0.5 mg / ml eye drops , solution
Epinastine hydrochloride
What Relestat is and what it is used for
Relestat is a medicine used to treat allergies.
It is an eye drop solution used to treat the symptoms of seasonal allergic inflammation in the conjunctiva of the eye, a seasonal allergic disease that affects the eye. The main symptoms treated with Relestat are watery eyes and itchy, red, or swollen eyes and eyelids.
Epinastine hydrochloride contained in Relestat may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Relestat
Do not use Relestat
- if you are allergic to epinastine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Relestat.
- if you are wearing soft contact lenses: you must remove them before using Relestat eye drops. Wait at least 15 minutes after using the drops before replacing the lenses. See also section 2, “Relestat contains benzalkonium chloride”.
- if you need to use any other eye drops while you are being treated with Relestat: leave at least 10 minutes between the use of Relestat and the other drops.
Other medicines and Relestat
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
If you need to use any other eye drops while you are being treated with Relestat, see the “Warnings and Precautions” section above.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
It is unknown whether Relestat passes into breast milk. Talk to your doctor or pharmacist before using this medicine while breastfeeding.
Driving and using machines
Your vision may become blurred for a short time just after using Relestat. Do not drive or use machines until your vision is clear again.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Relestat contains benzalkonium chloride and phosphates
This medicine contains 0.5 mg benzalkonium chloride in each 5 ml solution, equivalent to 0.1 mg/ml.
Relestat contains the preservative benzalkonium chloride which can be absorbed by soft contact lenses and may discolor the contact lenses.
If you use soft contact lenses (also called hydrophilic lenses), you must remove them before using Relestat. After using Relestat, you must wait at least 15 minutes before re-inserting the lenses.
Benzalkonium chloride can be irritating to the eyes, especially if you have dry eyes or problems with the cornea (the clear membrane at the front of the eye). If you experience irritation, tingling, or pain in the eye after using the medicine, consult a doctor.
This medicine contains 23.75 mg of phosphates in each 5 ml solution, equivalent to 4.75 mg/ml. If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment (see section 4).
How to use Relestat
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Use for adults and adolescents (12 years and older)
The recommended dose is one drop in each eye that needs treatment twice daily, for example in the morning and evening.
You should use Relestat every day if you have symptoms in your eyes during the allergy season, but no longer than 8 weeks.
Use Relestat as follows :
If the seal on the neck of the bottle is broken before using the bottle for the first time, do not use it. Apply your eye drops as follows:
- Wash your hands. Tilt your head back and look at the ceiling.
- Carefully pull down the lower eyelid so that it becomes a small “pocket”.
- Turn the bottle upside down and squeeze it so that a drop comes into each eye to be treated
- Release the eyelid and close the eye for 30 seconds.
Try again, if the drop does not get in the eye.
To prevent contamination of the contents of the bottle, make sure that the tip of the bottle does not come into contact with your eye or anything else.
Replace the cover and screw it on immediately after use.
Wipe off any excess fluid from the cheek with a clean napkin.
The right technique must be used when treating with eye drops. If you have any further questions, ask your doctor or pharmacist.
Use for children
Relestat should not be used by children under 12 years of age.
If you use more Relestat than you should
If you use more drops of Relestat than you should, it is unlikely to cause any harm. Apply the next drop (s) at the usual time. If you have any further questions, ask your doctor or pharmacist.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to use Relestat
If you have missed a dose, take it as soon as you remember, if it is not time for your next dose, then skip the missed dose. Then take your next dose at the usual time and return to your routine.
Do not take a double dose to make up for a forgotten dose.
If you stop using Relestat
Use Relestat exactly as your doctor has told you.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. It is unlikely that any of the side effects are serious, most side effects are likely to be mild and only affect the eye.
If the following happens, stop using Relestat and contact your doctor immediately or see your nearest hospital:
- asthma (an allergic disease that affects the lungs and causes difficulty breathing)
- if you get symptoms of angioedema (swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing)
The following side effects may also occur:
Common (may affect up to 1 in 10 people)
- burning sensation or irritation of the eye (mostly weak)
Uncommon (may affect up to 1 in 100 people)
General side effects:
- headache
- swelling and irritation of the nose, which may cause a runny or stuffy nose, sneezing
- abnormal taste in the mouth.
Side effects that affect the eye:
- Red eyes
- dry eyes
- itchy eyes
- difficulty seeing clearly
- watery eyes
Has been reported (occurs in an unknown number of users) :
- increased tear production
- pain in the eye
- allergic reactions in the eyes
- swelling of eyes
- swelling of eyelids
- skin rash and redness
Other side effects have been reported with eye drops containing phosphate
This medicine contains 23.75 mg of phosphate per 5 ml, which is equivalent to 4.75 mg/ml.
If you have severely damaged cornea, in very rare cases, phosphate can cause cloudy spots on the cornea due to the accumulation of calcium during treatment (see section 2).
How to store Relestat
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.
Do not use this medicine if you notice that the eye drops show signs of deteriorating quality, such as a change in color, and return the product to the pharmacy.
Do not store above 25 ° C.
Store the bottle in the outer carton. Sensitive to light.
You must discard the bottle 28 days after you first opened it, even if there are still a few drops left. This protects against infection. As an aid to memory, write the date when you opened the bottle on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is epinastine hydrochloride. One ml of eye drops, the solution contains 0.5 mg of epinastine hydrochloride.
- The other ingredients are benzalkonium chloride (a preservative ), sodium edetate, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium hydroxide / hydrochloric acid (for pH adjustment), and purified water.
What the medicine looks like and the contents of the pack
Relestat is a clear and colorless eye drop solution in a plastic bottle with a screw cap. Each unopened bottle is half full and contains 5 ml of solution.
Each pack contains 1 bottle.
Marketing Authorization Holder and Manufacturer
Allergan Pharmaceuticals Ireland
Castlebar Road
Westport
County Mayo
Ireland
This medicinal product is authorized under the European Economic Area under the names:
| Name of Member State | The name of the drug |
| Austria, Germany | RELESTAT 0.5 mg / ml eye drops |
| Belgium | RELESTAT, 0.5 mg / ml, eye drops, solution |
| Czech Republic | PURIVIST 0.5 mg / ml oèní kapky, roztok |
| Denmark, Greece, Luxembourg, Poland, Sweden | RELESTAT |
| France | PURIST (0.5 mg / ml, collyre in solution) |
| Hungary | RELESTAT 0.5 mg / ml oldatos szemcsepp |
| Ireland, UK | RELESTAT, 0.5 mg / ml, eye drops solution |
| Italy | RELESTAT, 0.5 mg / ml, collirio, solution |
| Holland | RELESTAT, eye drops, solution, 0.5 mg / ml |
| Portugal | RELESTAT, 0.5 mg / ml, color, solution |
| Slovakia | PURIST |
| Spain | RELESTAT 0.5 mg / ml colirio in solution |