Nifedipine Mylan Generics Italia: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Nifedipine Mylan Generics Italia 30 mg prolonged-release coated tablets, 60 mg prolonged-release coated tablets

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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Nifedipine Mylan Generics Italia is and what it is used for
What you need to know before taking Nifedipine Mylan Generics Italia
How to take Nifedipine Mylan Generics Italia
Possible side effects
How to store Nifedipine Mylan Generics Italia
Contents of the pack and other information

1. What Nifedipine Mylan Generics Italia is and what it is used for

Nifedipine Mylan Generics Italia contains as its active substance nifedipine, which belongs to the
class of medicines known as calcium antagonists.
Nifedipine Mylan Generics Italia is used to treat the following conditions:

exertional angina (angina pectoris), which consists of severe chest pain behind the breastbone due to inadequate blood and oxygen supply to the heart (usually following physical exertion). Nifedipine acts by dilating the coronary arteries, thereby increasing blood and oxygen supply to the heart tissue. Additionally, since it also acts on peripheral blood vessels, it reduces the heart's oxygen demand.
high blood pressure (arterial hypertension), as it causes relaxation of blood vessels and increases the excretion of sodium and water. This results in a lowering of blood pressure, particularly marked in patients with high blood pressure.

2. What you need to know before taking Nifedipine Mylan Generics Italia

Do not take Nifedipine Mylan Generics Italia

if you are allergic to nifedipine or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant or suspect you may be pregnant (up to week 20) or during breastfeeding (see "Pregnancy and breastfeeding");
if you have a circulatory disorder causing insufficient blood flow to the body (cardiovascular shock), characterized by difficulty breathing, paleness, cold sweating, and dry mouth;
if you have undergone intestinal surgery called Kock pouch (ileostomy after proctocolectomy);
if you are taking a medicine containing rifampicin, an antibiotic used to treat certain types of infections. In this case, nifedipine blood levels may become insufficient (see "Other medicines and Nifedipine Mylan Generics Italia").

Warnings and precautions

Talk to your doctor or pharmacist before taking Nifedipine Mylan Generics Italia.

Be especially careful with Nifedipine Mylan Generics Italia if:

You have very low blood pressure (systolic pressure below 90 mmHg), heart failure (weak heart), or severe aortic stenosis (narrowing of a heart valve);
You have severe narrowing of the gastrointestinal tract, as symptoms of intestinal blockage (intestinal obstruction) may occur. Rarely, non-deformable materials may form large masses in the stomach called bezoars, which cannot be eliminated through the intestine and sometimes require surgical intervention. In isolated cases, symptoms of blockage have occurred even in patients who had never experienced gastrointestinal problems. If you undergo radiographic examinations of the digestive tract using barium contrast, be aware that Nifedipine Mylan Generics may produce images that could be misinterpreted as polyps.
Your liver is not working properly. In this case, careful monitoring may be required and, if your condition is severe, a reduction in the dose of Nifedipine Mylan Generics Italia may be necessary.
You are pregnant, since available information does not exclude the possibility of adverse effects on the fetus and newborn. For this reason, Nifedipine Mylan Generics Italia must not be used during the first 20 weeks of pregnancy (see "Do not take Nifedipine Mylan Generics Italia" and "Pregnancy and breastfeeding"). Beyond this period, it may be used only after a very careful assessment of potential risks and expected benefits, and when other therapies are unsuitable or ineffective. Your doctor will decide whether treatment with Nifedipine Mylan Generics Italia is appropriate for you. If prescribed Nifedipine Mylan Generics Italia, you will likely undergo frequent blood pressure checks, especially if the medicine is administered concomitantly with intravenous magnesium sulfate, due to the risk of excessive blood pressure drop, which could harm both you and the fetus.
You are breastfeeding, since nifedipine passes into breast milk. For immediate-release formulations, it is recommended to delay breastfeeding or milk expression by 3 to 4 hours after taking the medicine to reduce infant exposure to nifedipine. As there are no data on possible effects on the newborn, if treatment with nifedipine becomes necessary during this period, breastfeeding should be discontinued.

If you are undergoing a laboratory test to measure urinary vanillylmandelic acid levels (a test used to diagnose adrenal gland tumors), be aware that, in the presence of nifedipine and depending on the method used, results may be falsely elevated.

Children and adolescents

The use of Nifedipine Mylan Generics Italia is not recommended in children and adolescents under 18 years of age, as limited efficacy and safety data are available in this population.

Other medicines and Nifedipine Mylan Generics Italia

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Regarding Nifedipine Mylan Generics Italia, please note:

Nifedipine is metabolized in the body through a specific system of molecules (enzymes). If other medicines that affect or use this same system are taken concomitantly, a decrease or increase in blood concentration—and thus in the effect—of nifedipine or the other medicine may occur. Therefore, adjustment of the dose of nifedipine or the other medicine and/or more frequent blood pressure monitoring may be necessary.

Medicines that may alter the effect of nifedipine include:

rifampicin (an antibiotic); never take Nifedipine Mylan Generics Italia together with medicines containing rifampicin (see "Do not take Nifedipine Mylan Generics Italia");
certain antibiotics belonging to the macrolide class, such as erythromycin;
certain medicines for AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir, or saquinavir;
certain antifungal medicines, such as ketoconazole, itraconazole, or fluconazole;
fluoxetine, nefazodone (medicines for depression);
quinupristin/dalfopristin (an antibiotic used for specific infections);
phenytoin, carbamazepine, phenobarbital, valproic acid (medicines for seizures);
cimetidine, cisapride (medicines used for stomach ulcers).

Nifedipine may alter the effect of the following medicines:

Nifedipine may enhance the blood pressure-lowering effect of other medicines that reduce blood pressure. In particular, if taken concomitantly with beta-blockers, your doctor must monitor you closely, as it may also worsen the heart's ability to pump blood.
digoxin, quinidine (heart medicines);
tacrolimus (a medicine used to prevent transplant rejection).

Medicines containing the following substances do not appear to alter nifedipine blood concentrations and/or their metabolism is not affected by nifedipine: ajmaline (antiarrhythmic medicine), acetylsalicylic acid at a dose of 100 mg (medicine 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 Italia with food and drinks

Do not drink grapefruit juice during treatment with Nifedipine Mylan Generics Italia, as it may increase nifedipine blood levels and prolong its effect. If you regularly drink grapefruit juice, this effect may last for more than 3 days after stopping.

Avoid consuming alcoholic beverages during treatment with Nifedipine Mylan Generics Italia.

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Nifedipine Mylan Generics Italia if you are in the first 20 weeks of pregnancy or if you are breastfeeding (see "Do not take Nifedipine Mylan Generics Italia").

Nifedipine should not be used during pregnancy unless the patient's clinical condition requires treatment with nifedipine. Nifedipine use should be reserved for women with severe hypertension who have not responded to standard therapy (see "Warnings and precautions").

Breastfeeding

Nifedipine is not recommended during breastfeeding because it has been reported to pass into breast milk, and the effects of oral absorption of small amounts of nifedipine are unknown.

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 antagonists such as nifedipine may be contributing to the problem.

Driving and using machines

Nifedipine Mylan Generics Italia may cause dizziness or lightheadedness, especially at the beginning of treatment or when taken with alcoholic drinks. If you experience these effects, do not drive or operate machinery.

3. How to take Nifedipine Mylan Generics Italia

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 30 mg coated tablet once daily in the morning.
The safety and efficacy of Nifedipine Mylan Generics Italia in patients under 18 years of age has not
been established.
The dose may be gradually increased, at the discretion of the doctor, up to a maximum of 60 mg
(one 60 mg coated tablet) in arterial hypertension or 120 mg (two 60 mg coated tablets) in pectoris
angina, taking the medicine once daily in the morning. Your doctor may start your treatment with
one 20 mg tablet daily or may prescribe intermediate doses of 40 mg (20 + 20) or 50 mg (20 + 30).
Nifedipine Mylan Generics Italia is for oral use. Swallow the tablet whole with some liquid. Do
not chew or break the tablets. You may take Nifedipine Mylan Generics Italia with or without
food. Remove the tablets from the blister pack only at the time of administration.
Your doctor will determine how long you should continue treatment with Nifedipine Mylan
Generics Italia.
Use in elderly patients
If you are an elderly patient, a lower dosage may be required compared to younger patients.
Use in patients with impaired liver function
If your liver function is impaired, careful monitoring of blood pressure may be necessary and, in
severe cases, a dose reduction may be required.
If you take more Nifedipine Mylan Generics Italia than you should
It is important that you take exactly the dose prescribed by your doctor. If you have accidentally
taken too many tablets, the following may occur:
disturbances of consciousness up to coma, lowering of blood pressure, changes in heart rhythm,
increased blood sugar levels (hyperglycaemia), alteration of blood pH (metabolic acidosis), reduced
oxygen supply (hypoxia), serious heart problems such as cardiogenic shock with fluid accumulation
around the lungs (pulmonary oedema).
If you have taken more tablets than prescribed, contact your doctor immediately or go to the
nearest hospital emergency department.
If you forget to take Nifedipine Mylan Generics Italia
If you forget to take your medicine, take it as soon as you remember on the same day. If you miss a
dose for an entire day, take your usual dose the next day. Do not take a double dose to make up for
the forgotten dose.
If you are unsure what to do, consult your doctor or pharmacist.
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 everybody gets them.
The following side effects have been observed during clinical trials with nifedipine:

