1 mg / ml eye drops , solution 
diclofenac sodium

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Dicloabak is and what it is used for 
2. What you need to know before you use Dicloabak 
3. How to use Dicloabak 
4. Possible side effects 
5. How to store Dicloabak 
6. Contents of the packaging and other information 

1. What Dicloabak is and what it is used for

This medicine contains an anti-inflammatory painkiller ( NSAID ) for use in the eyes.

It is used during certain eye surgeries and after surgeries:

  • prevention of miosis ( pupil contraction ) during cataract surgery
  • prevention of inflammation after cataract surgery and after surgery on the front of the eye 
  • treatment of eye pain in photorefractive keratectomy (surgery for refractive errors such as myopia) up to 24 hours after surgery

Diclofenac sodium found in Dicloabak may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before using Dicloabak

Do not use Dicloabak

  • if you are allergic (hypersensitive) to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6).
  • if you have had allergies, urticaria (itchy hives ), acute runny nose, swelling and irritation of the nose, or asthma, started with the use of these eye drops or a similar medicine, such as anti-inflammatory painkillers or acetylsalicylic acid.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Dicloabak. You should use this medicine with caution:

  • Dicloabac, like other anti-inflammatory painkillers, can in rare cases cause anaphylactic reactions (severe allergic reactions that cause difficulty breathing and dizziness), even without prior use of the medicine.
  • You should stop treatment and contact your doctor or emergency department in case of hypersensitivity reactions or symptoms suggestive of allergy to this medicine, especially if you have asthma attacks or sudden swelling of the face and neck.
  • Before using this medicine, tell your doctor if you have asthma in combination with a chronic runny nose, chronic sinusitis, and/or nasal polyps.
  • An acute eye infection can be obscured by topical use of anti-inflammatory painkillers. Anti-inflammatory painkillers lack bactericidal properties. If an eye infection occurs, caution should be exercised when using these medicines in combination with one or more bactericidal medicines.
  • Concomitant use in the eye of anti-inflammatory painkillers and steroids (eg dexamethasone) may increase the risk of delayed healing.
  • Anti-inflammatory painkillers can delay the healing of the cornea.
  • If you tend to bleed or if you are being treated with anticoagulants(medicines that thin the blood).
  • The use of topical anti-inflammatory painkillers in high doses and for a long time can lead to corneal inflammation.
  • The risk of side effects affecting the cornea may increase in patients who have had repeated eye surgeries within a short period of time, have diabetes, a disease that affects the surface of the eye (eg chronically dry eyes), rheumatoid arthritis.
  • The use of contact lenses is not recommended immediately after cataract surgery. Consult your doctor when you can wear contact lenses again.

If your symptoms get worse or not get better, you need to see a doctor.

Other medicines and Dicloabak

If you use other eye drops at the same time as Dicloabak, you should have a 15-minute break between treatments.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

When using eye drops containing diclofenac sodium, a very low uptake into the rest of the body is expected. Nevertheless, Dicloabak should only be used during pregnancy if prescribed by a doctor. The minimum dose and the shortest possible use time should be sought.

Dicloabak can be used during breast-feeding.

Driving and using machines

You may experience short-term visual disturbances after applying Dicloabak. Do not drive or use dangerous machines until vision is normalized.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Dicloabak contains macrogol glycerol ricinoleate

Dicloabac contains macrogol glycerol ricinoleate, which may cause skin reactions (contact dermatitis).

3. How to use Dicloabak

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Dosage

The recommended dose for adults and the elderly are:

Prevention of miosis ( papillary contraction ) during cataract surgery:

  • Before surgery: apply 1 drop no more than 5 times for 3 hours before surgery

Cataract surgery and surgery on the front of the eye:

  • Before surgery: apply 1 drop no more than 5 times for 3 hours before surgery
  • After surgery: apply 1 drop 3 times immediately after the operation and then 1 drop 3-5 times daily for a maximum of 4 weeks

Eye pain during photorefractive keratectomy (myopia correction surgery):

  • Before surgery: apply 2 drops within one hour before surgery
  • After surgery: apply 2 drops within one hour after surgery and then four drops within the first 24 hours after surgery

Do not exceed the recommended dose.

Use for children:

No studies have been performed on children.

Administration

This medicine should be administered to the eye.

Do not inject, do not swallow.

The eye drops must not be administered by periocular or intraocular injection.

  1. Wash your hands thoroughly before using this medicine.
  2. Avoid touching the eye or eyelid with the tip of the bottle.
  3. Apply a drop to the eye while looking upwards and gently pulling down the lower eyelid.
  4. Close the bottle after use.
  5. After application, close the eye and press lightly with the finger in the corner of the eye closest to the nose for 2 minutes. This prevents Dicloabak from entering other parts of the body.

If you forget to use Dicloabak

Do not take a double dose to make up for a forgotten dose.

If you take more Dicloabak then you should

If you have ingested too much of the medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects have been reported:

Uncommon (may affect up to 1 in 100 people):

  • burning sensation when applying the eye drops
  • visual disturbances when applying the eye drops.

Rare (may affect up to 1 in 1,000 people):

  • hypersensitivity reaction , itching and redness
  • photosensitivity ( allergic reaction to sunlight exposure)
  • punctual keratitis (a special type of corneal inflammation ), ulcers on the cornea, thinning of the cornea
  • breathing difficulties
  • worsening asthma .

Has been reported (occurs in an unknown number of users):

  • Suva
  • red eyes, allergic inflammation of the conjunctiva, swollen eyelids
  • cough
  • hives (itching), skin rash, contact dermatitis.

Due to the fact that the medicine contains macrogol glycerol ricinoleate, skin reactions (contact dermatitis) may occur.

5. How to store Dicloabak

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

The eye drops should not be used longer than 8 weeks after opening the bottle for the first time.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is diclofenac sodium in a concentration of 1 mg / ml.
  • The other ingredients are macrogolglycerol ricinoleate, trometamol, boric acid and water for injections.

What the medicine looks like and the contents of the pack

Dicloabak is a yellowish liquid provided in a bottle containing 10 ml of eye drops , solution.

Marketing Authorization Holder and Manufacturer

Holder of approval

Laboratories THEA

12, rue Louis Blériot

63017 Clermont-Ferrand Cedex 2

France

Manufacturer

Excelvision

27, rue de la Lombardière

ZI la Lombardière

07100 Annonay

France

This medicinal product is authorized under the European Economic Area under the names:

Belgium, Bulgaria, Czech Republic, Finland, Greece, Luxembourg, Netherlands, Poland, Portugal, Spain

Denmark: Voltabak

France: Voltarenophtabak

Italy: Voltaren Ofta Abak

Norway and Austria: Voltaren Ophtha Abak

Muhammad Nadeem

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