Ofloxacin-pos

Warnings and precautions

Before starting to use Ofloxacin-POS, discuss it with your doctor:

Long-term use of this medicine may lead to the development of a new bacterial infection that is resistant to Ofloxacin-POS. When using eye drops containing ofloxacin, avoid excessive exposure to sunlight or ultraviolet radiation (e.g. quartz lamps, solarium, etc.) (potential light hypersensitivity reactions). Contact lenses should not be worn during eye infection treatment. Tendonitis and tendon rupture have occurred in people taking fluoroquinolones orally or intravenously, especially in older patients and those treated with corticosteroids at the same time. Treatment with Ofloxacin-POS should be discontinued if pain or swelling of the tendon (tendinitis) occurs.

When to be particularly cautious when using Ofloxacin-POS.

Important information before using Ofloxacin-POS

Heart disease

When using this type of medicine, caution should be exercised if you or your family members have a prolonged QT interval (visible on an ECG, a record of the heart's electrical activity), you have an electrolyte imbalance (especially low potassium or magnesium levels in the blood), you have a very slow heart rate (called 'bradycardia'), you have a weak heart (heart failure), you have had a heart attack (myocardial infarction), you are a woman or an elderly person, or you are taking other medicines that can cause abnormal changes on the ECG (see section Using Ofloxacin-POS with other medicines).

Children and adolescents

The product can be used in children. The safety and efficacy of the medicine in children under 1 year of age have not been studied.

Other medicines and Ofloxacin-POS

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Inform your doctor about taking other medicines that affect heart rhythm: medicines belonging to the group of anti-arrhythmic drugs (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antibacterial drugs (belonging to the group of macrolides), some antipsychotic drugs. Edition 04/2020

• 1.3.1 SPC, labelling and package leaflet If other eye drops or ointments are used in addition to Ofloxacin-POS, a 15-minute interval should be maintained between administrations of the medicines. Eye ointment should always be used as the last preparation.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using Ofloxacin-POS. The doctor will decide whether you can use Ofloxacin-POS. It is not recommended to use Ofloxacin-POS in pregnant women. Before using any medicine, consult your doctor or pharmacist.

Driving and using machines

Temporary blurred vision may occur for a few minutes after administering the preparation to the eye. During this time, do not drive vehicles, operate machines, or perform work without stable support for your feet.

Ofloxacin-POS contains benzalkonium chloride.

The medicine contains 0.125 mg of benzalkonium chloride in every 5 ml, which corresponds to 0.025 mg/ml. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and waited at least 15 minutes before reinserting. Benzalkonium chloride can also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer on the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, consult your doctor.

3. HOW TO USE OFLOXACIN-POS

This medicine should always be used exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Dosage

For the first two days, it is recommended to administer 1 drop of Ofloxacin-POS to the affected eye(s) every 2-4 hours, and then use the medicine four times a day. To be effective, Ofloxacin-POS must be taken regularly.

Method of administration

• 1. Wash your hands.
• 2. Gently dry the skin around the eyes with a clean, disposable cloth (Fig. 1).
• 3. Unscrew the cap and check if the dropper is clean.
• 4. Tilt your head slightly back and gently pull the lower eyelid down (Fig. 2).
• 5. Instill 1 or 2 drops of the medicine into the conjunctival sac (Fig. 3). Do not touch the eye with the dropper tip.
• 6. Release the eyelid and gently press the inner corner of the eye from the side of the nose (Fig. 4). Then, while still pressing with your finger, perform a few gentle blinks to spread the drops over the surface of the eye.
• 7. Gently wipe away any excess medicine with a cloth.
• 8. Repeat the above steps when instilling the medicine into the other eye.

Edition 04/2020

• 1.3.1 SPC, labelling and package leaflet

Fig. 1
Fig. 2
Fig. 3
Fig. 4
If the drop does not get into the eye, try again.
To prevent contamination, do not allow the dropper tip to come into contact with the eye and other objects.
Immediately after use, put the cap back on and tighten the bottle.
Proper instillation into the eye is very important. If you have any questions, consult your doctor or pharmacist.

Duration of treatment

Treatment should not last longer than 14 days. If symptoms persist after this time, consult your doctor.

Use in children

The product can be used in children. The safety and efficacy of the medicine in children under 1 year of age have not been studied.

Using a higher dose of Ofloxacin-POS than recommended

In case of using a higher dose of the medicine than recommended, rinse your eyes with clean water. The next dose should be used at the usual time.

If you have any further doubts about using this medicine, consult your doctor.

Missing a dose of Ofloxacin-POS

If you miss a dose, use the medicine as soon as you remember, but if it is almost time for the next dose, skip the missed dose and continue using the medicine as usual. Do not use a double dose to make up for the missed dose.

Stopping treatment with Ofloxacin-POS

Ofloxacin-POS should be used as directed by your doctor.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of an allergic reaction (including swelling of the skin and mucous membranes, neck/throat or tongue, and shortness of breath), discontinue use of the medicine and contact your doctor immediately.
Edition 04/2020

• 1.3.1 SPC, labelling and package leaflet Severe side effects with unknown frequency (which cannot be estimated from the available data): During the use of ofloxacin eye drops, life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported, initially appearing as red spots or oval patches on the torso, often with blisters in the center.

Eye irritation and discomfort in the eye are common side effects (may occur in 1 in 10 people).
The frequency of the following side effects is not known.
You should consult your doctor if any of the following side effects cause you problems or do not go away on their own:
Eye disorders:
eye redness/eye allergy,
itching,
blurred vision,
increased tearing,
dry eye,
eye pain,
increased sensitivity to light,
swelling around the eyes (including eyelid swelling)
General disorders:
allergic reaction,
dizziness,
numbness,
nausea,
headache,
facial swelling.

Heart disease

Unknown frequency: Abnormal, rapid heart rhythm, life-threatening irregular heart rhythm, change in heart rhythm (called 'prolonged QT interval', visible on an ECG, a record of the heart's electrical activity).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the national reporting system:
Department for the Surveillance of Adverse Reactions to Medicinal Products, Medical Devices and Biocides
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Edition 04/2020

• 1.3.1 SPC, labelling and package leaflet

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OFLOXACIN-POS

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after: EXP. The expiry date refers to the last day of the month stated.
The bottle should be discarded no later than four weeks after first opening, even if there are still drops left in it.
Do not store above 25°C.
Keep the container in the outer packaging to protect from light.
Do not use the medicine if you notice a greenish-yellow discoloration of 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 PACK AND OTHER INFORMATION

What Ofloxacin-POS contains

The active substance of the medicine is ofloxacin at a concentration of 3 mg/ml.
The other ingredients are: benzalkonium chloride, sodium chloride, hydrochloric acid, and sodium hydroxide (for pH adjustment), water for injections.

What Ofloxacin-POS looks like and what the pack contains

Ofloxacin-POS is a clear eye drop solution with a light yellow or slightly greenish-yellow color, available in a plastic bottle with a dropper and cap.
One carton contains one plastic bottle of 5 ml.

Marketing authorization holder and manufacturer

Marketing authorization holder:

URSAPHARM Poland sp. z o. o.
ul. Malarska 6,
05-092 Łomianki, Poland
Phone: 22 732 07 90
Fax: 22 732 07 99
E-mail: [email protected]

Manufacturer:

URSAPHARM Arzneimittel GmbH, Industriestraße 35, 66129 Saarbrücken, Germany
Edition 04/2020

• 1.3.1 SPC, labelling and package leaflet

Date of the last update of the leaflet:

Edition 04/2020