Fixapost

Patient Information Leaflet

Fixapost, 50 micrograms/ml + 5 mg/ml, eye drops, solution in a single-dose container
Latanoprostum + Timololum
Please read this leaflet carefully before using this medicine, because it contains important
information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Fixapost is and what it is used for
2. What you should 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 active substances: latanoprost and timolol. Latanoprost belongs to a group of medicines known as prostaglandin analogues. Timolol belongs to a group of medicines called beta-blockers. Latanoprost works by increasing the natural outflow of aqueous humour from the eye into the bloodstream. Timolol reduces the production of aqueous humour in the eye. Fixapost is used to reduce intraocular pressure when a patient has open-angle glaucoma or ocular hypertension. Both of these conditions are associated with increased pressure inside the eyeball and may affect vision. Your doctor may prescribe Fixapost if other medicines are not sufficiently effective.

2. Important information before using Fixapost

Fixapost may be used by adult men and women (including elderly people),
but it is not recommended for individuals under 18 years of age.
When not to use Fixapost:

• if the patient is allergic (hypersensitive) to latanoprost, timolol, beta-blockers, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient currently has or has had in the past respiratory disorders such as bronchial asthma, severe chronic obstructive pulmonary disease (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-term cough),
• if the patient has serious heart problems or cardiac arrhythmias (irregular heartbeat).

Warnings and precautions
Before starting to use Fixapost, discuss with your doctor, pharmacist, or
nurse if any of the following conditions currently apply to you or have applied in the past:

• ischemic heart disease (symptoms may include chest pain or tightness, shortness of breath, angina), heart failure, low blood pressure,
• heart rhythm disorders, such as slow heartbeat,
• breathing problems, asthma, chronic obstructive pulmonary disease (COPD),
• if the patient has a condition associated with poor blood circulation (such as Raynaud's disease or syndrome),
• diabetes, because timolol may mask subjective and objective symptoms related to low blood sugar,
• hyperthyroidism, because timolol may mask subjective and objective symptoms of this condition,
• if the patient is scheduled for any eye surgery (including cataract surgery) or has had such a procedure in the past,
• if the patient suffers from eye disorders (such as eye pain, eye irritation, eye inflammation, or blurred vision),
• if the patient has dry eye syndrome,
• if the patient wears contact lenses. Fixapost can still be used, but instructions for contact lens wearers in section 3 must be followed,
• if the patient suffers from angina (especially a type called Prinzmetal's angina),
• if the patient experiences severe allergic reactions, which usually require hospital treatment,
• if the patient has or has had in the past a viral eye infection caused by herpes simplex virus (HSV).

Before surgery, inform your doctor about using Fixapost, as timolol may
affect the action of certain drugs used during anesthesia.
Fixapost and other medicines
Tell your doctor or pharmacist about all medicines you are currently using,
have recently used, or plan to use, including eye drops and over-the-counter medicines.
Some medicines may affect the action of Fixapost, and Fixapost may also affect the action of other medicines, including other eye drops used in glaucoma treatment. Inform your doctor if you are using or plan to use medicines that lower blood pressure, heart medications, or antidiabetic drugs.
In particular, talk to your doctor or pharmacist if you are taking
any of the following medicines:

• prostaglandins, analogues or derivatives of prostaglandins,
• beta-blockers,
• epinephrine,
• medicines used to lower blood pressure, such as oral calcium channel blockers, guanethidine, antiarrhythmics, cardiac glycosides, or parasympathomimetics,
• quinidine (a medicine used to treat heart conditions and certain types of malaria),
• antidepressants known as fluoxetine and paroxetine.

Fixapost with food and drink
Eating meals, food, and drink do not affect the timing or method of using Fixapost.
Pregnancy, breastfeeding, and fertility
Do not use Fixapost during pregnancy or while breastfeeding.
Fixapost may pass into breast milk.
Animal studies have shown that latanoprost and timolol do not affect fertility in women
or men.
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, she should
consult her doctor before using this medicine.
Driving and using machines
Using Fixapost may cause temporary visual disturbances. In such cases,
do not drive, use tools, or operate machinery until the disturbances resolve.
Fixapost contains macrogolglycerol hydroxystearate (derived from castor oil) which
may cause skin reactions.

3. How to use Fixapost medicine

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
The recommended dose for adults (including elderly people) is one drop into the affected eye (eyes)
once daily.
Do not use Fixapost medicine more than once a day, as more frequent use may reduce
the effectiveness of treatment.
Fixapost medicine should be used as directed by the doctor until the doctor decides
to discontinue treatment.
The doctor may recommend more frequent monitoring of heart and circulatory system function during
treatment with Fixapost.
Contact lens wearers
Contact lenses must be removed before instilling Fixapost. After applying the medicine, wait
15 minutes before reinserting contact lenses.
Method of administration
This medicine is intended for ophthalmic use.
To apply the drops, follow the instructions below:

1. Wash your hands and assume a comfortable standing or sitting position.
2. Open the sachet containing 5 single-dose containers. Record the date of first opening on the sachet.
3. Break off one single-dose container from the strip.

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

5. Gently pull down the lower eyelid of the affected eye with a finger.
6. Hold the tip of the single-dose container close to the eye, but without touching the eye surface.
7. Gently squeeze the single-dose container so that one drop falls into the eye, then release the lower eyelid.

8. Press with a finger on the inner corner of the eye near the nose bridge. Hold for 2 minutes with eyes closed.

9. Repeat the steps for the second eye if directed by the doctor. Each single-dose container contains enough solution to treat both eyes.
10. Dispose of the single-dose container after use. Do not store for reuse. Since sterility cannot be maintained after opening a single-dose container, a new container must be opened for each use.
11. Return unused single-dose containers to the sachet. Store the opened sachet in the carton. After first opening the sachet: the shelf life of unopened single-dose containers is 1 month.

Using Fixapost with other eye drops
Wait at least 5 minutes between applying Fixapost and other eye drops.
Using more than the recommended dose of Fixapost
Applying too many eye drops may cause mild eye irritation, tearing, and redness. These symptoms should resolve, but if they persist or concern the patient, medical advice should be sought.
Accidental swallowing of Fixapost drops
If Fixapost is accidentally swallowed, contact a doctor for advice. Swallowing a large amount of Fixapost drops may cause nausea, abdominal pain, feeling of fatigue, facial skin redness, dizziness, and sweating.
Missed dose of Fixapost
Continue using the prescribed dose at the usual time. Do not use a double dose to make up for a missed dose. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You can usually continue using the eye drops unless the adverse effects are severe. If in doubt, consult a doctor or pharmacist.
Do not stop using Fixapost without consulting your doctor.

The following are known adverse effects associated with the use of Fixapost. The most significant possible adverse effect is a gradual, permanent change in eye colour. There is also a possibility of serious changes in heart function. If the patient experiences changes in heart rhythm or heart function, they should contact their doctor and inform them of the use of Fixapost.

The following adverse effects have been observed during treatment with Fixapost:

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

• Gradual change in eye colour due to increased amount of brown pigment in the coloured part of the eye, the so-called iris. This effect is more frequently observed in patients with mixed-colour irises (blue-brown, grey-brown, yellow-brown or green-brown) than in patients with uniformly coloured eyes (blue, grey, green or brown). The change in eye colour may develop over years. This change may be permanent and may be more noticeable when Fixapost is administered in only one eye. No associated discomfort has been reported with the change in eye colour. These changes do not progress after discontinuation of Fixapost.

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

• Eye irritation (burning sensation, grittiness, itching, stinging or foreign body sensation in the eye) and eye pain.

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

• Headache,
• Eye redness, eye infection (conjunctivitis), blurred vision, tearing, blepharitis, eye surface irritation or damage,
• Skin rash or itching,
• Nausea, vomiting.

Other adverse effects
Like other eye medicines, Fixapost (latanoprost and timolol) is absorbed into the bloodstream. The frequency of systemic adverse effects after using eye drops is lower than with oral or injectable medicines.
Although the following additional adverse effects have not been observed with Fixapost, they may occur during treatment because they have been reported with the active substances in Fixapost (latanoprost and timolol). The listed adverse effects include reactions observed during treatment of eye diseases with beta-adrenergic blocking agents (e.g. timolol):

• Development of viral eye infection caused by herpes simplex virus (HSV)
• General allergic reactions, including subcutaneous oedema which may occur in the face and limbs and may compromise airway patency, making swallowing and breathing difficult, urticaria or itchy rash, localised and generalised rash, pruritus, severe, sudden, life-threatening allergic reaction.
• Low blood glucose levels.
• Dizziness
• Sleep disturbances (insomnia), depression, nightmares, memory loss, hallucinations.
• Fainting, stroke, reduced blood flow to the brain, worsening of myasthenia symptoms (muscle disorder), unusual sensations such as tingling and prickling, headache.
• Swelling at the back of the eye (macular oedema), fluid-filled cyst in the coloured part of the eye (iris cyst), light sensitivity (photophobia), sunken appearance of the eyes (deepening of the eyelid crease).
• Objective and subjective symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), blepharitis, keratitis, blurred vision and detachment of the layer beneath the retina containing blood vessels following a filtering procedure, which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), drooping of the upper eyelid (causing the eye to be partially closed), double vision.
• Darkening of the skin around the eyes, changes in the appearance of eyelashes and fine hairs around the eye (increased number, length, thickness and darkening), changes in the direction of eyelash growth, swelling around the eye, 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 pectoris in patients with heart disease.
• Slow heart rate, chest pain, palpitations (awareness of heartbeat), oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with shortness of breath and swelling of feet and legs due to fluid accumulation), types of arrhythmia, myocardial infarction, heart failure.
• Low blood pressure, poor blood circulation causing numbness and paleness of fingers and toes, cold hands and feet.
• Shallow breathing (dyspnoea), narrowing of airways in the lungs (mainly in patients with pre-existing lung disease), breathing difficulties, cough, asthma, worsening of asthma.
• Taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with silvery-white appearance (psoriasiform rash or exacerbation 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 any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Fixapost

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box, sachet,
and single-dose container. The expiry date refers to the last day of the stated month.
No special temperature storage requirements for this medicine.
After first opening the sachet: the shelf life of unopened single-dose containers is
1 month.
Write down the date of first opening on the sachet.
After first opening the single-dose container: use immediately and discard the
single-dose container after use.
Store single-dose containers in the sachet to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the package and other information

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

What Fixapost looks like and contents of the pack
This medicinal product is available as eye drops solution in single-dose containers. The solution is slightly yellowish and opalescent, contains no preservatives, and is practically free from visible solid particles. It is supplied in single-dose containers, with 5 units packed in sachets. Each single-dose container holds 0.2 ml of the medicinal product.
Pack sizes contain either 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
Laboratoires THEA
12 rue Louis Blériot
63017 Clermont-Ferrand Cedex 2
France

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

Detailed information on this medicinal product is available on the website www.urpl.gov.pl