Fixapost

P_TITLE P_REF version P_REVISION

Patient Information Leaflet: Information for the user

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

latanoprost/timolol
Please read all of this leaflet carefully before using this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including 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 using 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 Fixapost is and what it is used for

Fixapost contains two medicines: latanoprost and timolol. Latanoprost belongs to a class of medicines known as prostaglandin analogues. Timolol belongs to a class 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 reducing the production of fluid inside the eye.
Fixapost is used to reduce pressure within the eye when you have conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with increased eye pressure, which may eventually impair vision. Your doctor usually prescribes Fixapost when other medicines have not worked adequately.

2. What you need to know before using Fixapost

Fixapost can be used in adult women and men (including the elderly), but is not recommended for individuals 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 previously had respiratory problems such as asthma, or severe chronic obstructive pulmonary disease (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders.

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

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure,
• Heart rhythm disorders such as slow heartbeat,
• Respiratory problems, asthma, or chronic obstructive pulmonary disease,

P_TITLE P_REF version P_REVISION

• A disease associated with poor blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar,
• Overactive thyroid gland, as timolol may mask its signs and symptoms,
• Are about to undergo any eye surgery (including cataract surgery) or have previously undergone eye surgery,
• Eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision),
• Known dry eye disease,
• Wear contact lenses. You may use Fixapost, but follow the instructions for contact lens wearers provided in section 3,
• Known angina (particularly a type of angina called Prinzmetal's angina),
• Known severe allergic reactions that usually require hospital treatment,
• Had or currently have a viral eye infection caused by the herpes simplex virus (HSV). Before undergoing surgery, inform your doctor that you are using Fixapost, as timolol may alter the effects of certain medicines used during anesthesia.

Other medicines and Fixapost
Inform 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 taking, including other eye drops for glaucoma. Inform your doctor if you are taking or intend to take medicines to lower blood pressure, for heart conditions, or for diabetes treatment.
In particular, inform your doctor or pharmacist if you are taking a medicine belonging to the following classes:

• Prostaglandins, prostaglandin analogues, 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 conditions and certain types of malaria),
• Known antidepressants such as fluoxetine and paroxetine.

Fixapost with food and drink
Normal meals, food, or drinks do not affect how or when to use Fixapost.
Pregnancy, breastfeeding, and fertility
Do not use Fixapost during pregnancy or while breastfeeding.
Fixapost may pass into breast milk.
In animal studies, latanoprost and timolol did not show any effect on male or female fertility.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
When using Fixapost, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.
Fixapost contains macrogolglycerol hydroxystearate (derived from castor oil), which may cause skin reactions.

3. How to use Fixapost

P_TITLE P_REF version P_REVISION
Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose for adults (including elderly patients) is one drop, once daily in the affected eye(s).
Do not use Fixapost more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.
Use Fixapost as directed by your doctor, until your doctor tells you to stop.
Your doctor may recommend additional checks on your heart and circulation if you are using Fixapost.

Contact lens wearers
If you wear contact lenses, remove them before using Fixapost. After using Fixapost, wait 15 minutes before reinserting your lenses.

Instructions for use
This medicine is intended for ocular administration.
Follow these instructions to use the drops:

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

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

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

P_TITLE P_REF version P_REVISION

8. Press with a finger at the inner corner of the affected eye, near the nose, for 2 minutes, keeping the eye closed.

9. Repeat the procedure in the other eye if instructed by your doctor. Each single-dose container contains enough solution for both eyes.
10. Discard the single-dose container after use. Do not keep it for later use. Since sterility cannot be maintained after opening the single-dose container, a new container must be opened each time.
11. Store unused single-dose containers in the pouch. Place the opened pouch back into the carton. Unused containers must be used within 1 month of opening the pouch.

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

If you use more Fixapost than you should
If you have instilled too many drops into your eye, mild eye irritation may occur, and your eyes may water or become red. This should resolve on its own, but if you are concerned, consult your doctor.

