Skip to Content

NICARDIPINE HYDROCHLORIDE CAPSULES 20MG

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER

NICARDIPINE HYDROCHLORIDE
CAPSULES 20 mg
NICARDIPINE HYDROCHLORIDE
CAPSULES 30 mg
(Nicardipine Hydrochloride)

Read all of this leaflet carefully
before you start taking using
this medicine • Keep this leaflet. You
may need to read it again • If you
have any further questions, ask your
doctor or pharmacist • This medicine
has been prescribed for you. Do 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.
In this leaflet:
1. What Nicardipine is and what it is
used for
2. Before you take Nicardipine
3. How to take Nicardipine
4. Possible side effects
5. How to store Nicardipine
6. Further information.
1. WHAT NICARDIPINE IS AND
WHAT IT IS USED FOR
Nicardipine belongs to a group of
medicines called calcium channel
blockers. They allow the blood vessels in
the body and heart to relax and widen,
allowing more blood to flow to the heart
and around the body. Nicardipine is
used to treat the following conditions:
• high blood pressure (hypertension)
• chest pain (angina). Nicardipine helps
prevent chest pains which may occur
when your heart cannot get enough
oxygen, such as when doing exercise.
Nicardipine does not provide immediate
relief of chest pain from angina.
2. BEFORE YOU TAKE NICARDIPINE
Do not take Nicardipine if you:
• are allergic (hypersensitive) to
nicardipine, other dihydropyridine
antagonists (eg. Isradipine, Felodipine,
Nifedipine), or any of the ingredients
of this medicine (see Section 6 for a
list of other ingredients)
• suffer from severe heart valve disease
(eg. aortic valve narrowing)
• have suffered from cardiogenic shock
(when blood pressure becomes so low
that your heart stops working properly
and medical treatment is required)
• suffer from unstable angina (chest
pain occurring at rest or during slight
exercise) or you are having a sudden
angina attack
• have had a heart attack in the last
4 weeks
• are pregnant, plan to become
pregnant or are breast-feeding

• if you suffer from Porphyria (a rare
blood pigment disorder).
Take special care with Nicardipine You should tell your doctor before
taking this medicine if you:
• suffer from heart failure (when the
heart cannot adjust to pump enough
blood around the body)
• have liver or kidney disease
• have recently had a stroke
• are already taking any of the
following medicines:
* beta-blockers (used to treat high blood
pressure and heart conditions). If you
are changing from a beta-blocker
medicine to Nicardipine you should
not suddenly stop taking the beta-blocker
* diuretics ('water' tablets) to treat
swollen ankles or breathlessness.
Taking other medicines - Please
tell your doctor or pharmacist if
you are taking or have recently
taken any other medicines,
including medicines obtained
without a prescription, or herbal
preparations, or any of the
following medicines:
• Digoxin (for heart failure). Your doctor
may need to reduce your dose of
Digoxin. Your doctor will monitor the
digoxin level in your blood
• Ciclosporin (used to prevent rejection
of organ transplants)
• Cimetidine (for stomach ulcers and
indigestion) as the effect of
Nicardipine may be increased
• Rifampicin (used to treat tuberculosis)
as the effect of Nicardipine may be
reduced.
Other medicines used to lower
high blood pressure - If you take
one of the medicines listed below
with Nicardipine you may
become dizzy or faint due to your
blood pressure dropping too low:
• beta-adrenoreceptor blocking agents
(beta blockers) eg. Propranolol, Atenolol
• ACE inhibitors eg. Captopril, Enalapril
Maleate, Valsartan or Losartan
• alpha-1-blockers eg. Doxazosin or
Terazosin
• diuretics or 'water' tablets
eg. Hydrochlorothiazide, Furosemide,
Spironolactone.
If you need to have an operation and
will require an anaesthetic, tell your
doctor you are taking this medicine.
Taking Nicardipine with food and
drink - Do not drink grapefruit juice
when you are taking Nicardipine. This
can increase the effect of Nicardipine.
Pregnancy and breast-feeding - If
you are pregnant or think you could be
pregnant or you are breast-feeding, you
must not take Nicardipine. You should
consult your doctor.

111-111-11

Driving and using machines - Do
not drive or operate machinery if you
feel less alert while taking this medicine.
This is more likely at the start of
treatment, if your doctor increases your
dose or you have been drinking alcohol.
3. HOW TO TAKE NICARDIPINE
Always take Nicardipine as instructed by
your doctor. You should ask your doctor
or pharmacist if you are unsure about
anything. Swallow the capsules whole
with a glass of water. The capsules may
be taken with or without food. Do not
chew or crush the capsules.
The usual dose is: Adults - The
usual starting dose is 20 mg three times
a day. Your doctor may slowly increase
the dose to 40 mg three times a day.
Elderly - You may be more sensitive to
the effects of Nicardipine. Your doctor
may increase your dose more slowly and
monitor you closely.
If you have liver or kidney
problems, or you are already
taking other blood pressure
medicine - You may be more sensitive
to the effects of Nicardipine. Your doctor
may give you a lower dose and monitor
you closely.
Children and adolescents Nicardipine should not be given to
children or adolescents under 18 years
old.
If you take more Nicardipine than
you should - Contact your doctor
or nearest hospital emergency
department immediately. Take the
container and any remaining tablets with
you. Symptoms of overdose include low
blood pressure, slow heart beat, irregular
heart rhythm, flushing, drowsiness,
confusion and slurred speech.
If you forget to take Nicardipine Take the next dose as soon as you
remember unless it is almost time for your
next dose. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Nicardipine Do not stop taking your medicine as it
may cause serious changes in your
blood pressure.
If you have any further questions
on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Nicardipine is usually well tolerated but,
as with any medicine, people can
experience side effects, particularly
when treatment is first started.

If your angina pain becomes
worse after taking Nicardipine
tell your doctor immediately.
The most common side effects are:
• headache • ankle swelling • heat
sensation and flushing • palpitations
(when you feel your heartbeat) • feeling
sick • dizziness.
Other side effects include: • angina
pectoris. If you already have angina
attacks, they may become more severe,
occur more often, and last longer
• drowsiness • difficulties with sleeping
• ringing in the ears • pins and needles
• itching • rashes • difficulty passing
water • increased need to pass water
• shortness of breath • tummy upset
• decreased numbers of blood platelets
called thrombocytes • inability to get or
maintain an erection • depression.
If any side effect gets serious, or
if you notice any side effects not
listed in this leaflet, please tell
your doctor or pharmacist.
5. HOW TO STORE NICARDIPINE
Keep out of the reach and sight of
children. Keep your medicine in the
original container. Do not use Nicardipine
after the expiry date which is stated on
the carton after 'EXP'. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.
6. FURTHER INFORMATION
What Nicardipine contains - The
active substance is nicardipine
hydrochloride. The other ingredients are
pregelatinised maize starch, magnesium
stearate, indigotine (E132), titanium
dioxide (E171) and gelatine.
What Nicardipine looks like and
the contents of the pack Nicardipine Hydrochloride 20 mg
Capsules are hard, blue and white
capsules marked 'NC 20' and 'G'.
Nicardipine Hydrochloride 30 mg
Capsules are hard, pale-blue and blue
capsules marked 'NC 30' and 'G'.
Nicardipine is available in plastic
containers and in PVC/aluminium blister
packs containing 5, 7, 10, 14, 15, 20,
21, 25, 28, 30, 50, 56, 60, 84, 90,
100 & 200 capsules. Not all pack sizes
may be marketed.
Marketing Authorisation Holder:
Generics [UK] Limited, Station Close,
Potters Bar, Hertfordshire, EN6 1TL, UK.
Date of revision:
June 2009

013-657-01
10001812

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide