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NICARDIPINE HYDROCHLORIDE 30MG CAPSULES

Active substance(s): NICARDIPINE HYDROCHLORIDE

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• 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
PATIENT INFORMATION LEAFLET
failure)
Please read this entire leaflet carefully before
- breathless even with the slightest exercise
you start taking this medicine.
(poor heart reserve)
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your • If you have suffered from a stroke
• If you are changing from beta-blockers (other
doctor or your pharmacist.
medicines for high blood pressure and angina
• This medicine has been prescribed for you
e.g. Atenolol) to Nicardipine as the dose of
personally and you should not pass it on to
your beta-blocker should be reduced
others. It may harm them, even if their
gradually, preferably over 8 – 10 days
symptoms are the same as yours.
• If any of the side effects gets serious, or if you • If you are to have laboratory tests as there is a
possibility that Nicardipine may affect the
notice any side effects not listed in this leaflet,
results.
please tell your doctor or pharmacist.
Taking other medicines
IN THIS LEAFLET:
Please inform your doctor or pharmacist if you
1. What Nicardipine Capsules are and what are
are taking, or have recently taken, any other
they used for
medicines, including medicines obtained without
2. Before you take Nicardipine Capsules
a prescription.
3. How to take Nicardipine Capsules
In particular you should inform your doctor or
4. Possible side effects
pharmacist if you are taking any of the following
5. Storing Nicardipine Capsules
since some medicines may influence the effect
6. Further information
of, or be influenced by Nicardipine Capsules:
WHAT NICARDIPINE CAPSULES ARE AND • Digoxin (used to treat heart failure and
1 WHAT ARE THEY USED FOR
abnormal heart rhythms)
• Cimetidine (used to treat and prevent ulcers
Nicardipine belongs to a group of medicines
and reduce stomach acidity)
called calcium channel blockers. It works by
reducing the heart rate and increasing coronary • Ciclosporin (used to reduce the body’s natural
immunity in patients who receive organ
blood flow in the heart.
transplants)
Nicardipine Capsules are used:
• Beta-blockers, for high blood pressure and
• To prevent attacks of chest pain (angina)
other heart problems (such as Atenolol) and
diagnosed by your doctor as chronic stable
diuretics (water tablets such as bumetanide,
angina.
indapamide)
Angina is chest pain caused by a narrowing of • Rifampicin (used to treat bacterial infections).
the arteries in the heart muscle. Chronic stable
angina is a pattern of attacks of chest pain that If you require surgery you must tell your doctor
or the appropriate medical staff that you are
are predictable and happen under certain
conditions such as after exercise, stress or in taking Nicardipine because of the possibility of
an interaction with the anaesthetic Fentanyl.
cold weather.
• To treat high blood pressure (Hypertension).
Taking Nicardipine Capsules with food and
drinks
YOU TAKE NICARDIPINE
Do not drink grapefruit juice whilst being treated
2 BEFORE
CAPSULES
with Nicardipine Capsules.
DO NOT take Nicardipine Capsules if:
Pregnancy and breast-feeding
• You are allergic to Nicardipine, to other
Do not take Nicardipine Capsules if you are
similar medicines (known as
pregnant, thinking of becoming pregnant or
dihydropyridines) or any of the other
breast-feeding.
ingredients (see Section 6)
Driving or using machinery
• You are pregnant or breast-feeding
Nicardipine Capsules may affect your ability to
• You have a narrowing of the heart artery
drive and operate machinery by causing
(aortic stenosis)
drowsiness, nausea (the sensation of feeling sick)
• You are suffering from unstable angina
and dizziness. If you do experience any effects,
i.e. unpredictable, often occurring at rest, or
do not drive or operate machinery and consult
sudden, short-lived attacks of chest pain
your doctor.
(acute angina)
• You have suffered from a heart attack within
Important information about some of the
one month
ingredients of Nicardipine Capsules
• You want to prevent a heart attack from
Nicardipine Hydrochloride 30 mg Capsules
re-occurring
contain sunset yellow (E110), which may cause
• You suffer from porphyria, an inherited blood allergic type reactions.
disorder that can cause increased sensitivity
to light.
3 HOW TO TAKE NICARDIPINE CAPSULES

NICARDIPINE HYDROCHLORIDE
20 mg and 30 mg CAPSULES

Nicardipine Capsules should not be given to
children.

You should always take this medicine as
prescribed by your doctor. Do not take more than
Take special care with Nicardipine Capsules and the doctor has told you to. Read and follow the
instructions on the pharmacist’s label. If you are
check with your doctor or pharmacist before
not sure about anything, please ask your doctor
taking:
• If you have problems with your kidneys or liver 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.

4

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).








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.

5

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 how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

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
(E110) 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

Other side effects:
Nicardipine Hydrochloride 30 mg Capsules:
• Itching
PL 11311/0102
• Rash
The leaflet was revised in July 2009.
• 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
50542-T

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Further information

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