Prospect: information for the user

Lercanidipine TecniGen 10 mg film-coated tabletsEFG

Lercanidipine

Read this prospect carefully before starting to use the medication:

- Keep this prospect, as you may need to refer to it.

- If you have any doubts, consult your doctor or pharmacist.

- This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

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

2.Before taking Lercanidipine TecniGen

3.How to take Lercanidipine TecniGen

4.Possible adverse effects

5.Storage of Lercanidipine TecniGen

6.Additional information

Lercanidipino belongs to a group of medicines called calcium channel blockers (from the dihydropyridines group).

Lercanidipino TecniGen 10 mg is used for the treatment of mild or moderate essential hypertension.

Do not take Lercanidipino TecniGen

-If you are allergic to lercanidipino, to other dihydropiridinas (such as amlodipino, nicardipino, felodipino, isradipino, nifedipino, or lacidipino) or to any of the excipients.

-If you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

-If you have heart diseases such as, uncontrolled heart failure, obstruction of blood flow from the heart, unstable angina (angina at rest or progressively increasing) and during the first month after suffering a myocardial infarction.

-If you have severe liver or kidney disease.

-If you are taking certain medications such as ciclosporina, ketoconazol, itraconazol, ritonavir, erythromycin, and/or troleandomycin.

Be especially careful with Lercanidipino TecniGen

-If you have liver or kidney disease of mild or moderate intensity, you must inform your doctor.

-If you have certain heart diseases and/or have a pacemaker, you must inform your doctor before starting to take Lercanidipino TecniGen 10 mg film-coated tablets.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. In particular, inform your doctor or pharmacist if:

•You are takingbeta blockers, for example, metoprolol,diuretics(medications to increase urine elimination)or ACE inhibitors(medications to treat hypertension).

•You are takingcimetidina(more than 800 mg per day, a medication for ulcers, indigestion, or heartburn).

• You are takingdigoxina(a medication to treat heart problems).

• You are takingmidazolam(a medication that helps you sleep).

• You are takingrifampicina(a medication to treat tuberculosis).

• You are takingastemizol or terfenadina(medications for allergies).

•You are takingamiodarona or quinidina(medications to treat tachycardia).

•You are takingphenytoin or carbamazepine(medications for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual.

•You are takingantimicotics(such as ketoconazol or itraconazol), macrolide antibiotics (such as erythromycin or troleandomycin) or antivirals (such as ritonavir). The effect ofLercanidipino TecniGenmay be increased. Therefore, simultaneous administration should be avoided (see “Do not takeLercanidipino TecniGen”).

•You are takingciclosporina(a medication that reduces the body's resistance to diseases). The effect of Lercanidipino TecniGen and ciclosporina may be increased. Therefore, simultaneous administration should be avoided (see “Do not takeLercanidipino TecniGen”).

• You are takingsimvastatina(a medication that reduces cholesterol levels).

Lercanidipino TecniGen should be taken in the morning, and simvastatina, at night.

Taking Lercanidipino TecniGen with food and drinks:

Do not take Lercanidipino TecniGen with grapefruit juice.

Do not consume alcoholic beverages while taking Lercanidipino TecniGen.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

Before starting treatment, inform your doctor if you are pregnant or planning to become pregnant or are not using an effective contraceptive method.

You should not use this medication if you are pregnant or breastfeeding.

Driving and operating machinery:

Since Lercanidipino TecniGen may rarely cause dizziness, fatigue, and drowsiness, you should exercise extreme caution when driving vehicles or operating hazardous machinery.

Follow exactly the administration instructions for Lercanidipino TecniGen indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Adults: The usual dose is one Lercanidipino TecniGen 10 mg tablet daily, at the same time every day, preferably in the morning, at least 15 minutes before breakfast , because a meal high in fats significantly increases the blood concentration of the active ingredient. If necessary, your doctor may advise you to increase the dose to two tablets daily (20 mg per day).

The tablet should be taken whole, with a sufficient amount of liquid (for example, a glass of water).

Patients with renal or hepatic insufficiency and elderly patients: Your doctor will indicate the dose you should take, which may not be the one recommended above. Lercanidipino TecniGen 10 mg is contraindicated in patients with severe renal or hepatic insufficiency.

Children and adolescents under 18 years: Since the safety and efficacy of Lercanidipino TecniGen have not been established in children and adolescents under 18 years, its use is not recommended in this population group.

If you take more Lercanidipino TecniGen than you should:

A Lercanidipino TecniGen 10 mg overdose may cause blood pressure to drop too low and the heart to beat irregularly and faster. It may also lead to loss of consciousness.

In case of an overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Lercanidipino TecniGen:

Take the missed dose as soon as you remember. Then, continue the next day as your doctor had indicated.

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

If you interrupt treatment with Lercanidipino TecniGen:

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

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

Like all medications, Lercanidipino TecniGen 10 mg may cause side effects, although not everyone will experience them. In the evaluation of side effects, the following frequencies are used:

Very frequent:May affect more than 1 in 10 patients.

Some side effects may be severe:

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

Rare: angina pectoris (chest pain due to lack of blood flow to the heart).

Very rare: chest pain, decreased blood pressure, dizziness, and allergic reactions (symptoms include itching, skin rash, hives).

If you have had a previous heart attack, treatment with medications in the group to which Lercanidipino TecniGen belongs may cause an increase in the frequency, duration, or severity of these attacks. Cases of myocardial infarction may be observed.

Other possible side effects:

Infrequent: headache, dizziness, tachycardia, palpitations (increased heart rate), sudden redness of the face, neck, or upper face, swelling of the ankles.

Rare: drowsiness, nausea, vomiting, chest discomfort, stomach pain, diarrhea; skin rash, muscle pain, large amounts of urine, fatigue.

Very rare: gum swelling, changes in liver function (detected by blood tests), increased frequency of urination.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use Lercanidipino TecniGen 10 mg after the expiration date that appears on the packaging (on the carton box and on the blister pack), after “EXP”. The expiration date is the last day of the month indicated. Do not use Lercanidipino TecniGen 10 mg if you observe visible signs of deterioration.

Store in the original packaging, to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Lercanidipino TecniGen 10 mg:

The active ingredient is lercanidipino. Each tablet contains 10 mg of lercanidipino (as hydrochloride).

The other components are:

Core:Maize starch, Sodium glycolate starch (type A), Colloidal silica dioxide, Microcrystalline cellulose (pH 113), Poloxamer 188, Sodium fumarate stearate, Macrogol 6000.Coating:6 cps Hypromellose, Macrogol 6000, Yellow Iron Oxide (E 172), Titanium Dioxide (E 171).

Appearance of the product and contents of the package:

Lercanidipino TecniGen 10 mg are yellow, round, biconvex tablets with a notch on one face and flat on the other face.

Lercanidipino TecniGen 10 mg tablets EFG are presented in aluminum/PVC blisters in packages of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3º D.

Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Madrid. Spain

Responsible manufacturer:

Tecnimede – Sociedade Técnico-Medicinal; S.A.

Quinta da cerca, Caixaria, 2565-187 Dois Portos, Portugal

or

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira, 2710-089 Sintra

Portugal

This leaflet was approved in November 2015