Common side effects (may affect up to 1 in 10 people)

headache,
oedema, including peripheral oedema (generalised swelling or swelling in the extremities),
vasodilation (dilation of blood vessels),
constipation,
malaise (feeling unwell).

Uncommon side effects (may affect up to 1 in 100 people)

allergic reaction,
allergic oedema/angioedema (swelling of the skin, face and mucous membranes, including laryngeal oedema, potentially life-threatening),
anxiety reactions,
sleep disorders,
dizziness,
migraine (unilateral headache),
vertigo,
tremor,
visual disturbances,
tachycardia (rapid heartbeat),
palpitations (awareness of rapid or irregular heartbeat),
hypotension (low blood pressure),
syncope (fainting),
epistaxis (nosebleed),
nasal congestion (stuffy nose),
gastrointestinal and abdominal pain (stomach ache),
nausea,
dyspepsia (indigestion),
flatulence (gas in the intestine),
dry mouth,
transient increase in liver enzymes,
erythema (redness of the skin),
muscle cramps,
joint swelling,
polyuria (increased volume of urine),
dysuria (difficulty urinating),
erectile dysfunction (difficulty achieving and maintaining erection),
non-specific pain,
chills.

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

pruritus (itching),
urticaria (itching and small skin spots),
rash,
paresthesia/dysesthesia (altered sensation, e.g., tingling),
gingival hyperplasia (overgrowth of the gums).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

agranulocytosis (lack of certain blood cells called granulocytes),
leucopenia (decrease in the number of white blood cells),
anaphylactic/anaphylactoid reaction (severe allergic or allergy-like reaction),
hyperglycaemia (increased blood sugar levels),
hypoesthesia (reduced sensation),
somnolence (drowsiness),
eye pain,
chest pain (angina pectoris),
dyspnoea (breathing difficulty, shortness of breath),
bezoars (formation of large masses in the stomach),
dysphagia (difficulty swallowing),
intestinal obstruction (blockage of intestinal content passage),
intestinal ulcer,
vomiting,
gastroesophageal sphincter insufficiency (regurgitation),
jaundice (yellowing of the skin and whites of the eyes),
toxic epidermal necrolysis (a severe skin disease),
photoallergic reaction (skin reaction following exposure to sunlight),
palpable purpura (a specific type of skin rash),
arthralgia (joint pain),
myalgia (muscle pain),
breathing difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Nifedipine Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
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 Italia contains
Nifedipine Mylan Generics Italia 30 mg prolonged-release coated tablets
The active substance is nifedipine.
Each prolonged-release coated tablet contains 30 mg of nifedipine.
The other components are: povidone, talc, hypromellose, carbomer 974P, anhydrous colloidal silica,
lactose monohydrate, magnesium stearate, macrogol 4000, titanium dioxide (E 171), iron oxide (E
172), basic polymethacrylate (Eudragit “E”).
Nifedipine Mylan Generics Italia 60 mg prolonged-release coated tablets
The active substance is nifedipine.
Each prolonged-release coated tablet contains 60 mg of nifedipine.
The other components are: povidone, talc, hypromellose, carbomer 974P, anhydrous colloidal silica,
lactose monohydrate, magnesium stearate, macrogol 4000, titanium dioxide (E 171), iron oxide (E
172), basic polymethacrylate (Eudragit “E”).
Description of the appearance of Nifedipine Mylan Generics Italia and pack contents
Pack containing 14 prolonged-release coated tablets.
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy
Manufacturer
Valpharma S.p.A., Via Ranco 112, 47899 Serravalle (Republic of San Marino)
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 S. Prospero S/S (Modena)