Carteol Lp 2% Preservative Free

Leaflet attached to the packaging: information for the user

Carteol LP 2% Preservative Free

20 mg/ml, eye drops with prolonged release, solution

Carteolol hydrochloride

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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% Preservative Free and what is it used for
• 2. Important information before using Carteol LP 2% Preservative Free
• 3. How to use Carteol LP 2% Preservative Free
• 4. Possible side effects
• 5. How to store Carteol LP 2% Preservative Free
• 6. Contents of the packaging and other information

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

Carteol LP 2% Preservative Free belongs to a group of beta-adrenergic blocking agents.
Carteol LP 2% Preservative Free, 20 mg/ml, eye drops, solution is indicated for use in adult patients for the symptomatic treatment of the following diseases:

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

Carteol LP 2% Preservative Free does not contain preservatives.

2. Important information before using Carteol LP 2% Preservative Free

When not to use Carteol LP 2% Preservative Free

• if the patient is allergic to carteolol hydrochloride or any of the other ingredients of this medicine (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), as Carteol LP 2% Preservative Free may worsen bronchospasm and exacerbate symptoms of these diseases,
• if the patient has a slow heart rate, heart failure, or rhythm disorders (irregular heartbeat, sick sinus syndrome, including sinoatrial block), as Carteol LP 2% Preservative Free may slow the heart rate and worsen the patient's condition,
• if the patient has an atrioventricular block of second or third degree not controlled by a pacemaker, as Carteol LP 2% Preservative Free may increase the risk of atrioventricular block,
• if the patient has bradycardia or sinus bradycardia (slower heart rate than normal, e.g. below 45-50 beats per minute), as Carteol LP 2% Preservative Free may decrease the heart rate and thereby worsen these symptoms,

Free may decrease the heart rate and thereby worsen these symptoms,

• if the patient has an untreated pheochromocytoma (excessive production of a hormone, causing severe hypertension), as carteolol may increase blood pressure and worsen the patient's condition.

Warnings and precautions

Before starting treatment with Carteol LP 2% Preservative Free, the patient should discuss with their doctor or pharmacist if they currently have or have had:

• heart disease
• breathing problems, asthma, or chronic obstructive pulmonary disease (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 reduced blood sugar levels (hypoglycemia),
• hyperthyroidism, as carteolol may mask its symptoms,
• treated pheochromocytoma, as carteolol may increase blood pressure,
• 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% Preservative Free, as carteolol may affect the action of some anesthetics.
The effectiveness of the treatment should be monitored. For this purpose, during the use of this medicine, the patient should be examined by an ophthalmologist at the beginning of treatment and then after about 4 weeks.
Additionally, in the case of long-term treatment, annual examinations are necessary to confirm the effectiveness of the treatment and the absence of treatment failure symptoms.
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.
This medicine contains 19.2 µg of phosphates in each drop, which corresponds to 0.509 mg/ml.
In patients with severe damage to the clear, front part of the eye (cornea), phosphates may rarely cause corneal clouding due to calcium deposition during treatment.

Children and adolescents

These eye drops should not be used in children or adolescents. There is no data on the safety and efficacy of using eye drops containing carteolol in children and adolescents.

Carteol LP 2% Preservative Free 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% Preservative Free may affect other medicines taken by the patient, and other medicines may affect Carteol LP 2% Preservative Free; 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% Preservative Free as the last one.
• 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% Preservative Free, 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 (medicines that lower blood pressure, causing slower and weaker heartbeats), it is often necessary to adjust the dose of Carteol LP 2% Preservative Free by the doctor.

• Although the beta-adrenergic blocking agent administered to the eye is absorbed into the bloodstream in a small amount, interactions observed with oral beta-adrenergic blocking agents should be considered:
• The use of amiodarone (administered to treat rhythm disorders), certain calcium channel blockers (used to treat hypertension, such as diltiazem and verapamil), fingolimod (used to treat multiple sclerosis), or other beta-adrenergic blocking agents (used to treat heart failure) is not recommended. If the use of these medicines is necessary, the doctor will closely monitor the course of therapy.
• The patient should tell their doctor if they are taking or plan to take medicines that lower blood pressure, heart medicines, medicines used to treat diabetes, cholinergic medicines used to treat Alzheimer's disease, medicines used to treat urinary disorders, multiple sclerosis, depression, psychotic disorders, cancer (e.g. during the use of amifostine), or medicines used to treat or prevent malaria (e.g. during the use of mefloquine), muscle spasms (e.g. during the use of baclofen), or joint diseases, such as osteoarthritis (e.g. during the use of non-steroidal anti-inflammatory drugs, such as ibuprofen or celecoxib). If necessary, the doctor will monitor the course of therapy.

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% Preservative Free should not be used if the patient is pregnant, unless the doctor considers it necessary.
Information on methods to reduce systemic absorption of the medicine can be found in section 3.

Breastfeeding

Due to the low concentration and the way the medicine is administered, it is unlikely that the use of Carteol LP 2% Preservative Free will cause carteolol to pass into breast milk to a level that could harm the baby.
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.

3. How to use Carteol LP 2% Preservative Free

The medicine is intended for use in the eye (eyes).
This medicine should always be used as directed by the doctor. If in doubt, the patient should consult their doctor or pharmacist.

Recommended dose

The usual dose is one drop into the affected eye (eyes) once a day, in the morning.
However, the doctor may decide to adjust the dose (e.g. 1 drop every other day), especially if the patient is also taking oral beta-adrenergic blocking agents (see section 2 "Carteol LP 2% Preservative Free 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% Preservative Free and wait 15 minutes before putting them back on.
• When using these eye drops, the patient should wash their hands thoroughly before opening the bottle and perform the following steps:

A. Before the first administration of the medicine to the eye

• 1. Remove the protective ring.

