Sverige - svenska - Läkemedelsverket (Medical Products Agency)
Package Leaflet: Information for the user
Tavu 50 micrograms/mL and 5 mg/mL Eye Drops, Solution
Latanoprost + Timolol
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:
What Tavu is and what it is used for
What you need to know before you use Tavu
How to use Tavu
Possible side effects
How to store Tavu
Contents of the pack and other information
1. What Tavu is and what it is used for
Tavu contains two medicines: latanoprost and timolol. Latanoprost belongs to a group of
medicines known as prostaglandin analogues. Timolol belongs to a group of medicines
known as beta-blockers. Latanoprost works by increasing the natural outflow of fluid from
the eye into the bloodstream. Timolol works by slowing the formation of fluid in the eye.
Tavu is used to reduce the pressure in your eye if you have conditions known as open angle
glaucoma or ocular hypertension. Both these conditions are linked to an increase in the
pressure within your eye, eventually affecting your eyesight. Your doctor will usually
prescribe you Tavu when other medicines have not worked adequately.
2. What you need to know before you use Tavu
Tavu can be used in adult men and women (including the elderly), but is not recommended
for use if you are less than 18 years of age.
Do not use Tavu eye drops solution:
if you are allergic (hypersensitive) to either of the medicines in Tavu (latanoprost or
timolol), beta-blockers, or any of the other ingredients of Tavu (listed in section 6)
if you have now or have had in past respiratory problems such as asthma, severe chronic
obstructive bronchitis (severe lung disease which may cause wheeziness, difficulty in
breathing and/or long-standing cough)
if you have serious heart problems or heart rhythm disorders
Warnings and precautions
Talk to your doctor or pharmacist before using Tavu if you have now or have had in the past:
coronary heart disease (symptoms can include chest pain or tightness, breathlessness or
choking), heart failure, low blood pressure
disturbances of heart rate such as slow heart beat
breathing problems, asthma or chronic obstructive pulmonary disease
poor blood circulation disease (such as Raynaud’s disease or Raynaud’s syndrome)
diabetes as timolol may mask signs and symptoms of low blood sugar
overactivity of the thyroid gland as timolol may mask signs and symptoms
you are about to have any kind of eye surgery (including cataract surgery) or have had
any kind of eye surgery in the past
you suffer from eye problems (such as eye pain, eye irritation, eye inflammation or
you know that you suffer from dry eyes
you wear contact lenses. You can still use Tavu but follow the instructions for contact
lens wearers in section 3
you know that you suffer from angina (particularly a type known as Prinzmetal angina)
you know that you suffer from severe allergic reactions that would usually require
you have suffered or are currently suffering from a viral infection of the eye caused by
the herpes simplex virus (HSV)
Tell your doctor before you have an operation that you are using Tavu
as timolol may change
effects of some medicines used during anaesthesia.
Other medicines and Tavu
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including using eye drops and medicines obtained without a prescription.
Tavu can affect or be affected by other medicines you are using, including other eye drops
for the treatment of glaucoma. Tell your doctor if you are using or intend to use medicines to
lower blood pressure, heart medicine or medicines to treat diabetes.
In particular, speak to your doctor or pharmacist if you know that you are taking any of the
following types of medicine:
Prostaglandins, prostaglandin analogues or prostaglandin derivates
Drugs used to treat high blood pressure such as oral calcium channel blockers,
guanethidine, antiarrythmics, digitalis glycosides or parasympathomimetics
Quinidine (used to treat heart conditions and some types of malaria)
Antidepressants known as fluoxetine and paroxetine
Tavu with food and drink
Normal meals, food or drink have no effect on when or how you should use Tavu.
Pregnancy, breast-feeding and fertility
Do not use Tavu if you are pregnant unless your doctor considers it necessary. Tell your
doctor immediately if you are pregnant, think you are pregnant or are planning to become
Do not use Tavu if you are breast-feeding. Tavu may get into your milk. Ask your doctor for
advice before taking any medicine during breast-feeding.
Latanoprost and timolol have been found to have no effect on male or female fertility in
Driving and using machines
When you use Tavu your vision may become blurred for a short time. If this happens to you,
do not drive or use any tools or machines until your vision becomes clear again.
Tavu contains benzalkonium chloride
Tavu contains a preservative called benzalkonium chloride. This preservative may cause eye
irritation or disruption to the surface of the eye. It can be absorbed by contact lenses and is
known to discolour soft contact lenses. Therefore, avoid contact with soft contact lenses. See
the instructions for contact lens wearers in section 3.
3. How to use Tavu
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose for adults (including the elderly) is one drop once a day in the
Do not use Tavu more than once a day, because the effectiveness of the treatment can be
reduced if you administer it more often.
Use Tavu as instructed by your doctor until your doctor tells you to stop.
Your doctor may want you to have extra checks on your heart and circulation if you use
Contact lens wearers
If you wear contact lenses, you should remove them before using Tavu. After using Tavu you
should wait 15 minutes before putting your contact lenses back in.
Instructions for use
Wash your hands and sit or stand comfortably.
Twist off the outer cap (which can be thrown away).
Unscrew the protective inner cap. The protective cap
should be retained.
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
Squeeze the bottle gently so that only one drop goes
into your eye, then release the lower eyelid.
After using Tavu, press a finger into the corner of
your eye, by the nose (figure 4) for 2 minutes. This
helps to stop latanoprost + timolol getting into the
rest of the body.
Repeat in your other eye if your doctor has told you to do this.
Put the protective inner cap back on the bottle.
If you use Tavu with other eye drops
Wait at least 5 minutes between using Tavu and using the other eye drops.
