Minims Prednisolone 5 mg/ml eye drops in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Minims Prednisolone 5 mg/ml eye drops solution in single-dose container

sodium prednisolone phosphate

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Minims Prednisolone is and what it is used for
2. What you need to know before using Minims Prednisolone
3. How to use Minims Prednisolone
4. Possible adverse effects
5. How to store Minims Prednisolone
6. Contents of the pack and other information

1. What Minims Prednisolone is and what it is used for

Minims Prednisolone contains sodium prednisolone phosphate, which belongs to a group of medicines called corticosteroids. It is used to treat ocular inflammation (redness and pain in the eyes) when not caused by infection. The part of the eye affected varies depending on the cause of the inflammation.

This medicine is intended for use in adults.

Minims Prednisolone is not suitable for the treatment of ocular infections.

2. What you need to know before using Minims Prednisolone

Do not use Minims Prednisolone:

• if you are allergic to prednisolone or to any of the other ingredients of this medicine (listed in section 6).
• if you have an eye infection caused by a virus, fungus, or bacteria.

Warnings and precautions

Consult your doctor or pharmacist if you notice blurred vision or any visual disturbances.

You should not wear contact lenses while using this medicine, as their use may increase the risk of infection.

Prolonged use may lead to increased pressure inside the eye. You should not use this medicine if you are at risk of developing glaucoma.

Children and adolescents

This medicine must not be used in children and adolescents.

Other medicines and Minims Prednisolone

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Minims Prednisolone may increase the effects of:

• medicines used to treat epilepsy (barbiturates)
• medicines used to help you sleep or to relieve anxiety (sedative hypnotics)
• medicines used to treat depression (tricyclic antidepressants)

Minims Prednisolone may decrease the effects of:

• medicines such as anticholinesterases (used to reduce intestinal motility and for myasthenia gravis (a disease that weakens muscles))
• medicines used to treat viral eye infections
• medicines similar to aspirin called salicylates (used for inflammation, pain, fever, and to prevent excessive blood clotting)

Other medicines may increase the effects of Minims Prednisolone, and your doctor may wish to monitor you closely if you are taking them (including some HIV medicines such as cobicistat).

If used in combination with other ophthalmic preparations, an interval of at least 5 minutes should be left between successive applications. Ophthalmic gels and ointments should always be administered last.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

You may experience blurred vision for a short period of time immediately after applying Minims Prednisolone. If this occurs, wait until your vision is clear before driving or operating machinery.

Excipients

This medicine contains 0.07 mg of phosphates per drop, equivalent to 0.91 mg/0.5 ml.

If you have severe damage to the transparent layer at the front of the eye (cornea), phosphates may cause (in very rare cases) opaque spots on the cornea due to calcium deposits during treatment.

3. How to use Minims Prednisolone

Follow exactly the instructions for using this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Important: Minims Prednisolone is for use in the eyes only. The drops are for single use and are supplied in single-dose units containing 13.5 drops, which is sufficient to treat both eyes if necessary. Once opened, use immediately. Discard any unused portion.

Recommended dose:

One drop into one or both eyes as often as directed by your doctor. Usually, one drop is administered four times a day for 1 to 3 weeks, followed by one drop twice a day. In more severe cases, your doctor may instruct you to start with one drop eight times a day during the first week.

Method of administration (how to apply Minims Prednisolone eye drops)

If you are administering the eye drops yourself, follow these instructions carefully. For easier and correct application, it may be helpful at first to sit in front of a mirror so you can see what you are doing.

1. Wash your hands.
2. Gently clean around your eyes with a tissue to remove any moisture.
3. Open the single-dose container (Figure 1).

Figure 1

1. Gently pull down the lower eyelid (Figure 2).

Figure 2

1. Carefully place one drop into the middle of the lower eyelid pouch. Be careful not to let the container touch your eye (Figure 3).

Figure 3

1. Release the lower eyelid and gently press the inner corner of the eye against the bridge of the nose for 1 or 2 minutes. While pressing with your finger, blink slowly several times to help spread the drop over the entire eye surface (Figure 4).

Figure 4

1. Wipe away any excess medicine with a tissue.
2. Repeat these steps for the other eye if needed; then discard the container, even if some solution remains.

If you use more Minims Prednisolone than you should:

If you accidentally use too much Minims Prednisolone in your eye, you are unlikely to experience any problems. If you have any concerns, consult your doctor. If you accidentally swallow Minims Prednisolone, or if you suddenly feel unwell after using this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Minims Prednisolone:

Use the eye drops as soon as you remember, and then take the next dose at your usual time. Do not use a double dose to make up for a forgotten dose.

If you stop using Minims Prednisolone:

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Very common adverse effects (may affect up to 1 in 10 people):

Increased intraocular pressure.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Cases of corneal calcification have been reported in patients with significantly damaged corneas.

Adverse effects of unknown frequency:

Blurred vision.

Prolonged and frequent use of corticosteroids may lead to lens opacity (cataract formation).

Secondary glaucoma, a condition that may damage the optic nerve and cause vision loss, may occur as a result of increased intraocular pressure.

Consult your doctor if you notice any changes in vision.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/.

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

5. Storage of Minims Prednisolone

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

Do not use this medicine after the expiry date stated on the cardboard box and on the packaging bag, following «EXP».

Use the single-dose container once only and discard any remaining solution.

Store below 25 °C. Do not refrigerate or freeze. Keep in the original packaging and maintain the blister in the outer packaging, as the product is highly sensitive to light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Punto Sigre collection point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Minims Prednisolone

• The active substance is sodium prednisolone phosphate.
• The other components are: disodium edetate, sodium dihydrogen phosphate dihydrate, sodium chloride, sodium hydroxide (to adjust pH), purified water.

Description of the product and contents of the container

Minims Prednisolone is supplied in a sealed, conical polypropylene container (0.5 ml) with a screw cap. Each single-dose container is individually wrapped in a polypropylene/paper pouch.

Each carton contains 20 single-dose containers.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

BAUSCH + LOMB IRELAND LIMITED
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer

Laboratoire Chauvin
Zone Industrielle de Ripotier
50 Avenue Jean Monnet
07200 Aubenas
France

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorisation Holder.

Local representative in Spain

Bausch & Lomb S.A.
Avda. Valdelaparra, nº4
28108 Alcobendas, Madrid
Tel: 91 – 657 63 00

This patient information leaflet was last reviewed in September 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/