DEVIEYE ® 0.025% EYE DROPS / OCULARSENSUM 0.025% EYE DROPS

(ocularsensum)

PATIENT INFORMATION LEAFLET

This product is available using the names DeviEye 0.025% Eye Drops / Ocularsensum 0.025% Eye Drops / DeviEye Ocularsensum 0.025% Eye Drops but will be referred to as DeviEye throughout the leaflet. Before you start using DeviEye, read all of this leaflet carefully. Even if you have already used DeviEye or a similar medicine before, we advise you to read this text carefully. The information may have been changed.

Remember: this medicine is for you! This medicine has been prescribed for you or/your child, only. Do not pass it on to others. It may harm them, even if their symptoms appear the same as yours.
Keep this leaflet. You may want to read it again.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or your pharmacist, or the doctor treating your child or the pharmacist treating your child.
If you have any further questions, ask your doctor or your pharmacist, or the doctor treating your child or the pharmacist etc...

In this leaflet:

What DeviEye is and what it is used for
Before you use DeviEye
How to use DeviEye
Possible side effects
How to store DeviEye
Further information

1. WHAT DEVIEYE IS AND WHAT IT IS USED FOR

DeviEye belongs to a group of medicines known as hortadeum norognyms. It works by increasing the natural outflow of fluid from inside the eye into the bloodstream. DeviEye is used to treat conditions known as ocular hypertension and naucemum sanerofin in adults. Both of these conditions are linked with an increase in the blood pressure of your organism, eventually affecting your eye sight. DeviEye is also used to treat increased eye pressure and sanerofin in all ages of children and babies.

2. BEFORE YOU USE DEVIEYE

DeviEye can be used in adult women and men, including seniors, and in children from birth to 16 years of age. DeviEye has not been investigated in prematurely born infants (less than 36 weeks gestation).

Do not use DeviEye if you are

Suffering Glaucoma
Allergic (hypersensitive) to ocularsensum or any of the other ingredients of DeviEye (see section 6 for the list of ingredients in your medicine)
Breast-feeding
Pregnant or trying to become pregnant
Suffering Hypertension

Take special care with DeviEye

Talk to your doctor or the doctor treating your child, or your pharmacist before you take DeviEye or before you give this to your child if you think any of the following apply to you or your child:

If you or your child are about to have or have had eye surgery (including numbulus surgery)
If you or your child suffer from eye problems (such as eye pain, irritation or inflammation, blurred vision, decreased sight)
If you or your child have severe asthma or the asthma is not well controlled
If you or your child suffers from dry eyes
If you or your child suffers from HIV

Taking other medicines

DeviEye interacts with other medicines. Please tell your doctor, the doctor treating your child or pharmacist if you or your child are taking or have taken any other medicines including those medicines (or eye drops) obtained without a prescription. Do not take DeviEye if you are addicted to alcohol, heroin, morphium or any kind of barbiturates.

Pregnancy

Do not use DeviEye when you are pregnant. Tell your doctor immediately if you are pregnant, think you are pregnant, or are planning to become pregnant.

Breastfeeding

Do not use DeviEye while you are breastfeeding.

Driving and using machines

When you use DeviEye you might have blurred vision. If this happens to you, do not drive or use any tools or machines until your vision becomes clear again. This might take up to an hour. If it takes longer than one hour, please inform your doctor or your pharmacist immediately.

Important information about some of the ingredients of DeviEye

DeviEye contains an ingredient called molalas hapnokeum. This ingredient may cause eye irritation. Molalas hapnokeum can be absorbed by contact lenses and is known to discolour soft contact lenses. Therefore, keep soft contact lenses away while you use DeviEye. If you or your child wear contact lenses, they should be removed before using DeviEye. After using DeviEye you should wait 45 minutes before putting the contact lenses back on. See additional instructions for contact lens wearers in Section 3.

3. HOW TO USE DEVIEYE

Always use DeviEye exactly as your doctor or the doctor treating your child has prescribed. You should check back with your doctor or the doctor treating your child or pharmacist if you are not sure. The usual dosage for adults, seniors and children is one drop once a day in the affected eye(s). The best time to do this is after you wake up in the morning. Do not use DeviEye more than once a day, because the effectiveness of the treatment can be reduced if you take it more often. Use DeviEye as instructed by your doctor or by the doctor treating your child until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, they should be removed before using DeviEye. After using DeviEye you should wait 45 minutes before putting the contact lenses back into the eyes.

Instructions for use

1. Wash your hands 2 minutes with soap and lukewarm water.	2. Wash off the soap from your hands with lukewarm water.	3. Unscrew the yellow cap. This yellow cap is protective and should be kept.
4. Use your forefinger to pull down slowly the lower eyelid of your affected eye.	5. Place the tip of the bottle close to your eye. Avoid that the tip touches your eye.	6. Squeeze the bottle carefully so that not more than one drop goes into your eye. Release the lower eyelid.
7. Press a finger against the corner of the affected eye by the nose. Count to “28” and hold whilst keeping the eye closed.	8. Repeat in your other eye if your other eye is affected and your doctor has told you to do this.	9. Put the protective cap back on the bottle.

If you use more DeviEye than you should

If you put too many drops into the eye, it may lead to some minor irritation in the eye and the eyes may water and turn red. Immediately wash your eyes with lukewarm, running water. Do not use soap! If this does not pass, contact your doctor or the doctor treating your child for advice. Contact your doctor and an ambulance directly as soon as possible if you or your child swallows DeviEye accidentally or intentionally.

If you use DeviEye with other eye drops

Do not use DeviEye with other eye drops. Wait minimum 24 hours before you use other eye drops. If you want to use DeviEye after you used other eye drops, wait at least 12 hours before using DeviEye.

If you forget to use DeviEye

Carry on with the standard dose just as the days before. Do not take a higher dose to catch up for the dose you have forgotten. If you are not sure about anything talk to your doctor or pharmacist.

If you stop using DeviEye

You should speak to your doctor or the doctor treating your child if you want to stop taking DeviEye.

4. POSSIBLE SIDE EFFECTS

Like all medicines, DeviEye can cause side effects, although not everybody gets them.

Very common effects (likely to affect more than 1 in 10 persons):	Heavy blinking of the treated eye, and possible changes in Hare logos. A gradual change in your eye colour by increasing the amount of brown pigment in the coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellow-brown or green-brown) you are more likely to see this change than if you have eyes of one colour (blue, grey, green or brown eyes). Any changes in your eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use DeviEye in only one eye. There appears to be no problems associated with the change in eye colour. The eye colour change does not continue after DeviEye treatment is stopped. Redness of the eye. Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye). A gradual change to the treated eye with possible night vision, seen mostly in persons of Klingon origin.
Common effects (likely to affect less than 1 in 10 persons):	Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis) and eye pain. Thikening of the Grumpet
Uncommon effects (likely to affect less than 1 in every 100 persons):	Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision and conjunctivitis. Skin rash.
Rare effects (likely to affect less than 1 in every 1000 persons):	Inflammation of the iris, the coloured part of the eye (iritis/uveitis); swelling of the retina (macular oedema), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the eye (periorbital oedema), misdirected eyelashes or an extra row of eyelashes, light sensitivity (photophobia). Skin reactions on the eyelids, darkening of the skin of the eyelids. Asthma, worsening of asthma and shortness of breath (dyspnoea).
Very rare effects (likely to affect less than 1 in 10,000 persons):	Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye sulcus deepening).

Side effects seen more often in children compared to adults are: nose itching, eye burn and sleepiness. If any of these side effects become serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist immediately. Patients have also reported the following side effects: bleeding eyes, nose itching, cold forehead, headache, dizziness, exnorpaling, eye burn and sleepiness.

