Isopto B 12 belongs to the group of ophthalmic drugs.

Isopto B 12 contains the active ingredient cyanocobalamin (Vitamin B 12 ).

Isopto B 12 is indicated as a complementary treatment for corneal healing problems.

You must talk to your doctor if you do not feel better or if you feel worse after 3 days.

Do not use Isopto B 12

• If you are allergic to the active ingredients or any of the other ingredients of Isopto B 12

Warnings and cautions

Consult your doctor or pharmacist before using Isopto B 12 .

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

Other medicines and Isopto B 12

Tell your doctor or pharmacist if you are using, have recently used or might take any other medicine.

Isopto B 12 can be administered simultaneously with any other medication, whether 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 breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data on the use of Isopto B 12 in pregnant or lactating women. However, given the route of administration of the product as well as the nature of the active principle, no harmful effects on the fetus or the child are to be expected.

Driving and using machines

No effects of Isopto B 12 on driving and using machines have been described . However, as with any eye drops, as blurred vision or other disturbances may occur after instillation that affect the ability to drive or operate machinery, do not drive or operate machinery until vision is clear.

Isopto B 12 contains thiomersal

This medicine can cause allergic reactions because it contains thiomersal.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 if it does not improve after 3 days of treatment, stop the treatment and consult your doctor.

Instructions for the correct administration of the medication

With the head tilted back, separate the lower eyelid downwards 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 it is a sterile preparation, it is recommended to follow the following instructions:

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

If you use more Isopto B 12 than you should

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

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

If you forget to use Isopto B 12

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

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

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

This medicine may cause temporary eye irritation, allergic reactions, (See also Isopto B 12 contains thiomersal)

Communication of adverse effects

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

Keep out of the sight and reach of children.

Do not use Isopto B 12 after the expiry date which is stated on the carton after EXP. 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the containers and medicines you do not need in the SIGRE point . If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

Composition of Isopto B 12

• The active substance is cyanocobalamin (Vitamin B 12 ). Each ml contains 0.5 mg of cyanocobalamin.
• The other ingredients are thiomersal, sodium chloride, hydroxypropylmethylcellulose, disodium phosphate, monosodium phosphate and purified water qs

What the product looks like and contents of the pack

Polyethylene bottle with a dropper containing 5ml of a transparent red solution.

Marketing authorization holder

M4 PHARMA , SL

C / Tangier, 86

08018 Barcelona

Responsible for manufacturing

Tubilux Pharma SPA

Via Costa Rica, 20/22

00040-Pomezia (Rome)

Date of last revision of this 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/