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HAMITUF 40 MICROGRAMS/ML EYE DROPS SOLUTION

Active substance(s): TRAVOPROST

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Package leaflet: Information for the user
HAMITUF 40 micrograms/mL eye drops, solution
Travoprost
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 Hamituf is and what it is used for
2.
What you need to know before you use Hamituf
3.
How to use Hamituf
4.
Possible side effects
5.
How to store Hamituf
6.
Contents of the pack and other information

1.

What Hamituf is and what it is used for

Hamituf contains travoprost, one of a group of medicines called prostaglandin analogues. It works by
reducing the pressure in the eye. It may be used on its own or with other drops e.g. beta-blockers, which also
reduce pressure.
Hamituf is used to reduce high pressure in the eye in adults. This pressure can lead to an illness called
glaucoma.

2.

What you need to know before you use Hamituf

Do not use Hamituf


if you are allergic to travoprost or any of the other ingredients of this medicine (listed in section 6).

Ask your doctor for advice if this applies to you.
Warnings and precautions
Talk to your doctor or, pharmacist before using Hamituf


Hamituf may increase the length, thickness, colour and/or number of your eyelashes. Changes in the
eyelids including unusual hair growth or in the tissues around the eye have also been observed.



Hamituf may change the colour of your iris (the coloured part of your eye). This change may be
permanent. A change in the colour of the skin around the eye may also occur.



If you have had cataract surgery, talk to your doctor before you use Hamituf



If you have current or previous history of an eye inflammation (iritis and uveitis), talk to your doctor
before you use Hamituf
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Hamituf may rarely cause breathlessness or wheezing or increase the symptoms of asthma. If you
are concerned about changes in your breathing pattern when using Hamituf advise your doctor as soon
as possible.



Travoprost may be absorbed through the skin. If any of the medicinal product comes into contact
with the skin, it should be washed off straight away. This is especially important in women who are
pregnant or are attempting to become pregnant.



If you wear soft contact lenses, do not use the drops with your lenses in. After using the drops wait 15
minutes before putting your lenses back in.

Children and adolescents
Use of Hamituf is not recommended to those under 18 years of age.
Other medicines and Hamituf
Tell your doctor or pharmacist if you are taking, have recently taken or used any other medicines.
Pregnancy, breast-feeding and fertiliy
Do not use Hamituf if you are pregnant. If you think that you may be pregnant speak with your doctor
right away. If you could become pregnant you must use adequate contraception whilst you use Hamituf.
Do not use Hamituf if you are breast feeding, Hamituf may get into your milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
You may find that your vision is blurred for a time just after you use Hamituf. Do not drive or use machines
until this has worn off.
Hamituf contains macrogolglycerol hydroxystearate and propylene glycol
which may cause skin reactions and irritation.

3.

How to use Hamituf

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you
are not sure.
The recommended dose is
One drop in the affected eye or eyes, once a day - in the evening.
Only use Hamituf in both eyes if your doctor told you to. Use it for as long as your doctor told you to.
Only use Hamituf for dropping in your eyes.

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Immediately before using a bottle for the first time, write the date of opening on the carton in the
space provided
Wash your hands
Twist off the cap
After cap is removed, if tamper evident snap collar is loose, remove before using the product.
Hold the bottle, pointing down, between your thumb and fingers
Tilt your head back. Pull down your eyelid with a clean finger, until there is a ‘pocket’ between the
eyelid and your eye. The drop will go in here.
Bring the bottle tip close to the eye. Use a mirror if it helps.
Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. It could infect
the drops.
Gently squeeze the bottle to release one drop of Hamituf at a time
After using Hamituf, keep the eyelid closed, apply gentle pressure by pressing a finger into the
corner of your eye, by the nose for at least 1 minute. This helps to stop Hamituf getting into the rest
of the body.
If you use drops in both eyes, repeat the steps for your other eye.
Close the bottle cap firmly immediately after use
Only use one bottle at a time.

If a drop misses your eye, try again.
If you are using other eye preparations such as eye drop or eye ointment, wait for at least 5 minutes
between putting in Hamituf and the other eye preparations.
If you use more Hamituf than you should
Rrinse all the medicine out with warm water. Don’t put in any more drops until it’s time for your next
regular dose.
If you forget to use Hamituf
Continue with the next dose as planned. Do not use a double dose to make up for a forgotten dose. Never use
more than one drop in the affected eye(s) in a single day.
If you stop using Hamituf
Do not stop using Hamituf without first speaking to your doctor, the pressure in your eye will not be
controlled which could lead to loss of sight.
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.
You can usually carry on using the drops, unless the side effects are serious. If you’re worried, talk to a
doctor or pharmacist. Do not stop taking Hamituf without speaking to your doctor.
The following side effects have been seen with travoprost containing eye drops
Very common side effects: may affect more than 1 in 10 people
Effects in the eye: eye redness
Common side effects: may affect up to 1 in 10 people
Effects in the eye: changes in the colour of the iris (coloured part of the eye), eye pain, eye discomfort, dry
eye, itchy eye, eye irritation
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Uncommon side effects: may affect up to 1 in 100 people
Effects in the eye: corneal disorder, eye inflammation, iris inflammation, inflammation inside the eye, eye
surface inflammation with/out surface damage, sensitivity to light, eye discharge, eyelid inflammation, eyelid
redness, swelling around the eye, eyelid itching, reduced vision, blurred vision, increased tear production,
infection or inflammation of the conjunctiva (conjunctivitis), abnormal turning outward of the lower eyelid,
clouding of the eye, eyelid crusting, growth of eyelashes, discolouration of the eyelashes, tired eyes.
General side effects: increased allergic symptoms, headache, dizziness, irregular heart beat, shortness of
breath, asthma, stuffy nose, throat irritation, darkening of skin around the eye (s), skin darkening, abnormal
hair texture, excessive hair growth.
Rare: may affect up to 1 in 1,000 people
Effects in the eye: perception of flashing lights, eczema of the eyelids, eye swelling, halo vision, decreased
eye sensation, inflammation of the glands of the eyelids, pigmentation inside the eye, increase in pupil size,
change in the texture of the eyelashes.
General side effects: eye viral infection, bad taste, irregular or decreased heart rate, increased or decreased
blood pressure, cough, voice changes, gastrointestinal discomfort or ulcer, constipation, dry mouth, redness
or itching of the skin, rash, hair colour change, loss of eyelashes, musculoskeletal pain, generalised
weakness.
Not known: frequency cannot be estimated from the available data
Effects in the eye: inflammation of the back of the eye, eyes appear more inset.
General side effects: depression, anxiety, sensation of false movement, ringing in ears, chest pain,
worsening of asthma, diarrhea, abdominal pain, nausea, itching, abnormal hair growth, joint pain,
painful or involuntary urination, increase in prostate cancer marker.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system via the Yellow Card
Scheme at: 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 Hamituf

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and the box after ‘Exp’. The
expiry date refers to the last day of the month.
This medicine does not require any special temperature storage conditions. Keep the bottle in the outer
carton in order to protect from light.
You must throw away the bottle 4 weeks after you first opened it, to prevent infections, and use a new
bottle. Write down the date you opened it in the space on the carton box.
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 protect the environment.

6.

Contents of the pack and other information
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What Hamituf contains
-

The active substance is travoprost 40 micrograms/ml.
The other ingredients are: Polyquaternium-1, macrogolglycerol hydroxystearate 40, propylene glycol
(E1520), sodium chloride, boric acid (E284), mannitol (E421) and purified water. Sodium hydroxide
or hydrochloric acid for pH adjustment.

What Hamituf looks like and contents of the pack
Hamituf is a clear, colourless solution, practically free of particles in a pack containing either 1, 3 or 6 plastic
bottles each with a screw cap. Each bottle contains 2.5 ml solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL. United Kingdom.
Manufacturer
S.C. ROMPHARM COMPANY S.R.L., Eroilor Street, no. 1A, Otopeni, Ilfov., Romania 075100.
This leaflet was last revised in 08/2015

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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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