MercuryPharma

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Nicardipine 10 mg/10 ml solution for injection

Nicardipine hydrochloride

Read all of this leaflet carefully before you start taking 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, pharmacist, or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

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

•    The name of your medicine is “Nicardipine 10 mg/10 ml solution for injection” but in the rest of the leaflet it will be called as ‘Nicardipine solution for injection’. What is in this leaflet:

1.    What Nicardipine solution for injection is and what it is used for

2.    What you need to know before you take Nicardipine solution for injection

3.    How to take Nicardipine solution for injection

4.    Possible side effects

5.    How to store Nicardipine solution for injection

6.    Contents of the pack and other information

1. WHAT NICARDIPINE SOLUTION FOR INJECTION IS AND WHAT IT IS USED FOR

Nicardipine solution for injection contains Nicardipine hydrochloride, which belongs to a group of medicines called calcium channel blockers. Nicardipine solution for injection is used to treat very severe high blood pressure. It can also be used to control high blood pressure after an operation.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NICARDIPINE SOLUTION FOR INJECTION

Do not take Nicardipine solution for injection

•    If you are allergic to Nicardipine or any of the other ingredients of this medicine (listed in section 6)

•    If you have chest pain

•    If your high blood pressure is because of narrowing of a heart valve or other defects in the heart

•    If you have had a heart attack in the last eight days.

Warnings and precautions:

Your doctor will take special care:

•    If you have heart failure

•    If you have angina

•    If your liver is not working properly, or you have had liver disease in the past

•    If you have high pressure in the brain

•    If you have suffered a recent stroke

•    If you are taking beta-blockers

•    If you are pregnant

•    If you are under 18 years of age.

• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you have these conditions, your doctor may need to monitor additional tests or change the dose. If any of the above apply to you, or you are not sure, tell your doctor before receiving Nicardipine solution for injection.

Other medicines and Nicardipine solution for injection

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Nicardipine solution for injection can affect the way some other medicines work. Also, some other medicines can affect the way Nicardipine solution for injection works.

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

•    Dantrolene (used to treat long-term muscle stiffness)

•    Beta-blockers (used to treat high blood pressure and heart conditions) such as propranolol, atenolol and metoprolol

•    Medicines used to control seizures, such as carbamazepine, phenobarbitone, primidone and phenytoin

•    Baclofen (used to treat muscle spasms)

•    Medicines used to control the body’s immune system, such as tacrolimus, sirolimus and ciclosporin

•    Itraconazole (used to treat certain types of fungal infection)

•    Rifampicin (used to treat tuberculosis and certain other types of infection)

•    Alpha-blockers (used to treat high blood pressure, or prostate problems in men) such as doxazosin, prazosin and terazosin

•    Any other medicine for high blood pressure

•    Cimetidine (to treat indigestion or stomach ulcers)

•    Digoxin (used for heart conditions)

•    Amifostine (used to protect against the harmful effects of certain cancer treatments)

•    Medicines to treat depression, anxiety or other mental health problems

•    Strong painkilling medicines like morphine or codeine

•    Medicines used to treat inflammation such as steroids and tetracosactide

•    Magnesium injection (used to treat severe high blood pressure in pregnancy).

If you are having an operation, your anaesthetist will need to know which other medicines you are taking, as some of these can affect the way Nicardipine solution for injection works.

Do not drink grapefruit juice or eat grapefruit whilst taking this medication as it may increase the blood levels of Nicardipine.

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The following information is intended for medical or healthcare professionals only:

Posology and method of administration:

Nicardipine solution for injection should be administered by continuous intravenous infusion only. It should only be administered by specialists in well controlled environments, such as hospitals and intensive care units, with continuous monitoring of blood pressure. The speed of administration must be accurately controlled by the use of an electronic syringe driver or a volumetric pump. Blood pressure and heart rate must be monitored at least every 5 minutes during the infusion, and then until vital signs are stable, but at least for 12 hours after the end of the administration of Nicardipine.

The antihypertensive effect will depend on the administered dose. The dosage regimen to achieve the desired blood pressure can vary depending on the targeted blood pressure, the response of the patient, and the age or status of the patient.

Unless given by a central venous line, dilute to a concentration of 0.1 - 0.2 mg/ml before use.

Adults:

Initial dose: Treatment should start with the continuous administration of Nicardipine at a rate of 3-5 mg/h for 15 minutes. Rates can be increased by increments of 0.5 or 1 mg every 15 minutes.

The infusion rate should not exceed 15 mg/h.

Maintenance dose: When the target pressure is reached, the dose should be reduced progressively, usually to between 2 and 4 mg/h, to maintain the therapeutic efficacy.

Older patients:

Elderly patients may be more sensitive to Nicardipine effects because of impaired renal and/or hepatic function. It is recommended to provide a continuous infusion of Nicardipine starting at the dose of 1 to 5 mg/h, depending on the blood pressure and clinical situation. After 30 minutes, depending on the effect observed, the rate should be increased or decreased by increments of 0.5 mg/h. The rate should not exceed 15 mg/h.

Pregnancy:

It is recommended to use the same dose regimens as for elderly patients in pregnant women.

Hepatic Impairment:

Nicardipine should be used with particular caution in these patients. It is recommended to use the same dose regimens as for elderly patients in patients with impaired liver function or reduced hepatic blood flow.

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 taking this medicine.

This medicine contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Important information about some of the ingredients of Nicardipine solution for injection

This medicine contains sorbitol. If you have an intolerance to some sugars, contact your doctor before being given this medicine.

3. HOW TO TAKE NICARDIPINE SOLUTION FOR INJECTION

This medicine will be given to you in hospital.

Your doctor will decide on the amount of Nicardipine solution for injection you will be given. This will depend on how much and how fast they want to reduce your blood pressure by.

The medicine will be injected slowly into a vein. Your blood pressure will be taken whilst you are receiving treatment and the dose adjusted to make sure you have a fall in your blood pressure to normal levels.

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

Nicardipine solution for injection will be given to you by a doctor, who will ensure that the correct dose is given for your condition. If you have any concerns tell your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

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

Headache is the most common side effect, and may affect more than 1 in 10 people.

Other common side effects (these may affect up to 1 in 10 people) are:

•    Dizziness

•    Swollen legs or ankles

•    Increased heart rate, feeling your heart beat (palpitations)

•    Low blood pressure, especially on standing up. This may cause dizziness, lightheadedness or fainting

•    Feeling sick or being sick

•    Flushing of the skin.

Other side effects (Frequency unknown)

•    Reduction in blood platelets, which may increase the risk of bleeding or bruising

•    Slow heart rhythm

•    Chest pain

•    Heart problems leading to increased fluid in the lungs and shortness of breath

•    Abdominal pain

•    Redness of the skin

•    Inflammation of the vein where the medicine has been given

•    Changes in blood tests of how your liver is working.

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 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.

5. HOW TO STORE NICARDIPINE SOLUTION FOR INJECTION

Your hospital will store this medicine appropriately.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nicardipine solution for injection contains

The active substance is Nicardipine. Each Nicardipine solution for injection ampoule contains Nicardipine hydrochloride 10mg/10ml.

The other ingredients are sorbitol, citric acid monohydrate, sodium citrate, hydrochloric acid, sodium hydroxide and water for injections.

What Nicardipine solution for injection looks like and contents of the pack

Nicardipine solution for injection is a clear colourless solution. It is available in brown glass ampoules containing 10ml of the solution for injection. Each pack contains 5, 10 or 50 ampoules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mercury Pharmaceuticals Limited,

Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufacturer

Laboratoire Aguettant,

1 Rue Alexander Fleming,

69007 Lyon, France.

This leaflet was approved in March 2014.

101933/LF/2

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Renal Impairment:

Nicardipine should be used with particular caution in these patients. It is recommended to use the same dose regimens as for elderly patients in patients with renal impairment.

Paediatric population:

Nicardipine solution for injection safety and efficacy has not been established in low birth weight infants, newborns, nursing infants, infants, and children.

Nicardipine should only be used for life-threatening hypertension in paediatric intensive care settings or post-operative contexts.

Initial dose: In case of emergency, a starting dose of 0.5 to 5 mcg/kg/min is recommended.

Maintenance dose: The maintenance dosage of 1 to 4 mcg/kg/min is recommended.

Nicardipine should be used with particular caution in children with renal impairment. In this case, only the lowest posology should be used.

Incompatibilities:

Nicardipine solution for injection should not be mixed with other medicinal products except those mentioned under posology and method of administration section.

A risk of precipitation exists with products presenting a pH in solution greater than 6. A risk of adsorption of Nicardipine exists on plastic materials in devices for infusion in the presence of saline solutions.

Shelf life:

Before opening: 2 years.

After opening: The physicochemical stability of the undiluted solution or diluted in a solution of 5% dextrose in water in a polypropylene syringe has been demonstrated for 24 hours at temperatures of +25°C, away from light. Nonetheless, from a microbiological standpoint, the product should be used immediately.