Angiodrox 120 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Angiodrox 120 mg prolonged-release hard capsules

diltiazem

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Angiodrox 120 mg capsules are and what they are used for

2. What you need to know before taking Angiodrox 120 mg capsules

3. How to take Angiodrox 120 mg capsules

4. Possible side effects

5. How to store Angiodrox 120 mg capsules

6. Contents of the pack and other information

1. What Angiodrox 120 mg capsules is and what it is used for

Angiodrox 120 mg capsules, whose active substance is diltiazem, belongs to a group of medicines called calcium antagonists. Angiodrox is used for the treatment and prevention of angina pectoris, as it widens (dilates) the arteries of the heart, increasing blood flow.

2. What you need to know before starting to take Angiodrox 120 mg capsules

Do not take Angiodrox 120 mg capsules:

• if you have certain heart diseases such as various types of arrhythmia (irregular heartbeat due to sinus node syndrome or second- or third-degree atrioventricular block, unless you have a pacemaker)
• if you have a very slow pulse, below 40 beats per minute
• if you have left ventricular failure (when the left ventricle does not completely pump oxygenated blood to the rest of the body), with fluid accumulation in the lungs
• if you have congestive heart failure with pulmonary edema (the heart's inability to pump sufficient blood to the rest of the body and fluid accumulation)
• if you are allergic (hypersensitive) to diltiazem or to any of the other components of Angiodrox listed in section 6
• if you are simultaneously receiving an intravenous infusion of dantrolene (a medication used to relax muscles)
• if you have hypotension (low blood pressure)
• if you have acute myocardial infarction complicated by very slow pulse, severe hypotension, and left ventricular failure
• if you are pregnant, planning to become pregnant, or intend to breastfeed
• if you are taking a medication containing ivabradine for the treatment of certain heart conditions.
• If you are already taking a medication containing lomitapide used to treat high cholesterol levels (see section “Other medicines and Angiodrox 120 mg capsules”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angiodrox 120 mg capsules.

If you have a history of heart failure, new onset breathing difficulty, slow heart rate, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions; your doctor may need to monitor your renal function.

Since therapeutic effects have not been compared between different diltiazem formulations with immediate or modified (retard) release, depending on whether they are rapidly absorbed or not in the gastrointestinal tract, substitution of one formulation for another is not recommended unless specifically advised by the prescribing physician.

Close observation is required in patients with cardiac problems.

If you are diabetic, you may require adjustment of your current treatment.

If you have liver or kidney disease or are elderly, your doctor will carefully monitor you for any changes, especially in your heart rate (beats per minute).

Calcium channel blockers such as Angiodrox may be associated with mood changes, including depression.

Angiodrox has an inhibitory effect on intestinal motility. Therefore, it should be used with caution in patients at risk of developing intestinal obstruction. Residues from slow-release tablets may pass into the patient's feces; however, this has no clinical significance.

If you suffer from acute porphyria, it is not safe to take Angiodrox.

The use of Angiodrox in chronic stable angina should be limited to patients who do not tolerate adequate doses or are refractory to treatment with beta-blockers and/or oral nitrates.

If you have cardiac arrhythmias (sinoatrial node disease, atrioventricular block) or are receiving treatment with other medications used to treat heart conditions (beta-blockers, digitalis), because using diltiazem in these situations may lead to excessively slow heart rate and rhythm (bradycardia).

If you have hypotension (low blood pressure): treatment with diltiazem may cause an excessive drop in blood pressure. Your doctor will advise you on how to avoid symptoms resulting from hypotension and what measures to take if such symptoms occur.

Rarely, Angiodrox may cause liver damage, which is reversible upon discontinuation of treatment.

If you are scheduled for any surgical procedure requiring general anesthesia, you must inform your doctor and anesthesiologist that you are taking Angiodrox.

If you have liver or kidney disease, Angiodrox should be used with caution.

The use of diltiazem has been associated with skin reactions. Your doctor will evaluate these symptoms and advise you on appropriate measures.

Other medicines and Angiodrox 120 mg capsules

Inform your doctor or pharmacist if you are currently using or have recently used any other medicines, including those obtained without a prescription.

Contraindicated combinations with other medicines:

The combination of diltiazem and intravenous dantrolene (a muscle relaxant) is potentially dangerous.

Combinations requiring caution:

Lithium (used to treat certain mental illnesses): increased risk of lithium-induced neurotoxicity.

Nitrate derivatives (used to treat hypertension): increased hypotensive effects (excessive drop in blood pressure) and fainting. In all patients treated with Angiodrox, nitrate derivatives should only be prescribed in gradually increasing doses.

Theophylline (used to treat asthma): increased blood levels of theophylline.

Alpha-antagonists (used to treat hypertension): may cause or worsen hypotension. The combination of diltiazem with an alpha-antagonist should only be considered with strict blood pressure monitoring.

Amiodarone (used to reduce heart rate), digoxin (used to treat heart conditions): increased risk of bradycardia (reduced heart rate). Caution is required when combining these drugs with diltiazem, particularly in elderly patients and when high doses are used.

Beta-blockers (used to treat hypertension): possible cardiac disturbances.

Other antiarrhythmic agents (used to prevent or suppress cardiac rhythm disturbances): since diltiazem has antiarrhythmic properties, concomitant prescription with other antiarrhythmic agents is not recommended.

Carbamazepine (used to treat epilepsy): increased blood levels of carbamazepine.

Rifampicin (antibiotic): risk of decreased blood levels of diltiazem after starting treatment with rifampicin.

Agents used to reduce stomach acid production (cimetidine, ranitidine): increased blood concentrations of diltiazem.

Cyclosporine (used to suppress the immune system): increased blood levels of cyclosporine.

In particular, do not take this medicine and inform your doctor if you are taking:

Medications containing lomitapide used to treat high cholesterol levels.

Diltiazem may increase lomitapide concentration, which could lead to an increased likelihood and severity of liver-related side effects.

Concomitant use of Angiodrox with other drugs should be under medical supervision with gradual dose adjustments.

General information to be aware of:

Due to the possibility of additive effects, caution and careful evaluation are required in patients receiving Angiodrox simultaneously with other agents known to affect the heart.

Angiodrox is metabolized in the liver by the CYP3A4 isoenzyme but also inhibits it. Other drugs share similar or opposing metabolic pathways, and interactions may occur leading to increased blood concentrations of one or both drugs, depending on whether they inhibit or induce this liver enzyme.

Benzodiazepines (midazolam, triazolam used to treat anxiety): diltiazem increases blood concentrations of midazolam and triazolam.

Corticosteroids (methylprednisolone, used to treat inflammatory conditions): diltiazem may increase blood concentrations of methylprednisolone, and dose adjustment of methylprednisolone may be necessary.

Statins (medications to lower blood cholesterol levels): diltiazem increases blood concentrations of certain statins. There is a risk of myopathy (muscle disorder) and rhabdomyolysis (muscle necrosis with complications such as renal failure) with concomitant use of diltiazem and certain statins.

Taking Angiodrox 120 mg capsules with food and drink

Take this medicine preferably before meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not take Angiodrox if you are pregnant or planning to become pregnant. Women of childbearing potential should use an effective contraceptive method. If you become pregnant while taking Angiodrox, stop taking the medicine immediately and consult your doctor.

Angiodrox is excreted in breast milk; therefore, you should not breastfeed while being treated with Angiodrox. If the use of Angiodrox is considered essential, an alternative method of infant feeding should be used.

Driving and using machines

Based on reported adverse reactions such as dizziness (common), general malaise (common), the ability to drive and operate machinery may be impaired. Therefore, it is advisable not to perform tasks requiring special attention (driving vehicles, operating dangerous machinery, etc.) until your response to the medicine is satisfactory.

Important information about some of the ingredients of Angiodrox 120 mg capsules

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Angiodrox 120 mg capsules

Follow exactly the administration instructions for Angiodrox given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Angiodrox is administered orally. For initial treatment, lower-dose Angiodrox capsules should be used. Your doctor may gradually increase your dose depending on your response to treatment. Your doctor will tell you how many capsules you should take each day.

Adults:

The dose is 1 capsule every 12 hours. Your doctor will gradually increase the dose until the optimal response is achieved. The maximum dose is 480 mg/day.

Elderly patients, renal or hepatic impairment: Initial dose adjustment should be performed with caution.

All dose modifications and monitoring must be carried out under medical supervision.

Instructions for correct administration

Swallow the capsules whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). Angiodrox should preferably be taken before meals.

Take Angiodrox every day and at approximately the same time each day. Taking the capsules at the same time daily will provide better control of your blood pressure and will help you remember when to take them.

Follow these instructions unless your doctor has given you different advice. Remember to take your medicine.

Your doctor will tell you how long your treatment with Angiodrox should last. Do not stop treatment prematurely, as this may be harmful to your health.

If you feel that the effect of Angiodrox is too strong or too weak, consult your doctor or pharmacist.

If you take more Angiodrox 120 mg capsules than you should

If you take more tablets than prescribed, inform your doctor or go immediately to the nearest hospital emergency department. Take the medicine packaging with you so the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeat, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Angiodrox 120 mg capsules

Do not take a double dose to make up for forgotten doses. It is important to take Angiodrox regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for your next dose, do not take the missed capsule.

If you stop taking Angiodrox 120 mg capsules

If you interrupt treatment with Angiodrox, your condition may worsen, with symptoms such as chest pain or tightness, or a sudden increase in blood pressure. Do not stop treatment with Angiodrox without first consulting your doctor.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Angiodrox may produce adverse effects, although not everyone experiences them. The adverse effects of diltiazem vary in intensity from patient to patient and should be especially considered at the beginning of treatment or when changing medication.

Listed below are very common adverse effects (may affect more than 1 in 10 people):

• Peripheral edema (swelling of ankles, feet, and legs).

Listed below are common adverse effects (may affect up to 1 in 10 people):

• Headache, dizziness.
  • Heart rhythm disturbances: atrioventricular block (interruption or alteration of the electrical signal in the heart, moderate or severe, which may be first degree [mild], second, or third degree; bundle branch block may occur), palpitations, bradycardia.
  • Flushing (reddening of the skin).
  • Constipation, indigestion, stomach pain, nausea.
  • Erythema (redness of the skin), skin rashes.
  • General malaise, swelling (edema), fatigue (asthenia).

Listed below are uncommon adverse effects (may affect up to 1 in 100 people):

• Enlargement of lymph nodes (lymphadenopathy), increase in a specific type of white blood cells (eosinophils).
• Nervousness, difficulty falling or staying asleep (insomnia), memory loss (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that are not there while awake), personality changes, gait disturbances, drowsiness, tingling, somnolence, fainting, tremor.
• Chest pain or tightness (angina pectoris), irregular heartbeats (arrhythmias), abnormal heart contractions (ventricular extrasystoles), reduced cardiac muscle tone, disturbance in the heart's electrical signal (sinoatrial block), heart failure with generalized swelling (congestive heart failure).
• Orthostatic hypotension (drop in blood pressure upon standing or prolonged standing), low blood pressure (hypotension).
• Vomiting, diarrhea, abnormal loss of appetite (anorexia), heartburn, taste disturbances (dysgeusia), weight gain, dry mouth.
• Abnormal liver function tests (increased transaminase values), increased lactate dehydrogenase (LDH) and increased alkaline phosphatase (ALP) enzyme levels in blood tests.
• Small red spots on the skin (petechiae), itching (pruritus), skin rash (exanthema), urticaria, increased skin sensitivity to sunlight (photosensitivity), including flat warts in sun-exposed areas, skin lesions, usually circular with a red center, pale ring, and outer reddish ring (erythema multiforme), including Stevens-Johnson syndrome (the most severe form of erythema multiforme that may involve internal organs) and toxic epidermal necrolysis (with blisters and skin peeling).
• Sexual dysfunction.
• Thirst.
• Ringing in the ears (tinnitus).
• Increased blood glucose levels (hyperglycemia) in patients who also have diabetes mellitus.
• Amblyopia (partial loss of vision in one or both eyes), eye irritation.
• Muscle and bone pain.
• Need to urinate at night (nocturia) and increased frequency of urination (polyuria).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), nasal congestion.
• Increased creatine phosphokinase (CPK) enzyme levels in blood tests.

