Bimatoprost 300micrograms/ml eye drops

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Bimatoprost

Tillgänglig från:

Aspire Pharma Ltd

ATC-kod:

S01EE03

INN (International namn):

Bimatoprost

Dos:

300microgram/1ml

Läkemedelsform:

Eye drops

Administreringssätt:

Ocular

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 11060000; GTIN: 5060209731698

Bipacksedel

PACKAGE LEAFLET: INFORMATION FOR THE USER
BIMATOPROST 0.3MG/ML, EYE DROPS,
SOLUTION
Bimatoprost
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the
same as yours.
- If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bimatoprost is and what it is used for
2. What you need to know before you use
Bimatoprost
3. How to use Bimatoprost
4. Possible side effects
5. How to store Bimatoprost
6. Contents of the pack and other information
1. WHAT BIMATOPROST IS AND WHAT
IT IS USED FOR
Bimatoprost is an antiglaucoma preparation.
It belongs to a group of medicines called
prostamides.
Bimatoprost eye drops are used to reduce
high pressure in the eye. This medicine may be
used on its own or with other drops called
beta-blockers which also reduce pressure.
Your eye contains a clear, watery liquid that
feeds the inside of the eye. Liquid is constantly
being drained out of the eye and new liquid is
made to replace this. If the liquid cannot drain
out quickly enough, the pressure inside the eye
builds up. This medicine works by increasing the
amount of liquid that is drained. This reduces
the pressure inside the eye. If the high pressure
is not reduced, it could lead to a disease called
glaucoma and eventually damage your sight.
2. WHAT YOU NEED TO KNOW BEFORE
YOU USE BIMATOPROST
DO NOT USE BIMATOPROST:
- if you are allergic to bimatoprost or any of the
other ingredients of this medicine (listed in
section 6);
- if you have had to stop using eye drops in
the past because of a side effect of the
preservative benzalkonium chloride.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmaci

Produktens egenskaper

OBJECT 1
BIMATOPROST ASPIRE 0.3 MG/ML EYE DROPS, SOLUTION
Summary of Product Characteristics Updated 17-Apr-2018 | Aspire Pharma
Ltd
1. Name of the medicinal product
Bimatoprost Aspire 0.3 mg/ml eye drops, solution
2. Qualitative and quantitative composition
One ml of solution contains 0.3 mg bimatoprost.
Excipient with known effect:
One ml of solution contains 0.05 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Eye drops, solution.
Clear, colourless solution, free from visible particles.
pH: 6.8-7.8
Osmolality: 290 mOsm/kg
4. Clinical particulars
4.1 Therapeutic indications
Reduction of elevated intraocular pressure in chronic open-angle
glaucoma and ocular hypertension in
adults (as monotherapy or as adjunctive therapy to beta-blockers).
4.2 Posology and method of administration
Posology
The recommended dose is one drop in the affected eye(s) once daily,
administered in the evening. The
dose should not exceed once daily as more frequent administration may
lessen the intraocular pressure
lowering effect.
_Paediatric population_:
The safety and efficacy of Bimatoprost Aspire in children aged 0 to 18
years has not yet been established.
Patients with hepatic and renal impairment:
Bimatoprost has not been studied in patients with renal or moderate to
severe hepatic impairment and
should therefore be used with caution in such patients. In patients
with a history of mild liver disease or
abnormal alanine aminotransferase (ALT), aspartate aminotransferase
(AST) and/or bilirubin at baseline,
bimatoprost 0.3 mg/ml eye drops, solution had no adverse effect on
liver function over 24 months.
Method of administration
If more than one topical ophthalmic medicinal product is being used,
each one should be administered at
least 5 minutes apart.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Bimatoprost Aspire 0.3 mg/ml is contraindicated in patients who have
had a suspected previous adverse
reaction to benzalko