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LATANOPROST BAUSCH & LOMB 0.05 MG/ ML EYE DROPS SOLUTION

Active substance(s): LATANOPROST / LATANOPROST / LATANOPROST

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Package leaflet: Information for the user
Latanoprost Bausch & Lomb 50 micrograms/ml, eye drops, solution
Latanoprost
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.

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What is in this leaflet:
1.
What Latanoprost Bausch & Lomb is and what it is used for
2.
What you need to know before you use Latanoprost Bausch & Lomb
3.
How to use Latanoprost Bausch & Lomb
4.
Possible side effects
5.
How to store Latanoprost Bausch & Lomb
6.
Contents of the pack and other information
1.

What Latanoprost Bausch & Lomb is and what it is used for

Latanoprost Bausch & Lomb belongs to a group of medicines known as prostaglandin analogues. It
works by increasing of the natural outflow of fluid from inside the eye out into the bloodstream.
Latanoprost Bausch & Lomb is used to treat conditions known as open angle glaucoma and ocular
hypertension. Both of these conditions can be linked with an increase in the pressure within your eye
and eventually they may affect your eyesight.
Latanoprost Bausch & Lomb is also used to treat increased eye pressure and glaucoma in all ages of
children and babies.
2.

What you need to know before you use Latanoprost Bausch & Lomb

Latanoprost Bausch & Lomb can be used in adult men and women (including the elderly) and in
children from birth to 18 years of age. Latanoprost Bausch & Lomb has not been investigated in
prematurely born infants (less than 36 weeks gestation).
Do not use Latanoprost Bausch & Lomb:
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if you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or trying to become pregnant;
if you are breast feeding.

Warnings and precautions
Talk to your doctor or doctor treating your child or your pharmacist before you take Latanoprost Bausch
& Lomb or before you give this to your child:
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if you or your child are about to have had eye surgery (including cataract surgery);

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if you or your child suffer from the eye problems (such as eye pain, irritation or inflammation, blurred
vision);
if you or your child suffers from dry eyes;
if you or your child have severe asthma, or the asthma is not well controlled;
if you or your child wear contact lenses. You can still use Latanoprost Bausch & Lomb, but follow
the instruction for contact lenses wear in Section 3;
if you have suffered or are currently suffering from a viral infection of the eye caused by the herpes
simplex virus (HSV).

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Other medicines and Latanoprost Bausch & Lomb
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription.
Interaction of Latanoprost Bausch & Lomb with other medicines is possible.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not
use this medicine.
Driving and using machines
When you use Latanoprost Bausch & Lomb you might have blurred vision, for a short time. If this
happen to you, do not drive or use any tools or machines until your vision becomes clear again.
Latanoprost Bausch & Lomb contains benzalkonium chloride that may cause eye irritation or
disruption to the surface of eye. Benzalkonium chloride can be absorbed by contact lenses and is known
to discolour soft contact lenses. Therefore avoid contact with soft contact lenses.
If you or your child wears contact lenses, they should be removed before using Latanoprost Bausch &
Lomb. After using Latanoprost Bausch & Lomb you should wait 15 minutes before putting the contact
lenses back in. See the instruction for contact lens wearers in Section 3.
3. How to use Latanoprost Bausch & Lomb
Always use this medicine exactly as your doctor or doctor treating your child has told you. Check with
your doctor or doctor treating your child or pharmacist if you are not sure.
The usual dose for adults (including elderly) and children is one drop once a day into the affected
eye(s).The best time to do this is in the evening.
Do not use Latanoprost Bausch & Lomb more often than once daily, because the effect of the treatment
can be reduced if you administer it more often.
If you or your child are also using other eye drops you must wait at least 5 minutes before
administering those other eye drops.
Contact lens wearers
Avoid contact with soft contact lenses. If you or your child wears contact lenses, they should be
removed before using Latanoprost Bausch & Lomb. After using Latanoprost Bausch & Lomb you
should wait at least 15 minutes before putting the contact lenses back into eyes.
Instruction for use
1.
2.
3.
4.
5.

Wash your hands and sit or stand comfortably.
Twist off the cap.
Use your finger to gently pull down the lower eyelid of your affected eye.
Place the tip of the bottle close to, but not touching your eye.
Squeeze the bottle gently so that only one drop goes into your eye, then release the lower
eyelid.

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6. Press a finger against the corner of the affected eye by the nose. Hold for 1 minute whilst
keeping the eye closed.
7. Repeat in your other eye if your doctor has told you to do this.
8. Put the cap back on the bottle.

If you use more Latanoprost Bausch & Lomb than you should
Be careful when you are squeezing the bottle so that you only put one drop into the affected eye.
If you put too many drops in your eye, you may feel some slight irritation in the eye and the eyes may
water and turn red. This should pass, but if you are worried contact your doctor or the doctor treating
your child for advice.
Contact your doctor as soon as possible if you or your child swallows Latanoprost Bausch & Lomb
accidentally.
If you forget to use Latanoprost Bausch & Lomb
If you forget to use your eye drops at the usual time, wait until it is time for your next dose.
Do not take double dose to make up for a forgotten dose.
If you stop using Latanoprost Bausch & Lomb
You should speak to your doctor or the doctor treating your child if you want to stop using this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are known side effects of using Latanoprost Bausch & Lomb:
Very common (may affect more than 1 in 10 people)
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A gradual change in your eye colour by increasing the amount of brown pigmentation the coloured
part of the eye known as the iris. If you have mixed-colour eyes (blue-brown, grey-brown, yellowbrown or green-brown) you are more likely to see this change than if you have eyes of one colour
(blue, grey, green or brown eyes). Any changes in your eye colour may take years to develop although
it is normally seen within 8 months of treatment. The colour change may be permanent and may be
more noticeable if you use Latanoprost Bausch & Lomb in only one eye. There appears to be no
problems associated with the change in eye colour. The colour change does not continue after
Latanoprost Bausch & Lomb treatment is stopped.
Redness of the eye.
Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in
the eye).
A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly
in people of Japanese origin. These changes involve an increase of the colour (darkening), length,

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thickness and number of your eye lashes.
Common (may affect up to 1 in 10 people):
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Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis), eye pain and light
sensitivity (photophobia).

Uncommon (may affect up to 1 in 100 people)
Eyelid swelling, dryness of eye, inflammation or irritation of the surface of the eye (keratitis),
blurred vision, conjunctivitis;
Skin rash.

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Rare (may affect up to 1 in 1,000 people)
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Inflammation of the iris, the coloured part of the eye (iritis/uveitis), swelling of the retina (macular
oedema), symptoms of swelling or scratching/damage to the surface of the eye, swelling around the
eyes (periorbital oedema), misdirected eyelashes or extra row of eyelashes.
Skin reaction on the eyelids, darkening of the skin of the eyelids.
Asthma, worsening of asthma and shortness of breath (dyspnoea).

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Very rare (may affect up to 1 in 10,000 people)
Worsening of angina in patients who also have heart disease, chest pain, sunken eye appearance (eye
sulcus deepening).

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Patients have also reported the following side-effects: fluid filled area within the coloured part of the eye
(iris cyst), headache, dizziness, awareness of heart rhythm (palpitations), muscle pain, joint pain and
developing a viral infection of the eye caused by herpes simplex virus (HSV).
Side effects seen more often in children compared to adults are runny itchy nose and fever.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye (cornea) have
developed cloudy patches on the cornea due to calcium build-up during treatment.
Reporting of side effects
If you or your child get any side effects, talk to your doctor or the doctor treating your child or pharmacist.
This includes any side effects not listed in this leaflet. You can also report side effects directly via:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.
5.

How to store Latanoprost Bausch & Lomb

Keep this medicine out of the sight and reach of children.
Before Latanoprost Bausch & Lomb is first opened, store and transport refrigerated (2°C – 8°C).
Keep the bottle in the outer carton in order to protect from light. After opening, do not store above 25°C.
Each bottle should be thrown away 4 weeks after first opening.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The
expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.

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6.

Contents of the pack and other information

What Latanoprost Bausch & Lomb contains
The active substance is latanoprost. Each ml contains 50 micrograms latanoprost.
2.5 ml of eye drops, solution (content of a bottle) contains 125 micrograms of latanoprost.
The other ingredients are:
- benzalkonium chloride 0.2 mg/ml
- sodium chloride
- sodium dihydrogen phosphate monohydrate
- disodium phosphate anhydrous
- water, purified
What Latanoprost Bausch & Lomb looks like and contents of the pack
The eye drops are a colourless or pale-yellow, clear solution. Each bottle contains 2.5 ml eye drops,
solution.
Latanoprost Bausch & Lomb is available in the following pack sizes: one bottle of 2.5 ml, 3 bottles of
2.5 ml and 6 bottles of 2.5 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
Telephone:+49 (0)30 33093-0
Fax:+49 (0)30 33093-350
Manufacturer
Dr. Gerhard Mann Chem.-pharm. Fabrik GmbH
Brunsbütteler Damm 165-173
13581 Berlin
Germany
Telephone:+49 (0)30 33093-0
Fax:+49 (0)30 33093-350
This medicinal product is authorized in the Member States of the EEA under the following names:
Austria, Bulgaria, Czech Republic, Estonia, Greece, Italy, Latvia,
Arulatan
Lithuania, Luxembourg, The Netherlands, Poland, Romania, Slovak
Republic, Spain
Belgium

Latanoprost Dr. Mann
Pharma
Latanoprost Dr. Gerhard
Mann Chem.-pharm. Fabrik

France, Portugal
Germany

Latan-Ophtal

Hungary

Lanotan

United Kingdom

Latanoprost Bausch & Lomb

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This leaflet was last revised in 11/2016

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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