NICARDIPINA 40 mg Hard Capsules, Prolonged Release

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1. Nicardipina Mylan Generics 40 mg prolonged-release hard capsules
   1. What is Nicardipina Mylan Generics and what it is used for
   2. What you need to know before you take Nicardipina Mylan Generics
   3. How to take Nicardipina Mylan Generics
   4. Possible side effects
   5. How to store Nicardipina Mylan Generics
   6. Contents of the pack and other information

Nicardipina Mylan Generics 40 mg prolonged-release hard capsules

Equivalent Medicinal Product
Read this leaflet carefully before 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 they have the same symptoms as you, 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 Nicardipina Mylan Generics is and what it is used for
• 2. What you need to know before you take Nicardipina Mylan Generics
• 3. How to take Nicardipina Mylan Generics
• 4. Possible side effects
• 5. How to store Nicardipina Mylan Generics
• 6. Contents of the pack and other information

1. What is Nicardipina Mylan Generics and what it is used for

Nicardipina Mylan Generics contains the active ingredient nicardipine hydrochloride, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists).
Nicardipina Mylan Generics is indicated for:

• preventing and treating chest pain caused by a condition called angina pectoris
• treating high blood pressure

2. What you need to know before you take Nicardipina Mylan Generics

Do not take Nicardipina Mylan Generics

• if you are allergic to nicardipine, to any other calcium antagonist medicine, or to any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding in the brain (cerebral hemorrhage)
• if you have a stroke with increased pressure inside the skull
• if you have a severe problem with blood circulation that involves insufficient blood flow to the body (cardiovascular shock)
• if you suffer from a severe narrowing or obstruction of the aortic valve of the heart (aortic valve stenosis)
• if you have serious heart problems that mean the heart is unable to supply blood in adequate quantities to the body (left ventricular dysfunction and heart failure)
• if you are pregnant
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nicardipina Mylan Generics.
If you experience pain due to a decrease in blood flow (ischemic pain) within 30 minutes
of starting therapy or after increasing the dose, stop treatment with this medicine.
If you are already being treated with other medicines used for high blood pressure, called beta-blockers, and
need to replace them with nicardipine, you must gradually reduce the dose of these medicines, preferably
over 8-10 days (see section “Other medicines and Nicardipina Mylan Generics”).
Take this medicine with caution and under the direct supervision of your doctor in the following cases:

• if you suffer from glaucoma, an eye disease, in which there is an increase in internal pressure in the eye;
• if you suffer from low blood pressure, because this medicine can cause a significant decrease in your blood pressure;
• if you have liver problems, because this medicine can alter the values of substances that relate to the proper functioning of your liver. In this case, undergo periodic liver checks and possibly stop treatment.
• if you have kidney problems;
• if the function of your heart is insufficient (heart failure) and the ability of your heart to increase the amount of blood pumped to the body is poor (poor cardiac reserve);
• if you suffer from a disease that affects the muscles called Duchenne muscular dystrophy, because this medicine can worsen breathing;
• if you have problems with your stomach or intestines (e.g., hypermotility or gastrointestinal obstruction);
• if you suffer from chest pain (angina), because this medicine can worsen the symptoms at the beginning of treatment and when the dose is increased. This medicine can increase the risk of serious blood circulation problems such as ischemic cardiovascular events.

Nicardipina Mylan Generics can cause skin reactions such as erythema multiforme and exfoliative
dermatitis. If you experience signs of skin rash and widespread itching, stop treatment.
Stop treatment if you experience a decrease in a type of white blood cells (granulocytopenia).

Children and adolescents
There is no experience with the use of Nicardipina Mylan Generics in children and adolescents. Therefore Nicardipina
Mylan Generics is not recommended in children and adolescents.

