Isopto B12 0.5 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Isopto B12 0.5 mg/ml eye drops, solution
Cyanocobalamin
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Always follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.
- Keep this leaflet as you may need to read it again.
- If you need advice or more information, consult your pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if you do not improve after 3 days.
Contents of the leaflet
- What Isopto B12 is and what it is used for
- What you need to know before using Isopto B12
- How to use Isopto B12
- Possible side effects
- How to store Isopto B12
- Contents of the pack and other 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 its active substance.
Isopto B12 is indicated as an adjunctive treatment for corneal healing problems.
You should consult your doctor if your condition 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 substances 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 is for ocular use only. It must not be ingested or injected.
- When applying the medicine, avoid contact between the dropper tip and the eye or fingers to prevent possible contamination.
Other medicines and Isopto B12
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Isopto B12 may be administered simultaneously with any other medication, whether local or systemic.
If you use more than one eye drop, applications 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 regarding 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 substance, harmful effects on the fetus or infant are not expected.
Driving and using machines
No effects of Isopto B12 on driving or operating machinery have been reported. However, as with any eye drop, blurred vision or other visual disturbances may occur after instillation, which could affect your ability to drive or operate machinery. Do not drive or operate machinery until you have regained clear vision.
Isopto B12 contains thiomersal
This medicine may cause allergic reactions because it contains thiomersal.
3. How to use Isopto B12
Follow exactly the instructions for use provided in this leaflet or those given 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 your condition worsens or does not improve after 3 days of treatment, discontinue treatment and consult your doctor.
Instructions for correct administration of the medicine
Tilt your head backward, gently pull down the lower eyelid and instill the drops into the conjunctival sac (the space between the eye and the eyelid), while looking upward. Gently close your eyes and keep them closed for a few seconds.
Recommendations for the use of eye drops
Since this is a sterile preparation, the following instructions are recommended:
- Each patient should use their own container.
- Eye drop administration should be performed with maximum hygiene: wash hands thoroughly and avoid, as much as possible, any contact between the dropper tip and any surface (including the eye).
- After each application, keep the bottle tightly closed.
- Discard the container one month after opening.
If you use more Isopto B12 than you should
Due to the characteristics of this medicine, intoxication symptoms are not expected.
In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at telephone number 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 missed doses.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
This medicine may cause transient ocular irritation, allergic reactions. (See also: Isopto B12 contains thiomersal)
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 via 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 Isopto B12
Keep out of the sight and reach of children.
Do not use Isopto B12 after the expiry date stated on the container, after EXP. The expiry date refers to 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 drains or household waste. Ask your pharmacist how to properly dispose of unused medicines and their containers at the SIGRE collection point. If you are in doubt, consult your pharmacist on how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Isopto B12
- The active substance is cyanocobalamin (Vitamin B12). Each ml contains 0.5 mg of cyanocobalamin.
- The other components are thimerosal, sodium chloride, hypromellose, disodium phosphate, hydrochloric acid (pH regulator), monosodium phosphate monohydrate, and water for injection q.s.
Appearance of the product and contents of the container
Polyethylene bottle with dropper containing 5 ml of a transparent red solution.
Marketing Authorization Holder
Reva Health Europe, S.L.
Pl. Ausiàs March, 1, 4-6
08195 Sant Cugat del Vallès, Spain
Manufacturer responsible
Tubilux Pharma S.P.A
Via Costa Rica, 20/22
00071 Pomezia (Rome)
Date of the most recent revision of this leaflet:
January 2026
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/