BIMATOPROST SANDOZ 300 MCG/ML EYE DROPS - patient leaflet, side effects, dosage

is and what it is used for

Bimatoprost is an antiglaucoma preparation. It belongs to a group of medicines called prostamides.

Bimatoprost is 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.

What you need to 2

know before you use Bimatoprost

• Do not use Bimatoprost: if you are allergic (hypersensitive) 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 pharmacist before using Bimatoprost.

Talk to your doctor, if:

• You have any breathing problems.
• You have liver or kidney problems.
• You have had a cataract surgery in the past.
• You have dry eye.
• You have or have had any problems with your cornea (front transparent part of the eye).
• You wear contact lenses (see “Important information about some of the ingredients of Bimatoprost”).
• You have or have had low blood pressure or low heart rate.
• You have had a viral infection or inflammation of the eye.

Bimatoprost may cause your eyelashes to darken and grow, and cause the skin around the eyelid to darken too. The colour of your iris may also go darker over time. These changes may be permanent. The change may be more noticeable if you are only treating one eye.

Children and adolescents Bimatoprost has not been tested in children under the age of 18 and therefore Bimatoprost should not be used by patients under 18 years.

Other medicines and Bimatoprost

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Bimatoprost may get into breast milk so you should not breast-feed while you are using Bimatoprost.

Driving and using machines

Your sight may become blurred for a short time just after using Bimatoprost. You should not drive or use machines until your sight is clear again.

Bimatoprost contains benzalkonium chloride

Bimatoprost contains benzalkonium chloride, a preservative which may cause eye irritation and which can discolour soft contact lenses. Avoid contact with soft contact lenses. Do not use the drops when you are wearing your lenses. Wait 15 minutes after using the drops before you put your lenses back in.

o How to use Bimatoprost

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Bimatoprost should only be applied to the eye. The recommended dose is one drop of Bimatoprost in the evening, once daily in each eye that needs treatment.

If you use Bimatoprost with another eye medicine, wait at least five minutes between using Bimatoprost and the other eye medicine.

Do not use more than once a day as the effectiveness of treatment may be reduced.

Instructions for use:

You must not use the bottle if the tamper-proof seal on the bottle neck is broken before you first use it.

• 1. Wash your hands. Tilt your head back and look at the ceiling.

• 2. Gently pull down the lower eyelid until there is a small pocket.

• 3. Turn the bottle upside down and squeeze it to release one drop into each eye that needs treatment.

• 4. Let go of the lower lid, and close your eye for 30 seconds.

Continued on the next page >>

00000000

SZ00000LT000

Artwork Proof Box

Ref: V004 – Update SPC & PIL to align with reference product

Proof no. Date prepared: Font size:

004.0 19/07/2016 9pt

Colours: Fonts:

• ■ Black □ Helvetica

• □ □

Dimensions: 100 × 630 mm

	Wipe off any excess that runs down the cheek. If a drop misses your eye, try again.	Worsening of the lung diseases called obstructive pulmonary disease (COPD) Shortness of breath
	To help prevent infections,	Other side effects
	do not let the tip of the	reported with eye drops
	bottle touch your eye or	containing phosphates
	anything else. Put the cap	In very rare cases, some
	back on and close the	patients with severe
	bottle straight after you	damage to the clear layer
	have used it.	at the front of the eye (the
		cornea) have developed
	If you use more	cloudy patches on the
	Bimatoprost than you	cornea due to calcium
	should	build-up during treatment.
	If you use more
	Bimatoprost than you	Reporting of side effects
	should, it is unlikely to	If you get any side effects,
	cause you any serious	talk to your doctor or
	harm. Put your next dose	pharmacist. This includes
	in at the usual time. If you	any possible side effects
	are worried, talk to your	not listed in this leaflet.
	doctor or pharmacist.	You can also report side
		effects directly via the
	If you forget to use	Yellow Card Scheme
	Bimatoprost	(
	If you forget to use	yellowcard). By reporting
	Bimatoprost, use a single	side effects you can help
	drop as soon as you	provide more information
	remember, and then go	on the safety of this
	back to your regular	medicine.
	routine. Do not use a
	double dose to make up
	for a forgotten dose.	E

How to store

If you stop using

Bi Bimatoprost

Bimatoprost

Bimatoprost should be

used every day to work

Keep this medicine out of

properly. If you stop using

the sight and reach of

Bimatoprost the pressure

children.

inside your eye may go up,

therefore talk to your

This medicine does not

doctor before stopping this

require any special

treatment.

storage conditions.

If you have any further

Do not use this medicine

questions on the use of

after the expiry date which

this medicine, ask your

is stated on the bottle label

doctor or pharmacist.

and the carton after EXP.

The expiry date refers to

the last day of that month.

p Possible side

You must throw away the

effects

bottle, at the latest, four

weeks after you first

opened it, even if there are

Like all medicines, this

still some drops left. This

medicine can cause side

will prevent infections. To

effects, although not

help you remember, write

everybody gets them.

down the date you opened

it in the space on the box.

Very common side

effects (may affect more

Medicines should not be

than 1 in 10 people)

disposed of via

wastewater or household

Affecting the eye

waste. Ask your

• Longer eyelashes (up to

pharmacist how to dispose

45% of people)

of medicines no longer

• Slight redness (up to

required. These measures

44% of people)

will help to protect the

• Itchiness (up to 14% of

environment.

people)

Common side effects

Contents of the

(may affect up to 1 in 10

6 pack and other

people)

information

Affecting the eye

• An allergic reaction in

What Bimatoprost

the eye

contains

• Tired eyes

The active substance is Sensitivity to light

bimatoprost. One ml of

• Darker skin colour

solution contains 0.3 mg

around the eye

bimatoprost. One drop

• Darker eyelashes

contains approximately

• Pain

7.5 micrograms

• A feeling that something

bimatoprost.

is in your eye

• The other ingredients

Sticky eyes

are benzalkonium

• Darker iris colour

chloride (preservative),

• Difficulty in seeing

citric acid monohydrate,

clearly

disodium phosphate

• Irritation

heptahydrate, sodium

• Burning

chloride, purified water

• Inflamed, red and itchy

and sodium hydroxide or

eyelids

hydrochloric acid.

• Tears

Dryness

What Bimatoprost looks

• Worsening of vision

like and contents of the

• Blurred vision

pack

• Swelling of the

Bimatoprost is a clear,

see-through layer which

colourless solution,

covers the surface of the

practically free from

eye

particles in a pack

• Small breaks in the

containing either 1 plastic

surface of the eye, with

bottle or 3 plastic bottles

or without inflammation

each with a screw cap.

Each bottle is

Affecting the body

approximately half full and

• Headaches

contains either 2.5

• An increase in blood-test

millilitres or 3 millilitres of

results that show how

solution. This is enough for

your liver is working

4 weeks’ usage.

• Increased blood

pressure

Not all pack sizes may be

marketed.

Uncommon side effects

(may affect up to 1 in 100

Marketing Authorisation

people)

Holder and Manufacturer

Affecting the eye

Marketing Authorisation

• Cystoid macular

Holder:

oedema (swelling of the

Sandoz Limited

retina within the eye

Frimley Business Park,

leading to worsening

Frimley, Camberley,

vision)

Surrey,

• Inflammation within the

GU16 7SR

eye

United Kingdom

• Retinal bleeding

Swollen eyelids

Manufacturer:

• Eyelid twitching

S.C. Rompharm Company

• Eyelid has moved away

s.r.l.

from surface of eye

Eroilor Street, no. 1A

• Skin redness around the

Otopeni 075100, Ilfov.

eye

Romania

Affecting the body

or

• Nausea

Dizziness

Aeropharm GmbH

• Weakness

Francois-Mitterrand-Allee

• Hair growth around the

1

eye

D-07407 Rudolstadt

Germany

Not known (frequency

cannot be estimated from

or

the available data)

Lek Pharmaceuticals d.d.

Affecting the eye

Verovskova 57

• Eyes appear sunken

1526 Ljubljana

Slovenia

Affecting the body

• Symptoms of allergic

reaction (swelling,

This leaflet was last

redness of the eye and

revised in 07/2016.

rash of the skin)

• Asthma

Worsening of asthma

00000000 SZ00­000LT000