PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

NIFEDIPINE MYLAN GENERICS 20 mg prolonged-release tablets

Nifedipine
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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NIFEDIPINE MYLAN GENERICS is and what it is used for
What you need to know before taking NIFEDIPINE MYLAN GENERICS
How to take NIFEDIPINE MYLAN GENERICS
Possible side effects
How to store NIFEDIPINE MYLAN GENERICS
Contents of the pack and other information

1. What NIFEDIPINA MYLAN GENERICS is and what it is used for

NIFEDIPINA MYLAN GENERICS contains the active substance nifedipine, which belongs to a group of
medicines called calcium channel blockers (calcium antagonists).
NIFEDIPINA MYLAN GENERICS is used to treat high blood pressure (hypertension) and for a certain type of chest pain caused by heart problems known as chronic stable angina (exertional angina).

2. What you need to know before taking NIFEDIPINE MYLAN GENERICS

Do not take NIFEDIPINE MYLAN GENERICS

if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6)
if you have a blood circulation disorder causing insufficient blood flow to the body (cardiovascular shock), characterized by difficulty breathing, paleness, cold sweating, and dry mouth
if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections
if you are pregnant, think you may be pregnant, or are breastfeeding (see Pregnancy, breastfeeding, and fertility).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIFEDIPINE MYLAN GENERICS.
Take this medicine with caution and always under medical supervision in the following cases:

if you have very low blood pressure. In this case, your doctor needs to monitor your blood pressure regularly.
if you have reduced heart function
if you have been diagnosed with severe aortic valve stenosis (narrowing of the heart's aortic valve)
if you are concurrently taking medicines known as beta-blockers or other medicines to lower blood pressure (antihypertensives)
if during pregnancy you experience an emergency condition such as eclampsia, a serious, potentially life-threatening condition characterized by seizures, or if you are receiving intravenous magnesium sulfate (which may cause excessive drop in blood pressure, leading to harm to both mother and fetus)
if you are breastfeeding
if you have impaired liver function. In this case, careful monitoring and possibly a dose reduction may be required
if you are taking other medicines that may increase nifedipine blood levels. In such cases, your doctor must closely monitor your blood pressure and may need to reduce the dose (see section "Other medicines and NIFEDIPINE MYLAN GENERICS").
if you have or are at risk of developing diabetes. In this case, you should carefully monitor your blood glucose levels, and if high levels occur, treatment should be discontinued.

Children and adolescents
There is no experience with the use of NIFEDIPINE MYLAN GENERICS in children and adolescents. Therefore,
NIFEDIPINE MYLAN GENERICS is not recommended for children and adolescents under 18
years of age.
Other medicines and NIFEDIPINE MYLAN GENERICS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Do not take this medicine in combination with medicines containing rifampicin, an antibiotic used
to treat certain types of infections (see "Do not take NIFEDIPINE MYLAN GENERICS").
Be especially careful and inform your doctor if you are taking the following medicines:

antibiotics such as erythromycin and rifampicin
medicines used to treat AIDS, such as amprenavir, indinavir, nelfinavir, ritonavir, saquinavir
medicines used to treat fungal infections, such as ketoconazole, itraconazole, fluconazole
fluoxetine and nefazodone, used to treat depression
quinupristin and dalfopristin, used to treat infections
valproic acid, phenytoin, carbamazepine, and phenobarbital, used to treat epilepsy
cimetidine and cisapride, used for stomach disorders
medicines used to lower blood pressure (diuretics, beta-blockers, ACE inhibitors, angiotensin receptor antagonists, other calcium antagonists, α-blockers, α-methyldopa)
diltiazem, used to treat high blood pressure
digoxin, a heart medicine
quinidine, used to treat heart rhythm disorders
tacrolimus, used to prevent organ rejection after transplantation
medicines used to treat erectile dysfunction. Medicines containing the following substances do not appear to alter nifedipine blood concentrations and/or their metabolism is not affected by nifedipine: ajmaline (antiarrhythmic), acetylsalicylic acid at a dose of 100 mg (used for flu symptoms or blood thinning), benazepril, doxazosin, candesartan cilexetil, irbesartan, debrisochine, talinolol (medicines for high blood pressure), omeprazole, pantoprazole, ranitidine (medicines for heartburn), orlistat (weight-loss medicine), rosiglitazone (medicine for diabetes), triamterene hydrochlorothiazide (diuretic).

NIFEDIPINE MYLAN GENERICS with food, drinks, and alcohol
Grapefruit and grapefruit juice must not be consumed by patients taking NIFEDIPINE
MYLAN GENERICS. This is because grapefruit and grapefruit juice can increase nifedipine blood levels, which may lead to an unpredictable increase in the blood pressure-lowering effect of NIFEDIPINE MYLAN GENERICS.
If grapefruit juice is regularly consumed, this effect may last for more than 3 days after the last intake.
Avoid alcoholic beverages during treatment with NIFEDIPINE MYLAN GENERICS.
Pregnancy, breastfeeding, and fertility
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.
Pregnancy
Do not take NIFEDIPINE MYLAN GENERICS during pregnancy. Consult your doctor if you are pregnant or planning a pregnancy.
Breastfeeding
Do not take this medicine if you are breastfeeding, as nifedipine passes into breast milk.
Discontinue breastfeeding if you need to take this medicine and consult your doctor.
Fertility
In men experiencing infertility with in vitro fertilization (an assisted reproductive technique), and when no other causes can be identified, consider the possibility that calcium channel blockers such as nifedipine may be contributing to the problem.
Driving and using machines
The use of NIFEDIPINE MYLAN GENERICS may affect your ability to drive or operate machinery, as adverse effects such as dizziness may occur, especially at the beginning of treatment, when changing medication, or when consuming alcohol. If this happens, avoid driving or operating machinery.
NIFEDIPINE MYLAN GENERICS contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take NIFEDIPINE 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 for adults is 1 tablet twice daily.
Your doctor will adjust the dose and duration of treatment according to your condition.