• 2. Remove the protective cap.

• 3. Hold the bottle upside down. Squeeze the middle of the bottle hard enough to release 1-2 drops.

If a drop does not come out, repeat steps A2 and A3.

B. Instillation of the eye drop solution

• 1. Looking up, gently pull down the lower eyelid, place the bottle over the eye, and slowly squeeze the middle of the bottle until a drop appears. Do not let the tip of the dropper come into contact with the eyeball or eyelids.
• 2. The patient should blink to help spread the drop over the surface of the eye. Without opening the eye, wipe away any excess medicine from the eyelids.
• 3. After each use of the medicine, the patient should press the corner of the closed eye near the nose with their finger for 2 minutes. This helps reduce the absorption of the medicine into the body.

C. After each instillation

To remove any remaining drops:

• 1. Hold the middle of the bottle with the dispenser pointing upwards.

• 2. Turn the bottle quickly downwards, hard enough to remove any remaining drops.
• 3. Put the protective cap back on.
• In the case of using other eye drops, the patient should wait 15 minutes before instilling them.
• If Carteol LP 2% Preservative Free 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% Preservative Free should be started from the next day, as directed by the doctor. Carteol LP 2% Preservative Free may be used as a supplement to the current treatment
• If the action of Carteol LP 2% Preservative Free seems too weak or too strong, the patient should inform their doctor or pharmacist.

Duration of treatment

The patient should follow the doctor's instructions. The doctor will inform them how long they should use Carteol LP 2% Preservative Free.

Using more than the recommended dose of Carteol LP 2% Preservative Free

In the case of administering more drops than recommended to the eye (eyes), the patient should rinse them with a sterile sodium chloride solution 9 mg/ml (0.9%). If the patient does not have access to a sterile sodium chloride solution, they can use clean water.
In the event of accidental ingestion of the contents of the container, the patient should immediately contact their doctor or pharmacist.

Missing a dose of Carteol LP 2% Preservative Free

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

Stopping the use of Carteol LP 2% Preservative Free

Stopping the treatment may lead to an increase in intraocular pressure, which can lead to vision disorders.
The patient should never stop using Carteol LP 2% Preservative Free without first consulting their doctor or pharmacist.
If the patient has any further doubts about the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, the patient can continue using the drops, unless the side effects are severe. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not stop using Carteol LP 2% Preservative Free without consulting their doctor.
Common side effects (may affect 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 feeling of a foreign body in the eye (keratitis)
• taste disturbances

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

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

In very rare cases, in some patients with severe damage to the outer, clear layer of the eye (cornea), during treatment, cloudy spots appeared on the cornea due to calcium deposition.
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 levels.
• difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• fainting, stroke, decreased blood flow to part of the brain, worsening of objective and subjective symptoms of myasthenia (muscle disorders), feeling of tingling and numbness in the hands and feet, feeling of numbness, chest pain, fluid retention (edema).
• swelling of the eyelids (blepharitis), blurred vision, visual disturbances after eye surgery (retinal detachment after filtration surgery), decreased corneal sensitivity, dry eye, damage to the outer layer of the eye (corneal ulceration), drooping of the upper or lower eyelid, double vision, refractive changes.
• 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, shortness of breath (dyspnea), cough.
• nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• hair loss, psoriasis-like rash (rash with white and silvery scales) or worsening of psoriasis, 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 the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels).
• sexual disorders, impotence.
• asthenia (unjustified muscle weakness) or myalgia (muscle pain not caused by physical activity) 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,
Phone: +48 22 49 21 301,
Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Carteol LP 2% Preservative Free

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the bottle after EXP. The expiry date refers to the last day of the month.
There are no special recommendations for the storage temperature of the medicine.
The medicine should be stored in the outer carton to protect it from light.
The shelf life after opening the container is 2 months. The patient should note the date of opening on the packaging.
The medicine should not be used if the packaging is damaged.
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 packaging and other information

What Carteol LP 2% Preservative Free contains

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

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

This medicine is a beta-adrenergic blocking agent for use in the eye.
Carteol LP 2% Preservative Free is a clear, slightly brownish-yellow eye drop solution with prolonged release, available in a 8 ml bottle. The whole is packaged in a cardboard box.

Marketing authorization holder:

Bausch+Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
[email protected]
Manufacturer:
Laboratoire Chauvin
Zone Industrielle de Ripotier
50 Avenue Jean Monnet
07200 Aubenas
France

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

Netherlands Arteoptic zonder conserveermiddel 20 mg/ml, oogdruppels, oplossing met verlengde afgifte
Belgium
Arteoptic LA Sine Conservans 20 mg/ml Oogdruppels, oplossing met verlengde afgifte/ Collyre en solution à libération prolongée/ Augentropfen mit verlängerter Wirkungsdauer
Luxembourg Arteoptic LA Sine Conservans 20 mg/ml Oogdruppels, oplossing met verlengde afgifte/ Collyre en solution à libération prolongée/ Augentropfen mit verlängerter Wirkungsdauer
France:
Carteol L.P. 2% sans conservateur, collyre en solution à libération prolongée
Italy:
Fortisoc, 20 mg/ml, collirio, soluzione a rilascio prolungato
Spain:
Arteoptic PF 2% Colirio de liberación prolongada
Portugal:
Physioglau PF 2%
Croatia
Cartelomb 20 mg/ml, kapi za oko otopina s produljenim oslobađanjem
Slovenia
Cartelomb 20 mg/ml kapljice za oko, raztopina s podaljšanim sproščanjem
Poland
Carteol LP 2% Preservative Free

Date of the last update of the leaflet: