Package Leaflet: Information for the User

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

Carteolol hydrochloride

Read this leaflet carefully before you start using this medicine because 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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. Storage of ARTEOPTIC in single-dose container.

6. Contents of the single-dose container and additional information

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

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

- A certain form of glaucoma (open-angle chronic glaucoma).

- Increase in eye pressure (intraocular hypertension).

Do not use ARTEOPTIC in single-dose packaging

- If you are allergic to hydrochloride carteolol or any of the other components of this medication (listed in section 6).

- If you have or have had respiratory diseases such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing, and/or coughing over a long period).

- If you have a slow heart rate, heart failure, or irregular heart rhythm (irregular heartbeat).

- If you have bradycardia (pulse less than 45-50 beats per minute).

- If you have an untreated phaeochromocytoma (excessive production of hormones that causes severe high blood pressure).

Warnings and precautions

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

• Coronary heart disease (symptoms may include chest pain or weakness, fatigue, or asphyxia), heart failure, decreased blood pressure,
• Cardiac arrhythmias such as bradycardia (slow heart rate),
• Respiratory problems, asthma, or chronic obstructive pulmonary disease (lung disease that can cause wheezing, difficulty breathing, and/or coughing over a long period),
• Circulatory problems, Raynaud's disease or Raynaud's syndrome,
• Diabetes, as carteolol may mask the signs and symptoms of low blood sugar,
• Diabetes may mask the signs and symptoms of low blood sugar (hypoglycemia),
• Carteolol may mask the signs and symptoms of hyperthyroidism,
• Treated phaeochromocytoma,
• Psoriasis,
• Corneal disease,
• History of allergic reactions,
• Renal or hepatic disease

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

To control that you are not developing resistance to the therapeutic efficacy of this product, when using this medication, you must be subjected to periodic ophthalmological examinations at the beginning of treatment and subsequently, approximately every 4 weeks. Additionally, in the case of long-term treatment, examinations must control if a treatment failure (loss of efficacy of the medication) is produced.

If you use contact lenses: an inhibition of tear production possibly related to this class of medications may cause a risk of intolerance in contact lens users.

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

The active ingredient of this medication may produce a positive result in antidoping control tests.

Children and adolescents

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

Use of ARTEOPTIC in single-dose packaging with other medications

ARTEOPTIC may affect or be affected by other medications when used, including other eye drops for the treatment of glaucoma.

• If you are using other eye medications, you must:
• • Apply the other eye medication
  • Wait 15 minutes
  • 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).
• A follow-up ophthalmological examination is necessary if you use an adrenaline/epinephrine eye drop at the same time as ARTEOPTIC (due to the risk of pupil dilation).
• If you take oral beta-blockers at the same time, it is often necessary to adjust the dose of ARTEOPTIC.

Although the amount of beta-blocker that reaches the blood after application to the eyes is low, you should be aware of the interactions that have been observed with oral beta-blockers:

When using more than one topical eye medication, the administration of medications should be spaced at least 15 minutes apart. Eye creams should be administered last.

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

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription. They will monitor you specifically if necessary.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not use ARTEOPTIC if you are pregnant, unless your doctor considers it necessary.

There are no adequate data on the use of hydrochloride carteolol in pregnant women.

To reduce systemic absorption, see section 3.

Breastfeeding

Do not use ARTEOPTIC if you are breastfeeding. Hydrochloride carteolol may pass into breast milk.

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

Ask your doctor before taking any medication during breastfeeding.

Driving and operating machinery

After applying this product to the eyes, blurred vision may appear.

Do not drive or operate machinery until you have regained normal vision.

ARTEOPTIC in single-dose packaging contains phosphate buffer

This medication contains 0.049 mg of phosphates in each drop, equivalent to 1.4 mg/ml.

This medication must be administered in the eyes (ophthalmic route).

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

ARTEOPTIC contains a specific excipient that has physical properties that allow for a single administration per day.

The recommended dose is one drop in the affected eye or eyes, once a day, in the morning.

However, your doctor may decide to adjust the dose, especially if you are taking oral beta-blockers (by mouth) at the same time (see section 2 “Use of other medications”).

Usage instructions

• If you wear contact lenses, you must remove them before applying ARTEOPTIC and wait 15 minutes before putting them back on.
• To administer ARTEOPTIC correctly:
• • Wash your hands carefully before applying the drops.
  • Before each new use, separate a single-use vial from the strip.
  • Turn the end of the vial to open the single-use vial. Place the single-use vial upside down, gently tap the body of the single-use vial to make the solution move towards the opening.
  • Avoid touching the eye or eyelid with the edge of the vial.
  • To treat, gently pull the lower eyelid and instill one drop while looking up.
  • After administration, close the eye for a few seconds.
  • With the eye closed, gently clean up any excess.
  • After administering ARTEOPTIC, press with your finger on the angle of the eye near the nose for 2 minutes. This prevents the active substance (carteolol) from passing into the rest of the body.
  • With your eyes closed, discard any excess medication.
  • Dispose of the single-use vial immediately after use.
  • Do not use the contents of opened or started single-use vials.
  • The amount of drops in a single-use vial is sufficient for the treatment of both eyes.

SeparateTurn the cap to open it

Invert the vial completelyInstill in the eye

Dispose of after use

• If you are using another eye medication, you must:
• • Administer the other eye medication first
  • Wait 15 minutes
  • Finally, apply ARTEOPTIC
• If your doctor has prescribed ARTEOPTIC in place of another medication, you must stop using the other eye drops at the end of a complete day of treatment.
• Start treatment with ARTEOPTIC the next day, at the dosage indicated by your doctor.
• If you estimate that the action of ARTEOPTIC is too strong or too weak, inform your doctor or pharmacist.

Do not inject or swallow.

Treatment duration

Follow your doctor's instructions. He will tell you how long you need to use ARTEOPTIC. Do not stop treatment before.

If you use more ARTEOPTIC in a single-use vial than you should:

If you administer too many drops in the eyes, wash them with clean water.

In case of accidental oral administration of the contents of the vial, certain side effects may appear such as a feeling of empty-headedness, difficulty breathing, or the impression that your pulse is slower.

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

If you forgot to useARTEOPTIC in a single-use vial

Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with ARTEOPTIC in a single-use vial

If you interrupt treatment, your eye pressure may increase and you may experience blurry vision.

Do not interrupt treatment without consulting your doctor or pharmacist first.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

You can usually 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 medications administered in the eyes (topically administered eye medications), ARTEOPTIC may be absorbed and pass into the blood. This can cause side effects that are seen with systemic beta-blockers. The frequency of side effects after topical administration in the eyes is lower than with other medications administered orally or by injection. The following side effects listed include adverse reactions seen with other beta-blocker eye agents:

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

• Signs and symptoms of eye irritation (e.g. burning), eye pain (e.g. stinging), sensation of itching, swelling, tearing, red eyes, conjunctival redness, conjunctivitis, eye irritation or sensation of having something in the eye (keratitis).
• Alterations in taste.

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

• Positive results for antinuclear antibodies.

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 side effects is unknown (the frequency cannot be estimated from the available data)

• Allergic reactions including sudden swelling of the face, lips, mouth, tongue, or throat that may cause breathing or swallowing problems, hives, localized and generalized rash, itching, life-threatening allergic reaction.
• Low blood sugar levels
• Difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• Fainting, heart attack, decreased blood flow to certain parts of the brain, worsening of myasthenia gravis symptoms (muscular alteration), tingling or numbness in the hands and feet, pins and needles, headache, memory loss.
• Swollen eyelids (blepharitis), blurry vision, decreased corneal sensitivity after eye surgery (corneal detachment after glaucoma surgery filtration), decreased corneal sensitivity, dry eyes, damage to the front layer of the eyeball (corneal erosion), drooping eyelid, double vision, changes in refraction (sometimes due to withdrawal of treatment with miotic eye drops).
• Slow heart rate, palpitations, changes in heart rhythm or rate, heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation (congestive heart failure), cardiac 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).
• Asthma-like symptoms (difficulty breathing or wheezing - predominantly in patients with pre-existing bronchospastic disease), shortness of breath, cough.
• Nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, psoriasis-like rash with a silvery-white appearance (psoriform 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, chest pain, fluid accumulation (edema).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Vigilance System for Human Use:https://www.noficaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after “EXP” (English abbreviations for expiration). The expiration date is the last day of the month indicated.
• Do not store at a temperature above 25°C.
• It must be discarded after 28 days of the first opening of the bottle.
• Do not use if the closure is damaged.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

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

• The active ingredient is:hydrochloride of carteolol.

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

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

Appearance of the product and contents of the packaging

This medication is an ocular beta-blocker.

ARTEOPTIC 20 mg/ml prolonged-release eye drops are presented in the form of a transparent and slightly yellow-brown solution packaged in strips of single-dose packaging of 0.2 ml and conditioned in a pouch (polyester/aluminum/polyethylene).

Package of 30 single-dose packaging.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Responsible for manufacturing:

Laboratoire CHAUVIN

Zone Industrielle Ripotier Haut - 07200 Aubenas

France

Local representative:

Bausch&LombS.A.

Avda. Valdelaparra nº4

28108 Alcobendas (Madrid)

This medication is authorized in the Member States of the European Economic Area with the following names:

France: Carteol L.P 1% and Carteol L.P 2% eye drops with prolonged release in single-dose packaging

Portugal: Physioglau 1% and Physioglau 2% eye drops with prolonged release, single-dose packaging.

Italy: Fortinol 1% & 2% monodose, eye drops with prolonged release, single-dose container.

Spain: ARTEOPTIC 20 mg/ml, eye drops with prolonged release, single-dose packaging.

Last review date of this leaflet:February 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/