Nolok

Patient Information Leaflet: Information for the User

NOLOK 5 mg/ml eye drops, suspension, 5 mg/ml eye drops, suspension in single-dose container

Loteprednol Etabonate
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NOLOK is and what it is used for
2. What you need to know before using NOLOK
3. How to use NOLOK
4. Possible side effects
5. How to store NOLOK
6. Contents of the pack and other information

1. What NOLOK is and what it is used for
NOLOK is an eye drop suspension.
NOLOK is used to treat post-operative inflammation of the eye.
Sometimes the eye can become inflamed (red and painful). Loteprednol Etabonate belongs to a group of medicines called corticosteroids. It works by reducing inflammation and relieving symptoms.
Since it is used in small doses directly on the affected area, its action is mainly limited to the site of application.

2. What you need to know before using NOLOK
Do not use NOLOK:

• if you are allergic to the active substance (Loteprednol Etabonate) or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to any corticosteroid;
• if you have eye diseases caused by viruses, such as herpes simplex, vaccinia, or varicella;
• if you have eye diseases caused by mycobacteria or fungi;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using NOLOK.
Tell your doctor if you have glaucoma.
Contact your doctor if you experience blurred vision or other visual disturbances.
Inform your doctor if you develop eye pain, or if redness, itching, or inflammation worsen.
Consult your doctor if symptoms do not improve within the first two days. Your doctor may wish to reassess your condition.
You should not use NOLOK for longer than ten days unless your doctor has checked your eye pressure.
Long-term use of NOLOK or other steroid-containing eye drops may cause glaucoma or increase intraocular pressure, leading to optic nerve damage, visual problems, and cataract.
Long-term use of NOLOK or other steroid-containing eye drops may reduce resistance to infections and increase the risk of developing eye infections, including herpes simplex.
The use of steroid eye drops such as NOLOK may worsen and prolong the duration of viral eye diseases.

Contact lenses
Wearing contact lenses after cataract surgery is not recommended.
If you normally wear contact lenses, your doctor will likely advise you to wear glasses for a certain period after cataract surgery. This allows the eyes to heal properly after surgery. Your doctor will inform you when you can start wearing contact lenses again (see also “NOLOK in 5 ml bottle contains benzalkonium chloride”).

Other medicines and NOLOK
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, inform your doctor if you are using:

• medicines known as anticholinergics (used to treat various conditions such as abdominal cramps, muscle spasms, urge incontinence, or asthma),
• eye drops used to treat high intraocular pressure. Some medicines may increase the effects of NOLOK, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
You may still be prescribed NOLOK, but an alternative treatment may also be considered.
NOLOK must not be used during breastfeeding.

Driving and using machines
The eye drops may blur your vision. This usually passes quickly. Do not drive or operate machinery until your vision has returned to normal.

NOLOK in 5 ml bottle contains benzalkonium chloride.
This medicine, in the 5 ml bottle pack, contains 0.1 mg of benzalkonium chloride per 1 ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may cause discoloration. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outer layer of the eye). If you experience an unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.

3. How to use NOLOK
Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults and elderly patients is 1–2 drops four times a day.
Treatment with NOLOK usually starts 24 hours after surgery and continues for two weeks.

Use in adults:
5 ml bottle
Do not use the bottle if the seal around the cap is broken before first opening.
Wash your hands thoroughly before opening the bottle. Tilt your head back and look at the ceiling.

1. Shake the NOLOK bottle well before use.
2. Look upwards and gently pull down the lower eyelid of the affected eye(s) (fig.1).
3. Instil one or two drops of NOLOK into the space between the eyeball and the eyelid, four times a day or as prescribed by your doctor (fig.2).
4. Release the lower eyelid (fig.3).
5. Avoid letting the bottle tip touch any surface, as this may contaminate the medicine.
6. Close the bottle immediately after use.

Your doctor will advise you on the duration of treatment with NOLOK.
Do not stop treatment without first consulting your doctor.

Single-dose containers of 0.30 ml
Before use, ensure the single-dose container is intact.
Wash your hands thoroughly before opening the container.

1. Detach the single-dose container from the strip (fig. 1).
2. Hold the single-dose container by the base and shake downwards (fig. 2).
3. Open by twisting the top and pulling (fig. 3).
4. Look upwards and gently pull down the lower eyelid of the affected eye(s).
5. Turn the container upside down and squeeze to instil one or two drops of NOLOK into the space between the eyeball and the eyelid, four times a day or as prescribed by your doctor (fig. 4).

