Relestat

Package leaflet: Information for the user

Relestat, 0.5 mg/ml, eye drops, solution

Epinastine hydrochloride
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 information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen. Contents of this leaflet :
  1. What Relestat is and what it is used for
  2. What you need to know before using Relestat
  3. How to use Relestat
  4. Possible side effects
  5. How to store Relestat
  6. Contents of the pack and other information

1. What Relestat is and what it is used for

Relestat is an antiallergic medicinal product.
It is an ophthalmic solution used to treat the symptoms of seasonal allergic conjunctivitis,
a seasonal allergic condition affecting the eye. The main symptoms treated by
Relestat include eye tearing, itching, redness, and swelling of the eyes or eyelids.

2. What you should know before using Relestat

Do not use Relestat:

• If you are allergic to epinastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Relestat.

• If you wear soft contact lenses: you must remove them before using Relestat eye drops. After using Relestat, wait at least 15 minutes before reinserting your lenses. See also section 2, “Relestat contains benzalkonium chloride”.
• If you have used any other eye drops during treatment with Relestat: wait at least 10 minutes between administering Relestat and other eye drops.

Other medicines and Relestat
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
If you have used any other eye drops during treatment with Relestat, see the section
“Warnings and precautions” above.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Breastfeeding
It is not known whether Relestat passes into breast milk. Consult your doctor or pharmacist before using this medicine during breastfeeding.
Driving and using machines
Shortly after administration of Relestat, blurred vision may occur for a short period of time. If this happens, do not drive or operate machinery until your vision has cleared.
Relestat contains benzalkonium chloride and phosphates
This medicine contains 0.5 mg of benzalkonium chloride per 5 ml of solution, equivalent to 0.1 mg/ml.
Relestat contains a preservative called benzalkonium chloride, which can be absorbed by soft contact lenses and may cause discoloration.
If you wear soft contact lenses (also known as hydrophilic lenses), you must remove them before using Relestat eye drops. After using Relestat, wait at least 15 minutes before reinserting your lenses.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (affecting the transparent outer layer of the eye). If you experience any unusual sensation, burning, or pain in the eye after using this medicine, speak with your doctor.
This medicine contains 23.75 mg of phosphates per 5 ml, equivalent to 4.75 mg/ml.
If you have severe damage to the outer transparent layer of the eye (the cornea), phosphates may very rarely cause opaque corneal spots due to calcium accumulation during treatment (see section 4).

3. How to use Relestat

Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Use in children
Relestat must not be used in children under 12 years of age.

Use in adults and adolescents (12 years of age and older)
The recommended dose is 1 drop in each affected eye, twice daily, for example in the morning and evening.
Relestat should be used every day during the allergy season when ocular symptoms occur, but for no longer than 8 weeks.

Instructions for use

Do not use the bottle if the tamper-evident seal on the neck of the bottle is broken before use. Apply the eye drops as follows:

1. Wash your hands. Tilt your head backwards and look upwards.
2. Gently pull down your lower eyelid to form a small "pocket".
3. Invert the bottle and squeeze to instill one drop of eye drops into each eye to be treated.
4. Release the lower eyelid and close your eye for 30 seconds.

If the drop does not enter the eye, repeat the procedure.
To avoid contamination of the solution in the bottle, the tip of the bottle must not touch the eye or any other surface.
Replace the cap and screw it on tightly after use.
Remove any excess liquid from the cheek with a clean tissue.
Proper application of the eye drops is very important. If you have any doubts, consult your doctor or pharmacist.

If you use more Relestat than you should
If you have used more drops of Relestat than recommended, it is unlikely to cause any harm. Apply the next dose at your usual time. If you are concerned, consult your doctor or pharmacist.

If you forget to use Relestat
If you miss a dose, apply the eye drops as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and take the next one at the regular time.
Do not use a double dose to make up for a forgotten dose.

If you stop using Relestat
Relestat should be used as prescribed by your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
It is unlikely that any of these side effects will be serious; most are probably mild and limited to the eye.
If you experience any of the following side effects, stop using Relestat and contact your doctor immediately or go to the nearest hospital:

• asthma (an allergic condition affecting the lungs and causing breathing difficulties)
• symptoms of angioedema (swelling of the face, tongue or throat; difficulty swallowing; itching and breathing difficulties)

The following side effects may occur:
Common (may affect up to 1 in 10 people)

• sensation of burning or eye irritation (usually mild)

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

• headache
• swelling and irritation inside the nose, which may cause runny or blocked nose, sneezing

Eye-related side effects:

• redness of the eyes
• dry eyes
• itchy eyes
• difficulty seeing clearly
• eye discharge

Not known (frequency cannot be estimated from the available data)

• increased lacrimation
• eye pain
• allergic reaction in the eyes
• eye swelling
• eyelid swelling
• skin rashes and redness

Other side effects reported with eye drops containing phosphates
This medicine contains 23.75 mg of phosphates per 5 ml, equivalent to 4.75 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause opaque spots on the cornea due to calcium deposits during treatment (see section 4).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 Relestat

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle label and on the carton after EXP.
Do not use this medicine if you notice any signs of deterioration, for example a change in colour; in such cases return it to your pharmacist.
Store below 25°C.
Keep the bottle in its outer carton to protect the product from light.
Discard the bottle 28 days after first opening, even if there are still eye drops remaining. This will help prevent infection. To help you remember, write the date of first opening in the space provided on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Relestat contains
The active substance is epinastine hydrochloride. One ml of eye drops, solution, contains 0.5 mg of epinastine hydrochloride.
The other components are benzalkonium chloride (a preservative), disodium edetate, sodium chloride, monosodium phosphate dihydrate, sodium hydroxide/hydrochloric acid (to adjust pH), and purified water.

Description of the appearance of RELESTAT and contents of the pack
RELESTAT is a clear, colourless eye drop solution in a plastic bottle with a screw cap.
When unopened, each bottle is approximately half full and contains 5 ml of solution.
Each pack contains 1 bottle.

Marketing Authorization Holder
AbbVie S.r.l.
S.R. 148 Pontina km 52 snc
04011 Campoverde di Aprilia (LT)
Italy

Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland

This medicinal product is authorized in the European Economic Area Member States under the following names: