Arteoptic 1% prolonged-release eye drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Arteoptic 1% prolonged-release eye drops

Arteoptic 2% prolonged-release eye drops

Carteolol hydrochloride

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Arteoptic is and what it is used for
2. What you need to know before using Arteoptic
3. How to use Arteoptic
4. Possible adverse effects
5. How to store Arteoptic
6. Contents of the pack and other information

1. What Arteoptic 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 glau游戏副本

2. What you need to know before using Arteoptic

Do not use Arteoptic

• If you are allergic (hypersensitive) to carteolol hydrochloride or to 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 heart rate, heart failure, or heart rhythm disorders (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 artery disease (symptoms may include chest pain, weakness, fatigue, or breathlessness), heart failure, low blood pressure,
• Cardiac conduction disorders such as bradycardia (slow heartbeat),
• Respiratory problems, asthma, or chronic obstructive pulmonary disease (a lung disease 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),
• Hypothyroidism, as carteolol 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 undergo periodic ophthalmological examinations at the beginning of treatment and thereafter approximately every 4 weeks. Additionally, in case of long-term treatment, these examinations should monitor for possible 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. Furthermore, the preservative used (benzalkonium chloride) may be absorbed by soft contact lenses and may change their color. You should remove your contact lenses before using this medicine and reinsert them 15 minutes after applying the medication.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or corneal disorders (damage to the transparent outer layer of the eye). If you experience a foreign body sensation, itching, or pain after using this medicine, consult your doctor.

If you have severe damage to the transparent front layer of the eye (the cornea), phosphates may very rarely cause blurred vision due to calcium accumulation during treatment.

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

Children and adolescents

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

Use of Arteoptic with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Arteoptic may affect or be affected by other medicines when used concurrently, including other eye drops for glaucoma treatment.

• If you are using other eye medications, you should:
  • Apply the other eye 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 necessary if you are using adrenaline/epinephrine eye drops concurrently 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 that reaches the bloodstream after eye application is low, you should be aware of the interactions observed with oral beta-blockers:

• Concomitant use of amiodarone (used to treat heart rhythm disorders), 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, the different drugs should be administered at least 15 minutes apart. Ocular ointments should be administered last.

Inform your doctor if you are using or plan 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 plan 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 minimize 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 signs of beta-blockade in infants. To reduce systemic absorption, see section 3.

Driving and use of 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 contains benzalkonium chloride

Preservative used: benzalkonium chloride. See section 2, paragraph "Warnings and precautions".

This medicine contains 0.00165 mg of benzalkonium chloride per drop, equivalent to 0.05 mg/ml.

ARTEOPTIC contains phosphate buffer

This medicine contains 0.046 mg of phosphates per drop, equivalent to 1.4 mg/ml.

3. How to use Areoptic

This medicine is for use in the eyes (ophthalmic route).

Always follow exactly the instructions given by your doctor. If in doubt, ask your doctor or pharmacist.

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

The recommended dose is one drop in 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 (taken by mouth) at the same time (see section 2 “Using other medicines”).

Instructions for use

• If you wear contact lenses, you must 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.
  • Avoid touching the eye or eyelid with the tip of the container.
  • To administer the treatment, gently pull down the lower eyelid and instill one drop while looking upward.
  • After administration, close the eye for a few seconds.
  • After administering ARTEOPTIC, press with your finger on the inner corner of the eye near the nose for 2 minutes. This prevents the active substance (carteolol) from passing into the rest of the body.
  • With eyes closed, wipe away any excess medicine.
  • Close the container tightly after use.

• If you are using another eye medication, you should:

  • Apply the other ophthalmic medicine first.
  • Wait 15 minutes.
  • Then apply ARTEOPTIC.

• If your doctor prescribes Arteoptic as a replacement for another medicine, you must stop using the other eye drops at the end of a full day of treatment.

• Begin treatment with Arteoptic the following day, at the dosage prescribed by your doctor.

• If you feel 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 you should use Arteoptic. Do not stop treatment prematurely.

If you use more Arteoptic than you should:

If you administer 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 a feeling that your pulse is slower.

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

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

If you stop using Arteoptic

If you stop treatment, intraocular pressure in your eyes may increase, causing 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 may cause adverse effects, although not everyone will experience them.

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

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

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 opacification due to calcium deposits during treatment.

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

• Allergic reactions including sudden swelling of the face, lips, mouth, tongue or throat which may cause difficulty breathing or swallowing, 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 hands and feet, pins and needles, 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 drop treatment).
• Slow heartbeat, palpitations, changes in heart rhythm or 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, 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 a silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin eruptions.
• Systemic lupus erythematosus.
• Sexual dysfunction, impotence.
• Unusual muscle weakness or pain not caused by exercise (asthenia), or fatigue, fluid accumulation (edema).

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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

• Keep this medicine out of the sight and reach of children.
• Do not use Arteoptic after the expiry date stated on the packaging after "Exp". The expiry date is the last day of the month indicated.
• This medicine does not require any special storage conditions.
• Discard the medicine 28 days after first opening the bottle. Please write down the date of opening on the container.
• 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 you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Arteoptic 1% and Arteoptic 2% prolonged-release eye drops

• The active substance is: carteolol hydrochloride.

Arteoptic 1%: each ml of eye drops contains 10 mg of carteolol hydrochloride.

Arteoptic 2%: each ml of eye drops contains 20 mg of carteolol hydrochloride.

The other components are: benzalkonium chloride (preservative), alginic acid (E400), sodium dihydrogen phosphate dihydrate (E339), disodium phosphate dodecahydrate (E339), sodium chloride, sodium hydroxide (to adjust pH), and purified water.

Appearance of the medicine and contents of the pack

This medicine is a beta-blocker for ophthalmic use.

Arteoptic 1% and Arteoptic 2% prolonged-release eye drops are presented as a clear, slightly coloured solution in a 3 ml container.

1 container of 3 ml

3 containers of 3 ml

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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:

Bauch & Lomb S.A.

Avda. Valdelaparra nº4.

28108 Alcobendas, Madrid,

Spain.

This medicine is authorised in the Member States of the European Economic Area under the following names:

France: Carteol L.P 1%- 2% collyres à libération prolongée

Portugal: Physioglau 1%-2% colírio de libertação prolongada

Italy: Fortinol 1%- 2% collirio a rilascio prolungato

Spain: Arteoptic 1% and 2%, colirio de liberación prolongada.

Belgium, Luxembourg: Arteoptic LA 2%

Poland, Czech Republic, Slovak Republic: Carteol LP 2%

Romania: Fortinol EP 2%.

Date of the most recent revision of this leaflet: July 2022.

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