Avoid letting the tip of the container touch the eye, surrounding tissue, or anything else to prevent eye infections. After administration, do not use any remaining suspension left in the single-dose container.

Use in children and adolescents
NOLOK should not be used in children and adolescents until further data are available.

If you use more NOLOK than you should
Inform your doctor or pharmacist.

If you forget to use NOLOK
Do not use a double dose to make up for the missed dose.
Wait until the next scheduled dose and continue as normal.

If you stop using NOLOK
Use this medicine exactly as your doctor has instructed. Do not stop using NOLOK without first talking to your doctor.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.

If you experience any of the following symptoms: redness, itching or swelling of the membrane covering the white part of the eye and/or the eyelid(s), or general symptoms such as difficulty breathing, difficulty swallowing, facial redness or flushing, and swelling of the face or tongue, you must stop using this medicine and seek immediate medical help.
These may be signs of a serious allergic reaction.
Because you may require urgent medical treatment, contact your doctor immediately if you experience any of the following adverse events:

• worsening of eye pain, especially when exposed to bright light, and eye redness during treatment with this medicine. This may be due to inflammation of the coloured part of the eye, called iritis – uncommon side effect (may affect up to 1 in 100 people),
• lump or thickening in any area of the breast, changes in size, shape or sensitivity of the breast, swelling or lump under the arm, or changes in the shape of the nipple. These may be symptoms of breast cancer, which is a rare side effect (may affect up to 1 in 1,000 people),
• involuntary muscle contraction (muscle twitching) – rare side effect (may affect up to 1 in 1,000 people),
• nervousness – rare side effect (may affect up to 1 in 1,000 people),
• ringing or noise (buzzing) in the ears (tinnitus) – rare side effect (may affect up to 1 in 1,000 people),
• chest pain – rare side effect (may affect up to 1 in 1,000 people).

The following side effects listed below may occur during treatment with this medicine:
Common side effects (may affect up to 1 in 10 people):
Ocular side effects:
corneal defects, eye discharge, eye discomfort, dry eye, tearing, sensation of foreign body in the eye, eye redness, eye itching, burning sensation at the site of instillation, and increased intraocular pressure.
General side effects:
headache.

Uncommon side effects (may affect up to 1 in 100 people):
Ocular side effects:
abnormal vision, conjunctival swelling, conjunctivitis, eye irritation, eye pain, mild elevation of the conjunctiva, light sensitivity, eye inflammation, inflammation of the cornea and conjunctiva, eye infection, and lens opacity.
General side effects:
fatigue, runny nose, and sore throat.

Rare side effects (may affect up to 1 in 1,000 people):
General side effects:
migraine, taste distortion, dizziness, numbness, feeling cold, fever and pain, cough, urinary tract infection or inflammation, hives, rash, dry skin, eczema, diarrhoea, nausea and vomiting, weight gain.

Not known: frequency cannot be estimated from the available data:
Ocular side effects: blurred vision.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NOLOK

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
5 ml bottle
Store the container in an upright position.
After opening the multidose bottle, use the medicine within 28 days from the date of opening.
0.30 ml single-dose containers
After first opening the aluminium pouch, use the containers within 10 days; after this period, the containers must be discarded. The single-dose medicine must be used immediately after opening; any remaining medicine must be discarded.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NOLOK contains
5 ml bottle

• The active substance is Loteprednol Etabonate. Each ml contains 5 mg (0,5%) of Loteprednol Etabonate.
• The excipients are: Disodium Edetate, Glycerol, Povidone, Purified Water and Tyloxapol.
• Benzalkonium Chloride (0.1 mg/ml) is added as a preservative.
• Sodium Hydroxide is added to adjust the pH.

Single-dose containers of 0.30 ml

• The active substance is Loteprednol Etabonate. Each ml contains 5 mg (0.5%) of Loteprednol Etabonate.
• The excipients are: Disodium Edetate, Glycerol, Povidone, Purified Water and Tyloxapol.
• Sodium Hydroxide is added to adjust the pH.

Description of the appearance of NOLOK and contents of the pack
NOLOK is a milky ophthalmic suspension.
NOLOK is available in:

• Pack containing 1 multidose polyethylene bottle of 5 ml with dropper and cap with tamper-evident seal;
• Pack containing 30 single-dose polyethylene containers of 0.30 ml.

Marketing Authorisation Holder and Manufacturer
ALFA INTES Industria Terapeutica Splendore S.r.l.
Via Fratelli Bandiera, 26
80026 Casoria (NA)
Italy