ARTEOPTIC PF 2% Extended-Release Eye Drops

Introduction

Package Leaflet: Information for the Patient

Arteoptic PF 2% Eye Drops in Prolonged-Release Solution

carteolol hydrochloride

Read the package leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Arteoptic PF and what is it used for

Arteoptic PF belongs to a group of medicines called beta-blockers.

Arteoptic PF 2% eye drops in prolonged-release solution are indicated in adult patients for the symptomatic treatment of:

• a certain type of glaucoma (chronic open-angle glaucoma);
• increased eye pressure (intraocular hypertension).

Arteoptic PF is a preservative-free solution.

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

Do not use Arteoptic PF

• 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 had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and long-lasting cough), as carteolol may increase bronchial spasms and worsen these conditions;
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats, sick sinus syndrome, including sinoatrial block), as this medicine may decrease heart rate and, therefore, worsen these conditions;
• if you have an uncontrolled second- or third-degree atrioventricular block, as carteolol may increase the risk of atrioventricular blocks;
• if you have bradycardia or sinus bradycardia (a heart rate slower than normal, i.e., <45-50 beats per minute), as carteolol may decrease heart rate and, therefore, worsen these conditions;
• if you have untreated pheochromocytoma (excessive production of a hormone that causes severe high blood pressure), as carteolol may increase blood pressure and worsen this disease.

Warnings and precautions

Tell your doctor or pharmacist before you start using this medicine if you have or have had:

• heart disease;
• respiratory problems, asthma, or chronic obstructive pulmonary disease (severe lung disease that can cause wheezing, difficulty breathing, and/or long-lasting cough);
• diseases due to poor blood circulation (such as Raynaud's disease and Raynaud's syndrome);
• diabetes, as carteolol may mask the signs and symptoms of low blood sugar (hypoglycemia);
• hyperthyroidism, as carteolol may mask its signs and symptoms;
• treated pheochromocytoma, as carteolol may increase blood pressure;
• psoriasis;
• corneal diseases;
• history of allergic reactions;
• kidney or liver disease.

Before surgery with anesthesia, inform your doctor that you are using this medicine, as carteolol may alter the effects of some medicines used during anesthesia.

To monitor that the treatment is working, you should undergo ophthalmological examinations at the start of treatment and approximately 4 weeks after starting it. Additionally, in case of long-term treatment, you should undergo annual examinations to check if the treatment is still effective and there are no signs of loss of efficacy of the medicine.

If you use contact lenses: the inhibition of tear production possibly associated with this class of drugs may generate a risk of intolerance in contact lens users.

Excipients

This medicine contains 19.2 µg of phosphates per drop, which is equivalent to 0.509 mg/ml. If you have severe damage to the clear layer on the front of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches on the cornea due to calcium deposits.

Children and adolescents

This eye drop should not be used in children and adolescents. There is no information available on the safety and efficacy of using carteolol eye drops in children and adolescents.

Other medicines and Arteoptic PF

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This medicine may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma.

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

• use the other eye medicine;
• wait 15 minutes;
• apply Arteoptic PF last.

• Your doctor may also prescribe miotic eye drops for the treatment of certain types of glaucoma (such as closed-angle glaucoma).

• You should undergo ophthalmological examinations if you use adrenaline/epinephrine-based eye drops at the same time as carteolol (due to the risk of pupil dilation).

If you take oral beta-blockers (medicines that lower blood pressure by making the heart beat slower and with less force) at the same time, it is usually necessary to adjust the dose of this medicine.

• Although the amount of beta-blockers that reaches the bloodstream after application in the eyes is low, your doctor should take into account the interactions observed with oral beta-blockers.

• The use of amiodarone (for the treatment of heart rhythm disorders), certain calcium antagonists (for the treatment of high blood pressure, such as diltiazem and verapamil), fingolimod (for the treatment of multiple sclerosis), or beta-blockers (when used for the treatment of heart failure) is not recommended. When the use of such medicines is necessary, your doctor should closely monitor the treatment.
• Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, to treat diabetes, cholinergic medicines to treat Alzheimer's disease, medicines to treat urine flow problems, multiple sclerosis, depression, psychotic disorders, cancer (e.g., amifostine), medicines to treat or prevent malaria (e.g., mefloquine), muscle spasms (e.g., baclofen), and joint disorders such as arthritis (e.g., when using non-steroidal anti-inflammatory drugs like ibuprofen or celecoxib). Your doctor will monitor the treatment 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 this medicine if you are pregnant unless your doctor considers it necessary.

See the information on how to reduce systemic absorption in section 3.

Breastfeeding

Due to the low concentration and the form of administration, it is unlikely that the use of this medicine will cause its excretion into breast milk to a level that could harm the baby.

See the information on how to reduce systemic absorption in section 3.

Consult your doctor before using any medicine during breastfeeding.

Driving and using machines

You may experience blurred vision after applying this product to your eyes.

Do not drive or use machines until your vision has returned to normal.

3. How to use Arteoptic PF

This medicine should be administered in the eye(s) (ophthalmic route).

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

Posology

The usual dose is one drop in the affected eye once a day in the morning.

However, your doctor may adjust the dose (e.g., 1 drop every other day), especially if you are taking oral beta-blockers at the same time (see section 2, Other medicines and Arteoptic PF).

Method and route of administration

• If you use contact lenses, you should remove them before applying this medicine and wait 15 minutes before putting them back on.

