Optispring 0.5 mg/ml eye drops solution in single-dose containers
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Optispring 0.5 mg/ml eye drops solution in single-dose containers
Tetrizoline Hydrochloride
Read the entire 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 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 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 2 days of treatment.
Contents of the leaflet
- What Optispring is and what it is used for
- What you need to know before using Optispring
- How to use Optispring
- Possible side effects
- How to store Optispring
- Contents of the pack and other information
1. What Optispring is and what it is used for
This medicine belongs to the group of decongestant medicines known as sympathomimetics. It is an ophthalmic decongestant medicine containing tetrizoline as the active substance. Tetrizoline administered by the ophthalmic route produces local constriction of blood vessels, thereby reducing ocular congestion.
It is indicated for the temporary relief of mild eye irritation in adults and children over 6 years of age. You should consult a doctor if symptoms worsen or do not improve after 2 days of treatment.
2. What you need to know before using Optispring
Do not use Optispring
- If you are allergic to tetrahydrozoline or to any of the other components of this medicine (listed in section 6).
- If you have increased intraocular pressure (narrow-angle glaucoma).
- If you have heart disease or high blood pressure (hypertension).
- If you have a tumor of the adrenal glands (pheochromocytoma).
- If you have an overactive thyroid gland (hyperthyroidism).
- If you have diabetes controlled with insulin.
- If you are being treated with antidepressants of the monoamine oxidase inhibitor class or with blood pressure-raising agents.
- If you have dry rhinitis.
- If you have inflammation of the cornea and conjunctiva (keratoconjunctivitis).
- In children under 2 years of age.
Warnings and precautions
Consult your doctor or pharmacist before starting to use Optispring.
Especially:
- If you experience eye pain, headache, changes in vision, sudden appearance of floaters, persistent redness or irritation of the eye, pain after exposure to light, or double vision. If any of these occur, or if symptoms worsen or persist, or new symptoms appear, you must stop using the medicine and consult your doctor.
- If you are over 65 years of age.
When using this product, the pupils may temporarily dilate.
If you wear contact lenses, they must be removed before administering the medicine.
Excessive or prolonged use of this product may lead to increased eye redness.
To avoid contamination of the product, do not touch any surface with the tip of the container. Do not use the product if the solution changes color or becomes cloudy.
Children and adolescents
Do not use in children under 2 years of age.
Other medicines and Optispring
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Optispring must not be used if you are being treated with:
- Antidepressant medicines known as monoamine oxidase inhibitors.
- Medicines that raise blood pressure.
In particular, if you are taking the following medicine, a dose adjustment may be necessary:
- Tricyclic antidepressant medicines.
Consult your doctor before administering any other ophthalmic medicine; it is recommended to wait at least 5 minutes between administrations.
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.
Driving and using machines
Optispring in single-dose containers has negligible or no effect on the ability to drive and use machinery. In rare cases, the ability to drive and use machinery may be impaired due to blurred vision or glare.
Optispring contains sodium. This medicine contains less than 23 mg of sodium (1 mmol) per ml; hence, it is essentially "sodium-free".
3. How to use Optispring
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.
Recommended dose:
Adults and children over 6 years of age
Apply 1 to 2 drops in each eye 2 or 3 times a day as needed, up to a maximum of 4 times daily.
Children aged 2 to 6 years
Use only under strict medical supervision.
Children under 2 years of age
Do not use in children under 2 years of age. It is contraindicated.
Elderly population (over 65 years of age)
Consult your doctor or pharmacist before using this medicine.
How to use
This medicine is administered by ophthalmic route.
Before application, wash your hands and dry your eyes.
The amount contained in the single-dose container is sufficient for one application in both eyes.
Separate one single-dose container from the strip. Remove the closure device. Tilt your head backward. Using your index finger, gently pull down the lower eyelid to separate it from the eyeball and instill the recommended dose into the eye by gently squeezing the container.
After application, gently blink for a few seconds to help evenly distribute the drops.
Discard the container after each use.
This medicine should be used only for minor eye irritations. If you do not experience relief within 48 hours, or if redness worsens or persists, discontinue use and consult your doctor.
Use only until symptoms resolve and never for longer than one week.
If you use more Optispring than you should
Excessive use or oral ingestion may lead to cardiovascular instability, central nervous system depression including drowsiness and coma, and respiratory depression including apnea.
Particular risk exists in neonates and children due to product absorption, for example through accidental ingestion.
Symptoms associated with overdose include pupil dilation, bluish discoloration of the skin and mucous membranes, vomiting, sedation, drowsiness, stupor, drooling, nausea, fever, cramps, heart rhythm disturbances, cardiac arrest, increased blood pressure, pulmonary edema, and respiratory and mental disturbances.
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 ingested.
If you forget to use Optispring
Use this medicine only when you experience symptoms. If you do not have symptoms, do not use it.
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, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Frequent (may affect up to 1 in 10 patients): Eye irritation (pain, stinging, burning), visual disturbances.
Uncommon (may affect up to 1 in 100 people): Burning sensation in the ocular mucosa, dry eye, rebound redness (hyperemia), palpitations, headache, tremor, weakness, sweating, and increased blood pressure.
Rare (may affect up to 1 in 1,000 patients): Blurred vision, irritation of the ocular conjunctiva, and pupil dilation (mydriasis).
Very rare (may affect up to 1 in 10,000 people): Reactions at the application site (including ocular or periocular burning, erythema, irritation, edema, pain, and itching).
Frequency not known (cannot be estimated from available data): Increased lacrimation.
Prolonged and frequent use may lead to dry eye syndrome.
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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Optispring
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 is the last day of the month indicated.
Do not store above 30°C.
Discard the container after each use.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, 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 Optispring
- The active substance is tetrizoline hydrochloride. Each ml of eye drops contains 0.5 mg of tetrizoline hydrochloride. Each single-dose container of 0.5 ml contains 0.25 mg of tetrizoline hydrochloride.
- The other components (excipients) are: boric acid (E-284), sodium borate, sodium chloride and purified water.
Appearance of the product and contents of the pack
Optispring 0.5 mg/ml in single-dose containers is a clear eye drop solution supplied in single-dose containers of 0.5 ml made of low-density polyethylene, contained within a pouch. Each pack contains 10 single-dose containers.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
FARMIGEA S.p.A.
Via G.B. Oliva, 8 56121 Pisa, ITALY
Date of the most recent review of this leaflet: March 2021
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/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77462/P_77462.html
QR code link: https://cima.aemps.es/cima/dochtml/p/77462/P_77462.html