FIXAPOST 50 MICROGRAMMI/ML + 5 MG/ML Eye drops, solution in single-dose container

Зміст інструкції

1. Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container
   1. What is Fixapost and what is it used for
   2. What you need to know before using Fixapost
   3. How to use Fixapost
   4. POSSIBLE SIDE EFFECTS
   5. How to store Fixapost
   6. Contents of the pack and other information

Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container

latanoprost/timolol

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What Fixapost is and what it is used for
• 2. What you need to know before you use Fixapost
• 3. How to use Fixapost
• 4. Possible side effects
• 5. How to store Fixapost
• 6. Contents of the pack and other information

1. What is Fixapost and what is it used for

Fixapost contains two medicines: latanoprost and timolol. Latanoprost belongs to the category of medicines
known as prostaglandin analogues. Timolol belongs to the category of medicines known as beta-
blockers. Latanoprost works by increasing the natural outflow of fluid from inside the eye into the bloodstream. Timolol works by slowing down the production of fluid inside the eye.
Fixapost is used to reduce pressure inside the eye if it is affected by conditions known as open-angle glaucoma
or ocular hypertension. Both of these conditions are linked to an increase in intraocular pressure, ultimately altering vision. Your doctor will usually prescribe Fixapost when other medicines have not
worked adequately.

2. What you need to know before using Fixapost

Fixapost can be used in women and adult men (including the elderly) but is not recommended
if you are under 18 years of age.

Do not use Fixapost:

• If you are allergic (hypersensitive) to latanoprost, timolol, beta-blockers, or to any of the other ingredients of this medicine (listed in section 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or persistent cough).
• If you have severe heart problems or irregular heartbeat.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Fixapost if you have or have had in the past:

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath or a feeling of suffocation), heart failure, low blood pressure,
• irregular heartbeat such as a slowed heart rate,
• respiratory problems, asthma or chronic obstructive lung disease,
• a disease associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes because timolol can mask the signs and symptoms of low blood sugar levels,
• hyperactivity of the thyroid gland because timolol can mask its signs and symptoms,
• are about to undergo any eye surgery (including cataract surgery) or if you have had any eye surgery in the past,
• have eye problems (such as eye pain, eye irritation, eye inflammation or blurred vision),
• know that you suffer from dry eyes,
• wear contact lenses. You can use Fixapost, but follow the instructions for contact lens wearers in section 3,
• know that you suffer from angina (especially a form of angina known as Prinzmetal's angina),
• know that you suffer from severe allergic reactions that usually require hospital treatment,
• have suffered or are currently suffering from a viral eye infection caused by the herpes simplex virus (HSV). Before undergoing surgery, tell your doctor that you are using Fixapost because timolol can alter the effects of some medicines used during anesthesia.

Other medicines and Fixapost
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including eye drops and over-the-counter medicines.
The effect of Fixapost may be altered or Fixapost may alter the effect of 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, for the heart or for the treatment of diabetes.
In particular, tell your doctor or pharmacist if you are taking a medicine belonging to the following
classes:

• Prostaglandins, prostaglandin analogs or prostaglandin derivatives,
• Beta-blockers,
• Epinephrine,
• Medicines used to treat high blood pressure such as oral calcium channel blockers, guanethidine, antiarrhythmics, digitalis glycosides or parasympathomimetics,
• Quinidine (used to treat heart disease and some types of malaria),
• Known antidepressants such as fluoxetine and paroxetine.

Fixapost with food and drink
Taking normal meals, food or drinks does not affect how and when to take Fixapost.

Pregnancy, breastfeeding and fertility
Do not use Fixapostif you are pregnant or if you are breastfeeding.
Fixapost can pass into breast milk.
In animal studies, latanoprost and timolol have not been shown to have any effect on male or
female fertility.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines
When using Fixapost you may experience transient blurred vision. If this happens, do not drive
vehicles or use equipment or machinery until your vision is clear again.

Fixapost contains hydroxystearate macrogolglycerol(derived from castor oil) which may cause skin
reactions.

3. How to use Fixapost

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
The usual dosage for adults (including the elderly) is one drop, once a day in the affected eye(s).
Do not use Fixapost more than once a day, because the effectiveness of the treatment may be reduced if it is
administered more frequently.
Use Fixapost following your doctor's instructions, until your doctor tells you to stop.
Your doctor may prescribe additional checks on your heart and circulation if you use Fixapost.

Contact lens wearers
If you wear contact lenses, you must remove them before using Fixapost. After using Fixapost you should wait 15
minutes before putting the lenses back in.

Instructions for use
This medicine is intended to be administered into the eyes.
Follow these instructions to use the drops:

• 1. Wash your hands and sit or lie down comfortably.
• 2. Open the sachet containing the 5 single-dose containers. Write the date of first opening on the sachet.
• 3. Detach the single container from the strip.

• 4. Rotate the top of the single-dose container as shown. Do not touch the tip after opening the container.

• 5. Gently lower the lower eyelid of the affected eye using a finger.
• 6. Bring the opening of the single-dose container close to the eye, but without touching it.
• 7. Gently compress the single-dose container so that only one drop falls into the eye, then release the lower eyelid.

• 8. Press a finger on the corner of the affected eye, near the nose, for 2 minutes while keeping the eye closed.

