Rapibloc 300 mg powder for solution for infusion

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

The full name of your medicine is Rapibloc 300 mg powder for solution for infusion. In this leaflet the shorter name Rapibloc is used.

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

• You are allergic to landiolol or any of the other ingredients of this medicine (listed in section 6).
• You have a very slow heartbeat (less than 50 beats per minute).
• You have a fast or alternating fast and slow heartbeat (a problem called the “sick sinus” syndrome).
• You have a problem called “severe heart block”. Heart block is a problem with the electrical messages that control your heartbeat.
• You have a problem with the blood supply to your heart (a problem called “cardiogenic shock”).
• You have very low blood pressure.
• You have serious heart failure symptoms.
• You have increased pressure in the lungs (pulmonary hypertension).
• You have a gland disease called phaeochromocytoma which has not been treated. Phaeochromocytoma arises from the adrenal gland and may cause a sudden increase of blood pressure, severe headache, sweating and increased heartbeat.
• You have asthma symptoms that are worsening rapidly.
• You have very high levels of acids in your body (severe metabolic acidosis) which cannot be corrected.

You will not be given Rapibloc if any of the above applies to you. If you are not sure if you have any of these conditions, talk to your doctor or nurse before having this medicine.

• Talk to your doctor or nurse before being given this medicine.
• Rapibloc is a powder and must be dissolved by your doctor or nurse before it is given to you.
• Usually, your heartbeat, blood pressure and the electrical activity of your heart will be continuously monitored while you are treated with this medicine.

Your doctor will take special care with this medicine if:

• You have diabetes or low blood sugar. Landiolol can mask the symptoms of a low blood sugar.
• You have low blood pressure.
• You have a problem called “pre-excitation syndrome” in combination with an irregular and rapid heartbeat (atrial fibrillation).
• You have problems with the electrical messages that control your heartbeat (heart block).
• You have problems with the progression of electrical impulses through the heart and are receiving verapamil or diltiazem.
• You have a particular type of angina (chest pain) called “Prinzmetal´s angina”.
• You have or had heart problems (such as congestive heart failure). Your doctor will monitor you very closely for any heart symptoms. If necessary, the treatment will be stopped, the dosage lowered, or special treatment initiated.
• You have certain heart rhythm disorders called supraventricular arrhythmias and you:
  • have other heart problems or
  • are taking other heart medicines
• You have kidney problems.
• You have a gland disease called phaeochromocytoma which has been treated with medicines called alpha-receptor blockers.
• You have narrowing of your airways or wheezing, such as with asthma.
• You have circulation problems, such as paleness of your fingers (Raynaud’s disease) or aching, tired and sometimes burning pains in your legs.
• You have any allergies, or you are at risk of anaphylactic reactions (severe allergic reactions). Rapibloc can make allergies more severe and more difficult to treat.

If any of the above applies to you (or you are not sure), talk to your doctor or nurse before being given this medicine.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines that you have obtained yourself, without a prescription, including herbal medicines and natural products. Your doctor will check that any other medicines you are taking will not alter the way that Rapibloc works.

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

• Medicines used to treat heart rhythm problems (such as diltiazem, verapamil, propafenone, disopyramide, amiodarone, digoxin, digitalis) and high blood pressure (such as nifedipine).
• Medicines used to treat diabetes, including insulin and medicines taken by mouth.
• Medicines usually used during an operation to relax your muscles (such as suxamethonium) or medicines used to reverse the effect of muscle relaxants called cholinesterase inhibitors (such as neostigmine, distigmine, edrophonium). Your doctor will also take special care when using Rapibloc during operations, when you will be receiving anaesthetics and other treatments.
• Medicines known as ganglion blocking agents (such as trimetaphan).
• Medicines used as pain killers, such as non-steroidal anti-inflammatory drugs known as NSAIDs.
• Floctafenine, which is a pain killer.
• Amisulpride, a medicine that is used to treat mental problems.
• “Tricyclic” antidepressant medicines (such as imipramine and amitriptyline).
• Barbiturates (such as phenobarbital, used to treat epilepsy).
• Phenothiazines (such as chlorpromazine, used to treat mental disorders).
• Medicines used to treat asthma.
• Medicines used to treat colds or a blocked nose, called “nasal decongestants”.
• Medicines that can lower the blood pressure (such as reserpine and clonidine).
• Epinephrine, which is used to treat allergic reactions.
• Heparin, which is used to thin the blood.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before having Rapibloc.

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

There are no data available about the use of Rapibloc during pregnancy. Because of the lack of experience, the use of this medicine during pregnancy is not recommended.

Tell your doctor if you are breast-feeding. Rapibloc may pass into breast milk, so you should not be given this medicine if you are breast-feeding.

If you have liver problems, your doctor will start your treatment with a lower dose.

There is limited experience on the use of Rapibloc in children and adolescents. Your doctor will decide about the treatment with Rapibloc.

If you have the feeling that you have received too much Rapibloc, tell your doctor or nurse straight away.

Your doctor will take appropriate measures (your treatment may be stopped immediately, and you may receive supportive therapy).

You may experience the following symptoms if you have been given too much of this medicine:

• Severe drop in blood pressure (you may feel dizzy or lightheaded)
• Very slow heartbeat
• Reduced heart function
• Shock occurring because of decreased heart function
• Breathing problems
• Loss of consciousness ranging to coma
• Convulsions (cramps)
• Nausea
• Vomiting
• Low blood sugar
• High blood potassium level (hyperkalaemia)

Suddenly stopping Rapibloc does usually not cause symptoms of a rapid heartbeat (tachycardia) to return. Your doctor will monitor you closely if your treatment with this medicine will be stopped.

If you get any side effects, talk to your doctor 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 landiolol hydrochloride. A vial contains 300 mg landiolol hydrochloride (as a powder) which is equivalent to 280 mg landiolol. After dilution, 1 ml contains 6 mg of landiolol hydrochloride.

The other ingredients are mannitol and sodium hydroxide (to ensure the correct pH).

Rapibloc is a powder for solution for infusion which is white to almost white.

The pack size is one 50 ml vial.