Nicardipine Hydrochloride 30mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Nicardipine Hydrochloride 20mg & 30mg Capsules
(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 further questions, ask your doctor or pharmacist.
• 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. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
^ What Nicardipine is and what it is used for 0 Possible side effects
2 What you need to know before you take Nicardipine m How to store Nicardipine
3 How to take Nicardipine □ Contents of the pack and other information
What Nicardipine is and what it is used for
Nicardipine belongs to a group of medicines called calcium channel blockers. It works by reducing the heart rate and increasing coronary blood flow in the heart.
Nicardipine is used:
■ To prevent attacks of chest pain (angina) diagnosed by your doctor as chronic stable angina.
■ To treat mild to moderate high blood pressure (hypertension).
What you need to know before you take Nicardipine
DO NOT take Nicardipine if:
■ You are allergic to Nicardipine, other dihydropyridines or any of the other ingredients (listed in section 6)
■ You are pregnant or breast feeding
■ You have a narrowing of the heart artery (severe aortic stenosis)
■ You are suffering from unstable angina i.e. unpredictable, often occurring at rest, or sudden, short-lived attacks of chest pain (acute angina)
■ You have suffered from a heart attack within one month
■ You want to prevent a heart attack from re-occurring
■ You suffer from porphyria, an inherited blood disorder that can cause increased sensitivity to light
Warnings and precautions
Talk to your doctor before taking Nicardipine if:
■ You have problems with your kidneys or liver
■ You have heart problems, such as:
- ischemic heart disease
- severe tiredness, shortness of breath, ankle/leg swelling or persistent cough often with mucus or blood (congestive heart failure)
- breathless even with the slightest exercise (poor heart reserve)
■ You have suffered from a stroke
■ You are due to have laboratory tests as there is a possibility that Nicardipine may affect the results
■ You are changing from beta-blockers (other medicines for high blood pressure and angina e.g. atenolol) to Nicardipine as the dose of your beta-blocker should be reduced gradually, preferably over 8 - 10 days
■ You are being prescribed Nicardipine as the only medicine to treat your illness, as this may result in very low blood pressure
Other medicines and Nicardipine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
This includes herbal medicines.
Medicines which may influence the effect of, or be influenced by Nicardipine:
■ Digoxin (used to treat heart failure and abnormal heart rhythms)
■ Cimetidine (used to treat and prevent ulcers and reduce stomach acidity)
■ Ciclosporin, tacrolimus and sirolimus (used to reduce the body's natural immunity in patients who receive organ transplants)
■ Beta-blockers and other medicines used for high blood pressure and other heart problems (such as atenolol) and diuretics (water tablets such as bumetanide, indapamide)
■ Rifampicin (used to treat bacterial infections)
■ Carbamazepine (used to control seizures and epilepsy)
Having an anaesthetic
If you require surgery you must tell your doctor or the appropriate medical staff that you are taking Nicardipine because of the possibility of an interaction with the anaesthetic Fentanyl.
Taking Nicardipine with food and drink
Do not drink grapefruit juice whilst being treated with Nicardipine.
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 for advice before taking this medicine.
Pregnancy
Do not take Nicardipine if you are pregnant. Breast-feeding
If you are breast-feeding, do not take Nicardipine as it is passed into breast milk.
Driving and using machines
Nicardipine may affect your ability to drive and operate machinery by causing drowsiness, nausea (feeling sick) and dizziness. If you experience these effects, do not drive or operate machinery and consult your doctor.
Nicardipine Hydrochloride 30mg Capsules contains sunset yellow (E110)
It may cause allergic type reactions.
continued....
61
How to take Nicardipine
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ Nicardipine should be taken orally.
■ The capsules should be swallowed whole with water.
■ Do not drink grapefruit juice whilst being treated with Nicardipine.
Adults:
■ The usual starting dose is 20mg three times a day.
■ The usual effective dose is 30mg three times a day (a total daily dose of 60mg - 120mg).
Elderly:
The usual starting dose is 20mg three times a day.
Use in children:
Nicardipine is not recommended for children under the age of 18 years.
If you have taken more Nicardipine than you should:
If you accidentally take too many capsules, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining capsules with you.
Symptoms of an overdose may include: low blood pressure (hypotension), slower heartbeat (bradycardia), feeling your heartbeat (palpitations), redness of the skin (flushing), drowsiness, confusion or slurred speech.
If you forget to take your Nicardipine:
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Nicardipine
It is important that you keep taking Nicardipine for as long as your doctor has told you to. Do not stop taking the capsules even though you may feel better.
If you have further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Nicardipine and seek medical advice immediately if you develop the following symptoms:
■ Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)
Most frequent side effects:
■ Headache ■ Dizziness
■ Feeling sick (nausea) ■ Feeling hot
■ Swelling up of the calves or feet (peripheral oedema)
■ Redness of the skin (flushing)
■ Feeling your heart beat (palpitations)
Other side effects:
■ Severe Itching (pruritus) ■ Rashes (erythema)
■ Upset stomach
■ Swelling of the gums (gingival hyperplasia)
■ General weakness (asthenia)
■ Inability to maintain an erection (impotence)
■ Drowsiness
■ Liver problems. Symptoms may include an increase in liver enzymes (detected by blood tests)
■ Kidney problems. Symptoms may include difficulty or an increase in passing urine
■ Difficulty in sleeping (insomnia)
■ Ringing in the ears (tinnitus)
■ Tingling or numbness in the hands or feet (paraesthesia)
■ Fluid accumulation in the lungs which causes difficulty in breathing (pulmonary oedema)
■ Low blood pressure (hypotension), dizziness or lightheadedness after a change in position (orthostatic hypotension)
■ Depression
■ Physical or mental weariness (lassitude)
■ Nervousness
■ Shortness of breath or difficulty in breathing (dyspnoea)
■ Reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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.
51 How to store Nicardipine
■ 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 after EXP. The expiry date refers to the last date of that month.
■ Do not store above 25°C. Store in the original container.
■ Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
What Nicardipine contain:
Each capsule contains either 20mg or 30mg of Nicardipine Hydrochloride.
The other ingredients are: maize starch, sodium starch glycollate, pregelatinised maize starch, gelatin, titanium dioxide (E171) and erythrosine (E127).
The 30mg capsule also contains sunset yellow (E110) and patent blue V (E131).
What Nicardipine looks like and contents of the pack:
Nicardipine 20mg are hard gelatin capsules filled with a light yellow granule. The capsules are size 3, have a white opaque body with a pink opaque cap.
Nicardipine 30mg are hard gelatin capsules filled with a light yellow granule. The capsules are size 2, have an orange opaque body with a violet opaque cap.
Nicardipine is available in:
Nicardipine Capsules are available in blister packs of 28 and 56 capsules.
Not all pack sizes may be marketed.
Product Licence Numbers:
■ Nicardipine 20mg Capsules: PL 11311/0101
■ Nicardipine 30mg Capsules: PL 11311/0102
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire PE19 8ET,
United Kingdom.
Date of revision: July 2016
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