Oftalmowell eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Oftalmowell eye drops solution
Polymyxin B sulfate, neomycin sulfate, gramicidin
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
Leaflet contents
- What Oftalmowell is and what it is used for
- What you need to know before using Oftalmowell
- How to use Oftalmowell
- Possible adverse effects
- How to store Oftalmowell
- Contents of the pack and other information
1. What Oftalmowell is and what it is used for
Oftalmowell contains several antibiotics (polymyxin B sulfate, neomycin sulfate, and gramicidin) that act against certain microorganisms causing bacterial infections in the eyes.
Antibiotics are used to treat bacterial infections and are not effective against viral infections.
It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the sink or throwing them in the trash.
Oftalmowell is indicated for the treatment of bacterial infections such as purulent bacterial conjunctivitis, keratitis, corneal ulcers, and chronic dacryocystitis.
Oftalmowell is also indicated for pre- and postoperative ophthalmic prophylaxis, including surgical procedures and removal of foreign bodies from the eye.
2. What you need to know before using Oftalmowell
Do not use Oftalmowell
- If you are allergic to polymyxin B sulfate, neomycin sulfate, gramicidin, or any of the other components of this medicine (listed in section 6).
- If you are allergic to other related antibiotics such as framycetin, kanamycin, or gentamicin.
- There is a possibility of increased absorption in very young children; therefore, use is not recommended in neonates or children under 2 years of age. In these populations, absorption through immature skin may be enhanced, and renal function may not be sufficiently developed.
Warnings and precautions
Consult your doctor before starting to use Oftalmowell.
- Use this medicine only in your eye(s).
- Prolonged use of Oftalmowell may lead to overgrowth of non-susceptible microorganisms, including fungi. In such cases, treatment should be discontinued and appropriate therapy initiated.
- The use of contact lenses during treatment of an ocular infection is not recommended. See section “Oftalmowell contains benzalkonium chloride”.
- Caution is advised when using concomitantly with other aminoglycosides or other polypeptide antibiotics administered systemically.
Using Oftalmowell with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy.
It is unknown whether the active substances/metabolites of this medicine are excreted in breast milk. A decision should be made on whether to discontinue breastfeeding or discontinue treatment, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.
Driving and using machines
Immediately after applying Oftalmowell, you may experience blurred vision. Do not drive or operate machinery until these effects have subsided.
Oftalmowell contains benzalkonium chloride
This medicine may cause ocular irritation because it contains benzalkonium chloride. Avoid contact with soft contact lenses. Remove contact lenses before application and wait at least 15 minutes before reinserting them. May discolor soft contact lenses.
3. How to use Oftalmowell
Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Recommended dosage:
Adults (over 18 years of age):
Purulent bacterial conjunctivitis, Keratitis, Corneal ulcers, and Chronic dacryocystitis
During the first two days, instill one or two drops into the affected eye(s) every 2–4 hours during the day.
Thereafter, instill one or two drops every 4–6 hours until the infection has resolved.
The dosing regimen and duration of treatment will be adjusted according to medical assessment.
Surgical prophylaxis
Your doctor will determine the dose and administration schedule to be followed both in the days prior to surgery, during the procedure, and in the days following surgery.
Treatment should continue for at least two days after resolution of the condition but should not be prolonged for more than 7 days without medical supervision.
Paediatric population:
Oftalmowell eye drops are suitable for use in children (over 2 years of age) at the same dosage as adults. As there is a possibility of increased absorption in very young children, use is not recommended in neonates and children under 2 years of age.
Elderly patients:
Oftalmowell is suitable for use in elderly patients. Special caution should be taken in cases of reduced renal function, as significant systemic absorption of neomycin sulfate may occur.
Method of administration
Ophthalmic use.
If more than one ophthalmic medication is being used, applications should be spaced at least 5 minutes apart. Ophthalmic ointments should be administered last.
To avoid possible contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the tip of the bottle. Keep the bottle tightly closed when not in use.
Instructions for use:
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Wash your hands. Tilt your head backward and look up toward the ceiling.
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Gently pull down the eyelid to create a pouch between the eyelid and the eye, into which the drop should fall (Figure 1).
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Bring the tip of the bottle close to the eye. A mirror may be helpful.
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Do not touch the eye, eyelid, nearby areas, or other surfaces with the bottle. The drops could become contaminated.
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Invert the bottle and gently squeeze it to release one drop at a time into the eye requiring treatment (Figure 2). Squeeze gently; there is no need to apply force.
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Release the lower eyelid and keep the eye closed for 30 seconds (Figure 3).
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After using the eye drops, press with your finger on the inner corner of the eye near the nose. This helps prevent the eye drops from draining into the throat and then into the rest of the body (Figure 4).
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If drops are to be applied to both eyes, repeat all the previous steps for the other eye. Close the bottle tightly immediately after use.
If a drop misses the eye, try again.
If you use more Oftalmowell than you should
If too much has been applied, excess can be removed by rinsing the eyes with lukewarm water. Do not apply additional drops until the next scheduled dose.
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 Oftalmowell
If you forget to use Oftalmowell, apply a single dose as soon as you remember, and then continue with your regular treatment schedule. Do not apply 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 may cause adverse effects, although not everyone will experience them.
The following local adverse reactions may occur: burning, irritation, dryness, folliculitis (inflammation of the hair follicle area), hypertrichosis (excessive hair growth), rashes, and striae. These symptoms disappear upon discontinuation of application.
The incidence of allergy to neomycin sulfate in the general population is low, but sensitization may occur following its use.
Allergic reactions following topical application of polymyxin B sulfate and gramicidin are rare.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves 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 Oftalmowell
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 25°C. Keep in the original packaging to protect from light.
Discard the bottle four weeks after first opening.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point 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 Oftalmowell
The active substances are polymyxin B sulfate, neomycin sulfate and gramicidin. Each ml of sterile solution contains (1 ml = 40 drops): 5,000 IU of polymyxin B sulfate, 1,700 IU of neomycin sulfate and 25 IU of gramicidin.
The other components are: sodium chloride, 96% ethanol, propylene glycol, poloxamer 188, benzalkonium chloride, sodium hydroxide or diluted sulfuric acid to adjust pH, and purified water.
Appearance of the product and pack contents
Oftalmowell is a sterile eye drop solution supplied in polypropylene bottles with an integrated dropper and screw cap. Each bottle contains 5 ml of solution.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Teofarma S.r.l.
Via F.lli Cervi, 8 – 27010
Valle Salimbene (PV) - Italy
Manufacturer: Alcalá Farma S.L.
Avenida de Madrid 82
28802 Alcalá de Henares
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.gob.es/