Acuolens 3 mg/ml + 5.5 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
ACUOLENS 3 mg/ml + 5.5 mg/ml eye drops solution in single-dose container
Hypromellose / Sodium chloride
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 this medicine as described 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 adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if your condition worsens or if there is no improvement after 3 days.
Contents of the leaflet
- What ACUOLENS is and what it is used for
- What you need to know before using ACUOLENS
- How to use ACUOLENS
- Possible side effects
- How to store ACUOLENS
- Contents of the pack and other information
1. What ACUOLENS is and what it is used for
ACUOLENS is an eye drop that, due to its components—hypromellose and sodium chloride—lubricates and protects the cornea, relieving any discomfort (dryness and irritation) caused by decreased tear production.
It 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 using ACUOLENS
Do not use ACUOLENS
- if you are allergic to hypromellose, sodium chloride, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use ACUOLENS.
Use this medicine only in your eye(s).
If you experience headache, eye pain, changes in vision, eye irritation, persistent redness, or if symptoms worsen or last longer than 3 days, stop treatment and consult your doctor.
Children
Specific studies in children have not been conducted. Consult your doctor before using this medicine in children.
Other medicines and ACUOLENS
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breast-feeding and fertility
Consult your doctor before using any medicine.
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
As with other eye drops, immediately after application of this medicine you may notice blurred vision. Do not drive or operate machinery until your vision is clear.
ACUOLENS contains phosphate buffer
This medicine contains 2 mg of phosphates in each 0,5 ml.
If you have severe corneal damage (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, lead to blurred vision due to calcium accumulation.
3. How to use ACUOLENS
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.
Recommended dose:
Adults (including elderly patients)
Instill 1 or 2 drops into each affected eye as often as necessary.
The number of daily applications and duration of treatment may be adjusted according to medical judgment.
Instructions for use:
1 2 3
- Open the aluminum pouch and remove the single-dose strip.
- Hold the strip with the long smooth end facing upwards and separate one single-dose unit by pulling it towards you, while firmly holding the rest. You will need to detach it at the points where it is connected to the other units (Figure 1).
- Keep the separated single-dose unit. Return the remaining units back into the aluminum pouch.
- Make sure you have a mirror nearby and wash your hands.
- Hold the single-dose unit between your fingers, with the long smooth end, and open it by twisting the other end (Figure 2).
- Tilt your head backwards. Gently pull down the lower eyelid with one finger to form a pouch, into which the drop should fall (Figure 3).
- Hold the single-dose unit between your fingers with the open tip pointing downwards.
- Bring the tip of the container close to the eye. Using a mirror may help.
- Do not touch the eye, eyelid, surrounding areas, or any other surface with the tip of the container. The drops could become contaminated.
- Gently squeeze the container so that one drop falls into the pouch formed between the eyelid and the eye.
- If applying drops to both eyes, repeat the previous steps for the other eye, using the same container.
- Immediately discard the container and any remaining solution.
- Discard any unused containers one week after opening the aluminum pouch, including those still unopened.
If a drop misses the eye, try again.
If you are using other ophthalmic medicines, wait at least 5 minutes between applying this eye drop and any other ophthalmic medicines. Ophthalmic ointments should be applied last.
If you use more ACUOLENS than you should, wash your eyes with lukewarm water to remove it.
Due to the characteristics of this preparation, intoxication phenomena are not expected with ophthalmic use of the product.
In case of overdose or accidental ingestion, consult your doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.
If you forget to use ACUOLENS, do not worry; apply the drops as soon as possible. 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, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects observed.
Frequency not known (frequency cannot be estimated from available data):
- Eye effects: blurred vision, eye pain, abnormal sensation in the eye, eye irritation, eye redness, eye allergy, and eye itching
- Body effects: allergic reaction (hypersensitivity)
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 ACUOLENS
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the single-dose unit and on the carton after "EXP". The expiry date refers to the last day of the month indicated.
Dispose of the single-dose unit immediately after use. Once the aluminium pouch has been opened, discard any unused single-dose units one week after opening.
Medicines must not be disposed of via wastewater or household waste. Instead, return unused containers and medicines to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of ACUOLENS
- The active substances are hypromellose and sodium chloride. One ml of solution contains 3 mg of hypromellose and 5.5 mg of sodium chloride.
- The other components are potassium chloride, magnesium chloride hexahydrate, calcium chloride dihydrate, zinc chloride, disodium hydrogen phosphate dodecahydrate, monosodium phosphate monohydrate, sodium hydrogen carbonate and purified water.
Appearance of the product and contents of the pack
This medicine is a liquid (clear and colourless) supplied in a box containing 30 single-dose plastic containers of 0.5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Alcon Healthcare S.A.
World Trade Center Almeda Park
Plaça de la Pau s/n, Edificio 6, planta 3
08940 - Cornellà de Llobregat (Barcelona)
Spain
Manufacturer
Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
or
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium
Date of the most recent revision of this leaflet: August 2022
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/