Levofloxacin pf rafarm
Poland
Table of Contents
Patient Information Leaflet
Levofloxacin PF RAFARM, 5 mg/ml, eye drops, solution
Levofloxacin
Read the following information carefully before using this medicine, as it contains important information for the patient.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Table of Contents
- What Levofloxacin PF RAFARM is and what it is used for
- Important information before using Levofloxacin PF RAFARM
- How to use Levofloxacin PF RAFARM
- Possible side effects
- How to store Levofloxacin PF RAFARM
- Contents of the pack and other information
1. What Levofloxacin PF RAFARM is and what it is used for
Levofloxacin is an antibiotic belonging to a group known as fluorochinolones (sometimes referred to simply as quinolones).
The medicine works by destroying certain types of bacteria that can cause infections.
Levofloxacin eye drops are used in children over the age of one year and in adults for the treatment of bacterial infections affecting the front part of the eye.
One such infection is bacterial conjunctivitis, which is an infection of the outer membrane of the front of the eye (conjunctiva).
Use of Levofloxacin PF RAFARM is not recommended in children under one year of age.
If there is no improvement after 5 days of treatment, or if symptoms worsen, consult your doctor.
2. Important information before using Levofloxacin PF RAFARM
When not to use Levofloxacin PF RAFARM:
- if the patient is allergic to levofloxacin or to other quinolones, or to any of the other components of this medicine (listed in section 6).
If in doubt, consult a doctor or pharmacist.
Warnings and precautions
Before starting treatment with Levofloxacin PF RAFARM, discuss this with your doctor,
pharmacist, or nurse.
- if an allergic reaction occurs, even after a single dose, discontinue use of the medicine immediately
- if during treatment the patient notices worsening of eye-related symptoms, they should contact a doctor immediately
- if there is no improvement after the treatment period agreed with the doctor, contact the doctor as soon as possible
- in general, during eye infection, no type of contact lenses should be worn
In patients taking fluorochinolones orally or intravenously, tendon swelling and rupture have been observed, especially in elderly patients and in patients concurrently treated with corticosteroids. If tendon pain or swelling (tendonitis) occurs, discontinue use of Levofloxacin PF RAFARM.
Children and adolescents
Special warnings and precautions for use of this medicine are the same for adults,
adolescents, and children aged 1 year and older.
Levofloxacin PF RAFARM and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Before starting treatment with Levofloxacin PF RAFARM, inform your doctor or pharmacist if the patient is using any other eye drops or eye ointment.
If the patient is using other eye drops, they should wait at least 15 minutes between applying Levofloxacin PF RAFARM and other eye drops.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Levofloxacin PF RAFARM may be used in pregnant women only when the expected benefits outweigh the potential risks to the fetus.
Levofloxacin passes into blood and human milk in very small amounts; however, after administration of eye drops, the likelihood of harmful effects on the developing child is very low. The treating physician is aware of potential risks and will decide whether Levofloxacin PF RAFARM should be used in such a case.
When used as directed, Levofloxacin PF RAFARM has no adverse effect on fertility (the ability to conceive in women or to father children in men).
Driving and operating machinery
Levofloxacin PF RAFARM has a minor influence on the ability to drive and operate machinery.
If the eye drops cause blurred vision, wait until full visual acuity is restored before driving or operating machinery.
3. How to use Levofloxacin PF RAFARM
This medicine should always be used exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.
Levofloxacin PF RAFARM is intended for ocular administration and must be applied to the outer surface of the eye.
The recommended dose for patients over 1 year of age is as follows:
DAYS 1–2:
- Instill one to two drops into the infected eye(s) every two hours.
- Use a maximum of 8 times per day.
DAYS 3–5: - Instill one to two drops into the infected eye(s).
- Use a maximum of 4 times per day.
Dose adjustment is not required in elderly patients.
Treatment usually lasts five days. Your doctor will inform you how long you should continue using
the drops.
If you are using any other eye medication, wait at least 15 minutes between administering different types of eye drops.
Use in children and adolescents
Dose adjustment is not required in children and adolescents aged 1 year and older. Levofloxacin PF RAFARM is not recommended for use in children under 1 year of age.
Before administering the drops:
- Wash your hands before opening the bottle.
- Do not use the medicine if the tamper-evident seal on the bottle neck is broken before first use.
- At first use, before administering the eye drops, practice using the dropper bottle by slowly squeezing it to release one drop outside the eye.
- Once you are confident you can administer a single drop, assume a comfortable position for instillation (you may sit, lie on your back, or stand in front of a mirror).
Administering the drops
- Hold the bottle by the cap and unscrew it to open. To avoid contaminating the solution, take special care that the tip of the bottle does not touch anything (e.g. skin around the eyes or fingers).
- Tilt your head backward and hold the bottle over the eye.
