Minims Artificial Tears, Eye drops solution
Active ingredient: sodium chloride, hyetellose
- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
Minims Artificial Tears
2. Qualitative and quantitative composition
Clear, colourless, sterile eye drops containing hyetellose 0.44% w/w and sodium chloride 0.35% w/w.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Sterile single-use eye drop.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of dry eye syndromes associated with deficient tear secretion.
4.2 Posology and method of administration
One or two drops instilled into the affected eye three or four times daily, or as often as is required.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
If irritation persists or worsens or continued redness occurs, discontinue use and consult a physician or ophthalmologist.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
There is no evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. If drug therapy is needed in pregnancy this preparation can be used if recommended by a physician and it is considered that the benefits outweigh the possible risks.
4.7 Effects on ability to drive and use machines
May cause transient blurring of vision on instillation. Do not drive or operate hazardous machinery unless vision is clear.
4.8 Undesirable effects
May cause transient mild stinging or temporarily blurred vision.
Reporting of suspected adverse reactions
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 the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdose would not be expected to produce symptoms.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Artificial tears and other indifferent preparations,
ATC code: S01XA20
The viscolising properties of hyetellose combined with sodium chloride have been shown to increase the tear break-up time in animal models, whilst also acting as a lubricating agent for dry eyes.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
No adverse safety issues were detected during the development of this formulation. The active ingredients are well-established in clinical ophthalmology.
6. Pharmaceutical particulars
6.1 List of excipients
Purified water
Borax
Boric acid
6.2 Incompatibilities
Not applicable
6.3 Shelf life
18 months.
6.4 Special precautions for storage
Store below 25°C. Do not freeze. Protect from light.
6.5 Nature and contents of container
A sealed conical shaped polypropylene container fitted with a twist and pull off cap. Each Minims unit is overwrapped in an individual polypropylene/paper pouch.
6.6 Special precautions for disposal and other handling
Each Minims unit should be discarded after a single use.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
7. Marketing authorisation holder
Bausch & Lomb UK Limited
Bausch & Lomb House
106 London Road KingstonUpon-Thames Surrey, UK
KT2 6TN
8. Marketing authorisation number
PL 03468/0067
9. Date of first authorisation/renewal of the authorisation
11 January1990
10. Date of revision of the text
27/09/2020