Nitresan 10 mg

Package Leaflet: Information for the User

Nitresan 10 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, tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Nitresan 10 mg and what is it used for
• 2. Important information before taking Nitresan 10 mg
• 3. How to take Nitresan 10 mg
• 4. Possible side effects
• 5. How to store Nitresan 10 mg
• 6. Package contents and other information

1. What is Nitresan 10 mg and what is it used for

Nitrendipine, the active substance of Nitresan 10 mg, belongs to a group of medicines called calcium antagonists. It helps to reduce tension and dilate blood vessels. As the blood vessels dilate, blood pressure decreases. Your doctor will prescribe the tablets to reduce high blood pressure.

2. Important information before taking Nitresan 10 mg

When not to take Nitresan 10 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 heart disease, occurring at rest and during minimal exertion),
• if you are taking rifampicin,
• during pregnancy.

Warnings and precautions

Before starting to take Nitresan 10 mg, discuss it with your doctor or pharmacist:

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

During treatment with Nitresan 10 mg, regular medical check-ups are necessary.

Children and adolescents

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

Nitresan 10 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. The following medicines or groups of medicines may affect the action of Nitresan 10 mg:

• Do not take rifampicin, an anti-tuberculosis medicine, at the same time as Nitresan 10 mg, as it may reduce its effect.
• The following medicines may enhance the effect of Nitresan 10 mg:
  • Macrolide antibiotics (erythromycin, troleandomycin, clarithromycin, roxithromycin)
  • HIV protease inhibitors (such as ritonavir)
  • Antifungal medicines (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 10 mg:
  • Phenytoin, phenobarbital, and carbamazepine (antiepileptic medicines)
• Nitresan 10 mg may affect the action of other medicines:
• Blood pressure-lowering medicines: Nitresan 10 mg may enhance the blood pressure-lowering effect of concomitantly used 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 10 mg at the same time as any of the above-mentioned medicines, your doctor should closely monitor your blood pressure and, if necessary, adjust the treatment.

Nitresan 10 mg with food and drink

Grapefruit juice inhibits the metabolism of nitrendipine. Therefore, during treatment with Nitresan 10 mg, do not consume grapefruit juice.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine. The use of Nitresan 10 mg during pregnancy is contraindicated. Experimental studies with nitrendipine have shown developmental disorders in the fetus. Data on the use of Nitresan 10 mg 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 attempted 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, during dose increases, when changing to another medicine, or during concurrent consumption of alcohol.

Nitresan 10 mg contains lactose monohydrate

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

Nitresan 10 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 10 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 twice a day (morning and evening), which corresponds to 20 mg of nitrendipine per day. If the reduction in blood pressure is not satisfactory, the daily dose can be increased to 2 tablets twice a day (which corresponds to 40 mg of nitrendipine per day). The maximum daily dose of nitrendipine is 40 mg. The tablets should be taken after meals (morning and evening), with a sufficient amount of liquid. Do not take the tablets with grapefruit juice, as Nitresan 10 mg may then work too strongly. Treatment for high blood pressure is long-term. Your doctor will inform you how long you should take the medicine. Use in children and adolescentsNitresan 10 mg is not intended for use in children and adolescents; there is 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 10 mg. The doctor will prescribe the smallest dose that allows blood pressure control. Patient with impaired kidney functionThere is no need to adjust the dose in patients with impaired kidney function. Elderly patientsThe doctor will prescribe the smallest effective dose and will monitor the patient's condition.

Taking a higher dose of Nitresan 10 mg than recommended

Symptoms of acute overdose are: sudden flushing, headache, decreased blood pressure (with circulatory collapse), and changes in heart rate (fast or slow pulse). If you have taken a dose higher than recommended, consult a doctor.

Missing a dose of Nitresan 10 mg

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

Stopping treatment with Nitresan 10 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
• ankle and foot swelling
• vasodilation
• flushing of the face and skin
• feeling of heat (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, intestinal, and abdominal pain, diarrhea, constipation
• gingival hyperplasia
• dryness of the oral mucosa
• indigestion
• 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, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug 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 10 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. Package contents and other information

What Nitresan 10 mg contains

The active substance is nitrendipine. Each tablet contains 10 mg of nitrendipine. The other ingredients are: lactose monohydrate, corn starch, microcrystalline cellulose, povidone K-25, sodium docusate, magnesium stearate.

What Nitresan 10 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, with a diameter of 7 mm. 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 10 mg Tablets Estonia: Nitresan 10 mg Lithuania: Nitresan 10 mg Latvia: Nitresan 10 mg Poland: Nitresan 10 mg Slovakia: NITRESAN 10 mg Czech Republic: Nitresan Date of last revision of the package leaflet:20.08.2021