FORTINOL 1% Sustained-release eye drop

Зміст інструкції

1. FORTINOL 1% e FORTINOL 2% Prolonged-release eye drops
   1. WHAT IS FORTINOL AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORTINOL
   3. HOW TO USE FORTINOL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FORTINOL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

FORTINOL 1% e FORTINOL 2% Prolonged-release eye drops

Carteolol hydrochloride

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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What FORTINOL is and what it is used for
• 2. What you need to know before you use FORTINOL
• 3. How to use FORTINOL
• 4. Possible side effects
• 5. How to store FORTINOL
• 6. Contents of the pack and other information

1. WHAT IS FORTINOL AND WHAT IT IS USED FOR

FORTINOL belongs to a category of drugs called beta-blockers.
It is used for the local treatment of the following eye conditions:

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

2. WHAT YOU NEED TO KNOW BEFORE YOU USE FORTINOL

Do not use FORTINOL:

• if you are allergic to carteolol hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from or have suffered in the past from respiratory problems such as asthma and severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough);
• if you have a slowed heartbeat, heart failure or heart rhythm problems (irregular heartbeat);
• if you suffer from bradycardia (heartbeat slower than normal, for example less than 40-45 beats per minute);
• if you suffer from untreated pheochromocytoma (excessive production of a hormone that causes severe high blood pressure).

Warnings and precautions
Talk to your doctor or pharmacist before using FORTINOL if you currently suffer from or have suffered
in the past from:

• coronary heart disease (symptoms may include chest pain or a feeling of tightness, shortness of breath or suffocation), heart failure, low blood pressure;
• heart conduction disorders, such as bradycardia (slowing of the heartbeat);
• respiratory problems, asthma or chronic obstructive pulmonary disease (lung disease that can cause wheezing, difficulty breathing and/or long-lasting cough);
• disease related to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome);
• diabetes, as carteolol may mask signs and symptoms related to low blood sugar levels (hypoglycemia);
• hyperactivity of the thyroid gland as carteolol may mask its signs and symptoms;
• treated pheochromocytoma;
• psoriasis;
• corneal disease;
• history of allergic reactions;
• kidney or liver disease.

Before a surgical anaesthetic, tell your doctor that you are using FORTINOL as
carteolol may alter some effects of the medicines used during anaesthesia.
When using this medicine, you should undergo regular eye examinations, at the beginning of
treatment and also later, approximately every 4 weeks, to check that you are not
developing resistance to the therapeutic efficacy of the product. Furthermore, in the case of long-term
treatment, some tests will be needed to verify any treatment failure (loss of
drug efficacy).
If you wear contact lenses: this category of medicines can create a reduction in the production of
tears and therefore increase the risk of intolerance to contact lenses.
In addition, the preservative (benzalkonium chloride) can be absorbed by soft contact lenses and
can lead to a change in their colour. Remove your contact lenses before using this
medicine and wait 15 minutes before re-applying them.
Benzalkonium chloride can also cause eye irritation, especially if you have dry eyes or
corneal disorders (the most superficial transparent layer of the eye). If you experience an
abnormal sensation in your eye, burning or pain after using this medicine, talk to your doctor.
If you have severe damage to the outermost transparent layer of your eye (the cornea), phosphates can
in very rare cases cause opaque spots on the cornea due to calcium accumulation during
treatment.
The active substance contained in this medicine may determine positivity to doping tests.

Children and adolescents
This eye drop must not be used in newborns or premature babies, children or adolescents.

Other medicines and FORTINOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
FORTINOL can affect or be affected by other medicines, including other eye drops for
the treatment of glaucoma.

• If you are taking other medicines to instill in the eye, you must:
• instill the other ophthalmic medicine,
• wait 15 minutes,
• instill FORTINOL last.
• For the treatment of some types of glaucoma (such as angle-closure glaucoma), your doctor may also prescribe miotic eye drops.
• If you apply adrenaline/epinephrine-based eye drops at the same time as FORTINOL, an ophthalmologist's check-up is necessary (due to the risk of pupillary dilation).
• If you take beta-blockers orally at the same time, it may be necessary to adjust the dosage of FORTINOL.
• Even if the amount of beta-blockers that reaches the blood after application to the eye/s is low, keep in mind the possibility of interactions with oral beta-blockers:
• the use of amiodarone (used for the treatment of heart rhythm disorders), some calcium antagonists (used for the treatment of hypertension, such as diltiazem, fingolimod, ozanimod and verapamil) or other beta-blockers (used for the treatment of heart attack) is not recommended;
• all beta-blockers can mask some symptoms of hypoglycemia: palpitations and tachycardia;
• an increase in blood levels of lidocaine (administered by IV) may occur, which may increase the risk of adverse events at the cardiac and neurological level.

In case of concomitant use of more than one topical ophthalmic medicine, the administrations must
have an interval of at least 15 minutes from each other. Ophthalmic ointments must be
administered last.
Tell your doctor if you are using or intend to take medicines to lower your
blood pressure, heart medicines, or medicines to treat diabetes or multiple sclerosis .
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription. They will check you specifically
if necessary.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
FORTINOL should not be used during pregnancy unless your doctor considers it
necessary.
There are no adequate data on the use of carteolol hydrochloride in 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 the therapeutic doses of carteolol
hydrochloride eye drops, the amount that passes into breast milk is not sufficient to produce beta-blocker symptoms in newborns. To reduce systemic absorption, see section 3.
Ask your doctor for advice before taking any medicine while breastfeeding.

Driving and using machines
After applying this medicine to the eye/s, blurred vision may occur.
Do not drive or use machines 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 in each drop, equivalent to
0.05 mg/ml.

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

3. HOW TO USE FORTINOL

This medicine must be administered into the eye/eyes (ophthalmic use).
Always use this medicine exactly as your doctor tells you. If you have any doubts, consult your
doctor or pharmacist.

Dosage
FORTINOL contains a specific excipient with physical properties that allow for a single
administration per day.
The usual dose is one drop per affected eye/eyes once a day, 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 re-applying them.
• For correct administration of FORTINOL:
• wash your hands thoroughly before using the medicine,
• avoid touching the eye and eyelids with the tip of the applicator,
• instill one drop into the eye/eyes looking upwards and gently pulling down the lower eyelid,
• after administration, keep the eye/eyes closed for a few seconds,
• after using FORTINOL, press with a finger on the corner of the eye, near the nose for 2 minutes. This helps to prevent the active ingredient (carteolol) from reaching the rest of the body,
• with the eye/eyes closed, wipe away any excess medicine,
• reclose the container after use.
• If you are using any other medicine to be instilled into the eye, you must:
• instill the other ophthalmic medicine,
• wait 15 minutes,
• instill FORTINOL last.
• If your doctor has prescribed FORTINOL to replace another medicine, the use of the other eye drop must be stopped after appropriate daily administration. You can start treatment with FORTINOL the next day, at the dosage prescribed by your doctor.
• If you have the impression that FORTINOL has too much or too little effect, inform your doctor or pharmacist.

Do not inject, do not ingest.

Duration of treatment
Follow your doctor’s instructions. He/she will tell you how long you should use FORTINOL. Do not
interrupt the treatment before as indicated by your doctor.

If you use more FORTINOL than you should
If you accidentally apply more drops than necessary into your eyes, wash your eyes with plenty of
running water.
If you accidentally ingest the contents of the bottle, you may experience adverse events such as mild
mental disorientation, difficulty breathing 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 a missed dose.

If you stop using FORTINOL
If you stop the treatment, the pressure in your eyes may increase and lead to a
worsening of vision.
Never stop treatment without first consulting your doctor or pharmacist.
If you have any doubts 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 everyone will experience them.
You can usually continue to use the drops unless the side effects are serious. 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 can 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 the medicines are taken, for example, orally or injected.
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 people).

• Signs and symptoms of eye irritation (e.g., burning), eye pain (e.g., stinging sensation), itching, tearing, eye redness, conjunctival redness, conjunctivitis, irritation or feeling 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 people).

• 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 1000 people).

• Positive test results for antinuclear antibodies.

In very rare cases, some patients with severe damage to the transparent front part of the eye
(cornea) have developed opaque spots on the cornea during treatment due to calcium deposits.
The frequency of the following adverse events is not known (the frequency cannot be estimated based on
the available data).

• Allergic reactions, including sudden swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing, hives, localized and widespread rash, itching, acute allergic reactions that are life-threatening.
• Low blood sugar levels.
• Difficulty falling asleep (insomnia), depression, nightmares, decreased libido.
• Fainting, stroke, decreased blood flow to certain areas of the brain, increased signs and symptoms of myasthenia gravis (muscle problems), tingling or numbness of hands and feet, formication, 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 front 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 heartbeat, palpitations, changes in the rhythm and rate of the heartbeat, heart conditions that cause 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 - normally 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 silvery-colored patches (psoriasiform rash) or worsening of psoriasis, skin eruptions.
• Systemic lupus erythematosus.
• Sexual dysfunction, impotence.
• Unusual muscle weakness or pain not caused by exercise (asthenia) or fatigue, chest pain, fluid accumulation (edema).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 indicated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. The bottle must
be discarded after 28 days from first opening. Note the date of opening on the
packaging.
Do not use if the packaging is damaged.
Do not dispose of any medicine in the 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 FORTINOL contains:

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

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

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

Not all pack sizes may be marketed.

Marketing Authorisation 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 medicine is authorised in the member states of the European Union with 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%