Calmira

Package leaflet: Information for the user

CALMIRA 1 mg/mL eye drops, solution

olopatadine
Generic medicine
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment. Contents of this leaflet
  1. What CALMIRA is and what it is used for
  2. What you need to know before using CALMIRA
  3. How to use CALMIRA
  4. Possible side effects
  5. How to store CALMIRA
  6. Contents of the pack and other information

1. What CALMIRA is and what it is used for

CALMIRA is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain substances (allergens) such as pollen, house dust, or animal fur
can cause allergic reactions, resulting in itching, redness, and sometimes swelling of the eye surface.
CALMIRA is a medicine for the treatment of allergic eye conditions. It works by reducing
the intensity of the allergic reaction.

2. What you need to know before using CALMIRA

Do not use CALMIRA

• If you are allergic (hypersensitive) to olopatadine or to any of the other ingredients of this medicine (listed in section 6).
• Do not use CALMIRA if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using CALMIRA.
If you wear contact lenses, you must remove them before using CALMIRA.
Children
Do not use CALMIRA in children under 3 years of age. Do not give this medicine to children under 3 years of age, as there are no data confirming that it is safe and effective in children below 3 years of age.
Other medicines and CALMIRA
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, wait at least 5 minutes between using one medicine and the next. Ointments should be used last.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use CALMIRA if you are breastfeeding: consult your doctor before using this medicine.
Driving and using machines
You may experience blurred vision for a period of time after using CALMIRA. Do not drive or operate machinery until this effect has worn off.
CALMIRA contains benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per 5 ml, which is equivalent to 0.1 mg/ml.
The preservative benzalkonium chloride contained in CALMIRA may be absorbed by soft contact lenses and may cause a change in their colour. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the transparent outermost layer of the eye). If you experience any unusual sensation in the eye, such as burning or pain, after using this medicine, speak with your doctor.
CALMIRA contains anhydrous dibasic sodium phosphate
This medicine contains 16.72 mg of phosphate buffer (in 25 mg of anhydrous dibasic sodium phosphate) per 5 ml bottle, which is equivalent to 3.34 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use CALMIRA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one drop in the eye/eyes, twice daily—morning and evening.
Use this dose unless your doctor has given you different instructions. Instill CALMIRA in both eyes only if specifically prescribed by your doctor. Use the product for the length of time specified by your doctor.
CALMIRA is for ophthalmic use only.

How to use CALMIRA (continued)

1 2
How much to use (see previous page)

• Take the CALMIRA bottle and a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After removing the cap, if the safety ring has loosened, remove it before using the product.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Figure 1).
• Bring the tip of the bottle close to the eye. Use the mirror if it helps.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle to release one drop of CALMIRA at a time.
• Do not squeeze the bottle: it is designed so that only gentle pressure on the bottom is needed (Figure 2).
• If instilling drops in both eyes, repeat the same procedure for the other eye.
• Immediately replace the cap after use, screwing it back on properly.

If a drop misses the eye, try again.

If you use more CALMIRA than you should
Rinse the eye with lukewarm water. Do not instill the eye drops again until it is time for your next scheduled dose.

If you forget to use CALMIRA
Instill one drop as soon as possible, then return to your regular dosing schedule. However, if it is almost time for your next dose, do not instill the missed dose and continue with your regular dosing schedule. Do not use a double dose to make up for the forgotten dose.

If you stop using CALMIRA
Do not stop treatment with this medicine without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been observed with CALMIRA:
Common (may affect up to 1 in 10 people)
Eye disorders
Eye pain, eye irritation, dry eye, abnormal sensation in the eyes, eye discomfort.
General side effects
Headache, fatigue, dry nose, bad taste.
Uncommon (may affect up to 1 in 100 people)
Eye disorders
Blurred, reduced or abnormal vision, corneal disorder, inflammation of the surface of the eye with or without damage, conjunctival inflammation or infection, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
General side effects
Abnormal or reduced sense of sensitivity, dizziness, runny nose, dry skin, skin inflammation.
Not known (frequency cannot be estimated from the available data)
Eye disorders
Eye swelling, corneal swelling, change in pupil size.
General side effects
Shortness of breath, worsening of allergy symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinusitis, skin redness and itching.
In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) have developed opaque spots on the cornea due to calcium deposits during treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CALMIRA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The bottle should be discarded 28 days after first opening to prevent possible infections, and a new bottle should be used.
Record the date of opening in the designated space (i) on the bottle label and on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use.
This will help protect the environment.

6. Contents of the pack and other information

What CALMIRA contains

• The active substance is olopatadine. Each mL of solution contains 1 mg of olopatadine (as hydrochloride).
• The other components are benzalkonium chloride, sodium chloride, anhydrous disodium phosphate (E339), hydrochloric acid (E507) (to adjust pH) and/or sodium hydroxide (E524) (to adjust pH), and water for injections.

Description of the appearance of CALMIRA and contents of the pack
CALMIRA is a clear, colourless liquid (a solution) supplied in a pack containing one 10 ml bottle filled up to 5 ml or three 10 ml plastic bottles filled up to 5 ml with screw caps. It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
RAFARM S.A.
Korinthou 12
Neo Psihiko Attiki Postal code 15451, Greece
RAFARM S.A.
Thesi Pousi-Xatzi Agiou Louka Paiania Attiki
Postal code: 19002, Greece

This leaflet was last updated in