If you use more Tavu than you should
If you put too many drops in your eye you may experience some minor irritation in your eye
and your eyes may water and turn red. This should pass but if you are worried contact your
doctor for advice.
If you swallow Tavu
If you swallow Tavu accidentally you should contact your doctor for advice. If you swallow
a lot of Tavu you may feel sick, have stomach pains, feel tired, flushed and dizzy and start to
If you forget to use Tavu
Carry on with the usual dosage at the usual time. Do not use a double dose to make up to the
dose you have forgotten. If you are unsure about anything talk to 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 effects are serious. If you're worried,
talk to a doctor or pharmacist. Do not stop using Tavu without speaking to your doctor.
Listed below are the known side effects of using Tavu. The most important side-effect is the
possibility of a gradual, permanent change in your eye colour. It is also possible that Tavu
might cause serious changes in the way your heart works. If you notice changes in your heart
rate or heart function you should speak to a doctor and tell them you have been using Tavu.
The following are known side effects of using Tavu:
Very common (may affect more than 1 in 10 people):
A gradual change in your eye colour by increasing the amount of brown pigment in the
coloured part of the eye known as the iris. If you have mixed-colour eyes (blue-brown,
grey-brown, yellow-brown 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. The colour change may be permanent and may be more
noticeable if you use Tavu in only one eye. There appears to be no problems associated
with the change in eye colour. The eye colour change does not continue after Tavu
treatment is stopped.
Common (may affect up to 1 in 10 people):
Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a
foreign body in the eye) and eye pain.
Uncommon (may affect up to 1 in 100 people):
Redness of the eye, eye infection (conjunctivitis), blurred vision, watery eyes,
inflammation of the eyelids, irritation or disruption of the surface of the eye
Skin rashes or itching (pruritus)
Other side effects
Like other medicines used in the eyes, Tavu (latanoprost and timolol) is absorbed into the
blood. The incidence of side effects after using eye drops is lower than when medicines are,
for example, taken by mouth or injected.
Although not seen with Tavu, the following additional side effects have been seen with the
medicines in Tavu (latanoprost and timolol) and therefore might occur when you use Tavu.
The listed side effects include reactions seen within the class of beta-blockers (e.g. timolol)
when used for treating eye conditions:
Developing a viral infection of the eye caused by the herpes simplex virus (HSV)
Generalized allergic reactions including swelling beneath the skin that can occur in areas
such as the face and limbs and can obstruct the airway which may cause difficulty
swallowing or breathing, hives or itchy rash, localized and generalized rash, itchiness,
severe sudden life-threatening allergic reaction.
Low blood glucose levels.
Difficulty sleeping (insomnia), depression, nightmares, memory loss.
Fainting, stroke, reduced blood supply to the brain, increases in signs and symptoms of
myasthenia gravis (muscle disorder), unusual sensations like pins and needles, and
Swelling at the back of the eye (macular oedema), fluid filled cyst within the coloured
part of the eye (iris cyst), light sensitivity (photophobia), sunken eye appearance
(deepening of the eye sulcus).
Signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness),
inflammation of the eyelid, inflammation in the cornea, blurred vision and detachment of
the layer below the retina that contains blood vessels following filtration surgery which
may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion
(damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye
stay half closed), double vision.
Darkening of the skin around the eyes, changes to the eyelashes and fine hairs around the
eye (increased number, length, thickness and darkening), changes to the direction of
eyelash growth, swelling around the eye, swelling of the coloured part of the eye
(iritis/uveitis), scarring of the surface of the eye.
Whistling/ringing in the ears (tinnitus).
Angina, worsening of angina in patients who already have heart disease
Slow heart rate, chest pain, palpitations (awareness of heart rhythm), oedema (fluid build
up), changes in the rhythm or speed of the heartbeat, congestive heart failure (heart
disease with shortness of breath and swelling of the feet and legs due to fluid build up), a
type of heart rhythm disorder, heart attack, heart failure.
Low blood pressure, poor blood circulation which makes the fingers and toes numb and
pale, cold hands and feet.
Shortness of breath, constriction of the airways in the lungs (predominantly in patients
with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with white silvery coloured appearance (psoriasiform rash) or
worsening of psoriasis, skin rash.
Joint pain, muscle pain not caused by exercise, muscle weakness, tiredness.
Sexual dysfunction, decreased libido.
In very rare cases, some patients with severe damage to the clear layer at the front of the eye
(the cornea) have developed cloudy patches on the cornea due to calcium build-up during
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible
side effect not listed in this leaflet.
You can also report side effects directly via the national
reporting system listed in Appendix V. By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Tavu
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated after EXP on the carton and
bottle label. The expiry date refers to the last day of that month.
Store the unopened bottle of Tavu in a refrigerator (between 2°C to 8°C). After opening the
bottle it is not necessary to store it in a refrigerator but do not store it above 25°C. After
opening do not use this bottle for more than 4 weeks. When you are not using Tavu, keep the
bottle in the outer carton, in order to protect from light.
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
6. Contents of the pack and other information
What Tavu contains
The active substances are latanoprost 50 micrograms/mL and timolol (as timolol maleate)
The other ingredients are:
Sodium dihydrogen phosphate monohydrate (E399i)
Disodium phosphate anhydrous (E399ii)
Hydrochloric acid solution (for adjustment to pH 6.0)
Sodium hydroxide solution (for adjustment to pH 6.0)
Water for injections
What Tavu looks like and contents of the pack
This pack contains one bottle containing 2.5 mL of Tavu Eye Drops, Solution.
Tavu is a clear, colourless liquid.
Tavu is available in pack sizes of 1and and 3 bottles. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: <To be completed nationally>Manufacturer: Pfizer
Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium.
This leaflet was last revised 2017-06-16
Marknadsförs ej för närvarande.