LERCADIP

Package leaflet: Information for the user

LERCADIP 10 mg film-coated tablets, 20 mg film-coated tablets

lercanidipine hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lercadip is and what it is used for
2. What you need to know before taking Lercadip
3. How to take Lercadip
4. Possible side effects
5. How to store Lercadip
6. Contents of the pack and other information

1. What Lercadip is and what it is used for

Lercadip, lercanidipine hydrochloride, belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives) that reduce blood pressure.
Lercadip is used for the treatment of high blood pressure, also known as hypertension, in adults over 18 years of age (it is not recommended for children under 18 years of age).

2. What you should know before taking Lercadip

Do not take Lercadip

• If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any of the other ingredients of Lercadip tablets.
• If you suffer from certain heart conditions such as:
  • obstruction of blood flow from the heart
  • uncontrolled heart failure
  • unstable angina (chest pain occurring at rest or progressively worsening)
  • heart attack occurred less than one month ago.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that are inhibitors of hepatic metabolism such as:
  • antifungals (e.g. ketoconazole or itraconazolo)
  • macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin)
  • antiviral agents (e.g. ritonavir).
• If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lercadip:

• If you have heart problems.
• If you have liver or kidney problems.

You must inform your doctor if you think you are (or might become) pregnant or are breastfeeding (see section
Pregnancy, breastfeeding and fertility).
Children and adolescents
The safety and efficacy of Lercadip in children up to 18 years of age have not been established.
Other medicines and Lercadip
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine. This is because when Lercadip is taken with other medicines, the effect of Lercadip or the other medicine may be altered, or certain side effects may occur more frequently (see also section 2 Do not take Lercadip).
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (medicines for treating allergies)
• amiodarone, quinidine or sotalol (medicines for treating tachycardia)
• midazolam (a medicine that helps you sleep)
• digoxin (a medicine for treating heart problems)
• beta-blockers, e.g. metoprolol (a medicine for treating high blood pressure, heart failure and heart rhythm disorders)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine to lower blood cholesterol)
• other medicines for treating high blood pressure

Lercadip with food, beverages and alcohol

• A high-fat meal significantly increases blood levels of the medicine (see section 3).
• Alcohol may enhance the effect of Lercadip. Do not consume alcohol during treatment with Lercadip.
• Lercadip must not be taken with grapefruit or grapefruit juice (as they may increase its hypotensive effect) (See section 2 - Do not take Lercadip).

Pregnancy, breastfeeding and fertility
Lercadip is not recommended during pregnancy and must not be used during breastfeeding. There are no data on the use of Lercadip in pregnant or breastfeeding women. If you are pregnant or breastfeeding, if you are not using any contraceptive method, think you might be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
If you experience dizziness, weakness or drowsiness with this medicine, do not drive or operate machinery.
Lercadip contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Lercadip

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults: The recommended dose is 10 mg once daily, taken at the same time each day, preferably in the morning at least 15 minutes before breakfast. If necessary, your doctor may advise increasing the dose to Lercadip 20 mg once daily (see section 2, Lercadip with food, drink and alcohol).

The tablets should preferably be swallowed whole with a little water.

Use in children: This medicine must not be used in children under 18 years of age.

Elderly patients: No adjustment of the daily dose is required. However, particular caution should be exercised at the start of treatment.

Patients with liver or kidney problems: Particular care is required at the beginning of treatment in these patients, and increasing the daily dose to 20 mg should be carefully considered.

If you take more Lercadip than you should

Do not exceed the prescribed dose.

If you have taken more than the prescribed amount, consult your doctor or go to hospital immediately. Take the packaging with you.

Taking more than the correct dose may cause excessive lowering of blood pressure and your heart may beat irregularly or more rapidly.

If you forget to take Lercadip

If you forget to take a tablet, simply skip the missed dose and continue with your next dose as prescribed the following day.

Do not take a double dose to make up for the missed dose.

If you stop taking Lercadip

If you stop taking Lercadip, your blood pressure may rise again. Consult your doctor before stopping treatment.

If you have any doubts about how to use 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 occur with this medicine:
Some side effects can be serious:
If you experience any of the following side effects, consult your doctor immediately.
Rare (may affect up to 1 in 1,000 people): angina pectoris (e.g. chest tightness caused by inadequate blood supply to the heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.
Patients with pre-existing angina pectoris may experience an increase in frequency, duration, or severity of attacks while taking medicines of the same class as Lercadip. Isolated cases of myocardial infarction may be observed.
Other possible side effects:
Common (may affect up to 1 in 10 people): headache, fast heartbeat, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (flushing), ankle swelling.
Uncommon (may affect up to 1 in 100 people): dizziness, drop in blood pressure, heartburn, nausea, stomach ache, skin rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000 people): somnolence, vomiting, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from available data): gum swelling, changes in liver function (detected by blood tests), cloudy fluid (when performing dialysis through a catheter in the abdomen), swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercadip

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lercadip contains
The active substance is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine) or
20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).
The other components are:
Tablet core: monohydrate lactose, microcrystalline cellulose, sodium carboxymethylamide, povidone K30, magnesium stearate.
Film coating: hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Description of the appearance of Lercadip and pack sizes
Lercadip 10 mg: yellow, round, biconvex, film-coated tablet with a break line on one side. The break line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Lercadip 20 mg: pink, round, biconvex, film-coated tablet with a break line on one side.
Lercadip is available in blisters containing 7, 14, 28, 35, 42, 50, 56, 98 or 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
INNOVA PHARMA S.p.A. - Via Matteo Civitali, 1 – 20148 Milan (Italy).
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milan (Italy).