Difadol 0,1%

Package Leaflet: Information for the Patient

Difadol 0.1% 1 mg/ml, eye drops, solution
Diclofenac sodium

Read the package 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 or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Difadol 0.1% and what is it used for
• 2. Important information before using Difadol 0.1%
• 3. How to use Difadol 0.1%
• 4. Possible side effects
• 5. How to store Difadol 0.1%
• 6. Contents of the pack and other information

1. What is Difadol 0.1% and what is it used for

Difadol 0.1% contains diclofenac sodium, which is a derivative of aminophenylacetic acid, belongs to the group of non-steroidal anti-inflammatory drugs, and also has analgesic properties.
Difadol 0.1% is used:

• for post-operative inflammatory conditions after cataract surgery and other surgical procedures;
• to counteract symptoms of eye pain and photophobia;
• to inhibit pupil constriction during cataract surgery;
• for the prevention of cystic edema of the macula after cataract surgery with lens implantation.

2. Important information before using Difadol 0.1%

When not to use Difadol 0.1%

• if the patient is hypersensitive to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has hypersensitivity to salicylate derivatives or other non-steroidal anti-inflammatory drugs (symptoms of hypersensitivity - asthma attacks, skin reactions, nasal mucosa inflammation).

Warnings and precautions

Before starting treatment with Difadol 0.1%, the patient should discuss it with their doctor.

• In patients taking medications that prolong bleeding time or have hemostasis disorders, as there is a potential risk of exacerbating bleeding disorders.
• Like other non-steroidal anti-inflammatory drugs, Difadol 0.1% may mask symptoms of eye infection - in such cases, the doctor will also prescribe an appropriate antibacterial agent.

Difadol 0.1% and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No interactions with eye drops containing diclofenac have been reported.
Difadol 0.1% can be safely used in combination with antibiotics, steroids, and beta-adrenergic receptor blockers.
If the patient is using another eye medicine, they should wait at least 5 minutes between instillations.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
The medicine should not be used during the last three months of pregnancy, unless the doctor decides it is absolutely necessary.
Breastfeeding
Diclofenac passes into breast milk in such small amounts that it is unlikely to cause side effects in the breastfed child.

Driving and using machines

Basically, the medicine does not affect the ability to drive or operate machines.
However, after instillation of the medicine, transient vision disturbances may occur. Patients with vision disturbances should not drive or operate machines.

Difadol 0.1% contains benzalkonium chloride

The medicine contains 0.05 mg of benzalkonium chloride per milliliter.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before instillation and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Difadol 0.1%

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Adults

Eye surgery and its complications
Before surgery: 5 times 1 drop every 3 hours.
After surgery: 3 times 1 drop per day after surgery, and for the next few days 1 drop 3 to 5 times a day, as long as necessary.
Treatment of pain and photophobia symptoms
1 drop every 4 to 6 hours.
If the pain is a result of surgery, the patient should use 1 to 2 drops 1 hour before surgery, 1 to 2 drops 15 minutes after surgery, and 1 drop every 4 to 6 hours for 3 days after surgery.

Elderly patients

No dose adjustment is necessary.

Use in children

No studies have been conducted on the efficacy and safety of the medicine in children.
Note: If the patient is using another eye medicine, they should wait at least 5 minutes between instillations. Eye ointments should be used last.

Method of administration

The medicine is intended for external use only - locally into the conjunctival sac.
Do not touch the tip of the dropper, as this may contaminate the contents of the bottle.

• 1. Before instilling the medicine, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Invert the bottle and gently press the thumb or index finger on the wall until one drop of medicine is released into the eye. Do not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, instill another one.
• 5. After instilling the medicine, gently press the inner corner of the eye for about 2 minutes. This will help prevent the medicine from being absorbed into the body.
• 6. If the doctor has prescribed instillation of the medicine into the other eye, repeat steps 3, 4, and 5.
• 7. The dropper is designed to measure drops accurately, so do not enlarge the opening of the dropper.
• 8. After instillation, replace the cap on the bottle. Do not overtighten it.

Using more than the recommended dose of Difadol 0.1%

Overdose after administration into the conjunctival sac, as well as after accidental oral ingestion, is unlikely due to the small amount of active substance.
In case of instillation of too much medicine, excess can be removed by rinsing the eye with saline or cooled boiled water.

Missing a dose of Difadol 0.1%

Do not use a double dose to make up for a missed dose.
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.
The most common side effect is a transient burning sensation of mild to moderate severity.
Rarely, itching, eye redness, and blurred vision have been observed, which occurred immediately after instillation of the medicine.
After long-term use of the medicine, cases of punctate keratitis and corneal epithelium damage have been reported.
In patients treated with corticosteroid anti-inflammatory drugs, with infection or rheumatoid arthritis, there is a risk of corneal ulceration or thinning, which in rare cases may be increased by diclofenac.
Rarely, shortness of breath and exacerbation of asthma symptoms have been reported.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Difadol 0.1%

Store in a temperature below 25°C.
Keep the bottle tightly closed, in the outer packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation "EXP" means the expiry date, and after the abbreviation "Lot" means the batch number.
After opening the bottle, do not use the medicine for more than 4 weeks.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 does Difadol 0.1% contain

• The active substance of the medicine is diclofenac sodium. Each milliliter of solution contains 1 mg of diclofenac sodium.
• The other ingredients are: polysorbate 80; boric acid; borax; sodium chloride; benzalkonium chloride solution; disodium edetate; purified water.

What Difadol 0.1% looks like and contents of the pack

Difadol 0.1% is a sterile eye drop solution, in the form of a colorless or pale yellow, clear liquid.
The medicine is available in polyethylene bottles containing 5 ml of solution, packaged in a cardboard box.

Marketing authorization holder

PHARMACEUTICAL WORKS POLPHARMA S.A.
Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Warsaw Pharmaceutical Works Polfa S.A.
Karolkowa 22/24, 01-207 Warsaw

Date of last revision of the leaflet: