Document: Prednisolon mibe eye drops, suspension ENG PL change

• Prednisolon mibe eye drops, suspension PL
• Prednisolon mibe eye drops, suspension ENG PL

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Package leaflet: Information for the user

Prednisolon mibe 10 mg/ml eye drops, suspension

Prednisolone acetate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Prednisolon mibe is and what it is used for

2. What you need to know before you use Prednisolon mibe

3. How to use Prednisolon mibe

4. Possible side effects

5. How to store Prednisolon mibe

6. Contents of the pack and other information

1. What Prednisolon mibe is and what it is used for

Prednisolon mibe is used in adults for the short-term treatment of

• severe, non-infectious inflammation of the anterior part of the eye, such as inflammation of the middle layer of the eye (uveitis anterior).

• inflammation after eye surgery, e.g. after cataract surgery.

Prednisolon mibe contains the active substance prednisolone acetate.

Prednisolone acetate is a glucocorticoid (a steroid) with a potent anti-inflammatory action. It prevents the release of inflammatory substances and thereby works against the signs of inflammation, e.g. oedema, blood vessel dilation and scarring.

2. What you need to know before you use Prednisolon mibe

Do not use Prednisolon mibe:

• if you are allergic to prednisolone acetate, other glucocorticoids or any of the other ingredients of this medicine (listed in section 6).

• if you have an acute herpes simplex infection (dendritic keratitis) or any other viral eye infection.

• if you have an eye infection caused by bacteria or fungi, which is not being treated with appropriate antibiotic co-therapy.

• in cases of narrow-angle and advanced glaucoma which cannot be adequately controlled by medicinal products alone.

Warnings and precautions

Talk to your doctor or pharmacist before using Prednisolon mibe.

Take special care with Prednisolon mibe, if you have a history of herpes simplex.

In this case, Prednisolon mibe may only be used under strict medical supervision. Talk to your doctor before using this medicine, if you have ever suffered from this condition in the past.

Talk to your doctor before using Prednisolon mibe, if you currently have, or have ever had, any of the following conditions:

• eye ulcers or a history of tissue thinning as a result of disease or eye treatment.

• if you have glaucoma or if you are being treated for increased inner eye pressure.

• if you have had a cataract operation.

• eye infections caused by bacteria, viruses or fungi.

Before using Prednisolon mibe, tell your doctor, if you are, or have been using, other eye drops containing steroids, as frequent or prolonged use of steroids can lead to additional side effects.

Children

The safety and efficacy of Prednisolon mibe in children have not yet been established.

The lowest possible dose should be used. Long term treatment should be avoided in children.

Other medicines and Prednisolon mibe

Tell your doctor or pharmacist, if you are taking/using, have recently taken/used or might take/use any other medicines.

No interactions with other medicines have occurred to date.

Apart from the use of Prednisolon mibe, if you need to use other eye drops that can increase inner eye pressure, this side effect can be enhanced.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Prednisolon mibe can lead to temporary blurred vision. Do not drive or use machines until this side effect has worn off.

Prednisolon mibe contains benzalkonium chloride

May cause eye irritation.

Avoid contact with soft contact lenses.

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.

Known to discolour soft contact lenses.

3. How to use Prednisolon mibe

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist, if you are not sure.

Unless otherwise prescribed by the doctor, instil 1 drop into the affected eye(s), 4 times daily.

During the first two days of treatment, you may be instructed to use the eye drops every hour. Their use should then be reduced slowly in the following days and weeks.

Directions for use

Do not use the bottle contents, if the protective seal on the bottle neck is damagedbefore first opening.

Wash your hands.

To prevent contamination, please ensure that the dispenser tip does not touch your eye nor the eyelid or the area around the eye or any other objects.

When opening the bottle for the first time please shake the bottle 10 times.

Please shake the bottle vigorously before use.

Open the bottle. Hold the bottle between thumb and fingers with the opening to the bottom.

Lean back your head. Pull the lower eyelid down with the index finger, until there is a 'pocket' between eyelid and eye. Position the tip of the dripper very closely to your eye. Look upwards and drop one drop into the 'pocket' by slightly pressing the bottle.

Close your eye and press onto the corner of your eye beside the nose for a minute or gently close the eyelid. Please immediately clean excess overflow from the face. This prevents Prednisolon mibe from passing into the rest of the body via the tear duct and the skin.

If you use the eye drops in both eyes, repeat the procedure for the other eye.

Immediately after use, close the bottle by screwing the cap back on tightlyin order to avoid contamination.

If you use more Prednisolon mibe than you should

Instillation of too many drops into the eye(s) is unlikely to lead to unwanted side effects. If you have inserted too many drops into your eye(s), rinse out your eye(s) with clear water. If this medicine has been drunk by mistake, tell your doctor immediately.

If you forget to use Prednisolon mibe

If you have forgotten a dose, make up for it as soon as you realise. However, if it is almost time for your next dose, skip the forgotten dose altogether, apply the next dose at the scheduled time and then continue your treatment as normal.

Do not use a double dose to make up for a forgotten dose.

If you stop using Prednisolon mibe

Use Prednisolon mibe as instructed by your doctor. Do not stop using Prednisolon mibe until your doctor tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

As soon as you get any of the following side effects, please contact your doctor immediately:

• ulcers on the eye surface (corneal ulcers)

• severe eye pain.

Please contact your doctor, if any of the following side effects gets serious or if they persist over a prolonged period:

• allergic reaction

• headache

• increased inner eye pressure

• clouding of the lens inside the eye (cataract)

• eye infections

• eye irritation

• blurred or poor vision

• pupil dilation

• impaired sense of taste

• rash or itching.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below).

By reporting side effects you can help provide more information on the safety of this medicine.

<to be completed nationally>

5. How to store Prednisolon mibe

Keep this medicine out of the sight and reach of children.

Do not use this medicine, if you notice that the protective seal on the bottle is damaged.

Do not store above 25 °C.

Keep the bottle in the outer carton in order to protect from light.

Store the bottle upright.

Do not use this medicine after the expiry date which is stated on the label and outer carton after {abbreviation used for expiry date}. The expiry date refers to the last day of that month.

After opening the bottle, Prednisolon mibe has a shelf life of 28 days maximum.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Prednisolon mibe contains

1 ml eye drops contains 10 mg prednisolone acetate.

What Prednisolon mibe looks like and contents of the pack

Prednisolon mibe is a white or almost white, sterile eye drops suspension and supplied in a plastic dropper container.

Each bottle contains 5 ml eye drops suspension.

Prednisolon mibe is available in packs with

1 x 5 ml,

2 x 5 ml,

3 x 5 ml and

6 x 5 ml

eye drops, suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<to be completed nationally>

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria Prednisolon mibe 10 mg/ml eye drops, suspension

Germany Prednisolon mibe 10 mg/ml eye drops, suspension

Sweden Prednisolon mibe

This leaflet was last revised in 2016-07-08