Adalat Retard 20 Mg Modified-release Tablets - Summary of Product Characteristics (SmPC) - (EMC)

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  Adalat retard 20 mg modified-release tablets Bayer plc contact details Active ingredient nifedipine Legal Category POM: Prescription only medicine SmPC (/emc/product/2227/smpc) Show table of contents This information is intended for use by health professionals 1. Name of the medicinal product  Adalat retard 20 mg modified-release tablets 2. Qualitative and quantitative composition Each modified-release tablet contains 20 mg nifedipine.Excipient with known effect: Lactose monohydrateFor the full list of excipients, see section 6.1. 3. Pharmaceutical form Modified-release tablets.Grey-pink, round, modified-release tablets marked with 1U on one side and a Bayer cross on the reverse. 4. Clinical particulars 4.1 Therapeutic indications For the prophylaxis of chronic stable angina pectoris and the treatment of hypertension. 4.2 Posology and method of administration  The recommended starting dose of Adalat retard is 10 mg every 12 hours swallowed with water with subsequenttitration of dosage according to response. Adalat retard tablets permit titration of the initial dosage, which may beadjusted to 40 mg every 12 hours, to a maximum daily dose of 80 mg.Co-administration with CYP 3A4 inhibitors or CYP 3A4 inducers may result in the recommendation to adapt thenifedipine dose or not to use nifedipine at all (see section 4.5). Duration of treatment  Treatment may be continued indefinitely.  Additional information on special populationsPaediatric population The safety and efficacy of Adalat retard in children below 18 years of age has not been established. Currently availabledata for the use of nifedipine in hypertension are described in section 5.1 Older people (>65 years) The pharmacokinetics of Adalat retard are altered in the older people so that lower maintenance doses of nifedipinemay be required Patients with hepatic impairment  Nifedipine is metabolised primarily by the liver and therefore patients with mild, moderate or severe liver dysfunctionshould be carefully monitored and a dose reduction may be necessary. The pharmacokinetics of nifedipine has not beeninvestigated in patients with severe hepatic impairment (see section 4.4 and 5.2). Patients with renal impairment  Based on pharmacokinetic data, no dosage adjustment is required in patients with renal impairment (see section 5.2).Method of administrationOral use. As a rule, tablets are swallowed whole with a little liquid, either with or without food. Adalat retard should not be taken with grapefruit juice (see section 4.5). 4.3 Contraindications  Adalat retard must not be administered to patients with known hypersensitivity to the active substance, or to other dihydropyridines because of the theoretical risk of cross-reactivity, or to any of the excipients listed in section 4.4 and6.1. Adalat retard must not be used in cases of cardiogenic shock, clinically significant aortic stenosis, unstable angina, or during or within 4 weeks of a myocardial infarction. Adalat retard should not be used for the treatment of acute attacks of angina.The safety of Adalat retard in malignant hypertension has not been established. Adalat retard should not be used for secondary prevention of myocardial infarction. Adalat retard should not be administered concomitantly with rifampicin since effective plasma levels of nifedipine maynot be achieved owing to enzyme induction (see section 4.5). 4.4 Special warnings and precautions for use   Adalat retard is not a beta-blocker and therefore gives no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be a gradual reduction of the dose of beta-blocker preferably over 8 - 10 days. Adalat retard may be used in combination with beta-blocking drugs and other antihypertensive agents but the possibilityof an additive effect resulting in postural hypotension should be borne in mind. Adalat retard will not prevent possiblerebound effects after cessation of other antihypertensive therapy.Care must be exercised in patients with very low blood pressure (severe hypotension with systolic pressure less than 90mm Hg). Adalat retard should not be used during pregnancy unless the clinical condition of the woman requires treatment withnifedipine. Adalat retard should be reserved for women with severe hypertension who are unresponsive to standardtherapy (see section 4.6).Careful monitoring of blood pressure must be exercised when administering nifedipine with I.V. magnesium sulfate,owing to the possibility of an excessive fall in blood pressure, which could harm both mother and foetus. For further information regarding use in pregnancy, refer to section 4.6. Adalat retard is not recommended for use during breast-feeding because nifedipine has been reported to be excreted inhuman milk and the effects of nifedipine exposure to the infant are not known (see section 4.6).In patients with mild, moderate or severe impaired liver function, careful monitoring and a dose reduction may benecessary. The pharmacokinetics of nifedipine has not been investigated in patients with severe hepatic impairment(see section 4.2 and 5.2). Therefore, nifedipine should be used with caution in patients with severe hepatic impairment. Adalat retard should be used with caution in patients whose cardiac reserve is poor. Deterioration of heart failure hasoccasionally been observed with nifedipine.The use of Adalat retard in diabetic patients may require adjustment of their control.In dialysis patients with malignant hypertension and hypovolaemia, a marked decrease in blood pressure can occur.Nifedipine is metabolised via the cytochrome P450 3A4 system. Drugs that are known to either inhibit or to induce thisenzyme system may therefore alter the first pass or the clearance of nifedipine (see section 4.5).Drugs that are known inhibitors of the cytochrome P450 3A4 system, and which may therefore lead to increased plasmaconcentrations of nifedipine include, for example:- macrolide antibiotics (e.g., erythromycin)- anti-HIV protease inhibitors (e.g., ritonavir)- azole antimycotics (e.g., ketoconazole)- the antidepressants, nefazodone and fluoxetine- quinupristin/dalfopristin- valproic acid- cimetidineUpon co-administration with these drugs, the blood pressure should be monitored and, if necessary, a reduction of thenifedipine dose should be considered (see section 4.5).Since this medicinal product contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapplactase deficiency or glucose-galactose malabsorption should not take this medicine.For use in special populations see section 4.2.  . Drugs that affect nifedipineNifedipine is metabolised via the cytochrome P450 3A4 system, located both in the intestinal mucosa and in the liver.Drugs that are known to either inhibit or to induce this enzyme system may therefore alter the first pass (after oraladministration) or the clearance of nifedipine (see Section 4.4).The extent as well as the duration of interactions should be taken into account when administering nifedipine together with the following drugs: Rifampicin: Rifampicin strongly induces the cytochrome P450 3A4 system. Upon co-administration with rifampicin, thebioavailability of nifedipine is distinctly reduced and thus its efficacy weakened. The use of nifedipine in combinationwith rifampicin is therefore contraindicated (see Section 4.3).Upon co-administration of known inhibitors of the cytochrome P450 3A4 system, the blood pressure should bemonitored and, if necessary, a reduction in the nifedipine dose considered (see Sections 4.2 and 4.4). In the majority of these cases, no formal studies to assess the potential for a drug interaction between nifedipine and the drug(s) listedhave been undertaken, thus far.Drugs increasing nifedipine exposure:ã macrolide antibiotics (e.g., erythromycin) ã anti-HIV protease inhibitors (e.g., ritonavir) ã azole anti-mycotics (e.g., ketoconazole) ã fluoxetine ã nefazodone ã quinupristin/dalfopristin ã cisapride ã valproic acid  ã cimetidine ã diltiazem Upon co-administration of inducers of the cytochrome P450 3A4 system, the clinical response to nifedipine should bemonitored and, if necessary, an increase in the nifedipine dose considered. If the dose of nifedipine is increased duringco-administration of both drugs, a reduction of the nifedipine dose should be considered when the treatment isdiscontinued.Drugs decreasing nifedipine exposure:ã rifampicin (see above) ã  phenytoin ã carbamazepine ã  phenobarbital  Effects of nifedipine on other drugsNifedipine may increase the blood pressure lowering effect of concomitant applied antihypertensives.When nifedipine is administered simultaneously with beta-receptor blockers the patient should be carefully monitored,since deterioration of heart failure is also known to develop in isolated cases.
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