Carteol lp 2%

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Carteol LP 2%
20 mg/ml, prolonged-release eye drops
Carteololi hydrochloridum
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

1. What Carteol LP 2% is and what it is used for
2. What you need to know 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 Carteol LP 2% is and what it is used for

Carteol LP 2% belongs to a group of medicines known as beta-adrenolytics.
Carteol LP 2% is used locally in the eye for the treatment of the following conditions:

• One form of glaucoma (chronic open-angle glaucoma),
• Increased intraocular pressure (pressure in the eye).

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 previously had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease which may cause wheezing, difficulty breathing and/or long-term cough),
• if the patient has a slow heartbeat, heart failure or cardiac arrhythmia (irregular heartbeat),
• if the patient has bradycardia (slower heart rate than normal, e.g. below 45–50 beats per minute),
• if the patient has untreated phaeochromocytoma (excessive hormone production causing severe hypertension).

Warnings and precautions
Before starting treatment with Carteol LP 2%, consult a doctor or pharmacist if the patient currently has or has previously had:

• coronary heart disease (symptoms may include chest pain or tightness, shortness of breath, coughing), heart failure, low blood pressure,
• cardiac arrhythmias such as bradycardia (slow heartbeat),
• breathing problems, asthma or chronic obstructive pulmonary disease (lung disease which may cause wheezing, difficulty breathing and/or long-term cough),
• diseases associated with impaired blood circulation (such as Raynaud’s disease or Raynaud’s syndrome),
• diabetes, because carteolol may mask objective and subjective symptoms of low blood sugar (hypoglycaemia),
• hyperthyroidism, because carteolol may mask its objective and subjective symptoms,
• treated phaeochromocytoma,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease.

Before undergoing anaesthesia for surgery, inform the doctor about using Carteol LP 2%, as carteolol may alter the effects of certain drugs used during anaesthesia.
It is necessary to monitor for the development of resistance to the effect of this medicine. For this purpose, during treatment, the patient should be examined by an ophthalmologist at the beginning of therapy and then approximately every 4 weeks. Additionally, in case of long-term treatment, these examinations will help confirm possible treatment failure (i.e. loss of drug efficacy).
In patients wearing contact lenses, reduced tear production, which may occur with use of medicines in this class, may increase the risk of contact lens intolerance.
The preservative contained in this medicine (benzalkonium chloride) may also be absorbed by soft contact lenses and may alter their colour. Contact lenses should be removed before instillation and at least 15 minutes should be waited before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (transparent layer at the front of the eye). If abnormal sensations, stinging or eye pain occur after using the medicine, consult a doctor.
In patients with severe damage to the transparent, front part of the eye (cornea), phosphates may very rarely cause corneal calcification and clouding during treatment.
The active substance contained in this medicine may give a positive result in anti-doping tests.

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

Carteol LP 2% and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
Carteol LP 2% may affect other medicines the patient is taking, and other medicines may affect Carteol LP 2%; this includes other eye drops used in glaucoma treatment.

• When using other ophthalmic medicines:
• Apply the other ophthalmic medicine first,
• Wait 15 minutes,
• Then apply Carteol LP 2% last.
• In the treatment of certain types of glaucoma (such as closed-angle glaucoma), the doctor may also recommend using pupil-constricting medicines.
• When using eye drops containing adrenaline/epinephrine simultaneously with Carteol LP 2%, continuous monitoring by an ophthalmologist is required (due to the risk of pupil dilation).
• When using oral beta-adrenergic blocking agents concurrently, dose adjustment of Carteol LP 2% by the doctor is often necessary. Although the medicine is absorbed into the bloodstream in small amounts, interactions observed with oral beta-blockers should be considered:
• Concomitant use of amiodarone (used in treatment of cardiac arrhythmias), certain calcium channel blockers (used in treatment of hypertension, such as diltiazem, fingolimod, ozanimod and verapamil), or other beta-adrenergic blocking agents (used in treatment of heart failure) is not recommended.
• All beta-blockers may mask some symptoms of hypoglycaemia: palpitations and tachycardia.
• Increased lidocaine (administered intravenously) blood levels may occur, increasing the risk of cardiac and neurological adverse effects.

When using more than one ophthalmic medicinal product for local application, each medicine should be administered at least 15 minutes apart. Ocular ointments should be applied last.
Inform the doctor if the patient is taking or plans to take medicines that lower blood pressure, medicines used for heart diseases, or medicines used in diabetes or multiple sclerosis treatment.
Inform the doctor about all medicines currently used or recently used, 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use Carteol LP 2% if the patient is pregnant unless the doctor considers it necessary. There is insufficient data on the use of carteolol hydrochloride in pregnant women. For information on methods to reduce systemic absorption of the medicine, see section 3.

Breastfeeding
Do not use Carteol LP 2% if the patient is breastfeeding. Carteolol hydrochloride may pass into breast milk.
Beta-blockers are excreted in breast milk. However, when carteolol hydrochloride is used as eye drops at therapeutic doses, it is unlikely that concentrations in breast milk would be sufficient to cause clinically significant beta-adrenergic blockade in the infant. For information on methods to reduce systemic absorption of the medicine, see section 3.
During breastfeeding, consult a doctor before using any medicine.

Driving and operating machinery
After instillation of this medicine into the eye, blurred vision may occur.
Do not drive or operate machinery until normal vision is restored.

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, equivalent to 0.05 mg/ml.

Carteol LP 2% contains phosphate buffers
This medicine contains 0.046 mg of phosphates per drop, equivalent to 1.4 mg/ml.

3. How to use Carteol LP 2%
This medicine is intended for ophthalmic use (in the eye[s]).
Always use this medicine exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.

Recommended dose
Carteol LP 2% contains a special component enabling once-daily administration.
The usual dose is 1 drop into the affected eye(s) once daily, in the morning.
Nevertheless, the doctor may decide to adjust the dose, especially if oral beta-adrenergic blocking agents are used concurrently (see section 2 "Carteol LP 2% and other medicines").

Use in children and adolescents
Do not use this medicine in children and adolescents.

Method and route of administration

• If wearing contact lenses, remove them before using Carteol LP 2% and wait at least 15 minutes before reinserting.
• To properly administer Carteol LP 2%:
• Wash hands thoroughly before application.
• Avoid touching the dropper tip to the eyeball or eyelids.
• Look upwards, gently pull down the lower eyelid and instil one drop into the eye.
• Close the eye for a few seconds after instillation.
• After applying Carteol LP 2%, press with a finger on the inner corner of the eye near the nose for 2 minutes. This helps prevent systemic absorption of the active substance (carteolol).
• Without opening the eye, wipe away any excess medicine from the eyelids.
• Close the bottle immediately after use.
• If the doctor prescribes other eye drops:
• Apply the other ophthalmic medicine first,
• Wait 15 minutes,
• Then apply Carteol LP 2% last.
• If Carteol LP 2% is prescribed as a replacement for another medicine, continue using the previous medicine until the end of the day. Start using Carteol LP 2% the next day as directed by the doctor.
• If the effect of Carteol LP 2% seems too weak or too strong, inform the treating doctor or pharmacist.

Do not inject or swallow the medicine.

Duration of treatment
Follow the doctor’s instructions. The doctor will inform how long to use Carteol LP 2%. Do not stop treatment prematurely.

Use of a higher than recommended dose of Carteol LP 2%
If more drops than recommended are instilled into the eye(s), rinse the eye(s) with clean water.
If the contents of the container are accidentally swallowed, adverse effects such as a feeling of emptiness in the head, difficulty breathing or a sensation of reduced heart rate may occur. Seek immediate medical advice from a doctor or pharmacist.

Missed dose of Carteol LP 2%
Do not use a double dose to make up for a missed dose.

Stopping treatment with Carteol LP 2%
Discontinuing treatment may lead to increased intraocular pressure, which may result in vision disturbances.
Do not stop treatment without first consulting the doctor.

If there are any further questions regarding the use of this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You can usually continue using the eye drops unless the side effects are severe. If in doubt,
consult your doctor or pharmacist. Do not stop using Carteol LP 2% without consulting your doctor.

As with other eye medicines (ophthalmic medicines applied locally), carteolol hydrochloride is
absorbed into the bloodstream. This may lead to side effects similar to those observed with systemically
acting beta-blocking medicines. The frequency of side effects with eye drop formulations is lower than
with medicines taken orally or by injection.
The side effects listed below are those observed with the entire group of beta-blocking medicines used
in the treatment of eye diseases.

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

• Subjective and objective symptoms of eye irritation (e.g. burning), eye pain (e.g. stinging), itching, tearing, eye redness, conjunctival hyperaemia, conjunctivitis, eye irritation or sensation 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.

Rare side effects (may affect up to 1 in 1000 people)

• Positive test result for antinuclear antibodies.

In very rare cases, in some patients with serious damage to the outer transparent layer of the eyeball (cornea), cloudy corneal spots due to calcium deposits have appeared during treatment.

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, urticaria, localised or generalised rash, itching, sudden life-threatening allergic reaction;
• Low blood glucose levels;
• Difficulty sleeping (insomnia), depression, nightmares, decreased libido;
• Fainting, stroke, reduced blood flow to parts of the brain, worsening of subjective and objective symptoms of severe myasthenia (muscle disorders), tingling and prickling sensations in hands and feet, numbness, headache, memory loss;
• Eyelid swelling (blepharitis), blurred vision, visual disturbances after eye surgery (retinal detachment following filtration surgery), reduced corneal sensitivity, dry eyes, damage to the outer layer of the eyeball (corneal erosion), drooping of the upper or lower eyelid, double vision, refractive changes (in some cases due to discontinuation of miotic medication);
• 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 during walking (claudication);
• Bronchospasm (wheezing, breathing difficulties – most commonly in patients with pre-existing bronchospastic disease), shortness of breath (dyspnoea), cough;
• Nausea, dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting;
• Hair loss, rash with white and silvery lesions (psoriasiform rash) or worsening of psoriasis, rashes;
• Systemic lupus erythematosus;
• Sexual dysfunction, impotence;
• Unexplained muscle weakness or muscle pain not caused by physical activity (asthenia) or fatigue, chest pain, fluid retention (oedema).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Carteol LP 2%

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
The shelf-life after first opening the bottle is 28 days. The date of opening should be recorded on the container.
Do not use this medicine if the packaging is damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Carteol LP 2% contains

• The active substance is carteolol hydrochloride. 1 ml of prolonged-release Carteol LP 2% eye drops contains 20 mg of carteolol hydrochloride.
• Other components are: benzalkonium chloride, solution (preservative), alginic acid (E 400), disodium phosphate dodecahydrate (E 339), sodium dihydrogen phosphate dihydrate (E 339), sodium chloride, sodium hydroxide (for pH adjustment), purified water.

What Carteol LP 2% looks like and contents of the pack
This medicine is a beta-blocker for ophthalmic use.
Carteol LP 2% is a prolonged-release eye drop solution, clear, with a slightly brownish-yellow tint, available in a 3 ml bottle.
Packaging of the medicine:

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

For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing authorisation number in Spain, the country of export: 650195.5
Parallel import authorisation number: 420/14
This medicinal product is authorised for marketing in the European Economic Area member states 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%