Lertiv 20 mg Lercanidipine - 30 Tablets

Do not take Lertiv

• If you are allergic to Lercanidipine hydrochloride or any of the other ingredients of this medicine

• If you are suffering from certain heart diseases:

• Obstruction to flow of blood from the heart

• Untreated heart failure

• Unstable angina (chest discomfort occurring at rest or progressively increasing)

• Within one month of heart attack.

• If you have severe liver problems.

• If you have severe kidney problems or you are undergoing dialysis.

• If you are taking medicines that are inhibitors of the hepatic metabolism, such as:

• antifungal medicines (such as ketoconazole or itraconazole)

• macrolide antibiotics (such as erythromycin. troleandomycin or clarithromycin)

• antivirals (such as ritonavir).

• If you are taking another medicine called ciclosporin or cyclosporin (used after transplants

• to prevent organ rejection).

• With grapefruit or grapefruit juice.

Warning and precautions

Talk to your doctor or pharmacist before taking Lertiv:

• if you have a heart problem

• if you have liver or kidney problems

You must tell your doctor if you think you are (or might become) pregnant or breast-feeding (see pregnancy, breast-feeding and fertility section).
Children and adolescents.

The safety and efficacy of Lertiv in children aged up to 18 years have not been established.

Other medicines and Lertiv

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when Lertiv is taken with other medicines the effect of Lertiv or of the other medicine may be changed or certain side effects may occur more frequently (see also section 2 “Do not take Lertiv”).

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

• phenytoin, phenobarbital or carbamazepine (medicines for epilepsy)

• rifampicin (a medicine to treat tuberculosis)

• astemizole or terfenadine (medicines for allergies)

• amiodarone, quinidine or sotalol (medicines to treat a fast heart beat)

• midazolam (a medicine that helps you sleep)

• digoxin (a medicine to treat a heart problem)

• beta-blockers e.g. metoprolol (a medicine to treat high blood pressure, heart failure and abnormalheart rhythm)

• cimetidine (more than 800 mg, a medicine for ulcers, indigestion, or heartburn)

• simvastatin (a medicine to lower cholesterol in your blood)

• other medicines to treat high blood pressure

Lertiv with food, drink and alcohol

• A high fat meal significantly increases blood levels of the medicine (see section 3).

• Alcohol can increase the effect of Lertiv. Do not consume alcohol during treatment with Lertiv.

• Lertiv must not be taken with grapefruit or grapefruit juice (they can increase its hypotensive effect). See section 2 “Do not take Lertiv”.

Pregnancy, breast-feeding and fertility

Lertiv is not recommended if you are pregnant, it should not be used during breast-feeding. There are no data from the use of Lertiv in pregnant women and in nursing mothers. If you are pregnant or breast-feeding, if you are not using any contraceptive method, you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

If you develop dizziness, weakness or drowsiness with this medicine, do not drive a vehicle or operate machines.

Lertiv contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your

Doctor before taking this medicinal product.

Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially

“Sodium-free”.

Always take this medicine exactly as your doctor has told you. Check with your doctor or

Pharmacist if you are not sure.

Adults: the recommended dose is 10 mg once daily at the same time each day, preferably in the morning at least 15 minutes before breakfast. Your doctor may advise you to increase the dose to one Lertiv 20 mg daily, if needed. (see section 2 “Lertiv with food, drink and alcohol”).

Lertiv 10 mg: the score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Lertiv 20 mg: the tablet can be divided into equal doses.

The tablets should preferably be swallowed whole with some water.

Use in children: This medicine should not be used in children under 18 years of age.

Elderly patients: No adjustment of the daily dose is required. However, special care should be exercised in starting treatment.

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

If you take more Lertiv than you should

Do not exceed the prescribed dose. If you have taken more than the prescribed dose, talk to your doctor or go to the hospital straight away. Take the medicine pack with you. Taking more than the correct dose can cause an excessive drop in blood pressure and your heart can beat irregularly or faster.

If you forget to take Lertiv

If you forget to take your tablet simply miss that dose and then go on as before. Do not take a double dose to make up for a forgotten dose.

If you stop taking Lertiv

If you stop taking Lertiv your blood pressure may increase again. Please consult your doctor before stopping the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

• Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:


• Some side effects can be serious.


• If any of the following happen, tell your doctor straight away:


• Rare (may affect up to 1 in 1,000 people): angina pectoris (e.g. chest tightness due to lack of blood to your heart), allergic reactions (symptoms include itching, rash, urticaria), fainting.


• Patients with pre-existing angina pectoris may experience increased frequency, duration or severity


• of these attacks with the group of medicines to which Lertiv belongs. Isolated cases of heart attack may be observed.


• Other possible side effects:


• Common (may affect up to 1 in 10 people): headache, fast heart rate, feeling of fast or uneven heart beat (palpitations), sudden reddening of your face, neck or upper chest (flushing), ankle swelling. Uncommon (may affect up to 1 in 100 people): dizziness, fall in blood pressure, heartburn, feeling sick, stomach pain, skin rash, itching, muscle pain, passage of large amounts of urine, feeling weak or feeling tired.


• Rare (may affect up to 1 in 1,000 people): sleepiness, vomiting, diarrhoea, hives, increase in the usual number of times one urinates, chest pain.


• Not known (frequency cannot be estimated from the available data): swelling of gums, changes in liver function (detected by blood tests), cloudy fluid (when performing dialysis through a tube into your abdomen), swelling of your face, lip, tongue or throat which may cause difficulty in breathing or swallowing.


• Reporting of suspected adverse reactions


• Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

• Store below 30°C.

• Keep out of reach of children.

• Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of the month.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no longer use. These measures will help protect the environment.