1 - 2

• Apply one or two drops into the affected eye(s) every two hours.
• Apply the drops no more than 8 times per day. DAYS 3 - 5
• Apply one or two drops into the affected eye(s).
• Apply the drops no more than 4 times per day.

No dosage adjustment is required in elderly patients.
Generally, the total duration of treatment is five days. Your doctor will advise you on how long you should continue using the eye drops.
If you are using any other eye medicines, you must wait at least 15 minutes between applications of each different eye drop.
Use in children and adolescents
Dosage adjustments are not necessary in children aged 1 year and older and in adolescents. The use of levofloxacin is not recommended in children under 1 year of age.
Before applying the eye drops:
If possible, ask someone to help you apply the eye drops. Before application, ask the person assisting you to read these instructions together with you.

1. Wash your hands.
2. Open the bottle. Take particular care to avoid the dropper tip of the bottle touching the eye, the skin around the eye, or your fingers. If this happens accidentally, inform your doctor or pharmacist immediately so that you can obtain a clean bottle. Tilt your head backwards while sitting or lie down on your back.

3. Position the tip of the bottle close to the eye.

4. Pull down the lower eyelid and look upwards.

5. Gently squeeze the bottle and let one drop fall into the space between the lower eyelid and the eye.

6. Close the eye and press with a finger on the inner corner of the eye for about one minute. This helps prevent the eye drop from draining into the tear duct.

7. Remove any excess solution remaining on the skin around the eye.
   If you need to apply another drop or treat both eyes, repeat steps 3 to 6.
   Replace the cap and close the bottle properly after use.
   Do not inject KIN Ofta into the eyeball.
   If you use more KIN Ofta than you should
   If you use more KIN Ofta than recommended, you should rinse the eye(s) with water and consult your doctor or pharmacist.
   If you forget to use KIN Ofta
   If you forget to use the eye drops, apply the next dose as soon as you remember. Do not use a double dose to make up for the missed dose.
   If you accidentally ingest KIN Ofta
   The amount of levofloxacin contained in the provided bottle is very small and unlikely to cause adverse effects. However, if you are concerned, consult your doctor or pharmacist, who will advise you on any necessary measures.
   If you stop treatment with KIN Ofta earlier than instructed, healing may be delayed.
   If you have any doubts about using this medicine or wish to discontinue treatment, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
A side effect occurs in about one out of ten people using KIN Ofta. Most of these side effects affect only the eye and are not long-lasting. If you experience any severe or persistent side effect, you must stop using KIN Ofta eye drops and consult your doctor urgently.
The frequency of possible side effects is defined as follows:

Very rarely, this medicine may cause serious allergic reactions.
The following symptoms may occur even after the first dose of KIN Ofta:

• swelling and tightness in the throat
• difficulty breathing. In rare cases, other allergic reactions may also develop. Symptoms of these reactions include:
• worsening of eye redness and itching
• increase or sudden onset of swelling of the eyelids. If any of these symptoms occur, stop using levofloxacin and consult a doctor immediately.

Common side effects (may affect from 1 to 10 users in 100):

• burning sensation in the eye
• reduced vision or mucus in the eye

Uncommon side effects (may affect from 1 to 10 users in 1,000):

• stinging or irritation of the eye
• painful eyes
• dry or inflamed eyes
• swelling or redness (bloodshot eyes) of the conjunctiva (the front part of the eye) or eyelids
• unusual sensitivity to light
• itching of the eyes
• sticky eyelids
• headache
• skin rash around the eyes
• stuffy nose or runny nose

Rare side effects (may affect from 1 to 10 users in 10,000):

• allergic reactions, e.g. skin rash

Very rare side effects (may affect less than 1 user in 10,000):

• swelling and tightness in the throat
• difficulty breathing

Additional side effects in children and adolescents
The frequency, type, and severity of side effects in children and adolescents are expected to be the same as those observed in adults.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KIN Ofta

Keep this medicine out of the sight and reach of children.
Store the bottle tightly closed.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of that month.
Do not use this medicine if, before starting a new bottle, you notice that the plastic seal around the cap and neck is missing or broken.
KIN Ofta must be used within 28 days of first opening the bottle. For safe disposal of any remaining solution, please ask your pharmacist.
To prevent infections, you must discard the bottle 28 days after first opening and use a new one.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What KIN Ofta contains

• The active substance is levofloxacin (as hemihydrate) 5 mg/ml.
• The other components of KIN Ofta are: benzalkonium chloride (preservative, 0.05 mg in 1 ml of solution), sodium chloride, sodium hydroxide solution or hydrochloric acid, and water for injections.

Description of the appearance of KIN Ofta and contents of the pack
Clear, yellowish-green aqueous solution.
5 ml of solution are supplied in a 5 ml LDPE (low-density polyethylene) bottle with an LDPE dropper and a cap made of HDPE (high-density polyethylene) or HDPE/LDPE.

Marketing Authorization Holder
OFF ITALIA S.R.L. OFTALMICA FARMACEUTICA ITALIA
Via G. Paisiello, 10
50144 Firenze, Italy

Manufacturer
Rafarm Hellas SA, Thesi Poussi Hantzi Agiou Louka, Paiania, Attiki, 19002 - Greece

This medicinal product is authorized in the European Economic Area countries under the following names:
Portugal: Levofloxacina NTC 5 mg/ml Colírio, solução
Italy: KIN Ofta 5 mg/ml eye drops, solution