Carmellose Sodium 0.5 Eye Drops, Carmize Lubricant Ophthalmic Solution 10ml (2 x 10ml Bottles)

Product Information

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme

soaking a flannel in warm water (not hot) and gently press it on the area around your eyes – this makes the oil produced by the glands around your eyes more runny Use one drop into the eye (or eyes) affected by dryness. Many people find it is sufficient to use the drops three or four times a day, but you can use the drops more frequently if your eyes are very dry. If the drops have been prescribed for you then follow the directions given by your doctor.

5. Side effects

Carmellose sodium comes in a bottle with an eye dropper, or as a box of single-dose droppers. The single-dose droppers do not contain preservatives. How to use the eye drops Please take care that the dropper doesn't touch your eye, your fingers, or any other surface. This could contaminate the drops left in the bottle.

At the time of writing there is limited published experience regarding the safety of carmellose sodium in human pregnancy, however, carmellose sodium eye drops have been used for many years with no adverse effects reported and the manufacturer states no special precautions are necessary during pregnancy. Schaefer advises that artificial tears may be used for all appropriate indications during pregnancy (Schaefer 2007). The frequency of adverse reactions documented during clinical trials is given. The frequency is defined as follows: Very Common (≥ 1/10); Common (≥1/100, <1/10); Uncommon (≥1/1,000, <1/100); Rare (≥1/10,000, <1/1,000); Very Rare (<1/10,000), not known (cannot be estimated from the available data).

Children

Summary of Product Characteristics: Celluvisc 0.5% w/v eye drops solution. Allergan Ltd. Revised May 2010. Advise patients that instillation of eye drops may cause transient blurring of vision and to avoid driving or operating machinery until vision is clear.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London. Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.Uncommon: Lacrimation increased, vision blurred, eye discharge, eyelid margin crusting and/or medication residue, foreign body sensation in eye, ocular hyperemia, visual impairment. Concomitant ocular medication should be administered 15 minutes prior to the instillation of carmellose sodium eye drops. If irritation, pain, redness and changes in vision occur, or worsen, treatment should be discontinued and a new assessment considered.