If you swallow Fixapost
If you accidentally swallow Fixapost, contact your doctor for advice. If you swallow a large amount of Fixapost, you may feel unwell, experience stomach pain, feel tired, flushed, dizzy, and begin to sweat.

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
P_TITLE P_REF version P_REVISION
You can generally continue using the drops unless the side effects are severe. If you are concerned, speak
to a doctor or pharmacist. Do not stop using Fixapost without speaking 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 eye colour. Fixapost may also cause serious changes in heart function. If you notice changes in your heartbeat or heart function, you must consult your doctor and inform him or her that you are using Fixapost.
The following are adverse reactions associated with the use of Fixapost:
Very common (may affect more than 1 in 10 people):

• A gradual change in the colour of your eye due to an increase in brown pigment in the coloured part of the eye, known as the iris. If your eyes have mixed colouring (blue-brown, grey-brown, yellow-brown or green-brown), these changes may be more noticeable than in people with uniformly coloured eyes (blue, grey, green or brown). All changes in eye colouring may take years to develop. The colour change may be permanent and may be more noticeable if you use Fixapost in only one eye. There appear to be no associated problems with the colour change. The change in eye colouring does not continue after stopping treatment with Fixapost.

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

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

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

• Headache.
• Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, eye irritation or abrasion of the eye surface.
• Skin rashes or itching.
• Nausea, vomiting.

Other adverse reactions
Like other eye medicines, Fixapost (latanoprost and timolol) is absorbed into the bloodstream.
The incidence of adverse reactions after using eye drops is lower than when medicines are taken orally or injected, for example.
Although not observed with Fixapost, the following additional adverse reactions have been observed with medicines such as Fixapost (latanoprost and timololo) and may therefore occur when using Fixapost. The listed adverse reactions include those observed within the class of beta-blockers (e.g. timololo) when used to treat ocular conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).

• Generalised allergic reactions including swelling under the skin that may occur in areas such as the face and limbs and may obstruct the airways causing difficulty in swallowing and breathing, urticaria or itching, localised and generalised rash, pruritus, severe, life-threatening allergic reaction.

• Low blood sugar levels.

• Dizziness, difficulty sleeping (insomnia), depression, nightmares, memory loss.

• Fainting, stroke, reduced blood flow to the brain, worsening of signs and symptoms of myasthenia gravis (muscle disorders), unusual sensations such as pins and needles, and headache.

• Swelling at the back of the eye (macular oedema), fluid-filled cysts within the coloured part of the eye (iris cysts), light sensitivity (photophobia), sunken appearance of the eyes (deepening of the eyelid groove).

• Signs and symptoms of eye irritation (such as burning, stinging pain, itching, watering, redness), eyelid inflammation, corneal inflammation, blurred vision and detachment of the layer beneath the retina containing blood vessels after filtering surgery, which may cause visual disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the outer layer of the eyeball), drooping of the upper eyelid (causing the eye to be half-closed), double vision.

• Darkening of the skin around the eyes, changes in 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 coloured part of the eye (iritis/uveitis), scarring of the eye surface.

• Ringing or buzzing in the ears (tinnitus).

• Angina, worsening of angina in patients who already have heart disease. Slow heartbeat, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rhythm or heart rate, congestive heart failure (heart disease with breathlessness and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.

• Low blood pressure, poor blood circulation causing numbness and paleness in fingers and toes, cold hands and feet.

• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing disease), breathing difficulties, cough, asthma, worsening of asthma.

• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.

• Hair loss, skin rash with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin rash.

• Joint pain, muscle pain not caused by physical exercise, muscle weakness, fatigue.

• Sexual dysfunction, decreased libido.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
P_TITLE P_REF version P_REVISION

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 stated on the carton, sachet, and single-dose container.
The expiry date refers to the last day of that month.
This medicine requires no special 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 unused single-dose containers in the opened sachet to protect them from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Fixapost contains
The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other components are: macrogol glycerol hydroxystearate, sorbitol, carbomer, disodium edetate, sodium
hydroxide (to adjust pH), water for injections.
P_TITLE P_REF version P_REVISION
Description of the appearance of Fixapost and contents of the pack
This medicine is an eye drop solution in single-dose containers. The solution is slightly yellowish and opalescent, without preservatives, practically free from particles, supplied in single-dose containers packed in a pouch of 5 units; each single-dose container contains 0.2 ml of product.
A pack contains 30 (6 x 5) or 90 (18 x 5) single-dose containers.
It is possible that not all pack sizes are 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 medicine is authorised in the European Economic Area countries under the following
names:
This leaflet was last approved in: March 2022
Detailed information on this medicine is available on the website of the Italian Medicines Agency (AIFA).
Patient Information Leaflet: Information for the user

Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution

latanoprost/timolol
Please read this entire leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including 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
   P_TITLE P_REF version P_REVISION

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

7. What Fixapost is and what it is used for

Fixapost contains two medicines: latanoprost and timolol. Latanoprost belongs to a class of medicines known as prostaglandin analogues. Timolol belongs to a class 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 reducing the production of fluid inside the eye.
Fixapost is used to reduce intraocular pressure in patients affected by conditions known as open-angle glaucoma or ocular hypertension. Both of these conditions are associated with elevated eye pressure, which may eventually impair vision. Your doctor usually prescribes Fixapost when other medicines have not worked adequately.
Fixapost is a preservative-free ophthalmic solution.

8. What you need to know before using Fixapost

Fixapost can be used in adult women and men 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 any of the other ingredients of this medicine (listed in section 6).
• If you have or have previously had respiratory problems such as asthma, or severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, breathing difficulties, and/or persistent cough).
• If you have severe heart problems or heart rhythm disorders.

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

• Coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, or a feeling of suffocation), heart failure, low blood pressure,
• Heart rhythm disorders such as slow heartbeat,
• Respiratory problems, asthma, or chronic obstructive pulmonary disease,
• A disease associated with poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome),
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar,
• Overactive thyroid gland, as timolol may mask its signs and symptoms,
• Are about to undergo any eye surgery (including cataract surgery) or have previously undergone any eye surgery,
• Eye problems (such as eye pain, eye irritation, eye inflammation, or blurred vision),
• Known dry eye syndrome,
• Wear contact lenses. You may use Fixapost, but follow the instructions for contact lens wearers provided in section 3,
• Known angina (particularly a type of angina called Prinzmetal's angina),
• Known to suffer from severe allergic reactions that usually require hospital treatment,
• Had or currently have a viral eye infection caused by the herpes simplex virus (HSV).

P_TITLE P_REF version P_REVISION
Before undergoing surgery, inform your doctor that you are using Fixapost, as timolol may alter the effects of certain medicines used during anesthesia.
Other medicines and Fixapost
Inform 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.
Fixapost may be altered by, or may alter, other medicines you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or intend to use medicines to lower blood pressure, for heart conditions, or for diabetes treatment.
In particular, inform your doctor or pharmacist if you are taking a medicine belonging to the following classes:

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

Fixapost with food and drink
Eating regular meals, food, or drink does not affect how or when to take Fixapost.
Pregnancy, breast-feeding, and fertility
Do not use Fixapost during pregnancy or while breast-feeding.
Fixapost may pass into breast milk.
In animal studies, latanoprost and timolol did not show any effect on male or female fertility.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
When using Fixapost, you may experience transient blurred vision. If this occurs, do not drive or operate machinery until your vision is clear again.
Fixapost contains macrogol glycerol hydroxystearate (derived from castor oil), which may cause skin reactions.

