CARDIOVASC 10 mg Tabletki Powlekane

Treść ulotki

1. CARDIOVASC 10 mg film-coated tablets
   1. What is Cardiovasc and what is it used for
   2. What you need to know before you take Cardiovasc
   3. How to take Cardiovasc
   4. Possible side effects
   5. How to store Cardiovasc
   6. Contents of the pack and other information

CARDIOVASC 10 mg film-coated tablets

CARDIOVASC 20 mg film-coated tablets
lercanidipine hydrochloride

Read this leaflet carefully before you start taking 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Cardiovasc and what is it used for

Cardiovasc, lercanidipine hydrochloride, belongs to a group of medicines called Calcium antagonists (dihydropyridine derivatives) which reduce blood pressure.
Cardiovasc 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 under the age of 18).

2. What you need to know before you take Cardiovasc

Do not take Cardiovasc

• If you are allergic (hypersensitive) to lercanidipine hydrochloride or to any of the other ingredients of Cardiovasc tablets.
• If you suffer from certain heart conditions such as: o obstruction of blood flow from the heart or uncontrolled heart failure or angina pectoris (chest pain that occurs at rest or that progressively worsens) or a heart attack that occurred less than a month ago.
• If you have severe liver problems
• If you have severe kidney problems or are undergoing dialysis.
• If you are taking medicines that are inhibitors of hepatic metabolism such as: o antifungals (e.g. ketoconazole or itraconazole) o macrolide antibiotics (e.g. erythromycin, troleandomycin or clarithromycin) o antivirals (e.g. ritonavir).
• If you are taking another medicine called cyclosporine (used after transplants to prevent organ rejection).
• With grapefruit or grapefruit juice.

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

• If you have heart problems.
• If you have liver or kidney problems.

You must inform your doctor if you think you are (or may become) pregnant or are breastfeeding (see section Pregnancy, breastfeeding and fertility).

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

Other medicines and Cardiovasc
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because when Cardiovasc is taken with other medicines the effect of Cardiovasc or of the other medicine may be altered or some undesirable effects may occur more frequently (see also section 2 Do not take Cardiovasc).
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 for the treatment of tuberculosis)
• astemizole or terfenadine (medicines for the treatment of allergies)
• amiodarone, quinidine or sotalol (medicines for the treatment of tachycardia)
• midazolam (a medicine that helps you sleep)
• digoxin (a medicine for the treatment of heart problems)
• beta-blockers e.g. metoprolol (a medicine for the treatment of high blood pressure, heart failure and heart rhythm abnormalities)
• cimetidine (more than 800 mg, a medicine for ulcers, indigestion or heartburn)
• simvastatin (a medicine for lowering cholesterol in the blood)
• other medicines for the treatment of high blood pressure

Cardiovasc with food, beverages and alcohol

• A meal rich in fats significantly increases the blood levels of the medicine (see section 3).
• Alcohol may increase the effect of Cardiovasc. Do not drink alcohol during treatment with Cardiovasc.
• Cardiovasc should not be taken with grapefruit or grapefruit juice (they can increase its hypotensive effect) (See section 2 - Do not take Cardiovasc).

Pregnancy, breastfeeding and fertility
Cardiovasc is not recommended in case of pregnancy, it should not be used during breastfeeding. There are no data on the use of Cardiovasc in pregnant and breastfeeding women. If you are pregnant or breastfeeding, if you are not using any method of contraception, 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 operating machinery
If you experience dizziness, weakness or drowsiness with this medicine, do not drive vehicles or operate machinery.

Cardiovasc contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine.

3. How to take Cardiovasc

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

Adults:The recommended dose is 10 mg once a day, taken at the same time each day,
preferably in the morning at least 15 minutes before breakfast. If necessary, your doctor may advise you to
increase the dose to Cardiovasc 20 mg once a day (see section 2 Cardiovasc with food,
drinks and alcohol).
The tablets should preferably be swallowed 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
attention should be paid at the start of treatment.

Patients with liver or kidney problems:Particular attention is required at the start of treatment of
these patients and an increase in the daily dose to 20 mg should be carefully evaluated.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

If you take more Cardiovasc than you should
Do not exceed the dose prescribed to you.
If you have taken a higher dose than prescribed, consult your doctor or go directly to hospital. Bring
the packaging with you.
Taking more than the correct dose can cause an excessive drop in blood pressure and your heart may
beat irregularly or faster.

If you forget to take Cardiovasc
If you forget to take a tablet, simply skip the missed dose and then continue taking
as prescribed the next day.
Do not take a double dose to make up for a missed dose.

If you stop taking Cardiovasc
If you stop taking Cardiovasc, 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.
The following side effects may occur with this medicine:

Some side effects may be serious
If you experience any of the following side effects, consult your doctor immediately.
Rare (may affect up to 1 in 1,000 people):angina pectoris (e.g. chest tightness caused by
insufficient blood supply to the heart), allergic reactions (symptoms include itching, rash, hives),
fainting.
Patients with pre-existing angina pectoris may experience an increase in the frequency, duration or
severity of these attacks with the group of drugs to which Cardiovasc also belongs. Isolated cases of
myocardial infarction may be observed.

Other possible side effects:
Common (may affect up to 1 in 10 people): headache, fast heartbeat, sensation of
fast or irregular heartbeat (palpitations), sudden flushing of the face, neck or upper
chest (flushing), ankle swelling
Uncommon (may affect up to 1 in 100 people):dizziness, low blood pressure,
heartburn, nausea, stomach pain, skin rash, itching, muscle pain, passing large
amounts of urine, feeling weak or tired..
Rare (may affect up to 1 in 1,000 people):drowsiness, vomiting, diarrhea, , hives. increased
urination frequency, chest pain.
Not known (frequency cannot be estimated from available data): swollen gums, changes
in liver function (detected by blood tests), cloudy fluid (when performing dialysis
through a catheter in the abdomen), swelling of the face, lips, tongue or throat which may cause
difficulty breathing or swallowing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Cardiovasc

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 box and blister after Expires. The
expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light.
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. Contents of the pack and other information

What Cardiovasc contains
The active ingredient is lercanidipine hydrochloride.
Each film-coated tablet contains 10 mg of lercanidipine hydrochloride (equivalent to 9.4 mg of lercanidipine) or
20 mg of lercanidipine hydrochloride (equivalent to 18.8 mg of lercanidipine).
The other ingredients are:

Tablet core:lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose, povidone
K30, magnesium stearate.

Film coating:hypromellose, talc, titanium dioxide (E171), macrogol 6000, iron oxide (E172).

Description of the appearance of Cardiovasc and contents of the pack
Cardiovasc 10 mg: yellow, circular, biconvex, film-coated tablet with a break line on one side.
The break line on the tablet is to facilitate breaking it to make it easier to swallow and not to divide it into equal doses.
Cardiovasc 20 mg: pink, circular, biconvex, film-coated tablet with a break line on one side.
Cardiovasc is available in packs of 7, 14, 28, 35, 42, 50, 56, 98 and 100 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milano (Italy).
Manufacturer:
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milano (Italy).