Nicardipine Hydrochloride 30mg Capsules
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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:
n What Nicardipine is and what it is used for Q Possible side effects
2 What you need to know before you take Nicardipine m How to store Nicardipine
3 How to take Nicardipine a 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.
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 predicable and happen under certain conditions such as after exercise, stress or in cold weather.
■ To treat high blood pressure (Hypertension).
What you need to know before you take Nicardipine
DO NOT take Nicardipine if:
■ You are allergic to Nicardipine to other similar medicines (known as 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 (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.
Warnings and precautions
Talk to your doctor before taking Nicardipine:
■ 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 to have laboratory tests as there is a possibility that Nicardipine may affect the results
■ 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
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.
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.
Nicardipine with food and drinks
Do not drink grapefruit juice whilst being treated with Nicardipine Capsules.
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.
Do not take Nicardipine Capsules if you are pregnant, thinking of becoming pregnant or breast-feeding.
Driving and using machines
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 30mg Capsules contain sunset yellow (E110), which may cause allergic type reactions.
continued....
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 Capsules should be taken orally
■ Nicardipine Capsules should be swallowed whole with water
■ Do not take with grapefruit juice
The recommended dose is:
Adults:
The usual dose is 20mg three times a day. Your doctor may increase this dosage until a suitable dose is reached.
The usual effective dose is 30mg three times a day (a total daily dose of 60mg - 120mg).
Elderly:
The usual dose is 20mg 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 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 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 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 sick (Nausea) ■ Feeling hot
■ Swelling up of the feet or foot (Pedal oedema)
■ Redness of the skin (Flushing)
■ Feeling your heart beat (Palpitations)
Other side effects:
■ Itching ■ Rash
■ Upset stomach ■ Impotence
■ Drowsiness
■ 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
■ 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)
■ 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)
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 internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Nicardipine
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original package.
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 the month.
Do not throw away any medicine 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 Capsules contain:
Each capsule contains either 20mg or 30mg of active ingredient 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 Hydrochloride Capsules looks like and contents of the pack:
Nicardipine Hydrochloride 20mg 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 30mg 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 20mg Capsules:
PL 11311/0101
Nicardipine Hydrochloride 30mg Capsules:
PL 11311/0102
Date of last revision: October 2013
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