Anticude leaflet – Spain

How to use Anticude

Introduction

Package Insert: Information for the User

ANTICUDE 25mg/2ml ampoules

Edrofonium Bromide

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

Keep this package insert, as you may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medication has been prescribed to you alone, 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 package insert. See section 4.

1. What Anticude is and for what it is used

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

3. How to use Anticude

4. Possible adverse effects

5. Storage of Anticude

6. Contents of the package and additional information

1. What is Anticude and what is it used for

Anticude is a medication used as an antidote for curarizing agents, including synthetic ones, in prolonged apnea and in any syndrome that involves atonia of the striated or smooth muscle.

It is also used for the diagnosis and treatment of myasthenia gravis and to facilitate differential diagnosis of arrhythmias caused by digitalis intoxication.

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

Do not use Anticude

If you are allergic (hypersensitive) to Edrofonium bromide or to any of the other components of Anticude.

Be especially careful with Anticude

In hyperadrenergic states.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

No interactions of Anticude with other medications have been described.

Anticude is incompatible with the use of any sympathomimetic or anticholinergic.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Important information about some of the components of Anticude

This medication contains Sodium bisulfite (E-222) so it may produce severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains 0.8mg per ampoule.

This medication contains less than 23mg (1mmol) of sodium per ampoule, so it is considered essentially "sodium-free".

3. How to use Anticude

Follow exactly the administration instructions for Anticude as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Although the average dose as an antidote for myorelaxants is 1 to 3 ampoules, it varies according to the clinician's criteria, the patient's idiosyncrasy, and the type of curarizing agent employed whose action is of interest to antagonize.

Anticude is administered exclusively by intravenous route.

If you use more Anticude than you should

Consult your doctor, pharmacist immediately, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Anticude

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

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

4. Possible Adverse Effects

Like all medications, Anticude may produce adverse effects, although not all people will experience them.

No known adverse effects are known, and it is exempt from the secondary effects inherent to most cholinesterase inhibitors, such as hypotension, salivation, etc., which should be avoided in the recently operated.

No clinical intoxication cases have been described due to effects of Edrofonio. However, if this incidence occurs, antagonistic action drugs, that is, sympathomimetics or anticholinergics, should be administered.

If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Conservation of Anticude

No requires special conditions for conservation.

Keep out of reach and sight of children.

Do not use Anticude after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use Anticude ampoules if you observe visible signs of deterioration.

Dispose of the packaging and medications you do not need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you do not need. In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Anticude

The active principle is Edrofonio bromide. Each ampule of 2mL contains 25mg of Edrofonio bromide.
The other components are: Sodium chloride, Sodium bisulfite, and Water for injection c.s.

Appearance of the product and contents of the packaging

Box with 2 ampules of 2mL.

Holder of the marketing authorization:

MANA PHARMA, S.L.

Carr. Fuencarral 22

Alcobendas 28108

(Madrid) Spain

Telephone: 910 68 44 50

Responsible for manufacturing:

B. BRAUN MEDICAL, S.A.

Ronda de los Olivares

Polígono Industrial Los Olivares

Parcela 11

23009, Jaén, Spain

Telephone:+34 953 24 98 80

Fax: +34 953 28 13 51

Date of the last review of this leaflet11/2023

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