LERCANIDIPINE TARBIS 10 mg FILM-COATED TABLETS

2. What you need to know before you take Lercanidipine Tarbis

Do not take Lercanidipine Tarbis

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

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

• If you have severe liver problems.
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking certain medicines 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 medicines containing cyclosporin (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 Lercanidipine Tarbis:

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

You should inform your doctor if you think you are pregnant (or might become pregnant) or are breast-feeding (see section on pregnancy, breast-feeding and fertility).

Children and adolescents

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

Other medicines and Lercanidipine Tarbis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when Lercanidipine is combined with other medicines, the effect of Lercanidipine or the other medicine may change or the frequency of certain side effects may increase (see section 2 “Do not take Lercanidipine Tarbis”).

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

Taking Lercanidipine Tarbis with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility

It is not recommended to take Lercanidipine if you are pregnant and it should not be taken during breast-feeding. There are no data on the use of Lercanidipine in pregnant or breast-feeding women. If you are pregnant or breast-feeding, if you are not using an effective contraceptive method, think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

If you experience dizziness, weakness or numbness when taking this medicine, do not drive vehicles or use machines.

Lercanidipine Tarbis contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Lercanidipine Tarbis contains sodium

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

3. How to take Lercanidipine Tarbis

Follow exactly the administration instructions of this medicine 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 each day, preferably in the morning and at least 15 minutes before breakfast. Your doctor may increase your dose to one 20 mg Lercanidipine tablet daily, if necessary (see section 2 “Taking Lercanidipine Tarbis with food, drinks and alcohol”).

The tablets should be swallowed whole with a little water.

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

Elderly population:No dose adjustment is required. However, they may require special care at the start of treatment.

Patients with kidney or liver problems:Special care is needed when starting treatment in these patients and an increase in dose to 20 mg daily should be done with caution.

If you take more Lercanidipine Tarbis than you should

Do not take more than the prescribed dose. In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Taking a dose higher than the correct dose may cause an excessive drop in blood pressure and irregular and faster heartbeats.

If you forget to take Lercanidipine Tarbis

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

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

If you stop taking Lercanidipine Tarbis

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

If you have any other questions about the use of 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 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 (chest pain due to lack of blood in the heart)
• allergic reactions (with symptoms such as itching, rash and hives)
• fainting.

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

Other possible side effects

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

• headache
• increased heart rate
• palpitations (strong or rapid heartbeats)
• sudden reddening of the face
• neck or upper chest
• swelling of the ankles.

Uncommon(may affect up to 1 in 100 patients):

• dizziness
• drop in blood pressure
• heartburn
• discomfort
• stomach 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
• hives
• increased frequency of urination
• chest pain.

Frequency not known(cannot be estimated from the available data):

• gum swelling
• changes in liver function (detected in blood tests)
• cloudy liquid (when performing hemodialysis through a tube into the abdomen)
• swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing.

Reporting of side effects

If you experience any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Lercanidipine Tarbis

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

Do not use this medicine after the expiry date, which is stated on the blister and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the empty pack or any unused medicine in the pharmacy’s SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the pack or any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lercanidipine Tarbis

The active substance is lercanidipine hydrochloride.

Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 10.139 mg of lercanidipine hydrochloride hemihydrate).

Each film-coated tablet contains 20 mg of lercanidipine hydrochloride (equivalent to 20.278 mg of lercanidipine hydrochloride hemihydrate).

The other ingredients are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose (type A), sodium carboxymethyl starch (type A) (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 and packaging:

Lercanidipine Tarbis 10 mg film-coated tablets EFG

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

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

Lercanidipine Tarbis 20 mg film-coated tablets EFG

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

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

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Lercanidipin Amarox 10 mg/20 mg film-coated tablets

Spain: Lercanidipine Tarbis 10 mg/20 mg film-coated tablets EFG

Netherlands: Lercanidipine HCl Amarox 10 mg/20 mg film-coated tablets

Date of last revision of this leaflet:February2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/