What NEVANAC is and what it is used for
NEVANAC contains the active substance nepafenac and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NEVANAC is used in adults:
to prevent and relieve pain and inflammation in the eye after cataract surgery;
to reduce the risk of macular edema (swelling in the back of the eye) following cataract surgery in diabetic patients.
2. What you need to know before using NEVANAC
Do not use NEVANAC:
if you are allergic to nepafenac or any of the other ingredients of this medicine (listed in section 6);
if you are allergic to other non-steroidal anti-inflammatory drugs (NSAIDs);
if you have had asthma, skin allergy or severe inflammation of the nose when using other NSAIDs. Examples of NSAIDs are: acetylsalicylic acid, ibuprofen, ketoprofen, piroxicam, diclofenac.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using NEVANAC:
if you are easily getting bruises or have bleeding problems or have had them in the past;
if you have any other eye disorder (eg eye infection) or if you are using other ophthalmic medicines (especially topical steroids);
if you have diabetes;
if you have rheumatoid arthritis;
if you have had several eye surgery for a short period of time.
Avoid sunlight during treatment with NEVANAC.
It is not recommended to wear contact lenses after a cataract surgery. Your doctor will advise you when you will be able to use contact lenses again (see also "NEVANAC contains benzalkonium chloride").
Children and adolescents
Do not give this medicine to children and adolescents below 18 years of age because the safety and efficacy in this population have not been established.
Other medicines and NEVANAC
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
NEVANAC may affect or be affected by other medicines you are using, including other eye drops to treat glaucoma.
Also tell your doctor if you are taking medicines that reduce blood clotting (warfarin) or other NSAIDs. They may increase the risk of bleeding.
Pregnancy and breastfeeding
If you are pregnant or are likely to become pregnant, talk to your doctor before using NEVANAC.
Women who may become pregnant should use effective contraception during treatment with NEVANAC. The use of NEVANAC is not recommended during pregnancy. Do not use NEVANAC unless clearly prescribed by your doctor.
If you are breast-feeding, NEVANAC may penetrate into breast milk. No effects on the infant are expected. NEVANAC can be used during breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Do not drive or operate machinery until your vision is clear. Immediately after placement of NEVANAC you may find that your vision is temporarily blurred.
NEVANAC contains benzalkonium chloride
The Benzalkonium Chloride Preservative contained in NEVANAC can change the color of soft contact lenses and cause irritation in the eye and corneal side effects (problems on the surface of the eye). If your doctor has told you that you can still wear contact lenses, please note that you should remove them before administration and wait for at least 15 minutes before reinserting them.
3. How to use NEVANAC
Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Use NEVANAC only for your eyes. Do not swallow or inject.
The recommended dose is
One drop in the affected eye or eyes, once a day. Use at the same time each day.
When to apply and how long
Start the day before surgery on the curtain of the eye. Continue on the day of surgery. Then use the drops for as long as your doctor tells you. This may take up to 3 weeks (to prevent and relieve pain and inflammation in the eye) or up to 60 days (to prevent the development of macular edema) after your operation.
How to use it
Wash your hands before you start.
Shake well before use.
Turn the closed bottle down and shake it once before each use.
Unscrew the bottle cap.
Once the cap is removed, if it has a protective ring and is loose, remove it before using the product.
Keep the bottle pointing down between your thumb and fingers.
Tilt your head back.
Dissolve the lower eyelid with the cleared finger so that a pocket is formed between it and the eye. The drop should fall into that place.
Make the top of the bottle close to the eye. Make it in front of a mirror if that makes it easy for you.
Do not touch the eye or eyelid, the surrounding area or other surfaces with the tip of the applicator-dropper. This can pollute the drops.
Carefully squeeze the bottle until one drop separates into your eye.
If you use the drops for both eyes, repeat the same steps for the other eye. There is no need to close and shake the bottle between applications in both eyes. After use, immediately insert the bottle cap and close it well.
If the drop does not fall into the eye, try again.
If you use other eye drops, wait at least five minutes between inserting NEVANAC and the other drops.
If you use more NEVANAC than you should
Rinse your eye with warm water. Do not put more drops until the time comes for the next regular dose.
If you forget to use NEVANAC
Put one drop as soon as you remember. If it's almost time for the next dose, skip this and continue with the next dose on your regular schedule. Do not put a double dose to make up for the missed dose. Do not put more than one drop into the affected eye (s).
If you stop using NEVANAC
Do not stop using NEVANAC if you have not first been consulted with your doctor. You can usually continue taking the drops unless you get serious side effects.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
The risk of side effects affecting the cornea (eye surface problems) may be increased if you have:
complicated eye surgery;
several eye surgery for a short period of time;
some disturbances of the surface of the eye, such as inflammation or dryness in the eye;
some common diseases such as diabetes or rheumatoid arthritis.
Contact your doctor immediately if your eyes turn red or become more painful while using the drops. This may be the result of inflammation of the eye surface with or without cell loss or damage, or irritation of the colored part of the eye (iritis). These side effects have been seen in up to 1 in 100 people.
The following side effects have been reported with NEVANAC 3 mg / ml eye drops, suspension or NEVANAC 1 mg / ml eye drops, suspension, or both:
Uncommon side effects (may affect up to 1 in 100 people):
Eye side effects: inflammation of the eye surface with or without loss or damage to cells, foreign body sensation in the eyes, eyelid crust or eyelid drop.
Rare side effects (may affect up to 1 in 1,000 people):
Eye irritation: irritation of the eye, eye pain, eye discomfort, eye dryness, edema of the eyelids, eye irritation, itchy eye, eye discharge, allergic conjunctivitis (eye allergy), increased teardrop, fluid or swelling in the back of the eye, flushing of the eye;
Common side effects: dizziness, headache, allergic symptoms (eyelid edema), nausea, skin inflammation, redness and itching.
Adverse reactions of unknown frequency (can not be estimated from the available data):
Eye side effects: damage to the surface of the eye, such as thinning or perforation, impaired eye healing, scar on the eye surface, clogging, decreased vision, swelling of the eye, blurred vision;
General side effects: vomiting, increased blood pressure.
Reporting of side effects
If any of the side effects gets serious, tell your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information on the safety of this medicine.
5. How to store NEVANAC
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 25 ° C. Keep the bottle in the outer carton in order to protect from light.
Discard the bottle 4 weeks after the first opening to avoid possible infections. Write the date of opening the designated area on the cardboard label.
Do not dispose of medicines in the sewage system or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What NEVANAC contains
The active substance is nepafenac. One ml of the suspension contains 3 mg nepafenac.
The other ingredients are: boric acid, propylene glycol, carbomer, sodium chloride, guar, sodium citrate, disodium edetate, benzalkonium chloride (see section 2) and purified water. Small amounts of sodium hydroxide and / or hydrochloric acid were added to maintain a normal level of acidity (pH level).
What NEVANAC looks like and contents of the pack
NEVANAC eye drops, eye drops (liquid drops) are liquid (light yellow to dark orange suspension) and supplied in a plastic bottle with a screw cap. Each bottle can be placed in a bag.
Each pack contains one bottle of 3 ml.