Active ingredients: Olopatadine
OPATANOL 1 mg / mL eye drops, solution
Why is Opatanol used? What is it for?
OPATANOL is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain materials (allergens) such as pollen, house dust or animal hair can cause allergic reactions, causing itching, redness and even swelling of the surface of the eye.
OPATANOL is a medicine to treat allergic conditions of the eye. It works by reducing the intensity of the allergic reaction.
Contraindications When Opatanol should not be used
Do not use OPATANOL
- If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of this medicine
- You should not use OPATANOL if you are breast-feeding.
Precautions for use What you need to know before taking Opatanol
Talk to your doctor or pharmacist before using OPATANOL.
If you wear contact lenses, you must remove them before using OPATANOL.
Children
- Do not use OPATANOL in children under 3 years of age. Do not give this medicine to children under 3 years of age as there is no data to confirm that it is safe and will work in children under 3 years of age.
Interactions Which drugs or foods can modify the effect of Opatanol
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are using other eye drops or ophthalmic ointments, leave at least 5 minutes between using one medicine and the next. Ointments should be used last.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or conceiving possible, talk to your doctor before using OPATANOL.
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 using this medicine.
You should not use OPATANOL if you are breast-feeding: ask your doctor for advice before using this medicine.
Driving and using machines
You may have blurred vision for some time after using OPATANOL. Do not drive or operate machinery until this sensation has subsided.
OPATANOL contains benzalkonium chloride.
Benzalkonium chloride can cause eye irritation and is known to discolour soft contact lenses, so contact with soft lenses should be avoided. If you wear contact lenses, you should remove them before fitting and wait at least 15 minutes before reinserting the lenses.
Dose, Method and Time of Administration How to use Opatanol: Posology
Always use this medicine exactly as your doctor or pharmacist has told you.
If in doubt, consult your doctor or pharmacist. The recommended dose is one drop in the eye (s), twice a day - morning and evening. Use this dose, unless your doctor tells you otherwise. Only instill OPATANOL in both eyes if so directed by your doctor. doctor Use the product for the period of time specified by your doctor.
OPATANOL is to be used only as an eye drop.
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How much to use (see previous page)
- Take the OPATANOL bottle and a mirror
- Wash your hands
- Take the bottle and unscrew the cap
- After removing the cap, if the safety ring has come loose, remove it before using the product.
- Hold the bottle upside down between your thumb and middle finger
- Tilt your head back. Lower the eyelid with a clean finger until a pouch forms between the eyelid and the eye. The drop will need to be instilled here
- Bring the tip of the bottle close to your eye. Use the mirror if it helps
- Do not touch your eye, eyelid, surrounding areas or other surfaces with the dropper tip to avoid infecting the drops left in the bottle.
- Gently squeeze the base of the bottle, letting out one drop of OPATANOL at a time
- Do not squeeze the bottle - it is designed in such a way that only gentle pressure on the bottom is enough
- If you instill the drops in both eyes, repeat the same procedure for the other eye
- Replace the cap immediately after use, screwing it back on properly.
If a drop misses your eye, try again.
If you forget to use OPATANOL, instill one drop as soon as possible and then return to your normal instillation times. However, if it is almost time to instill the next dose, do not instill the missed dose and return to your normal instill times. Do not use a double dose to make up for a forgotten one.
If you stop taking OPATANOL Do not stop taking this medicine without first talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken an overdose of Opatanol
If you use more OPATANOL than you should, wash it off with warm water. Do not instill the drops again until it is time for your next dose.
Side Effects What are the side effects of Opatanol
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been observed with OPATANOL
Common: may affect up to 1 in 10 people.
Effects in the eye: eye pain, eye irritation, dry eye, abnormal eye sensation, eye discomfort.
General side effects: headache, fatigue, dry nose, bad taste
Uncommon: may affect up to 1 in 100 people.
Effects on the eye: blurred, reduced or abnormal vision, corneal disturbance, inflammation, with or without damage, of the surface of the eye, inflammation or infection of the conjunctiva, eye discharge, sensitivity to light, increased tear production, itchy eye , eye redness, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
General side effects: abnormal or reduced sensitivity, dizziness, runny nose, dry skin, inflammation of the skin.
Not known: frequency cannot be estimated from the available data
Effects on the eye: eye swelling, corneal swelling, change in pupil size
General side effects: shortness of breath, increased allergy symptoms, swelling of the face, drowsiness, generalized weakness, nausea, vomiting, sinusitis, redness of the skin and itching.
In very rare cases, some patients with severe damage to the clear layer in front of the eye (cornea) have developed opaque spots on the cornea due to calcium buildup during treatment.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach 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 the month. This medicinal product does not require any special storage conditions.
The bottle should be discarded 4 weeks after first opening to prevent possible infections and a new bottle should be used. Note the date of opening in the space provided on the bottle label and box.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other Information
What OPATANOL contains
The active ingredient is olopatadine. Each mL of solution contains 1 mg of olopatadine (as hydrochloride). The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) and / or sodium hydroxide (E524) and purified water.
Description of what OPATANOL looks like and contents of the pack
OPATANOL is a clear and colorless liquid (solution) supplied in a pack containing one 5 ml bottle or three 5 ml plastic bottles with screw caps. Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
OPATANOL 1 MG / ML EYE DROPS, SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 1 mg of olopatadine (as hydrochloride)
Excipients with known effects: Benzalkonium chloride 0.1 mg / ml.
For the full list of excipients, see 6.1
03.0 PHARMACEUTICAL FORM
Eye drops, solution (eye drops).
Clear and colorless solution.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.
04.2 Posology and method of administration
Dosage
The dose is one drop of OPATANOL in the conjunctival sac of the affected eye (s) twice daily (every 8 hours). Treatment can be extended up to four months if considered necessary.
Use in the elderly
No dose adjustment is required in elderly patients.
Pediatric population
OPATANOL can be used in pediatric patients (3 years and older) at the same dose as for adults. The safety and efficacy of OPATANOL in children under the age of 3 have not yet been established. There are no data available.
Use in patients with hepatic and renal insufficiency
Olopatadine, in the form of eye drops (OPATANOL), has not been studied in patients with liver or kidney disease. However, in case of hepatic or renal insufficiency, no dosage adjustment is considered necessary (see section 5.2).
Method of administration
For ophthalmic use only.
After the cap has been removed, if the safety ring has come loose, remove it before using the product. In order to prevent contamination of the dropper tip and the solution, take special care not to touch the eyelids, the surrounding areas. or other surfaces with the dropper tip of the bottle Keep the bottle tightly closed when not in use.
In case of concomitant therapy with other topical ocular medicinal products, a five-minute interval should be left between one administration and the next. Eye ointments should be given last.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6
04.4 Special warnings and appropriate precautions for use
OPATANOL is an antiallergic / antihistamine which, although administered topically, is absorbed systemically. In case of severe reactions or hypersensitivity, discontinue treatment.
OPATANOL contains benzalkonium chloride which may cause eye irritation.
Benzalkonium chloride has been reported to cause punctate keratopathy and / or toxic ulcerative keratopathy. Patients with dry eye or other conditions in which the cornea is compromised should be carefully monitored for frequent or prolonged use.
Contact lenses
Benzalkonium is known for the discoloring action of soft contact lenses. Avoid contact with soft contact lenses.
Patients should be advised to remove contact lenses prior to administering eye drops and to wait at least 15 minutes after instillation before reinserting contact lenses.
04.5 Interactions with other medicinal products and other forms of interaction
Interaction studies with other medicinal products have not been conducted.
Education in vitro demonstrated that olopatadine does not inhibit metabolic reactions involving cytochrome P-450 isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that olopatadine is unlikely to induce metabolic interactions with other concomitantly administered active substances.
04.6 Pregnancy and breastfeeding
Pregnancy
Data on the use of ophthalmic olopatadine in pregnant women do not exist or are limited in number.
Animal studies have shown reproductive toxicity following systemic administration (see section 5.3). Olopatadine is not recommended during pregnancy and in women of childbearing potential who are not using contraceptive measures.
Feeding time
Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3). A risk to the newborns / infants cannot be excluded.
OPATANOL should not be used during breastfeeding.
Fertility
No studies have been performed to evaluate the effect on human fertility of topical ophthalmic administration of olopatadine.
04.7 Effects on ability to drive and use machines
OPATANOL has no or negligible influence on the ability to drive or use machines.
As with any other eye drops, transient blurred vision or other visual disturbances may affect the ability to drive and use machines. If blurred vision occurs after instillation, the patient will need to wait for the vision to clear beforehand. to drive vehicles or use machines.
04.8 Undesirable effects
Summary of the safety profile.
In clinical studies in 1680 patients, OPATANOL was administered one to four times daily in both eyes for up to four months, as monotherapy or add-on therapy to 10 mg loratadine.
Approximately 4.5% of patients may experience adverse reactions associated with the use of OPATANOL; however, only 1.6% of patients discontinued the clinical trial due to these adverse reactions.
Clinical studies did not report any serious ophthalmic or systemic adverse reactions related to OPATANOL. The most frequent treatment-related adverse reaction is eye pain, reported with an overall incidence of 0.7%.
Tabular list of adverse reactions
The following adverse reactions have been reported during clinical trials and post-marketing data and are classified according to the following convention: very common (≥1 / 10), common (≥1 / 100 to
Within each frequency class, adverse reactions are listed in order of decreasing severity.
In some patients with significantly damaged cornea, cases of corneal calcification have been reported very rarely in association with the use of eye drops containing phosphates.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. in Annex V.
04.9 Overdose
There are no data on human overdose following accidental or deliberate ingestion. Olopatadine is characterized by a low order of acute toxicity in animals.
Accidental ingestion of the entire contents of a bottle of OPATANOL would result in a maximum systemic exposure of 5 mg of olopatadine. This exposure would be equivalent to a final dose of 0.5 mg / kg in a 10 kg child assuming 100% absorption.
QTc interval prolongation was observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure, indicating minimal relevance for clinical purposes. An oral dose of 5 mg was administered twice daily, for 2.5 days, to 102 young and elderly healthy male and female volunteers, with no significant prolongation of the QTc interval compared to placebo. The peak interval steady-state plasma concentrations of olopatadine (35 to 127 ng / mL) observed in this study represent a safety margin of at least 70 times for topical olopatadine with respect to effects on cardiac repolarization.
In the event of an overdose, appropriate monitoring and treatment of the patient should be undertaken.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: ophthalmologicals, decongestants and antiallergics; other antiallergics.
ATC code: S01GX09
Olopatadine is a potent and selective antiallergic / antihistamine that exerts its effect through multiple and distinct mechanisms of action. It is a histamine antagonist (the main mediator of allergic responses in humans) and prevents the production of inflammatory cytokines induced by histamine by human conjunctival epithelial cells. Data obtained from studies in vitro suggest that it can act on human conjunctival mast cells, inhibiting the release of pro-inflammatory mediators. In patients with patency of the nasolacrimal ducts, topical ocular administration of OPATANOL reduces the nasal signs and symptoms that frequently accompany seasonal allergic conjunctivitis. OPATANOL does not induce any clinically significant change in pupil diameter.
05.2 Pharmacokinetic properties
Absorption
Olopatadine, like other topically administered medicines, is absorbed systemically. However, systemic absorption of topically administered olopatadine is minimal, with plasma concentrations ranging from below the limit of quantification of the assay (
Elimination
Pharmacokinetic studies following oral administration have shown a "plasma half-life of approximately 8-12 hours, with" elimination predominantly by renal excretion. About 60-70% of the dose was recovered in the urine as the active substance. Two metabolites, mono-desmethyl and N-oxide, have been identified at low concentrations in the urine.
Since olopatadine is mainly excreted in the urine as unchanged active substance, impaired renal function modifies the pharmacokinetics of olopatadine with 2-3 times greater peak plasma concentrations in patients with severe renal insufficiency (mean creatinine clearance of 13.0 ml / min) compared to healthy adults. After an oral dose of 10 mg in patients undergoing hemodialysis (without urine flow), plasma concentrations of olopatadine were significantly lower on the day of hemodialysis than on one day of non-hemodialysis, suggesting that olopatadine can be eliminated by hemodialysis.
Studies comparing the pharmacokinetics of a 10 mg oral dose of olopatadine in young (mean age 21 years) and elderly (mean age 74 years) subjects did not show significant differences in plasma concentrations (AUC) between young and elderly subjects. , in the protein binding or urinary excretion of the unchanged active substance and metabolites.
A clinical study was conducted after oral administration of olopatadine in patients with severe renal insufficiency. The results indicate that a slightly higher plasma concentration can be expected in this population after administration of OPATANOL. Since plasma concentrations after topical ocular administration of olopatadine are 50 to 200 times lower than those observed after well tolerated oral doses, no change in dosage is expected in the elderly or in subjects with renal insufficiency. Hepatic metabolism is a minor route of elimination. It is therefore not considered necessary to change the dosage in case of hepatic insufficiency.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and reproductive toxicity.
Animal studies have shown a reduction in the growth of suckling pups from mothers treated with systemic doses of olopatadine much higher than the maximum recommended level for ophthalmic use in humans. Olopatadine was detected in the milk of lactating rats following oral administration.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Benzalkonium chloride,
sodium chloride,
disodium phosphate dodecahydrate (E339),
hydrochloric acid (E507) (to adjust the pH),
sodium hydroxide (E524) (to adjust the pH),
purified water.
06.2 Incompatibility
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
06.3 Period of validity
3 years.
Shelf life after first opening.
Discard the product four weeks after first opening.
06.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
5ml opaque low density polyethylene bottles with polypropylene screw caps (DROPTAINER).
Cartons containing 1 bottle or 3 bottles. Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
UK
08.0 MARKETING AUTHORIZATION NUMBER
ALL "MARKETING
EU / 1/02/217/001 (AIC n ° 035723016 / E)
EU / 1/02/217/002 (AIC n ° 035723028 / E)
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: May 17, 2002
Date of last renewal: 22 May 2007
10.0 DATE OF REVISION OF THE TEXT
D.CCE 24/04/2017
