Nitresan 20 mg

Package Leaflet: Information for the User

Nitresan 20 mg Tablets

(Nitrendipine)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Package Leaflet Contents:

• 1. What is Nitresan 20 mg and what is it used for
• 2. Important information before taking Nitresan 20 mg
• 3. How to take Nitresan 20 mg
• 4. Possible side effects
• 5. How to store Nitresan 20 mg
• 6. Contents of the pack and other information

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

Nitrendipine, the active substance of Nitresan 20 mg, belongs to a group of medicines called calcium antagonists. It helps to reduce tension and widen blood vessels. As the blood vessels are widened, blood pressure is lowered. The doctor will prescribe the tablets to reduce high blood pressure.

2. Important information before taking Nitresan 20 mg

When not to take Nitresan 20 mg

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

Warnings and precautions

Before starting to take Nitresan 20 mg, discuss it with your doctor or pharmacist:

• if you have liver disease, blood pressure may decrease more.
• the doctor will consider reducing the dose if you have impaired heart function or heart rhythm disorders.

During treatment with Nitresan 20 mg, regular medical check-ups are necessary.

Children and adolescents

The medicine is not indicated for use in children and adolescents.

Nitresan 20 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take. The following medicines or groups of medicines may affect the action of Nitresan 20 mg:

• Rifampicin, an anti-tuberculosis medicine, must not be taken at the same time as Nitresan 20 mg, as it may reduce its effect.
• The following medicines may enhance the effect of Nitresan 20 mg:
  • Macrolide antibiotics (erythromycin, troleandomycin, clarithromycin, roxithromycin)
  • HIV protease inhibitors (such as ritonavir)
  • Antifungal agents (azole antifungals, such as ketoconazole)
  • Nefazodone and fluoxetine (antidepressants)
  • Cinupristin and dalfopristin (antibiotics)
  • Valproic acid (a medicine used to treat epilepsy)
  • Cimetidine and ranitidine (medicines used to treat stomach and duodenal ulcers)
• The following medicines may reduce the effect of Nitresan 20 mg:
  • Phenytoin, phenobarbital, and carbamazepine (antiepileptic medicines)
• Nitresan 20 mg may affect the action of other medicines:
• Blood pressure-lowering medicines: Nitresan 20 mg may enhance the blood pressure-lowering effect of other antihypertensive medicines, such as:
  • Diuretics
  • Beta-blockers
  • ACE inhibitors
  • Angiotensin II receptor antagonists
  • Other calcium antagonists
  • Alpha-adrenergic blockers
  • PDE-5 inhibitors (used to treat erectile dysfunction and pulmonary hypertension)
  • Alpha-methyldopa
• Digoxin (a heart medicine). The effect of digoxin may be enhanced.
• Certain muscle relaxants (pancuronium). The effect of this medicine may be enhanced and prolonged.

When taking Nitresan 20 mg 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, during treatment with Nitresan 20 mg, do not consume grapefruit juice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The use of Nitresan 20 mg during pregnancy is contraindicated. Experimental studies with nitrendipine have shown developmental disorders in the fetus. Data on the use of the medicine in pregnant women are insufficient. Nitrendipine passes into human milk in small amounts. The effect of nitrendipine on newborns and breastfed children is unknown. Nitrendipine may affect fertility in men. In men who have repeatedly and unsuccessfully tried to become fathers through fertilization procedures, the use of nitrendipine should be considered as a possible cause of failure. If pregnancy is planned, alternative treatment should be considered.

Driving and using machines

During treatment for high blood pressure, the patient should be under control. Treatment for high blood pressure may affect the ability to drive vehicles and operate machinery. This is especially likely at the beginning of treatment, when increasing the dose, when changing the medicine, or when consuming alcohol at the same time.

Nitresan 20 mg contains lactose

If you have been diagnosed with an intolerance to some sugars, contact your doctor before taking the medicine.

Nitresan 20 mg contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Nitresan 20 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. Since the medicine is sensitive to light, the tablets should 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 reduction in blood pressure is not satisfactory, the daily dose can be increased to 1 tablet twice a day (corresponding to 40 mg of nitrendipine per day). The maximum daily dose of nitrendipine is 40 mg. The tablets should be taken after a meal (in the morning and evening), with a sufficient amount of liquid. Do not take the tablets with grapefruit juice, as Nitresan 20 mg may then work too strongly. Treatment for high blood pressure is long-term. The doctor will inform you how long you should take the medicine. Use in children and adolescentsNitresan 20 mg is not indicated for use in children and adolescents due to a lack of sufficient experience with the use of the medicine in this age group. Patient with impaired liver functionPatients with impaired liver function may be more sensitive to the effect of Nitresan 20 mg. The doctor will recommend the smallest dose that allows control of blood pressure. Patient with impaired kidney functionThere is no need to adjust the dose in patients with impaired kidney function. Elderly patientsThe doctor will recommend the smallest effective dose and will monitor the patient's condition.

Taking more than the recommended dose of Nitresan 20 mg

Symptoms of acute overdose are: sudden flushing, headache, decreased blood pressure (with circulatory collapse), and changes in heart rate (fast or slow pulse). In case of overdose, consult a doctor.

Missing a dose of Nitresan 20 mg

Do not take a double dose to make up for a forgotten dose. Take the next tablet at the normal time.

Stopping treatment with Nitresan 20 mg

If you want to stop taking the medicine, e.g., due to side effects, consult your doctor first. Do not stop treatment without your doctor's advice. If you have any further questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Common(may affect up to 1 in 10 people):

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

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

• allergic reactions, including skin reactions and angioedema
• central dizziness
• fatigue
• migraine
• decreased sensitivity to touch
• sleep disorders
• vision disorders
• tinnitus
• peripheral dizziness
• angina pectoris
• rapid heart rate (tachycardia)
• heart rhythm disorders
• chest pain
• low blood pressure
• shortness of breath
• nasal bleeding
• nausea, vomiting, stomach pain, intestinal and abdominal pain, diarrhea, constipation
• gingival hyperplasia
• dryness of the oral mucosa
• dyspepsia
• gastrointestinal disorders
• liver function disorders (increased activity of certain liver enzymes)
• muscle pain
• excessive urine production (polyuria)
• unusual pain

Frequency not known

• myocardial infarction.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nitresan 20 mg

Keep the 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 after "EXP". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nitresan 20 mg contains

The active substance is nitrendipine. Each tablet contains 20 mg of nitrendipine. The other ingredients are: lactose monohydrate, 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 line on one side and a strength marking on the other side, 7 mm in diameter. The dividing line is not intended for breaking the tablet. Pack sizes: 20, 30, 50, 60, or 100 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED. CS. Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Nitresan 20 mg Tablets Estonia: Nitresan 20 mg Lithuania: Nitresan 20 mg Latvia: Nitresan 20 mg Poland: Nitresan 20 mg Slovakia: NITRESAN 20 mg Czech Republic: Nitresan Date of last revision of the package leaflet:20.08.2021