NIFEDIPINA 30 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

1. Nifedipina Mylan Generics Italia 30 mg prolonged-release coated tablets, 60 mg prolonged-release coated tablets
   1. What is Nifedipina Mylan Generics Italia and what is it used for
   2. What you need to know before taking Nifedipina Mylan Generics Italia
   3. How to take Nifedipina Mylan Generics Italia
   4. Possible side effects
   5. How to store Nifedipina Mylan Generics Italia
   6. Package Contents and Other Information

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

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 their symptoms are the same as yours, 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 Nifedipina Mylan Generics Italia is and what it is used for
• 2. What you need to know before you take Nifedipina Mylan Generics Italia
• 3. How to take Nifedipina Mylan Generics Italia
• 4. Possible side effects
• 5. How to store Nifedipina Mylan Generics Italia
• 6. Contents of the pack and other information

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

Nifedipina Mylan Generics Italiacontains nifedipine as its active ingredient, which belongs to the
class of medicines called calcium antagonists.
Nifedipina Mylan Generics Italiais used for the treatment of the following conditions:

• angina pectoris(exertional angina), which consists of severe chest pain in the region behind the sternum, due to an insufficient supply of blood and oxygen to the heart (generally following exertion). Nifedipine works by dilating the coronary arteries, thereby increasing the supply of blood and oxygen to the heart tissue. Furthermore, as it also acts at the level of peripheral vessels, it reduces the heart's oxygen requirement.
• high blood pressure(arterial hypertension), as it causes relaxation of blood vessels and increases the elimination of sodium and water. This results in a lowering of blood pressure, particularly pronounced in patients with high blood pressure.

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

Do not take Nifedipina 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 or suspect you are pregnant (up to the 20th week) and during breastfeeding (see “Pregnancy and breastfeeding”);
• if you have a blood circulation problem that results in insufficient blood flow to the body (cardiovascular shock) characterized by difficulty breathing, paleness, cold sweat and dryness of the mouth;
• - if you have undergone surgery on the intestine called a 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, the levels of nifedipine in the blood may
be insufficient (see “Other medicines and Nifedipina Mylan Generics Italia”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Nifedipina Mylan Generics Italia.

Take special care with Nifedipina Mylan Generics Italia, especially:

• If you have very low blood pressure(systolic pressure below 90 mm of mercury), if you suffer from heart failure (weak heart) or severe aortic stenosis (narrowing of a heart valve);
• If you have a severe narrowing of the gastrointestinal tract, symptoms of intestinal blockage (intestinal obstruction) may occur. Exceptionally, non-deformable materials can lead to the formation of bulky masses in the stomach, called bezoars, which cannot be eliminated through the intestine and sometimes require surgery. In isolated cases, blockage symptoms have also occurred in patients who have never experienced gastrointestinal problems. If you undergo X-rays of the digestive tract with barium contrast, be aware that Nifedipina Mylan Generics can give images that may be falsely interpreted as polyps.
• If your liver is not functioning properly. In this case, careful monitoring may be necessary and, if your condition is severe, a reduction in the dosage of Nifedipina Mylan Generics Italia may also be required.
• If you are pregnant, given that the available information does not allow excluding the possibility of adverse effects on the unborn child and newborn. For this reason, Nifedipina Mylan Generics Italia should not be used in the first 20 weeks of pregnancy (see “Do not take Nifedipina Mylan Generics Italia” and “Pregnancy and breastfeeding”) and, in the following weeks, can only be used after a very careful assessment of the possible risks and expected benefits and when other therapies are not suitable or have not been effective. Your doctor will then decide whether treatment with Nifedipina Mylan Generics Italia is suitable for you. If they prescribe Nifedipina Mylan Generics Italia, they are likely to monitor your blood pressure frequently, especially if it is administered in association with magnesium sulfate intravenously, due to the possibility of an excessive drop in blood pressure, which can harm both you and the fetus.
• If you are breastfeeding, as nifedipine passes into breast milk. For immediate-release formulations, it is recommended to delay breastfeeding or milk expression for 3 or 4 hours after taking the medicine in order to reduce the infant's exposure to nifedipine. Since there are no data on possible effects on the newborn, if treatment with nifedipine is necessary during this period, breastfeeding should be discontinued.

If you are going to undergo a laboratory test to determine the values of vanillyl-
mandelic acid in the urine (a test to diagnose a tumor of the adrenal gland), be aware that,
in the presence of nifedipine and depending on the method used, the values may be falsely
increased.