Other medicines and Nicardipina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Pay particular attention and tell your doctor if you are taking the following medicines. Careful monitoring or a dose adjustment may be necessary:

• medicines that dilate blood vessels (vasodilators) and medicines that lower blood pressure (antihypertensives);
• carbamazepine, a medicine used for epilepsy;
• cimetidine, a medicine used for stomach ulcers;
• in particular, tell your doctor if you are using other medicines used to control the body's immune system, such as cyclosporine, tacrolimus or sirolimus;
• digoxin, a medicine used for heart problems;
• medicines called beta-blockers, used for heart problems or to treat high blood pressure;
• fentanyl, a painkiller also used as an anesthetic;
• medicines used to treat infections caused by fungi (antifungals). Nicardipina Mylan Generics with food, beverages and alcoholAvoid drinking grapefruit juice and alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Take this medicine only if strictly necessary and under direct medical supervision.
Nicardipina Mylan Generics is not recommended in the last stage of pregnancy and in case of multiple pregnancy (twin or higher order multiple), if used to reduce uterine contractions and taken
concurrently with medicines used for asthma, called beta-2 agonists (see section
“Possible side effects”).
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.

Driving and using machines
This medicine, especially when taken in combination with alcohol, can affect your ability to
drive vehicles and operate machinery because it may cause side effects such as dizziness. If
this happens to you, avoid driving vehicles or using machinery.

Nicardipina Mylan Generics contains sucrose
This medicine contains a sugar, sucrose. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him/her before taking this medicine.

3. How to take Nicardipina Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is one 40 mg capsule twice a day. The doctor will establish the necessary dose
according to your condition.
Swallow the capsule whole and take it with a little water.

If you take more Nicardipina Mylan Generics than you should
If you take an excessive dose of this medicine, a severe drop in blood pressure may occur.
The signs of an overdose may be low blood pressure, slowed heartbeat, fast or irregular heartbeat, flushing, dizziness, confusion and drowsiness.
In case of accidental ingestion/taking of an excessive dose of Nicardipina Mylan Generics, immediately inform
your doctor or go to the Emergency Room of the nearest hospital.
If you forget to take Nicardipina Mylan Generics
If you forget to take a capsule, do so as soon as you remember, unless it is almost time to take
the next dose. Do not take a double dose to make up for the forgotten capsule.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur:

Rare(may affect up to 1 in 1,000 people)

• Excessive salivation;
• Headache, drowsiness, feeling dizzy
• Breathing problems (dyspnea);
• Vision disorders;
• Frequent need to urinate.

Very rare(may affect up to 1 in 10,000 people)

• Chest pain. Not known(frequency cannot be estimated based on available data)
• Fluid accumulation in the lungs (especially during pregnancy, if used to reduce uterine contractions, see section “Pregnancy and breastfeeding”);
• Sudden, potentially life-threatening allergic reaction (anaphylactic reaction)
• Loss or reduction of appetite
• Dizziness
• Fast or irregular heartbeat
• Decrease in blood pressure, sudden drop in blood pressure when standing up
• Nausea
• Heartburn
• Constipation
• Diarrhea
• Swelling of the gums
• Liver disorders
• Increased liver enzymes
• Skin redness
• Itching
• Skin rash
• Feeling of warmth
• Swelling due to fluid retention in the lower limbs (Edema of the lower limbs)
• Fatigue
• Decreased platelets in the blood

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 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 Nicardipina Mylan Generics

Keep this medicine out of sight and 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 that month.
Store in the original package to protect the medicine from light.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in waste water 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

WhatNicardipina Mylan Generics contains
The active ingredient is nicardipine hydrochloride. One capsule contains 40 mg of nicardipine hydrochloride
The other ingredients are: sucrose, corn starch, polymethacrylic resin, polysorbate 80, talc. Capsule:
hard gelatin, titanium dioxide.

Description of the appearance of Nicardipina Mylan Generics and contents of the pack
Hard prolonged-release capsules. Pack containing 30 capsules.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers
Mipharm S.p.A, Via B. Quaranta 12, 20141 Milan
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero, Modena