Posology : מינונים

4.2     Posology and method of administration
Posology

Adults:
Dosage must be adjusted according to each patient's needs. Therapy for either hypertension or angina should be initiated with 30 or 60 mg once daily.
Nifedilong Prolonged Release tablets should be swallowed whole and should not be bitten or divided. In general, titration should proceed over at 7-14 day period so that the physician can fully assess the response to each dose level and monitor blood pressure before proceeding to higher doses. Since steady- state plasma levels are achieved on the second day of dosing, if symptoms so warrant, titration may proceed more rapidly provided the patient is assessed frequently. Titration to doses above 120 mg are not recommended.


A Switch over from Nifedipine capsules to Nifedilong
Angina patients controlled on Nifedipine capsules alone or in combination with other antianginal medications may be safely switched to Nifedilong Prolonged Release tablets at the nearest, equivalent total daily dose (e.g. 1 Nifedipine capsule of 10 mg t.i.d. up to q.i.d. may be changed to 30 mg once daily of Nifedilong Prolonged Release tablet). Subsequent titration to higher doses may be necessary and should be initiated as clinically warranted. Experience with doses greater than 90 mg in patients with angina is limited. Therefore, doses greater than 90 mg should be used with caution and only when clinically warranted.
No "rebound effect" has been observed upon discontinuation of Nifedilong Prolonged Release tablets. However, if discontinuation of nifedipine is necessary the dosage should be decreased gradually with close physician supervision.


Switch over from Nifedipine tablets to Nifedilong
Patients controlled on Nifedipine tablets may be safely switched to Nifedilong Prolonged Release tablets at the nearest equivalent total daily dose (e.g., 1 Nifedipine tablet of 10 mg t.i.d. or 20 mg b.i.d. may be changed to 30 mg once daily of Nifedilong Prolonged Release tablet).


Co-administration with other Anti-anginal drugs
Sublingual nitroglycerin may be taken as required for the control of acute manifestations of angina, particularly during nifedipine titration. See Special Warnings and special Precautions, Interactions with other medicinal products, for information on co-administration of nifedipine with beta blockers or long acting nitrates.
As a rule, Nifedilong Prolonged Release tablets should be swallowed whole with a little water independently of mealtimes. Under no circumstances should they be chewed or broken up.
The medication is formulated in such way that it releases the active substance in the intestine with a practically constant rate over a 16 to 18 hour time period.
Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt the nifedipine dose or not to use nifedipine at all (see section 4.5).


Duration of treatment

The attending doctor will determine the duration of use.
Additional information on special populations
      Paediatric population
The safety and efficacy of Nifedilong in children below 18 years has not been established. Currently available data for the use of nifedipine in hypertension are described in section 5.1
Elderly
Based on pharmacokinetic data for Nifedilong no dose adaptation in elderly people above 65 years is necessary.
Renal impairment
Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment (see section 5.2).


Method of administration
Oral use.
The tablets should be swallowed whole with a glass of water, either with or without food. The tablets should be taken at approximately 24-hour intervals, i.e., at the same time each day, preferably during the morning. Nifedilong tablets must be swallowed whole; under no circumstances should they be bitten, chewed or broken up.
Nifedilong should not be taken with grapefruit juice (see section 4.5).