Lagroben 5 mg/ml eye drops solution in single-dose container
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Lagroben 5 mg/ml eye drops solution in single-dose container
Sodium carmellose
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse 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 Lagroben is and what it is used for
- What you need to know before using Lagroben
- How to use Lagroben
- Possible adverse effects
- How to store Lagroben
- Contents of the pack and other information
1. What Lagroben is and what it is used for
Lagroben is a tear substitute and contains a lubricant called Natrium carmellose. This medicine is used for the symptomatic relief of eye irritation and dryness.
You should consult a doctor if symptoms worsen or do not improve after 3 days.
2. What you need to know before starting to use Lagroben
Do not use Lagroben
If you are allergic to carmellose sodium or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If irritation, pain, redness or changes in vision occur, or if you consider your condition is worsening, stop using this medicine and consult your doctor or pharmacist.
Using Lagroben with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Lagroben may be used during pregnancy and breastfeeding.
Driving and using machines
Lagroben may cause short-term blurred vision, usually lasting from 1 to 15 minutes. If you experience temporary blurred vision, do not drive or operate machinery until your vision is clear.
3. How to use Lagroben
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Lagroben is administered by the ophthalmic route (applied into the eye).
The recommended dose is one drop into the affected eye or eyes as often as necessary or as directed by your specialist.
Ensure that the single-dose container is intact before use. The solution must be used immediately after opening. To avoid possible contamination of the dropper tip and solution, the dropper must not come into contact with the eye or any other surface.
Wash your hands before use.
For correct administration, follow the instructions below:
- Detach one unit from the strip of single-dose containers.
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Check that the single-dose container is not damaged.
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Hold the single-dose container between the index finger and thumb of one hand.
With the index finger and thumb of the other hand, gently lever the winged piece to open it. Do not twist to break.
- Remove the winged piece.
- Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to apply one drop into each eye. Blink a few times.
Do not reuse the single-dose container even if there is solution remaining.
If more than one ophthalmic medicine is being used, administration of the different medicines should be spaced at least 5 minutes apart.
If you use more Lagroben than you should
This will not cause you any harm. If you are concerned, speak to your doctor or pharmacist.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount administered or ingested.
If you forget to use Lagroben
Apply the next dose as needed, or according to the usual schedule prescribed by your doctor or pharmacist. Do not use a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Lagroben may cause adverse effects, although not everyone experiences them.
The following adverse effects have been reported, but the number of affected individuals is unknown:
- Eye irritation, burning or stinging sensation,
- Blurred vision,
- Increased tear production (also known as lacrimation).
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lagroben
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
Store the single-dose containers in the original packaging.
Discard the opened single-dose container after use (do not reuse the container once opened for subsequent doses).
Do not use this medicine if you notice that the solution changes colour or becomes cloudy.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the Sigre Point collection system at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Lagroben:
- The active substance is sodium carmellose. Each ml of solution contains 5 mg of sodium carmellose.
- The other components are sodium chloride, sodium lactate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, and water for injections.
The components of Lagroben have been designed to simulate the natural composition of your tear fluid.
Appearance of the product and contents of the pack
Lagroben is supplied as sterile solution in single-dose containers, each containing 0.4 ml. Each cardboard box contains an aluminium pouch with 10 or 30 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Teva Pharma, S.L.U.
C/ Anabel Segura, 11. Ed. Albatros B, 1st floor
28108 Alcobendas - Madrid, Spain
Manufacturer responsible for manufacturing
Neuraxpharm Pharmaceuticals, S.L.
Avda. de Barcelona, 69
08970 Sant Joan Despí (Barcelona), Spain
Date of the most recent revision of this package leaflet: February 2014
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/