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Dosage and administration, duration of therapy:

The instructions given below apply unless your doctor has prescribed Nifedipin T 20 Stada retard otherwise for you. Please comply with the dosing instructions for effective and safe Nifedipin T 20 Stada retard therapy.

 

Treatment should be individualised to reflect disease severity and patient responsiveness.

 

Dependent on the respective clinical picture, stabilization with reference to the final dose should be made slowly. Patients with limited liver function should be carefully controlled; in some cases, a reduction of dose may be necessary.

 

The following dosage is recommended for adults:

1. Coronary heart disease

– Vasospastic angina pectoris ((Prinzmetalis angina, variant angina): 1 Nifedipin T 20 Stada retard modified-release tablet twice daily (equivalent to 20mg of nifedipine twice daily)

– Chronic stable angina pectoris (effort angina): 1 Nifedipin T 20 Stada retard modified-release tablet twice daily (equivalent to 20mg of nifedipine twice daily)

The recommended dosage is 1 modified-release tablet twice daily (equivalent to 20mg of nifedipine twice daily), but it can be increased to 2 Nifedipin T 20 Stada retard modified-release tablets twice daily (equivalent to 40mg of nifedipine twice daily).

 

2. Essential hypertension (high blood pressure)

1 Nifedipin T 20 Stada retard modified-release tablet twice daily (equivalent to 20mg of nifedipine twice daily)

The recommended dosage is 1 modified-release tablet twice daily (equivalent to 20mg of nifedipine twice daily), but it can be increased to 2 Nifedipin T 20 Stada retard modified-release tablets twice daily (equivalent to 40mg of nifedipine twice daily).

 

How and when should you take Nifedipin T 20 Stada retard?

Nifedipin T 20 Stada retard modified-release tablets are usually swallowed whole after meals with a sufficient amount of liquid (about a glass of water). Concurrent food intake will delay absorption. There should be an interval of at least 4 hours between any two recommended doses of 20mg.

 

For how long should you take Nifedipin T 20 Stada retard?

The duration of therapy will be decided by the treating doctor.

 

Overdosage and other violations of dosing schedule:

What should you do in the event of a (deliberate or inadvertent) Nifedipin T 20 Stada retard overdose?

Overdosage or poisoning with Nifedipin T 20 Stada retard may produce severe blood pressure fall, clouding of consciousness to the point of loss of consciousness, heart rhythm disturbances and breathlessness. Should this happen, see a doctor without delay.

 

What should you do if you took less than the prescribed dose of Nifedipin T 20 Stada retard or missed a dose?

Continue treatment at the dosage prescribed by your doctor. In no event must you take a double dose next time to make up for the missed dose.

 

What should you know if you intend to interrupt or stop treatment prematurely?

Nifedipin T 20 Stada retard – especially when used in high doses – should be tapered off gradually to avoid an increase in anginal attacks.

 

You should therefore inform your doctor if you wish to interrupt or stop treatment prematurely.

 

Side Effects

What adverse reactions could you experience while using Nifedipin T 20 Stada retard?

You may experience headache, reddening of the face (flushing) and sensation of heat.

 

There have been occasional reports of skin reactions, tingling sensations in the arms and legs (paraesthesias), dizziness and fatigue, and of nausea, constipation and diarrhoea.

 

There have also been occasional reports of blood pressure reduction below normal (hypotensive circulatory response), palpitations and a rise in pulse rate (tachycardia) as well as leg oedemas (fluid accumulation in the lower legs) due to widening of blood vessels.

 

There have been reports of blood formation changes, such as anaemia, leucopoenia, thrombocytopenia and thrombocytopenic purpura, being associated with Nifedipin T 20 Stada retard therapy.

 

Prolonged treatment has, on extremely rare occasions, been associated with gum alterations (gingival hyperplasia), which resolved completely upon discontinuation. There have been isolated reports of impaired liver function (intrahepatic cholestasis, transaminase elevations) and allergic hepatitis.

 

There have been very rare reports of elevated blood glucose concentrations in serum (hyperglycaemia). This should be borne in mind in patients with diabetes mellitus in particular.

 

There have been isolated reports of breast enlargement in men (gynaecomastia), resolving upon discontinuation of the drug in all cases so far.

 

Abrupt withdrawal of Nifedipin T 20 Stada retard in patients with high blood pressure (hypertension) or coronary heart disease may precipitate a hypertensive crisis or reduce the blood flow to the heart muscle (myocardial ischaemia) as a consequence of what is known as 'rebound'.

 

Especially at the start of therapy, patients may occasionally experience anginal attacks or patients with pre- existing angina pectoris may occasionally experience an increase in the frequency, duration and severity of anginal attacks. There have been isolated reports of myocardial infarction. Notify your doctor if you should experience any of these symptoms.

 

Caution must be exercised in dialysis patients with severe high blood pressure (malignant hypertension) and irreversible kidney failure with reduced circulating blood volume (hypovolaemia) because they may experience a significant blood pressure fall through widening of blood vessels (vasodilatation).

 

Should you experience any adverse effects, be sure to inform your doctor or pharmacist.

 

Shelf life and storage instructions

The expiry date of this medicinal product is printed on the box and blister foil. Do not use this medicinal product after this expiry date.

Do not store above 25°C.

Keep dry and protect from light.

Keep all medicines away from reach of children.

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