Carteol Lp 2%

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Carteol LP 2%

20 mg/ml, eye drops with prolonged release
Carteolol hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should 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 packaging 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 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),
• 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%, you should discuss it with your doctor or pharmacist if you currently have or have had:

• coronary heart 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 (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, you should inform your doctor about using Carteol LP 2%, as carteolol may affect the action of some anesthetics.
You should be monitored to see if resistance to the action of this medicine develops. To do this, 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 you to confirm any failure of treatment (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 contained in the medicine (benzalkonium chloride) can also be absorbed by soft contact lenses and change their color. You should remove contact lenses before instilling the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride can also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain in the eye after using the medicine, you should contact your doctor.
In patients with severe damage to the transparent, anterior part of the eye (cornea), phosphates may rarely cause corneal clouding during treatment due to calcium deposition.
The active substance contained in this medicine may give a positive result in doping tests.

Children and adolescents

These eye drops should not be used in premature infants, newborns, children, or adolescents.

Carteol LP 2% and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Carteol LP 2% may affect other medicines you are taking, 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% 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 using medicines that constrict the pupil.
• 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 the use of oral beta-adrenergic blocking agents should be taken into account:
• The use of amiodarone (given to treat heart rhythm disorders), some 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 can 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 intervals of at least 15 minutes. Eye ointments should be administered last.
You should inform your doctor if you are taking or plan to take medicines that lower blood pressure, medicines used to treat heart diseases, or medicines used to treat diabetes or multiple sclerosis.
You should tell your doctor about all medicines you are currently taking or have recently taken, including those available without a prescription. If necessary, your doctor will be able to monitor you during treatment.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Pregnancy

You should not use Carteol LP 2% if you are pregnant, unless your doctor considers it necessary. There is not enough 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

You should not use Carteol LP 2% if you are 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, you should consult your doctor before using any medicine.

Driving and using machines

After administering this medicine to the eye, blurred vision may occur.
You should not drive a car or operate machines until your 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 in each drop, which corresponds to 0.05 mg/ml.

Carteol LP 2% contains phosphates

This medicine contains 0.046 mg of phosphates in each 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 as directed by your doctor. In case of doubts, you should consult your 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, your 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").

Use in children and adolescents

You should not use the medicine in children and adolescents.

Method and route of administration

• In the case of using contact lenses, you 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, you should wash your hands thoroughly.
• Do not allow the tip of the dropper to come into contact with the eyeball or eyelids.
• Looking up, gently pull down the lower eyelid and instill one drop of the medicine into the eye.
• Close your eye for a few seconds after administration.
• After using Carteol LP 2%, press the corner of your eye near your nose with your finger for 2 minutes. This helps to retain the active substance (carteolol) in the eye.
• Without opening your eye, wipe away any excess medicine from your eyelids.
• The bottle should be closed immediately after use.
• If your doctor prescribes other eye drops, you should:
• use another eye medicine
• wait 15 minutes
• use Carteol LP 2% as the last one.
• If Carteol LP 2% is prescribed as a replacement for another medicine, you 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, according to your doctor's instructions.
• If the effect of Carteol LP 2% seems too weak or too strong, you should inform your doctor or pharmacist.

You should not inject or swallow the medicine.

Duration of treatment

You should follow your doctor's instructions. Your doctor will inform you how long you should use Carteol LP 2%. You 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), you 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. You should contact your doctor or pharmacist immediately.

Missing a dose of Carteol LP 2%

You 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.
You should not stop treatment without prior agreement with your doctor.
In case of any further doubts related to the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Usually, you can continue using the drops, unless the side effects are severe. In case of doubts, you should consult your doctor or pharmacist. You should not stop using Carteol LP 2% without consulting your doctor.
Like other eye medicines (locally used ophthalmic medicines), carteolol hydrochloride is absorbed into the bloodstream. This can lead to the occurrence of similar side effects as those observed with the use of 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 1000 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 appeared on the cornea due to calcium deposition.
The frequency of the following side effects is unknown(cannot be determined based on 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), feeling of tingling and numbness in the hands and feet, 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 outer layer of the eyeball (corneal ulceration), drooping of the upper or lower eyelid, double vision, refractive changes (in some cases due to withdrawal of pupil-constricting medicine);
• 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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 181C, 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, you can help gather more information on the safety of the medicine.

5. How to store Carteol LP 2%

The medicine should be stored out of sight and reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special precautions for storage.
The shelf life after opening the bottle: 28 days. You should note the date of opening on the packaging.
You should not use this medicine if the packaging is damaged.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 does Carteol LP 2% contain?

• 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.
• The other ingredients are: benzalkonium chloride (preservative), 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 does Carteol LP 2% look like and what does the packaging contain?

This medicine is a beta-blocker for use in the eye.
Carteol LP 2% is a clear, slightly brown-yellow eye drop with prolonged release, available in a 3 ml bottle.
Packaging of the medicine:

• 1 polyethylene bottle with a dropper and a polypropylene cap, containing 3 ml of eye drops with prolonged release, placed in a cardboard box.

For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

BAUSCH + LOMB IRELAND LIMITED, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer:

Laboratoire CHAUVIN, Zone Industrielle de Ripotier, 50 Avenue Jean Monnet, 07200 Aubenas, France

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Authorization number in Spain, the country of export:650195.5
Parallel import authorization number:420/14

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: 28.10.2024

[Information about the trademark]