Nicardipine Hydrochloride 20mg Capsules
NICARDIPINE HYDROCHLORIDE 20 mg and 30 mg CAPSULES
PATIENT INFORMATION LEAFLET
Please read this entire leaflet carefully before
you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
I NTH IS LEAFLET:
1. What Nicardipine Capsules are and what are they used for
2. Before you take Nicardipine Capsules
3. How to take Nicardipine Capsules
4. Possible side effects
5. Storing Nicardipine Capsules
6. Further information
OWHAT NICARDIPINE CAPSULES ARE AND WHAT ARE THEY 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 Capsules are used:
• To prevent attacks of chest pain (angina) diagnosed by your doctor as chronic stable angina.
Angina is chest pain caused by a narrowing of the arteries in the heart muscle. Chronic stable angina is a pattern of attacks of chest pain that are predictable and happen under certain conditions such as after exercise, stress or in cold weather.
• To treat high blood pressure (Hypertension).
BEFORE YOU TAKE NICARDIPINE CAPSULES
DO NOT take Nicardipine Capsules if:
• You are allergic to Nicardipine, to other similar medicines (known as dihydropyridines) or any of the other ingredients (see Section 6)
• You are pregnant or breast-feeding • You have a narrowing of the heart artery (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.
Nicardipine Capsules should not be given to children.
Take special care with Nicardipine Capsules and check with your doctor or pharmacist before taking:
• If you have problems with your kidneys or liver
• If you have heart problems, such as:
- 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)
• If you have suffered from a stroke
• If 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
• If you are to have laboratory tests as there is a possibility that Nicardipine may affect the results.
Taking other medicines
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
In particular you should inform your doctor or pharmacist if you are taking any of the following since some medicines may influence the effect of, or be influenced by Nicardipine Capsules:
• Digoxin (used to treat heart failure and abnormal heart rhythms)
• Cimetidine (used to treat and prevent ulcers and reduce stomach acidity)
• Ciclosporin (used to reduce the body's natural immunity in patients who receive organ transplants)
• Beta-blockers, 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).
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 Capsules with food and drinks
Do not drink grapefruit juice whilst being treated with Nicardipine Capsules.
Pregnancy and breast-feeding
Do not take Nicardipine Capsules if you are pregnant, thinking of becoming pregnant or breast-feeding.
Driving or using machinery
Nicardipine Capsules may affect your ability to drive and operate machinery by causing drowsiness, nausea (the sensation of feeling sick) and dizziness. If you do experience any effects, do not drive or operate machinery and consult your doctor.
Important information about some of the ingredients of Nicardipine Capsules
Nicardipine Hydrochloride 30 mg Capsules contain sunset yellow (E110), which may cause allergic type reactions.
Q HOW TO TAKE NICARDIPINE CAPSULES
You should always take this medicine as prescribed by your doctor. Do not take more than the doctor has told you to. Read and follow the instructions on the pharmacist's label. If you are not sure about anything, please ask your doctor or pharmacist.
• Nicardipine Capsules should be taken orally.
• Do not take with grapefruit juice.
Continued
Adults:
The usual dose is 20 mg three times a day. Your doctor may increase this dosage until a suitable dose is reached.
The usual effective dose is 30 mg three times a day (a total daily dose of 60 mg - 120 mg).
Elderly:
The usual dose is 20 mg three times a day. Your doctor may increase this dosage until a suitable dose is reached.
Patients with kidney or liver problems
You should be given the lowest starting dose and your doctor may reduce the number of daily doses.
Children:
Nicardipine Capsules are not recommended for children.
If you have taken more Nicardipine Capsules than you should:
Contact your doctor immediately or go to the nearest Accident and Emergency department. Remember to take this leaflet or any remaining capsules with you. Symptoms of an overdose may include, low blood pressure, which may cause lightheadedness, fainting or dizziness, especially when going from sitting or lying position to standing up, slower heart beat, feeling your heart beat, redness of the skin (flushing), drowsiness, confusion or slurred speech.
If you forget to take Nicardipine Capsules:
Take them as soon as you remember. Do not take a double dose to make up for the forgotten individual dose.
If you stop taking Nicardipine Capsules
It is important that you keep on taking Nicardipine Capsules until the prescribed dose has finished. Do not stop taking the capsules even though you may feel better. If you have further questions about these Capsules, ask your doctor or pharmacist.
Q POSSIBLE SIDE EFFECTS
Nicardipine Capsules are usually well tolerated, however like most medicines, they can cause unwanted side effects in some patients.
Stop taking Nicardipine Capsules and tell your doctor immediately if you experience the following:
• An attack of angina (chest pain) within 30 minutes of starting therapy or after an increase in dosage.
Tell your doctor as soon as possible if you experience the following:
• An increase in the severity or frequency of chest pain during treatment.
Most frequent side effects:
• Headache
• Dizziness
• Feeling hot
• Swelling up of the feet or foot (Pedal oedema)
• Redness of the skin (Flushing)
• Feeling your heart beat (Palpitations)
• Feeling sick (Nausea).
Other side effects:
• Itching
• Rash
• Liver problems. Symptoms may include an increase in liver enzymes (detected by blood tests) or yellowing of skin or white of the eyes (jaundice)
• Kidney problems. Symptoms may include difficulty or increase in passing urine
• Upset stomach
• Impotence
• Drowsiness
• Difficulty in sleeping (Insomnia)
• Ringing in the ears (Tinnitus)
• Tingling or numbness in the hands or feet (Paraesthesia)
• Weakness, exhaustion and nervousness (Depression, lassitude)
• Shortness of breath or difficulty in breathing (Dyspnoea)
• Reduction in blood platelets, which increases risk of bleeding or bruising (Thrombocytopenia).
If any of the side effects gets serious or you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.
STORING NICARDIPINE CAPSULES
Keep out of the reach and sight of children.
Do not store above 25°C.
Store in the original package.
Do not use Nicardipine after the expiry date which is stated on the carton/bottle after "EXP". The expiry date refers to the last date of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist howto dispose of medicines no longer required. These measures will help to protect the environment.
Q FURTHER INFORMATION
What Nicardipine Capsules contain:
Active ingredient: 20 mg or 30 mg of Nicardipine Hydrochloride.
Other ingredients: maize starch, sodium starch glycollate, pregelatinised maize starch, gelatin, titanium dioxide (E171) and erythrosine (E127).
The 30 mg capsule also contains sunset yellow (El 10) and patent blue V (E131).
What Nicardipine Hydrochloride Capsules look like and contents of the pack:
Nicardipine Hydrochloride 20 mg Capsules 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 Hydrochloride 30 mg Capsules 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.
They are available in blister packs of 28 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road, Eaton Socon, St Neots, Cambridgeshire. PE19 8ET,
United Kingdom.
Product Licence Number:
Nicardipine Hydrochloride 20 mg Capsules:
PL 11311/0101
Nicardipine Hydrochloride 30 mg Capsules: PL 11311/0102
The leaflet was revised in July 2009.
TEUZD
50542-T