ANTICUDE

Introduction

Package Leaflet: Information for the User

ANTICUDE 25mg/2ml ampoules

Edrophonium Bromide

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

• Keep this 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 symptoms are the same as yours.
• If you experience 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 pack

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

1. What Anticude is and what it is used for

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

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

2. What you need to know before you use Anticude

Do not use Anticude

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

Take special care with Anticude

In hyperadrenergic states.

Using other medicines

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

No interactions with other medicines have been described for Anticude.

The use of Anticude is incompatible with any sympathomimetic or anticholinergic agent.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Important information about some of the ingredients of Anticude

This medicine contains Sodium Bisulfite (E-222), which may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains 0.8mg per ampoule.

This medicine 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 of Anticude indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

Anticude is administered exclusively by the intravenous route.

If you use more Anticude than you should

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 Anticude

Do not use a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Anticude can cause side effects, although not everybody gets them.

No side effects are known, and it is also exempt from the secondary effects inherent to most cholinesterase inhibitors, such as hypotension, salivation, etc., which should be avoided in the post-operative patient.

No cases of clinical intoxication due to Edrophonium effects have been described. However, if this incidence occurs, drugs with antagonistic action should be administered, i.e., sympathomimetics or anticholinergics.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storing Anticude

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Anticude after the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

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

Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Anticude

• The active ingredient is Edrophonium bromide. Each 2mL ampoule contains 25mg of Edrophonium bromide.
• The other ingredients are: Sodium Chloride, Sodium Bisulfite, and Water for Injection.

Appearance of the product and contents of the pack

Box with 2 ampoules of 2mL.

Marketing Authorisation Holder:

MANA PHARMA, S.L.

Carr. Fuencarral 22

Alcobendas 28108

(Madrid) Spain

Phone: 910 68 44 50

Manufacturer:

• BRAUN MEDICAL, S.A.

Ronda de los Olivares

Polígono Industrial Los Olivares

Parcela 11

23009, Jaén, Spain

Phone: +34 953 24 98 80

Fax: +34 953 28 13 51

Date of the last revision of this leaflet11/2023

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