Lercanidipine ratiopharm Italia: detailed information

Package leaflet: Information for the user

Lercanidipina ratiopharm Italia 10 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 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:

What Lercanidipina ratiopharm Italia is and what it is used for
What you need to know before taking Lercanidipina ratiopharm Italia
How to take Lercanidipina ratiopharm Italia
Possible side effects
How to store Lercanidipina ratiopharm Italia
Contents of the pack and other information

1. What Lercanidipine ratiopharm Italia is and what it is used for

Lercanidipine ratiopharm Italia belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives). Lercanidipine ratiopharm Italia is used to treat mild to moderate high blood pressure, also known as hypertension.

2. What you need to know before taking Lercanidipina ratiopharm Italia

Do not take Lercanidipina ratiopharm Italia

If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
If you have had allergic reactions to medicines closely related to Lercanidipina ratiopharm Italia (such as amlodipine, nicardipine, felodipina, isradipine, nifedipine or lacidipine).
If you suffer from certain heart conditions:
- untreated heart failure;
- obstruction of blood flow from the heart;
- unstable angina (angina at rest or progressively worsening);
- heart attack within the last month.
If you have severe liver or kidney problems.
If you are taking medicines that inhibit the CYP3A4 isoenzyme:
- antifungal agents (such as ketoconazole or itraconazole);
- macrolide antibiotics (such as erythromycin or troleandomycin);
- antiviral drugs (such as ritonavir).
If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
If you are consuming grapefruit or grapefruit juice.
Do not take this medicine if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding” for further information).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipina ratiopharm Italia if:

You have heart problems and do not have a pacemaker, or if you have pre-existing angina.
You have liver or kidney problems, or if you are on dialysis.

Children and adolescents
Lercanidipina ratiopharm Italia must not be used in children and adolescents under 18 years of age.

Other medicines and Lercanidipina ratiopharm Italia
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if:

You are taking beta-blockers, e.g. metoprolol, diuretics (water tablets), or ACE inhibitors (medicines used to treat high blood pressure).
You are taking cimetidine (more than 800 mg daily, a medicine used for ulcers, indigestion or heartburn).
You are taking digoxin (a medicine used to treat heart problems).
You are taking midazolam (a medicine that helps you sleep).
You are taking rifampicin (a medicine used to treat tuberculosis).
You are taking astemizole or terfenadine (medicines used for allergies).
You are taking amiodarone or quinidine (medicines used to treat rapid heartbeat).
You are taking phenytoin or carbamazepine (medicines used for epilepsy). Your doctor will monitor your blood pressure more frequently.
You are taking antifungal agents (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin or troleandomycin), or antiviral drugs (such as ritonavir). The effect of Lercanidipina ratiopharm Italia may be increased. Therefore, concomitant use must be avoided (see “Do not take Lercanidipina ratiopharm Italia”).
You are taking cyclosporine (a medicine that suppresses the immune system). The effect of both Lercanidipina ratiopharm Italia and cyclosporine may be increased. Therefore, concomitant use must be avoided (see “Do not take Lercanidipina ratiopharm Italia”).
You are taking simvastatin (a medicine that lowers cholesterol levels). Lercanidipina ratiopharm Italia should be taken in the morning and simvastatin in the evening.

Lercanidipina ratiopharm Italia with food, drinks and alcohol

Patients must not consume alcohol during treatment with Lercanidipina ratiopharm Italia, as it may enhance the effect of the medicine.
Patients must not eat grapefruit or drink grapefruit juice.

Pregnancy and breastfeeding
Do not take Lercanidipina ratiopharm Italia if you are pregnant, breastfeeding, planning a pregnancy, or not using any contraceptive method.
If you are taking Lercanidipina ratiopharm Italia and think you might be pregnant, consult your doctor.

Driving and using machines
Be careful, as dizziness, weakness and fatigue may occur. Do not drive or operate machinery until you know how Lercanidipina ratiopharm Italia affects you.

3. How to take Lercanidipine ratiopharm Italia

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults: The recommended dose is one tablet of Lercanidipine ratiopharm Italia (equivalent to 10 mg of lercanidipine hydrochloride) daily, always at the same time, preferably in the morning at least 15 minutes before breakfast, since a meal high in fat significantly increases blood levels of the active substance. Your doctor may advise increasing the dose to two tablets of Lercanidipine ratiopharm Italia (equivalent to 20 mg of lercanidipine hydrochloride) daily, if necessary.
The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water).
Elderly: No adjustment of the daily dose is required. However, particular caution should be exercised when starting treatment.
Patients with liver or kidney problems: In these patients, particular care should be taken when starting treatment; an increase in the daily dose to 20 mg should be carried out cautiously.
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 ratiopharm Italia than you should
Do not exceed the prescribed dose.
If you take more than the prescribed amount, or in case of overdose, consult a doctor immediately and, if possible, bring the tablets and/or the container with you.
Taking more than the correct dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat. It may also lead to vomiting or unconsciousness.
If you forget to take Lercanidipine ratiopharm Italia
If you forget to take your tablet, do not take the missed dose; continue your treatment as before. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Lercanidipine ratiopharm Italia
If you stop treatment with Lercanidipine ratiopharm Italia, your blood pressure may rise again. Consult your doctor before stopping treatment.
If you have any 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 will experience them.
Some side effects may be serious:
If you experience any of these side effects, contact your doctor immediately.
Rare (may affect up to 1 in 1,000 people): angina pectoris (chest pain caused by insufficient blood supply to the heart).
Very rare (may affect up to 1 in 10,000 people): chest pain, drop in blood pressure, fainting, and allergic reactions (symptoms include itching, skin rashes, hives).
If you have pre-existing angina pectoris, treatment with the group of medicines to which Lercanidipina ratiopharm Italia belongs may lead to an increase in the frequency, duration, or severity of these acute episodes. Isolated cases of myocardial infarction have been observed.

Other possible side effects
Uncommon (may affect up to 1 in 100 people): headache, dizziness, increased heart rate, palpitations (pounding or racing heartbeat), sudden redness of the face, neck, or upper chest, swollen ankles.
Rare (may affect up to 1 in 1,000 people): drowsiness, nausea, vomiting, heartburn, stomach pain, diarrhoea, skin rashes, muscle pain, increased urination, fatigue.
Very rare (may affect up to 1 in 10,000 people): swollen gums, changes in liver function (detected by blood tests), increased frequency of urination.
If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

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 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 Lercanidipine ratiopharm Italia

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

6. Package contents and other information

What Lercanidipina ratiopharm Italia contains

The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
The other components are Tablet core: maize starch; sodium starch glycolate (type A); anhydrous colloidal silica; microcrystalline cellulose; poloxamer 188; sodium stearyl fumarate; macrogol 6000. Film coating: hypromellose; macrogol 6000; yellow iron oxide (E172); titanium dioxide (E171).

Description of the appearance of Lercanidipina ratiopharm Italia and contents of the pack
Lercanidipina ratiopharm Italia film-coated tablets are round, biconvex, yellow in colour, with a break line on one side and smooth on the other. 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.
Packs: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands

Responsible manufacturer for batch release
Merckle GmbH Ludwig-Merckle-Str. 3, 89143 Blaubeuren Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Lercanidipin-ratiopharm 10 mg Filmtabletten
Austria: Lercanidipin-ratiopharm 10 mg Filmtabletten
Denmark: Lercanidipinhydrochlorid Teva
Italy: Lercanidipina ratiopharm Italia 10 mg compresse rivestite con film
Portugal: Lercanidipina ratiopharm
Spain: Lercanidipino ratiopharm 10 mg comprimidos recubiertos con película EFG

Package leaflet: Information for the user

Lercanidipine ratiopharm Italia 20 mg film-coated tablets

Lercanidipine hydrochloride
Generic 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Lercanidipine ratiopharm Italia is and what it is used for
What you need to know before taking Lercanidipine ratiopharm Italia
How to take Lercanidipine ratiopharm Italia
Possible side effects
How to store Lercanidipine ratiopharm Italia
Contents of the pack and other information

1. What Lercanidipine ratiopharm Italia is and what it is used for

2. What you need to know before taking Lercanidipine ratiopharm Italia

Do not take Lercanidipine ratiopharm Italia

If you are allergic to lercanidipine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
If you have had allergic reactions to medicines closely related to Lercanidipine ratiopharm Italia (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine or lacidipine).
If you have certain heart conditions:
- untreated heart failure;
- obstruction of blood flow from the heart;
- unstable angina (angina at rest or progressively worsening);
- heart attack within the last month.
If you have severe liver or kidney problems.
If you are taking medicines that inhibit the CYP3A4 isoenzyme:
- antifungal medicines (such as ketoconazole or itraconazole);
- macrolide antibiotics (such as erythromycin or troleandomycin);
- antiviral medicines (such as ritonavir).
If you are taking another medicine called cyclosporine (used after organ transplants to prevent organ rejection).
If you are consuming grapefruit or grapefruit juice.
Do not take this medicine if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding” for further information).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lercanidipine ratiopharm Italia if:

You have heart problems and do not have a pacemaker, or if you have pre-existing angina.
You have liver or kidney problems, or if you are on dialysis.

Children and adolescents
Lercanidipine ratiopharm Italia must not be used in children and adolescents under 18 years of age.

Other medicines and Lercanidipine ratiopharm Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if:

You are taking beta-blockers, e.g. metoprolol, diuretics ("water tablets"), or ACE inhibitors (medicines for treating high blood pressure).
You are taking cimetidine (more than 800 mg per day, a medicine for ulcers, indigestion or heartburn).
You are taking digoxin (a medicine for treating heart problems).
You are taking midazolam (a medicine to help you sleep).
You are taking rifampicin (a medicine for treating tuberculosis).
You are taking astemizole or terfenadine (medicines for allergies).
You are taking amiodarone or quinidine (medicines for treating a fast heartbeat).
You are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will monitor your blood pressure more frequently.
You are taking antifungal medicines (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin or troleandomycin), or antiviral medicines (such as ritonavir). The effect of Lercanidipine ratiopharm Italia may be increased. Therefore, concomitant use must be avoided (see “Do not use Lercanidipine ratiopharm Italia”).
You are taking cyclosporine (a medicine that reduces the body's resistance to disease). The effects of both Lercanidipine ratiopharm Italia and cyclosporine may be increased. Therefore, concomitant use must be avoided (see “Do not use Lercanidipine ratiopharm Italia”).
You are taking simvastatin (a medicine that lowers cholesterol levels). Lercanidipine ratiopharm Italia should be taken in the morning and simvastatin in the evening.

Lercanidipine ratiopharm Italia with food, drinks and alcohol

Patients must not consume alcohol during treatment with Lercanidipine ratiopharm Italia, as it may enhance the effect of Lercanidipine ratiopharm Italia.
Patients must not eat grapefruit or drink grapefruit juice.

Pregnancy and breastfeeding
Do not take Lercanidipine ratiopharm Italia if you are pregnant, breastfeeding, planning to become pregnant, or not using any contraceptive method.
If you are taking Lercanidipine ratiopharm Italia and think you might be pregnant, consult your doctor.

Driving and using machines
Be careful, as dizziness, weakness and fatigue may occur. Do not drive or operate machinery until you know how Lercanidipine ratiopharm Italia affects you.

3. How to take Lercanidipine ratiopharm Italia

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 of lercanidipine hydrochloride once daily, always at the same time, preferably in the morning at least 15 minutes before breakfast, since a meal high in fat significantly increases blood levels of the active substance. The 10 mg dose is not available with the tablets described in this leaflet. Your doctor may advise you to increase the dose to 20 mg of lercanidipine hydrochloride per day, corresponding to one tablet daily of Lercanidipine ratiopharm Italia 20 mg, if necessary.
The tablet should be taken with a sufficient amount of liquid (e.g. a glass of water).
Elderly patients: No adjustment of the daily dose is required. However, particular caution is advised when starting treatment.
Patients with liver or kidney problems: In these patients, particular care should be taken when starting treatment; an increase in the daily dose to 20 mg should be done cautiously.
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 ratiopharm Italia than you should
Do not exceed the prescribed dose.
If you take more than the prescribed dose or in case of overdose, consult a doctor immediately and, if possible, bring the tablets and/or the container with you.
Taking more than the correct dose may cause excessive lowering of blood pressure and irregular or rapid heartbeat. It may also result in vomiting or unconsciousness.
If you forget to take Lercanidipine ratiopharm Italia
If you forget to take your tablet, do not take the missed dose; continue your treatment as before. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Lercanidipine ratiopharm Italia
If you stop treatment with Lercanidipine ratiopharm Italia, your blood pressure may rise again. Consult your doctor before stopping treatment.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences
them.
Some adverse reactions may be serious:
If you experience any of these adverse reactions, contact your doctor immediately.
Rare (may affect up to 1 in 1,000 people): angina pectoris (chest pain caused by inadequate blood
supply to the heart).
Very rare (may affect up to 1 in 10,000 people): chest pain, drop in blood pressure, fainting, and allergic
reactions (symptoms include itching, skin rashes, urticaria).
If you have pre-existing angina pectoris, with the group of medicines to which Lercanidipina
ratiopharm Italia belongs, there may be an increase in the frequency, duration, or severity of these
acute episodes. Isolated cases of myocardial infarction have been observed.
Other possible adverse reactions
Uncommon (may affect up to 1 in 100 people): headache, dizziness, increased heart rate, palpitations
(sensation of pounding or racing heartbeat), sudden flushing of the face, neck, or upper chest, ankle
swelling.
Rare (may affect up to 1 in 1,000 people): drowsiness, nausea, vomiting, heartburn, stomach pain,
diarrhoea; skin rashes, muscle pain, increased urination, fatigue.
Very rare (may affect up to 1 in 10,000 people): gum swelling, changes in liver function (detected by
blood tests), increased frequency of urination.
If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet,
inform your doctor or pharmacist.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or
pharmacist. You may also report adverse reactions directly via the national reporting system at
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Lercanidipine ratiopharm Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging.
The expiry date refers to the last day of that month.
Store in the original container 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Lercanidipine ratiopharm Italia contains

The active substance is lercanidipine hydrochloride. Each film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other components are:
Tablet core: microcrystalline cellulose; maize starch; sodium starch glycolate (type A); anhydrous colloidal silica; povidone K 30; sodium stearyl fumarate.
Film coating: hypromellose; macrogol 6000; iron oxide red (E172); titanium dioxide (E171).

Description of the appearance of Lercanidipine ratiopharm Italia and pack contents
The film-coated tablets of Lercanidipine ratiopharm Italia are round, biconvex, pink in colour, with a breakline on one side and smooth on the other. The breakline on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended for dividing the tablet into equal doses.
Pack sizes: 7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Teva B.V. - Swensweg 5 - 2031 GA Haarlem - The Netherlands

Responsible person for batch release
Merckle GmbH Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: Lercanidipin-ratiopharm 20 mg Filmtabletten
Austria: Lercanidipin-ratiopharm 20 mg Filmtabletten
Denmark: Lercanidipinhydrochlorid Teva
Italy: Lercanidipina ratiopharm Italia 20 mg film-coated tablets
Portugal: Lercanidipina ratiopharm
Spain: Lercanidipino ratiopharm 20 mg comprimidos recubiertos con película EFG