Leaflet: information for the user

Lercanidipine Tarbis 10 mg film-coated tablets

Lercanidipine Tarbis 20 mg film-coated tablets

lercanidipine hydrochloride

Read this leaflet carefully before you start taking this medicine,

because it contains important information for you.

-Keep this leaflet, as 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 others even if they have similar symptoms to you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Lercanidipine Tarbis

3. How to take Lercanidipine Tarbis

4. Possible side effects

5. Storage of Lercanidipine Tarbis

6. Contents of the pack and additional information

Lercanidipino Tarbis, lercanidipino hydrochloride, belongs to a group of medications called calcium channel blockers (from the dihydropyridines group) that lower blood pressure.

Lercanidipino is used for the treatment of high blood pressure, also known as hypertension in adults over 18 years of age (not recommended for children under 18 years of age).

Do not take Lercanidipino Tarbis

• If you are allergic to lercanidipine hydrochloride or any of the other components of this medication (listed in section 6).
• If you have heart conditions such as:

• obstruction of blood flow from the heart,
• uncontrolled heart failure,
• unstable angina (chest discomfort at rest or progressively increasing)
• within the first month after suffering a myocardial infarction.

• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medications that inhibit liver metabolism such as:

• antifungals (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin, troleandomycin, or clarithromycin)
• antivirals (such as ritonavir).

• If you are taking other medications containing ciclosporina (used after a transplant to prevent organ rejection).
• With grapefruit or grapefruit juice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lercanidipino Tarbis:

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

You must inform your doctor if you think you are pregnant (you may become pregnant) or are breastfeeding (see section on pregnancy, breastfeeding, and fertility).

Children and adolescents

The safety and efficacy of Lercanidipino Tarbis have not been demonstrated in children under 18 years old.

Other medications and Lercanidipino Tarbis

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This is because combining Lercanidipino with other medications may alter the effect of Lercanidipino or the other medication, or increase the frequency of certain adverse effects (see section 2 “Do not take Lercanidipino Tarbis”).

Specifically, inform your doctor or pharmacist if you are taking any of the following medications:

• phenytoin, phenobarbital, or carbamazepine (medications for treating epilepsy)
• rifampicin (medication for treating tuberculosis)
• astemizol or terfenadine (medications for allergies)
• amiodarone, quinidine, or sotalol (medications for treating arrhythmias)
• midazolam (medication to help you sleep).
• digoxin (medication for treating heart problems)
• beta-blockers such as metoprolol (a medication for treating high blood pressure, heart failure, and abnormal heart rhythm)
• cimetidine (more than 800 mg, a medication for ulcers, indigestion, or heartburn)
• simvastatin (a medication for lowering blood cholesterol levels)
• other medications for treating high blood pressure

Taking Lercanidipino Tarbis with food, drinks, and alcohol

• Fatty meals significantly increase the concentration of the medication in the blood (see section 3).
• Alcohol may increase the effect of Lercanidipino. Do not consume alcohol during treatment with Lercanidipino Tarbis.
• Lercanidipino should not be taken with grapefruit or grapefruit juice as it may increase the hypotensive effect. See section 2 “Do not take Lercanidipino Tarbis”.

Pregnancy, breastfeeding, and fertility

It is not recommended to take Lercanidipino if you are pregnant and should not be taken during breastfeeding. There are no data on the use of Lercanidipino in pregnant women and breastfeeding women. If you are pregnant or breastfeeding, and not using an effective contraceptive method, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

If you experience dizziness, weakness, or numbness when taking this medication, do not drive vehicles or operate machinery.

Lercanidipino Tarbis contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Lercanidipino Tarbis contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults:The usual recommended dose is one 10 mg tablet daily at the same time every day, preferably in the mornings and at least 15 minutes before breakfast. Your doctor may increase your dose to one 20 mg tablet daily if necessary (see section 2 “Taking Lercanidipino Tarbis with food, drinks, and alcohol”).

Tablets should be taken whole with a little water.

Use in children:This medication should not be given to children under 18 years old.

Geriatric population:No dose adjustment is required. However, they may need to be especially careful at the start of treatment.

Patients with kidney or liver problems:Special care is needed at the start of treatment for these patients, and an increase in dose to 20 mg daily should be done with caution.

If you take more Lercanidipino Tarbis than you should

Do not take more doses than prescribed. In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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Taking a dose higher than the correct dose may cause excessive lowering of blood pressure and irregular and faster heartbeats.

If you forgot to take Lercanidipino Tarbis

If you forgot to take your tablet, do not take the missed dose. Then, continue the next day as your doctor indicated.

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

If you interrupt treatment with Lercanidipino Tarbis

If you stop taking Lercanidipino, your blood pressure will increase again. Consult your doctor before interrupting treatment.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The following side effects may occur when taking this medicine:

Some of these side effects can be serious.

If you experience any of these side effects, consult your doctor.

Rare(may affect up to 1 in 1,000 patients):

• Angina pectoris (chest tightness due to lack of blood to the heart)
• Allergic reactions (with symptoms such as itching, hives, and urticaria)
• Loss of consciousness.

Patients with pre-existing angina pectoris may experience an increase in the frequency, duration, or severity of these attacks with medications in the group to which Lercanidipino belongs. Isolated cases of heart attacks have been observed.

Other possible side effects

Frequent(may affect up to 1 in 10 patients):

• Headache
• Increased heart rate
• Palpitations (strong or rapid heartbeats)
• Sudden redness of the face, neck, or upper chest
• Swelling of the ankles.

Possibly frequent(may affect up to 1 in 100 patients):

• Dizziness
• Low blood pressure
• Heartburn
• Discomfort
• Abdominal pain
• Skin rash
• Itching
• Muscle pain
• Increased urine production
• Weakness or fatigue

Rare(may affect up to 1 in 1,000 patients):

• Drowsiness
• Vomiting
• Diarrhea
• Urticaria
• Increased urine frequency
• Chest pain.

Unknown frequency(cannot be estimated from available data):

• Swelling of the gums
• Changes in liver function (detected in blood tests)
• Cloudy fluid (during hemodialysis through a tube inside the abdomen)
• Swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.

Reporting side effects

If you experience any type of side effect, consult your doctor, nurse, or pharmacist, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date, which appears on the blister and on the box after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lercanidipino Tarbis

The active ingredient is lercanidipine hydrochloride.

Each coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 10,139 mg of lercanidipine hydrochloride hemihydrate).

Each coated tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 20,278 mg of lercanidipine hydrochloride hemihydrate).

The other components are:

Tablet core:Lactose monohydrate, microcrystalline cellulose (type A), sodium carboxymethylcellulose (type A) (from potato), povidone, magnesium stearate.

Coating:Partially hydrolyzed polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol (E1521), talc (E553b), yellow iron oxide (E172) (only for 10 mg), red iron oxide (E172).

Appearance of the product and contents of the package:

Lercanidipino Tarbis 10 mg coated tablets with film EFG

Yellow tablets, coated with film, round, biconvex, with an approximate diameter of 6.6 mm and engraved with “3” and “4” on either side of the scored line on one side of the tablet and “HL” on the other side.

The score is only for breaking and facilitating swallowing but not for dividing into equal doses.

Lercanidipino Tarbis 20 mg coated tablets with film EFG

Pink to peach-colored tablets, coated with film, round, biconvex, with an approximate diameter of 8.5 mm and engraved with “3” and “5” on either side of the score on one side of the tablet and “HL” on the other side.

The score is only for breaking and facilitating swallowing but not for dividing into equal doses.

Lercanidipino Tarbis is available in blisters of 28, 30, 50, and 100 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Lercanidipin Amarox 10 mg/20 mg Filmtabletten

Spain:Lercanidipino Tarbis 10 mg/20 mg coated tablets with film EFG

Netherlands:Lercanidipine HCl Amarox 10 mg/20 mg, filmomhulde tabletten

Last review date of this leaflet: February 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/