Carteol

Patient Information Leaflet

Carteol 20 mg/ml Eye Drops, solution

Carteolol hydrochloride
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet; 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Carteol is and what it is used for

Carteol contains the active substance carteolol hydrochloride, a beta-blocker with antiglaucoma activity, capable of reducing the pressure inside the eye.
Carteol is indicated for the treatment of ocular hypertension and primary open-angle glaucoma. Treatment with Carteol, by reducing intraocular pressure, helps prevent glaucoma-related complications that may impair vision.
If, at the end of the prescribed treatment, you do not notice any improvement or if you notice a worsening, consult your doctor.

2. What you should know before using Carteol

Do not use Carteol

• if you are allergic to or have experienced episodes of hypersensitivity to carteolol hydrochloride, beta-blockers, or any of the other components of this medicine (listed in section 6);
• if you currently have or have previously had respiratory diseases such as asthma or severe chronic obstructive pulmonary disease (a serious lung condition that may cause shortness of breath, breathing difficulties, and/or persistent cough);
• if you have congestive heart failure, overt heart failure, or cardiogenic shock;
• if you have heart rhythm disorders (sinus bradycardia, sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block not controlled by a pacemaker);
• during pregnancy or while breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using Carteol.
Before using this medicine, inform your doctor if you have or have previously had:

• chronic heart diseases (symptoms may include chest pain or tightness, shortness of breath, or suffocation), heart failure, or low blood pressure;
• heart rate disorders such as slow heartbeat;
• respiratory problems, asthma, or chronic obstructive pulmonary disease;
• conditions characterized by poor blood circulation (e.g., Raynaud's syndrome);
• diabetes, as carteolol hydrochloride may mask signs and symptoms of low blood sugar (hypoglycemia);
• overactivity of the thyroid gland, as carteolol hydrochloride may mask its signs and symptoms. Abrupt discontinuation of beta-blocker therapy may worsen symptoms of hyperthyroidism.
• pheochromocytoma, as the use of beta-blockers in treating hypertension due to treated pheochromocytoma requires close monitoring of blood pressure;
• therapy with beta-blockers may worsen symptoms of myasthenia gravis and psoriasis;
• severe allergic reactions, as sensitivity to allergens may increase during beta-blocker treatment;
• corneal disorders, as beta-blockers may cause dry eyes;
• choroidal detachment.

Before undergoing surgery, inform your doctor that you are using Carteol, as carteolol hydrochloride may affect the action of certain drugs used during anesthesia.
Particular caution is advised when administering Carteol to elderly patients, patients with renal or hepatic impairment, and when Carteol is used concomitantly with systemically administered beta-blockers.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Carteol contains phosphates: This medicine contains 0.05 mg of phosphate buffer per drop, equivalent to 1.36 mg/ml.
If you have severe damage to the outermost transparent layer of the eye (the cornea), phosphates may very rarely cause calcium deposits leading to opaque corneal spots during treatment.
Discontinue treatment and consult your doctor for appropriate management if signs of hypersensitivity to any component of the medicine occur.

Children and adolescents
The safety and efficacy of Carteol in children and adolescents have not been established.
Its use is not recommended in pediatric patients due to lack of clinical data.

Other medicines and Carteol
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other eye drops or other medicines, including those without a prescription.
You may use Carteol with other ophthalmic medicines, but follow the instructions in section 3.
In particular, inform your doctor if you are taking other medicines containing phosphates. Your doctor will check your cornea at regular intervals.
Carteol may interact with or be affected by other medicines you are taking, including other eye drops for glaucoma. Inform your doctor if you are using or plan to use medicines to lower blood pressure, heart medications, or medicines for diabetes treatment.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
This product should be used during pregnancy only if clearly needed and under direct medical supervision.

Breastfeeding
Do not use Carteol while breastfeeding. Carteolol hydrochloride may pass into breast milk.

Driving and using machines
Carteolol hydrochloride has a moderate effect on the ability to drive and use machinery. Possible side effects such as dizziness, fatigue, or visual disturbances (including double vision, drooping eyelid, blurred vision) may impair the ability to drive or operate machinery in some patients.
If you experience one or more of these effects, do not drive or operate machinery until symptoms have resolved.

3. How to use Carteol

Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is 1 drop twice daily.
If your doctor considers it necessary, Carteol may be combined with therapy using
parasympathomimetic agents, prostaglandin analogues, alpha-agonists, or carbonic anhydrase inhibitors.
When switching from other anti-glaucoma eye drops to Carteol, it is recommended to discontinue the
previous treatment after one full day of therapy and to start treatment with Carteol the following day, administering one drop twice daily.

Instructions for use
Before administering the eye drops:

• If you are using Carteol 20 mg/ml multidose eye drops without preservatives for the first time, practice using the dropper bottle according to the instructions before instilling a drop into the eye, by releasing one drop away from the eye.
• Once you are confident that you can dispense one drop at a time, choose the position that is most comfortable for you when administering the eye drops (sitting, lying down, or standing in front of a mirror).
  1. Wash/disinfect your hands thoroughly.
  2. Make sure the protective cap is intact before use.
  3. Remove the safety seal of the protective cap by pulling the tab end in an anticlockwise direction.

4. Remove the protective cap by pulling it upwards.

Do not apply any pressure to the bottle before removing the protective cap and inverting the bottle for administration.

5. Tilt your head backwards. Gently pull down the lower eyelid of the affected eye with your fingers.
6. Invert the bottle and instill the eye drop by applying gentle pressure to the bottle, taking care not to touch the eye, eyelid, or any other surface with the tip of the dropper; this helps prevent contamination.

7. Close your eye and press a finger against the inner corner of the affected eye near the nose. Hold for 2 minutes. This ensures the drop is absorbed by the eye and helps prevent the medicine from entering the rest of the body.

8. Repeat the procedure in the other eye, if necessary.
9. Shake the bottle downwards to remove any residual solution from the tip of the dropper.

10. Immediately after use, close the bottle with the protective cap.

11. Remember to write the date of first opening of the bottle on the carton.

If you use more Carteol than you should
Experience with overdose of Carteol is limited.
If you instill too many drops, you may experience dizziness, difficulty breathing, or a sensation of slowed heart rate, among other effects.
Contact your doctor or pharmacist immediately.

If you forget to use Carteol
As soon as you remember, instill one single drop and then return to your regular dosing schedule. Do not use a double dose to make up for a missed dose.

If you stop using Carteol
Do not stop treatment with Carteol without consulting your doctor. To work properly, Carteol must be used every day.

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

If you use Carteol with other ophthalmic medicines
If you are using other ophthalmic products, wait at least 15 minutes between using one product and the next. Ointments should be used last.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Like other ophthalmic medicines, carteolol hydrochloride is absorbed into the bloodstream; this may cause side effects similar to those observed with intravenous and/or oral beta-blockers. The likelihood of side effects occurring with eye drop administration is lower than with systemic administration (when medicines are taken orally or by injection).
The side effects listed include reactions observed within the class of ophthalmic beta-blockers:

Immune system disorders:
generalised allergic reactions including swelling under the skin, which may occur in areas such as the face and limbs and may obstruct airways causing difficulty in swallowing and breathing, urticaria, localised and generalised skin rash, pruritus, sudden severe allergic reaction with life-threatening risk, systemic lupus erythematosus.

Metabolism and nutrition disorders:
hypoglycaemia (low blood glucose levels).

Psychiatric disorders:
sleep disorders (insomnia), depression, nightmares, memory loss.

Nervous system disorders:
dizziness, headache, fainting, stroke, cerebral ischaemia (reduced blood supply to the brain).

Eye disorders:
signs and symptoms of eye irritation (e.g. burning, stinging, itching, tearing, redness), blepharitis (inflammation of the eyelid), corneal inflammation, blurred vision, choroidal detachment (separation of the layer beneath the retina containing blood vessels) following filtering surgery which may lead to visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion, drooping of the upper eyelid (causing the eye to appear partially closed), double vision.

Cardiac disorders:
bradycardia (reduced heart rate), chest pain, palpitations, oedema (fluid accumulation), changes in heart rhythm or heartbeat speed, congestive heart failure (heart disease associated with breathlessness and swelling of feet and legs due to fluid accumulation), myocardial infarction, heart failure.

Vascular disorders:
hypotension (reduced average blood pressure), Raynaud's syndrome, cold hands and feet.

Respiratory, thoracic and mediastinal disorders:
airway constriction in the lungs (predominantly in patients with pre-existing disease), breathing difficulties, cough.

Gastrointestinal disorders:
taste disturbances, nausea, indigestion, diarrhoea, dry mouth, abdominal pain, vomiting.

Skin and subcutaneous tissue disorders:
hair loss, psoriasiform dermatitis (skin eruptions with silvery appearance) or worsening of psoriasis, skin rash.

Musculoskeletal and connective tissue disorders:
worsening of signs and symptoms of myasthenia gravis (muscle disease), muscle weakness/fatigue, muscle pain not due to physical exertion.

Reproductive system and breast disorders:
sexual dysfunction, decreased libido, impotence.

There are insufficient data available to determine the frequency of the above-described side effects.
In very rare cases (less than 1 person in 10,000), some patients with severe damage to the clear layer at the front of the eye (cornea) have developed cloudy spots on the cornea due to calcium accumulation during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Carteol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month and applies only to the product properly stored in its original condition.
Store below 25°C. Do not refrigerate or freeze.
After first opening the bottle: store for 60 days at a temperature below 25°C. Discard the bottle 60 days after first opening.
Keep the bottle in the outer packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Carteol 20 mg/ml contains

• The active substance is carteolol hydrochloride; 100 ml of solution contain 2 g of carteolol hydrochloride;
• The other components are: monobasic sodium phosphate monohydrate, dibasic sodium phosphate dodecahydrate, sodium chloride, purified water.

Description of the appearance of Carteol and contents of the pack
Carteol eye drops, solution, is a clear, colourless solution.
This medicine is available in LDPE bottles (7 ml), each containing 6 ml of solution,
with a dropper made of polypropylene coated with HDPE and a tamper-evident cap made of LDPE.
The dropper has a valve system that prevents contaminated liquid from flowing back into the bottle and
allows filtered air to enter.

Marketing Authorization Holder and Manufacturer
SIFI S.p.A. - Via Ercole Patti, 36 – 95025 Aci S. Antonio (CT)

Detailed and updated information on this product is available by scanning the QR code
shown on the package leaflet and product packaging using a smartphone.
The same information is also available at the following URL:
https://qr.sifigroup.com/1g101830/
[ QRcode ]

Patient information leaflet

CARTEOL 10 mg/ml Eye Drops, Solution, 20 mg/ml Eye Drops, Solution

Carteolol Hydrochloride
Pharmacotherapeutic Category
Therapeutic Indications
Carteol is indicated for the treatment of ocular hypertension and primary open-angle glaucoma. Treatment with Carteol, by reducing intraocular pressure, helps prevent glaucoma-related complications that may impair visual function.

Contraindications
Do not use Carteol:

• if you are allergic to or have previously experienced hypersensitivity reactions to carteolol hydrochloride, beta-blockers, or any of the other components of this medicine;
• if you suffer from or have previously suffered from respiratory diseases such as asthma or severe chronic obstructive pulmonary disease (COPD) (a serious lung condition that may cause shortness of breath, breathing difficulties, and/or persistent cough);
• if you have congestive heart failure, overt heart failure, or cardiogenic shock;
• if you have cardiac rhythm disorders (sinus bradycardia, sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block not controlled by a pacemaker);
• during pregnancy and breastfeeding.

Precautions for Use
Consult your doctor or pharmacist before using Carteol.
Before using this medicine, inform your doctor if you have or have previously had:

• chronic heart diseases (symptoms may include chest pain or tightness, dyspnea, or suffocation), heart failure, low blood pressure;
• heart rate disorders such as slow heartbeat;
• respiratory problems, asthma, or chronic obstructive pulmonary disease. In asthmatic patients, respiratory reactions (including death due to bronchospasm) have been reported following administration of some ophthalmic beta-blockers;
• conditions characterized by poor blood circulation (e.g., Raynaud's syndrome);
• diabetes, as carteolol hydrochloride may mask signs and symptoms of low blood sugar (hypoglycemia);
• overactivity of the thyroid gland, as carteolol hydrochloride may mask its signs and symptoms. Abrupt discontinuation of beta-blocker therapy may accelerate worsening of hyperthyroidism symptoms;
• pheochromocytoma, as use of beta-blockers in treating hypertension due to treated pheochromocytoma requires close monitoring of blood pressure;
• beta-blocker therapy may worsen symptoms of myasthenia gravis and psoriasis.

Before undergoing surgery, inform your doctor that you are using Carteol, as carteolol hydrochloride may influence the effects of certain drugs used during anesthesia.
Particular caution is advised when administering Carteol to elderly patients, patients with renal and/or hepatic impairment, and when Carteol is used concomitantly with systemic beta-blocking agents.
This product should be used with caution in patients with compromised corneas and in cases where the patient uses other ophthalmic products containing phosphates (see section “Undesirable Effects”).
Discontinue treatment and consult your doctor for appropriate management if signs of sensitization to the components of the medicine occur.

Drug Interactions
Carteol may interact with or be influenced by other medications being used, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use other medicines, especially those used to lower blood pressure, for heart conditions, or for diabetes treatment.
Specifically, inform your doctor if you are taking other medications containing phosphates. Your doctor will monitor your cornea at regular intervals.

Special Warnings
Children and Adolescents
The safety and efficacy of Carteol in children and adolescents have not been established. Its use is not recommended in pediatric patients due to lack of clinical data.

Pregnancy and Breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, the product should only be administered when clearly needed and under direct medical supervision.
Do not use Carteol during breastfeeding. Carteolol hydrochloride may pass into breast milk.

For Athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Driving and Use of Machines
Carteolol hydrochloride has a moderate influence on the ability to drive vehicles and operate machinery. Possible adverse effects such as dizziness, fatigue, or visual disturbances (including double vision, eyelid drooping, blurred vision) may interfere with driving and machine use in some patients.
If you experience one or more of these effects, do not drive or operate machinery until symptoms resolve.

Carteol multi-dose eye drops contain benzalkonium chloride: this preservative may cause ocular irritation or alter the ocular surface. It can be absorbed by contact lenses and is known to discolor soft contact lenses. Therefore, avoid contact between this medicine and soft contact lenses.

Dosage, Method and Duration of Administration
The recommended dose is one drop twice daily of Carteol 10 mg/ml for patients who have never been previously treated pharmacologically.
If the therapeutic response is insufficient, switching to the higher concentration eye drop is advisable. If necessary, therapy may be combined with parasympathomimetic agents, adrenaline, or carbonic anhydrase inhibitors.
When replacing other anti-glaucoma eye drops with Carteol, it is recommended to discontinue the previous treatment after a full day of therapy and start Carteol the following day, instilling one drop twice daily.

Instructions for Use
Multi-dose Eye Drops

1. Wash/hygiene your hands thoroughly.
2. Ensure the protective cap is intact before use.
3. Remove the protective cap and unscrew the cap.
4. Tilt your head backward. Gently pull down the lower eyelid of the affected eye with your fingers.
5. Invert the bottle and instill the eye drop by applying gentle pressure to the bottle, taking care not to touch the eye, eyelid, or any other surface with the tip of the bottle to avoid contamination.
6. Close the eye and press a finger against the inner corner of the affected eye near the nose. Hold for 2 minutes.
7. Repeat the procedure in the other eye, if necessary.
8. Close the bottle by screwing the cap back on immediately after use.

9. Remember to write the date of first opening on the box.

Contact Lens Wearers
If you wear contact lenses, remove them before using multi-dose Carteol eye drops.
Wait 15 minutes after administering Carteol before reinserting your contact lenses.
If you need to use Carteol while wearing soft contact lenses, use the preservative-free single-dose formulation of Carteol eye drops.

Single-dose Eye Drops

1. Wash/hygiene your hands thoroughly.
2. Open the aluminum pouch and detach the single-dose unit from the strip.
3. Ensure the single-dose unit is intact.
4. Open by twisting the top part without pulling.
5. Tilt your head backward. Gently pull down the lower eyelid of the affected eye with your fingers.
6. Instill the eye drop, taking care not to touch the eye, eyelid, or any other surface with the tip of the single-dose unit to avoid contamination.
7. Close the eye and press a finger against the inner corner of the affected eye near the nose. Hold for 2 minutes.
8. Repeat the procedure in the other eye, if necessary.

If you use more eye drops than you should, it is unlikely to cause problems. Apply the next dose as usual.
Do not use a double dose to compensate for a missed dose.
Do not stop treatment with Carteol without consulting your doctor.
If you are using other ophthalmic products, wait at least 5 minutes between using one product and the next. Ointments should be used last.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

Undesirable Effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Like other ophthalmic medicines, carteolol hydrochloride can be absorbed into the bloodstream; this may cause adverse effects similar to those observed with intravenous and/or oral beta-blockers. The likelihood of experiencing adverse effects with eye drop administration is lower than with systemic administration (when medicines are taken orally or by injection).
The listed adverse effects include reactions observed within the class of ophthalmic beta-blockers.

Immune System Disorders:
Generalized allergic reactions including subcutaneous swelling, which may occur in areas such as the face and limbs and may obstruct airways causing difficulty in swallowing and breathing, urticaria, localized and generalized skin rash, pruritus, sudden severe allergic reaction with life-threatening risk, systemic lupus erythematosus.

Metabolism and Nutrition Disorders:
Hypoglycemia (low blood glucose levels).

Psychiatric Disorders:
Sleep disturbances (insomnia), depression, nightmares, memory loss.

Nervous System Disorders:
Dizziness, headache, fainting, stroke, cerebral ischemia (reduced blood supply to the brain).

Eye Disorders:
Signs and symptoms of eye irritation (e.g., burning, stinging, itching, tearing, redness), blepharitis (inflammation of the eyelid), corneal inflammation, blurred vision, choroidal detachment (separation of the vascular layer beneath the retina) following filtering surgery which may cause visual disturbances, reduced corneal sensitivity, dry eyes, corneal erosion, upper eyelid drooping (causing partial closure of the eye), double vision.
In very rare cases (fewer than 1 in 10,000 people), some patients with severe damage to the clear front layer of the eye (cornea) have developed cloudy spots on the cornea due to calcium accumulation during treatment.

Cardiac Disorders:
Bradycardia (reduced heart rate), chest pain, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease associated with shortness of breath and swelling of feet and legs due to fluid accumulation), heart attack, heart failure.

Vascular Disorders:
Hypotension (reduced blood pressure), Raynaud's syndrome, cold hands and feet.

Respiratory, Thoracic and Mediastinal Disorders:
Constriction of pulmonary airways (mainly in patients with pre-existing disease), breathing difficulties, cough.

Gastrointestinal Disorders:
Taste disturbances, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.

Skin and Subcutaneous Tissue Disorders:
Hair loss, psoriasiform dermatitis (silver-colored skin eruptions) or worsening of psoriasis, skin rash.

Musculoskeletal and Connective Tissue Disorders:
Worsening of signs and symptoms of myasthenia gravis (muscle disease), muscle weakness/fatigue, muscle pain not due to physical exertion.

Reproductive System and Breast Disorders:
Sexual dysfunction, decreased libido, impotence.
There are insufficient data available to determine the frequency of the above-mentioned effects.

Reporting of Adverse Effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

Expiry and Storage
Expiry: see the expiry date on the packaging.
The expiry date refers to the product in unopened packaging stored correctly.
Warning: do not use the medicine after the expiry date stated on the packaging.
This medicine does not require special storage conditions.
Multi-dose Carteol should not be used more than 28 days after first opening.
Single-dose Carteol should be used immediately after opening. Any remaining solution must not be reused.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

Composition
Multi-dose Eye Drops, Solution
100 ml contains:
Active Substance: Carteolol hydrochloride 1 g – 2 g
Excipients: Monobasic monohydrate sodium phosphate - Dibasic dodecahydrate sodium phosphate - Sodium chloride - Benzalkonium chloride - Purified water.

Single-dose Eye Drops, Solution
100 ml contains:
Active Substance: Carteolol hydrochloride 1 g – 2 g
Excipients: Monobasic monohydrate sodium phosphate - Dibasic dodecahydrate sodium phosphate - Sodium chloride - Purified water.

Pharmaceutical Form and Contents
Eye drops, solution in 5 ml bottle
Eye drops, solution 30 single-dose units of 0.3 ml each

Marketing Authorization Holder and Manufacturer
S.I.F.I. S.p.A. - Via Ercole Patti, 36 - 95025 Aci S. Antonio (CT)
Under license from Otsuka Pharmaceutical Co. Ltd.