PROSPECTO : INFORMATION FOR THE USER

Isopto B120,5 mg/ml eye drops in solution

Cyanocobalamin

Read this prospectus carefully before starting to use this medication, because it contains important information for you.

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist.

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

1. 5 Conservation of Isopto B12

1. Contents of the package and additional information

Isopto B12belongs to the group of ophthalmic medications.

Isopto B12contains cianocobalamina (Vitamin B12) as its active ingredient.

Isopto B12is indicated as a complementary treatment for problems with corneal healing.

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

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 medication should only be applied to the eye. Do not ingest or inject.
• When applying the medication, avoid contact between the dropper and the eye and fingers to prevent possible contamination.

Other medications and Isopto B12

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

Isopto B12may 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 breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There are no data on the use of Isopto B12in pregnant women or breastfeeding women. However, given the route of administration of the product and the nature of the active ingredient, no adverse effects on the fetus or child are expected.

Driving and operating machines

No effects of Isopto B12on driving and operating machines have been described. However, as with any eye drop, since blurred vision or other visual disturbances may occur after instillation, do not drive or operate machines until your vision clears.

Isopto B12contains thimerosal

This medication may cause allergic reactions because it contains thimerosal.

Follow exactly the administration instructions of the medication 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 does not improve after 3 days of treatment, discontinue treatment and consult your doctor.

Instructions for correct medication administration

With your head tilted back, separate the lower eyelid downward and let the drops fall into the conjunctival sac (space between the eye and the eyelid), while directing your gaze upward. Close your eyes gently and keep them closed for a few seconds.

Recommendations for the use of eye drops.

Since 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 maximum hygiene: hand washing and avoiding contact of the dropper with any surface (including the eye).
• After each application, keep the container perfectly closed.
• Discard the container after one month of opening.

If you use more Isopto B12than you should

Due to the characteristics of this medication, it is not expected to experience symptoms of intoxication.

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

If you forgot to use Isopto B12

Do not use a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

This medication may produce transient ocular irritation, allergic reactions, (See also Isopto B12contains thimerosal)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

Do not use Isopto B12after the expiration date appearing on the packaging, after CAD. The expiration date is the last day of the month indicated.

No special conservation conditions are required.

Dispose of at the end of the month after opening the packaging.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines at the SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

Composition of Isopto B12

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

Appearance of the product and contents of the packaging

Polyethylene vial provided with a dropper that contains 5ml of transparent red solution.

Holder of the marketing authorization

Reva Health Europe, S.L.

Pl. Ausiàs March,1, 4-6

08195 Sant Cugat del Vallès-Spain

Responsible for manufacturing

Tubilux Pharma S.P.A

Via costa rica, 20/22

00071-Pomezia (Rome)

Date of the last review of this leaflet:

October 2017

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/