Nitrendipine egis

Patient Information Leaflet

Nitrendypina EGIS, 10 mg, tablets
Nitrendypina EGIS, 20 mg, tablets
Nitrendipinum
Please read this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet Contents:

1. What Nitrendypina EGIS is and what it is used for
2. What you need to know 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 Nitrendypina EGIS is and what it is used for

Nitrendipine, the active substance in Nitrendypina EGIS, belongs to a group of medicines called calcium antagonists. It dilates blood vessels and reduces their tension, leading to a decrease in arterial blood pressure.
This medicine is indicated for the treatment of high blood pressure (hypertension).

2. Important information before using Nitrendypina EGIS

When not to use Nitrendypina EGIS

• if the patient is 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 the patient has cardiogenic shock (very weak pulse and low blood pressure),
• if the patient has hypotension (systolic blood pressure below 90 mmHg),
• if the patient has significant aortic valve 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 pregnant or breastfeeding,
• if the patient is taking rifampicin (a medicine used to treat tuberculosis).

Warnings and precautions
Before starting Nitrendypina EGIS, discuss this with your doctor or pharmacist:

• if the patient has liver disease, as blood pressure may decrease more significantly;
• if the patient has heart failure or cardiac arrhythmias, as the doctor may consider reducing the dose;
• if the patient has renal impairment.

Children and adolescents
This medicine is not indicated for use in children and adolescents.

Nitrendypina EGIS and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Nitrendypina EGIS may affect the action of other medicines, and other medicines may affect the action of Nitrendypina EGIS:

• other medicines that lower blood pressure: additional reduction in blood pressure;
• diuretics (water pills): additional reduction in blood pressure;
• muscle relaxants (pancuronium, vecuronium): enhanced and prolonged muscle-relaxing effect;
• cimetidine and ranitidine (used in peptic ulcer disease);
• digoxin (a heart medicine): the doctor may reduce the digoxin dose;
• phenytoin, carbamazepine (used in epilepsy treatment);
• phenobarbital (used in sleep disorders);
• valproic acid (used in epilepsy treatment);
• erythromycin, troleandomycin, clarithromycin, roxithromycin (antibiotics);
• ketoconazole, itraconazole, fluconazole (used in fungal and yeast infection treatment);
• 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, grapefruit and grapefruit juice should not be consumed.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Because experimental studies with nitrendipine have shown developmental disturbances in the fetus, Nitrendypina EGIS must not be used during pregnancy.
Nitrendipine passes into human milk. The effect of nitrendipine on the newborn/infant is unknown.
Use of Nitrendypina EGIS during breastfeeding is contraindicated.
Nitrendipine may impair fertility in men. If pregnancy is planned but fertility problems exist, the doctor may consider alternative treatment.

Driving and using machines
The doctor will monitor the patient's condition during treatment for high blood pressure.
Reactions to the medicine, which may vary in intensity among individual patients, may impair the ability to drive and operate machinery.
This is particularly likely at the beginning of treatment, during dose escalation, when switching from one medicinal product to another, or when alcohol is consumed concurrently.

Nitrendypina EGIS 10 mg and 20 mg tablets contain lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Nitrendypina EGIS 10 mg tablets contain carmoisine (E 124)
This medicine may cause allergic reactions.

3. How to use Nitrendypina EGIS

This medicine should always be taken as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
Since 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 per day.
The doctor may gradually increase the dose over several weeks up to a maximum of 40 mg per day (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, the doctor may reduce the dose to 10 mg per day (one 10 mg tablet per day).
The maximum daily dose of nitrendipine is 40 mg.
Tablets should be taken after a meal with sufficient fluid. Do not take the tablets with grapefruit juice, as Nitrendypina EGIS may then act too strongly.
Treatment of high blood pressure is long-term. The doctor will inform the patient how long the medicine should be taken.

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 insufficient experience with the use of the medicine in this age group.

Patients with impaired liver function
Patients with impaired liver function may be more sensitive to the effects of Nitrendypina EGIS. The doctor will recommend the lowest dose that allows control of blood pressure.

Patients with impaired kidney function
There is no need to adjust the dose in patients with impaired kidney function.

Elderly patients
In elderly patients, an adequate dose may be 5 mg (half a 10 mg tablet) administered once or twice daily.
The doctor will recommend the lowest effective dose and will monitor the patient's condition.

Taking more than the recommended dose of Nitrendypina EGIS
Symptoms of acute poisoning:
Sudden flushing (especially of the face), headache, decreased blood pressure (with circulatory collapse), and changes in heart rate (fast or slow pulse).
If an overdose of Nitrendypina EGIS is taken, consult a doctor immediately.

Missed dose of Nitrendypina EGIS
Do not take a double dose to make up for a missed dose.
Take the next tablet at the usual time.

Stopping Nitrendypina EGIS
If the patient wishes to stop taking the medicine, for example due to adverse effects, they should first contact their doctor. Do not stop treatment without medical advice.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The frequency of occurrence of adverse effects is described in the table below as follows:
Very common (may occur in more than 1 in 10 patients)
Common (may occur in up to 1 in 10 patients)
Uncommon (may occur in up to 1 in 100 patients)
Rare (may occur in up to 1 in 1,000 patients)
Very rare (may occur in up to 1 in 10,000 patients)
Frequency not known (frequency cannot be estimated from available data)

Very common: headache, sudden flushing of the face, swelling of the ankles and legs (especially at the beginning of treatment).

Common: particularly at the beginning of treatment, angina attacks (chest pain) may occur; in patients with pre-existing angina, an increase in frequency, duration, or severity of attacks (worsening of chest pain) may occur, anxiety, increased heart rate, palpitations, vasodilation, bloating, malaise.

Uncommon: allergic reactions, including severe swelling of lips, face, tongue or throat (angioedema), sleep disturbances, tingling and numbness of the skin (paresthesia), dizziness, fatigue, fainting, migraine, drowsiness, impaired or reduced sensitivity to touch (hypoesthesia), visual disturbances, blurred vision, low blood pressure, shortness of breath, nosebleeds, nausea, vomiting, abdominal pain, diarrhea, constipation, dryness of the oral mucosa, dyspepsia, gastritis and intestinal irritation, inflammation or swelling of the gums (gingival hyperplasia), skin hypersensitivity reactions such as itching (pruritus), urticaria, rash, photosensitivity (light sensitivity), muscle and joint pain, increased frequency of urination (polyuria), weight gain, excessive sweating, unusual pain, liver function abnormalities (increased activity of certain liver enzymes).

Rare: inflammation of small blood vessels (leukocytoclastic vasculitis).

Very rare: reduction in certain blood cells (decreased leukocytes, agranulocytosis), myocardial infarction, exfoliative dermatitis (skin peeling), erectile dysfunction, breast enlargement in men (gynecomastia), heavier than normal menstrual bleeding (menometrorrhagia), fever.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Nitrendipine EGIS
Store below 25°C. Keep in the original packaging to protect from light.
Keep the medicine out of 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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, polyvinylpyrrolidone, magnesium stearate,
colloidal silicon dioxide, sodium lauryl sulfate, microcrystalline cellulose.
The 10 mg tablets also contain cochineal red A (E-124).

What Nitrendypina EGIS looks like and contents of the pack
10 mg:
Round, biconvex tablets, pink in colour with white and dark pink specks, engraved with the number "10" on one side and a division line on the other.
The tablet can be divided into equal doses.
20 mg: Round, biconvex cream-coloured tablets with the number "20" engraved on one side.

Pack sizes:
30 tablets (1 blister of 30 tablets or 2 blisters of 15 tablets each) and
60 tablets (2 blisters of 30 tablets each or 4 blisters of 15 tablets each).

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

Manufacturer
Egis Pharmaceuticals PLC, Mátyás király u. 65
9900 Körmend
Hungary

For detailed information, please contact the local representative of the Marketing Authorisation Holder.
EGIS Polska Sp. z o.o.
ul. Komitetu Obrony Robotników 45D
02-146 Warsaw
Telephone: +48 22 417 92 00