• When you are going to use this eye drop, wash your hands well before opening the container and follow these steps:

• If your doctor has prescribed carteolol as a replacement for another medicine, the use of the other eye drop should be discontinued at the end of a full day of treatment.

You should start treatment with this medicine the next day and according to the dosage regimen prescribed by your doctor.

This eye drop can be added to an existing treatment.

• If you feel that this medicine is having an excessive or insufficient effect, tell your doctor or pharmacist.

Duration of treatment

Follow your doctor's instructions, who will indicate how long you should use carteolol.

If you use more Arteoptic PF than you should

If you apply too many drops in your eyes, rinse them with a sterile sodium chloride solution 9 mg/ml (0.9%). If you do not have a sterile sodium chloride solution, you can use clean water.

If you accidentally ingest the contents of the container, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Arteoptic PF

You should not apply a double dose to make up for the forgotten dose.

If you stop using Arteoptic PF

If you stop the treatment, the eye pressure could increase and cause you vision problems.

Never stop the treatment with this medicine without consulting your doctor or pharmacist first.

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

4. Possible side effects

Like all medicines, this eye drop can cause side effects, although not everybody gets them.

Generally, you will be able to continue using the eye drop, unless the effects are severe. If you are in doubt, consult a doctor or pharmacist. Do not stop the treatment with carteolol without consulting your doctor first.

The following side effects are common (may affect up to 1 in 10 people)

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

The following side effects are uncommon (may affect up to 1 in 100 people)

• Dizziness.

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

In very rare cases, some patients with severe damage to the clear layer on the front of the eye (cornea) have developed cloudy patches on the cornea due to calcium deposits that form during treatment.

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

• Allergic reactions, such as sudden swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing, hives, localized and generalized rash, itching, potentially life-threatening allergic reaction.
• Low blood sugar levels.
• Difficulty sleeping (insomnia), depression, nightmares, decreased libido.
• Fainting, stroke, decreased blood flow to parts of the brain, worsening of signs and symptoms of myasthenia gravis (muscle disorder), tingling or numbness of feet and hands, pins and needles, headache, memory loss.
• Swelling of eyelids (blepharitis), blurred vision, visual disturbances after eye surgery (choroidal detachment after filtration surgery), decreased corneal sensitivity, dry eye, damage to the front layer of the eyeball (corneal erosion), drooping of the upper or lower eyelid, double vision, changes in refraction.
• Slow heart rate, palpitations, changes in heart rate or rhythm, heart failure with difficulty breathing and swelling of feet and legs due to fluid accumulation (congestive heart failure), heart disease (atrioventricular block), heart attack, heart failure.
• Low blood pressure, Raynaud's phenomenon, cold hands and feet, leg cramps, and pain in the legs when walking (claudication).
• Bronchospasm, difficulty breathing (dyspnea), cough.
• Nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, psoriasiform rash (skin rash with a silvery white appearance) or worsening of psoriasis, skin rash.
• Systemic lupus erythematosus (an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels).
• Sexual dysfunction, impotence.
• Muscle weakness (asthenia) or myalgia (muscle pain not caused by exercise) or fatigue, chest pain, fluid accumulation (edema).

Reporting of side effects

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.noficaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Arteoptic PF

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». The expiry date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep the container in the outer packaging to protect it from light.

Do not store for more than 2 months once opened. Note the opening date on the container.

Do not use the product if the seal is damaged.

Medicines should not be disposed of via wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE collection point in the pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Arteoptic PF Contents

• The active ingredient is carteolol hydrochloride.

Arteoptic PF: each ml of eye drop solution contains 20 mg of carteolol hydrochloride.

• The other components are: alginic acid (E 400), sodium dihydrogen phosphate dihydrate (E 339), disodium phosphate dodecahydrate (E 339), sodium chloride, sodium hydroxide (for pH adjustment), purified water.

Appearance of Arteoptic PF and Package Contents

This medication is a beta-blocker for ophthalmic use.

Arteoptic PF is presented as an eye drop, as a clear yellowish-brown solution, with a content of 8 ml per package.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bausch + Lomb Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Local Representative

Bauch & Lomb S.A.

Avda. Valdelaparra nº4.

28108 Alcobendas, Madrid,

Spain

Manufacturer

Laboratoire Chauvin

Zone Industrielle De Ripotier

50 Avenue Jean Monnet

Aubenas – 07200 – France

This medication is authorized in the EEA member states under the following names

Netherlands: Arteoptic zonder conserveermiddel 20 mg/ml, oogdruppels, oplossing met verlengde afgifte

Belgium, Luxembourg: Arteoptic LA Sine Conservans 20 mg/ml Oogdruppels, oplossing met verlengde afgifte/ Collyre en solution à libération prolongée/ Augentropfen mit verlängerter Wirkungsdauer

Spain: Arteoptic PF 2% prolonged-release eye drops

France: Carteol LP 2% Collyre en solution à libération prolongée

Hungary: Cartelomb 20 mg/ml eye drops, solution with prolonged release

Italy: Fortinol SC 2%, prolonged-release eye drops

Poland: Carteol LP 2% Preservative Free

Portugal: Physioglau 2% Colírio solução de libertação prolongada

Slovenia: Cartelomb 20 mg/ml eye drops, solution with prolonged release

Date of the last revision of this prospectus:02/2024

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