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LERCANIDIPINE 10MG FILM-COATED TABLETS

Active substance(s): LERCANIDIPINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Lercanidipine Hydrochloride 10 mg
film-coated tablets
Lercanidipine Hydrochloride 20 mg
film-coated tablets
lercanidipine hydrochloride

Read all of this leaflet carefully before you
start using 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.
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
3. How to take Lercanidipine Hydrochloride
4. Possible side effects
5. How to store Lercanidipine Hydrochloride
6. Contents of the pack and other information

Other medicines and Lercanidipine
Hydrochloride
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any
other medicines.
Taking Lercanidipine Hydrochloride with certain
other medicines, may alter the effect of these
medicines or of Lercanidipine Hydrochloride.
It is especially important for your doctor to know
if you are already being treated with any of the
following medicines:
• phenytoin or carbamazepine (medicines
for epilepsy)
• rifampicin (a medicine to treat tuberculosis)
• midazolam (a medicine that helps you sleep)
• cimetidine, more than 800 mg (a medicine for
ulcers, indigestion, or heartburn)
• digoxin (a medicine to treat a heart problem)
• terfenadine or astemizole (medicines for allergies)
• amiodarone or quinidine (medicines to treat a
fast heart beat)
• medicines known as beta-blockers e.g. metoprolol
(medicines to treat high blood pressure)

1. What Lercanidipine Hydrochloride is and what
it is used for

Lercanidipine Hydrochloride with food, drink
and alcohol
• You must not consume alcohol during treatment
with this medicine since it may increase the effect
of lercanidipine.
• You must not eat grapefruit or drink grapefruit
juice as this may increase the effect of
lercanidipine.

Lercanidipine Hydrochloride belongs to a group
of medicines called calcium channel blockers that
block the entry of calcium into the muscle cells of
the heart and the blood vessels that carry blood
away from the heart (the arteries). It is the entry
of calcium into these cells that causes the heart to
contract and arteries to narrow. By blocking the
entry of calcium, calcium channel blockers decrease
contraction of the heart and dilate (widen) the
arteries, and the blood pressure is reduced.

Pregnancy and breast-feeding
Ask your doctor for advice before taking
any medicine.
If you are taking Lercanidipine Hydrochloride
and think that you may be pregnant, consult
your doctor.
Do not use this medicine if you are pregnant, or
if you wish to become pregnant or if you are a
woman in childbearing age and do not use any
contraceptive method.

This medicine has been prescribed to you to treat
your high blood pressure, also known
as hypertension.

Do not use Lercanidipine Hydrochloride if you are
breast-feeding.

2. What you need to know before you take
Lercanidipine Hydrochloride
Do not take Lercanidipine Hydrochloride
• if you are allergic to lercanidipine or to any of the
ingredients in this medicine (listed in section 6)
• if you have had allergic reactions to medicines
that are closely related to lercanidipine (such as
amlodipine, nicardipine, felodipine, isradipine,
nifedipine or lacidipine)
• if you are suffering from certain heart diseases:
* uncontrolled cardiac failure
* an obstruction to flow of blood from the heart
* unstable angina (angina at rest or
progressively increasing)
* if you have had heart attack less than one
month ago
• if you have severe liver or kidney problems
• if you are taking drugs that are inhibitors of
CYP3A4 isoenzyme:
* antifungal medicines (such as ketoconazole
or itraconazole)
* macrolide antibiotics (such as erythromycin
or troleandomycin)
* antivirals (such as ritonavir)
* at the same time as another drug called
ciclosporin or cyclosporin
* with grapefruit or grapefruit juice
• if you are pregnant, or if you wish to become
pregnant or if you are a woman in child-bearing
age and do not use any contraceptive method
• if you are breast-feeding
Warning and precautions
Talk to your doctor before taking Lercanidipine
Hydrochloride tablets:
• if you have certain other heart conditions, or if
you have a pacemaker
• if you have angina pectoris, lercanidipine may
very rarely cause increased frequency of attacks
that may last longer and become more severe.
Heart attack has been reported in isolated cases.
• if you have problems with your liver or kidney, or
you are on dialysis

Driving and using machines
Lercanidipine has a negligible influence on the
ability to drive or use machines. However, side
effects such as dizziness, weakness, tiredness and
rarely sleepiness may occur. You should be careful
until you know how you react to this medicine.
Lercanidipine Hydrochloride contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.
3. How to take Lercanidipine Hydrochloride
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 one Lercanidipine
Hydrochloride 10 mg film-coated tablet daily at
the same time each day, preferably in the morning
at least 15 minutes before breakfast, because a
high fat meal significantly increases your blood
levels of the medicine. Your doctor may advise
you to increase your dose to one Lercanidipine
Hydrochloride 20 mg film-coated tablet daily,
if needed.
The tablets should preferably be swallowed whole
with half a glass of water. The score line is only to
facilitate breaking for ease of swallowing and not
to divide into equal doses.
Older people
No adjustment of the daily dose is required.
However, special care should be taken when
starting treatment.
Patients with liver or kidney problems
Special care is needed when starting treatment.
Your doctor may decide to adjust your dose.
Use in children and adolescents
Lercanidipine Hydrochloride is not recommended
for use in children and adolescents below 18 years.

If you take more Lercanidipine Hydrochloride
than you should
Immediately contact a doctor, the nearest hospital
casualty department or the centre for poison
information for advice.
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
unconsciousness.
If you forget to take Lercanidipine Hydrochloride
If you forget to take your tablet, take it as soon as
you remember, unless it is almost time for your
next dose. Then go on as before. Do not take a
double dose.
If you stop taking Lercanidipine Hydrochloride
If you stop taking this medicine 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.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some side effects can be serious. If you
experience any of the following, tell your doctor
immediately or go to your nearest hospital
casualty department:
Rare (may affect up to 1 in 1,000 people)
• chest pain often spreading to the arms or neck
and sometimes to the shoulders and back due
to a lack of blood to your heart (angina pectoris).
If you have angina pectoris, Lercanidipine
Hydrochloride may very rarely cause increased
frequency of attacks that may last longer and
become more severe.
Very rare (may affect up to 1 in 10,000 people)
• allergic reactions including shortness of breath,
wheezing or difficulty breathing; swelling of the
face, lips, tongue or other parts of the body; rash,
itching or hives on the skin,
• heart attack, which is a condition caused by
lack of oxygen to your heart due to blockage
of major blood vessels which could lead to
problems such as heart failure, irregular heart
beat and blood clots.
Other side effects:
Uncommon (may affect up to up to 1 in 100 people)
• Headache, dizziness,
• Faster heartbeats, awareness of the beating
of the heart,
• Flushing (transient episodic redness of the face,
neck or upper chest),
• Ankle swelling.
Rare (may affect up to 1 in 1,000 people)
• Sleepiness, weakness, tiredness
• Nausea, vomiting, diarrhoea, abdominal pain,
indigestion
• Rash,
• Muscle pain,
• Passage of large amounts of urine.
Very rare (may affect up to 1 in 10,000 people)
• Fall in blood pressure which can cause dizziness,
light-headedness or fainting,
• Increase in liver enzyme blood test values,
• Increase in the usual number of times
one urinates.
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 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.

5. How to store Lercanidipine Hydrochloride
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date,
which is stated on the label, carton or bottle after
'EXP'. The expiry date refers to the last day of
that month.
Do not store above 25°C. Store in the original
package to protect from moisture.
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. Contents of the pack and other information
What Lercanidipine Hydrochloride contains
The active substance is lercanidipine
hydrochloride.
Each 10 mg film-coated tablet contains 10 mg
lercanidipine hydrochloride, equivalent to 9.4 mg
lercanidipine.
Each 20 mg film-coated tablet contains 20 mg
lercanidipine hydrochloride, equivalent to 18.8 mg
lercanidipine.
The other ingredients are: magnesium stearate,
povidone, sodium starch glycolate (type A), lactose
monohydrate, microcrystalline cellulose. The filmcoating of 10 mg tablets also contains macrogol,
polyvinyl alcohol (partly hydrolysed), talc, titanium
dioxide (E 171), yellow iron oxide (E 172).
The film-coating of 20 mg tablets also contains
macrogol, polyvinyl alcohol (partly hydrolysed),
talc, titanium dioxide (E 171), yellow iron oxide
(E 172), red iron oxide (E172).
What Lercanidipine Hydrochloride looks like
and contents of the pack
Lercanidipine Hydrochloride 10 mg tablets are
yellow, round, biconvex 6.5 mm film-coated
tablets, scored on one side, and marked 'L' on the
other side.
Lercanidipine Hydrochloride 20 mg tablets
are pink, round, biconvex 8.5 mm film-coated
tablets, scored on one side, and marked 'L' on
the other side.
The score line is only to facilitate breaking for ease
of swallowing and not to divide into equal doses.
Lercanidipine Hydrochloride10 mg film-coated
tablets are available in blister packs containing
14, 20, 28, 30, 50, 56, 98, 100 tablets or in bottles
containing 14, 25, 28, 30, 50, 56, 84, 90, 98, 100,
112 tablets
Lercanidipine Hydrochloride 20 mg film-coated
tablets are available in blister packs containing 28,
30, 50, 56, 98, 100 tablets or in bottles containing
28, 30, 50, 90, 98, 100, 105 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan
Potters Bar, Hertfordshire, EN6 1TL
Manufacturer
Actavis hf. Reykjavikurvegur 76-78, IS
220 Hafnarfjörður Iceland
BLB016 Bulebel Indusrial Estate,
Actavis Ltd.
Zejtun ZTN3000, Malta
Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse
Str., Dupnitza 2600, Bulgaria

This leaflet was last revised on 07/2014 416090

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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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