- Pull down the lower eyelid and look upward. Gently squeeze the center of the bottle so that one drop falls into the eye. Remember that there may be a delay of several seconds between squeezing the bottle and the drop appearing.
If you have any doubts about how to administer these drops, consult your doctor or pharmacist.
- Blink several times to spread the drop over the surface of the eye.
- Press gently with your finger on the inner corner of the eye next to the nose for a few minutes. This helps prevent the drops from being absorbed into the rest of the body.
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Repeat steps 2–5 to administer a drop into the other eye, if instructed by your doctor. Your doctor will inform you if treatment is only required in one eye, and if so, which eye is affected.
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After each use and before replacing the cap, shake the bottle gently while holding it upside down, without touching the dropper tip, to remove any residual liquid from the tip. This is necessary to ensure subsequent drops can be administered properly.
- After completing treatment as directed by your doctor, a small amount of Levofloxacin PF RAFARM will remain in the bottle. Do not attempt to use any excess medicine remaining in the bottle after treatment has ended. Do not use the eye drops more than 28 days after the first opening of the bottle.
Use of more than the recommended dose of Levofloxacin PF RAFARM
If more than the recommended dose of Levofloxacin PF RAFARM is used, rinse the eye(s) with water and consult your doctor or pharmacist.
Missed dose of Levofloxacin PF RAFARM
If you miss a dose of eye drops, administer it as soon as possible. Do not use a double dose to make up for a missed dose.
Accidental ingestion of Levofloxacin PF RAFARM
The amount of levofloxacin in the bottle is too small to cause adverse effects. However, if in doubt, consult your doctor or pharmacist, who will advise you on necessary actions.
Stopping Levofloxacin PF RAFARM before the recommended treatment period is completed may delay recovery.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects occur in approximately one out of ten people after using Levofloxacin PF RAFARM.
Most of these side effects affect only the eye and do not last long. If the patient experiences any severe or persistent side effects, use of these eye drops should be discontinued and medical advice should be sought immediately.
An allergic reaction to Levofloxacin PF RAFARM, although rare, is possible even after a single dose.
The patient may notice redness of the eyes, itching of the eyes, or eyelid swelling.
In such a case, use of Levofloxacin PF RAFARM should be stopped immediately and medical advice should be sought without delay.
Common side effects (may occur in up to 1 in 10 people)
- Burning sensation in the eye
- Blurred vision or mucus discharge from the eye
Uncommon side effects (may occur in up to 1 in 100 people)
- Stinging or irritation of the eye
- Eye pain
- Dryness or discomfort of the eye
- Swelling or redness (conjunctival hyperaemia) of the conjunctiva (the front layer covering the eye) or eyelid
- Light sensitivity
- Itching of the eye
- Sticky eyelids
- Headache
- Rash around the eye
- Nasal congestion or nasal discharge
Rare side effects (may occur in up to 1 in 1,000 people)
- Allergic reactions such as skin rash
Very rare side effects (may occur in less than 1 in 10,000 people)
- Swelling and tightness in the throat
- Breathing difficulties
Additional side effects in children and adolescents
The frequency, type, and severity of side effects expected in children and adolescents are considered to be the same as in adults.
Reporting of side effects
If any side effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps to provide more information on the safety of the medicine.
5. How to store Levofloxacin PF RAFARM
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and outer cardboard
pack after "EXP". The expiry date refers to the last day of the specified month. This
medicinal product does not require any special storage temperature.
Store the Levofloxacin PF RAFARM bottle in the outer cardboard box to protect it from light.
After first opening: Levofloxacin PF RAFARM may be used for 28 days after the first opening of the bottle.
After this period, any remaining drops should be discarded. Store below 30°C.
Keep the bottle in the outer cardboard box to protect it from light.
Do not use this medicine if insoluble particles are visible in the solution. Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures will help protect the environment.
6. Contents of the package and other information
What Levofloxacin PF RAFARM contains
The active substance is levofloxacin. 1 ml contains 5.12 mg of levofloxacin as levofloxacin hemihydrate, equivalent to 5 mg of levofloxacin.
The other components are: sodium chloride, hydrochloric acid concentrated (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
What Levofloxacin PF RAFARM looks like and contents of the pack
Levofloxacin PF RAFARM is a clear, light yellow solution free from solid particles, contained in a white, opaque bottle made of LDPE, with a dropper made of HDPE and silicone, and a closure made of HDPE with a tamper-evident seal, packed in a cardboard box.
Pack size: 1 vial containing 5 ml
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TACTICA Pharmaceuticals Sp. z o.o.
Królowej Jadwigi Street 148a/1a
30-212 Kraków
Tel.: +48 889 388 538
{Logo of the Marketing Authorisation Holder}
Manufacturer
RAFARM S.A.
Thesi Pousi –Xatzi Agiou Louka TK
19002, ΤΘ 37 Paiania Attiki
Greece
+30 210 6643835
+30 210 6645813