Naclof

Leaflet attached to the packaging: information for the user

Naclof, 1 mg/ml, eye drops, solution

Diclofenac sodium

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 or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Naclof and what is it used for
• 2. Important information before using Naclof
• 3. How to use Naclof
• 4. Possible side effects
• 5. How to store Naclof
• 6. Package contents and other information

1. What is Naclof and what is it used for

Naclof contains diclofenac sodium, a non-steroidal anti-inflammatory drug, which also has analgesic properties.
Indications for use

• Post-operative inflammatory conditions after cataract surgery and other surgical procedures.
• Prophylaxis of cystoid macular edema after cataract surgery with lens implantation.
• Post-traumatic inflammatory conditions in cases of non-perforating eye injuries.
• Inhibition of miosis during cataract surgery.
• Prevention of pain and photophobia symptoms.

2. Important information before using Naclof

When not to use Naclof:

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if the patient has asthma, urticaria, or nasal polyps after using acetylsalicylic acid. In patients with hypersensitivity to acetylsalicylic acid, cross-sensitivity to phenylacetic acid derivatives and other non-steroidal anti-inflammatory drugs may occur.

Warnings and precautions

Ophthalmic non-steroidal anti-inflammatory drugs may mask the onset and/or development of infections through their action. In case of infection or risk of infection, an appropriate antibacterial agent should be administered simultaneously with Naclof.
Although no such cases have been reported to date, there is a possibility that in patients taking medications that prolong bleeding time or in patients with a history of coagulation disorders, the use of diclofenac may exacerbate coagulation disorders.
Care should be taken when using non-steroidal anti-inflammatory drugs, such as diclofenac, in combination with locally acting steroids (see section Naclof and other medicines).
Naclof is for external use only - locally to the conjunctival sac. It should not be administered by subconjunctival injections or directly into the anterior chamber of the eye.

Naclof contains benzalkonium chloride

The medicine contains 0.0014 mg of benzalkonium chloride in each drop, which corresponds to 0.05 mg/ml.
Contact between the medicine and soft contact lenses should be avoided.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Contact lenses should be removed before instillation and not reinserted for at least 15 minutes.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the patient should consult a doctor.

Naclof and other medicines

The concomitant use of locally acting non-steroidal anti-inflammatory drugs, such as diclofenac, and locally acting steroids in patients with significant pre-existing corneal infection may increase the risk of complications. Therefore, caution should be exercised.
Naclof has been used safely in clinical trials in combination with antibiotics and beta-blockers.
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.

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.
In the first six months of pregnancy, Naclof should not be used unless it is necessary and recommended by a doctor. If use is necessary, the smallest dose should be administered for the shortest possible time.
Naclof should not be used during the last three months of pregnancy due to the possibility of premature closure of the fetal ductus arteriosus and potential inhibition of uterine contractions.
After oral administration of diclofenac (e.g., tablets), side effects may occur in the unborn child. It is not known whether the same risk applies to Naclof when used in the eye.
After oral administration of 50 mg of diclofenac (which is equivalent to 10 packages of eye drops), trace amounts of diclofenac were found in breast milk, which should not cause side effects in the child. The use of diclofenac in the eye is not recommended during breastfeeding unless the expected benefits outweigh the potential risk.

Driving and operating machinery

Patients who experience blurred vision after using Naclof should not drive or operate machinery during this time.

3. How to use Naclof

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

Adults

• Ophthalmic surgery and its complications: 5 times 1 drop in the 3 hours before surgery. Post-operatively - 3 times 1 drop per day after surgery, and in the following days 1 drop 3 to 5 times a day, for as long as necessary.
• Treatment of pain and photophobia symptoms: 1 drop every 4 to 6 hours. If pain is a result of surgical procedure, 1 to 2 drops are administered 1 hour before the procedure, 1 to 2 drops 15 minutes after the procedure, and 1 drop every 4 to 6 hours for 3 days after surgery.

Elderly patients

No dose adjustment is necessary in elderly patients.

Use in children and adolescents

Naclof is not recommended for use in children. Limited data are available from clinical trials of strabismus surgery in children.
The package contents remain sterile if the original seal is intact. The dropper tip should not be touched to the eye or its surroundings, as this may contaminate the contents of the container.
When using another eye medicine between instillations, a minimum of 5 minutes should be allowed to elapse.
Method of use

• Wash hands before instillation.
• Remove the cap and hold the bottle with the index finger and thumb, without touching the dropper.
• Tilt the head back and direct the dropper tip to the conjunctival sac, without touching it.
• Gently press the bottle to instill 1 drop.
• Gently press the inner corner of the closed eyelid.
• Replace the cap carefully.

Pressure on the lacrimal canal or closure of the eye for 5 minutes after administration may reduce overall absorption. This reduces the risk of side effects and increases local action.

Use of a higher than recommended dose of Naclof

No cases of diclofenac overdose after its use in the form of eye drops have been reported to date.
The risk of overdose, even in the event of accidental ingestion, is virtually non-existent, as the entire 5 ml package contains 5 mg of diclofenac, which is 3% of the recommended daily dose of this medicine in adults when administered orally.

4. Possible side effects

Like all medicines, Naclof can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined as follows:

• very common: (occurring in more than 1 in 10 people);
• common: (occurring in 1 to 10 people in 100);
• uncommon: (occurring in 1 to 10 people in 1,000);
• rare: (occurring in 1 to 10 people in 10,000);
• very rare: (occurring in less than 1 in 10,000 people);
• not known: (frequency cannot be estimated from the available data).

Immune system disorders:
Frequency not known: hypersensitivity.
Eye disorders:
Very common: eye pain.
Common: eye irritation.
Uncommon: eye itching, eye redness, blurred vision, punctate keratitis.
Rare: corneal disorders, corneal ulcers, corneal thickening, corneal thinning, corneal epithelial defects, corneal edema, visual disturbances, conjunctival redness, allergic conjunctivitis, eyelid irritation, eye allergy, eyelid edema.
Frequency not known: eyelid itching.
Respiratory, thoracic, and mediastinal disorders:
Rare: worsening of asthma symptoms, dyspnea.
Frequency not known: cough and rhinitis.
Skin and subcutaneous tissue disorders:
Frequency not known: urticaria, rash, erythema, pruritus.

Reporting side effects

If side effects occur, including any side effects not listed in the 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, 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 authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Naclof

The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
After opening the package, do not use for more than 1 month.
Do not use this medicine after the expiry date stated on the carton.
Do not use damaged or opened packages.
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. Package contents and other information

What Naclof contains

• The active substance of the medicine is diclofenac sodium. 1 ml of solution contains 1 mg of diclofenac sodium.
• The other ingredients are: disodium edetate, hydroxypropyl-γ-cyclodextrin, hydrochloric acid 1M, propylene glycol, trometamol, tyloxapol, water for injections, and benzalkonium chloride - 0.05 mg/ml.

What Naclof looks like and what the package contains

Naclof is available in a polyethylene bottle with a dropper, containing 5 ml of solution, in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
LABORATOIRES THÉA
12, rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
EXCELVISION
27, rue de la Lombardière
ZI la Lombardière
07100 Annonay
France

For more information, please contact the representative of the marketing authorization holder:

Thea Polska Sp. z o.o.
ul. Cicha 7
00-353 Warsaw
Tel. +48 22 642 87 77

Date of last revision of the leaflet: 26-08-2024