LERCANIDIPINE SANDOZ

Package leaflet: Information for the patient

Lercanidipine Sandoz 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please 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 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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Lercanidipine Sandoz is and what it is used for

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

2. What you need to know before taking Lercanidipine Sandoz

Do not take Lercanidipine Sandoz

• if you are allergic to lercanidipine or to any of the other ingredients of this medicine (listed in section 6)
• if you have certain heart conditions:
• uncontrolled heart failure
• obstruction to blood flow from the heart
• unstable angina (crushing chest pain at rest or worsening in intensity)
• heart attack occurred less than one month ago
• if you have serious liver problems
• if you have severe kidney problems or are on dialysis
• if you are taking drugs that inhibit liver metabolism, such as:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin or clarithromycin)
• antiviral drugs (such as ritonavir)
• if you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection)
• with grapefruit or grapefruit juice

Do not take this medicine if you are pregnant or breastfeeding, or if you are planning to become pregnant, or if you are a woman of childbearing age and are not using any contraceptive method (see section Pregnancy, breastfeeding and fertility for more information).
Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipine Sandoz:

• if you have certain heart conditions that have not been treated with a pacemaker or if you have pre-existing angina (crushing chest pain)
• if you have liver or kidney problems.

Children and adolescents
T he safety and efficacy of Lercanidipine Sandoz in children and adolescents up to 18 years of age have not been established.
Other medicines and Lercanidipine Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that your doctor knows if you are already taking any of the following medicines:

• beta-blockers, for example metoprolol (a medicine used to treat high blood pressure, heart failure and abnormal heart rhythms)
• other medicines affecting blood pressure (alpha-blockers for treating high blood pressure or enlarged prostate, tricyclic antidepressants and neuroleptics used for mental disorders)
• cimetidine, at doses higher than 800 mg (a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine to lower cholesterol levels in the blood)
• digoxin (a medicine used to treat heart problems)
• midazolam (a medicine that helps you sleep)
• rifampicin (a medicine used to treat tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone, quinidine or sotalol (medicines used to treat fast heartbeat)
• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy).

Lercanidipine Sandoz 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 this medicine. Do not consume alcohol during treatment with this medicine.
• Do not take this medicine with grapefruit or grapefruit juice (this may increase your blood pressure by reducing its effect). See section “Do not take Lercanidipine Sandoz”.

Pregnancy, breastfeeding and fertility
Lercanidipine Sandoz must not be used if you are pregnant or breastfeeding, if you are not using any maternal contraceptive method, or if you suspect or are planning a pregnancy.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Exercise caution, as dizziness, weakness, fatigue and rarely somnolence may occur. Do not drive or operate machinery until you know how Lercanidipine Sandoz affects you.
Lercanidipine Sandoz contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Lercanidipine Sandoz

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 one film-coated tablet of Lercanidipine Sandoz 10 mg once daily, always at the
same time, preferably in the morning at least 15 minutes before breakfast, since a high-fat meal significantly
increases the levels of the medicine in the blood.
If necessary, your doctor may advise increasing the dose up to one film-coated tablet of Lercanidipine
Sandoz 20 mg daily.
The tablets should preferably be swallowed whole with a glass of water. The break line is only intended to
facilitate swallowing and not to divide the tablet into equal doses.
Elderly
No adjustment of the daily dose is required. However, particular caution is recommended at the beginning of
treatment.
Patients with liver or kidney problems
Particular caution is required at the beginning of treatment in these patients, and increasing the daily dose to
20 mg should be carefully evaluated.
Use in children and adolescents
This medicine must not be used in children and adolescents under 18 years of age.
If you take more Lercanidipine Sandoz than you should
Do not exceed the dose prescribed for you.
If you take more than the prescribed dose or in case of overdose, consult your doctor immediately and, if
possible, bring the tablets and/or the packaging with you.
Taking a higher dose than recommended may cause excessive lowering of blood pressure and irregularities
in heart rhythm or tachycardia; you may experience dizziness or headache.
If you forget to take Lercanidipine Sandoz
If you forget to take your tablet, simply skip the missed dose and continue with your regular dosing
schedule. Do not take a double dose to make up for the missed dose.
If you stop taking Lercanidipine Sandoz
If you stop treatment with Lercanidipine Sandoz, your blood pressure may rise again. Consult your doctor
before stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious:
If you experience any of the following side effects, contact your doctor immediately:
Rare (may affect fewer than 1 in 10,000 patients):
Crushing chest pain (angina pectoris), fainting, and allergic reactions (symptoms include itching, rash, hives, difficulty breathing or swallowing, dizziness).
If you suffer from pre-existing angina pectoris, with the group of medicines to which Lercanidipine Sandoz belongs, an increase in the frequency, duration, and severity of angina attacks may occur.
Isolated cases of myocardial infarction may also be observed.
Not known (frequency cannot be estimated from the available data):
Swelling of the face, lips, tongue, or throat which may cause difficulty breathing or swallowing.

Other possible side effects:
Common (may affect up to 1 in 10 people):
Headache, faster heartbeat, palpitations (awareness of heartbeat or racing heart), flushing (e.g. in the face), swelling of the ankles.
Uncommon (may affect up to 1 in 100 people):
Dizziness, low blood pressure, indigestion, feeling unwell, stomach ache, rash, itching, muscle pain, passing large amounts of urine, feeling weak or tired.
Rare (may affect up to 1 in 1,000 people):
drowsiness, malaise, diarrhoea, urticaria, increased frequency of urination, chest pain.
Not known (frequency cannot be estimated from the available data):
swollen gums, changes in liver function test results (detected by blood tests), cloudy dialysis fluid (when undergoing dialysis through a tube in the abdomen).

Reporting of side effects
If you experience any side effect, 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:
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 Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the packaging after EXP.
The expiry date refers to the last day of that month.
Al/PVC blisters: Do not store above 25°C. Keep in the original packaging to protect from moisture.
Al/PVDC blisters: Do not store above 25°C. Keep in the original packaging to protect from moisture.
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 Sandoz contains

• The active substance is lercanidipine hydrochloride. Each 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Each 20 mg film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.

• The other components are: 10 mg film-coated tablets
  Tablet core: magnesium stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose
  Film coating: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), iron oxide yellow (E172)

  20 mg film-coated tablets
  Tablet core: magnesium stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose
  Film coating: macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172)

Description of the appearance of Lercanidipine Sandoz and package contents

10 mg film-coated tablets:
Yellow, round, biconvex tablets, 6.5 mm in diameter, bevelled on one side and marked with "L" on the other side.

20 mg film-coated tablets:
Pink, round, biconvex tablets, 8.5 mm in diameter, bevelled on one side and marked with "L" on the other side.
The break line is intended only to facilitate swallowing and not to divide the tablet into equal doses.

Pack sizes:
Blister packs (Al/PVC):
10 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 film-coated tablets
20 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets

Blister packs (Al/PVDC):
10 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 film-coated tablets
20 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni 1
21040 Origgio VA
Italy

Manufacturers
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben, Germany
Balkanpharma Dupnitsa AD
3 Samokovsko Str.,
Dupnitsa, 2600 Bulgaria
Lek Pharmaceuticals d.d.,
Verovskova 57
1526 Ljubljana
Slovenia

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Lercanidipin Sandoz 10 mg - Filmtabletten
Lercanidipin Sandoz 20 mg - Filmtabletten
Belgium: Lercanidipin Sandoz 10 mg filmomhulde tabletten
Lercanidipin Sandoz 20 mg filmomhulde tabletten
Denmark: Lercatio
Italy: Lercanidipina Sandoz 10 mg compresse rivestite con film
Lercanidipina Sandoz 20 mg compresse rivestite con film
Netherlands: Lercanidipine HCl Sandoz 10 & 20 mg, filmomhulde tabletten
Portugal: Lercanidipina Sandoz
Spain: Lercanidipino Sandoz 10 mg comprimidos recubiertos con película EFG
Lercanidipino Sandoz 20 mg comprimidos recubiertos con película EFG