AMARKOR 30 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

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

AMARKOR

“30 mg film-coated prolonged-release tablets”
“60 mg film-coated prolonged-release tablets”
Nifedipine

Generic Medicine
Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it may 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 AMARKOR is and what it is used for
• 2. What you need to know before you take AMARKOR
• 3. How to take AMARKOR
• 4. Possible side effects
• 5. How to store AMARKOR
• 6. Contents of the pack and other information

1. What is AMARKOR and what it is used for

AMARKOR contains the active substance nifedipine which belongs to a category of
medicines called calcium antagonists used to lower blood pressure
(antihypertensives) or in other diseases of the cardiovascular system.
AMARKOR is indicated for the treatment of:

• stable chronic angina pectoris (exertional angina) characterized by severe pain in the posterior region of the sternum, a feeling of constriction and decreased blood flow to the heart;
• arterial hypertension (high blood pressure).

2. What you need to know before taking AMARKOR

Do not take AMARKOR

• If you are allergic (hypersensitive) to nifedipine or 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, breastfeeding and fertility”).
• In case of severe and sudden events damaging the cardiovascular system (cardiogenic shock).
• If you have a Kock pouch (“deviation” after a destructive operation on the colon and rectum).
• If you are taking an antibiotic called rifampicin. In this case, simultaneous use reduces the concentration of nifedipine in the blood and therefore lowers its effectiveness (see “Other medicines and AMARKOR”).

Warnings and precautions
Talk to your doctor or pharmacist before taking AMARKOR.

Take care with AMARKOR:

• If you have very low blood pressure(systolic pressure less than 90 mmHg of mercury).
• If you suffer from heart failure or severe aortic stenosis (narrowing of a heart valve) or are being treated with beta-blockers (antihypertensives) or medicines that lower blood pressure (antihypertensives).
• If you experience chest pain (sometimes angina pectoris-like discomfort).
• If you suffer from a condition known as congestive heart failure and should experience the onset of swelling (edema).
• If you have a severe narrowing of the gastrointestinal tract: you may experience signs of obstruction. In rare cases, the formation of bulky masses (bezoar) may occur that cannot be eliminated through the intestine and sometimes require surgical intervention. In isolated cases, symptoms of blockage have also manifested in patients who have never experienced gastrointestinal disorders. If you undergo X-rays of the digestive tract with barium contrast, AMARKOR may 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 AMARKOR may also be required.
• If you are pregnant. AMARKOR should not be used in the first 20 weeks of pregnancy (See “Do not take AMARKOR” and “Pregnancy and breastfeeding”). In the following weeks, the doctor will assess whether treatment with AMARKOR is suitable for you after a very careful evaluation of the possible risks and expected benefits and when other therapies are not suitable or have not been effective. If AMARKOR is administered to you in association with magnesium sulfate intravenously, frequent blood pressure checks are necessary due to the possibility of excessive lowering of blood pressure, which may harm both you and the fetus in case of hypertensive emergency episodes, such as eclampsia (a serious pregnancy condition, potentially fatal, characterized by convulsions), the drug must be used under the responsibility and strict control of the doctor;
• If you are breastfeeding: nifedipine passes into human milk and since the effects on the newborn are unknown, if treatment with nifedipine is necessary during this period, breastfeeding should be discontinued (see “Breastfeeding”).
• If you are taking medicines known to activate or inhibit the process of eliminating nifedipine from the body (see “Other medicines and AMARKOR”):
• macrolide antibiotics (e.g. erythromycin),
• medicines used in the treatment of HIV (e.g. ritonavir),
• medicines for fungal infections (e.g. ketoconazole),
• antidepressants (nefazodone and fluoxetine),
• the combination of 2 antibiotics used for particular types of infections (quinupristin/dalfopristin),
• valproic acid used for seizures,
• cimetidine (antihistamine).
• If you have a severe decrease in kidney function (irreversible renal failure), are on dialysis, if you suffer from an abnormal increase in pressure (malignant hypertension) due to the possibility of excessive lowering of blood pressure.
• If you suffer from diabetes or are at risk.

Children and adolescents
The safety and efficacy of nifedipine in children and adolescents under 18 years of age
has not been established.

Other medicines and AMARKOR
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:

• Diltiazem: your doctor may advise you to reduce the dose of nifedipine.
• Rifampicin (an antibiotic); never take AMARKOR together with medicines containing rifampicin (see “Do not take AMARKOR”).
• Antibiotics belonging to the macrolide class, such as erythromycin.
• Medicines against AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir or saquinavir.
• Medicines against fungal infections, such as ketoconazole, itraconazole or fluconazole.
• Fluoxetine, nefazodone (medicines against depression).
• Quinupristin/dalfopristin (antibiotic used for particular infections).
• Phenytoin, carbamazepine, phenobarbital and valproic acid (medicines against seizures).
• Cimetidine, cisapride (medicines used in stomach ulcers).
• Antihypertensives such as diuretics, beta-blockers, ACE inhibitors, angiotensin II receptor antagonists (AT-1), other calcium channel blockers, alpha-blockers, PDE5 inhibitors, alpha-methyldopa; in these cases, an excessive reduction in blood pressure may occur and may also worsen the heart's ability to pump blood.
• Digoxin, quinidine (medicines for the heart).
• Tacrolimus (medicine used against transplant rejection).

Nifedipine may alter the results of a laboratory test for the determination of vanillyl-mandelic acid levels in the urine. Tell your doctor that you are taking AMARKOR.

AMARKOR with food, beverages
Do not take grapefruit or grapefruit juice during treatment with AMARKOR.
Simultaneous intake causes an increase in nifedipine concentrations in the blood and
prolongs its action as well as reducing blood pressure more than expected. If you regularly consume
grapefruit juice, this effect can last for more than 3 days after the last intake.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine-
le.

Pregnancy
Nifedipine should not be administered in the first 20 weeks of pregnancy.
The doctor will assess whether your clinical condition requires treatment with nifedipine. The use
of nifedipine should be limited to women with severe hypertension who do not respond to te-
rapia standard (see section 4).

Breastfeeding
Do not take this medicine if you are breastfeeding as nifedipine passes into breast milk
and it is currently not known whether the use of nifedipine during breastfeeding may have any ef-
fects on the infant.

Fertility
In cases of repeated failure of in vitro fertilization, not attributable to other reasons, the use
of antihypertensive drugs of the calcium channel blocker class such as nifedipine should be
considered as a possible cause as they are associated with functional alterations of spermatozoa.

Driving and using machines
AMARKOR may affect your ability to drive vehicles and operate machinery as it may
cause dizziness or lightheadedness, especially at the beginning of treatment or in asso-
ciation with alcoholic beverages. If this happens to you, do not drive vehicles or operate machinery.

3. How to take AMARKOR

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:

Your doctor will establish the dose based on the severity of the disease and how you respond to treatment.
In arterial hypertension, the doctor may gradually increase the dose up to a maximum of
60 mg to be taken once a day, in the morning.
In angina pectoris, the doctor may gradually increase the dose up to 120 mg to be taken
once a day, in the morning.

Method of administration
AMARKOR tablets must be swallowed with some water in the morning on an empty stomach.
The tablets must not be chewed or broken.
Do not change the dose you take without first informing your doctor. He will evaluate whether to increase or
reduce the dose.
Remove the tablet from the blister only at the time of taking it, avoiding exposing it to
sunlight and humidity.

Duration of treatment
Take AMARKOR for the period indicated by your attending physician. Your doctor will establish for
how long you should continue treatment with AMARKOR.

Use in patients with liver problems
If your liver does not function properly, accurate monitoring of blood pressure and a reduction in dosage may be necessary.

Use in children and adolescents
The safety and efficacy of nifedipine in children and adolescents under 18 years of age have not
been established.

If you take more AMARKOR than you should
It is important to adhere to the dose indicated by your doctor. In case of accidental ingestion/taking of an
excessive dose of AMARKOR, immediately inform your doctor or go to the
nearest hospital.

Symptoms
In cases of severe nifedipine poisoning, the following symptoms have been observed: disturbances of
consciousness up to coma, decreased blood pressure, alterations of heart rhythm of type ta-
chy/bradycardic (acceleration/slowing), hyperglycemia (increased blood sugar levels), decreased blood pH due to an increase in the amount of acidic substances
in the blood (metabolic acidosis), oxygen deficiency (hypoxia), heart shock (cardiogenic) with
swelling (edema) of the lungs.

If you forget to take AMARKOR
Do not take a double dose to make up for a missed dose. If you are unsure what to
do, consult your doctor or pharmacist.

If you stop taking AMARKOR
Do not stop taking the medicine without first consulting your doctor.

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.
The following side effects have been observed with the use of nifedipina:

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

• edema, including peripheral edema (generalized or extremity swelling) due to fluid retention;
• headache;
• vasodilation (blood vessel dilation, flushing, feeling of warmth);
• constipation;
• feeling unwell, fatigue

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;
• insomnia;
• nervousness;
• visual disturbances;
• increased heart rate (tachycardia);
• 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 (presence of gas in the intestine);
• diarrhea;
• dry mouth;
• transient increase in liver enzymes, severe impairment of bile flow to the duodenum due to an obstruction within the liver;
• erythema (redness of the skin);
• muscle cramps;
• joint swelling;
• polyuria (increased urine output);
• dysuria (difficulty urinating);
• erectile dysfunction;
• non-specific pain;
• chills, limb pain.

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

• pruritus (itching);
• urticaria (hives);
• skin rash;
• paresthesia/dysesthesia (altered sensation, e.g., tingling);
• gingival hyperplasia (gum enlargement);
• skin rash caused by sensitivity reactions to sunlight;
• development of breast tissue in men (gynecomastia).

Side effects with unknown frequency(frequency cannot be estimated on the basis of
available data)

• agranulocytosis (lack of certain blood cells, called granulocytes);
• leukopenia (reduced number of white blood cells in the blood);
• anaphylactic/anaphylactoid reaction (severe allergic or pseudo-allergic reaction);
• hyperglycemia (increased blood sugar levels);
• hypoesthesia (decreased sensitivity);
• somnolence (drowsiness);
• eye pain;
• chest pain (angina pectoris);
• dyspnea (breathing difficulty);
• bezoars (formation of bulky masses in the stomach);
• dysphagia (difficulty swallowing);
• intestinal obstruction (blockage of the passage 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 (bruise-like spots that can be felt);
• arthralgia (joint pain);
• myalgia (muscle pain);
• shortness of breath.

In patients on dialysis who suffer from excessively high blood pressure and have low
blood volumes, a severe drop in blood pressure may occur.

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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store AMARKOR

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 the designation
EXP. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging and correctly
stored.
Keep the medicine protected from direct sunlight and humidity. Protection from humidity
is only guaranteed inside the packaging, therefore the tablets should only be removed from the
blister immediately before use.
Do not dispose of any medicine in the wastewater 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

What AMARKOR contains
The active ingredient is nifedipine.

AMARKOR 30 mg film-coated prolonged-release tablets
Each tablet contains 30 mg of nifedipine.
The other ingredients are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal
silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), red iron oxide
(E 172).

AMARKOR 60 mg film-coated prolonged-release tablets
Each tablet contains 60 mg of nifedipine.
The other ingredients are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal
silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), red iron oxide
(E 172).

Description of the appearance of AMARKOR and contents of the pack

AMARKORis available in the following packs:

AMARKOR 30 mg film-coated prolonged-release tabletsin a cardboard box
containing a blister pack of 14 tablets.

AMARKOR 60 mg film-coated prolonged-release tabletsin a cardboard box
containing a blister pack of 14 tablets.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
S.F. GROUP Srl – Via Tiburtina, n° 1143 - 00156 Rome

MANUFACTURER
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) Italy