LERCANIDIPINA 10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Lercanidipina Sandoz 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is Lercanidipina Sandoz and what is it used for
   2. What you need to know before taking Lercanidipina Sandoz
   3. How to take Lercanidipina Sandoz
   4. Possible side effects
   5. How to store Lercanidipina Sandoz
   6. Package contents and other information

Lercanidipina Sandoz 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking 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 Lercanidipina Sandoz is and what it is used for
• 2. What you need to know before you take Lercanidipina Sandoz
• 3. How to take Lercanidipina Sandoz
• 4. Possible side effects
• 5. How to store Lercanidipina Sandoz
• 6. Contents of the pack and other information

1. What is Lercanidipina Sandoz and what is it used for

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

2. What you need to know before taking Lercanidipina Sandoz

Do not take Lercanidipina Sandoz

• if you are allergic to lercanidipine or to any of the other ingredients of this medicine (listed in section 6)
• if you suffer from certain heart diseases:
• uncontrolled heart failure
• obstruction to blood flow from the heart
• unstable angina (oppressive chest pain at rest or progressively increasing)
• heart attack that occurred less than a month ago
• if you have serious problems with your liver
• if you have severe kidney problems or are undergoing dialysis
• if you are taking drugs that inhibit hepatic metabolism, such as:
• antimycotic 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 cyclosporine (used after transplants to prevent organ rejection)
• with grapefruit or grapefruit juice

Do not take this medicine if you are pregnant or breastfeeding, or if you are trying to become pregnant or if you are
a woman of childbearing potential and not using any method of contraception (see section Pregnancy,
breastfeeding and fertility for more information).

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

• if you suffer from certain heart conditions that have not been treated with an insertion of a pacemaker or have pre-existing angina (oppressive chest pain)
• if you suffer from problems with your liver or kidneys.

Children and adolescents
The safety and efficacy of Lercanidipina Sandoz in children and adolescents up to 18 years of age have not
been established.

Other medicines and Lercanidipina Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
It is particularly important that your doctor knows if you are already being treated with any of
the following medicines:

• beta-blockers e.g. metoprolol, (a medicine to treat high blood pressure, heart failure and abnormal heart rhythms)
• other medicines that affect blood pressure (alpha-blockers for the treatment of high blood pressure or prostate enlargement, tricyclic antidepressants and neuroleptics for the treatment of mental disorders)
• cimetidine, at doses greater than 800 mg (a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine to lower cholesterol levels in the blood)
• digoxin (a medicine for the treatment of heart problems)
• midazolam (a medicine that helps you sleep)
• rifampicin (a medicine for the treatment of tuberculosis)
• astemizole or terfenadine (medicines for allergies)
• amiodarone quinidine or sotalol (medicines for the treatment of fast heartbeat)
• phenytoin, phenobarbital or carbamazepine (drugs for epilepsy).

Lercanidipina Sandoz with food, beverages and alcohol

• A meal rich in fats significantly increases the blood levels of the medicine (see section 3).
• Alcohol can increase the effect of this medicine. Do not consume alcohol during treatment with this medicine
• Do not take this medicine with grapefruit or grapefruit juice (this may increase your blood pressure by decreasing its effect). See the section “Do not take Lercanidipina Sandoz”.

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

Driving and using machines
Caution is required as dizziness, weakness, fatigue and rarely drowsiness may occur. Do
not drive or use machines until you know how Lercanidipina Sandoz affects you.

Lercanidipina Sandoz contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which is
essentially ‘sodium-free’.

3. How to take Lercanidipina Sandoz

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

Adults
The recommended dose is one film-coated tablet of Lercanidipina Sandoz 10 mg daily, always
at the same time, preferably in the morning at least 15 minutes before breakfast, because a meal high in
fat significantly increases the levels of the medicine in the blood.
If necessary, your doctor may advise you to increase the dose to one film-coated tablet of
Lercanidipina Sandoz 20 mg.
The tablets should be swallowed preferably whole with a little water. The score line is only for
splitting the tablet to make it easier to swallow and not for dividing it into equal doses.

Elderly
No dose adjustment is required. However, particular attention should be paid
at the beginning of treatment.

Patients with liver or kidney problems
Particular attention is required at the beginning of treatment for these patients and an increase in the daily
dose to 20 mg should be carefully evaluated.

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

If you take more Lercanidipina Sandoz than you should
Do not exceed the dose prescribed to you.
If you take a higher dose than prescribed or in case of overdose, consult your
doctor immediately and, if possible, bring the tablets and/or the packaging with you.
Taking a higher dose than recommended may cause an excessive reduction in blood pressure and
the appearance of irregularities in heart rhythm or tachycardia, you may experience dizziness or headache.

If you forget to take Lercanidipina Sandoz
If you forget to take your tablet, simply skip the missed dose and then continue with your
usual therapy. Do not take a double dose to make up for the missed dose.

If you stop taking Lercanidipina Sandoz
If you stop taking Lercanidipina Sandoz, your blood pressure may increase
again. Consult your doctor before stopping treatment.
If you have any doubts about the use of this medicine, ask 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 may be serious:
If you experience any of the following side effects, seek immediate medical attention:
Rare (may affect less than 1 in 10,000 people):
Oppressive chest pain (angina pectoris), fainting and allergic reactions (symptoms include
itching, rash, hives, difficulty breathing or swallowing, dizziness).
If you suffer from pre-existing angina pectoris, with the group of drugs to which Lercanidipina
Sandoz also belongs, an increase in the frequency, duration and severity of angina attacks may occur.
Isolated cases of myocardial infarction may be observed.
Not known (frequency cannot be estimated based on available data):
Swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing.

Other possible side effects:

Common(may affect up to 1 in 10 people):
Headache, faster heartbeat, palpitations (heartbeat or racing), flushing (e.g. on the face),
ankle swelling.

Uncommon(may affect up to 1 in 100 people):
Dizziness, low blood pressure, indigestion, feeling unwell, stomach pain, rash,
itching, muscle pain, passing large amounts of urine, feeling weak or feeling
tired

Rare(may affect up to 1 in 1,000 people):
drowsiness, malaise, diarrhea, hives, increased usual number of urinations, chest pain

Not known(frequency cannot be estimated based on available data):
swollen gums, changes in liver function values (detected by blood tests),
cloudy fluid (when performing dialysis through a tube in the abdomen).

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store Lercanidipina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, on the package after SCAD.
The expiry date refers to the last day of that month.
Al/PVC blisters: Do not store at a temperature above 25°C. Store in the original package
to protect from humidity.
Al/PVDC blisters: Do not store at a temperature above 25°C. Store in the original package
to protect from humidity.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate the
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lercanidipina Sandoz contains

• The active ingredient is lercanidipine hydrochloride. Each film-coated tablet containing 10 mg contains 10 mg of lercanidipine hydrochloride, equivalent to 9.4 mg of lercanidipine. Each film-coated tablet containing 20 mg contains 20 mg of lercanidipine hydrochloride, equivalent to 18.8 mg of lercanidipine.
• The other ingredients are:
• 10 mg film-coated tablets
• Tablet core: magnesium stearate, povidone, sodium starch glycolate (Type A), lactose monohydrate, microcrystalline cellulose Film coating :macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide (E171), yellow iron oxide (E172).

20 mg film-coated tablets
Tablet core: magnesium stearate, povidone, sodium starch glycolate (Type A), lactose
monohydrate, microcrystalline cellulose
Film coating :macrogol, polyvinyl alcohol (partially hydrolysed), talc, titanium dioxide
(E171), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Lercanidipina Sandoz and package contents

10 mg film-coated tablets:
Yellow, round biconvex, with a diameter of 6.5 mm, notched on one side, marked with “L” on the other side.

20 mg film-coated tablets:
Pink, round, biconvex with a diameter of 8.5 mm, notched on one side, marked with “L” on the other side.
The score line is only to allow the tablet to be broken for easier swallowing and not to divide it into equal doses.

Packs:

Blisters (Al/PVC):

10 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 film-coated tablets

20 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets

Blisters (Al/PVDC):

10 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 98, 100 film-coated tablets

20 mg film-coated tablets:
7, 10, 14, 20, 28, 30, 35, 42, 50, 56, 60, 98, 100 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorisation holder
Sandoz S.p.A Largo U. Boccioni 1 21040 Origgio VA

Manufacturers
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Salutas Pharma GmbH
Otto-von-Guericke Allee 1
39179 Barleben Germany
Balkanpharma Dupnitsa AD
3 Samokovsko Str.,
Dupnitsa, 2600 Bulgaria
Lek Pharmaceuticals d.d.,
Verovskova 57
1526 Ljubljana
Slovenia
This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Austria Lercanidipin Sandoz 10 mg - Filmtabletten
Lercanidipin Sandoz 20 mg - Filmtabletten
Belgium Lercanidipin Sandoz 10 mg filmomhulde tabletten
Lercanidipin Sandoz 20 mg filmomhulde tabletten
Denmark Lercatio
Italy Lercanidipina Sandoz 10 mg compresse rivestite con film
Lercanidipina Sandoz 20 mg compresse rivestite con film
Netherlands Lercanidipine HCl Sandoz 10 & 20 mg, filmomhulde tabletten
Portugal Lercanidipina Sandoz
Spain Lercanidipino Sandoz 10 mg comprimidos recubiertos con película EFG
Lercanidipino Sandoz 20 mg comprimidos recubiertos con película EFG