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Lercanidipine HCl 10 mg film-coated tablets
Lercanidipine HCl 20 mg film-coated tablets
lercanidipine hydrochloride
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:
What Lercanidipine HCl is and what it is used for
What you need to know before you take Lercanidipine HCl
How to take Lercanidipine HCl
Possible side effects
How to store Lercanidipine HCl
Contents of the pack and other information

What Lercanidipine HCl is and what it is used for
Lercanidipine HCl, lercanidipine hydrochloride, belongs to a group of medicines called Calcium
Channel Blockers (dihydropyridine derivatives)that lower blood pressure.
Lercanidipine HCl 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).

What you need to know before you take Lercanidipine HCl
Do not take Lercanidipine HCl:
• If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any other
ingredients of Lercanidipine HCl tablets
• If you have had allergic reactions to drugs closely related to Lercanidipine HCl tablets
(such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine)
• If you are suffering from certain heart diseases:
o untreated heart failure
o obstruction to flow of blood from the heart
o unstable angina (angina at rest or progressively increasing)
o 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:
o antifungal medicines (such as ketoconazole or itraconazole)
o macrolide antibiotics (such as erythromycin or troleandomycin)
o 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).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipine HCl:
• 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 HCl in children aged up to 18 years have not been
No data are available.
Other medicines and Lercanidipine HCl
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 you are taking beta-blockers e.g. metoprolol, diuretics (water tablets) or ACE-inhibitors
(medicines to treat high blood pressure)
• if you are taking cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or
• if you are taking digoxin (a medicine to treat a heart problem)
• if you are taking midazolam (a medicine that helps you sleep)
• if you are taking rifampicin (a medicine to treat tubercolosis)
• if you are taking astemizole or terfenadine (medicines for allergies)
• if you are taking amiodarone or quinidine (medicines to treat a fast heart beat)
• if you are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want
to monitor your blood pressure more frequently than usual.
Lercanidipine HCl with food, drink and alcohol
• Please do not consume alcohol during treatment with Lercanidipine HCl tablets since it may
increase the effect of Lercanidipine HCl tablets.
• Please do not take Lercanidipine HCl tablets with grapefruit or grapefruit juice
Pregnancy, breast-feeding and fertility
Lercanidipine HCl 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 HCl affects you.

Rev. Jan. 2015


Lercanidipine HCl contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product, as the tablets contain lactose

How to take Lercanidipine HCl
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 HCl 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 take more Lercanidipine HCl 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 HCl

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 HCl
If you stop taking Lercanidipine HCl 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.
Rev. Jan. 2015


Rare (may affect up to 1in 1,000people): angina pectoris (chest pain due to lack of blood to your
Very rare (may affect up to 1in 10,000 people): 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
HCl 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 (may affect up to 1 in 100 people): headache, dizziness, faster heart beats, palpitations
(heart pounding or racing), sudden reddening of the face, neck or upper chest, ankle swelling.
Rare (may affect up to 1 in 1,000 people): sleepiness, feeling sick, vomiting, heartburn, stomach
pain, diarrhoea; skin rash, muscle pain, passage of large amounts of urine, tiredness.
Very rare (may affect up to 1 in 10,000 people): swelling of gums, changes in liver function
(detected by blood tests), 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 By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Lercanidipine HCl
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date, which is stated on the carton and on blister after
EXP. The expiry date refers to the last day of that month.
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 protect the environment.


Contents of the pack and other information

What Lercanidipine HCl contains
The active substance is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg lercanidipine hydrochloride (equivalent to 9.4 mg
lercanidipine) or 20 mg lercanidipine hydrochloride(equivalent to 18.8 mg lercanidipine).
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, povidone
K30, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, ferric oxide (E172).
What Lercanidipine HCl looks like and contents of the pack
Lercanidipine HCl 10 mg: yellow, circular, biconvex, film coated tablet scored on one side. The
score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Rev. Jan. 2015


Lercanidipine HCl 20 mg: pink , circular, biconvex, film coated tablet scored on one side The tablet
can be divided into equal doses.
Lercanidipine HCl is available in blister packs of 7, 14, 28, 35, 42, 50, 56, 98, 100 tablets. Not all
pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali 1 - 20148 Milan, Italy
This medicinal product is authorised in the Member States of the EEA under the following
Germany: Carmen
Italy: Lercadip
United Kingdom: Lercanidipine HCl
This leaflet was last revised in 07/2015

Rev. Jan. 2015


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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.