Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Hypromellose may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR ISOPTO PLAIN is a slightly viscous solution that acts as an artificial tear. It is used to treat dry eyes caused by a lack of tears in the eye(s).
Replacement of the reduced natural tears with an artificial tear helps to soothe and lubricate your eyes and provide relief from irritation. It can also be used as a lubricant for artificial eyes.
2. BEFORE YOU USE ISOPTO® PLAIN Do not use ISOPTO PLAIN …
Driving and using machines
You may experience blurred vision after using ISOPTO PLAIN. Do not drive or operate hazardous machinery unless your vision is clear.
Take special care … This medicine is available without a prescription. However, you still need to use ISOPTO PLAIN carefully to get the best results from it.
Using other medicines Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast‐feeding If you are pregnant or might get pregnant, or if you are breast-feeding a baby, talk to your doctor before you use ISOPTO PLAIN.
Important information if you wear Contact Lenses Do not use the drops while wearing contact lenses. Wait at least 15 minutes after use before putting your lenses back in. There is a preservative in ISOPTO PLAIN (benzalkonium chloride) that can discolour soft contact lenses.
3. HOW TO USE ISOPTO® PLAIN The usual dose
Remove the loose collar from the cap when you open the bottle.
The usual dose is 1 or 2 drops in each affected eye 3 times daily or as specified by your doctor or Always use ISOPTO PLAIN exactly as your doctor pharmacist. has told you. You should check with your doctor or pharmacist if you are not sure. If the irritation in your eyes does not get better or gets worse after 3 days or if you start to experience headache, eye pain, vision changes or continued redness in your eyes, stop using ISOPTO PLAIN and see your doctor.
Continued over
HOW TO USE ISOPTO® PLAIN (continued)
4.
POSSIBLE SIDE EFFECTS
Like all medicines, ISOPTO PLAIN can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
you can help provide more information on the safety of this medicine. In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.
5.
ISOPTO® PLAIN
6.
FURTHER INFORMATION
What ISOPTO PLAIN contains What ISOPTO PLAIN looks like and
Marketing authorisation holder: Alcon Eye Care UK Limited Park View, Riverside Way Watchmoor Park, Camberley Surrey, GU15 3YL United Kingdom.
Alcon
Manufacturer: Alcon Laboratories Belgium Lichterveld 3 2870 Puurs-Sint-Amands Belgium This leaflet was last revised in 01/2020
Isopto Plain 0.5% eye drops, solution comes as eye drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Isopto Plain 0.5% eye drops, solution is hypromellose.
Medicines with the same active substance, strength and form include: Hypromellose 0.3% w/v Eye Drops (FAMAR), Hypromellose Eye Drops BP, Hypromellose Eye Drops BPC 0.3%. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Isopto Plain 0.5% eye drops, solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Used topically to provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production. (Usually in cases of rheumatoid arthritis, keratoconjunctivitis sicca and xerophthalmia).
Also used as an ocular lubricant for artificial eyes.
Adults, children and the elderly. The dose depends on the need for lubrication. Usually one to two drops to each eye three times daily or as prescribed.
Hypersensitivity to any component of the product.
If irritation persists or worsens, or headache, eye pain, vision changes or continued redness occur, discontinue use and consult a physician.
To preserve sterility do not allow the dropper to touch the eye or any other surface.
The product contains benzalkonium chloride and should not be used when soft contact lenses are worn.
None known.
Fertility
Studies have not been performed to evaluate the effect of topical ocular administration of hypromellose on fertility. Hypromellose is a pharmacologically inert compound and it would not be expected to have any effect on fertility.
Pregnancy
There are no or limited amount of data from the use of ophthalmic hypromellose in pregnant women. Systemic exposure to hypromellose following topical ocular administration is negligible and the product has no pharmacological properties.
Lactation
It is unknown whether topical hypromellose/metabolites are excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to hypromellose is negligible. In addition to this, hypromellose is pharmacologically inert.
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
The following adverse reactions have been reported following administration of ISOPTO PLAIN. Frequency cannot be estimated from the available data.
System Organ Classification
Adverse Reaction
Eye disorders
Vision blurred, eye pain, foreign body sensation in eyes, eye irritation, ocular hyperaemia
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of benefit/risk balance of the medicinal product. Health care professionals are asked to report any suspected adverse reactions via their national reporting system:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product, nor in the event of accidental ingestion of the contents of one bottle.
Ask anything about Isopto Plain 0.5% eye drops, solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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