Nidipres

Package leaflet: Information for the user

NIDIPRES 10 mg film-coated tablets, 20 mg film-coated tablets

Lercanidipine hydrochloride
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NIDIPRES is and what it is used for
2. What you need to know before taking NIDIPRES
3. How to take NIDIPRES
4. Possible side effects
5. How to store NIDIPRES
6. Contents of the pack and other information

1. What NIDIPRES is and what it is used for

NIDIPRES, lercanidipine hydrochloride, belongs to a group of medicines called calcium channel blockers (dihydropyridine derivatives) which reduce blood pressure.
NIDIPRES is used to treat high blood pressure, also known as hypertension, in adults over 18 years of age (it is not recommended for children under 18 years).

2. What you need to know before taking NIDIPRES

Do not take NIDIPRES

• if you are allergic (hypersensitive) to lercanidipine or to any of the other ingredients of this medicine (listed in section 6)
• if you have had allergic reactions to medicines closely related to NIDIPRES tablets (such as amlodipine, nicardipine, felodipina, isradipine, nifedipine or lacidipine)
• if you suffer from certain heart diseases
• untreated heart failure
• obstruction of blood flow from the heart
• unstable angina (angina at rest or progressively worsening angina)
• if you have had a heart attack less than one month ago
• if you have severe liver or kidney problems
• if you are taking any of the following medicines which are inhibitors of the CYP3A4 isoenzyme:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin or troleandomycin)
• antiviral agents (such as ritonavir)
• if you are taking another medicine called cyclosporine (used after organ transplantation to prevent organ rejection)
• with grapefruit or grapefruit juice. Do not use it if you are pregnant or breastfeeding (see section Pregnancy, breastfeeding and fertility for more information).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIDIPRES:

• if you have other heart conditions that have not been treated with a pacemaker or if you have pre-existing angina
• if you have liver or kidney problems, or if you are on dialysis.

You must inform your doctor if you think you are (or might become) pregnant or if you are breastfeeding (see the section on pregnancy, breastfeeding and fertility).
Children and adolescents
The safety and efficacy of NIDIPRES in children up to 18 years of age have not been established.
No data are available.
Other medicines and NIDIPRES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Especially if you are already being treated with any of the following medicines:

• beta-blockers, e.g. metoprolol, diuretics or ACE inhibitors (medicines for treating high blood pressure)
• cimetidine, at doses higher than 800 mg (a medicine for ulcers, indigestion or heartburn)
• digoxin (a medicine for treating heart problems)
• midazolam (a medicine that helps you sleep)
• rifampicin (a medicine for treating tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone or quinidine (medicines for treating fast heartbeat)
• simvastatin (a medicine for high cholesterol levels)
• phenytoin or carbamazepine (medicines for epilepsy). Your doctor may want to monitor your blood pressure more frequently than usual.

NIDIPRES with food, drinks and alcohol
You must not consume alcohol during treatment with NIDIPRES tablets, as it may increase the effect of NIDIPRES tablets.
Do not take NIDIPRES tablets with grapefruit or grapefruit juice.
Pregnancy, breastfeeding and fertility
NIDIPRES must not be used if you are pregnant, if you suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding or not using any contraceptive method.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Exercise caution due to the possibility of dizziness, weakness, fatigue and, rarely, drowsiness. Do not drive or operate machinery until you know how NIDIPRES affects you.
NIDIPRES contains lactose monohydrate.
If your doctor has informed you that you have an intolerance to certain sugars, e.g. lactose intolerance, galactosemia or glucose/galactose malabsorption syndrome, contact your doctor before taking this medicine, as the tablets contain lactose.

3. How to take NIDIPRES

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 10 mg once daily, at the same time every day, preferably in the morning
at least 15 minutes before breakfast, as a high-fat meal increases blood levels of the
medicine. If necessary, your doctor may advise you to increase the dose to one tablet of
NIDIPRES 20 mg daily.
The tablets should preferably be swallowed whole with a little water.
Use in children
This medicine must not be used in children under 18 years of age.
Elderly patients
No adjustment of the daily dose is required.
However, particular caution should be exercised at the beginning of treatment.
Patients with liver or kidney problems
Particular caution is required at the start of treatment in these patients, and increasing the
daily dose to 20 mg should be done with caution.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you take more NIDIPRES than you should
Do not exceed the prescribed dose.
If you take more than the prescribed dose or in case of overdose, seek immediate medical attention and,
if possible, bring the tablets and/or the container with you.
Taking more than the correct dose may cause excessive lowering of blood pressure and irregular or rapid
heartbeat. It may also lead to loss of consciousness.
If you forget to take NIDIPRES
If you forget to take a tablet, simply skip that dose and continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop taking NIDIPRES
If you stop treatment with NIDIPRES, your blood pressure may rise again.
Consult your doctor before stopping treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious:
If you experience any of these side effects, inform your doctor immediately.
Rare (affecting less than 1 in 1,000 people):
Angina pectoris (chest pain due to reduced blood flow to the heart)
Very rare (affecting less than 1 in 10,000 people):
Chest pain, drop in blood pressure, fainting, and allergic reactions (symptoms include itching, rash, hives)
If you already suffer from angina pectoris, with the group of medicines to which Nidipres belongs, you may experience an increase in frequency, duration, or severity of these attacks.
Isolated cases of heart attack may occur.
Other possible side effects:
Uncommon (affecting less than 1 in 100 people):
Headache, dizziness, rapid heartbeat, palpitations (pounding or racing heartbeat), sudden redness of the face, neck, or upper chest, swollen ankles.
Rare (affecting less than 1 in 1,000 people):
Drowsiness, nausea, vomiting, heartburn, stomach discomfort, diarrhoea; skin rash, muscle pain, passing large amounts of urine, fatigue.
Very rare (affecting less than 1 in 10,000 people):
Swollen gums, changes in liver function (detected in blood tests), increased frequency of urination.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIDIPRES

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton and the blister pack after EXP. The expiry date refers to the last day of that month.
Storage conditions:
Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIDIPRES contains
The active substance is lercanidipine hydrochloride.
One 10 mg film-coated tablet contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine.
One 20 mg film-coated tablet contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
The other components are:
Tablet core: Magnesium stearate, povidone, sodium starch glycolate (type A), lactose monohydrate, microcrystalline cellulose.
Coating of 10 mg tablets: Macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172).
Coating of 20 mg tablets: Macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of NIDIPRES and contents of the pack
NIDIPRES 10 mg tablets are yellow, round, biconvex, film-coated tablets of 6.5 mm diameter, with a score line on one side and marked "L" on the other side.
NIDIPRES 20 mg tablets are pink, round, biconvex, film-coated tablets of 8.5 mm diameter, with a score line on one side and marked "L" on the other side.
The score line on the tablet is only intended to assist in breaking the tablet if you have difficulty swallowing it whole, and is not intended for dividing the tablet into equal doses.

Pack sizes:
NIDIPRES 10 mg film-coated tablets: 28 tablets
NIDIPRES 20 mg film-coated tablets: 28 tablets
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
LANOVA FARMACEUTICI S.R.L.
Via Conca D’Oro, 212
00141 Rome – Italy

Manufacturer
Actavis Hf.
Reykjavikurvegi 78
P.O.Box 420
IS-220 Hafnarfjordur
Iceland
and/or
Actavis Ltd.
B16
Bulebel Industrial Estate
Zejtun ZTN 08
MALTA
and/or
Balkanpharma – Dupnitsa AD
3 Samokovsko Schosse Str.
Dupnitsa 2600
Bulgaria

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Cardiopin
Italy: Nidipres