Lercanidipine hydrochloride Pensa

Patient Information Leaflet: Information for the User

Lercanidipine Hydrochloride Pensa 10 mg film-coated tablets, 20 mg film-coated tablets

Lercanidipine Hydrochloride
Equivalent medicine
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Lercanidipine belongs to a group of medicines called calcium antagonists (dihydropyridine derivatives)
which reduce blood pressure.
Lercanidipine is used to treat high blood pressure, also known as hypertension, in adults aged over 18 years (it is not recommended for children under 18 years of age).

2. What you need to know before taking Lercanidipine Hydrochloride Pensa

Do not take Lercanidipine Hydrochloride Pensa

• If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain heart conditions: obstruction of blood flow from the heart, untreated heart failure, unstable angina (chest pain occurring at rest or progressively worsening), or within one month after a heart attack.
• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that inhibit liver metabolism, such as:
  o antifungal medicines (e.g. ketoconazole or itraconazolo)
  o macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin)
  o antiviral medicines (e.g. ritonavir).
• If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
• Together with grapefruit or grapefruit juice.

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

• 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 if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
Children and adolescents
The safety and efficacy of Lercanidipine Hydrochloride Pensa in children up to 18 years of age have not been established.
Other medicines and Lercanidipine Hydrochloride Pensa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because when this medicine is taken together with other medicines, the effect of Lercanidipine Hydrochloride Pensa or of the other medicine may be altered, or certain side effects may occur more frequently (see also section 2 “Do not take Lercanidipine Hydrochloride Pensa”).
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 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 such as metoprolol (a medicine for treating 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 blood cholesterol)
• other medicines for treating high blood pressure.

Lercanidipine Hydrochloride Pensa 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 Lercanidipine Hydrochloride Pensa. Do not consume alcohol during treatment with this medicine.
• Lercanidipine Hydrochloride Pensa must not be taken with grapefruit or grapefruit juice (as they may increase its hypotensive effect). (See section 2 “Do not take Lercanidipine Hydrochloride Pensa”).

Pregnancy, breastfeeding and fertility
Lercanidipine Hydrochloride Pensa is not recommended during pregnancy and must not be used during breastfeeding. There are no data on the use of Lercanidipine Hydrochloride Pensa in pregnant women or in breastfeeding mothers. If you are pregnant or breastfeeding, if you are not using any contraceptive method, if you think you might be pregnant, or if you 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.
Lercanidipine Hydrochloride Pensa contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, i.e. essentially 'sodium-free'.

3. How to take Lercanidipine hydrochloride Pensa

Always take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or
pharmacist.
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 increasing the dose of this
medicine to 20 mg daily, if necessary (see section 2 “Lercanidipine hydrochloride Pensa with food,
drinks and alcohol”).
The tablets should preferably be swallowed whole with a glass of water.
The break line is only intended to help you split the tablet if you have difficulty swallowing it whole.
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 is needed at the beginning of
treatment.
Patients with liver or kidney problems
In these patients, particular care is required when starting treatment, and increasing the daily dose to 20 mg should be done cautiously.
If you take more Lercanidipine hydrochloride Pensa than you should
Do not exceed the prescribed dose.
If you take more than the prescribed dose, speak to your doctor or go to hospital immediately. Take the medicine pack with you. Taking more than the correct dose may cause excessive drop in blood pressure and your heart may beat irregularly or faster than normal.
If you forget to take Lercanidipine hydrochloride Pensa
If you forget to take the tablet, simply skip the dose and continue as before.
Do not take a double dose to make up for the missed dose.
If you stop taking Lercanidipine hydrochloride Pensa
If you stop taking this medicine, your blood pressure may rise again. Consult your doctor before stopping treatment.
If you have further questions about the use of this medicine, consult 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. a feeling of chest tightness due to reduced blood flow 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 with the group of medicines to which Lercanidipine hydrochloride Pensa belongs. Isolated cases of myocardial infarction may be observed.

Other possible side effects
Common (may affect up to 1 in 10 people): headache, tachycardia, sensation of rapid or irregular heartbeat (palpitations), sudden redness of the face, neck, or upper chest (flushing), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people): dizziness, low blood pressure, heartburn, feeling unwell, stomach pain, 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 compared to normal, chest pain.
Not known (frequency cannot be estimated from the available data): gum swelling, changes in liver function (detected by blood tests), cloudy dialysis fluid (when undergoing peritoneal dialysis), swelling of the face, lips, tongue, or throat which may cause difficulty in breathing or swallowing.

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 national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lercanidipine hydrochloride Pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month.
Lercanidipine hydrochloride Pensa 10 mg film-coated tablets:
Store in the original packaging to protect from light. Do not store above 25°C.
Lercanidipine hydrochloride Pensa 20 mg film-coated tablets:
Do not store above 25°C.
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 Lercanidipine Hydrochloride Pensa contains

• The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg or 20 mg of lercanidipine hydrochloride.
• The other components (excipients) are:
  Lercanidipine Hydrochloride Pensa 10 mg film-coated tablets:
  o Tablet core: maize starch, sodium glycolate starch (type A), anhydrous colloidal silica, microcrystalline cellulose, poloxamers, sodium stearil fumarate, macrogol.
  o Tablet coating: hypromellose, macrogol, yellow iron oxide (E172), titanium dioxide (E171).
  Lercanidipine Hydrochloride Pensa 20 mg film-coated tablets:
  o Tablet core: microcrystalline cellulose, maize starch, sodium glycolate starch (type A), anhydrous colloidal silica, povidone, sodium stearil fumarate.
  o Tablet coating: hypromellose, macrogol, red iron oxide (E172), titanium dioxide (E171).

What Lercanidipine Hydrochloride Pensa looks like and contents of the pack
Lercanidipine Hydrochloride Pensa 10 mg film-coated tablets are yellow, round, biconvex, film-coated tablets with a break line on one side and smooth on the other, with an approximate diameter of 6.5 mm.
Lercanidipine Hydrochloride Pensa 20 mg film-coated tablets are pink, round, biconvex, film-coated tablets with a break line on one side and smooth on the other, with an approximate diameter of 8.5 mm.
Pack sizes for Lercanidipine Hydrochloride Pensa 10 mg: 14, 28 and 56 film-coated tablets.
Pack size for Lercanidipine Hydrochloride Pensa 20 mg: 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6 – 20154 Milan – Italy
Manufacturer responsible for batch release:
Torrent Pharma (Malta) Ltd.
Central Business Centre, Level 2, Triq Hal Tarxien, Il-Gudja, GDJ 1907, Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Lercanidipino Pensa 10 mg, 20 mg compresi ricubiertos con film EFG
Italy: Lercanidipina cloridrato Pensa
Portugal: Lercanidipina toLife

This patient information leaflet was last reviewed on {MM/YYYY}.
[To be completed at national level]