CISATRACURIO ACCORDPHARMA 5 mg/ml INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Cisatracurio Accordpharma 5 mg/ml solution for injection and infusion 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 experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Cisatracurio 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 Cisatracurio Accordpharma

Do not use Cisatracurio Accordpharma:

• if you are allergic (hypersensitive) to cisatracurium, any other muscle relaxant or 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 Cisatracurio Accordpharma if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before using Cisatracurio Accordpharma.

Be especially careful with Cisatracurio 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 Cisatracurio Accordpharma.

Other medicines and Cisatracurio 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 remove 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 for 3 hours after the end of treatment.

Driving and using machines

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

3. How Cisatracurio Accordpharma is given

How the injection is given

Never try to give yourself this medicine. It should always be given by a person qualified to do so.

Cisatracurio 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 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 too much Cisatracurio Accordpharma

Cisatracurio Accordpharma will always be given under properly controlled conditions. However, if you think you have been given too much medicine, tell your doctor or nurse immediately.

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

4. Possible side effects

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

If you experience 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)

• slow heart rate
• low 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 experience any side effects, talk to your doctor, pharmacist or nurse, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cisatracurio 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 after 24 hours of 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 other information

What Cisatracurio Accordpharma contains

1 ml of solution for injection or infusion contains 6.70 mg of cisatracurium besylate, equivalent to 5 mg of cisatracurium.

1 vial of 30 ml of solution for injection or infusion contains 201 mg of cisatracurium besylate, equivalent to 150 mg of cisatracurium.

The other ingredients are benzenesulfonic acid and water for injections.

Appearance and packaging

Cisatracurio Accordpharma 5 mg/ml solution for injection and infusion is a colourless to light yellow or light yellow-green solution, practically free from visible particles, with a pH of 3.0-5.0, in a box containing one or five glass vials of 30 ml. Each 30 ml vial contains 150 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: Cisatracurio Accordpharma 5 mg/ml solution for injection and infusion EFG.

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

Italy: Cisatracurio Combino Pharm 2 mg/ml Soluzione iniettabile/infusione

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/