Children and adolescents
The use of Nifedipina Mylan Generics Italia is not recommended in children and adolescents under
the age of 18, because in this population only limited data on efficacy and
safety are available.

Other medicines and Nifedipina Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Regarding Nifedipina Mylan Generics Italia, be aware that:
Nifedipine is transformed in the body through a particular system of molecules (called
enzymes). If medicines that affect or use this same system are administered in association, a reduction or increase in the concentration in the blood, and therefore the effect of nifedipine or the other medicine, may be observed. It may then be necessary to adjust the dosage of nifedipine or the other medicine and/or more frequent monitoring of blood pressure.
Medicines that can change the effect of nifedipine are:

• rifampicin(an antibiotic); do not ever take Nifedipina Mylan Generics Italia together withmedicines containing rifampicin(see “Do not take Nifedipina Mylan Generics Italia”).
• certain antibiotics belonging to the class of macrolides, such as erythromycin;
• certain medicines against AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir orsaquinavir;
• certain medicines against fungal infections, such as ketoconazole, itraconazole or fluconazole;
• fluoxetine, nefazodone(medicines against depression);
• quinopristin/dalfopristin(antibiotic used for particular infections);
• phenytoin,carbamazepine, phenobarbital, valproic acid(medicines against seizures);
• cimetidine, cisapride(medicines used in stomach ulcers).

Nifedipine can change the effect of the following medicines:

• nifedipine can accentuate the effect of blood pressure lowering of other medicinesthat lower blood pressure.In particular, if you take beta-blockers in association, the doctor will have to monitor you carefully, as it can also worsen the heart's ability to pump blood.
• digoxin, quinidine(medicines for the heart).
• tacrolimus(medicine used against transplant rejection).

Medicines that contain the following substances do not seem to change the concentration of
nifedipine in the blood and/or their metabolism is not affected by nifedipine: ajmaline
(medicine against arrhythmias), acetylsalicylic acidat a dose of 100 mg (medicine against
flu symptoms or to thin the blood), benazepril, doxazosin, candesartan cilexetil,
irbesartan, debrisochine, talinolol(medicines against high blood pressure), omeprazole,
pantoprazole, ranitidine(medicines against heartburn), orlistat(weight loss medicine), rosiglitazone(medicine against diabetes), triamterene-hydrochlorothiazide(diuretic).

Nifedipina Mylan GenericsItaliawith food and drink
Do not drink grapefruit juiceduring treatment with Nifedipina Mylan Generics Italia, because
it can increase the concentration of nifedipine in the blood and prolong its effect. If you drink
grapefruit juice regularly, this effect can last for more than 3 days after stopping.
Avoid drinking alcoholic beverages during treatment with Nifedipina Mylan Generics Italia

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Nifedipina Mylan Generics Italia if you are in the first 20 weeks of pregnancy or if you are
breastfeeding (see “Do not take Nifedipina Mylan Generics Italia”).
Nifedipine should not be used during pregnancy unless the patient's clinical condition
requires treatment with nifedipine. The use of nifedipine should be reserved
for women with severe hypertension who have not responded to standard therapy
(see “Warnings and precautions”).
Breastfeeding
The use of nifedipine during breastfeeding is not recommended 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 the case of men with difficulty conceiving with in vitrofertilization (an assisted reproductive technique), and for whom no other causes can be identified, it is advisable to consider the possibility that calcium channel blockers such as nifedipine may be underlying the problem.

Driving and operating machinery
Nifedipina Mylan Generics Italiacan cause dizziness or lightheadedness, especially
at the beginning of treatment or in association with alcoholic beverages. If this happens to you, do not drive
vehicles or operate machinery.

3. How to take Nifedipina Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.
The recommended dose is one 30 mg coated tablet once a day, in the morning.
The safety and efficacy of Nifedipina Mylan Generics Italiain children under 18 years of age has not
been demonstrated.
The dose, at the doctor's discretion, may be gradually increased up to a maximum of 60 mg
(one 60 mg coated tablet) in arterial hypertension or 120 mg (two 60 mg coated tablets) in angina pectoris, taking the medicine once a day, in the morning. It is possible that
your doctor will start treatment with a 20 mg tablet per day, or will prescribe
intermediate doses of 40 mg (20 + 20) or 50 mg (20 + 30).
Nifedipina Mylan Generics Italia is for oral use. Swallow the tablet whole with some
liquid. Do not chew and do not break the tablets. You can take Nifedipina Mylan Generics Italia
with or without food. Remove the tablets from the blister only at the time of taking them.
Your doctor will determine how long you should continue treatment with Nifedipina Mylan
Generics Italia.

