Acetylcholine 10 mg/ml Cusí powder and solvent for solution for intraocular instillation

Patient Information Leaflet

Introduction

Patient Information Leaflet

ACETYLCHOLINE 10 mg/ml CUSÍ powder and solvent for solution for intraocular instillation

Read the entire leaflet carefully before you start using this medicine, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What ACETYLCHOLINE 10 mg/ml CUSÍ is and what it is used for
2. What you need to know before ACETYLCHOLINE 10 mg/ml CUSÍ is administered to you
3. How to use ACETYLCHOLINE 10 mg/ml CUSÍ
4. Possible side effects
5. How to store ACETYLCHOLINE 10 mg/ml CUSÍ
6. Contents of the pack and other information

Your doctor will administer ACETYLCHOLINE 10 mg/ml CUSÍ to you. This leaflet aims to inform you about the medicine.

1. What Acetilcolina 10 mg/ml CUSÍ is and what it is used for

The active substance in this medicine is acetylcholine chloride, which is involved in the transmission of nerve impulses in the body. Among other sites, it acts on a muscle in the iris of the eye.

Acetilcolina 10 mg/ml CUSÍ is indicated during cataract surgery and other types of anterior segment eye surgeries to constrict the pupil (the central part of the eye). This helps the surgeon to complete the procedure.

2. What you need to know before Acetylcholine 10 mg/ml CUSÍ is administered to you

Do not use Acetylcholine 10 mg/ml CUSÍ

• If you are allergic to acetylcholine chloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before Acetylcholine 10 mg/ml CUSÍ is administered to you.

Tell your doctor if you have:

• Closed-angle glaucoma
• Cardiovascular problems
• Bronchial asthma
• Ulcers
• Overactivity of the thyroid gland
• Intestinal problems
• Urinary tract problems
• Parkinson's disease

Patients over 65 years of age

Elderly patients (over 65 years) should exercise special caution, as they may be more prone to experience a drop in blood pressure (hypotension) and/or decreased heart rate (bradycardia) due to systemic absorption of the medicine.

Children

The safety and efficacy of Acetylcholine 10 mg/ml CUSÍ in children has not been established.

Other medicines and Acetylcholine 10 mg/ml CUSÍ

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interfere with the mechanism of action of this medicine. Inform your doctor if you are applying to your skin preparations containing NSAIDs (non-steroidal anti-inflammatory drugs) to treat pain and swelling.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before this medicine is administered to you.

Acetylcholine 10 mg/ml CUSÍ is not recommended during pregnancy.

If you are breastfeeding, you must decide whether to discontinue breastfeeding or discontinue treatment with this medicine, taking into account the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

You may experience difficulty adapting to darkness, blurred vision, and other visual disturbances for a prolonged period of time. Do not drive or operate machinery until this effect has disappeared.

3. How to use Acetylcholine 10 mg/ml CUSÍ

This medicine is for Hospital Use Only.

This medicine must be administered only by your doctor during eye surgery.

Recommended dose:

Adults

Your doctor will calculate the correct dose of this medicine for you.

If using the extemporaneous 10 mg/ml solution (a solution prepared for immediate use), it must be prepared according to the Reconstitution Instructions described below.

Using 0.5 to 2 ml usually achieves adequate pupil contraction (miosis) within seconds. The effect lasts for 10–20 minutes. If prolonged miosis is required, the application may be repeated, or an ophthalmic solution of pilocarpine (2%) may be used after surgery and before application of the eye dressing.

Your doctor will decide when to use this solution. In cataract surgery, it should only be used after lens extraction.

Your doctor will administer this medicine following the instructions below:

• Using a needle, draw the contents of the ampoule into a dry, sterile syringe.
• Add it to the vial containing the lyophilized acetylcholine chloride (powder).
• Gently shake until the powder is completely dissolved.
• Draw the solution back into the syringe and replace the needle with an appropriate atraumatic cannula for intraocular instillation.
• Instill the acetylcholine solution into the anterior chamber before or after securing one or more sutures.
• Instillation should be gentle, parallel to the iris plane, and tangential to the pupil margin.
• It is not necessary to remove the solution from the eye's anterior chamber after miosis has been achieved.
• Acetylcholine chloride solution is unstable. Therefore, it must be prepared by a healthcare professional immediately before use, and any unused solution must be discarded.

Use in children

The efficacy and safety of Acetylcholine 10 mg/ml CUSÍ have not been studied in children; therefore, its use is not recommended.

Use in elderly patients

See section 2, "Warnings and precautions."

If you use more ACETYLCHOLINE 10 mg/ml CUSÍ than you should

If more than the recommended amount is used, your doctor may need to administer an injection of atropine or other anticholinergic drugs to control symptoms.

Symptoms of overdose may include: slow heart rate, low blood pressure, flushing, difficulty breathing, and sweating.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are classified by frequency, defined as follows: Very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

The following adverse effects have been reported with this medicine:

Frequency not known:

• Eye effects: swelling or clouding of the cornea (the transparent layer protecting the front of the eye), inflammation inside the eye. This may affect your vision.

• General effects: flushing, sweating, slow heart rate, low blood pressure, and difficulty breathing. These effects rarely occur when acetylcholine is absorbed from the eye into the rest of the body. Patients over 65 years of age may be more likely to experience these effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcholine 10 mg/ml CUSÍ

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Use immediately after preparing the solution and discard any unused solution.

Do not use this medicine after the expiry date stated on the vial and carton following EXP. The expiry date refers to the last day of the month indicated.

6. Contents of the pack and other information

Composition of ACETYLCHOLINE 10 mg/ml CUSÍ

• The active substance is acetylcholine chloride. One ml of the reconstituted solution contains 10 mg of acetylcholine chloride (1%).
• The other components are mannitol (E-421) in the vial and water for injections in the ampoule.

Appearance of the medicinal product and contents of the container

The medicine is presented as a powder and solvent for solution for intraocular instillation.

The pack contains one vial with white powder and one ampoule with a clear, colourless solvent. The powder must be reconstituted with the solvent prior to use, resulting in a clear, colourless solution.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder and Manufacturer

Fidia Farmaceutici S.p.A.

Via Ponte della Fabbrica, 3/A - 35031 Abano Terme – Italy

Local representative

Laboratorios Fidia Farmacéutica S.L.U.

Parque Empresarial de la Moraleja

Edificio Torona. Avenida de Europa, 24 – Edificio A – 1 B

Alcobendas 28108 | Madrid Spain

Date of the most recent review of this leaflet: November 2016.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/