CISATRACURIO ACCORDPHARMA 2 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cisatracurium Accordpharma 2 mg/ml Solution for Injection and Perfusion EFG

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Cisatracurium Accordpharma is and what it is used for
2. What you need to know before you are given Cisatracurium Accordpharma
3. How Cisatracurium Accordpharma is given
4. Possible side effects
5. Storage of Cisatracurium Accordpharma
6. Contents of the pack and further information

1. What Cisatracurium Accordpharma is and what it is used for

Cisatracurium Accordpharma contains the active substance cisatracurium besylate, which belongs to a group of medicines called muscle relaxants.

Cisatracurium is used:

• to relax muscles during surgical operations, including heart surgery, in both adults and children over 1 month of age.
• to help with the insertion of a tube into the windpipe (tracheal intubation), if mechanical assistance to breathe is required.
• to relax muscles in adults in Intensive Care

Ask your doctor if you need more information about this medicine.

2. What you need to know before you are given Cisatracurium Accordpharma

Do not use Cisatracurium Accordpharma:

• if you are allergic (hypersensitive) to cisatracurium, to any other muscle relaxant or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously had an allergic reaction to an anaesthetic.

Do not use Cisatracurium Accordpharma if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Cisatracurium Accordpharma.

Take special care with Cisatracurium Accordpharma:

Talk to your doctor, nurse or pharmacist before using this medicine:

• if you have muscle weakness, tiredness or difficulty coordinating your movements (myasthenia gravis)
• if you have a neuromuscular disease that causes muscle wasting, paralysis, motor neuron disease or cerebral palsy
• if you have had burns that required medical attention

If you are not sure if any of the above applies to you, talk to your doctor, nurse or pharmacist before you are given Cisatracurium Accordpharma.

Other medicines and Cisatracurium Accordpharma

Tell your doctor if you are using, have recently used or might use any other medicines.

In particular, tell your doctor if you are taking any of the following medicines:

• anaesthetics (used to reduce sensitivity or pain during surgery)
• antibiotics (used to treat infections)
• medicines used to treat irregular heart rhythms (anti-arrhythmics)
• medicines used to treat high blood pressure (hypertension)
• medicines that help to lose fluids (diuretics), such as furosemide
• medicines for joint inflammation, such as chloroquine or penicillamine
• steroids
• medicines for seizures (epilepsy), such as phenytoin or carbamazepine
• medicines used in psychiatry, such as lithium or chlorpromazine (which may also be used to prevent vomiting)
• medicines that contain magnesium (such as those used to treat indigestion or heartburn)
• medicines used to treat Alzheimer's disease (anticholinesterases such as donepezil)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

A side effect of cisatracurium on the breast-fed baby cannot be excluded; however, it is not expected to occur if breast-feeding is resumed after the effects of the substance have disappeared. Cisatracurium is rapidly eliminated from the body. Women should not breast-feed during the 3 hours following the end of treatment.

Driving and using machines

If you are going to be in hospital for just one day, your doctor will tell you how long to wait before you can leave the hospital or drive. It may be dangerous to drive soon after surgery.

3. How Cisatracurium Accordpharma is given

How the injection is given

Under no circumstances try to give yourself this medicine. It should always be given by a qualified person.

Cisatracurium Accordpharma can be given:

• as a single injection into a vein (intravenous bolus injection)
• as a continuous infusion into a vein. This is when the medicine is given slowly over a long period of time.

Your doctor will decide on the dose and duration of treatment that they think is right for you.

This will depend on:

• your body weight
• the amount and duration of muscle relaxation that is needed
• the expected response of the patient to the medicine.

This medicine should not be given to children under 1 month of age.

If you are given more Cisatracurium Accordpharma than you should

Cisatracurium Accordpharma will always be given under properly controlled conditions. However, if you think you have been given more medicine than you should, tell your doctor or nurse immediately.

If you have any further questions on the use of this product, ask your doctor.

4. Possible side effects

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

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

Allergic reactions (affect less than 1 in 10,000 patients)

If you have had an allergic reaction, tell your doctor or nurse immediately. The signs may include:

• sudden wheezing, chest pain or tightness
• swelling of the eyelids, face, lips, mouth or tongue
• skin rash or hives anywhere on the body
• collapse and anaphylactic shock

Talk to your doctor, nurse or pharmacist if you notice any of the following:

Common side effects (affect less than 1 in 10 patients)

• slowing of the heart rate
• decrease in blood pressure (hypotension)

Uncommon side effects (affect less than 1 in 100 patients)

• skin rash or redness
• wheezing or coughing

Rare side effects (affect less than 1 in 10,000 patients)

• muscle weakness or pain

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cisatracurium Accordpharma

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

Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C). Do not freeze.

Store in the original packaging to protect from light.

If diluted, store the infusion solution between 2°C and 8°C and use within 24 hours. Any unused infusion solution should be discarded 24 hours after preparation.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cisatracurium Accordpharma

1 ml of solution for injection or infusion contains 2.68 mg of cisatracurium besylate, equivalent to 2 mg of cisatracurium.

1 vial of 2.5 ml of solution for injection or infusion contains 6.7 mg of cisatracurium besylate equivalent to 5 mg of cisatracurium.

1 vial of 5 ml of solution for injection or infusion contains 13.4 mg of cisatracurium besylate equivalent to 10 mg of cisatracurium.

1 vial of 10 ml of solution for injection or infusion contains 26.8 mg of cisatracurium besylate equivalent to 20 mg of cisatracurium.

The other ingredients are benzenesulfonic acid and water for injections.

Appearance and packaging

Cisatracurium Accordpharma 2 mg/ml solution for injection and perfusion is a colourless to light yellow or yellow-green solution, practically free from visible particles, with a pH of 3.0-5.0, and is presented in:

• 2.5 ml glass vials in packs of 5 (each 2.5 ml vial contains 5 mg of cisatracurium)
• 5 ml glass vials in packs of 5 (each 5 ml vial contains 10 mg of cisatracurium)
• 10 ml glass vials in packs of 5 (each 10 ml vial contains 20 mg of cisatracurium)

Not all pack sizes may be marketed.

Marketing authorisation holder

Accord Healthcare S.L.U.

World Trade Center. Moll de Barcelona, s/n,

Edifici Est, 6ª planta.

08039, Barcelona

Spain

Manufacturer

B Braun Medical, S.A.

Ronda de Los Olivares, parcela 11.

Pol. Ind. Los Olivares 23009 Jaén

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Spain: Cisatracurium Accordpharma 2 mg/ml solution for injection and perfusion EFG

Portugal: Cisatracúrio Accordpharma 2 mg/ml Solução injectável/perfusão MG

This leaflet was approved inDecember 2023

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