LERCANIDIPINE TECNIGEN 10 mg FILM-COATED TABLETS

2. Before taking Lercanidipine TecniGen

Do not take Lercanidipine TecniGen

• If you are allergic to lercanidipine, to other dihydropyridines (such as amlodipine, nicardipine, felodipine, isradipine, nifedipine, or lacidipine) 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 the outflow of blood from the heart, unstable angina (rest angina or progressively increasing angina), and during the first month after a heart attack.
• If you have severe liver or kidney disease.
• If you are taking certain medicines such as cyclosporin, ketoconazole, itraconazole, ritonavir, erythromycin, and/or troleandomycin.

Special warnings and precautions

• If you have mild or moderate liver or kidney disease, you should inform your doctor.
• If you have certain heart diseases and/or have a pacemaker, you should inform your doctor before starting to take Lercanidipine TecniGen 10 mg film-coated tablets EFG.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Using other medicines

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

• You are taking beta-blockers, such as metoprolol, diuretics (medicines that increase urine production), or ACE inhibitors (medicines for treating hypertension).
• 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 that helps 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 tachycardia).
• You are taking phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual.
• You are taking antifungals (such as ketoconazole or itraconazole), macrolide antibiotics (such as erythromycin or troleandomycin), or antivirals (such as ritonavir). The effect of Lercanidipine TecniGen may be increased. Therefore, simultaneous administration should be avoided (see "Do not take Lercanidipine TecniGen").
• You are taking cyclosporin (a medicine that reduces the body's resistance to diseases). The effect of Lercanidipine TecniGen and cyclosporin may be increased. Therefore, simultaneous administration should be avoided (see "Do not take Lercanidipine TecniGen").
• You are taking simvastatin (a medicine that lowers cholesterol levels).

Lercanidipine TecniGen should be taken in the morning, and simvastatin in the evening.

Taking Lercanidipine TecniGen with food and drinks:

Do not take Lercanidipine TecniGen with grapefruit juice.

Do not drink alcoholic beverages if you are being treated with Lercanidipine TecniGen.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medicine.

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 medicine if you are pregnant or breastfeeding.

Driving and using machines:

Since Lercanidipine TecniGen can rarely cause dizziness, fatigue, and somnolence, you should be extremely cautious when driving vehicles or operating hazardous machinery.

3. How to take Lercanidipine TecniGen

Follow the instructions for administration of Lercanidipine TecniGen exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

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

The tablet should be taken whole, with a sufficient amount of liquid (e.g., 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 described above. The use of Lercanidipine 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 Lercanidipine TecniGen have not been established in children and adolescents under 18 years, its use is not recommended in this population.

If you take more Lercanidipine TecniGen than you should:

Overdose of Lercanidipine TecniGen 10 mg can cause your blood pressure to drop too low and your heart rate to become irregular and faster. It can also lead to loss of consciousness.

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

If you forget to take Lercanidipine TecniGen

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

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

If you stop taking Lercanidipine TecniGen

If you stop taking Lercanidipine TecniGen, your blood pressure may rise again. Consult your doctor before stopping treatment.

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

4. Possible side effects

Like all medicines, Lercanidipine TecniGen 10 mg can cause side effects, although not everybody gets them. The following frequencies are used to evaluate side effects:

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

Some side effects can be serious:

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 previously suffered from angina pectoris, treatment with medicines of the same group as Lercanidipine TecniGen may cause an increase in the frequency, duration, or severity of these attacks. Isolated cases of myocardial infarction may be observed.

Other possible side effects:

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

Rare: somnolence, nausea, vomiting, heartburn, stomach pain, diarrhea; skin rash, muscle pain, increased urine production, 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 suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Lercanidipine TecniGen

Keep out of the reach and sight of children.

Do not use Lercanidipine TecniGen 10 mg after the expiration date stated on the packaging (on the carton and on the blister), after "EXP". The expiration date is the last day of the month indicated. Do not use Lercanidipine TecniGen 10 mg if you notice visible signs of deterioration.

Store in the original packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Further information

Composition of Lercanidipine TecniGen 10 mg:

The active substance is lercanidipine. Each tablet contains 10 mg of lercanidipine (as hydrochloride).

The other ingredients are:

Core:Cornstarch, Sodium starch glycolate (type A), Colloidal silicon dioxide, Microcrystalline cellulose (pH 113), Poloxamer 188, Sodium stearyl fumarate, Macrogol 6000. Coating:Hypromellose 6 cps, Macrogol 6000, Yellow iron oxide (E 172), Titanium dioxide (E 171).

Appearance of the product and packaging content:

Lercanidipine TecniGen 10 mg are yellow, round, biconvex tablets with a score line on one side and flat on the other side.

Lercanidipine TecniGen 10 mg film-coated tablets EFG are presented in aluminum/PVC blisters in packs of 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

TECNIMEDE ESPAÑA INDUSTRIA FARMACEUTICA, S.A.

Avda. de Bruselas, 13, 3º D.

Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas, Madrid. Spain

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