ARTEOPTIC 2% PROLONGED-RELEASE EYE DROPS

2. What you need to know before you start using Arteoptic:

Do not use Arteoptic

• If you are allergic (hypersensitive) to carteolol hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had respiratory diseases such as asthma, severe chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing and/or long-term coughing).
• If you have or have had a 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 an untreated pheochromocytoma (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 that may include chest pain or weakness, fatigue, or shortness of breath), heart failure, decreased blood pressure,
• heart rhythm disorders such as bradycardia (slow heartbeat),
• respiratory problems, asthma, or chronic obstructive pulmonary disease (lung disease that can cause wheezing, difficulty breathing, and/or long-term coughing),
• peripheral circulation disorders (Raynaud's disease or Raynaud's syndrome),
• diabetes, as carteolol may mask the signs and symptoms of low blood sugar levels,
• diabetes may mask the signs and symptoms of low blood sugar levels (hypoglycemia),
• carteolol may mask the signs and symptoms of hyperthyroidism,
• treated pheochromocytoma,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease.

Tell your doctor that you are taking Arteoptic before undergoing anesthesia, as carteolol may alter the effects of some medicines during anesthesia.

To monitor that you are not developing resistance to the therapeutic efficacy of this product, when using this medicine, you should undergo periodic ophthalmological examinations at the start of treatment and subsequently, approximately every 4 weeks. Additionally, in the case of long-term treatment, the examinations should monitor whether treatment failure occurs (loss of efficacy of the medicine).

If you use contact lenses: a possible inhibition of tear production related to this class of medicines may produce a risk of intolerance in contact lens users. Also, the preservative used (benzalkonium chloride) may be absorbed by soft contact lenses and may change the color of the contact lenses. You should remove your contact lenses before using this medicine and put them back 15 minutes after applying the medicine.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent outer layer of the eye). If you notice any unusual sensation in the eye, itching, or pain after using this medicine, consult your doctor.

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

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

Children and Adolescents

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

Using Arteoptic with Other Medicines

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

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

• If you are using other eye medicines, you should:
• • apply the other eye medicine
  • 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).
• Ophthalmological monitoring 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 bloodstream after application in the eyes is low, you should consider the interactions that have been observed with oral beta-blockers:

• It is not recommended to use amiodarone (used to treat heart rhythm disorders), certain calcium antagonists (used to treat high blood pressure, such as diltiazem, fingolimod, ozonimod, and verapamil), or other beta-blockers (used to treat heart failure).
• All beta-blockers can mask certain symptoms of hypoglycemia: palpitations and tachycardia.
• It may increase the blood level of lidocaine (administered intravenously), which would increase the risk of cardiac and neurological adverse effects.

When using more than one topical eye medicine, the administration of medicines should be spaced at least 15 minutes apart. Eye ointments should be administered last.

Tell your doctor if you are using or are going to use medicines to lower blood pressure, heart medicines, diabetes medicines, or multiple sclerosis medicines.

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription. They will monitor you specifically if necessary.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Do not use ARTEOPTIC if you are pregnant 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 if you are 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 there will be sufficient amounts in breast milk to produce clinical symptoms of beta-blockade in infants. To reduce systemic absorption, see section 3.

Driving and Using Machines

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

Do not drive or use machines 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, which is equivalent to 0.05 mg/ml.

ARTEOPTIC contains Phosphate Buffer

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

3. How to use Arteoptic

This medicine should be administered in the eyes (ophthalmic use)

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you are unsure, ask your doctor or pharmacist.

Arteoptic contains a specific excipient that has physical properties that allow for single daily administration.

The recommended dose is one drop in the affected eye(s) once daily, in the morning.

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

Instructions for use

• If you wear contact lenses, you should remove them before applying Arteoptic and wait 15 minutes before putting them back.
• For correct administration of Arteoptic
• • Wash your hands carefully before applying the drops.
  • Avoid touching the eye or eyelid with the edge of the container.
  • For treatment, gently pull the lower eyelid and instill one drop while looking up.
  • After administration, close your eye for a few seconds.
  • After administering ARTEOPTIC, press with your finger on the 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 your eyes closed, discard any excess medicine.
  • Close the container tightly after use.

• If you are using another eye medicine, you should:
• • Apply the other eye medicine first.
  • Wait 15 minutes.
  • Apply ARTEOPTIC last.
• If your doctor has prescribed Arteoptic to replace another medicine, you should stop using the other eye drop at the end of a full day of treatment.
• Start treatment with Arteoptic the next day, at the dosage indicated by your doctor.
• If you think the effect of Arteoptic is too strong or too weak, tell your doctor or pharmacist.

Do not inject or swallow.

Duration of Treatment

Follow your doctor's instructions. He will tell you how long you should use Arteoptic. Do not stop treatment before.

If you use more Arteoptic than you should:

If too many drops are administered in the eyes, rinse them with clean water.

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

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

If you forget to use Arteoptic

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

If you stop using Arteoptic

If you stop treatment, you may experience increased intraocular pressure in your eyes and blurred vision.

Never stop treatment without consulting your doctor or pharmacist first.

If you have any further questions about the use of this medicine, ask your 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 to use the eye drops, unless the effects are severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using Arteoptic without telling your doctor.

As with other eye medicines (topically administered ophthalmic medicines), Arteoptic may be absorbed and enter the bloodstream. This can produce the side effects that are seen with systemic beta-blockers. The frequency of side effects after topical administration in the eyes is lower than with oral or injectable medicines. The side effects listed below include adverse reactions seen with other beta-blocker eye medicines:

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

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

The frequency of the following side 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 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 of 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, which may cause breathing or swallowing problems, rash, 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 in some parts of the brain, increased signs and symptoms of myasthenia gravis (muscle disorder), tingling or numbness of hands and feet, tingling, headache, memory loss.
• Swollen eyelids (blepharitis), blurred vision, decreased corneal sensitivity after eye surgery (choroidal detachment after 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 treatment with miotic drops).
• Slow heartbeat, 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), 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 Side Effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use: https://www.noficaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Arteoptic

• Keep this medicine out of the sight and reach of children.
• Do not use Arteoptic after the expiration date stated on the container after "EXP". The expiration date is the last day of the month indicated.
• This medicine does not require special storage conditions.
• It should be discarded after 28 days of first opening the bottle. Note the opening date on the container.
• Do not use if the seal is damaged.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

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

• The active ingredient 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 (for pH adjustment) and purified water.

Appearance of the product and container content

This medication is an ocular beta-blocker.

Arteoptic 1% and Arteoptic 2% prolonged-release eye drops are presented in the form of a transparent and slightly colored solution in a 3 ml container.

1 container of 3 ml

3 containers of 3 ml

Only some package 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:

Bauch & Lomb S.A.

Avda. Valdelaparra nº4.

28108 Alcobendas, Madrid,

Spain.

This medication is authorized 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%, prolonged-release eye drops.

Belgium, Luxembourg: Arteoptic LA 2%

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

Romania: Fortinol EP 2%.

Date of the last revision of this prospectus: July 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/