Amarkor

Package leaflet: Information for the patient

AMARKOR

"30 mg prolonged-release film-coated tablets"
"60 mg prolonged-release film-coated tablets"
Nifedipine
Generic Medicine
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 others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 AMARKOR is and what it is used for

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

• chronic stable angina (exertional angina), characterized by severe pain behind the sternum, a feeling of tightness, and reduced 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 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, breastfeeding and fertility").
• In case of severe and sudden cardiovascular events (cardiovascular shock).
• If you have a Kock pouch ("diversion" following surgical removal of the colon and rectum).
• If you are taking an antibiotic called rifampicin. In this case, concomitant use reduces the blood concentration of nifedipine and thus lowers its effectiveness (see "Other medicines and AMARKOR").

Warnings and precautions
Talk to your doctor or pharmacist before taking AMARKOR.
Be careful with AMARKOR:

• If you have very low blood pressure (systolic blood pressure below 90 mmHg mercury).
• If you suffer from heart failure or severe aortic stenosis (narrowing of a heart valve), or if you are being treated with β-blocking agents (antihypertensives) or drugs that lower blood pressure (hypotensive agents).
• If you experience chest pain (sometimes symptoms similar to angina pectoris).
• If you suffer from a condition known as congestive heart failure and develop swelling (edema).
• If you have a severe narrowing of the gastrointestinal tract: you may develop signs of obstruction. In rare cases, large masses (bezoars) may form that cannot pass through the intestine and may sometimes require surgical intervention. In isolated cases, symptoms of blockage have also occurred in patients who had never previously experienced gastrointestinal disturbances. If you undergo gastrointestinal X-rays with barium contrast, AMARKOR may produce images that could be misinterpreted as polyps.
• If your liver is not functioning properly. In this case, careful monitoring may be required and, if your condition is severe, a reduction in the dose of AMARKOR may also be necessary.
• If you are pregnant. AMARKOR must not be used during the first 20 weeks of pregnancy (see "Do not take AMARKOR" and "Pregnancy and breastfeeding"). In subsequent weeks, your doctor will assess whether treatment with AMARKOR is suitable for you after a very careful evaluation of the potential risks and expected benefits, and when other therapies are unsuitable or ineffective. If AMARKOR is administered together with intravenous magnesium sulfate, frequent blood pressure monitoring is required due to the risk of excessive lowering of blood pressure. In emergency hypertensive conditions such as eclampsia (a severe, potentially life-threatening pregnancy disorder characterized by seizures), the drug must be used under the responsibility and strict supervision of a physician.
• If you are breastfeeding: nifedipine passes into human milk and, since its effects on the newborn are unknown, if treatment with nifedipine becomes necessary during this period, breastfeeding should be discontinued (see "Breastfeeding").
• If you are taking medicines known to activate or inhibit the elimination process of nifedipine from the body (see "Other medicines and AMARKOR"):
  • macrolide antibiotics (e.g., erythromycin),
  • drugs used in the treatment of HIV (e.g., ritonavir),
  • antifungal drugs (e.g., ketoconazole),
  • antidepressants (nefazodone and fluoxetine),
  • the combination of two antibiotics used for specific types of infections (quinupristin/dalfopristin),
  • valproic acid used for seizures,
  • cimetidine (an antihistamine).
• If you have severe reduction in kidney function (irreversible renal failure), are on dialysis, or suffer from malignant hypertension (abnormally high blood pressure), due to the risk 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 for AIDS, such as ritonavir, amprenavir, indinavir, nelfinavir, or saquinavir.
• Antifungal medicines, such as ketoconazole, itraconazole, or fluconazole.
• Fluoxetine, nefazodone (medicines for depression).
• Quinupristin/dalfopristin (an antibiotic used for specific infections).
• Phenytoin, carbamazepine, phenobarbital, and valproic acid (medicines for seizures).
• Cimetidine, cisapride (medicines used for stomach ulcers).
• Antihypertensives such as diuretics, β-blockers, ACE inhibitors, angiotensin II receptor antagonists (AT-1), other calcium antagonists, α-blockers, PDE5 inhibitors, α-methyldopa; in these cases, excessive reduction in blood pressure may occur and the heart's ability to pump blood may worsen.
• Digoxin, quinidine (heart medicines).
• Tacrolimus (a medicine used to prevent transplant rejection).

Nifedipine may alter the results of a laboratory test measuring vanillylmandelic acid levels in urine. Inform your doctor that you are taking AMARKOR.

AMARKOR with food and drink
Do not consume grapefruit or grapefruit juice during treatment with AMARKOR.
Concomitant intake causes an increase in nifedipine blood concentrations and prolongs its effect, leading to a greater than expected reduction in blood pressure. If you regularly consume grapefruit juice, this effect may last for more than 3 days after the last intake.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Nifedipine must not be administered during the first 20 weeks of pregnancy.
Your 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 standard therapy (see section 4).

Breastfeeding
Do not take this medicine if you are breastfeeding, as nifedipine passes into breast milk and it is currently unknown whether the use of nifedipine during breastfeeding may have effects on the infant.

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

Driving and using machines
AMARKOR may affect your ability to drive vehicles or operate machinery because it may cause dizziness or lightheadedness, especially at the beginning of treatment or when taken together with alcoholic beverages. If you experience these effects, do not drive or operate machinery.

3. How to take AMARKOR

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:

Your doctor will determine the dose based on the severity of your condition and your response to treatment.
In arterial hypertension, your doctor may gradually increase the dose up to a maximum of 60 mg once daily in the morning.
In angina pectoris, your doctor may gradually increase the dose up to 120 mg once daily in the morning.
Method of administration
AMARKOR tablets must be swallowed whole with a glass of water in the morning on an empty stomach.
The tablets must not be chewed or broken.
Do not change your dose without first consulting your doctor. Your doctor will assess whether the dose should be increased or reduced.
Remove the tablet from the blister pack only at the time of administration, avoiding exposure to sunlight and moisture.
Duration of treatment
Take AMARKOR for the duration prescribed by your treating physician. Your doctor will decide how long you should continue treatment with AMARKOR.
Use in patients with liver problems
If your liver function is impaired, careful 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 follow the dose prescribed by your doctor. In case of accidental ingestion or overdose of AMARKOR, contact your doctor immediately or go to the nearest hospital.
Symptoms
In cases of severe nifedipine intoxication, the following symptoms have been observed: disturbances of consciousness up to coma, low blood pressure, cardiac rhythm disturbances of tachy/bradycardic type (acceleration/slowing), hyperglycemia (increased blood sugar levels), decreased blood pH due to increased acid levels in the blood (metabolic acidosis), oxygen deficiency (hypoxia), cardiogenic shock with pulmonary edema.
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 this medicine without first consulting your doctor.
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 with the use of nifedipine:

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

• oedema, including peripheral oedema (generalised swelling or swelling in the extremities) due to fluid accumulation;
• headache;
• vasodilation (dilation of blood vessels, hot flushes, sensation of warmth);
• constipation;
• malaise, fatigue

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;
• insomnia;
• nervousness;
• visual disturbances;
• increased heart rate (tachycardia);
• 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 (intestinal gas);
• diarrhoea;
• dry mouth;
• transient increase in liver enzymes, severe impairment of bile flow to the duodenum due to intrahepatic obstruction;
• erythema (redness of the skin);
• muscle cramps;
• joint swelling;
• polyuria (increased volume of urine produced);
• dysuria (difficulty urinating);
• erectile dysfunction;
• non-specific pain;
• chills, pain in extremities.

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

• pruritus (itching);
• urticaria (hives);
• rash;
• paraesthesia/anaesthesia (altered sensation, e.g. tingling);
• gingival hyperplasia (overgrowth of the gums);
• rash caused by photosensitivity reactions;
• gynaecomastia (development of breast tissue in males).

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

• agranulocytosis (lack of certain blood cells called granulocytes);
• leucopenia (reduction 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);
• bezoars (formation of solid 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 (serious skin disease);
• photoallergic reaction (skin reaction following exposure to sunlight);
• palpable purpura (purple skin spots detectable by touch);
• arthralgia (joint pain);
• myalgia (muscle pain);
• laboured breathing.

In dialysis patients 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 experience any side effects, 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 the following address: 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 stated on the packaging after the word
EXP. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging and properly
stored.
Keep the medicine protected from direct sunlight and moisture. Protection from moisture
is ensured only within the original packaging; therefore, the tablets should be removed from the
blister pack only immediately before use.
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 AMARKOR contains
The active substance is nifedipine.
AMARKOR 30 mg prolonged-release film-coated tablets
Each tablet contains 30 mg of nifedipine.
The other components are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), iron oxide red (E 172).
AMARKOR 60 mg prolonged-release film-coated tablets
Each tablet contains 60 mg of nifedipine.
The other components are:
Hydroxypropylmethylcellulose, polyvinylpyrrolidone, carboxymethylcellulose, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol 6000, simethicone, titanium dioxide (E 171), iron oxide red (E 172).

Description of the appearance of AMARKOR and contents of the pack
AMARKOR is available in the following pack sizes:
AMARKOR 30 mg prolonged-release film-coated tablets in a cardboard carton containing one blister of 14 tablets.
AMARKOR 60 mg prolonged-release film-coated tablets in a cardboard carton containing one blister of 14 tablets.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
S.F. GROUP Srl – Via Tiburtina, No. 1143 - 00156 Rome, Italy
MANUFACTURER
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR), Italy