Arteoptic 20 mg/ml unit dose prolonged release eye drops in unit dose container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ARTEOPTIC 20 mg/ml single-dose prolonged-release eye drops in single-dose container

Hydrochloride carteolol

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What ARTEOPTIC in single-dose container is and what it is used for
2. What you need to know before using ARTEOPTIC in single-dose container
3. How to use ARTEOPTIC in single-dose container
4. Possible side effects
5. How to store ARTEOPTIC in single-dose container
6. Contents of the pack and other information

1. What ARTEOPTIC in single-dose container is and what it is used for

ARTEOPTIC belongs to a class of medicines called beta-blockers.

It is used for the local treatment of the following eye conditions:

• A certain form of glaucoma (chronic open-angle glaucoma).
• Increased pressure in the eye (intraocular hypertension).

2. What you need to know before using ARTEOPTIC in single-dose containers

Do not use ARTEOPTIC in single-dose containers

• If you are allergic to carteolol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have or have previously had respiratory diseases such as asthma, severe chronic obstructive bronchitis (a serious lung condition that may cause wheezing, difficulty breathing, and/or long-term cough).
• If you have slow heartbeat, heart failure, or cardiac arrhythmias (irregular heartbeat).
• If you have bradycardia (pulse less than 45–50 beats per minute).
• If you have untreated pheochromocytoma (excessive hormone production causing severe high blood pressure).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use ARTEOPTIC. If you have or have previously had:

• Coronary heart disease (symptoms may include chest pain, weakness, fatigue, or shortness of breath), heart failure, low blood pressure,
• cardiac rhythm disturbances such as bradycardia (slow heartbeat),
• respiratory problems, asthma, or chronic obstructive pulmonary disease (a lung condition that may cause wheezing, difficulty breathing, and/or long-term cough),
• peripheral circulation disorders (Raynaud's disease or Raynaud's syndrome),
• diabetes, as carteolol may mask the signs and symptoms of low blood sugar (hypoglycemia),
• the drug may mask signs and symptoms of hyperthyroidism,
• treated pheochromocytoma,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease.

Inform your doctor that you are taking ARTEOPTIC before undergoing anesthesia, as carteolol may alter the effects of certain medications used during anesthesia.

To monitor whether you are developing resistance to the therapeutic effect of this product, you should have periodic ophthalmological examinations at the beginning of treatment and approximately every 4 weeks thereafter. Additionally, in cases of long-term treatment, these examinations should monitor for treatment failure (loss of drug efficacy).

If you wear contact lenses: reduced tear production possibly associated with this class of medications may increase the risk of intolerance in contact lens wearers.

If you have severe corneal damage (the transparent front layer of the eye), treatment with phosphates may, in very rare cases, lead to blurred vision due to calcium accumulation.

The active substance in this medicine may produce a positive result in anti-doping control tests.

Children and adolescents

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

Using ARTEOPTIC in single-dose containers with other medicines

ARTEOPTIC may interact with or be affected by other medicines, including other eye drops used for glaucoma treatment.

• If you are using other eye medications, you should:
  • apply the other ophthalmic medication first,
  • wait 15 minutes,
  • then apply ARTEOPTIC last.
• Your doctor may also prescribe a miotic eye drop for the treatment of certain types of glaucoma (such as angle-closure glaucoma).
• Ophthalmological monitoring is required if you are using adrenaline/epinephrine eye drops simultaneously with ARTEOPTIC (due to the risk of pupil dilation).
• If you are taking oral beta-blockers at the same time, the dose of ARTEOPTIC often needs to be adjusted.

Although the amount of beta-blocker absorbed into the bloodstream after eye application is low, you should be aware of interactions observed with oral beta-blockers:

• The 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-blockers (used to treat heart failure) is not recommended.
• All beta-blockers may mask certain symptoms of hypoglycemia: palpitations and tachycardia.
• May increase blood levels of lidocaine (administered intravenously), thereby increasing the risk of cardiac and neurological adverse effects.

When using more than one topical ophthalmic medication, doses should be spaced at least 15 minutes apart. Ocular ointments should be administered last.

Inform your doctor if you are using or planning to use medications to lower blood pressure, heart medications, diabetes medications, or medications for multiple sclerosis.

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription. They will provide specific monitoring if necessary.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use ARTEOPTIC during pregnancy unless your doctor considers it necessary.

There are no adequate data on the use of Carteolol Hydrochloride in pregnant women.

To reduce systemic absorption, see section 3.

Breastfeeding

Do not use ARTEOPTIC while breastfeeding. Carteolol hydrochloride may pass into breast milk.

Beta-blockers are excreted in breast milk. However, at therapeutic doses of Carteolol Hydrochloride eye drops, it is unlikely that sufficient amounts will be present in breast milk to cause clinical symptoms of beta-blockade in infants. To reduce systemic absorption, see section 3.

Ask your doctor before taking any medicine during breastfeeding.

Driving and using machines

Blurred vision may occur after applying this product to the eyes.

Do not drive or operate machinery until your vision has returned to normal.

ARTEOPTIC in single-dose containers contains phosphate buffer

This medicine contains 0.049 mg of phosphates per drop, equivalent to 1.4 mg/ml.

3. How to use ARTEOPTIC in single-dose containers

This medicine is intended for ophthalmic (eye) use only.

Always follow exactly the instructions given by your doctor. If you are unsure, ask your doctor or pharmacist.

ARTEOPTIC contains a specific excipient with physical properties that allow for once-daily administration.

The recommended dose is one drop into the affected eye or eyes once daily in the morning.

However, your doctor may decide to adjust the dose, especially if you are also taking oral beta-blockers (see section 2 “Using other medicines”).

Instructions for use

• If you wear contact lenses, remove them before applying ARTEOPTIC and wait 15 minutes before reinserting them.
• For correct administration of ARTEOPTIC:
  • Wash your hands thoroughly before applying the drops.
  • Before each new use, detach a single-dose container from the strip.
  • Twist the end of the vial to open the single-dose container. Hold the single-dose container upside down and gently tap the body of the vial to move the solution toward the opening.
  • Avoid touching the eye or eyelid with the edge of the container.
  • For administration, gently pull down the lower eyelid and instill one drop while looking upward.
  • After administration, keep the eye closed for a few seconds.
  • With the eye closed, gently wipe away any excess.
  • After administering ARTEOPTIC, press your finger against the inner corner of the eye near the nose for 2 minutes. This helps prevent the active substance (carteolol) from passing into the rest of the body.
  • With eyes closed, wipe away any excess medication.
  • Immediately discard the single-dose container after use.
  • Do not use the contents of single-dose containers that have been previously opened or partially used.
  • The volume of drops in one container is sufficient for treatment of both eyes.

Separate Twist cap to open

Invert container completely Instill into eye

Dispose after use

• If you are using another eye medication:
  • Apply the other eye medicine first.
  • Wait 15 minutes.
  • Then apply ARTEOPTIC.
• If your doctor has prescribed ARTEOPTIC as a replacement for another medicine, discontinue the previous eye drop at the end of a full day of treatment.
• Begin ARTEOPTIC treatment the following day, at the dosage prescribed by your doctor.
• If you feel that the effect of ARTEOPTIC is too strong or too weak, inform your doctor or pharmacist.

Do not inject or swallow.

Duration of treatment

Follow your doctor’s instructions. Your doctor will tell you how long to use ARTEOPTIC. Do not stop treatment prematurely.

If you use more ARTEOPTIC in single-dose containers than you should:

If you instill too many drops into the eyes, rinse them with clean water.

In case of accidental oral ingestion of the container contents, certain side effects may occur, such as a sensation of emptiness in the head, difficulty breathing, or awareness of a slower heartbeat.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at Tel. (91) 562 04 20.

If you forget to use ARTEOPTIC in single-dose container

Do not use a double dose to make up for the missed dose.

If you stop using ARTEOPTIC in single-dose container

Stopping treatment may increase intraocular pressure in your eyes and cause blurred vision.

Never stop treatment without first consulting your doctor or pharmacist.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

You can generally continue using the eye drops unless the effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using ARTEOPTIC without informing your doctor.

Like other eye medications (topically administered ophthalmic medicines), ARTEOPTIC may be absorbed into the bloodstream. This may cause the side effects observed with systemic beta-blockers. The frequency of adverse effects after topical ocular administration is lower than with other medications administered orally or by injection. The adverse effects listed below include adverse reactions observed with other ophthalmic beta-blocking agents:

The frequency of the following adverse effects is frequent (may affect up to 1 in 10 people):

• Signs and symptoms of ocular irritation (e.g., burning), eye pain (e.g., stinging), itching sensation, swelling, tearing, red eyes, conjunctival redness, conjunctivitis, eye irritation or sensation of a foreign body in the eye (keratitis).
• Taste disturbances.

The frequency of the following adverse effects is uncommon (may affect up to 1 in 100 people):

• Dizziness
• Muscle weakness or pain not caused by exercise (myalgia), muscle cramps.

The frequency of the following adverse effects is rare (may affect up to 1 in 1,000 people):

• Positive antinuclear antibody test results.

In very rare cases, some patients with severe damage to the transparent layer at the front of the eye (cornea) have developed corneal opacity due to calcium deposits during treatment.

The frequency of the following adverse effects is unknown (frequency cannot be estimated from available data):

• Allergic reactions including sudden swelling of the face, lips, mouth, tongue, or throat that may cause breathing or swallowing difficulties, rash, localized and generalized rash, itching, sudden life-threatening allergic reaction (anaphylaxis).
• Low blood sugar levels.
• Difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• Fainting, heart attack, reduced blood flow to certain areas of the brain, worsening of signs and symptoms of myasthenia gravis (muscle disorder), tingling or numbness of the hands and feet, prickling sensations, headache, memory loss.
• Swollen eyelids (blepharitis), blurred vision, decreased corneal sensitivity after ophthalmic surgery (choroidal detachment following filtration surgery), decreased corneal sensitivity, dry eyes, damage to the front layer of the eyeball (corneal erosion), drooping of the upper or lower eyelid, double vision, changes in refraction (sometimes due to withdrawal of miotic eye drops).
• Slow heart rate, palpitations, changes in heart rhythm or heart rate, heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation (congestive heart failure), heart condition (atrioventricular block), heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet, leg cramps and/or leg pain when walking (claudication).
• Bronchospasm (difficulty breathing or wheezing—predominantly in patients with pre-existing bronchospastic disease), shortness of breath (dyspnea), cough.
• Nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, skin rash with silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin rashes.
• Systemic lupus erythematosus.
• Sexual dysfunction, impotence.
• Unusual muscle weakness or pain not caused by exercise (asthenia), fatigue, chest pain, fluid accumulation (edema).

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.noficaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ARTEOPTIC in single-dose containers

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the container after “EXP” (English abbreviation for expiry). The expiry date refers to the last day of the month indicated.
• Do not store above 25°C.
• Discard 28 days after first opening the bottle.
• Do not use if the closure is damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of ARTEOPTIC 2% prolonged-release eye drops in single-dose containers

• The active substance is: carteolol hydrochloride.

ARTEOPTIC 20 mg/ml: each ml of eye drops contains 20 mg of carteolol hydrochloride or each single-dose container (0.2 ml) contains 4 mg of carteolol hydrochloride.

• The other components are: sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, alginic acid, sodium hydroxide (to adjust pH) and purified water.

Appearance of the medicinal product and contents of the pack

This medicine is a beta-blocking agent for ocular use.

ARTEOPTIC 20 mg/ml prolonged-release eye drops are supplied as a clear, slightly yellowish-brown solution, packaged in single-dose containers of 0.2 ml, arranged in strips and enclosed in a pouch (polyester/aluminum/polyethylene).

Pack size: 30 single-dose containers.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

Laboratoire CHAUVIN
Zone Industrielle Ripotier Haut - 07200 Aubenas
France

Local representative:

Bausch&Lomb S.A.
Avda. Valdelaparra nº4
28108 Alcobendas (Madrid)
Spain

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

France: Carteol L.P 1% and Carteol L.P 2% prolonged-release eye drops in single-dose containers
Portugal: Physioglau 1% and Physioglau 2% prolonged-release eye drops, single-dose container
Italy: Fortinol 1% & 2% monodose, prolonged-release eye drops, single-dose container
Spain: ARTEOPTIC 20 mg/ml, prolonged-release eye drops, single-dose containers

Date of the most recent review of this leaflet: February 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/