Nicardipine 10 mg/10 ml solution for injection

• 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.

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

• 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 severe aortic stenosis (shrinking of the main artery from the heart)
• if you have had a heart attack in the last eight days.

Talk to your doctor or nurse before you are given Nicardipine solution for infusion:

• if you have heart failure
• if you have angina
• if your kidneys are not working properly.
• 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 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 infusion.

Not applicable

Tell your doctor 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 infusion can affect the way some other medicines work. Also, some other medicines can affect the way Nicardipine solution for infusion 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, fosphenytoin and phenytoin
• Baclofen (used to treat muscle spasms)
• Medicines used to control the body’s immune system, such as tacrolimus, sirolimus, everolimus, temsirolimus and ciclosporin
• Itraconazole, ketoconazole, voriconazole (used to treat certain types of fungal infection)
• Certain medicines used to treat certain viral diseases (boceprevir, ritonavir, telaprevir)
• Some antibiotics (clarithromycin, erythromycin, telithromycin)
• 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 alfuzosin, doxazosin, prazosin, silodosin, tamsulosin, terazosin and uradipil
• 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)
• Medicines used to treat chronic lymphocytic leukemia (Idelalisib)
• Nitrated and related drugs
• Medicines causing orthostatic hypotension.

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 infusion works.

Do not drink grapefruit juice or eat grapefruit whilst using this medication as it may increase blood levels of nicardipine.

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

Pregnancy

Nicardipine solution for infusion should be used with caution in women in the third trimester of pregnancy as it could interfere with the spontaneous induction on labour.

Nicardipine solution for infusion should not be used if you are having multiple children (twins or more) or if you have any issues with your heart except if no other suitable option is available.

Breast-feeding

Nicardipine solution for infusion should not be used during breast-feeding.

Nicardipine solution for infusion may affect the ability to drive or use machines. More particularly at the start or in case of modification of the treatment, as well as in combination with alcohol.

This medicine contains less than 1 mmol sodium (23 mg) per ampoule that is to say essentially ‘sodium-free’.

Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.

You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhea.

Immediately consult your doctor or your pharmacist.

Common (may affect up to 1 in 10 people)

• Dizziness
• Swollen legs or ankles
• Increased heart rate, feeling your heartbeat (palpitations)
• Low blood pressure, especially on standing up. This may cause dizziness, light-headedness or fainting
• Feeling sick or being sick

Not known (frequency cannot be estimated based on the available data)

• Reduction in blood platelets, which may increase the risk of bleeding or bruising
• Cardiac rhythm disorders with decreased heart rate which may evolve in fainting
• Slow heart rhythm
• Chest pain
• Heart problems leading to increased fluid in the lungs and shortness of breath
• Abdominal pain
• Redness of the skin (erythema)
• Inflammation of the vein where the medicine has been given
• Changes in blood tests of how your liver is working
• Allergic reactions
• Cutaneous rash
• Redness and flushing of the face.

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 website : www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

The active substance is nicardipine. Each ampoule contains 10 mg of nicardipine hydrochloride.

The other ingredients are: sorbitol (E420), citric acid monohydrate, sodium citrate, hydrochloric acid, sodium hydroxide and water for injections.

Nicardipine solution for injection is a clear, pale yellow colored solution. It is available in brown glass ampoules containing 10 ml of the solution for infusion.

Each pack contains 5, 10 or 50 ampoules. Not all pack sizes may be marketed.