NIDIPRES 10 mg Film-Coated Tablets

Зміст інструкції

1. NIDIPRES 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is NIDIPRES and what is it used for
   2. What you need to know before you take NIDIPRES
   3. How to take NIDIPRES
   4. Possible side effects
   5. How to store NIDIPRES
   6. Package Contents and Other Information

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

Lercanidipine hydrochloride
Generic medicine

Read this leaflet carefully before you start to use this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is NIDIPRES and what is it 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 of age).

2. What you need to know before you take NIDIPRES

Do not take NIDIPRES

• if you are allergic (hypersensitive) to lercanidipine or 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, felodipine, 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 with progressively increasing severity)
• if you have had a heart attack less than a month ago
• if you have severe liver or kidney problems
• if you are taking some of the following medicines which are CYP3A4 isoenzyme inhibitors:
• antifungal medicines (such as ketoconazole or itraconazole)
• macrolide antibiotics (such as erythromycin or troleandomycin)
• antivirals (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 the Pregnancy, breastfeeding and fertility section 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 the insertion of a pacemaker or 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 could become) pregnant or if you are breastfeeding (see the section relating to 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
Tell 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 to treat high blood pressure)
• cimetidine, at doses greater than 800 mg (a medicine for ulcers, indigestion or heartburn)
• digoxin (a medicine to treat heart problems)
• midazolam (a medicine that helps you sleep)
• rifampicin (a medicine to treat tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone or quinidine (medicines to treat fast heartbeat)
• simvastatin (a medicine for high cholesterol levels).
• phenytoin or carbamazepine (medicines for epilepsy). Your doctor will want to monitor your blood pressure more frequently than usual.

NIDIPRES with food, drinks and alcohol
You should not consume alcohol during treatment with Nidipres tablets as it may increase the effect of Nidipres tablets.
You should not take Nidipres tablets with grapefruit or grapefruit juice.

Pregnancy, breastfeeding and fertility
Nidipres should not be used if you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk or are not using any method of contraception.
Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
You should be careful due to the possibility of dizziness, weakness, fatigue and rarely drowsiness. Do not drive or use machines until you know how Nidipres affects you.

NIDIPRES contains lactose monohydrate.
If your doctor has told you that you have an intolerance to some sugars, e.g. lactose intolerance, galactosaemia or glucose/galactose malabsorption syndrome, contact him before taking this medicine, as the tablets contain lactose.

3. How to take NIDIPRES

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Adults
The recommended dose is 10 mg once a day, at the same time each day, preferably in the
morning at least 15 minutes before breakfast, as a meal high in fat increases the levels of the
medicine in the blood. If necessary, your doctor may advise you to increase the dose to one
NIDIPRES 20 mg tablet per day.
The tablets should be swallowed preferably whole with a little water.

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

Elderly patients
No dose adjustment is required.
However, particular caution should be exercised at the start of treatment.

Patients with liver or kidney problems
Particular caution is required in these patients at the start of treatment and increasing the daily
dose to 20 mg should be done with caution.
If you have any doubts about using 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.
Exceeding the correct dose can cause an excessive lowering of blood pressure and an
irregular or faster heartbeat. It can 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 missed dose.

If you stop taking NIDIPRES
If you stop taking NIDIPRES your blood pressure may increase again.
Consult your doctor before stopping treatment.
If you have any doubts about using 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.
manifest.

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 lack of blood 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 suffer from pre-existing angina pectoris, with the group of medicines to which Nidipres belongs, you may
experience an increase in the frequency, duration or severity of these attacks.
Isolated cases of heart attack may be observed.

Other possible side effects:
Uncommon (affecting less than 1 in 100 people):
Headache, dizziness, fast heartbeat, palpitations (heart beating strongly or quickly), sudden
flushing of the face, neck or upper chest, swollen ankles.
Rare (affecting less than 1 in 1,000 people):
Drowsiness, nausea, vomiting, heartburn, stomach pain, 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 usual number of times
you urinate.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, on the carton and on the blister
after EXP. The expiry date refers to the last day of that month.
Storage conditions:
Do not store at a temperature above 25°C. Store in the original packaging to protect the
medicine from moisture.
Do not dispose of any medicine in 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 ingredient is lercanidipine hydrochloride.
One film-coated tablet containing 10 mg contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg
of lercanidipine.
One film-coated tablet containing 20 mg contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8
mg of lercanidipine.
The other ingredients are: Tablet core: Magnesium stearate, povidone, sodium starch glycolate
(Type A), lactose monohydrate, microcrystalline cellulose.
Tablet coating 10 mg: Macrogol, polyvinyl alcohol (partially hydrolysed), talc,
titanium dioxide (E171), yellow iron oxide (E172).
Tablet coating 20 mg: Macrogol, polyvinyl alcohol (partially hydrolysed), talc,
titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of NIDIPRES and package contents
NIDIPRES 10 mg tablets are yellow, round, biconvex, 6.5 mm film-coated, with a breaking line on one side and marked “L” on the other side.
NIDIPRES 20 mg tablets are pink, round, biconvex, 8.5 mm film-coated with a breaking line on one side and marked “L” on the other side.
The breaking line on the tablet is only to help you break the tablet if you have difficulty swallowing it whole and not to divide it into equal doses.

Packs:
NIDIPRES 10 mg film-coated tablets: 28 tablets
NIDIPRES 20 mg film-coated tablets: 28 tablets
Not all pack sizes may be 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 Member States of the European Economic Area under the following
names:
Denmark Cardiopin
Italy Nidipres