Carteol Lp 2%

Package Leaflet: Information for the User

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Carteol LP 2%

20 mg/ml, eye drops with prolonged release

Carteolol hydrochloride

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Carteol LP 2% and what is it used for
• 2. Important information before using Carteol LP 2%
• 3. How to use Carteol LP 2%
• 4. Possible side effects
• 5. How to store Carteol LP 2%
• 6. Contents of the pack and other information

1. What is Carteol LP 2% and what is it used for

Carteol LP 2% belongs to a group of beta-adrenergic blocking agents.
Carteol LP 2% is used locally in the eye for the following diseases:

• one of the forms of glaucoma (chronic glaucoma with open angle of filtration),
• increased pressure in the eye (eyes) (intraocular hypertension).

2. Important information before using Carteol LP 2%

When not to use Carteol LP 2%

• if the patient is allergic to carteolol hydrochloride or any of the other ingredients of Carteol LP 2% (listed in section 6),
• if the patient currently has or has had respiratory problems, such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing),
• if the patient has a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeat),
• if the patient has bradycardia (slower heart rate than normal, e.g., below 45-50 beats per minute),
• if the patient has an untreated pheochromocytoma (excessive production of a hormone that causes severe hypertension).

Warnings and precautions

Before starting to use Carteol LP 2%, the patient should discuss it with their doctor or pharmacist if they currently have or have had:

• coronary artery disease (symptoms may include chest pain or tightness, shortness of breath, wheezing), heart failure, low blood pressure,
• heart rhythm disorders, such as bradycardia (slow heart rate),
• breathing problems, asthma, or chronic obstructive pulmonary disease (a lung disease that can cause wheezing, difficulty breathing, and/or prolonged coughing),
• diseases related to impaired blood circulation (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, as carteolol may mask the symptoms of low blood sugar (hypoglycemia),
• hyperthyroidism, as carteolol may mask its symptoms,
• treated pheochromocytoma,
• psoriasis,
• corneal disease,
• allergic reactions in the medical history,
• kidney or liver disease.

Before anesthesia for surgery, the patient should inform their doctor about the use of Carteol LP 2%, as carteolol may affect the action of some anesthetics.
The patient should be monitored to check if resistance to the action of this medicine develops. For this purpose, during the use of this medicine, the patient should be examined by an ophthalmologist at the beginning of treatment and then approximately every 4 weeks. Additionally, in the case of long-term treatment, these examinations will allow confirmation of any treatment failure (i.e., loss of efficacy of the medicine).
In people using contact lenses, the inhibition of tear production possible with the use of medicinal products from this group may create a risk of intolerance to contact lenses.
The preservative benzalkonium chloride, which is a component of the medicine, may also be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before instilling the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or disorders related to the cornea (the transparent layer at the front of the eye). If abnormal sensations in the eye, stinging, or eye pain occur after using the medicine, the patient should contact their doctor.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.
The active substance contained in this medicine may give a positive result in doping tests.

Children and adolescents

Carteol LP 2% should not be used in premature infants, newborns, children, or adolescents.

Carteol LP 2% and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Carteol LP 2% may affect other medicines taken by the patient, and other medicines may affect Carteol LP 2%; this includes other eye drops used to treat glaucoma.

• In the case of using other eye medicines:
• use another eye medicine,
• wait 15 minutes,
• use Carteol LP 2% last.
• In the case of treating certain types of glaucoma (such as glaucoma with closed angle of filtration), the doctor may also recommend the use of pupil-constricting medicines.
• In the case of using eye drops containing adrenaline/epinephrine at the same time as Carteol LP 2%, constant monitoring by an ophthalmologist is necessary (due to the risk of pupil dilation).
• In the case of concurrent use of oral beta-adrenergic blocking agents, it is often necessary to adjust the dose of Carteol LP 2% by the doctor. Although the medicine is absorbed into the bloodstream in small amounts, interactions observed with oral beta-adrenergic blocking agents should be taken into account:
• The use of amiodarone (given to treat heart rhythm disorders), certain calcium channel blockers (used to treat hypertension, such as diltiazem, fingolimod, ozanimod, and verapamil), or other beta-adrenergic blocking agents (used to treat heart failure) is not recommended.
• All beta-adrenergic blocking agents may mask some symptoms of hypoglycemia: palpitations and tachycardia.
• There may be an increase in the concentration of lidocaine (given intravenously) in the blood, which increases the risk of cardiac and neurological side effects.

In the case of using more than one ophthalmic medicinal product for local administration, the administration of the medicine should be done at an interval of at least 15 minutes. Eye ointments should be administered last.
The patient should inform their doctor if they are taking or plan to take medicines that lower blood pressure, medicines used for heart diseases, or medicines used to treat diabetes or multiple sclerosis.
The patient should tell their doctor about all medicines they are currently taking or have recently taken, including those available without a prescription. If necessary, the doctor will be able to monitor the patient during treatment.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Pregnancy

Carteol LP 2% should not be used if the patient is pregnant, unless the doctor considers it necessary. There is insufficient data on the use of carteolol hydrochloride in pregnant women. Information on methods to reduce systemic absorption of the medicine can be found in section 3.

Breastfeeding

Carteol LP 2% should not be used if the patient is breastfeeding. Carteolol hydrochloride may pass into breast milk.
Beta-adrenergic blocking agents are excreted in breast milk. However, during the use of carteolol hydrochloride in the form of eye drops in therapeutic doses, it is unlikely to achieve concentrations in milk that could cause clinical symptoms of beta-adrenergic blockade in the infant. Information on methods to reduce systemic absorption of the medicine can be found in section 3.
During breastfeeding, the patient should consult their doctor before using any medicine.

Driving and using machines

After administering this medicine to the eye, blurred vision may occur.
The patient should not drive a car or operate machines until their vision returns to normal.

Carteol LP 2% contains benzalkonium chloride

Preservative: benzalkonium chloride, see section 2 "Warnings and precautions".
This medicine contains 0.00165 mg of benzalkonium chloride per drop, which corresponds to 0.05 mg/ml.

Carteol LP 2% contains phosphates

This medicine contains 0.046 mg of phosphates per drop, which corresponds to 1.4 mg/ml.

3. How to use Carteol LP 2%

The medicine is intended for use in the eye (eyes).
This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose

Carteol LP 2% contains a special ingredient with properties that allow the medicine to be used once a day.
The usual dose is 1 drop into the affected eye (eyes) once a day, in the morning.
Despite this, the doctor may decide to adjust the dose, especially if oral beta-adrenergic blocking agents are used at the same time (see section 2 "Carteol LP 2% and other medicines").

Method and route of administration

• In the case of using contact lenses, the patient should remove them before using Carteol LP 2% and wait 15 minutes before putting them back on.
• To properly administer Carteol LP 2%:
• Before administering the medicine, the patient should wash their hands thoroughly.
• The patient should not allow the tip of the dropper to come into contact with the eyeball or eyelids.
• Looking up, the patient should gently pull down the lower eyelid and instill one drop of the medicine into the eye.
• The patient should close their eye for a few seconds after administration.
• After using Carteol LP 2%, the patient should press the inner corner of their eye with their finger for 2 minutes. This helps to retain the absorption of the active substance (carteolol) into the body.
• Without opening their eye, the patient should wipe away any excess medicine from their eyelids.
• The container should be closed immediately after use.
• If the doctor prescribes another eye medicine:
• the patient should use the other eye medicine,
• wait 15 minutes,
• use Carteol LP 2% last.
• If Carteol LP 2% is prescribed as a replacement for another medicine, the patient should continue using the previous medicine until the end of the day. The use of Carteol LP 2% should be started from the next day, in accordance with the doctor's recommendations.
• If the action of Carteol LP 2% seems too weak or too strong, the patient should inform their doctor or pharmacist.

The patient should not inject or swallow the medicine.

Duration of treatment

The patient should follow their doctor's recommendations. The doctor will inform them how long they should use Carteol LP 2%. The patient should not stop treatment early.

Using more than the recommended dose of Carteol LP 2%

In the case of administering more drops than recommended into the eye (eyes), the patient should rinse them with clean water.
In the event of accidental ingestion of the contents of the container, side effects such as dizziness, difficulty breathing, or a feeling that the heart rate has decreased may occur. The patient should contact their doctor or pharmacist immediately.

Missing a dose of Carteol LP 2%

The patient should not use a double dose to make up for a missed dose.

Stopping the use of Carteol LP 2%

Stopping the use of the medicine may lead to an increase in intraocular pressure, which can lead to vision disorders.
The patient should not stop treatment without prior agreement with their doctor.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
It is usually possible to continue using the drops, unless the side effects are severe. In case of doubts, the patient should contact their doctor or pharmacist. The patient should not stop using Carteol LP 2% without consulting their doctor.
Like other eye medicines (locally used ophthalmic medicines), carteolol hydrochloride is absorbed into the blood. This may lead to the occurrence of similar side effects as those observed with systemic beta-adrenergic blocking agents. The frequency of side effects for eye drops is lower than for medicines given, for example, orally or by injection.
The listed side effects include reactions observed for the entire group of beta-adrenergic blocking agents used to treat eye diseases.

Common side effects (may occur in up to 1 in 10 people)

• objective and subjective symptoms of eye irritation (e.g., burning), eye pain (e.g., stinging), itching, tearing, redness of the eye, conjunctival hyperemia, conjunctivitis, irritation, or a feeling of a foreign body in the eye (keratitis),
• taste disorders.

Uncommon side effects (may occur in up to 1 in 100 people)

• dizziness,
• muscle weakness or muscle pain not caused by physical activity (myalgia), muscle cramps.

Rare side effects (may occur in up to 1 in 1,000 people)

• positive result of the test for antinuclear antibodies.

In very rare cases, in some patients with severe damage to the external, transparent layer of the eyeball (cornea), during treatment, cloudy spots caused by calcium deposition appeared on the cornea.
The frequency of the following side effects is unknown (cannot be estimated from the available data)

• allergic reactions, including sudden swelling of the face, lips, mouth, tongue, or throat, which may make swallowing or breathing difficult, hives, localized or generalized rash, itching, sudden, life-threatening allergic reaction.
• low blood sugar.
• difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• fainting, stroke, decreased blood flow to a part of the brain, worsening of objective and subjective symptoms of severe myasthenia (muscle disorders), a feeling of tingling and numbness in the hands and feet, a feeling of numbness, headache, memory loss.
• eyelid edema (blepharitis), blurred vision, visual disturbances after eye surgery (retinal detachment after filtration surgery), decreased corneal sensitivity, dry eye, damage to the external layer of the eyeball (corneal ulceration), ptosis of the upper or lower eyelid, double vision, refractive changes (in some cases due to withdrawal of pupil-constricting medicines).
• slow heart rate, palpitations, changes in heart rhythm and rate, heart disease with shortness of breath, swelling of the feet and legs due to fluid retention (congestive heart failure), heart disorders (atrioventricular block), heart attack, heart failure.
• low blood pressure, Raynaud's phenomenon, cold hands, cold feet, leg cramps and/or leg pain while walking (claudication).
• bronchospasm (wheezing, difficulty breathing - most often in patients with pre-existing bronchospastic disease), shortness of breath (dyspnea), cough.
• nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• hair loss, rash with white and silvery scales (psoriasiform rash) or exacerbation of psoriasis, rashes.
• systemic lupus erythematosus.
• sexual disorders, impotence.
• unjustified muscle weakness or muscle pain not caused by physical activity (asthenia) or fatigue, chest pain, fluid retention (edema).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
By reporting side effects, it is possible to gather more information on the safety of the use of the medicine.

5. How to store Carteol LP 2%

• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Translation of abbreviations on the immediate packaging:

Lote - batch number, Fecha fab. - production date, Cad. - expiry date.

• There are no special precautions for storage.
• Shelf life after first opening the bottle: 28 days.
• Do not use this medicine if the packaging is damaged.
• The medicine should be stored out of sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Carteol LP 2% contains

• The active substance of the medicine is carteolol hydrochloride. 1 ml of Carteol LP 2% eye drops with prolonged release contains 20 mg of carteolol hydrochloride.
• Excipients: benzalkonium chloride, solution, alginic acid (E 400), sodium dihydrogen phosphate dihydrate (E 339), disodium phosphate dodecahydrate (E 339), sodium chloride, sodium hydroxide, purified water.

What Carteol LP 2% looks like and what the pack contains

Carteol LP 2% is a clear, slightly brownish-yellow eye drop with prolonged release, available in a 3 ml bottle.
This medicine is a beta-blocker for use in the eye.
Packaging of the medicine:
Bottle with dropper made of PE with a PP cap, containing 3 ml of eye drops with prolonged release.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Laboratoire CHAUVIN S.A.
48/56 Boulevard Jean Mathon
Zone Industrielle Ripotier Haut
07200 Aubenas
France

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in Spain, the country of export: 650195.5
Parallel import authorization number: 246/18

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France:
Carteol L.P. 2%
Belgium, Luxembourg:
Arteoptic LA 2%
Portugal:
Physioglau 2%
Spain:
Arteoptic 2%
Poland, Czech Republic, Slovakia:
Carteol LP 2%
Italy:
FORTINOL 2 %
Romania:
Fortinol EP 2%
Date of leaflet approval: 21.04.2023
[Information about the trademark]