NIFEDIPIN T 20 Stada® retard

Active ingredient: Nifedipine

Composition:

Each modified-release tablet contains:

Pharmacologically active ingredient: Nifedipine 20mg

Other ingredients: Microcrystalline cellulose, lactose monohydrate, macrogol 6000, magnesium stearate, maize starch, hydroxypropyl methylcellulose, polysorbate 80, talcum dyestuffs E171 and E 172 Presentation and contents: Original pack of 100 modified-release tablets Nifedipin T 20 Stada® retard is a medicine for the treatment of coronary heart disease and high blood pressure (calcium antagonist)

Indications:

1. For the treatment of coronary heart disease (conditions characterized by inadequate oxygen supply to the heart muscle

-- Vasospastic angina pectoris ((Prinzmetalis angina, variant angina)

-- Chronic stable angina pectoris (effort angina)

2. For the treatment of essential hypertension (high blood pressure)

Contraindications:

When must you not use Nifedipin T 20 Stada® retard?

You must not use Nifedipin T 20 Stada® retard in cardiovascular shock, with narrowing of the aorta (higher-grade aortic stenosis), with known hypersensitivity to nifedipine, with unstable angina pectoris and acute myocardial infarction (within the first 4 weeks)

When should you use Nifedipin T 20 Stada® retard only after consulting your doctor?

With the following conditions Nifedipin T 20 Stada® retard should be used only with particular caution. Discuss with your doctor also if any of these conditions applied to you previously.

Your doctor will be monitoring you with particular care if you have extremely low blood pressure (severe hypotension with systolic blood pressure under 90mmHg) or existing (decompensated) heart muscle weakness.

What should you be aware of if you are pregnant or breast-feeding?

Nifedipin T 20 Stada® retard must not be used during the entire pregnancy because animal studies have produced evidence of teratogenic effects (malformations). No experience with use in humans is available.

Small amounts of nifedipine are excreted in breast milk. As nothing is known about possible effects on the infant, Nifedipin T 20 Stada® retard must not be used during lactation. You should therefore stop breast-feeding if treatment with Nifedipin T 20 Stada® retard should become necessary during lactation.

Precautions for use and warnings:

What precautions must be borne in mind?

In patients with essential (non-organ related) hypertension or chronic angina pectoris treated with regular or immediate release (short-acting dosage forms of nifedipine, there is evidence to suggest a dose-related increase in complications of the cardiovascular system (e.g. myocardial infarction) and increased mortality. Such preparations should therefore be used in these two conditions only if other drugs are not indicated.

The maximum dose is limited to 60mg.

Simultaneous users of drugs that enhance the effect of Nifedipin T 20 Stada® retard or whose effect is altered by Nifedipin T 20 Stada® retard (see "Interactions") or patients with impaired liver or kidney function should be particularly careful about seeing their doctor as scheduled.

There have been rare reports of elevated blood glucose concentrations in serum (hyperglycaemia). Diabetics should therefore ensure particularly careful blood glucose monitoring.

Dialysis patients with severe, life-threatening high blood pressure (malignant hypertension) and irreversible kidney failure with reduced plasma volume (hypovolaemia) may experience particularly great blood pressure reduction through widening of blood vessels (vasodilatation).

What should you bear in mind when driving, operating machinery or working without a firm support?

Treatment of high blood pressure with this medicine requires regular monitoring.

Due to individually different reactions, alertness may be altered to such an extent that the ability to actively participate in road traffic or to operate machines or to work without a firm support is impaired. This applies especially at the start of treatment, when increasing the dose and when switching medicines as well as in combination with alcohol.

Drug Interactions:

What medicines interfere with the effect of Nifedipin T 20 Stada® retard or are themselves influenced in their effect by Nifedipin T 20 Stada® retard?

The blood pressure-lowering effect of Nifedipin T 20 Stada® retard may be enhanced by other blood pressure- lowering drugs and by tricyclic antidepressants (see "Precautions').

Concurrent use of Nifedipin T 20 Stada® retard and beta-receptor blocking drugs (medicines for the treatment of high blood pressure and coronary heart disease) may produce increased blood pressure reduction (see "Precautions").

Development of heart muscle weakness has occasionally been observed.

Concurrent use of Nifedipin T 20 Stada® retard and cimetidine (drug for gastric and intestinal ulcers) may enhance the effect of nifedipine. The digoxin plasma concentration may be increased by Nifedipin T 20 Stada® retard.

Nifedipin T 20 Stada® retard may enhance the myocardial contractility-weakening (negative isotropic) effect of anti-arrhythmics (medicines for heart rhythm disturbances), such as amiodarone and quinidine.

Bear in mind that this information may also apply to recently used medicines.

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