Skip to Content

LERCANIDIPINE HYDROCHLORIDE 10MG FILM-COATED TABLETS

Active substance(s): LERCANIDIPINE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Ref: 1621/160316/1/F

Lercanidipine Hydrochloride 10mg film-coated Tablets
Patient Information Leaflet
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.
Your medicine is called Lercanidipine Hydrochloride 10mg film-coated
Tablets but will be referred to as Lercanidipine Hydrochloride throughout the
rest of this leaflet. Please note that the leaflet also contains information
about the other strength of medicine Lercanidipine Hydrochloride 20mg
film-coated Tablets.
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

3

How to take Lercanidipine Hydrochloride

4

Possible side effects

5

How to store Lercanidipine Hydrochloride

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) that lower blood pressure.
Lercanidipine Hydrochloride is used to treat high blood pressure also known
as hypertension in adults over the age of 18 years (it is not recommended
for children under 18 years old).

2

What you need to know before you take
Lercanidipine Hydrochloride

Do not take Lercanidipine Hydrochloride:
* If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any
other ingredients of Lercanidipine Hydrochloride.
* If you have had allergic reactions to drugs closely related to Lercanidipine
Hydrochloride (such as amlodipine, nicardipine, felodipine, isradipine,
nifedipine or lacidipine)
* If you are suffering from certain heart diseases:
- untreated heart failure
- obstruction to flow of blood from the heart
- unstable angina (angina at rest or progressively increasing)
- within one month of heart attack
* 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)
* If you are taking another drug called ciclosporin or cyclosporin (used after
transplants to prevent organ rejection).
* With grapefruit or grapefruit juice.
Do not use if you are pregnant or breastfeeding (see section Pregnancy,
breast-feeding and fertility for more information).
Warning and precautions
Talk to your doctor or pharmacist before taking Lercanidipine Hydrochloride.
* if you have certain other heart conditions which have not been treated by
insertion of a pacemaker or have pre-existing angina.
* if you have problems with your liver or kidneys or you are on dialysis.
You must tell your doctor if you think you are (or might become) pregnant or
breast-feeding (see pregnancy, breast-feeding and fertility section).

Children and adolescents
The safety and efficacy of Lercanidipine Hydrochloride in children aged up to
18 years have not been established.
No data are available.
Other medicines and Lercanidipine Hydrochloride
Please tell your doctor or pharmacist if:
* You are taking or have recently taken any other medicines, including
medicines obtained without a prescription
* You are taking beta-blockers e.g. metoprolol, diuretics (water tablets) or
ACE-inhibitors (medicines to treat high blood pressure)
* You are taking cimetidine (more than 800 mg, a medicine for ulcers,
indigestion, or heartburn)
* You are taking digoxin (a medicine to treat a heart problem)
* You are taking midazolam (a medicine that helps you sleep)
* You are taking rifampicin (a medicine to treat tubercolosis)
* You are taking astemizole or terfenadine (medicines for allergies)
* You are taking amiodarone or quinidine (medicines to treat a fast heart
beat)
* You are taking phenytoin or carbamazepine (medicines for epilepsy). Your
doctor will want to monitor your blood pressure more frequently than usual.
Lercanidipine Hydrochloride with food, drink and alcohol
Please do not consume alcohol during treatment with Lercanidipine
Hydrochloride since it may increase the effect of Lercanidipine
Hydrochloride.
* Please do not take Lercanidipine Hydrochloride with grapefruit or
grapefruit juice.

*

Pregnancy, breast-feeding and fertility
Lercanidipine Hydrochloride should not be used if you are pregnant or
breast-feeding, think you may be pregnant or are planning to have a baby or
you are not using any contraceptive method.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Caution should be exercised because of the possibility of dizziness,
weakness, tiredness and rarely sleepiness. Do not drive or use machines
until you know how Lercanidipine Hydrochloride affects you.
Lercanidipine Hydrochloride contains lactose
If you have been told by your doctor that you have an intolerance to
some sugars, e.g. intolerance to lactose, galactosaemia or glucose/
galactose malabsorption syndrome, contact your doctor before taking this
medicinal product, as the tablets contain lactose

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 10 mg once 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 drug. Your doctor
may advise you to increase the dose to one Lercanidipine Hydrochloride
20 mg daily, if needed. The tablets should preferably be swallowed whole
with some water.
Use in children: This medicine should not be used in children under 18
years of age.
Elderly patients: No adjustment of the daily dose is required. However,
special care should be exercised in starting treatment.
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.
If you have any further questions on the use of this medicine ask your doctor
or pharmacist.

Ref: 1621/160316/1/B

Lercanidipine Hydrochloride 10mg film-coated Tablets
Patient Information Leaflet (continued)
If you take more Lercanidipine Hydrochloride 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
unconsciousness.
If you forget to take Lercanidipine Hydrochloride
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 dose.
If you stop taking Lercanidipine Hydrochloride
If you stop taking Lercanidipine Hydrochloride 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 these side effects tell your doctor straight
away.
Rare (affecting less than 1 out of 1,000 patients): angina pectoris (chest pain
due to lack of blood to your heart)
Very rare (affecting less than 1 out of 10,000 patients): chest pain, fall in
blood pressure, fainting and allergic reactions (symptoms include itching,
rash, hives)
If you suffer from pre existing angina pectoris, with the group of medicines to
which Lercanidipine Hydrochloride belongs, you may experience increased
frequency, duration or severity of these attacks. Isolated cases of heart
attack may be observed.
Other possible side effects:
Uncommon (affecting less than 1 out of 100 patients):
headache, dizziness, faster heart beats, palpitations (heart pounding or
racing), sudden reddening of the face, neck or upper chest, ankle swelling.
Rare (affecting less than 1 out of 1,000 patients): sleepiness, feeling sick,
vomiting, heartburn, stomach pain, diarrhoea; skin rash, muscle pain,
passage of large amounts of urine, tiredness.
Very rare (affecting less than 1 out of 10,000 patients): swelling of gums,
changes in liver function (detected by blood tests), increase in the usual
number of times one urinates.
Reporting of suspected adverse reactions
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 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

Store in the original package in order to protect from light.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take this medicine after the expiry date shown on the packaging.
If your doctor tells you to stop taking this medicine, return any unused
tablets to your pharmacist for safe disposal.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater of 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:
Each film-coated tablet contains 10mg of lercanidipine hydrochloride
(equivalent to 9.4mg of lercanidipine).
Other ingredients are lactose monohydrate, microcrystalline cellulose,
sodium starch glycolate, povidone K30, magnesium stearate,
hypromellose, talc, titanium dioxide (E171), macrogol 6000 and ferric oxide
(E172).
What Lercanidipine Hydrochloride looks like and contents of the pack
Lercanidipine Hydrochloride are yellow, circular, biconvex tablets, scored on
one side and plain on the other side.
Each pack contains 28 film-coated tablets.
Manufacturer and Licence Holder
Manufactured by Recordati Industria Chimica and Farmaceutica S.p.A., Via
Matteo Civitali, 1 20148 Milan, Italy and is procured from within the EU and
repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1621

Lercanidipine Hydrochloride
10mg film-coated Tablets

Revision date: 16/03/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand view ⇕

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