NACLOF Kolir 5 ml
Naclof is nonsteroidal anti-inflammatory composition for topical application to the eye. The active substance of Naclof is diclofenac sodium. Like all medicines, besides the active substance, Naclof contain excipients. They are:
- Preservative benzalkonium chloride
- Other excipients: disodium edetate, hydroxypropyl-gamma-cyclodextrin (HP / -CD), hydrochloric acid, propylene glycol, trometamol, tyloxapol, water for injections.
How does Naclof?
Naclof comprises diclofenac sodium, a non-steroidal anti-inflammatory compound with analgesic properties. Has expressed activity to inhibit prostaglandin synthesis and believes that this is important for its mechanism of action.
Clinical studies have shown that diclofenac inhibits miosis during cataract surgery and reduces ocular inflammation and pain associated with corneal epithelial defects after some types of surgery.
No data diclofenac to have any side effects on wound healing.
Naclof contains a cyclodextrin, hydroxypropyl-y-cyclodextrin. Cyclodextrins increase the water solubility of some lipophilic, water-insoluble substances. It is believed that cyclodextrins act as true vectors by trapping hydrophobic molecules of the drug in the solution and releasing them on the surface of biological membranes.
What is Naclof?
• Post-operative inflammation in cataract surgery and other surgical interventions.
• Alleviation of eye pain and photophobia.
• Post-traumatic inflammation in non-invasive injuries ..
• Inhibition of miosis during cataract surgery.
• Prevention of cystoid macular edema, arising after extraction of the lens in cataract and implantation of new ocular lens.
2. BEFORE YOU USE NACLOF
Do not use Naclof:
• If you have or previously had hypersensitivity to the active substance or to any of the excipients
• If you have asthma, urticaria or acute rhinitis, your symptoms may be intensified due to inhibition of prostaglandin synthesis.
• If you have or have had hypersensitivity reactions to acetylsalicylic acid, derivatives of phenylacetate and other NSAIDs.
Be especially careful when using Naclof:
• anti-inflammatory activity of ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) may mask the onset and / or progression of ocular infections. If you have an eye infection, your doctor will prescribe you a treatment that can apply simultaneously Naclof.
• If you get drugs that prolong bleeding time (anticoagulants) or you have bleeding problems, tell your doctor about it.
• eye drops are not for injection. They should never be injected into the eye.
• If you wear soft contact lenses. The lenses must be removed before dispensing and can be placed again at least 15 minutes afterwards.
• If you are pregnant or planning to become pregnant
• If you are breastfeeding
Tell your doctor before you start treatment with Naclof.
Use in elderly patients
Naclof can be used by the elderly.
Use in children
Operation of Naclof in children has not been studied, therefore not recommended for use in children 2 years and older.
Naclof stop taking and consult your doctor if you become pregnant during treatment with this medicine.
Ask your doctor or pharmacist before taking any medications during pregnancy.
Tell your doctor if you are breast-feeding before starting to use Naclof.
Seek advice to your doctor or pharmacist before taking any medicine while breast-feeding.
Driving and using machines
Naclof can cause blurred vision If you experience these symptoms, you should not drive or operate machinery.
Taking other medicines
Tell your doctor or pharmacist about any other medicine you are taking.
Interactions with other medicines have not been reported so far.
Naclof been administered in clinical trials safely in combination with steroids, antibiotics and beta-blockers for use in the eye.
3. HOW TO USE NACLOF?
Dispenser remains sterile until the original closure. Do not touch the end of the applicator to the eye or surrounding structures as this may contaminate the solution.
If necessary, the application of more than one drug in the eye, it must be ensured 5-minute interval between administration of each drug.
If you wear contact lenses need to download them before instillation of Naclof and wait 15 minutes after that, before putting them back.
Your doctor or pharmacist will tell you exactly how to apply Naclof. Strictly follow the instructions of your doctor or pharmacist.
A) Ocular surgery and complications:
Preoperatively: up to 5 times in 1 drop within 3 hours before the operation.
Postoperatively 3 times in 1 drop per day of the operation, and subsequently 3-5 times 1 drop a day, as needed.
B) Alleviation of pain and sensitivity to light (Photophobia):
One drop of 4-6 hours.
When pain is due to a surgical procedure (eg. A refractive surgery), 1-2 drops within one hour prior to surgery, 1 to 2 drops within the first 15 min. After the operation and 1 drop every 4 to 6 hours during the next 3 days .
There is no evidence that the dose should be adjusted in elderly patients.
No studies have been performed in pediatric patients.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS OF NACLOF?
Like all medicines Naclof can have some side effects.
The most common side effect is transient, mild to moderate burning sensation in the eye.
Other, less common side effects include itching, redness of the eye, blurred vision immediately after instillation of the eye drops.
Keratitis punctata or corneal epithelial defects are observed, usually after frequent application.
In patients at risk for corneal ulcers and thinning, as seen in the use of corticosteroids or in patients with concomitant diseases (such as infections or rheumatoid arthritis), in rare cases, diclofenac has been associated with corneal ulcer or thinning. Most patients were treated for a prolonged period of time.
In rare cases have been reported dyspnoea and exacerbation of asthma.
If you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
No evidence of overdose Naclof. Accidental ingestion of Naclof no risk of adverse effects as a pack of 5 ml contains 5 mg of diclofenac sodium, which is equivalent to 3% of the recommended maximum daily dose for oral administration.
The recommended oral dose of diclofenac to children is 2 mg / kg body weight.
5. HOW TO STORE NACLOF?
Close the bottle immediately after use.
Do not use for more than one month after first opening.
Do not store above 25 * C.
Medicines should be kept out of reach of children.