Carmelosa Qualigen 5 mg/ml eye drops solution in single-dose containers
SpainTable of Contents
- Patient Information Leaflet
- Introduction
- 1. What Carmelosa Qualigen is and what it is used for
- 2. What you need to know before starting to use Carmelosa Qualigen
- 3. How to use Carmelosa Qualigen
- 4. Possible adverse effects
- 5. Storage of Carmelosa Qualigen
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Carmelosa Qualigen 5 mg/ml eye drops solution in single-dose container
Sodium carmellose
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those given 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 this leaflet
- What Carmelosa Qualigen is and what it is used for
- What you need to know before using Carmelosa Qualigen
- How to use Carmelosa Qualigen
- Possible side effects
- How to store Carmelosa Qualigen
- Contents of the pack and other information
1. What Carmelosa Qualigen is and what it is used for
Carmelosa Qualigen is an artificial tear preparation containing a lubricant called sodium 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 Carmelosa Qualigen
Do not use Carmelosa Qualigen
If you are allergic to sodium carmellose or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
If irritation, pain, redness, changes in vision occur, or if you feel your condition worsens, stop using this medicine and consult your doctor or pharmacist.
Use of Carmelosa Qualigen with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy, breastfeeding and fertility
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.
Carmelosa Qualigen may be used during pregnancy and breastfeeding.
Driving and using machines
Carmelosa Qualigen 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 Carmelosa Qualigen
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.
Carmelosa Qualigen is administered by the ophthalmic route (applied into the eye).
The recommended dose is one drop into the affected eye(s) as often as necessary or as directed by your specialist.
Ensure the single-dose container is intact before use. The solution should 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:
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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.
Using the index finger and thumb of the other hand, gently lever the winged part to open it. Do not twist to break open.
- Remove the winged part.
- Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze it to instill 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 Carmelosa Qualigen than you should
This will not cause you any harm. If you are concerned, speak with 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, stating the name of the medicine and the amount administered or ingested.
If you forget to use Carmelosa Qualigen
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, Carmelosa Qualigen may produce adverse effects, although not everyone will experience them.
The following adverse effects have been reported, but the number of people affected 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 it is a possible adverse effect 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 Carmelosa Qualigen
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 Punto Sigre collection point at your pharmacy. If in doubt, please 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 Carmelosa Qualigen
- 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 Carmelosa Qualigen have been designed to simulate the natural composition of your tears.
Appearance of the medicine and contents of the pack
Carmelosa Qualigen is supplied as single-dose containers containing 0.4 ml of sterile solution. Each cardboard carton contains an aluminium pouch with 10 or 30 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Neuraxpharm Spain, S.L.U.
Avda. Barcelona, 69
08970 Sant Joan Despí
Barcelona – Spain
Manufacturer
Neuraxpharm Pharmaceuticals, S.L.
Avda. Barcelona 69
08970 Sant Joan Despí (Barcelona), Spain
Date of the most recent revision of this leaflet: July 2013
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es