Minims artificial tears 0.44% eye drops 0.5ml unit dose

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Hydroxyethylcellulose

Boleh didapati daripada:

Bausch & Lomb UK Ltd

Kod ATC:

S01XA20

INN (Nama Antarabangsa):

Hydroxyethylcellulose

Dos:

4.4mg/1ml

Borang farmaseutikal:

Eye drops

Laluan pentadbiran:

Ocular

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 11080100; GTIN: 5027519001101

Risalah maklumat

Graphics&Packing
Technology Section
ICN POLFA RZESZÓW S.A.
ULOTKA PIL
Nazwa produktu
Product Name
MINIMS ARTIFICIAL TEARS
0.35% W/W & 0.44% W/W
DRP SOL
Kolor nadruku Colours
Black
Kraj
Country (ISO)
UNITED KINGDOM (UK),
IRLEAND (IE)
Nr wykrojnika
Spec No
5336
Opracowane przez
Designed by
Kod Wytwórcy
Manufacturer code
76845
Nr korekty
Proof No
2
Data
Date
11.02.2015
Kod farmaceutyczny
Pharmacode
76845 DATA MATRIX
Kod wersji
Valeant version code
P1UKIE02
Inny kod
Other code
-
Rozmiar czcionki
Font size
MINIMUM 6 PT
Wymiar ulotki
PIL size
80 X 140 MM
Krój czcionki
Font used
BAUSH&LOMB BOLD
Baush&Lomb Regular
Gramatura papieru
Paper weight
- G/M
2
Komentarze Comments (Reason for the change)
MAH TRANSFER FROM CHAUVIN PHARMACEUTICALS LTD UK TO B+L UK LTD
PMR_ICN-14-0933-A
PACKING SITE: LABORATOIRE CHAUVIN, AUBENAS, FRANCE
Akceptacja Techniczna Technical Approval
Akceptacja Działu ds. Rejestracji Regulatory Affairs Dept. Approval
0.35% W/W SODIUM CHLORIDE + 0.44%W/W HYETELLOSE EYE DROPS, SOLUTION
Read all this leaflet carefully before you start using your medicine.
It contains
a summary of the information available on your medicine. If you have
any
questions or are not sure about anything, ask your doctor or
pharmacist.
Remember this medicine is for you. Do not give it to someone else.
IN THIS LEAFLET:
1.
What Minims
®
Artificial Tears eye drops is and what it is used for
2.
Before you use your eye drops
3.
How to use your eye drops
4.
Possible side effects
5.
How to store your eye drops
6.
Further information
1.
WHAT MINIMS® ARTIFICIAL TEARS EYE DROPS IS AND WHAT IT IS USED FOR
Minims
®
Artificial Tears contains a lubricant. It is used as a substitute for
natural tears.
This medicine is indicated for children, adults and the elderly.
2.
BEFORE YOU USE YOUR EYE DROPS
There are no special precautions which should be taken before using
this product.
IF YOU ARE PREGNANT, MAY BE PREGNANT, OR ARE BREASTFEEDING
You can use Minims
®
Artificial Tears as it will not harm your baby, and it is safe
to use during breastfee

Ciri produk

OBJECT 1
MINIMS ARTIFICIAL TEARS, EYE DROPS SOLUTION
Summary of Product Characteristics Updated 08-Dec-2015 | Bausch & Lomb
U.K Limited
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/yello