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LERCANIDIPINE HYDROCHLORIDE 10 MG FILM-COATED TABLETS

Active substance(s): LERCANIDIPINE HYDROCHLORIDE

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TEVA UK Ref:

LERCANIDIPINE HYDROCHLORIDE
10 mg AND 20 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Placement for Pharmacode no.

Version:

231-30-87786-C LEA LERCANIDIPINE A/S F/C TAB TUK
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 any 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 or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Lercanidipine Hydrochloride is and
what it is used for
2. What you need to know before you take
Lercanidipine Hydrochloride Film-Coated
Tablets
3. How to take Lercanidipine Hydrochloride
Film-Coated Tablets
4. Possible side effects
5. How to store Lercanidipine Hydrochloride
Film-Coated Tablets
6. Contents of the pack and other information

1

WHAT LERCANIDIPINE HYDROCHLORIDE
IS AND WHAT IT IS USED FOR

Lercanidipine Hydrochloride belongs to a group
of medicines called calcium channel blockers
(dihydropyridine derivatives). Lercanidipine is
used to treat mild to moderate high blood
pressure also known as hypertension.

2

WHAT YOU NEED TO KNOW BEFORE YOU
TAKE LERCANIDIPINE HYDROCHLORIDE
FILM-COATED TABLETS

Do not take Lercanidipine:
allergic (hypersensitive) to
lercanidipine hydrochloride or to any of the
other ingredients of this medicine (listed in
section 6)
allergic reactions to
medicinal products closely related to
Lercanidipine (such as amlodipine,
nicardipine, felodipine, isradipine, nifedipine
or lacidipine)
certain heart
diseases:

progressively increasing)
severe liver or kidney problems
medicinal products that are
inhibitors of CYP3A4 isoenzyme:
or itraconazole)
erythromycin or troleandomycin)
ciclosporin or cyclosporin (used after
transplants to prevent organ rejection)
Do not use if you are pregnant or
breast-feeding (see section Pregnancy and
breast-feeding for more information).
Warnings and precautions
Talk to your doctor or pharmacist before taking
lercanidipine hydrochloride Film-Coated Tablets
if:
do not have a pacemaker, or you have
pre-existing angina
or you are on dialysis.
Children and adolescents
Lercanidipine should not be used for children
and adolescents under 18 years.

2

13 January 2015

Other medicines and Lercanidipine
Hydrochloride Film-Coated Tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Please tell your doctor or pharmacist if:
beta-blockers e.g. metoprolol,
diuretics (water tablets) or ACE-inhibitors
(medicines to treat high blood pressure)
cimetidine (more than 800 mg
per day, a medicine for ulcers, indigestion, or
heartburn)
digoxin (a medicine to treat a
heart problem)
midazolam (a medicine that
helps you sleep)
rifampicin (a medicine to treat
tuberculosis)
astemizole or terfenadine
(medicines for allergies)
amiodarone or quinidine
(medicines to treat a fast heart beat)
phenytoin or carbamazepine
(medicines for epilepsy). Your doctor will
want to monitor your blood pressure more
frequently than usual.
antifungal medicines (such as
ketoconazole or itraconazole), macrolide
antibiotics (such as erythromycin or
troleandomycin) or antivirals (such as
ritonavir). The effect of Lercanidipine may be
increased. Therefore the co-administration
should be avoided (see “Do not take
Lercanidipine”).
ciclosporin (a medicine which
lowers the body’s resistance to disease). The
effect of Lercanidipine as well as of
ciclosporin may be increased. Therefore the
co-administration should be avoided (see
“Do not take Lercanidipine”).
simvastatin (a medicine which
lowers cholesterol level). Lercanidipine
should be taken in the morning and
simvastatin in the evening.
Lercanidipine with food and drink and alcohol
not consume alcohol during
treatment with Lercanidipine since it may
increase the effect of Lercanidipine
not take grapefruit or
grapefruit juice.
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 or pharmacist for advice
before taking this medicine.
Do not take Lercanidipine if you are pregnant or
breast-feeding, or you wish to become
pregnant or if you are not using any
contraceptive method.
Driving and using machines
Caution should be exercised because of the
possibility of dizziness, weakness and tiredness.
Do not drive or use machines until you know
how Lercanidipine affects you.

3

HOW TO TAKE LERCANIDIPINE
HYDROCHLORIDE FILM-COATED
TABLETS

Always take this medicine exactly as your
doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Adults: The recommended dose is 10 mg
lercanidipine hydrochloride daily at the same
time each day, preferably in the morning at
least 15 minutes before breakfast, because a
high fat meal significantly increases blood
levels of the active substance. Your doctor may
advise you to increase the dose to two 10 mg
tablets or one 20 mg tablets Lercanidipine
(corresponding to 20 mg lercanidipine
hydrochloride) daily, if needed.
The tablet should be swallowed with a
sufficient amount of fluid (e.g. one glass of
water).
Older people: No adjustment of the daily dose
is required. However, special care should be
exercised in starting treatment.

Placement for Pharmacode no.

TEVA UK Ref:

Placement for Pharmacode no.

231-30-87786-C LEA LERCANIDIPINE A/S F/C TAB TUK
Patients with liver or kidney problems: Special
care is needed in starting treatment in these
patients and an increase in daily dose to 20 mg
should be approached with caution.
Use in children and adolescents: This medicine
should not be used in children and adolescents
under 18 years of age.
If you have any further questions on the use of
this product ask your doctor.
If you take more Lercanidipine than you should
Do not exceed the prescribed dose.
If you take more than the prescribed dose or in
the event of overdose, seek medical advice
immediately and, if possible, take your tablets
and/or the container with you.
Exceeding the correct dosage may cause blood
pressure to become too low, and the heart to
beat irregularly or faster. It may also lead to
vomiting or unconsciousness.
If you forget to take Lercanidipine
If you forget to take your tablet, simply miss
that dose and then go on as before .
Do not take a double dose to make up for a
forgotten tablet.
If you stop taking Lercanidipine
If you stop taking Lercanidipine your blood
pressure may increase again. Please consult
your doctor before stopping the treatment.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

Version:

2

13 January 2015

This medicinal product does not require any
special temperature storage conditions Store in
the original package in order to protect from
light.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help to
protect the environment.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Lercanidipine Hydrochloride Film-Coated
Tablets contain
The active substance is lercanidipine
hydrochloride.
One 10 mg Lercanidipine Hydrochloride
Film-Coated Tablet contains 10 mg lercanidipine
hydrochloride, equivalent to 9.4 mg
lercanidipine.
The other ingredients are:
Core: Maize starch, sodium starch glycolate
(type A), silica, colloidal anhydrous, cellulose,
microcrystalline, poloxamer 188, sodium stearyl
fumarate, macrogol 6000.
Film-coating: Hypromellose (E464), macrogol
6000, iron oxide yellow (E 172), titanium
dioxide (E 171).
One 20 mg Lercanidipine Hydrochloride
Film-Coated Tablet contains 20 mg lercanidipine
hydrochloride, equivalent to 18.8 mg
lercanidipine.
POSSIBLE SIDE EFFECTS
The other ingredients are:
Like all medicines, this medicine can cause side Core: Cellulose, microcrystalline, maize starch,
effects, although not everybody gets them.
sodium starch glycolate (type A), silica, colloidal
anhydrous, povidone K 30, sodium stearyl
Some side effects can be serious:
fumarate.
If you experience any of these side effects tell
Film-coating: Hypromellose (E464), macrogol
your doctor straight away.
6000, iron oxide red (E 172), titanium dioxide
Rare (may affect up to 1 in 1,000 people):
angina pectoris (chest pain due to lack of blood (E 171).
to your heart).
What Lercanidipine Hydrochloride Film-Coated
Very rare (may affect up to 1 in 10,000 people): Tablets look like and contents of the pack
10 mg: Lercanidipine Hydrochloride 10 mg
chest pain, fall in blood pressure, fainting and
Film-Coated Tablets are yellow, round shaped
allergic reactions (symptoms include itching,
biconvex, film-coated tablets of 6.5 mm
rash, hives).
If you suffer from pre-existing angina pectoris, diameter, with score line on one side and plain
on the other side. The score line is only to
with the group of medicines to which
facilitate breaking for ease of swallowing and
Lercanidipine belongs, you may experience
not to divide into equal doses.
increased frequency, duration or severity of
these attacks. Isolated cases of heart attack may 20 mg: Lercanidipine Hydrochloride 20 mg
Film-Coated Tablets are pink, round shaped
be observed.
biconvex, film-coated tablets of 8.5 mm
Other possible side effects:
Uncommon (may affect up to 1 in 100 people): diameter, with score line on one side and plain
on the other side. The score line is only to
headache, dizziness, faster heart beats,
palpitations (heart pounding or racing), sudden facilitate breaking for ease of swallowing and
not to divide into equal doses.
reddening of the face, neck or upper chest,
Available in pack sizes of: 14, 28, 30, 50 x 1, 56,
ankle swelling.
98, 100 film-coated tablets.
Rare (may affect up to 1 in 1,000 people):
Not all pack sizes may be marketed.
sleepiness, feeling sick, vomiting, heartburn,
stomach pain, diarrhoea; skin rash, muscle
Marketing Authorisation Holder is:
pain, passage of large amounts of urine,
TEVA UK Limited, Eastbourne, BN22 9AG.
tiredness.
Very rare (may affect up to 1 in 10,000 people): Manufacturer is:
TEVA Czech Industries s.r.o., Ostravská 29,
swelling of gums, changes in liver function
(detected by blood tests), increase in the usual c.p. 305, 747 70 Opava-Komárov,
Czech Republic.
number of times one urinates.
Reporting of side effects
This leaflet was last revised January 2015
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also PL 00289/1283-4
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.

4

5

HOW TO STORE LERCANIDIPINE
HYDROCHLORIDE FILM-COATED
TABLETS

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date
which is stated on each blister strip and on the
outer carton after EXP The expiry date refers to
.
the last day of that month.

87786-C

Placement for Pharmacode no.

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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.

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