Angitil SR/XL Capsules
- Revised
- 22/07/2025
- Source updated
- 29 Jul 2025
- MA number
- Angitil SR 90 mg Capsules: PL 06934/0195 Angitil SR 120 mg Capsules: PL 06934/0196 Angitil SR 180 mg Capsules: PL 06934/0197 Angitil XL 240 mg Capsules: PL 06934/0198 Angitil XL 300 mg Capsules: PL 06934/0199
- ATC
- C08DB01
- Legal status
- Prescription only medicine
Indications
Concepts (26)
+BreastfeedingContraindicated
block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Decompensated cardiac failure. • Lactation. • Concurrent use with dantrolene infusion (see section 4.5). • Combination with ivabradine (see section 4.5). • Concurrent use with lomitapide (see section 4.5). • Concurrent use with asunapr
Source SmPC ↗+Heart conditionsContraindicated
nus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Decompensated cardiac failure. • Lactation. • Concurrent use with dantrolene infusion (see section 4.5). • Combination with ivabradine (see section 4.5). • Concurrent use with lomitapide (see section 4.5). • Concurrent u
Source SmPC ↗+Taken with other medicinesContraindicated
ts without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Decompensated cardiac failure. • Lactation. • Concurrent use with dantrolene infusion (see section 4.5). • Combination with ivabradine (see section 4.5). • Concurrent use with lomitapide (see section 4.5). • Concurrent use with asunaprevir (see section 4.5).
Source SmPC ↗+Heart rhythm blockContraindicated
• Hypersensitivity to diltiazem or to any of the excipients listed in section 6.1. • Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Decompensated cardiac failure. • Lactation. • Concurrent use with dantrolene infu
Source SmPC ↗+Allergy to the medicineContraindicated
• Hypersensitivity to diltiazem or to any of the excipients listed in section 6.1. • Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary s
Source SmPC ↗+Breathing conditionsContraindicated
of the excipients listed in section 6.1. • Sick sinus syndrome, 2nd or 3rd degree AV block in patients without a functioning pacemaker. • Severe bradycardia (less than 50 beats per minute). • Left ventricular failure with pulmonary stasis. • Decompensated cardiac failure. • Lactation. • Concurrent use with dantrolene infusion (see section 4.5). • Combination with ivabradine (see section 4.5). • Concurrent use with lomitapide
Source SmPC ↗+Bleeding riskWarning
em in considered unsafe in patients with acute porphyria. Residues from slow-release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance. Caution should be exercised when direct oral anticoagulants (DOACs) are co-administered with Diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5). This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium-free'.
Source SmPC ↗+Older peopleWarning
have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vasc
Source SmPC ↗+Liver conditionsWarning
have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and close monitoring, particularly of heart rate, should be carried out at the beginning of treatment. In the case of general anaesthesia, the anaesthetist must be informed that the patient is taking diltiazem. The depression of cardiac contractility, conductivity and automaticity as well as the vasc
Source SmPC ↗+Low blood pressureWarning
entricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and
Source SmPC ↗+Sodium and potassium contentWarning
when direct oral anticoagulants (DOACs) are co-administered with Diltiazem which is a moderate CYP3A4 and a weak P-gp inhibitor, particularly in patients at high risk of bleeding (see section 4.5). This medicine contains less than 1 mmol sodium (23mg) per capsule, that is to say essentially 'sodium-free'.
Source SmPC ↗+BlockageWarning
es, including depression (see section 4.5 and 4.8). Early recognition of relevant symptoms is important, especially in predisposed patients. In such cases, drug discontinuation should be considered. Diltiazem has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing an intestinal obstruction. Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose. The use of diltiazem may induce bronchospasm, including asthma agg
Source SmPC ↗+PorphyriaWarning
ith preexisting bronchial hyper-reactivity. Cases have also been reported after dose increase. Patients should be monitored for signs and symptoms of respiratory impairment during diltiazem therapy. Diltiazem in considered unsafe in patients with acute porphyria. Residues from slow-release formulations of the product may pass into the patient's stools; however, this finding has no clinical relevance. Caution should be exercised when direct oral anticoagulan
Source SmPC ↗+Kidney conditionsWarning
entricular function, bradycardia (risk of exacerbation) or with a 1st degree AV block or prolonged PR interval detected on the electrocardiogram (risk of exacerbation and rarely, of complete block). Cases of acute renal failure secondary to decreased renal perfusion have been reported in patients with existing cardiac disease especially reduced left ventricular function, severe bradycardia or severe hypotension. Careful monitoring of renal function is advised. Increase of plasma concentrations of diltiazem may be observed in the elderly and patients with renal or hepatic insufficiency. The contraindications and precautions should be carefully observed and
Source SmPC ↗+UnclassifiedWarning
scontinuation should be considered. Diltiazem has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing an intestinal obstruction. Careful monitoring is necessary in patients with latent or manifest diabetes mellitus due to a possible increase in blood glucose. The use of diltiazem may induce bronchospasm, including asthma aggravation, especially in patients with preexisting bronchial hyper-reactivity. Cases have also been reported after dose increase. Pat
Source SmPC ↗+AlcoholInteraction
e potential for additive effects, caution and careful titration are necessary in patients receiving diltiazem concomitantly with other agents known to affect cardiac contractility and/or conduction. Angitil capsules should not be taken at the same time as alcohol. In vitro data suggests that in combination with Angitil capsules, alcohol may increase the rate of in vivo release of the product from the prolonged-release preparation. Alcohol may increase dose-dependent effects and lead to potential adverse pharmacodynamic interactions. Alcohol use could therefore increase the rate and seriousness of diltiazem adverse drug reactions such as vasodilatory related events.
Source SmPC ↗+Heart rhythm (QT interval)Interaction
(see section 4.8). Amiodarone, Digoxin Increased risk of bradycardia; caution is required when these are combined with diltiazem, particularly in elderly subjects and when high doses are used. Antiarrhythmic agents Since diltiazem has antiarrhythmic properties, its concomitant prescription with other antiarrhythmic agents is not recommended due to the risk of increased cardiac adverse effects due to an additi
Source SmPC ↗+PregnancyPregnancy
Pregnancy There is very limited data from the use of diltiazem in pregnant patients. Diltiazem has been shown to have reproductive toxicity (see section 5.3) in certain animal species (rat, mice, rabbit). Di
Source SmPC ↗+Propylene glycolExcipient
ed iron oxide (E172) - (120 mg and 180 mg only) Yellow iron oxide (E172) - (120 mg, 180 mg and 300 mg only) Black iron oxide (E172) - (180 mg only) Indigotine (E132) - (120 mg only) Black Ink: Shellac, propylene glycol, ammonium hydroxide, potassium hydroxide, E172 black iron oxide.
Source SmPC ↗+Azo colourantsNot in scanned sections
+Intolerance to an ingredientNot in scanned sections
+Stomach and gutNot in scanned sections
+LactoseNot in scanned sections
+ChildrenNot in scanned sections
+ShockNot in scanned sections
+Gap needed after another medicineNot in scanned sections
Storage and shelf life
§6.3 — Shelf life
36 months
§6.4 — Special precautions for storage
The capsules should be stored in their original packaging. Do not store above 30°C.