Prospect: information for the user

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

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people 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 prospect. See section 4

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

The active substance of this medication is acetylcholine chloride, which is involved in the transmission of nerve impulses in the body. It acts, among other places, on a muscle of the iris of the eye.

Acetilcolina 10 mg/ml Cusí is indicated during cataract surgery and other types of operations on the anterior segment of the eyes to constrict the pupil (central part of the eye). This helps the surgeon to complete the operation.

Do not administer Acetilcolina 10 mg/ml Cusí

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

Warnings and precautions

Consult your doctor before Acetilcolina 10 mg/ml Cusí is administered to you.

Inform your doctor if you have:

• Angle-closure glaucoma
• Cardiovascular problems
• Asthma bronchial
• Ulcers
• Hyperthyroidism
• Gastrointestinal problems
• Urinary tract problems
• Parkinson's disease

Patients over 65 years old

Patients over 65 years old should exercise special caution as they may be more prone to experiencing a drop in blood pressure (hypotension) and/or a decrease in heart rate (bradycardia) due to the medication reaching the blood.

Children

The safety and efficacy of Acetilcolina 10 mg/ml Cusí in children have not been established.

Other medications and Acetilcolina 10 mg/ml Cusí

Inform your doctor if you are using, have used recently, or may need to use any other medication.

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

Pregnancy, breastfeeding, and fertility

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

Acetilcolina 10 mg/ml Cusí is not recommended during pregnancy.

If you are breastfeeding, you should decide whether to stop breastfeeding or interrupt treatment with this medication, taking into account the benefits of breastfeeding for the child and the benefits of treatment for the mother.

Driving and operating machinery

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

This medication is for hospital use only.

This medication should be administered only by your doctor during eye surgery.

The recommended dose is:

Adults

Your doctor will calculate the correct dose that corresponds to you from this medication.

If you use the extemporaneous solution of 10 mg/ml (solution prepared to be able to use the medication); it is prepared according to the Reconstitution Instructions that are explained below.

With the use of 0.5 to 2 ml, in most cases, a suitable pupil contraction (miosis) is achieved in a few seconds. The effect lasts for 10-20 minutes. If a longer miosis is needed, the application can be repeated, or a pilocarpine solution (2%) can be used via the eye after surgery and before applying the dressing.

Your doctor will decide when to use this solution. In cataract surgery, it should only be used after the crystalline lens has been extracted.

Your doctor will administer this medication following the instructions below:

• With the help of a syringe, aspirate the contents of the vial into a dry and sterile syringe.
• Add it to the vial containing lyophilized acetylcholine chloride (powder).
• Shake carefully until the powder is dissolved.
• Aspirate the solution again with 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.
• The instillation should be smooth, parallel to the iris face, and tangential to the pupil edge.
• It is not necessary to remove the acetylcholine solution from the anterior chamber of the eye after achieving miosis.
• The acetylcholine chloride solution is unstable. Therefore, it must be prepared by a healthcare professional immediately before use and discarded if not used.

Use in children

The efficacy and safety of Acetilcolina 10 mg/ml Cusí have not been studied in children, so it is not recommended for use.

Use in elderly patients

See the "Warnings and precautions" section in section 2.

If you use more ACETILCOLINA 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 medications to control symptoms.

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

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Adverse effects are classified by frequency, which is defined as: Very frequent (may affect more than 1 in 10 people); frequent (may affect up to 1 in 10 people); infrequent (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); unknown frequency (cannot be estimated from available data).

The following adverse effects have been reported with this medication:

Unknown frequency:

• Eye effects: corneal edema or opacity (the transparent layer that protects the front of the eye), inflammation within the eye. This may affect your vision.

• General effects: flushing, sweating, slow heart rate, low blood pressure, and difficulty breathing. These effects occur in rare instances when acetylcholine is absorbed from the eye into the rest of the body. Patients over 65 years old may be more prone to experiencing these effects.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.Reporting adverse effects can help provide more information about the safety of this medication.

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

No special storage conditions are required.

Use immediately after the solution has been prepared and discard any unused solution.

Do not use this medication after the expiration date that appears on the vial and on the box after CAD. The expiration date is the last day of the month indicated.

Composition of ACETILCOLINA 10 mg/ml CUSÍ

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

Appearance of the product and content of the packaging

The medication is presented in powder and solvent for solution for intraocular instillation.

The packaging contains a vial with white powder and an ampoule with transparent and colorless solvent. The powder must be reconstituted with the solvent before use, obtaining a transparent and colorless solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization and responsible for manufacturing

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

Last review date of this leaflet:November 2016.

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/