Nitrendipina Egis

Package Leaflet: Information for the User

Nitrendypina EGIS 10 mg, tablets

Nitrendypina EGIS, 20 mg, tablets

Nitrendipinum

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

• Keep this 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 leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Nitrendypina EGIS and what is it used for

Nitrendypina, the active substance of Nitrendypina EGIS, belongs to a group of medicines called calcium antagonists. It widens the blood vessels and reduces their tension, which leads to a decrease in blood pressure.
The medicine is indicated for the treatment of high blood pressure (hypertension).

2. Important information before taking Nitrendypina EGIS

When not to take Nitrendypina EGIS

• if you are allergic to nitrendipine, another calcium antagonist of the 1,4-dihydropyridine type, or 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 arterial hypotension (systolic blood pressure below 90 mmHg),
• if you have significant aortic 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 both at rest and during minimal exertion),
• if you are pregnant or breastfeeding,
• if you are taking rifampicin (a medicine used to treat tuberculosis).

Warnings and precautions

Before starting to take Nitrendypina EGIS, discuss it with your doctor or pharmacist:

• if you have liver disease, as blood pressure may decrease more;
• if you have heart failure or arrhythmias, as your doctor may consider reducing the dose;
• if you have kidney problems.

Children and adolescents

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

Nitrendypina EGIS and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about the medicines you plan to take.
Nitrendypina EGIS may affect the action of other medicines, and other medicines may affect the action of Nitrendypina EGIS:

• other blood pressure-lowering medicines: additional decrease in blood pressure;
• diuretics: additional decrease in blood pressure;
• muscle relaxants (pancuronium, vecuronium): increased and prolonged muscle relaxant effect;
• cimetidine and ranitidine (used in the treatment of stomach ulcers);
• digoxin (a heart medicine): your doctor may reduce the dose of digoxin;
• phenytoin, carbamazepine (used in the treatment of epilepsy);
• phenobarbital (used in sleep disorders);
• valproic acid (used in the treatment of epilepsy);
• erythromycin, troleandomycin, clarithromycin, roxithromycin (antibiotics);
• ketoconazole, itraconazole, fluconazole (used in the treatment of fungal and yeast infections);
• nefazodone and fluoxetine (antidepressants);
• amprenavir, atazanavir, ritonavir, indinavir, nelfinavir, saquinavir (antiviral medicines);
• quinupristin and dalfopristin (antibiotics);
• calcium supplements.

Nitrendypina EGIS with food and drink

Grapefruit juice inhibits the metabolism of nitrendipine. Therefore, during treatment with Nitrendypina EGIS, do not consume grapefruits or grapefruit juice.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Because experimental studies with nitrendipine have shown developmental disorders in the fetus, Nitrendypina EGIS should not be used during pregnancy.
Nitrendipine passes into breast milk. The effect of nitrendipine on newborns/infants is unknown.
The use of Nitrendypina EGIS during breastfeeding is contraindicated.
Nitrendipine may affect fertility in men. If pregnancy is planned but there are fertility disorders, your doctor may consider alternative treatment.

Driving and using machines

Your doctor will monitor your condition during treatment for high blood pressure.
Reactions to the medicine, which may have varying severity in individual patients, may impair the ability to drive and use machines.
This is especially likely at the beginning of treatment, during dose increase, when changing the medicinal product, or when consuming alcohol.

Nitrendypina EGIS, 10 mg and 20 mg tablets contain lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

Nitrendypina EGIS, 10 mg tablets contain E 124 (Ponceau 4R)

The medicine may cause allergic reactions.

3. How to take Nitrendypina EGIS

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Because the medicine is sensitive to light, tablets should be stored in the original packaging (see also section 5).
Adults: The initial dose is 10 mg once daily.
Your doctor may gradually increase the dose over several weeks to a maximum dose of 40 mg once daily (one 20 mg tablet twice daily).
The usual dose is one 20 mg tablet once daily or two 20 mg tablets, given in two divided doses.
During long-term treatment, your doctor may reduce the dose to 10 mg once daily (one 10 mg tablet once daily).
The maximum daily dose of nitrendipine is 40 mg.
Tablets should be taken after a meal, with a sufficient amount of liquid. Do not take the tablets with grapefruit juice, as Nitrendypina EGIS may then work too strongly.
Treatment of high blood pressure is long-term. Your doctor will inform you how long you should take the medicine.
Use in children and adolescents (under 18 years of age)
Nitrendypina EGIS is not indicated for use in children and adolescents (under 18 years of age), due to a lack of sufficient experience with the use of the medicine in this age group.
Patients with liver function disorders
Patients with liver function disorders may be more sensitive to the action of Nitrendypina EGIS. Your doctor will recommend the smallest dose that allows blood pressure control.
Patients with kidney function disorders
There is no need to adjust the dose in patients with kidney function disorders.
Elderly patients
In elderly patients, a dose of 5 mg (half a 10 mg tablet) given once or twice daily may be sufficient.
Your doctor will recommend the smallest effective dose and will monitor your condition.

What to do if you take more Nitrendypina EGIS than you should

Symptoms of acute overdose:
Sudden flushing (especially of the face), headache, decreased blood pressure (with circulatory collapse) and changes in heart rate (fast or slow pulse).
If you have taken more Nitrendypina EGIS than you should, consult your doctor.

What to do if you miss a dose of Nitrendypina EGIS

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

What to do if you stop taking Nitrendypina EGIS

If you want to stop taking the medicine, e.g. due to side effects, you should consult your doctor first. Do not stop treatment without your doctor's advice.
If you have any further questions on 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 frequency of side effects is described in the following categories:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Frequency not known (cannot be estimated from the available data)
Very common: headache, sudden flushing of the face, swelling of the ankles and feet (especially at the beginning of treatment).
Common: especially at the beginning of treatment, angina pectoris (chest pain) may occur, and in patients with pre-existing angina pectoris, the frequency, duration, or severity of angina attacks (severity of chest pain) may increase, anxiety, increased heart rate, palpitations, vasodilation, bloating, malaise.
Uncommon: allergic reaction, including severe swelling of the lips, face, tongue, or throat (angioedema), sleep disorders, tingling or numbness of the skin (paresthesia), dizziness, fatigue, fainting, migraine, drowsiness, impaired or decreased sensitivity to touch (hypoesthesia), visual disturbances, blurred vision, low blood pressure, shortness of breath, nosebleeds, nausea, vomiting, abdominal pain, diarrhea, constipation, dryness of the mucous membranes of the mouth, dyspepsia, gastrointestinal inflammation, gum hypertrophy (gingival hyperplasia), skin hypersensitivity reactions, such as itching (pruritus), hives, rash, increased sensitivity of the skin to light (photosensitivity), muscle and joint pain, frequent urination (polyuria), weight gain, excessive sweating, unusual pain, liver function disorders (increased activity of certain liver enzymes).
Rare: inflammation of small blood vessels (leukocytoclastic vasculitis).
Very rare: decreased number of certain blood cells (decreased number of leukocytes, agranulocytosis), myocardial infarction, exfoliative dermatitis (skin peeling), impotence, gynecomastia, menstrual bleeding (menorrhagia), fever.

Reporting of side effects

If you experience any side effects, including those not listed in this 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.: +48 22 49 21 301, Fax: +48 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 Nitrendypina EGIS

Store in a temperature below 25°C. Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. 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 Nitrendypina EGIS contains

The active substance is nitrendipine. Each tablet contains 10 mg or 20 mg of nitrendipine.
The other ingredients are: lactose, potato starch, povidone, magnesium stearate, colloidal silica, sodium lauryl sulfate, microcrystalline cellulose.
The 10 mg tablets also contain E 124 (Ponceau 4R).

What Nitrendypina EGIS looks like and contents of the pack

10 mg:
round, biconvex tablets, pink in color with white and dark pink speckles, with the inscription "10" on one side and a score line on the other.
The tablet can be divided into equal doses.
20 mg: round, biconvex tablets, cream in color with the inscription "20" on one side
Pack sizes:
30 tablets (1 blister pack of 30 tablets or 2 blister packs of 15 tablets each) and 60 tablets (2 blister packs of 30 tablets or 4 blister packs of 15 tablets each).

Marketing authorization holder

Egis Pharmaceuticals PLC, Keresztúri út 30-38, 1106 Budapest, Hungary

Manufacturer

Egis Pharmaceuticals PLC, Mátyás király u. 65, 9900 Körmend, Hungary
To obtain further information, please contact the local representative of the marketing authorization holder.
EGIS Polska Sp. z o.o., ul. Komitetu Obrony Robotników 45D, 02-146 Warsaw, Phone: +48 22 417 92 00
Date of last revision of the leaflet:28.07.2021