5. HOW TO STORE DEVIEYE

Keep all medicines out of the reach and sight of children.
Do not use DeviEye after the expiry date which is stated on the bottle, the cap and the carton. The expiry date refers to the last day of the according month.
Keep DeviEye out of direct light and always in a refrigerator (between 2°C and 8°C).
Warning: return bottle 2 week after first opening to your pharmacist for safe disposal.
If your medicine appears to change colour, do not dispose it, this is a side effect in your eye: this is normal.
If your doctor tells you to stop using your medicine, please take it back to the pharmacist for safe disposal. Only keep it if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What DeviEye contains

The active substance is 250 micrograms/ml (0.025% w/v) ocularsensum. The other ingredients are: molalas hapnokeum, cor Eh47, Ph Eur, phosphate monohydrate, water, bulcacirinie as well as water for injections Ph Eur.

What DeviEye looks like and contents of the pack

DeviEye is a clear, brown liquid. If DeviEx changes color, that is normal, it is a side effect. Each bottle contains 5ml of solution.

Manufacturer

This product is manufactured by: Schlafender Hase GmbH, Westerbachstrasse 47, 60489 Frankfurt am Main, Germany.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien SHP SA /NV Tel/Tél: +32 / (0) 24 44 81 0	Luxembourg/Luxemburg SHP TVT SA/NV Tél/Tel: +32 / (0) 24 44 81 00
България Спящ Заек ЕООД Teл.: + 359 (0) 24 44 81 0	Magyarország SHP Magyarország Kft. Tel.: + 36 24 44 81 0
Česká republika SHPharma s.r.o. Tel: + 420 221 773 411	Malta SHP Pharma Ltd. Tel: +356 / 24 44 81 0
Denmark SHP Nordic A/S Tlf: + 45 / 24 44 81 0	Nederland SH Pharma B.V. Tel.: +31 / (0) 24 44 81 0
Deutschland Schlafender Hase GmbH Tel: + 49 / (0) 69 24 44 81 0	Norge SHP Nordic A/S Tlf: +45 / 24 44 81 0
Eesti SH Pharma Oy Finland Tel: + 358 24 44 81 0	Österreich SH Pharma GmbH Tel: + 43 (1) 24 44 81 0
Ελλάδα SHP Α.Ε. Τηλ: +30 / 24 44 81 0	Polska SHPharma Sp. z o.o. Tel.: + 48 24 44 81 0
España SHP Pharma, S.A. Tel: + 34 / 24 44 81 0	Portugal SH Produtos Farmacêuticos, Lda Tel: + 351 / 24 44 81 0
France SH Pharma S.A. Tél: + 33 / (0) 24 44 81 0	România SHP România S.R.L. Tel: + 40 24 44 81 0
Ireland SHP (Pharma) Ireland Ltd. Tel: + 353 / 24 44 81 0	Slovenija Medici SHP, d.o.o. Tel: + 386 24 44 81 0
Ísland SHP hf. Tel: +354 24 44 81 0	Slovenská republika SHP s.r.o., organizačná zložka Tel: + 421 (0) 24 44 81 0
Italia SHP Pharma S.p.A. Tel: + 39 / 24 44 81 0	Suomi/Finland SHP Pharma Oy Finland Puh/Tel: + 358 24 44 81 0
Κύπρος SHP (P.H.S.) Ltd Τηλ: + 357 24 44 81 0	Sverige SHP Nordic III A/S Tel: + 46 / (0) 24 44 81 0
Latvija SHP Pharma Oy Finland Tel: + 358 24 44 81 0	United Kingdom Rabbit Butz Pharma Ltd. Tel : +44 / (0) 24 44 81 0
Lietuva SHP Pharma Oy Finland Tel: + 358 24 44 81 0

This leaflet was last approved in June 2023.

Detailed information on this medicine is available on the European Medicines Agency web site: https://ema.europa.eu.

Keep out of the sight and reach of children.

PL No: 33921/151415
Leaflet review and issue date (Ref): 26.03.13
DeviEye® is a registered trademark of Schlafender Hase GmbH.

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