NIFEDI-DENK 10 RETARD Tablet

Indication:

In the treatment of cardiac complaints, which are associated with insufficient oxygen supply to the heart muscle (angina pectoris), and in the treatment of hyper-tension.

- chronic stable angina pectoris (effort angina)

- vasospastic angina pectoris (Prinzmetal’s angina, variant angina)

- non-organ-related high blood pressure (essential hypertension).

Dosage:

Treatment should as far as possible be administered individually on the basis of the severity of the condition and the patient’s response.

The target dose should be reached gradually, depending on the medical condition concerned.

Patients with hepatic insufficiency should be monitored closely, and if necessary the dose should be reduced.

This medicine is suitable for patients with high blood pressure, who suffer from severe cerebrovascular disease, and for those, where an excessive reaction to nifedipine can be expected because of low body weight or because of concomitant treatment with other blood pressure reducing medicines. Patients whose side effects to the nifedipine treatment would seem to make a more subtle adjustment of the dosage level desirable should also have the dose of this medicine adapted individually.

Coronary heart disease

1 extended release tablet twice daily (corresponding to 20mg nifedipine daily).

If necessary a gradual increase of the daily dose is possible to 2 x 20mg (corresponding to 2 x 40mg (corresponding to 4 extended release tablets twice daily) nifedipine.

 

Hypertension

1 extended release tablet twice daily (corresponding to 20mg nifedipine daily).

If necessary a gradual increase of the daily dose is possible to 2 x 20mg (corresponding to 2 extended release tablets twice daily) up to 2 x 40mg (corresponding to 4 extended release tablets twice daily) nifedipine.

 

Children and adolescents

Nifedi-Denk 10 Retard is not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population.

 

Method of administration

This medicine should be swallowed whole, not chewed, with sufficient liquid (e.g. 1 glass of water, no grapefruit juice) after meals.

This medicine should be taken at the same time every morning and evening.

Due to the photosensitivity of the ingredient nifedipine, the extended-release tablets should not be divided, as otherwise the light shield provided by the lacquer is no longer guaranteed.

- if you are allergic to nifedipine or any of the other ingredients of this medicine

- if you have had a cardiogenic shock

- if you have aortic stenosis

- if you have unstable angina pectoris

- if you have had a heart attack within the last 4 weeks

- if you are taking rifampicin

- if you are pregnant (first 20 weeks of pregnancy)

- if you are breast-feeding.

Very common

Headaches, peripheral oedema (due to vaso-dilation).

Common

Dizziness, somnolence, feeling of weakness, palpitations, flushing, constipation, nausea, erythromelalgia (particularly at the commencement of treatment), sweating, erythema, malaise.

Uncommon

General allergic reactions, allergic reactions of the skin, such as pruritis, exanthema, swelling of the skin and mucosa (angioedema, facial oedema), including swelling of the larynx (laryngeal oedema), illness ranging from spasm of the bronchial musculature to life-threatening labored breathing. Anxiety, sleeping disorders, migraine, tremor, paraesthesia, hypoaesthesia, tiredness/drowsiness, nervousness, impaired vision, tachycardia, hypotension, syncopes, epistaxis, blocked nose, dyspnoea, gastrointestinal disorders, such as dyspepsia, tummy-ache, flatulence, dryness of mouth, diarrhoea, liver enzyme elevations, liver dysfunction (intrahepatic cholestasis, rise in transaminases), myalgia, muscle cramps, arthralgia, swollen joints, increased urgency of urination as well as increase daily urination, painful urge to urinate with difficulty in passing water, in cases of renal insufficiency, transient deterioration in renal function, erectile disorders, unspecific pain, shivering.

Particularly at the beginning of treatment there may be episodes of angina pectoris, and in patients already suffering from angina pectoris nifedipine may increase its frequency, duration and severity.

Rare

Changes in blood count, such as anaemia, leukopenia, thrombopenia, thrombocytopenic purpura, urticaria, hyperglycaemia, gingival hyperplasia, anorexia, sensation of fullness, burping, photo dermatitis, purpura, gynaecomastia, which is reversible after discontinuation of nifedipine.

Very rare

Agranulocytosis, myocardial infarction, exfoliative dermatitis.

Frequency not known

Anaphylactic/anaphylactoid reactions, asthenopia, vomiting, oesophagitis, toxic epidermal necrolysis.

Dialysis patients with high blood pressure and a low blood volume may experience a sudden drop in blood pressure.

Gum change, such as gingival hyperplasia, may occur during long-term therapy with nifedipine. These symptoms recede completely once the treatment has been discontinued.

Nifedipine is broken down with the help of a specific enzyme system (CYP3A4). For this reason, the simultaneous use of medicines that affect this enzyme system can result in interactions of these medicines with this medicine.

Both the extent and the duration of interactions should be considered when this medicine is taken together with the medicines listed below.

Enhancement of the effect and side effects of this medicine by other medicines

If you use the following other medicines at the same time as nifedipine, your blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose should be considered:

- certain antibiotics (e.g. erythromycin)

- certain anti-HIV medicines (e.g. ritonavir)

- certain medicines for fungal diseases (e.g. ketoconazole)

- nefazodone and fluoxetine

- quinupristin/dalfopristin (antibiotics)

- valproic acid

- cimetidine

- tricyclic

- tricyclic antidepressants

- vasodilators

- cisapride

Attenuation of the effect of this medicine by other medicines (see the package insert about the details.)

Rifampicin

Phenytoin

Carbamazepine and phenobarbital

How does this medicine influence the effect of other medicines?

This medicine can enhance the blood pressure-lowering effect of other medicines, such as:

- diuretics

- beta-receptor blockers

- ACE inhibitors

- angiotensin-1-receptor antagonists

- other calcium antagonists

- alpha-receptor blockers

- PDE-5 inhibitors

- alpha-methyldopa

Beta-receptor blockers (group of active substances of the family of blood pressure-lowering agents)

During simultaneous treatment with beta-receptor blockers, signs of heart failure can occur in isolated cases. In such cases your doctor will carefully monitor the course of treatment.

Digoxin

Theophylline

Vincristine

Cephalosporins

Quinidine

Tacrolimus

This medicine with food, drink and alcohol

See the package insert about the details.

Contraindicated.

See the package insert about the details.

The treatment with this medicine requires regular control by a physician:

- if you have low blood pressure (less than 90mmHg systolic)

- if you have decompensated cardiac insufficiency

- if you are a dialysis patient with very high blood pressure and a low blood volume since you might experience a sudden drug in blood pressure

- if you are pregnant

In patients with impaired liver function, the break-down of nifedipine can be delayed. The doctor will therefore carefully monitor the course of treatment and if necessary reduce the dose.