ADALAT® XL 30| Body as a whole: | Asthenia, edema, headache |
| Cardiovascular system: | Peripheral edema, palpitation, vasodilatation |
| Digestive system: | Constipation |
| Nervous system: | Dizziness |
| Body as a whole: | Abdominal pain, chest pain, leg pain, malaise, pain |
| Cardiovascular system: | Hypotension, postural hypotension, syncope, tachycardia |
| Digestive system: | Diarrhea, dry mouth, dyspepsia, flatulence, nausea |
| Musculo-skeletal system: |
Leg cramps |
| Nervous system: | Insomnia, nervousness, paresthesia, somnolence, vertigo |
| Respiratory system: | Dyspnea |
| Skin and appendages: | Pruritus, rash |
| Urogenital system: | Nocturia, polyuria |
| Body as a whole: | Allergic reaction, chest pain substernal, chills, face edema, fever |
| Cardiovascular system: | Angina pectoris (excl. unstable), cardiovascular disorder |
| Digestive system: | Anorexia, eructation, gastrointestinal disorder, gingivitis, gum hyperplasia, GGT increased, liver function test abnormal, vomiting |
| Musculo-skeletal system: |
Arthralgia, joint disorder, myalgia |
| Nervous system: | Hypesthesia, sleep disorder, tremor |
| Respiratory system: | Epistaxis |
| Skin and appendages: | Angioedema, macupopular rash, pustular rash, sweating, urticaria, vesiculobullous rash |
| Special senses: | Abnormal vision, eye disorder, eye pain |
| Urogenital system: | Dysuria, urinary frequency |
| Body as a whole: | Anaphylactic reaction |
| Digestive system: | Bezoar, dysphagia, esophagitis, gum disorder, intestinal obstruction, intestinal ulcer, jaundice, SGPT increased |
| Hemic and lymphatic system: | Leucopenia, purpura |
| Metabolic and nutritional disorder: |
Hyperglycemia, weight loss |
| Musculo-skeletal system: | Muscle cramps |
| Skin and appendages: | Exfoliative dermatitis, gynecomastia, and photosensitive dermatitis |
| Special senses: | Blurred vision |
| - | The blood-pressure lowering effect of nifedipine may be potentiated upon co-administration of other antihypertensive drugs. |
| - | When nifedipine is administered simultaneously with beta-receptor blockers the patient should be carefully monitored, since fairly severe hypotension can occur. Deterioration of heart failure is also known to develop in isolated cases. |
| - | Nifedipine 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 oral administration) or the clearance of nifedipine. |
| - | Digoxin The simultaneous administration of nifedipine and digoxin may lead to reduced digoxin clearance and hence an increase in plasma concentrations of digoxin. The patient should therefore be checked for symptoms of digoxin overdosage as a precaution and, if necessary, the glycoside dose should be reduced taking account of the plasma concentration of digoxin. |
| - | Phenytoin Phenytoin induces the cytochrome P450 3A4 system. Upon co-administration with phenytoin, the bioavailability of nifedipine is reduced and thus its efficacy weakened. When both drugs are concomitantly administered, the clinical response to nifedipine should be monitored and, if necessary, an increase of the nifedipine dose considered. If the dose of nifedipine is increased during co-administration of both drugs, a reduction of the nifedipine dose should be considered when the treatment with phenytoin is discontinued. |
| - | Quinidine When nifedipine and quinidine have been administered simultaneously, lowered quinidine or, after discontinuation of nifedipine, a distinct increase in plasma concentrations of quinidine has been observed in individual cases. For this reason, when nifedipine is either additionally administered or discontinued, monitoring of the quinidine plasma concentration and, if necessary, adjustment of the quinidine dose is recommended. Some authors reported increased plasma concentrations of nifedipine upon co-administration of both drugs, while others did not observe an alteration in the pharmacokinetics of nifedipine. Therefore, the blood pressure should be carefully monitored if quinidine is added to an existing therapy with nifedipine. If necessary, the dose of nifedipine should be decreased. |
| - | Quinupristin/Dalfopristin Simultaneous administration of quinupristin/dalfopristin and nifedipine may lead to increased plasma concentrations of nifedipine. Upon co-administration of both drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose considered |
| - | Cimetidine Due to its inhibition of cytochrome P450 3A4, cimetidine elevates the plasmaconcentrations of nifedipine and may potentiate the antihypertensive effect. |
| - | Rifampicin Rifampicin strongly induces the cytochrome P450 3A4 system. Upon co-administration with rifampicin, the bioavailability of nifedipine is distinctly reduced and thus its efficacy weakened. The use of nifedipine in combination with rifampicin is therefore contra-indicated. |
| - | Diltiazem Diltiazem decreases the clearance of nifedipine. Nifedipine increases the bioavailability and decreases the clearance of diltiazem. The combination of both drugs should be administered with caution and a reduction of both doses may be considered. |
| - | Grapefruit Juice Grapefruit juice inhibits the metabolism of nifedipine. Administration of nifedipine together with grapefruit juice thus results in elevated plasma concentrations of nifedipine due to an increase of drug bioavailability. As a consequence, the blood pressure lowering effect may be increased. |
| - | Cisapride Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine. Upon co-administration of both drugs, the blood pressure should be monitored and, if necessary, a reduction of the nifedipine dose considered. |
| - | Erythromycin Erythromycin is known to inhibit the cytochrome P450 3A4 mediated metabolism of other drugs. Therefore the potential for an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. |
| - | Fluoxetine Fluoxetine has been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. Therefore an increase of nifedipine plasma concentrations upon co-administration of both drugs cannot be excluded. When fluoxetine is given together with nifedipine, the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered. |
| - | Indinavir, Ritonavir, Saquinavir Drugs of this class are known to inhibit the cytochrome P450 3A4 system. In addition, indinavir and ritonavir have been shown to inhibit in vitro the cytochrome P450 3A4 mediated metabolism of nifedipine. When administered together with nifedipine, a substantial increase in plasma concentrations of nifedipine due to an increased absorption and decreased elimination cannot be excluded. Upon co-administration, the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered. |
| - | Ketoconazole, Itraconazole, Fluconazole Drugs of this class are known to inhibit the cytochrome P450 3A4 system. When administered orally together with nifedipine, a substantial increase in systemic bioavailability of nifedipine due to an increased absorption cannot be excluded. Upon co-administration, the blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered. |
| - | Tacrolimus Tacrolimus has been shown to be metabolised via the cytochrome P450 3A4 system. Upon co-administration of tacrolimus and nifedipine, the tacrolimus plasma concentrations should be monitored and, if necessary, a reduction in the tacrolimus dose considered. |
| - | Carbamazepine As carbamazepine has been shown to reduce the plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme induction, a decrease in nifedipine plasma concentrations and hence a decrease in efficacy cannot be excluded. |
| - | Phenobarbitone As phenobarbitone has been shown to reduce the plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme induction, a decrease in nifedipine plasma concentrations and hence a decrease in efficacy cannot be excluded. |
| - | Valproic acid As valproic acid has been shown to increase the plasma concentrations of the structurally similar calcium channel blocker nimodipine due to enzyme inhibition, an increase in nifedipine plasma concentrations and hence an increase in efficacy cannot be excluded. |
| - | Concomitant administration of nifedipine and pantoprazole does not significantly affect the pharmacokinetics of nifedipine. |
| - | Ranitidine co-administered with nifedipine does not significantly influence the pharmacokinetics of nifedipine. |
| - | Nifedipine may cause falsely increased spectrophotometric values of urinary vanillyl-mandelic acid. However, measurement with HPLC is unaffected. |
| ADALAT XL 30: | Y/7.1/314 |
| ADALAT XL 60: | Y/7.1/315 |