Patient Information Leaflet

Nitresan 20 mg tablets
Nitrendipine
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet Contents:

What Nitresan 20 mg is and what it is used for
What you need to know before taking Nitresan 20 mg
How to take Nitresan 20 mg
Possible side effects
How to store Nitresan 20 mg
Contents of the pack and other information

1. What Nitresan 20 mg is and what it is used for

Nitrendipine, the active substance in Nitresan 20 mg tablets, belongs to a group of medicines called calcium antagonists. It helps reduce tension and dilate blood vessels. As blood vessels are dilated, arterial blood pressure decreases.
Your doctor has prescribed this medicine to lower your high blood pressure.

2. Important information before taking Nitresan 20 mg

When not to take Nitresan 20 mg

if the patient is allergic to nitrendipine, to another calcium antagonist of the 1,4-dihydropyridine type, or to any of the other ingredients of this medicine (listed in section 6),
if the patient has cardiogenic shock (very weak pulse and low arterial blood pressure),
if the patient has severe aortic valve stenosis or subaortic stenosis,
if the patient has had a myocardial infarction within the last 4 weeks,
if the patient has unstable angina pectoris (chest pain caused by ischemic heart disease, occurring both at rest and with minimal exertion),
if the patient is taking rifampicin,
during pregnancy.

Warnings and precautions
Before starting treatment with Nitresan 20 mg, discuss with your doctor or pharmacist:

if the patient has liver disease, blood pressure may decrease more significantly.
the doctor may consider reducing the dose if the patient has impaired heart function or cardiac arrhythmias.

Regular medical monitoring is required during treatment with Nitresan 20 mg.
Children and adolescents
This medicine is not intended for use in children and adolescents.
Nitresan 20 mg and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The following medicines or groups of medicines, when taken concomitantly, may affect the action of Nitresan 20 mg:

Rifampicin, an anti-tuberculosis medicine, must not be used together with Nitresan 20 mg, as this may reduce its effectiveness.
The following medicines may enhance the effect of Nitresan 20 mg:
o Macrolide antibiotics (erythromycin, troleandomycin, clarithromycin, roxithromycin)
o Medicines used in HIV infection (protease inhibitors such as ritonavir)
o Antifungal medicines (azole antifungals such as ketoconazole)
o Nefazodone and fluoxetine (antidepressant medicines)
o Quinupristin and dalfopristin (antibiotics)
o Valproic acid (a medicine used in epilepsy treatment)
o Cimetidine and ranitidine (medicines used in peptic ulcer disease)
The following medicines may reduce the effect of Nitresan 20 mg:
o Phenytoin, phenobarbital and carbamazepine (antiepileptic medicines)
Nitresan 20 mg may affect the action of other medicines:
Medicines that lower blood pressure: Nitresan 20 mg may enhance the blood pressure-lowering effect of concomitantly administered antihypertensive medicines, such as:
o Diuretics (water-excreting medicines)
o β-blockers
o ACE inhibitors
o Angiotensin II receptor antagonists (AT_)
o Other calcium antagonists
o Alpha-adrenergic receptor blockers
o PDE-5 inhibitors (enzyme inhibitors used in the treatment of erectile dysfunction and pulmonary arterial hypertension)
o Alpha-methyldopa
Digoxin (a cardiac glycoside): the effect of digoxin may be enhanced.
Certain muscle relaxants (e.g. pancuronium): the effect of this medicine may be enhanced and prolonged.

When Nitresan 20 mg is used concomitantly with any of the above-mentioned medicines, the doctor should closely monitor blood pressure and, if necessary, adjust the treatment.
Nitresan 20 mg with food and drink
Grapefruit juice inhibits the metabolism of nitrendipine. Therefore, grapefruit juice must not be consumed during treatment with Nitresan 20 mg.
Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
The use of Nitresan 20 mg during pregnancy is contraindicated.
Experimental studies with nitrendipine have shown developmental disturbances in the fetus.
Data on use in pregnant women are insufficient.
Nitrendipine passes into human milk in small amounts. The effect of nitrendipine on newborns and breastfed infants is unknown.
Nitrendipine may impair fertility in men. In men who have repeatedly and unsuccessfully attempted to father children through assisted reproductive techniques without a known cause, nitrendipine use should be considered as a possible reason for failure. If pregnancy is planned, alternative treatment should be considered.
Driving and operating machinery
During treatment for high blood pressure, the patient should remain under medical supervision.
Treatment for high blood pressure may affect the ability to drive motor vehicles and operate mechanical equipment.
This is particularly likely at the beginning of treatment, during dose escalation, when switching from one medicine to another, or when alcohol is consumed concurrently.
Nitresan 20 mg contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Nitresan 20 mg contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Nitresan 20 mg

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
Since this medicine is light-sensitive, tablets must be stored in the original
packaging (see also section 5).
The recommended dose for adults is 1 tablet of Nitresan 20 mg in the morning (corresponding to 20 mg
of nitrendipine per day).
If the blood pressure reduction is inadequate, the daily dose may be increased to
1 tablet twice daily (corresponding to 40 mg of nitrendipine per day).
The maximum daily dose of nitrendipine is 40 mg.
Tablets should be taken after meals (in the morning and evening), with an adequate amount of fluid. Do
not take the tablets with grapefruit juice, as Nitresan 20 mg may then have an excessive effect.
Treatment of high blood pressure is long-term. Your doctor will inform you how long you should
continue taking the medicine.
Use in children and adolescents
Nitresan 20 mg is not indicated for use in children and adolescents due to insufficient
experience with the use of this medicine in this age group.
Patients with liver function impairment
Patients with impaired liver function may be more sensitive to the effects of Nitresan 20 mg. The physician will prescribe the lowest dose that effectively controls blood pressure.
Patients with kidney function impairment
Dose adjustment is not necessary in patients with impaired kidney function.
Elderly patients
The physician will prescribe the lowest effective dose and will monitor the patient's condition.
Taking more Nitresan 20 mg than prescribed
Symptoms of acute poisoning include:
sudden flushing, headache, reduction in blood pressure (with circulatory collapse),
and changes in heart rate (fast or slow pulse).
If an overdose has been taken, consult a doctor immediately.
If you forget to take Nitresan 20 mg
Do not take a double dose to make up for a missed dose.
Take the next tablet at the usual time.
Stopping Nitresan 20 mg
If you wish to stop taking the medicine, for example due to adverse effects, you should
consult your doctor first.
Do not discontinue treatment without medical advice.
If you have any further questions about the use of this medicine, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Common (may occur in up to 1 in 10 people):

headache
anxiety reactions
palpitations
swelling of ankles and legs
vasodilation
sudden flushing of the face and skin redness
sensation of warmth (flushing)
bloating
general feeling of discomfort, illness or fatigue

Uncommon (may occur in up to 1 in 100 people):

allergic reactions, including skin reactions and allergic swelling/angioedema
central dizziness
fatigue
migraine
decreased sensitivity to touch
sleep disorders
visual disturbances
tinnitus
peripheral dizziness
angina pectoris
increased heart rate (tachycardia)
heart rhythm disorders
chest pain
low blood pressure
shortness of breath
nosebleeds
nausea, vomiting, stomach, intestinal and abdominal pain, diarrhoea, constipation
gingival hyperplasia
dryness of the oral mucosa
dyspepsia
gastritis and enteritis
liver function disorders (increased activity of certain liver enzymes)
muscle pain
excessive urine volume (polyuria)
atypical pain

Frequency not known

myocardial infarction

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nitresan 20 mg

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging following
“EXP”. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This helps
protect the environment.

6. Contents of the package and other information

What Nitresan 20 mg contains
The active substance is nitrendipine. Each tablet contains 20 mg of nitrendipine.
The other ingredients are: monohydrate lactose, corn starch, microcrystalline cellulose,
povidone K-25, sodium docusate, magnesium stearate.

What Nitresan 20 mg looks like and contents of the pack
Yellow, flat tablets with a dividing groove on one side and strength identification on the other,
7 mm in diameter.
The division line on the tablet is not intended for breaking the tablet.
Pack sizes: 20, 30, 50, 60 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
PRO.MED. CS. Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorised in the European Economic Area countries under the following names:
Estonia: Nitresan 20 mg
Lithuania: Nitresan 20 mg
Latvia: Nitresan 20 mg
Poland: Nitresan 20 mg
Slovakia: NITRESAN 20 mg
Czech Republic: Nitresan