Carteol lp 2%

Patient Information Leaflet

Warning! Please keep the leaflet. The packaging information is in a foreign language.
Carteol LP 2% (Arteoptic 2%)
20 mg/ml, prolonged-release eye drops
Carteololi hydrochloridum
Carteol LP 2% and Arteoptic 2% are different trade names for the same medicine.
Please read this leaflet carefully before using the 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 person only. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents:

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

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

• one form of glaucoma (chronic open-angle glaucoma),
• elevated intraocular pressure (in one or both eyes).

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 that may cause wheezing, difficulty breathing, and/or prolonged cough),
• if the patient currently has bradycardia (slow heart rate), heart failure, or cardiac arrhythmias (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 pheochromocytoma (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 heart rate),
• breathing problems, asthma or chronic obstructive pulmonary disease (lung disease that may cause wheezing, difficulty breathing and/or prolonged cough),
• circulatory disorders (such as Raynaud's disease or Raynaud's syndrome),
• diabetes, because carteolol may mask the subjective and objective symptoms of low blood sugar (hypoglycaemia),
• hyperthyroidism, because carteolol may mask its subjective and objective symptoms,
• treated pheochromocytoma,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease.

Before undergoing surgical anaesthesia, inform the doctor about the use of Carteol LP 2%, as carteolol may alter the effects of certain drugs used during anaesthesia.
Resistance to the effect of this medicine should be monitored. 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 cases 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 the use of drugs in this class, may increase the risk of contact lens intolerance.
The preservative contained in the medicine (benzalkonium chloride) may 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 reinserting them.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging or pain in the eye occur after using the medicine, contact 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 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
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, 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 the treatment of glaucoma.

• 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 oral beta-adrenergic blocking agents are used concomitantly, dose adjustment of Carteol LP 2% by the doctor is often necessary. Although the medicine is absorbed into the systemic circulation in small amounts, interactions observed with oral beta-blockers should be considered:
  • Concomitant use of amiodarone (used to treat cardiac arrhythmias), 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-blockers may mask some symptoms of hypoglycaemia: palpitations and tachycardia.
  • Increased plasma lidocaine levels (when administered intravenously) may occur, increasing the risk of cardiac and neurological adverse effects.

When using more than one ophthalmic medicinal product for local administration, each medicine should be administered at least 15 minutes apart. Ophthalmic 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 conditions, or medicines used to treat diabetes or multiple sclerosis.
Tell the doctor about all medicines the patient is currently taking or has recently taken, including those available without a prescription. The doctor may need to monitor the patient during treatment.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Carteol LP 2% should not be used during pregnancy unless considered necessary by a doctor. 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
Carteol LP 2% should not be used during breastfeeding. Carteolol hydrochloride may pass into breast milk.
Beta-adrenergic blocking agents 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 clinical signs of 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 using machines
Blurred vision may occur after instilling this medicine into the eye.
Do not drive or operate machinery until normal vision is restored.

Carteol LP 2% contains benzalkonium chloride, solution
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%

The medicine is intended for ophthalmic use (in the eye(s)).
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Recommended dose
Carteol LP 2% contains a special component with properties enabling once-daily administration.
The usual dose is 1 drop into the affected eye(s) once daily, in the morning.
However, your doctor may decide to adjust the dose, especially if you are also taking oral beta-adrenergic blocking agents (see section 2 “Carteol LP 2% and other medicines”).
Method and route of administration

• If you wear contact lenses, remove them before using Carteol LP 2% and wait 15 minutes before reinserting them.
• To properly administer Carteol LP 2%:
  • Wash your hands thoroughly before applying the medicine.
  • Avoid contact between the dropper tip and the eye or eyelids.
  • Look upwards, gently pull down the lower eyelid and instill one drop of the medicine into the eye.
  • Close the eye for a few seconds after administration.
  • After applying Carteol LP 2%, press with your finger at 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 container immediately after use.
• If your doctor prescribes other eye drops, you should:
  • Apply the other ophthalmic medicine first.
  • Wait 15 minutes.
  • Then apply Carteol LP 2% last.
• If Carteol LP 2% has been prescribed as a replacement for another medicine, continue using the previous medicine until the end of the day. Begin using Carteol LP 2% the following day, as directed by your doctor.
• If the effect of Carteol LP 2% seems too weak or too strong, inform your doctor or pharmacist.

Do not inject or swallow the medicine.
Duration of treatment
Follow your doctor's instructions. Your doctor will inform you how long to use Carteol LP 2%. Do not stop treatment prematurely.
Overdose of Carteol LP 2%
If more than the recommended number of drops has been 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, breathing difficulties, or a sensation of reduced heart rate may occur. Seek immediate medical advice from your doctor or pharmacist.
Missed dose of Carteol LP 2%
Do not use a double dose to make up for a missed dose.
Stopping Carteol LP 2%
Discontinuing treatment may lead to increased intraocular pressure, which may result in visual disturbances.
Do not stop treatment without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You can usually continue using the eye drops unless the adverse reactions are severe. If in doubt,
consult your doctor or pharmacist. Do not stop using Carteol LP 2% without consulting your doctor.
As with other ophthalmic medicines applied locally, carteolol hydrochloride is absorbed into the
bloodstream. This may lead to adverse reactions similar to those observed with systemically acting
beta-blocking agents. The frequency of adverse reactions with ophthalmic drops is lower than with
medicines taken orally or by injection.
The adverse reactions listed below include those observed for the entire group of beta-blocking
agents used in the treatment of eye diseases.

Frequent adverse reactions (may occur in up to 1 in 10 people)

• Subjective and objective symptoms of eye irritation (e.g. burning, eye pain (e.g. stinging), itching, tearing, redness of the eye), conjunctival hyperaemia, conjunctivitis, eye irritation or sensation of a foreign body in the eye (keratitis),
• Taste disturbances.

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Dizziness,
• Muscle weakness or non-exercise-related muscle pain (myalgia), muscle cramps.

Rare adverse reactions (may occur in up to 1 in 1000 people)

• Positive test result for antinuclear antibodies.

In very rare cases, in some patients with severe damage to the outer transparent layer of the eyeball (cornea), hazy corneal spots due to calcium deposits have appeared during treatment.
Frequency of the following adverse reactions is unknown (cannot be estimated from available data)

• Allergic reactions, including sudden swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, urticaria, localised or generalised rash, itching, sudden life-threatening allergic reaction (anaphylaxis),
• 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 pricking sensations in hands and feet, numbness, headache, memory loss,
• Eyelid swelling (blepharitis), blurred vision, visual disturbances after eye surgery (retinal detachment after filtration surgery), reduced corneal sensitivity, dry eyes, damage to the outer layer of the eyeball (corneal erosion), drooping of 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 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, difficulty breathing – 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 exacerbation of psoriasis, rashes,
• Systemic lupus erythematosus,
• Sexual dysfunction, impotence,
• Unexplained muscle weakness or non-exercise-related muscle pain (asthenia) or fatigue, chest pain, fluid retention (oedema).

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Carteol LP 2%

Keep this medicine out of 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.
Translation of abbreviations appearing on the immediate packaging:
Batch number – Lote
Expiry date – Cad.
Date of manufacture – Fecha fab.
No special storage conditions are required for this medicine.
Period of validity after first opening of the bottle: 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. These measures 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.
• The other ingredients are: benzalkonium chloride solution, alginic acid (E 400), disodium dihydrogen phosphate dihydrate (E 339), disodium phosphate dodecahydrate (E 339), sodium chloride, sodium hydroxide, 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.
Pack sizes:
1 bottle with dropper and cap containing 3 ml of prolonged-release eye drops, packed in a cardboard box.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Spain, 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Spanish Marketing Authorisation number (country of export): 650195.5
Parallel Import Licence number: 73/19
This medicinal product is authorised for marketing in the European Economic Area under the following trade 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%