Fortinol: detailed information

Patient Information Leaflet: Information for the User

FORTINOL 1% and FORTINOL 2% Prolonged Release Eye Drops

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, ask your doctor or pharmacist.
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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What FORTINOL is and what it is used for
What you need to know before using FORTINOL
How to use FORTINOL
Possible side effects
How to store FORTINOL
Contents of the pack and other information

1. WHAT FORTINOL IS AND WHAT IT IS USED FOR

FORTINOL belongs to a class of medicines called beta-blockers.
It is used in the local treatment of the following eye conditions:

a certain type of glaucoma (chronic open-angle glaucoma),
increased pressure in the eye(s) (intraocular hypertension).

2. WHAT YOU NEED TO KNOW BEFORE USING FORTINOL

Do not use FORTINOL:

if you are allergic to carteolol hydrochloride or to any of the 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 wheezing, difficulty breathing and/or long-lasting cough);
if you have a slow heartbeat, heart failure or heart rhythm disorders (irregular heartbeats);
if you suffer from bradycardia (slower than normal heart rate, e.g. less than 40–45 beats per minute);
if you have untreated phaeochromocytoma (excessive production of a hormone causing severe high blood pressure).

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

coronary heart disease (symptoms may include chest pain or tightness, shortness of breath or suffocation), heart failure, low blood pressure;
cardiac conduction disorders, such as bradycardia (reduced heart rate);
respiratory problems, asthma or chronic obstructive pulmonary disease (lung disease that may cause wheezing, difficulty breathing and/or long-lasting cough);
circulation-related disorders (such as Raynaud's disease or Raynaud's syndrome);
diabetes, as carteolol may mask signs and symptoms of low blood sugar (hypoglycaemia);
overactivity of the thyroid gland, as carteolol may mask its signs and symptoms;
treated phaeochromocytoma;
psoriasis;
corneal disease;
history of allergic reactions;
kidney or liver disease.

Before undergoing surgical anaesthesia, inform your doctor that you are using FORTINOL, as carteolol may alter some effects of medicines used during anaesthesia.
When using this medicine, you should have regular eye examinations, both at the beginning of treatment and periodically thereafter, approximately every 4 weeks, to monitor whether you are developing resistance to the therapeutic effect of the product. Additionally, during long-term treatment, some tests will be needed to detect possible treatment failure (loss of effectiveness of the medicine).
If you wear contact lenses: this class of medicines may reduce tear production and thus increase the risk of intolerance to contact lenses.
Moreover, the preservative (benzalkonium chloride) may be absorbed by soft contact lenses and may cause a change in their colour. Remove your contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye or corneal disorders (the outermost transparent layer of the eye). If you experience an abnormal sensation in the eye, such as burning or pain after using this medicine, speak with your doctor.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may, in very rare cases, cause cloudy corneal deposits 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 newborns or premature infants, children or adolescents.

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

If you are using other eye drops, you must:
- instill the other ophthalmic medicine first,
- wait 15 minutes,
- then instill FORTINOL 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 at the same time as FORTINOL, ophthalmological monitoring is required (due to the risk of pupil dilation).
If you are taking oral beta-blockers concurrently, the dosage of FORTINOL may need to be adjusted.
Although the amount of beta-blocker reaching the bloodstream after ocular administration is low, consider the possibility of interactions with oral beta-blockers:
- concomitant use of amiodarone (used to treat heart rhythm disorders), certain calcium antagonists (used to treat high blood pressure, such as diltiazem, fingolimod, ozanimod and verapamil), or other beta-blockers (used to treat heart attack) is not recommended;
- all beta-blockers may mask some symptoms of hypoglycaemia: palpitations and tachycardia;
- increased blood levels of lidocaine (administered intravenously) may occur, increasing the risk of cardiac and neurological adverse events.

When using more than one topical ophthalmic medicine, each administration should be spaced at least 15 minutes apart. Ophthalmic ointments should be administered last.
Inform your doctor if you are using or intend to take medicines to lower blood pressure, heart medications, or medicines to treat diabetes or multiple sclerosis.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription. They will monitor you specifically if necessary.

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

Pregnancy
FORTINOL must not be used during pregnancy unless your doctor considers it necessary.
There are insufficient data on the use of carteolol hydrochloride during pregnancy.
To reduce systemic absorption, see section 3.

Breastfeeding
Do not use FORTINOL if you are breastfeeding, as carteolol hydrochloride may pass into breast milk.
Beta-blockers are excreted in breast milk. However, at therapeutic doses of carteolol hydrochloride eye drops, the amount passing into breast milk is not sufficient to cause beta-blocking symptoms in infants. To reduce systemic absorption, see section 3.
Consult your doctor before taking any medicine during breastfeeding.

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

FORTINOL contains benzalkonium chloride
Preservative used: benzalkonium chloride. See section 2 “Warnings and precautions”.
This medicine contains 0.00165 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/ml.

FORTINOL contains phosphate buffer
This medicine contains 0.046 mg of phosphate buffer per drop, equivalent to 1.4 mg/ml.

3. HOW TO USE FORTINOL

This medicine is to be administered into the eye(s) (ophthalmic use).
Always use this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.

Dosage
FORTINOL contains a specific excipient with physical properties allowing for once-daily administration.
The usual dose is one drop per affected eye(s) once daily in the morning.
However, your doctor may decide to adjust the dosage, especially if you are already taking oral beta-blockers (by mouth) (see section 2 “Other medicines and FORTINOL”).

Method and route of administration

If you wear contact lenses, you must remove them before instilling FORTINOL and wait 15 minutes before reinserting them.
For correct administration of FORTINOL:
wash your hands thoroughly before using the medicine,
avoid touching the eye or eyelids with the tip of the dispenser,
instill one drop into the eye(s) while looking upward and gently pulling down the lower eyelid,
after administration, keep the eye(s) closed for a few seconds,
after using FORTINOL, press a finger against the inner corner of the eye near the nose for 2 minutes. This helps prevent the active substance (carteolol) from reaching the rest of the body,
with the eye(s) closed, wipe away any excess medicine,
close the container after use.
If you are using any other eye medicine, you must:
instill the other ophthalmic medicine first,
wait 15 minutes,
then instill FORTINOL last.
If your doctor has prescribed FORTINOL as a replacement for another medicine, use of the previous eye drop should be discontinued after appropriate daily dosing. You may start treatment with FORTINOL the following day, at the dosage prescribed by your doctor.
If you feel that the effect of FORTINOL is too strong or too weak, inform your doctor or pharmacist.

Do not inject, do not swallow.

Duration of treatment
Follow your doctor’s instructions. Your doctor will tell you how long you should use FORTINOL. Do not stop treatment earlier than instructed by your doctor.

If you use more FORTINOL than you should
If you accidentally apply more drops than necessary into the eyes, rinse the eyes thoroughly with running water.
If you accidentally ingest the contents of the bottle, you may experience adverse events such as mild mental confusion, breathing difficulties, or a sensation of slowed heartbeat.
In these cases, contact your doctor or pharmacist immediately.

If you forget to use FORTINOL
Do not take a double dose to make up for the forgotten dose.

If you stop using FORTINOL
If you stop treatment, the pressure in your eyes may rise and lead to worsening of vision.
Never stop treatment without first consulting your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody will experience 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 FORTINOL without consulting your doctor.

Like other ophthalmic medicines applied to the eye (topical ophthalmic drugs), carteolol hydrochloride may be absorbed into the bloodstream. This may cause side effects similar to those observed with systemic beta-blockers. The frequency of adverse events after topical ocular administration is lower than when medicines are taken orally or by injection.

The list of adverse events includes reactions observed in the class of ophthalmic beta-blockers.
The frequency of the following adverse events is common (may affect up to 1 in 10 users):

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 having something in the eye (keratitis).
Taste disturbances.

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

Dizziness.
Muscle weakness or pain not caused by exercise (myalgia), muscle cramps.

The frequency of the following adverse events is rare (may affect up to 1 in 1,000 users):

Positive antinuclear antibody test results.

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, hives, 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 in certain areas of the brain, worsening of signs and symptoms of myasthenia gravis (muscle problems), tingling or numbness of hands and feet, tingling sensations, headache, memory loss.
Swollen eyelid (blepharitis), blurred vision, visual disturbances following surgery (choroidal detachment following 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 (sometimes due to discontinuation of treatment with miotic eye drops).
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), 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 (wheezing or difficulty breathing – usually in patients with pre-existing bronchospastic disease), shortness of breath (dyspnea), cough.
Nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
Hair loss, skin rash with silver-coloured patches (psoriasiform rash) or worsening of psoriasis, skin rashes.
Systemic lupus erythematosus.
Sexual dysfunction, impotence.
Unusual muscle weakness or pain not caused by physical exercise (asthenia) or fatigue, chest pain, fluid accumulation (edema).

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 FORTINOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. The bottle should be discarded 28 days after first opening. Note the date of opening on the packaging.
Do not use if the packaging is damaged.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What FORTINOL contains:

The active substance is carteolol hydrochloride.
Fortinol 1%: 1 ml of prolonged-release eye drops solution contains 10 mg of carteolol hydrochloride.
Fortinol 2%: 1 ml of prolonged-release eye drops solution contains 20 mg of carteolol hydrochloride.
The other excipients are: benzalkonium chloride solution (preservative), alginic acid (E 400), disodium hydrogen phosphate dihydrate (E 339), dodecahydrate disodium phosphate (E 339), sodium chloride, sodium hydroxide (pH regulator), purified water.

Description of the appearance of FORTINOL and packaging contents
This medicine is a beta-blocker for ophthalmic use.
FORTINOL 1% and FORTINOL 2% are presented as prolonged-action eye drops in the form of a clear, slightly coloured solution, in a 3 ml bottle.

FORTINOL 1%: - 3 ml in a dropper container with screw cap.
FORTINOL 2%: - 3 ml in a dropper container with screw cap. 3 x 3 ml in dropper containers with screw caps.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Bausch & Lomb-IOM S.p.A.
Viale Martesana, 12
20055 Vimodrone (MI), Italy
Manufacturer
Laboratoire CHAUVIN SA – Zone Industrielle de Ripotier Haut – 50 Avenue Jean Monnet
07200 Aubenas - France
This medicinal product is authorized in European Union member states under the following names:
France: CARTEOL L.P. 1% and CARTEOL L.P. 2%
Belgium, Luxembourg: ARTEOPTIC LA 2%
Italy: FORTINOL 1% and 2%
Portugal: PHYSIOGLAU 1% and PHYSIOGLAU 2%
Spain: ARTEOPTIC 1% and ARTEOPTIC 2%
Poland, Czech Republic, Slovak Republic: CARTEOL LP 2%
Romania: Fortinol EP 2%