Fortisoc

Patient Information Leaflet

Fortisoc 20 mg/ml, eye drops, prolonged-release solution

Carteolol hydrochloride
Please read 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Fortisoc is and what it is used for
2. What you need to know before using Fortisoc
3. How to use Fortisoc
4. Possible side effects
5. How to store Fortisoc
6. Package contents and other information

1. What Fortisoc is and what it is used for

Fortisoc belongs to a class of medicines called beta-blockers.
Fortisoc 20 mg/ml, eye drops, prolonged-release solution, is indicated in adults for the symptomatic treatment of:

• a certain type of glaucoma (chronic open-angle glaucoma),
• increased eye/ocular pressure (intraocular hypertension).

Fortisoc is a preservative-free solution.

2. What you should know before using Fortisoc

Do not use Fortisoc:

• if you are allergic to carteolol hydrochloride or to any of the other ingredients of this medicine (listed in section 6),
• if you currently have or have previously had respiratory problems such as asthma or severe chronic obstructive bronchitis (a serious lung disease that may cause shortness of breath, difficulty breathing and/or long-lasting cough), because Fortisoc may increase bronchial spasms and worsen these conditions,
• if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeats, sick sinus syndrome including sinoatrial block), because Fortisoc may reduce heart rate and thus worsen these conditions,
• if you have second- or third-degree atrioventricular block not controlled by a pacemaker, because Fortisoc may increase the risk of developing atrioventricular blocks,
• if you suffer from bradycardia or sinus bradycardia (slower than normal heart rate, e.g. less than 45–50 beats per minute), because Fortisoc may reduce heart rate and thus worsen these conditions,
• if you have untreated phaeochromocytoma (excessive production of a hormone causing severe arterial hypertension), because carteolol may increase blood pressure and worsen this condition.

Warnings and precautions
Talk to your doctor or pharmacist before using Fortisoc if you currently have or have previously had:

• heart disease,
• respiratory problems, asthma or chronic obstructive pulmonary disease (a lung disease that may cause shortness of breath, difficulty breathing and/or long-lasting cough),
• disease due to poor blood circulation (such as Raynaud’s disease or Raynaud’s syndrome),
• diabetes, because carteolol may mask signs and symptoms associated with low blood sugar levels (hypoglycaemia),
• overactivity of the thyroid gland, because carteolol may mask its signs and symptoms,
• treated phaeochromocytoma, because carteolol may increase blood pressure,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease.

Before undergoing surgical anaesthesia, inform your doctor that you are using Fortisoc, as carteolol may alter certain effects of some medicines used during anaesthesia.
To monitor treatment effectiveness, you must undergo eye examinations at the beginning of treatment and subsequently, approximately after 4 weeks. Moreover, for long-term treatment, annual examinations are necessary to ensure that the treatment remains effective and to detect any signs of loss of efficacy.
If you wear contact lenses: this class of medicines may reduce tear production and therefore increase the risk of intolerance to contact lenses.
This medicine contains 19.2 µg of phosphates per drop, equivalent to 0.509 mg/ml. If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause cloudy corneal spots due to calcium accumulation during treatment.
The active substance contained in this medicine may lead to positive results in anti-doping tests.

Children and adolescents
This eye drop must not be used in children and adolescents. Information on the safety and efficacy of eye drops containing carteolol in children and adolescents is not available.

Other medicines and Fortisoc
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Fortisoc may interact with or be affected by other medicines, including other eye drops used to treat glaucoma.

• If you are using other eye medications, you must: o administer the other ophthalmic medicine first, o wait 15 minutes, o then administer Fortisoc last.
• For the treatment of certain types of glaucoma (such as closed-angle glaucoma), your doctor may also prescribe miotic eye drops.
• If you use adrenaline/epinephrine eye drops concurrently with Fortisoc, ophthalmological monitoring is required (due to the risk of pupillary dilation).

If you are concurrently taking oral beta-blockers (medicines that reduce blood pressure by slowing down and weakening the heartbeat), it may be necessary to adjust the dosage of Fortisoc.

• Although the amount of beta-blockers reaching the bloodstream after ocular application is low, your doctor must consider the possibility of interactions with oral beta-blockers: o The use of amiodarone (used to treat heart rhythm disorders), certain calcium channel blockers (used to treat hypertension, such as diltiazem and verapamil), fingolimod (used to treat multiple sclerosis), or beta-blockers (used to treat heart attack) is not recommended. If use of the above-mentioned medicines is necessary, your doctor will closely monitor your treatment. o Inform your doctor if you are using or intend to use medicines to lower blood pressure, heart medications, medicines to treat diabetes, cholinergic medicines for Alzheimer’s disease, medicines to treat urinary flow problems, multiple sclerosis, depression, psychotic disorders, cancer (i.e. when using amifostine), medicines to treat or prevent malaria (i.e. when using mefloquine), muscle spasms (i.e. when using baclofen), or joint disorders such as osteoarthritis (i.e. when using so-called Non-Steroidal Anti-Inflammatory Drugs such as ibuprofen or celecoxib). Your doctor will monitor your treatment if necessary.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Fortisoc must not be used during pregnancy unless your doctor considers it necessary.
To reduce systemic absorption, see section 3.

Breastfeeding
Considering the low concentration and the route of administration, it is unlikely that the use of Fortisoc would result in carteolol passing into breast milk at levels harmful to your baby.
To reduce systemic absorption, see section 3.
Consult your doctor before taking any medicine while breastfeeding.

Driving and using machines
After instillation of this medicine in the eye(s), blurred vision may occur.
Do not drive or operate machinery until your vision returns to normal.

3. How to use Fortisoc

This medicine is intended for administration into the eye(s) (ophthalmic use).
Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Dosage
The usual dose is one drop in the affected eye(s) once daily in the morning.
However, your doctor may decide to adjust the dosage (e.g. one drop every other day), especially if you are already taking oral beta-blockers (by mouth) (see section 2 “Other medicines and Fortisoc”).

Method and route of administration

• If you wear contact lenses, you must remove them before instilling Fortisoc and wait 15 minutes before reinserting them.
• When using this eye drop solution, you must wash your hands thoroughly before opening the bottle and follow the steps below:

A. Before initial instillation into the eye

1. Remove the safety seal.
2. Remove the protective cap.

3. Hold the bottle upside down. Press firmly from the center of the bottle to dispense 1–2 drops. If the drop does not come out, repeat steps A2 and A3.

B. To instill the eye drop solution

1. Gently pull the lower eyelid downward while looking upward. Position the bottle above the eye and press gradually on the center of the bottle until a drop is released. Avoid touching the eye or eyelids with the tip of the bottle.
2. Blink once to help spread the drop across the entire surface of the eye. With the eye still closed, carefully wipe away any excess.
3. To reduce potential systemic absorption, it is recommended to press with a finger on the inner corner of the eye for 2 minutes after each instillation, keeping the eye closed.

C. After each instillation

To remove any residual drops:

1. Hold the bottle upright by the middle section.
2. Quickly rotate the bottle downward with enough force to expel the remaining drop.
3. Replace the protective cap after use.
   • If you are using another eye drop at the same time, wait 15 minutes between the two instillations.

• If your doctor has prescribed Fortisoc as a replacement for another medicine, the use of the other eye drop should be discontinued after appropriate daily administration. You may start treatment with Fortisoc the following day, at the dosage prescribed by your doctor. Fortisoc may be added to an ongoing treatment regimen.
• If you feel that Fortisoc is having too strong or too weak an effect, inform your doctor or pharmacist.

Duration of treatment
Follow your doctor’s instructions. They will advise you on how long to use Fortisoc.

If you use more Fortisoc than you should
If you apply more drops than necessary, rinse your eyes with a sterile sodium chloride solution 9 mg/ml (0.9%). If a sterile sodium chloride solution is not available, you may use clean water.
If you accidentally ingest the contents of the bottle, contact your doctor or pharmacist immediately.

If you forget to use Fortisoc
Do not use a double dose to make up for the missed dose.

If you stop using Fortisoc
If you stop treatment, the pressure in your eyes may increase, leading to worsening of vision.
Never stop the prescribed treatment with Fortisoc without first consulting your doctor or pharmacist.

If you have any questions about the use of this medicine, consult 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 continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Fortisoc without consulting your doctor.

The frequency of the following adverse events is common (may affect up to 1 in 10 people):

• Signs and symptoms of ocular irritation (e.g. burning), eye pain (e.g. stinging sensation), itching, tearing, eye redness, conjunctival redness, conjunctivitis, eye irritation or sensation of a foreign body in the eye (keratitis).
• Taste disturbances.

The frequency of the following adverse events is uncommon (may affect up to 1 in 100 people):

• Dizziness.
• Muscle weakness or non-exercise-related muscle pain (myalgia), muscle cramps.

In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea) have developed during treatment opaque corneal spots due to calcium deposits.

The frequency of the following adverse events is unknown (cannot be estimated from the available data):

• Allergic reactions, including sudden swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, urticaria, localized and generalized skin rash, itching, sudden life-threatening allergic reactions.
• Low blood sugar levels.
• Difficulty falling asleep (insomnia), depression, nightmares, decreased libido.
• Fainting, stroke, reduced blood flow to certain areas of the brain, worsening of signs and symptoms of myasthenia gravis (muscle problems), tingling or numbness of hands and feet, numbness, headache, memory loss.
• Swollen eyelid (blepharitis), blurred vision, visual disturbances following surgery (choroidal detachment after filtering surgery), decreased corneal sensitivity, dry eye, damage to the anterior membrane of the eye (corneal erosion), drooping of the upper or lower eyelid, double vision, changes in refraction.
• Slow heart rate, palpitations, changes in heart rhythm and rate, heart conditions causing shortness of breath and swelling of feet and legs due to fluid retention (congestive heart failure), heart disorder (atrioventricular block), heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet, leg cramps and/or leg pain when walking (claudication).
• Bronchospasm, shortness of breath (dyspnea), cough.
• Nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.
• Hair loss, psoriasiform rash (rash with silvery-coloured patches) or worsening of psoriasis, skin rashes.
• Systemic lupus erythematosus (an autoimmune disease in which the immune system attacks the body's own tissues, causing widespread inflammation and tissue damage in affected organs. It may affect joints, skin, brain, lungs, kidneys and blood vessels).
• Sexual dysfunction, impotence.
• Asthenia (unusual muscle weakness) or myalgia (non-exercise-related pain) or fatigue, chest pain, fluid accumulation (oedema).

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

5. How to store Fortisoc

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container, following "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature conditions.
Keep the bottle in the outer packaging to protect the medicine from light.
The bottle should be discarded 2 months after first opening. Note the date of opening on the packaging.
Do not use if the packaging is damaged.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Fortisoc contains:

• The active substance is carteolol hydrochloride. Fortisoc: 1 ml of ophthalmic solution, prolonged-release solution, contains 20 mg of carteolol hydrochloride.
• The other excipients are: alginic acid (E400), monobasic sodium phosphate dihydrate (E339), dibasic sodium phosphate dodecahydrate (E339), sodium chloride, sodium hydroxide (pH regulator), purified water.

Description of the appearance of Fortisoc and contents of the pack
This medicine is a beta-blocker for ophthalmic use.
Fortisoc is presented as an eye drop, in the form of a clear, slightly yellowish-brown solution contained in an 8 ml bottle.
Marketing Authorization Holder
Bausch + Lomb Ireland Limited
3013 Lake Drive - Citywest Business Campus
Dublin 24 – D24 PPT3
Ireland
Manufacturer
Laboratoire Chauvin
50 Avenue Jean Monnet - Zone Industrielle De Ripotier
07200 Aubenas
France
This medicine is authorized in the Member States of the European Union under the following names:
Belgium: Arteoptic LA Sine Conservans 20 mg/ml Oogdruppels, oplossing met verlengde afgifte/
Collyre en solution à libération prolongée/ Augentropfen mit verlängerter Wirkungsdauer
Croatia: Cartelomb 20 mg/ml kapi za oko, otopina s produljenim oslobađanjem
France: Carteol LP 2% Collyre en solution à libération prolongée
Luxembourg: Arteoptic LA Sine Conservans 20 mg/ml Oogdruppels, oplossing met verlengde afgifte/
Collyre en solution à libération prolongée/ Augentropfen mit verlängerter Wirkungsdauer
Italy: Fortisoc 20 mg/ml, eye drops, prolonged-release solution
Netherlands: Arteoptic zonder conserveermiddel 20 mg/ml, oogdruppels, oplossing met verlengde afgifte
Poland: Carteol LP 2% Preservative Free
Portugal: Physioglau 2% Colírio solução de libertação prolongada
Slovenia: Cartelomb 20 mg/ml kapljice za oko, raztopina s podaljšanim sproščanjem
Spain: Arteoptic PF 2% colirio de liberación prolongada