KINOFTA 5 mg /Ml Eye Drops, Solution

Зміст інструкції

1. What is KIN Ofta and what is it 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

KINOfta5 mg/ml eye drops, solution

Levofloxacin (as hemihydrate)
Generic medicine

Read this leaflet carefully before using this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse.

Contents of this leaflet:

• 1. What KIN Oftais and what it is used for
• 2. What you need to know before you use 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 is KIN Ofta and what is it used for

A bottle of KIN Oftacontains 5 ml of solution with levofloxacin as the active ingredient.
For the theoretical volume of one drop, equivalent to 0.05 ml, the amount of active ingredient is 0.256 mg
of levofloxacin hemihydrate, equivalent to 0.250 mg of levofloxacin.
Levofloxacin is an antibiotic of the fluoroquinolone type (also briefly called
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 that
affect the anterior surface of the eye in children aged 1 year or older
and in adults. One type of infection of this part of the eye is bacterial conjunctivitis,
an infection of the anterior lining of the eye (conjunctiva).
Levofloxacin is not recommended for children under 1 year of age.
See your doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using KIN Ofta

Do not use KINOfta

• 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, ask 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 again
• if, during treatment, you notice a worsening of your eye symptoms, contact your doctor as soon as possible
• if you do not notice any improvement within a certain treatment period agreed with your doctor, contact your doctor as soon as possible
• generally, the use of any type of contact lenses is not recommended while an infection is present in the eye
• KIN Oftacontains benzalkonium chloride as a preservative, which can cause eye irritation.

As with all products containing the preservative benzalkonium chloride, soft contact lenses
should not be worn during the use of this medicine because this can cause
irritation to the ocular surface.

Children and adolescents
The special warnings and precautions for the use of this medicine are the same for adults,
adolescents and children aged 1 year and over.

Other medicines and KINOfta
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines – including those available without a prescription.
In particular, tell your doctor or pharmacist if you are using any other type of eye drops or eye ointment
before starting to use KIN Ofta.
If you are using other eye drops, you should wait at least 15 minutes between applying KIN Oftaand any
other type of eye drops.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect you are pregnant or are planning a pregnancy, ask
your doctor or pharmacist for advice before using this medicine.
KIN Oftashould only be used during pregnancy if the potential benefit justifies the potential
risk to the fetus.
Although very small amounts of levofloxacin pass into the blood and breast milk,
respectively, after instillation of the eye drops it is very unlikely that this could cause
harm to the baby.
Your doctor is aware of the potential risks and will tell you if you can take KIN Ofta.
Fertility (the ability to become pregnant or conceive a child) is not impaired when
you apply levofloxacin following the instructions for use.

Driving and using machines
Levofloxacin slightly alters the ability to drive and operate machines.
If the use of the eye drops causes blurred vision, you should wait until this effect has passed
before driving or using machines.

KINOftacontains Benzalkonium chloride
This medicine contains 0.250 mg of benzalkonium chloride per bottle, which is equivalent to
0.050 mg/ml.
Benzalkonium chloride can be absorbed by soft contact lenses and can lead to
a change in their colour. Remove contact lenses before using this medicine and wait
15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the transparent outer layer of the eye). If you experience an unusual
sensation in the eye, burning or pain after using this medicine, talk to your doctor.

3. How to use KIN Ofta

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
KIN Oftais for ophthalmic use and must be applied to the external 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 to the affected eye(s) every two hours.
• Apply the drops at a maximum of 8 times a day. DAYS 3 - 5
• Apply one or two drops to the affected eye(s).
• Apply the drops at a maximum of 4 times a day.

No dosage adjustment is necessary in elderly patients.
Generally, the total duration of treatment is five days. Your doctor will be able to tell you how long you should apply the eye drops.
If you are using any other medicine for your eyes, you should wait at least 15 minutes between applications of the various eye drops.

Use in children and adolescents
No dosage adjustments are necessary in children aged 1 year or 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 apply the eye drops for you. Before applying the eye drops, ask the person helping you to read these instructions together with you.

• 1) Wash your hands.
• 2) Open the bottle. Pay particular attention to avoid touching the bottle’s dropper tip to the eye, the skin around the eye, or your fingers. If this happens accidentally, you should promptly inform your doctor or pharmacist so that you can obtain a clean bottle. Tilt your head back while sitting or lie on your back.

• 3) Position the bottle tip near the eye.

• 4) Pull down the lower eyelid and look upwards.

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

• 6) Close your eye and press with your finger on the inner corner of the eye for about one minute. This will prevent the eye drops from being eliminated into the tear duct.
• 7) Remove any residual solution present on the skin around the eye. If you need to apply another drop and if you need to treat both eyes, repeat steps 3 to 6.

Reapply the cap and close the bottle tightly after use.
You must not inject KIN Oftainto the eyeball.

If you use more KINOftathan you should
If you use more KIN Oftathan you should, you should rinse the eye(s) with water and consult your doctor or pharmacist.

If you forget to use KINOfta
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 swallow KINOfta
The amount of levofloxacin contained in the supplied bottle is very small to cause adverse effects. However, if you are concerned, consult your doctor or pharmacist who will inform you about any necessary measures.

If you stop the treatment with KINOftabefore than indicated, it may delay the healing process.
If you have any doubts about using this medicine or wish to stop the 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.
Approximately one in ten people who use KIN Oftaexperiences a side effect. Most of these side
effects only affect the eye and do not last long. If you experience any serious or persistent side effect, stop
using KIN Oftaeye drops and consult your doctor urgently.
The frequency of possible side effects is defined as follows:
Very rarely, this medicine can cause serious allergic reactions.
The following symptoms may appear after application of a single dose of KIN Ofta:

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

Common side effects (affecting 1 to 10 people out of 100):

• a burning sensation in the eye,
• reduced vision or mucus in the eye.

Uncommon side effects (affecting 1 to 10 people out of 1,000):

• stinging or irritation of the eye,
• painful eyes,
• dry or inflamed eyes,
• swelling or redness (bloodshot eyes) of the conjunctiva (the front lining of the eye) or eyelids,
• unusual light sensitivity,
• itchy eyes,
• sticky eyelids,
• headache,
• rash around the eyes,
• nasal congestion or runny nose.

Rare side effects (affecting 1 to 10 people out of 10,000)

• allergic reactions, e.g. rash.

Very rare side effects (affecting less than 1 person out of 10,000)

• swelling and a feeling of 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 should be the same as
observed in adults.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.

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 through the national reporting system at
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.
Keep the bottle tightly closed.
Do not use this medicine after the expiry date which is 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 Oftamust be used within 28 days of first opening the bottle. For safe disposal of any remaining solution, 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 in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment

6. Contents of the pack and other information

What KINOftacontains

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

Description of the appearance of KINOftaand contents of the pack
Clear aqueous solution, with a greenish-yellow colour.
5 ml of solution are supplied in a 5 ml LDPE (low density polyethylene) bottle with a
LDPE dropper and an HDPE (high density polyethylene) or HDPE/ LDPE cap.

Marketing Authorisation Holder
OFF ITALIA S.R.L. OFTALMICA FARMACEUTICA ITALIA
Via G. Paisiello, 10
50144 Florence

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Portugal: Levofloxacina NTC 5 mg/ml Colírio, solução
Italy: KIN Ofta5 mg/ml eye drops, solution