• 9. Repeat the operation in the other eye if your doctor has instructed you to do so. Each single-dose container contains enough solution for both eyes.
• 10. Dispose of the single-dose container after use. Do not store the container for further use. Because sterility cannot be maintained after opening the single-dose container, a new container must be opened before each use.
• 11. Repackage the unopened single-dose containers in the sachet. Place the opened sachet in the box. Unopened containers must be used within 1 month of opening the sachet.

If you use Fixapost together with other eye drops
Wait at least 5 minutes between administering Fixapost and another eye drop.

If you use more Fixapost than you should
If you have put too many drops in your eye, mild irritation in your eye may occur and your eyes
may water or become red. This should resolve, but if you are concerned, ask your doctor for advice.

If you swallow Fixapost
If you swallow Fixapost by mistake, contact your doctor for advice. If you swallow a lot of Fixapost you may
feel unwell, have stomach pain, feel tired, flushed and dizzy and start to sweat.

If you forget to use Fixapost
Continue with the usual dose at the usual time. Do not use a double dose to make up for a missed
dose. If you are unsure about anything, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Generally you can continue to use the drops, unless the effects are serious. If you are worried, talk
to a doctor or pharmacist. Do not stop using Fixapost without talking to your doctor.
Below are listed the known side effects of using Fixapost. The most important side effect is the
possibility of a gradual and permanent change in the color of the eyes. It is also possible that Fixapost
may cause serious changes in heart function. If you notice changes in your heartbeat or in
heart function, you should see a doctor and tell them that you are using Fixapost.
Below are the side effects of using Fixapost:

Very common (may affect more than 1 in 10 people):

• A gradual change in the color of your eye due to an increase in the amount of brown pigment in the colored part of the eye, known as the iris. If your eyes have a mixed coloration (blue-brown, grey-brown, yellow-brown or green-brown) you will more easily notice these changes compared to those who have eyes of only one color (blue, grey, green or brown eyes). All changes in eye coloration can take years to develop. The change in coloration may be permanent and may be more noticeable if you use Fixapost in only one eye. There do not seem to be any problems associated with the change of color. The change in eye coloration does not continue after stopping treatment with Fixapost.

Common (may affect up to 1 in 10 people):

• Eye irritation (feeling of burning, irritation, itching, stinging pain or a foreign body sensation in the eyes) and eye pain.

Uncommon (may affect up to 1 in 100 people):

• Headache.
• Redness of the eyes, eye infection (conjunctivitis), blurred vision, watering of the eyes, inflammation of the eyelids, irritation or abrasion of the surface of the eye.
• Skin rashes or itching.

Other side effects
Like other medicines used in the eyes, Fixapost (latanoprost and timolol) is absorbed into the blood. The incidence
of side effects after using eye drops is lower than when the drugs are, for example, taken by
mouth or injected.
Although not observed with Fixapost, the following additional side effects have been observed with
medicines like Fixapost (latanoprost and timolol) and therefore may occur when you use Fixapost. The
side effects listed include reactions observed within the beta-blocker class (e.g. timolol) if used for the treatment of eye conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalised allergic reactions including swelling under the skin that can occur in areas such as the face and limbs and can obstruct the airways causing difficulty swallowing and breathing, hives or itching, localised and generalised rash, itching, severe life-threatening sudden allergic reaction.
• Low blood glucose levels.
• Dizziness, difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke, reduced blood flow to the brain, increased signs and symptoms of myasthenia gravis (muscle disorders), unusual sensations such as pins and needles, and headache.
• Swelling in the back of the eye (macular oedema), fluid-filled cysts within the coloured part of the eye (iridic cysts), sensitivity to light (photophobia), sunken appearance of the eyes (deepening of the palpebral sulcus).
• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, watering, redness), inflammation of the eyelid, inflammation of the cornea, blurred vision and detachment of the layer under the retina containing blood vessels after filtering surgery which can cause visual disturbances, decreased corneal sensitivity, dry eyes, erosion of the cornea (damage to the front layer of the eyeball), drooping of the upper eyelid (making the eye half-closed), double vision.
• Darkening of the skin around the eyes, changes to the eyelashes and hairs around the eyes (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the colored 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. Slowed heartbeat, chest pain, palpitations (perception of the heartbeat), oedema (fluid accumulation), changes in the rhythm or rate of the heartbeat, congestive heart failure (heart disease with shortness of breath and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation that 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.
• Changes in taste, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, rash.
• Joint pain, muscle pain not caused by exercise, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your doctor
or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Fixapost

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 package, on the sachet and on the single-dose container.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.

After first opening of the sachet:use the single-dose containers within 1 month. Write the date of first opening
on the sachet.

After first opening of the single-dose container:use the single-dose container immediately and discard it
after use.
Keep the unused single-dose containers in the open sachet to protect them from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Fixapost contains
The active ingredients are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other ingredients are: macrogol hydroxystearate, sorbitol, carbomer, disodium edetate, sodium
hydroxide (for pH adjustment), water for injections.

Description of the appearance of Fixapost and contents of the pack
This medicinal product is an eye drop, solution in single-dose containers. The solution is slightly yellow
and opalescent without preservatives, practically particle-free, presented in single-dose
containers packaged in a pouch of 5 units, each single-dose container containing 0.2 ml of product.
One pack contains 30 (6 x 5) or 90 (18 x 5) single-dose containers.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Manufacturer
EXCELVISION
27, rue de la Lombardière
07100 Annonay
France
Or
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
This leaflet was last revised on:
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA).