Farmalat ER Special Precautions

Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less then 90 mm Hg), In case of manifest heart failure and in the case of severe aortic stenosis.
There are not safety and efficacy data from studies in pregnant women.
The available information is inadequate to rule out adverse drug effects on the unborn and newborn child. Therefore any use in pregnancy after week 20 requires a very careful individual risk benefit assessment and should only be considered if all other treatment options are either not indicated or have failed to be efficacious. Careful monitoring of blood pressure must be exercised, also when administered nifedipine with i.v magnesium sulfate, owing to the possibility of an excessive fall in blood pressure which could harm both mother and fetus. As with other non-deformable material care should be used when administering Farmalat ER in patients with pre-existing severe gastrointestinal narrowing because obstructive symptoms may occur. Bezoars can occur in very rare cases and may require surgical intervention. In single cases obstructive symptoms have been described without known history of gastrointestinal disorders.
When doing barium contrast X-ray Farmalat ER may cause false positive effects (e.g. filling defects interpreted as polyp). In patients with mild, moderate impaired liver function careful monitoring and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment. Therefore, nifedipine should be used with caution in patients with severe hepatic impairment. In the presence of coronary spasms (Prinzmetal angina, angina at rest) and particularly severe forms of coronary heart diseases or in the case of impending anginal attack or acute hypertension crisis which all require onset on effect, Farmalat ER which marked by rapid action should be taken. Farmalat ER should be used in with caution in patients whose cardiac reserve is poor.
Effect on Ability to Drive and Use Machines: Reactions to the drug, which vary in intensity from individual to individual, can impair the ability to drive or to operate machinery. This applies particularly at the start of the treatment, on changing the medication and in combination with alcohol.