Patient leaflet - Lercanidipine HCl 10 mg film-coated tablets

1. 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).

2. 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 are suffering from certain heart diseases:
o obstruction to flow of blood from the heart o untreated heart failure
o unstable angina (chest discomfort occurring at rest or progressively increasing) o within one month of heart attack.
If you have severe liver problems.
If you have severe kidney problems or you are undergoing dialysis.
If you are taking medicines that are inhibitors of the hepatic metabolism, such as: o antifungal medicines (such as ketoconazole or itraconazole)

o macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin) o antivirals (such as ritonavir)

If you are taking another medicine called ciclosporin or cyclosporin (used after transplants to prevent organ rejection).
With grapefruit or grapefruit juice.

Warnings and precautions

Talk to your doctor or pharmacist before taking Lercanidipine HCl:

if you have a heart problem
if you have liver or kidneys problems

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

established.

Other medicines and Lercanidipine HCl

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This is because when Lercanidipine HCl is taken with other medicines the effect of Lercanidipine HCl or of the other medicine may be changed or certain side effects may occur more frequently (see also section 2 “Do not take Lercanidipine HCl”).

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
rifampicin (a medicine to treat tubercolosis)
astemizole or terfenadine (medicines for allergies)
amiodarone, quinidine or sotalol (medicines to treat a fast heart beat)
midazolam (a medicine that helps you sleep)
digoxin (a medicine to treat a heart problem)
beta-blockers e.g. metoprolol (a medicine to treat high blood pressure, heart failure and abnormal heart rhythms)
cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn)
simvastatin (a medicine to lower cholesterol in your blood)
other medicines to treat high blood pressure

Lercanidipine HCl with food, drink and alcohol

A high fat meal significantly increases blood levels of the medicine (see section 3).
Alcohol can increase the effect of Lercanidipine HCl. Do not consume alcohol during treatment with Lercanidipine HCl
Lercanidipine HCl must not be taken with grapefruit or grapefruit juice (they can increase its hypotensive effect). See section 2 – Do not take Lercanidipine HCl.

Pregnancy, breast-feeding and fertility

Lercanidipine HCl is not recommended if you are pregnant, it should not be used during breast-

feeding. There are no data from the use of Lercanidipine HCl in pregnant women and in nursing mothers. If you are pregnant or breast-feeding, if you are not using any contraceptive method, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine

Driving and using machines

If you develop dizziness, weakness or drowsiness with this medicine, do not drive a vehicle or operate machines.

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.

3. 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. Your doctor may advise you to increase the dose to one Lercanidipine HCl 20 mg daily, if needed (see section 2 “Lercanidipine HCl with food, drink and alcohol”). 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.

XXXXXXXX A 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.

If you take more Lercanidipine HCl than you should

Do not exceed the prescribed dose. If you have taken more than the prescribed dose, talk to your

doctor or go to the hospital straight away. Take the medicine pack with you. Taking more than the correct dose can cause an excessive drop in blood pressure and your heart can beat irregularly or faster.

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. The following side effects may happen with this medicine:

Some side effects can be serious.

If any of the following happen, tell your doctor straight away:

Rare (may affect up to 1 in 1,000 people): angina pectoris (e.g. chest tightness due to lack of blood to your heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.

Patients with pre-existing angina pectoris may experience increased frequency, duration or severity of these attacks with the group of medicines to which Lercanidipine HCl belongs. Isolated cases of

heart attack may be observed.

Other possible side effects:

Common (may affect up to 1 in 10 people): headache, faster heart rate, feeling of fast or uneven

heart beat (palpitations), sudden reddening of your face, neck or upper chest (flushing), ankle swelling.

Uncommon (may affect up to 1 in 100 people): dizziness, fall in blood pressure, heartburn, feeling sick, stomach pain, skin rash, itching, muscle pain, passage of large amounts of urine, feeling weak or feeling tired.

Rare (may affect up to 1 in 1,000 people): sleepiness, vomiting, diarrhoea, hives, increase in the usual number of times one urinates, chest pain.

Not known (frequency cannot be estimated from the available data): swelling of gums, changes in liver function (detected by blood tests), cloudy fluid (when performing dialysis through a tube into your abdomen), swelling of your face, lip, tongue or throat which may cause difficulty in breathing or swallowing.

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 the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

6. 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.

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

Manufacturer: