Carmelosa Stada 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
Carmelosa Stada 5 mg/ml eye drops solution in single-dose container
Sodium Carmellose
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
Follow exactly the instructions for use 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 you get worse or do not improve after 3 days.
Contents of the leaflet:
- What Carmelosa Stada is and what it is used for
- What you need to know before using Carmelosa Stada
- How to use Carmelosa Stada
- Possible adverse effects
- How to store Carmelosa Stada
- Contents of the pack and other information
1. What Carmelosa Stada is and what it is used for
Carmelosa Stada belongs to a group of medicines called artificial tears; it 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 your condition worsens or does not improve after 3 days.
2. What you need to know before using Carmelosa Stada
Do not use Carmelosa Stada
If you are allergic to sodium carmellose or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Carmelosa Stada.
If irritation, pain, redness or changes in vision occur, or if you think your condition is worsening, stop using this medicine and consult your doctor or pharmacist.
Use of Carmelosa Stada with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy and breast-feeding.
Driving and using machines
This medicine 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 Stada
Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Carmelosa Stada is for ophthalmic use (applied to the eye).
The recommended dose is one drop in the affected eye(s) as often as needed 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 and the solution, the dropper tip must not come into contact with the eye or any other surface.
Wash your hands before use.
For correct administration, follow the instructions below:
- Remove a single-dose container from the strip.
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Check that the single-dose container is undamaged.
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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 part to open it. Do not twist to break.
- Gently pull off the winged part.
- Gently pull down the lower eyelid to form a pouch. Turn the single-dose container upside down and squeeze to apply one drop into each eye. Blink a few times.
Do not reuse the single-dose container even if some solution remains.
If more than one ophthalmic medication is being used, administration of different medications should be spaced at least 5 minutes apart.
If you use more Carmelosa Stada 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, Telephone 91 562 04 20, stating the medication and the amount administered or ingested.
If you forget to use Carmelosa Stada
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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The following medically relevant adverse reactions or adverse effects have been identified in clinical trials:
Frequent adverse effects (may affect up to 1 in 10 people):
Eye irritation (including burning and discomfort), eye pain, eye itching, visual disturbances.
Post-marketing experience
The following medically relevant adverse reactions or adverse effects have been reported during post-marketing experience:
Uncommon adverse effects (may affect up to 1 in 100 people):
Allergic reaction (including eye or eyelid swelling), blurred vision, increased tear production (also known as watery eyes), sticky eyes, eyelid crusting and/or medication residue, eye/eyelid redness, worsening of vision, eye surface injury due to the dropper tip touching the eye during administration of the eye drops.
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 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 Stada
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.
Dispose of the 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 should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the Punto Sigre collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Carmelosa Stada
- 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 injectable preparations.
The components of Carmelosa Stada have been designed to simulate the natural composition of your tear fluid.
Appearance of the product and contents of the pack
Carmelosa Stada is supplied in single-dose containers containing 0.4 ml of sterile solution. Each cardboard box contains an aluminium pouch with 10 or 30 single-dose containers.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (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: January 2018
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