Nicardipine Mylan Generics

Package leaflet

Nicardipine Mylan Generics 40 mg prolonged-release hard capsules

Generic medicine
Please read this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Nicardipina Mylan Generics contains the active substance 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 known as angina pectoris
• treating high blood pressure

2. What you need to know before taking Nicardipine Mylan Generics

Do not take Nicardipine Mylan Generics

• if you are allergic to nicardipine, to any other calcium channel blocker medicine, or to any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding in the brain (cerebral haemorrhage)
• if you have had a stroke with increased pressure inside the skull
• if you have a serious circulatory problem resulting in inadequate blood flow to the body (cardiovascular shock)
• if you suffer from severe narrowing or obstruction of the heart's aortic valve (aortic valve stenosis)
• if you have serious heart problems resulting in the heart being unable to supply sufficient blood 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 Nicardipine Mylan Generics.
If you experience pain due to reduced blood flow (ischaemic pain) within 30 minutes of starting treatment or after increasing the dose, stop taking this medicine.
If you are already being treated with other medicines for high blood pressure called beta-blockers and need to switch to nicardipine, you should gradually reduce the dose of these medicines, preferably over 8–10 days (see section “Other medicines and Nicardipine Mylan Generics”).
Take this medicine with caution and under direct medical supervision in the following cases:

• if you suffer from glaucoma, an eye disease in which there is increased internal pressure in the eye
• if you have low blood pressure, because this medicine may cause a marked decrease in your blood pressure
• if you have liver problems, because this medicine may alter the levels of substances related to proper liver function. In this case, undergo regular liver monitoring and possibly discontinue treatment
• if you have kidney problems
• if your heart function is inadequate (heart failure) and your heart's ability to increase the amount of blood pumped to the body is limited (poor cardiac reserve)
• if you suffer from a muscle disease called Duchenne muscular dystrophy, because this medicine may worsen breathing
• if you have stomach or intestinal problems (e.g. hypermotility or gastrointestinal obstruction)
• if you suffer from chest pain (angina), because this medicine may worsen symptoms at the beginning of treatment or when the dose is increased. This medicine may increase the risk of serious circulatory problems such as ischaemic cardiovascular events.

Nicardipine Mylan Generics may cause skin reactions such as erythema multiforme and exfoliative dermatitis. If you develop signs of skin rash or widespread itching, stop taking the medicine.
Stop taking the medicine if you experience a decrease in a type of white blood cells (granulocytopenia).
Children and adolescents
There is no experience with the use of Nicardipine Mylan Generics in children and adolescents. Therefore, Nicardipine Mylan Generics is not recommended for children and adolescents.
Other medicines and Nicardipine Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines. Close monitoring or 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
• especially, inform your doctor if you are taking 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, an analgesic also used as an anaesthetic
• medicines used to treat fungal infections (antifungals).
  Nicardipine Mylan Generics with food, drinks and alcohol Avoid drinking grapefruit juice and alcoholic beverages during treatment with this medicine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Take this medicine only if strictly necessary and under direct medical supervision.
Nicardipine Mylan Generics is not recommended during late pregnancy and in cases of multiple pregnancy (twins or more), when used to reduce uterine contractions and taken concomitantly with medicines 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, particularly when taken together with alcohol, may affect your ability to drive and use machinery because it may cause side effects such as dizziness. If this occurs, avoid driving or operating machinery.
Nicardipine Mylan Generics contains sucrose
This medicine contains a sugar called sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Nicardipine Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one 40 mg capsule twice daily. Your doctor will determine the appropriate dose based on your condition.
Swallow the capsule whole with a glass of water.

If you take more Nicardipine Mylan Generics than you should
If you take an excessive dose of this medicine, a severe drop in blood pressure may occur.
Signs of overdose may include low blood pressure, slow heartbeat, fast or irregular heartbeat, flushing, dizziness, confusion, and drowsiness.
If you or someone else has accidentally taken an excessive dose of Nicardipine Mylan Generics, contact your doctor immediately or go to the nearest hospital emergency department.

If you forget to take Nicardipine Mylan Generics
If you forget to take a capsule, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed capsule.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur:
Rare (may affect up to 1 in 1,000 people)

• Excessive salivation;
• Headache, drowsiness, dizziness
• Breathing problems (dyspnea);
• Vision disturbances;
• Frequent need to urinate.

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

• Chest pain. Not known (frequency cannot be estimated from the available data)
• Fluid accumulation in the lungs (especially during pregnancy, when used to reduce uterine contractions; see section “Pregnancy and breastfeeding”);
• Sudden potentially fatal allergic reaction (anaphylactic reaction)
• Loss or reduction of appetite
• Dizziness
• Fast or irregular heartbeat
• Decreased 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 (Peripheral edema)
• Fatigue
• Decreased number of blood platelets

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Nicardipine Mylan Generics

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 pack after “Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Nicardipina Mylan Generics contains
The active substance is nicardipine hydrochloride. One capsule contains 40 mg of nicardipine hydrochloride.
The other components are: sucrose, maize starch, polymethacrylic resin, polysorbate 80, talc. Capsule shell:
hard gelatin, titanium dioxide.

Description of the appearance of Nicardipina Mylan Generics and package contents
Prolonged-release hard capsules. Carton pack containing 30 capsules.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

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