Olopatadine misom
Poland
Table of Contents
Package leaflet: Information for the patient
Olopatadine Misom, 1 mg/mL, eye drops, solution
olopatadine
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents
- What Olopatadine Misom is and what it is used for
- Important information before using Olopatadine Misom
- How to use Olopatadine Misom
- Possible side effects
- How to store Olopatadine Misom
- Contents of the pack and other information
1. What Olopatadine Misom is and what it is used for
Olopatadine Misom is indicated for the treatment of objective and subjective symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis
Certain substances (allergens), such as plant pollen, house dust or animal fur, may cause allergic reactions manifested by itching, redness and swelling of the eye surface.
Olopatadine Misom is a medicine used in the treatment of allergic eye diseases. Its action consists of reducing the severity of allergic reactions.
2. Information before using Olopatadine Misom
When not to use Olopatadine Misom:
- If the patient is allergic to olopatadine or any of the other ingredients of this medicine (listed in section 6).
- Do not use Olopatadine Misom if the patient is breastfeeding.
Warnings and precautions
Before starting treatment with Olopatadine Misom, discuss this with a doctor or pharmacist.
If the patient wears contact lenses, they should be removed before administering Olopatadine Misom.
Children
- Do not use Olopatadine Misom in children under 3 years of age. This medicine should not be given to children under 3 years of age, as there is no data on safety and efficacy in children under 3 years of age.
Olopatadine Misom and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
If the patient is using other eye drops or ointments at the same time, at least a 5-minute interval should be maintained between administration of each product. Ophthalmic ointments should be administered last.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not use Olopatadine Misom if the patient is pregnant or breastfeeding. Consult a doctor before using this medicine.
Driving and operating machinery
For a short time after instilling Olopatadine Misom, vision may become blurred. Do not drive or operate machinery until this effect has passed.
Olopatadine Misom contains benzalkonium chloride
The medicinal product contains 0.1 mg of benzalkonium chloride per 1 mL of solution.
One drop of solution (approximately 0.03 mL) contains 0.003 mg of benzalkonium chloride.
The preservative benzalkonium chloride contained in Olopatadine Misom may be absorbed by soft contact lenses and may change their color. Contact lenses should be removed before instillation, and at least 15 minutes should be waited before reinserting them.
Benzalkonium chloride may also cause eye irritation, particularly in patients with dry eye or corneal disorders (the transparent front part of the eye). If unusual sensations, stinging, or eye pain occur after using this medicine, consult a doctor.
Olopatadine Misom contains phosphate buffer
This medicine contains 3.34 mg of disodium phosphate per 1 mL of solution.
One drop of solution (approximately 0.03 mL) contains 0.1 mg of disodium phosphate.
In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, very rarely, during treatment, cause corneal clouding due to calcium deposition.
3. How to use Olopatadine Misom
This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose is one drop in the affected eye or eyes, twice daily – in the morning and evening.
Use the drops as described above unless your doctor has instructed you otherwise.
Olopatadine Misom should be used in both eyes only if specifically advised by your doctor. Continue using the medicine for as long as your doctor recommends.
Olopatadine Misom is for ocular use only.
Instructions for use
Opening the bottle for the first time
- Before first use, check that the security ring between the bottle and the cap is intact (Fig. 1).
- Before first opening, break the security seal by tearing the ring (Fig. 2).
- To open the bottle, unscrew the cap by turning it counterclockwise (Fig. 3).
- To close the bottle, replace the cap and screw it on clockwise after each use (Fig. 4).
After opening the bottle as described above, follow the instructions below for administering the eye drops.
How to use eye drops
To correctly administer eye drops, it may be helpful to use a mirror during instillation, especially at first.
- Wash your hands.
- Remove the cap by turning it counterclockwise (Fig. 3).
- Hold the bottle between your thumb and fingers, with the tip pointing downward.
- Tilt your head backward and gently pull down the lower eyelid with your finger to create a small pocket between the eyelid and the eye, into which the drops will be instilled (Fig. 5).
- Gently squeeze the bottom of the bottle to release one drop of Olopatadine Misom. DO NOT TOUCH THE EYE, EYELID, SURROUNDING AREAS OF THE EYE, OR ANY OTHER SURFACES WITH THE TIP OF THE DROPPER. Failure to follow this instruction may result in contamination of the drops (Fig. 6).
- Do not squeeze the bottle; it is designed so that a light pressure on the bottom is sufficient to release a drop (Fig. 7).
- After instilling Olopatadine Misom, press gently with your finger on the inner corner of the eye or close the eyelids for 2 minutes to prevent the medicine from draining into other parts of the body (Fig. 8).
- If treating both eyes, repeat steps 3–7 for the second eye.
- To close the bottle, replace the cap and screw it on clockwise (Fig. 4).
If you use more Olopatadine Misom than you should
Rinse the eyes with lukewarm water.
Do not administer further drops until it is time for the next scheduled dose.
If you forget to use Olopatadine Misom
Instill one drop into the eye as soon as possible, then return to your regular dosing schedule. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for a forgotten dose.
If you stop using Olopatadine Misom
Do not stop using this medicine without first consulting your doctor.
If you have any further questions about how to use this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions have been observed during treatment with Olopatadine Misom:
Common adverse reactions (may occur in up to 1 in 10 people):
Eye-related reactions
Eye pain, eye irritation, dry eye, unusual sensations inside the eye, eye discomfort.
General symptoms
Headache, fatigue, dry nose, unpleasant taste in the mouth.
Uncommon adverse reactions (may occur in up to 1 in 100 people):
Eye-related reactions
Blurred, limited, or abnormal vision, corneal disorders, inflammation of the eye surface with or without surface damage, conjunctivitis (inflammation or infection of the conjunctiva), eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormalities, itching, redness, swelling, or lumps on the eyelids.
General symptoms
Abnormal or reduced sensation, dizziness, nasal inflammation, dry skin, skin inflammation.
Frequency not known (cannot be estimated from available data):
Eye-related reactions
Eye swelling, corneal swelling, change in pupil size.
General symptoms
Shortness of breath, worsening of allergic symptoms, facial swelling, drowsiness, general weakness, nausea, vomiting, sinus infection, skin redness and itching.
In patients with significantly damaged anterior transparent layer of the eye (cornea), cloudy corneal deposits due to calcium accumulation have very rarely been observed during treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Olopatadine Misom
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton label after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
To prevent infection, discard the bottle and use a new one 4 weeks after first opening. Record the date of opening on the designated space on each bottle label and on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Olopatadine Misom contains
The active substance is olopatadine.
1 mL of solution contains 1 mg of olopatadine hydrochloride, equivalent to 1 mg of olopatadine.
One drop of solution (approximately 0.03 mL) contains 0.03 mg of olopatadine.
The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate, water for injections,
hydrochloric acid, concentrated (for pH adjustment) and/or sodium hydroxide (for pH adjustment).
What Olopatadine Misom looks like and contents of the pack
White bottle made of LDPE, with a dropper made of LDPE and a cap made of HDPE with a tamper-evident ring, in a cardboard box.
Pack sizes: 1 x 5 mL
3 x 5 mL
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Brown & Burk IR Limited
22 Northumberland Road,
Ballsbridge, Dublin 4,
Ireland
Importer
Eurofins Analytical Services Hungary Kft.
Anonymus utca 6
1045 Budapest
Hungary
Misom Labs Limited
Malta Life Sciences Park,
LS2.01.06, Industrial Estate,
San Gwann, SGN 3000, Malta
This medicinal product is authorised in the European Economic Area under the following names:
Sweden: Olopatadine Misom
Poland: Olopatadine Misom
Romania: Olopatadină Misom 1 mg/mL picături oftalmice, soluție
Denmark: Olopatadin Misom
Ireland: Olopatadine Misom 1 mg/mL Eye drops, solution
Netherlands: Olopatadine Misom 1 mg/mL oogdruppels, oplossing