LEVOFLOXACIN 5 mg /Ml Drops

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Levofloxacin PF RAFARM and what is it used for
3. Important information before using Levofloxacin PF RAFARM
   1. When not to use Levofloxacin PF RAFARM:
   2. Warnings and precautions
   3. Children and adolescents
   4. Levofloxacin PF RAFARM and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
4. How to use Levofloxacin PF RAFARM
   1. Use in children and adolescents
   2. Before administering the drops:
   3. Using a higher dose of Levofloxacin PF RAFARM than recommended
   4. Missing a dose of Levofloxacin PF RAFARM
   5. Accidental ingestion of Levofloxacin PF RAFARM
5. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
6. How to store Levofloxacin PF RAFARM
7. Contents of the packaging and other information
   1. What Levofloxacin PF RAFARM contains
   2. Marketing authorization holder and manufacturer
   3. Manufacturer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Levofloxacin PF RAFARM, 5 mg/ml, eye drops, solution
Levofloxacin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Levofloxacin PF RAFARM and what is it used for
• 2. Important information before using Levofloxacin PF RAFARM
• 3. How to use Levofloxacin PF RAFARM
• 4. Possible side effects
• 5. How to store Levofloxacin PF RAFARM
• 6. Contents of the packaging and other information

1. What is Levofloxacin PF RAFARM and what is it used for

Levofloxacin is an antibiotic belonging to the group of fluoroquinolones (sometimes referred to as quinolones).
The action of the medicine involves destroying certain types of bacteria that can cause infections.
Levofloxacin in the form of eye drops is used in children over one year of age and in adults to treat bacterial infections of the front surface of the eye.
One type of infection in this area of the eye is bacterial conjunctivitis, which is an infection of the membrane covering the front part of the eye (conjunctiva).
It is not recommended to use Levofloxacin PF RAFARM in children under one year of age.
If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before using Levofloxacin PF RAFARM

When not to use Levofloxacin PF RAFARM:

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

In case of doubts, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use Levofloxacin PF RAFARM, discuss it with your doctor, pharmacist, or nurse.

• if an allergic reaction occurs, even after a single dose, discontinue the use of the medicine
• if during treatment the patient observes worsening of eye symptoms, they should immediately contact their doctor
• if after the treatment period established by the doctor there is no improvement, they should contact their doctor as soon as possible
• as a rule, during an eye infection, no contact lenses should be worn

In people taking fluoroquinolones orally or intravenously, swelling and tendon rupture have been observed, especially in older patients and those treated with corticosteroids at the same time. If tendon pain or inflammation (tendinitis) occurs, discontinue the use of Levofloxacin PF RAFARM.

Children and adolescents

Special warnings and precautions for using this medicine are the same for adults, adolescents, and children over one year of age.

Levofloxacin PF RAFARM and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Before starting to use Levofloxacin PF RAFARM, inform your doctor or pharmacist if you are taking any other eye drops or ointment.
If you are using other eye drops, wait at least 15 minutes between using Levofloxacin PF RAFARM and other eye drops.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Levofloxacin PF RAFARM can be used in pregnant women only if the expected benefits outweigh the potential risk to the fetus.
Levofloxacin penetrates into the blood and breast milk in very small amounts, and after using eye drops, the likelihood of their harmful effect on the developing child is very small. The attending doctor is aware of the potential risks and will decide whether to use Levofloxacin PF RAFARM in such a situation.
Using Levofloxacin PF RAFARM according to the recommendations does not have a negative effect on fertility (the ability to become pregnant in women or have offspring in men).

Driving and using machines

Levofloxacin PF RAFARM has a minor effect on the ability to drive and use machines.
If the eye drops cause blurred vision, wait until your vision is clear before driving or using machines.

3. How to use Levofloxacin PF RAFARM

This medicine should always be used exactly as prescribed by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist.
Levofloxacin PF RAFARM is intended for administration into the eye and must be applied to the outer surface of the eye.
For patients over one year of age, the recommended dose is:

DAYS 1-2.

• Administer one to two drops into the infected eye(s) every two hours.
• Use no more than 8 times a day. DAYS 3-5.
• Administer one to two drops into the infected eye(s).
• Use no more than 4 times a day.

No dose adjustment is necessary in elderly patients.
Treatment usually lasts for five days. The attending doctor will inform the patient how long to use the drops.
If you are using any other eye medicine, wait at least 15 minutes between administering different types of eye drops.

Use in children and adolescents

No dose adjustment is necessary in adolescents and children over one year of age. It is not recommended to use Levofloxacin PF RAFARM in children under one year of age.

Before administering the drops:

• Wash your hands before opening the bottle.
• Do not use the medicine if the seal on the bottle neck has been broken before the first use.
• When using the medicine for the first time, before administering the drops into the eye, practice using the dropper bottle by slowly squeezing the bottle to administer one drop outside the eye.
• When you are sure you can administer a single drop, take a comfortable position to administer the drops (you can sit, lie on your back, or stand in front of a mirror).

Administering the drops

• 1. Hold the bottle directly by the neck and unscrew it to open the bottle. Be careful not to touch the tip of the bottle to anything (e.g., the skin around the eyes or fingers) to avoid contaminating the solution.

• 2. Tilt your head back and hold the bottle over the eye.
• 3. Pull down the lower eyelid and look up. Gently squeeze the bottle in the middle so that one drop falls into the eye. Remember that there may be a few-second delay between squeezing the bottle and the drop appearing. Do not squeeze the bottle too hard.

In case of doubts about how to administer these drops, consult your doctor or pharmacist.

• 4. Blink several times to spread the drop over the surface of the eye.

• 5. For a few minutes, press the corner of your eye near your nose with your finger. This will prevent the drops from entering the entire body.

• 6. Repeat steps 2-5 to administer a drop to the other eye, if your doctor has prescribed it. The doctor will inform you if the treatment is only for one eye and which eye is infected.
• 7. After each use and before putting the cap back on, shake the bottle, holding it upside down, without touching the dropper tip, to remove any remaining liquid from the tip. This is necessary to ensure that the next drops can be administered.

• 8. After completing the treatment as recommended by your doctor, a small amount of Levofloxacin PF RAFARM will remain in the bottle. Do not attempt to use the excess medicine remaining in the bottle after completing the treatment cycle. Do not use the eye drops after 28 days of opening the bottle.

Using a higher dose of Levofloxacin PF RAFARM than recommended

In case of using a higher dose of Levofloxacin PF RAFARM than recommended, rinse the eye(s) with water and consult a doctor or pharmacist.

Missing a dose of Levofloxacin PF RAFARM

In case of missing a dose of eye drops, administer it as soon as possible. Do not use a double dose to make up for the missed dose.

Accidental ingestion of Levofloxacin PF RAFARM

The amount of levofloxacin in the bottle is too small to cause side effects. However, in case of doubts, consult a doctor or pharmacist, who will inform you about the necessary actions.
Stopping the use of Levofloxacin PF RAFARM before the end of the recommended treatment periodmay delay the recovery process.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
About one in ten people using Levofloxacin PF RAFARM may experience side effects. Most of them are related to the eye and do not last long. If you experience any severe or prolonged side effects, stop using the eye drops and contact your doctor immediately.
It is possible, though rare, to have an allergic reaction to Levofloxacin PF RAFARM, even after a single dose. You may notice redness of the eyes, itching of the eyes, or swelling of the eyelids.
In such a case, stop using Levofloxacin PF RAFARM and contact your doctor immediately.
Common side effects(may affect up to 1 in 10 people)

• burning sensation in the eye
• worsening of vision or mucous discharge in the eye.

Uncommon side effects(may affect up to 1 in 100 people)

• stinging or irritation of the eyes
• eye pain
• dryness or discomfort of the eyes
• swelling or redness (hyperemia) of the conjunctiva (the front layer covering the eye) or eyelid
• increased sensitivity to light
• itching of the eyes
• stickiness of the eyelids
• headache
• rash around the eye
• nasal congestion or discharge.

Rare side effects(may affect up to 1 in 1000 people)

• allergic reactions, such as skin rash.

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

• swelling and pressure in the throat
• difficulty breathing

Additional side effects in children and adolescents

It is expected that the frequency, type, and severity of side effects in children and adolescents will be the same as in adults.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levofloxacin PF RAFARM

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage temperature.
Store the Levofloxacin PF RAFARM bottle in the outer carton to protect it from light.
After first opening: Levofloxacin PF RAFARM can be used for 28 days after opening the bottle.
After this time, discard the remaining drops. Store below 30°C.
Store the bottle in the outer carton to protect it from light.
Do not use this medicine if there are visible particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Levofloxacin PF RAFARM contains

The active substance of the medicine is levofloxacin. 1 ml contains 5.12 mg of levofloxacin in the form of levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
The other ingredients are: sodium chloride, hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), water for injections.
What Levofloxacin PF RAFARM looks like and what the pack contains
Levofloxacin PF RAFARM is a clear, light yellow solution, free from particles, in a white, opaque LDPE bottle with an HDPE and silicone dropper, and an HDPE cap with a tamper-evident seal, in a carton box.
Pack size: 1 bottle containing 5 ml

Marketing authorization holder and manufacturer

RAFARM S.A.
12 Korinthou Str.,
Neo Psihiko Attiki,
15451 Athens,
Greece
Tel: +30 210 6776550-1
Fax: +30 210 6776552

Manufacturer

RAFARM S.A.
Thesi Pousi –Xatzi Agiou Louka
TK 19002, ΤΘ 37 Paiania Attiki
Greece
+30 210 6643835
+30 210 6645813

Date of last revision of the leaflet: