Label: information for the user

Arteoptic 1% prolonged-release eye drops

Arteoptic 2% prolonged-release eye drops

Carteolol hydrochloride

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Arteoptic and how it is used

2. What you need to know before starting to use Arteoptic.

3. How to use Arteoptic

4. Possible adverse effects

5. Storage of Arteoptic.

6. Contents of the package 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).

- Increased pressure in the eyes (intraocular hypertension).

Do not use Arteoptic

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

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

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

- 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 in the past:

• Coronary heart disease (symptoms that 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),
• peripheral circulation disorder (Raynaud's disease or Raynaud's syndrome),
• diabetes since carteolol can mask the signs and symptoms of low blood sugar,
• diabetes can mask the signs and symptoms of low blood sugar (hypoglycemia),
• carteolol can mask the signs and symptoms of hyperthyroidism,
• phaeochromocytoma treated,
• psoriasis,
• corneal disease,
• history of allergic reactions,
• kidney or liver disease

Inform your doctor that you are taking Arteoptic before undergoing anesthesia as carteolol can 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. In addition, 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 can cause a risk of intolerance in contact lens users. Similarly, the preservative used (benzalkonium chloride) can be absorbed by soft contact lenses and can change the color of the contact lenses. You should remove your contact lenses before using this medication and reinsert them 15 minutes after applying the medication.

Benzalkonium chloride can cause eye irritation, especially if you have dry eye or corneal disorders (the transparent superficial layer of the eye). If you notice a strange sensation in your eye, itching, or pain after using this medication, consult your doctor.

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

The active principle of this medication can 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 with other medications

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

Arteoptic can affect or be affected by other medications when used, including other eye drops for glaucoma treatment.

• 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 applying it 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 used recently other medications, even those purchased without a prescription. They will follow up specifically if necessary.

Pregnancy and lactation

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.

No adequate data are available on the use of hydrochloride of carteolol in pregnant women. To reduce systemic absorption, see section 3.

Lactation

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

Beta-blockers are excreted in breast milk. However, at therapeutic doses of the hydrochloride of carteolol eye drop, 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 operating machinery

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

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

Arteoptic contains benzalkonium chloride

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

This medication contains 0.00165 mg of benzalkonium chloride in each drop, equivalent to 0.05 mg/ml.

ARTEOPTIC contains phosphate buffer

This medication contains 0.046 mg of phosphates in each drop, equivalent to 1.4 mg/ml.

This medication should 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 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.
• For correct Arteoptic administration
• • 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 the eye for a few seconds.
  • After Arteoptic administration, 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.
  • Close the container tightly after use.

• If you are using another eye medication, you must:
• • Administer the other eye medication first.
  • Wait 15 minutes.
  • Apply Arteoptic last.
• If your doctor has prescribed Arteoptic in place of another medication, you must discontinue use of the other eye drop 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 should use Arteoptic. Do not interrupt 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 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

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

If you interrupt treatment with Arteoptic

If you interrupt treatment, your eye pressure may increase and you may experience blurred 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 rare cases, some patients with severe damage to the transparent layer of the front part of the eye (cornea) have developed corneal opacity 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
• Difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• Fainting, heart attack, decreased blood flow to some parts of the brain, worsening of myasthenia gravis symptoms (muscular alteration), tingling or numbness of the hands and feet, pins and needles, headache, memory loss.
• Swollen eyelids (blepharitis), blurred 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, muscle 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, psoriasis-like 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 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 Medicines Vigilance System: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 Arteoptic after the expiration date that appears on the packaging after “cad”. The expiration date is the last day of the month indicated.
• This medication does not require special storage conditions.
• It should be discarded after 28 days of the first opening of the bottle. Note the opening date on the packaging.
• Do not use if the closure is damaged.

Medications should not be thrown down the drain or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

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

• The active ingredient is:hydrochloride of carteolol.

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

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

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

Appearance of the product and contents of the package

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 commercially available

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:

Bauch & Lomb S.A.

Avda. Valdelaparra nº4.

28108 Alcobendas, Madrid,

Spain.

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

France: Carteol L.P 1%- 2% eye drops with prolonged release

Portugal: Physioglau 1%-2% eye drops with prolonged release

Italy: Fortinol 1%- 2% eye drops with prolonged release

Spain: Arteoptic 1% and 2%, eye drops with prolonged release.

Belgium, Luxembourg: Arteoptic LA 2%

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

Romania: Fortinol EP 2%.

Date of the last review of this leaflet: July 2022.

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/