Use in elderly patients
If you are an elderly patient, a lower dosage than younger patients may be necessary.

Use in patients with impaired liver function
If your liver is not functioning properly, careful monitoring of blood pressure may be necessary, and,
in severe cases, a reduction in dosage.

If you take more Nifedipina Mylan GenericsItalia than you should
It is important that you take exactly the dose indicated by your doctor. If you have accidentally taken too many tablets, the following may occur:
loss of consciousness up to coma, lowering of blood pressure, heart rhythm disturbances, increased blood sugar levels (hyperglycemia), alteration of blood pH
(metabolic acidosis), decreased oxygen supply (hypoxia), serious heart problems such as
cardiogenic shock with fluid accumulation around the lung (pulmonary edema).
If you have taken more tablets than necessary, contact your doctor immediately or
go to the Emergency Room of the nearest hospital.

If you forget to take Nifedipina Mylan Generics Italia
If you forget to take the medicine, take it as soon as you remember on the same day. If you happen
to miss a day, take the normal dose the next day. Do not take a double dose to
compensate for missing a dose.
If you are not sure what to do, consult your doctor or pharmacist.
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.
During nifedipine trials, the following side effects have been observed:
Common side effects (may affect up to 1 in 10 people)

• headache,
• edema, including peripheral edema (generalized or extremity swelling),
• vasodilation (widening of blood vessels),
• constipation,
• feeling unwell.

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

• allergic reaction,
• allergic edema/angioedema (swelling of the skin, face and mucous membranes, including laryngeal edema, potentially life-threatening),
• anxious reactions,
• sleep disturbances,
• dizziness,
• migraine (unilateral headache),
• lightheadedness,
• tremor,
• visual disturbances,
• tachycardia (fast heartbeat),
• palpitations (feeling of a fast 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 intestines),
• dry mouth,
• transient increase in liver enzymes,
• erythema (redness of the skin),
• muscle cramps,
• joint swelling,
• polyuria (increased urine output),
• dysuria (difficulty urinating),
• erectile dysfunction (difficulty achieving and maintaining an erection),
• unspecified pain,
• chills.

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

• pruritus (itching),
• urticaria (itching and small spots on the skin),
• skin rash,
• paresthesia/dysesthesia (altered sensation, e.g., tingling),
• gingival hyperplasia (gum enlargement).

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• agranulocytosis (lack of certain blood cells, called granulocytes),
• leukopenia (decrease in the number of white blood cells in the blood),
• anaphylactic/anaphylactoid reaction (severe allergic or pseudo-allergic reaction),
• hyperglycemia (increased blood sugar level),
• hypoesthesia (decreased sensitivity),
• somnolence,
• eye pain (pain in the eyes),
• chest pain (angina pectoris),
• dyspnea (difficulty breathing, shortness of breath),
• bezoars (formation of bulky masses in the stomach),
• dysphagia (difficulty swallowing),
• intestinal obstruction (blockage of intestinal contents),
• intestinal ulcer,
• vomiting,
• gastroesophageal sphincter insufficiency (regurgitation),
• jaundice (yellowing of the skin and whites of the eyes),
• toxic epidermal necrolysis (severe skin disease),
• photoallergic reaction (skin reaction following exposure to sunlight),
• palpable purpura (a particular type of skin rash),
• arthralgia (joint pain),
• myalgia (muscle pain),
• difficulty breathing.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Nifedipina Mylan Generics Italia

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 blister and the carton. The expiry
date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
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. Package Contents and Other Information

What Nifedipina Mylan Generics Italia contains
Nifedipina Mylan Generics Italia 30 mg prolonged-release coated tablets
The active ingredient is nifedipine.
Each prolonged-release coated tablet contains 30 mg of nifedipine.
The other ingredients 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”).

Nifedipina Mylan Generics Italia 60 mg prolonged-release coated tablets
The active ingredient is nifedipine.
Each prolonged-release coated tablet contains 60 mg of nifedipine.
The other ingredients 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 Nifedipina Mylan Generics Italia and package contents
Pack of 14 prolonged-release coated tablets.

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