Use in elderly patients
If you are an elderly patient, a lower dose may be required compared to younger patients.

Use in patients with liver problems
If you have liver problems, your doctor should monitor your blood pressure and, in more severe cases, reduce
the dose.

Use in children and adolescents
There is no experience with the use of NIFEDIPINE MYLAN GENERICS in children and adolescents.
Therefore, NIFEDIPINE MYLAN GENERICS is not recommended for use in children and adolescents
under 18 years of age.

Method of administration
Swallow the tablets whole with some water, regardless of meals.
Do not chew or break the tablets.
Remove the tablet from the blister pack only immediately before taking it, avoiding prolonged exposure to
direct sunlight.

If you take more NIFEDIPINE MYLAN GENERICS than you should
If you (or someone else) have taken several tablets at the same time, or if you suspect that a child has
ingested any tablets, contact a doctor immediately. Overdose may cause disturbances of consciousness up to
coma, low blood pressure, heart rhythm abnormalities, high blood sugar levels (hyperglycaemia),
decreased blood pH (metabolic acidosis), reduced oxygen supply (hypoxia), and serious heart problems such
as cardiogenic shock with fluid accumulation in the lungs (pulmonary oedema).

If you forget to take NIFEDIPINE MYLAN GENERICS
If you forget to take a dose, 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 forgotten dose.

If you stop taking NIFEDIPINE MYLAN GENERICS
The duration of treatment should be determined by your doctor. Discontinue treatment gradually, especially
if you are taking high doses, to avoid rapid increases in blood pressure or circulatory problems.

If you have any questions 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:
Common (may affect up to 1 in 10 people)

headache
swelling caused by fluid accumulation
flushing, hot flushes
constipation
general malaise, unusual weakness

Uncommon (may affect up to 1 in 100 people)

allergic reaction
swelling caused by allergic fluid accumulation
swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing and breathing (potentially life-threatening)
anxiety, sleep disorders, irritability
dizziness, recurrent headaches, vertigo, tremor
visual disturbances
increased heart rate, palpitations
low blood pressure, transient loss of consciousness
nosebleeds and nasal congestion
abdominal and intestinal pain, nausea, dyspepsia, excessive intestinal gas, dry mouth, diarrhoea
transient increase in liver enzymes
skin irritation, pustular rash, blisters, and bullae
muscle cramps, joint swelling
excessive urination, difficulty urinating
problems achieving and/or maintaining an erection
non-specific pain, chills

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

itching, urticaria, skin rash
tingling and numbness, burning sensation and pain like needles on the skin
gum swelling, feeling of fullness in the stomach and intestines
altered liver function

Not known (frequency cannot be estimated from the available data)

decrease in certain types of white blood cells
severe allergic reaction
high blood sugar levels
decreased sensitivity, drowsiness
eye pain
chest pain due to heart problems (angina pectoris)
breathing difficulties
vomiting, heartburn, and indigestion
yellowish discoloration of the skin and whites of the eyes due to liver dysfunction
blistering or peeling of the skin or mucous membranes (toxic epidermal necrolysis)
photosensitivity
skin condition characterized by bleeding (purpura)
joint and muscle pain
breast enlargement in men
redness, vasodilation, and increased temperature (erythromelalgia)
severe, widespread erythema with skin desquamation
reduced haemoglobin levels (a protein that carries oxygen within red blood cells) in the blood
reduced platelet count
liver inflammation, increased alkaline phosphatase or LDH
sexual dysfunction
stomach burning
intestinal cramps
insomnia
sore throat, cough, asthma, sweating, fever
joint stiffness and inflammation

In dialysis patients suffering from excessively high blood pressure and low blood volume, a severe drop in blood pressure may occur.
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 NIFEDIPINE 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 packaging after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
It is advisable not to expose the tablets to direct sunlight for prolonged periods.
Do not dispose of any medicine via 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 NIFEDIPINE MYLAN GENERICS contains
The active substance is nifedipine.
Each prolonged-release tablet contains 20 mg of nifedipine.
The other components are:
Tablet core: microcrystalline cellulose, maize starch, lactose monohydrate, polysorbate 80, magnesium stearate;
Coating: hypromellose, polyethylene glycol 4000, titanium dioxide (E 171), iron oxide red (E 172).

Description of the appearance of NIFEDIPINE MYLAN GENERICS and contents of the pack
Prolonged-release tablets.

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

Manufacturer
ABC Farmaceutici S.p.A., Via Cantone Moretti 29, Località San Bernardo, 10090 Ivrea (TO)