ISOPTO B12 0.5 mg/ml EYE DROPS SOLUTION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Isopto B120.5 mg/ml eye drops, solution

Cyanocobalamin

Read the package leaflet carefully before starting to use this medicine, as it contains important information for you.

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 3 days.

Contents of the package leaflet

1. What Isopto B12 is and what it is used for
2. What you need to know before using Isopto B12
3. How to use Isopto B12
4. Possible side effects

1. 5. Storage of Isopto B12

1. Contents of the pack and further information

1. What Isopto B12 is and what it is used for

Isopto B12 belongs to the group of ophthalmic medicines.

Isopto B12 contains cyanocobalamin (Vitamin B12) as the active ingredient.

Isopto B12 is indicated as a complementary treatment for corneal healing problems.

You should consult a doctor if it worsens or does not improve after 3 days.

2. What you need to know before using Isopto B12

Do not use Isopto B12

• If you are allergic to the active ingredients or to any of the other components of Isopto B12

Warnings and precautions

Consult your doctor or pharmacist before starting to use Isopto B12.

• This medicine should only be applied to the eye. It should not be ingested or injected.
• When applying the medicine, avoid contact between the dropper and the eye and fingers to prevent possible contamination.

Other medicines and Isopto B12

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Isopto B12 can be administered simultaneously with any other medication, either local or general.

If you use more than one eye drop, the applications between eye drops should be spaced at least 15 minutes apart.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data on the use of Isopto B12 in pregnant or breastfeeding women. However, given the route of administration of the product and the nature of the active ingredient, no harmful effects on the fetus or child are expected.

Driving and using machines

No effects of Isopto B12 on driving and using machines have been described. However, as with any eye drop, since blurred vision or other changes that affect the ability to drive or operate machinery may occur after instillation, do not drive or operate machinery until your vision is clear.

Isopto B12 contains thiomersal

This medicine may cause allergic reactions because it contains thiomersal.

3. How to use Isopto B12

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is 1 drop in the affected eye 3 to 4 times a day. If it worsens or does not improve after 3 days of treatment, discontinue treatment and consult your doctor.

Instructions for correct administration of the medicine

With your head tilted back, pull the lower eyelid down and drop the drops into the conjunctival sac (space between the eye and the eyelid), while looking up. Close your eyes gently and keep them closed for a few seconds.

Recommendations for the use of eye drops.

As this is a sterile preparation, it is recommended to follow the following instructions:

• Each patient will use their own container.
• The application of the eye drop should be carried out with maximum hygiene: hand cleaning and avoiding any contact between the dropper and any surface (including the eye) as much as possible.
• After each application, keep the bottle perfectly closed.
• Discard one month after opening the container

If you use more Isopto B12 than you should

Due to the characteristics of this medicine, intoxication phenomena are not expected.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 91 562 04 20, indicating the product and the amount ingested.

If you forget to use Isopto B12

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

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

This medicine may cause transient eye irritation, allergic reactions, (See also Isopto B12 contains thiomersal)

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Isopto B12

Keep out of sight and reach of children.

Do not use Isopto B12 after the expiration date stated on the container, after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Discard one month after opening the container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the container and any unused medicine in the SIGRE point. In case of doubt, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Isopto B12

• The active ingredient is cyanocobalamin (Vitamin B12). Each ml contains 0.5 mg of cyanocobalamin.
• The other ingredients are thiomersal, sodium chloride, hydroxypropylmethylcellulose, disodium phosphate, monosodium phosphate, and purified water.

Appearance of the product and contents of the container

Polyethylene bottle with dropper that contains 5ml of transparent red solution.

Marketing authorization holder

Reva Health Europe, S.L.

Pl. Ausiàs March, 1, 4-6

08195 Sant Cugat del Vallès-Spain

Manufacturer

Tubilux Pharma S.P.A

Via Costa Rica, 20/22

00071-Pomezia (Rome)

Date of the last revision of this package leaflet:

October 2017

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