9. How to use Fixapost

Use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose for adults (including elderly patients) is one drop, once daily in the affected eye(s).
Do not use Fixapost more than once a day, as the effectiveness of treatment may be reduced if administered more frequently.
Use Fixapost according to your doctor's instructions, until your doctor tells you to stop.
Your doctor may prescribe additional checks on your heart and circulation if you are using Fixapost.
This medicine is a preservative-free eye drop solution. Do not allow the tip of the bottle to touch the eye or surrounding areas. It could become contaminated with bacteria that may cause eye infections leading to serious eye damage, even loss of vision. To avoid possible contamination of the bottle, keep the tip of the bottle away from contact with any surface.
Contact lens wearers
If you wear contact lenses, you must remove them before using Fixapost. After using Fixapost, wait 15 minutes before reinserting your contact lenses.
P_TITLE P_REF version P_REVISION

Instructions for use

This medicine is intended for administration into the eyes.
It is important to follow the instructions below when using this product:

	Before first use: -Check that the tamper-evident cap is not broken. Then unscrew the tamper-evident cap firmly to open the bottle. -Wash hands thoroughly and remove the cap from the tip of the bottle. Press several times with the bottle inverted to activate the pumping mechanism until the first drop appears. This process is only required for the first use and will not be necessary for subsequent administrations.
	1. Before each use, wash hands thoroughly and remove the cap from the tip of the bottle. Avoid any contact between the tip of the bottle and fingers.
	2. Place the thumb on the tab at the top of the bottle and the index finger on the base of the bottle. Then also place the middle finger on the second tab at the base of the bottle. Hold the bottle inverted.
	3. To use, tilt the head slightly backward and hold the dropper vertically above the eye. With the index finger of the other hand, gently pull down the lower eyelid. The space created is called the lower conjunctival sac. Avoid contact between the tip of the bottle and fingers or eyes. To instill one drop into the lower conjunctival sac of the affected eye(s), press briefly and firmly on the bottle. Due to the automatic dosing mechanism, one drop is released precisely with each pump.
If the drop does not come out, gently shake the bottle to remove any remaining drop from the tip. In this case, repeat step 3.
	4. When using nasolacrimal occlusion or closing the eyelids for two minutes, systemic absorption is reduced. This may result in a reduction of systemic side effects and an increase in local activity.
	5. Immediately after use, close the tip of the bottle with the cap.

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
P_TITLE P_REF version P_REVISION
If you have instilled too many drops into your eye, mild eye irritation may occur and your eyes may
water or become red. This should resolve, but if you are concerned, consult your doctor.
If you swallow Fixapost
If you accidentally swallow Fixapost, consult a doctor. If you swallow a large amount of Fixapost, you may feel unwell,
experience stomach pain, feel tired, flushed, dizzy, and begin to sweat.
If you forget to use Fixapost
Continue with your usual dose at the usual time. Do not use a double dose to make up for a forgotten dose.
If you have any doubts, consult your doctor or pharmacist.
If you stop using Fixapost
Use Fixapost as directed by your doctor until your doctor tells you otherwise. Do not stop using Fixapost without first consulting your doctor.
If you have any questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

10. POSSIBLE ADVERSE EFFECTS

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
You can generally continue using the drops unless the effects are severe. If you are concerned, speak to a doctor or pharmacist. Do not stop using Fixapost without first talking to your doctor.

Listed below are the known side effects of using Fixapost. The most important side effect is the possibility of a gradual and permanent change in eye colour. Fixapost may also cause serious changes in heart function. If you notice changes in your heartbeat or heart function, you must consult your doctor and inform him or her that you are using Fixapost.

The following are the adverse effects associated with the use of Fixapost:

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

• A gradual change in the colour of your eye due to an increase in brown pigment in the coloured part of the eye, known as the iris. If your eyes have mixed colouration (blue-brown, grey-brown, yellow-brown or green-brown), you are more likely to notice these changes compared to people with uniformly coloured eyes (blue, grey, green or brown). All changes in eye pigmentation may take years to develop. The colour change may be permanent and may be more noticeable if you use Fixapost in only one eye. There appear to be no associated problems with this colour change. The change in eye pigmentation does not continue after stopping treatment with Fixapost.

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

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

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

• Headache.
• Eye redness, eye infection (conjunctivitis), blurred vision, watery eyes, eyelid inflammation, eye surface irritation or abrasion.
• Skin rash or itching.
• Nausea, vomiting.

Other adverse effects
P_TITLE P_REF version P_REVISION
Like other medicines used in the eyes, Fixapost (latanoprost and timolol) is absorbed into the bloodstream.
The incidence of adverse effects after using eye drops is lower than when medicines are taken orally or injected, for example.
Although not observed with Fixapost, the following additional adverse effects have been observed with medicines similar to Fixapost (latanoprost and timololo) and therefore may occur when using Fixapost. The listed adverse effects include reactions observed within the class of beta-blockers (e.g. timololo) when used to treat ocular conditions:

• Development of a viral eye infection caused by the herpes simplex virus (HSV).
• Generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs and may block the airways causing difficulty in swallowing and breathing, urticaria or pruritus, localized and generalized rash, itching, sudden severe life-threatening allergic reaction.
• Low blood glucose levels.
• Dizziness.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood flow to the brain, worsening of 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 edema), fluid-filled cysts within the coloured part of the eye (iris cysts), light sensitivity (photophobia), sunken appearance of the eyes (deepening of the eyelid groove).
• Signs and symptoms of eye irritation (such as burning, stinging, itching, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the layer beneath the retina containing blood vessels after filtering 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 (causing the eye to be half-closed), double vision.
• Darkening of the skin around the eyes, changes in eyelashes and surrounding hair (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eyes, swelling of the coloured part of the eye (iritis/uveitis), scarring of the eye surface.
• Ringing or buzzing in the ears (tinnitus).
• Angina, worsening of angina in patients who already have heart disease. Slow heartbeat, chest pain, palpitations (awareness of heartbeat), edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness in fingers and toes, cold hands and feet.
• Shortness of breath, narrowing of the lung airways (mainly in patients with pre-existing disease), difficulty breathing, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rash.
• Joint pain, muscle pain not caused by physical exertion, muscle weakness, fatigue.
• Sexual dysfunction, decreased libido.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.
P_TITLE P_REF version P_REVISION

11. How to store Fixapost

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry date refers to the last day of that month.
Before first opening: this medicine does not require any special storage conditions.
After first opening: Fixapost can be used for 4 weeks for the 2.5 ml bottle and up to 3 months for the 6 ml bottle, without any special storage requirements.
Record the date of first opening on the carton.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What Fixapost contains
The active substances are latanoprost 50 micrograms/ml and timolol (as timolol maleate) 5 mg/ml.
The other components are: macrogol glycerol hydroxystearate, sorbitol, carbomer, disodium edetate, sodium hydroxide (to adjust pH), water.

Description of the appearance of Fixapost and contents of the pack
Fixapost eye drops solution is slightly yellow and opalescent, practically free from particles.
Fixapost is available in the following pack sizes:

• One 2.5 ml bottle (at least 80 drops without preservative), for 4 weeks of treatment, with a pump equipped with the ergonomic Easygrip system support.
• One 6 ml bottle (at least 190 drops without preservative), for 3 months of treatment, with a pump equipped with the ergonomic Easygrip system support. 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
DELPHARM TOURS
Rue Paul Langevin
37170 Chambray Les Tours
France
Or
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France
Or
P_TITLE P_REF version P_REVISION
FARMILA-THEA Farmaceutici S.p.A.
Via Enrico Fermi, 50
20019 Settimo Milanese
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Fixapost: Austria, Czech Republic, France, Poland, Slovakia
Fixaprost: Belgium, Bulgaria, Cyprus, Germany, Greece, Spain, Luxembourg, Netherlands
Fixopost: Sweden, Denmark, Finland, Iceland, Lithuania, Latvia, Estonia, Norway
Monoprost duo: Portugal
Fixanpost: Romania
Fixalpost: Slovenia, Croatia

This leaflet was last approved in: March 2026
Detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA).