HYPROMELLOSE Eye Drops (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Hypromellose 0.3% w/v Eye Drops.
Qualitative and quantitative composition
Hypromellose 0.3% w/v. Excipients of known effect: Benzalkonium Chloride For the full list of excipients, see section 6.1.
Pharmaceutical form
Eye drops, Solution. Clear to slightly opalescent colourless, slightly viscous solution.
Therapeutic indications
To provide tear-like lubrication for the symptomatic relief of dry eyes and eye irritation associated with deficient tear production. As an ocular lubricant for artificial eyes.
Posology and method of administration
Posology Adults, children and the elderly The recommended dosage for adults, children and elderly is one or two drops topically instilled into the eye three times daily as needed, or as directed by a physician. ...
Contraindications
Hypersensitivity to the active substance, Hypromellose or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
May cause transient mild stinging or temporary blurred vision. If irritation persists or worsens, or headache, eye pain, vision changes or continuous redness occur, patients should discontinue use and ...
Interaction with other medicinal products and other forms of interaction
Hypromellose prolongs the contact time of topically applied drugs commonly used in ophthalmology.
Pregnancy and lactation
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 ...
Effects on ability to drive and use machines
May cause blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
Undesirable effects
Adverse events which have been associated with Hypromellose are given below, listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon ...
Overdose
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.
Pharmacodynamic properties
Pharmacotherapeutic group: Ophthalmologicals: other ophthalmologicals ATC code: S01XA20 Hypromellose is a soothing emollient solution with properties and uses similar to those of methylcellulose. Its advantages ...
Pharmacokinetic properties
Not applicable to topical (ophthalmic) preparations. Hypromellose is an inert substance. It has no pharmacological activity and not absorbed systemically. Hence, the pharmacokinetic properties have not ...
Preclinical safety data
Hypromellose is an inert substance and is not expected to be absorbed systemically. Hence, although no systemic toxicity studies have been conducted it is not expected to demonstrate any systemic toxicity ...
List of excipients
Purified water Sodium Chloride Potassium Chloride Borax Boric Acid Benzalkonium Chloride solution May contain sodium hydroxide or hydrochloric acid.
Incompatibilities
None known.
Shelf life
Shelf life: 36 months unopened. 28 days after opening.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Plastic tamper evident eye drop assembly. Fill volume 10ml.
Special precautions for disposal and other handling
Do not touch dropper tip to any surface as this may contaminate the contents. If the drop of medication is not retained in the eye upon dosing for any reason, instill another drop.
Marketing authorization holder
Martindale Pharmaceuticals Ltd, Bampton Road, Romford, RM3 8UG, England
Marketing authorization number(s)
PL 00156/0069
Date of first authorization / renewal of the authorization
06/06/1997
Date of revision of the text
14/06/2018
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