Atracurium Besilate 10mg/ml solution for Injection/Infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• 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.

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

• if you are allergic to atracurium besilate or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty of breathing or swelling of the face, lips, throat or tongue. You may know this from earlier experience.

Before you receive Atracurium, tell your doctor if you have:

• a disease that affects the muscles and/or their nervous control (neuromuscular disease such as myasthenia gravis or Eaton-Lambert syndrome)
• a severe electrolyte disorder
• cancer spread widely from a primary source (carcinomatosis)
• a sensitivity to histamine
• asthma-like symptoms (a history of allergy, asthma or bronchospasm)
• burns
• lack of adequate circulatory filling (hypovolaemia)

Children:

The use of Atracurium is not recommended in neonates (children under the age of one month). In the case of necessary treatment in newborn or premature newborn the dose has to be significantly lowered. Ask your doctor if you have any further questions.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines This is especially important with the following medicines as they may interact with your Atracurium:

• antibiotics (e.g. aminoglycosides, polymyxins, spectinomycin, tetracyclines, lincomycin, clindamycin and vancomycin)
• antiarrhythmic medicines (used to control the rhythm of the heart e.g. lidocaine, procainamide, quinidine)
• diuretics (water tablets, e.g. furosemide, thiazides, acetazolamide and mannitol)
• medicines used to control blood pressure, angina or other heart problems (e.g. propranolol, oxprenolol diltiazem, nicardipine, nifedipine and verapamil)
• antiepileptic medicines (e.g. carbamazepine, phenytoin)
• drugs used to treat rheumatism (e.g. chloroquine, d-penicillamine)
• corticosteroids (used to treat inflammation)
• trimetaphan, hexamethonium (used to lower blood pressure during surgery)
• dantrolene (a muscle relaxant)
• magnesium sulphate
• ketamine (an anaesthetic drug)
• lithium, chlorpromazine (treatment of mental illness)
• quinine (treatment of malaria or leg cramps)

It may still be all right for you to be given Atracurium and your doctor will be able to decide what is suitable for you.

Atracurium should not be given to pregnant women unless medically justified. Mothers should stop breast-feeding for 24 hours after receiving Atracurium. 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 taking this medicine.

After you have been given Atracurium, you must not drive, operate machinery, or work in dangerous situations. You should not go home alone and should not drink alcohol until fully recovered.

Atracurium is used during procedures that require that the patient is fully anaesthetized (unconscious), or heavily sedated.

The dosing will be worked out by the doctor. Atracurium must be given only by injection directly into a vein (intravenous use). Atracurium must not be injected into a muscle.

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

Common (may affect up to 1 in 10 people)

• tachycardia (rapid heartbeat)
• temporary hypotension (low blood pressure)
• wheezing
• bronchospasm (asthma-like symptoms)
• skin flushing
• urticaria (nettle rash)

Very rare (may affect up to 1 in 10,000 people)

• myasthenia and/or myopathy (weak or non-working muscles)
• severe allergic reactions including shock, circulatory failure and heart attack in patients receiving atracurium with one or more anaesthetic drugs
• seizures (fits) when taken with other drugs in at-risk patients
• laryngospasm (spasm of the vocal cords)

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is atracurium besilate.

1 ml of Atracurium contains 10 mg of atracurium besilate.

One ampoule with 2.5 ml solution contains 25 mg atracurium besilate

One ampoule with 5.0 ml solution contains 50 mg atracurium besilate.

The other ingredients are water for injections and benzenesulfonic acid.

Atracurium is a clear and colourless solution for injection/infusion.

3 ml or 5 ml clear glass ampoules

Box of 5 ampoules with 2.5 or 5 ml

Box of 10 ampoules with 2.5 or 5 ml

Box of 5 x 10 ampoules with 2.5 or 5 ml

Not all pack sizes may be marketed.

This medicinal product is authorised in the Member States of the EEA under the following names:

DE: Atracurium-hameln 10 mg/ml Injektions-/Infusionslösung

NL: Atracurium-hameln 10 mg/ml oplossing voor injectie/infusie

ES: Besilato de Atracurio-hameln 10 mg/ml solución inyectable y para perfusión EFG

SE: Atracurium-hameln 10 mg/ml injektions-/infusions vätska, lösning

UK: Atracurium besilate 10 mg/ml solution for injection/infusion