Listed below are adverse effects with unknown frequency (cannot be estimated from available data):

• Decreased platelets in the blood (thrombocytopenia), decreased total white blood cell count (leukopenia), hemolytic anemia (red blood cells are destroyed earlier than normal, resulting in insufficient red blood cells).
• Mood changes (including depression).
• Extrapyramidal syndrome (syndrome associated with rigidity, involuntary movements, lack of movement, and tremor), hypertonia (excessively high muscle tone), amnesia.
• Asymptomatic asystole (complete absence of electrical activity in the myocardium without symptoms), atrial flutter (a type of cardiac rhythm disorder), premature ventricular complexes (a type of ventricular arrhythmia), ventricular tachycardia (a sequence of three or more heartbeats with a rate exceeding 100 beats per minute), ventricular fibrillation (a cardiac rhythm disorder with a rapid ventricular rate >250 beats per minute), changes in electrocardiogram.
• Vasculitis (a disease involving inflammation of blood vessels), including leukocytoclastic vasculitis (vasculitis with necrosis of blood vessels), pallor.
• Gum enlargement, dental changes, intestinal obstruction.
• Liver inflammation (hepatitis).
• Angioneurotic edema (swelling of skin and mucous membranes, usually affecting face, mouth, tongue, throat, and hands), sweating, widespread skin peeling, acute eruption of sterile pustules, occasionally redness of the skin with peeling, with or without fever, hair loss (alopecia), cutaneous hyperkeratosis (calluses), purpura (purple spots on the skin caused by bleeding), drug-induced lichenoid eruption.
• Enlargement of one or both mammary glands in men, painful menstruation, vaginal mucosal inflammation, prostate disease.
• Fever.
• Vertigo.
• Blurred vision, retinopathy (any non-inflammatory disease affecting the retina).
• Neck pain, osteoarthritis (a disease caused by cartilage wear), bursitis (inflammation of the bursa, a sac-like structure located between bones, tendons, and muscles, caused by excessive joint use or direct injury), gout.
• Abnormally high urine production, cystitis (bladder inflammation), kidney stones.
• Increased cough, respiratory disturbances, rhinitis (inflammation of the nasal mucosa causing sneezing, itching, etc.), sinusitis (sinus infection), pharyngitis (inflammation of the pharynx), bronchitis (inflammation of the bronchi).
• Prolonged bleeding time (the time it takes for the first platelet clot to form and seal an injury, preventing bleeding).
• Condition in which the body's immune system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin rashes (called "lupus-like syndrome").

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Angiodrox 120 mg capsules

Store below 30 °C.

Keep this medicine out of the sight and reach of children.

Do not use Angiodrox 120 mg capsules after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Angiodrox 120 mg capsules

• The active substance is diltiazem. Each prolonged-release hard capsule contains 120 mg of diltiazem (as hydrochloride).
• The other components are sucrose, corn starch, povidone, ethylcellulose, talc, polyoxyethylcellulose, sodium lauryl sulfate, cetyl alcohol, dibutyl sebacate, gelatin, titanium dioxide (E-171), indigotine (E-132), and erythrosine (E-127).

Appearance of the medicinal product and pack contents

Angiodrox 120 mg prolonged-release hard capsules are presented as opaque red and opaque white capsules, in packs containing 30 or 60 capsules.

Other presentations

Angiodrox 90 mg prolonged-release hard capsules: packs containing 30 or 60 capsules.
Angiodrox 180 mg prolonged-release hard capsules: packs containing 30 or 60 capsules.
Angiodrox 300 mg prolonged-release hard capsules: packs containing 30 capsules.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Recipharm Parets, S.L.
Ramón y Cajal, 2
08150 Parets del Vallés (Barcelona)
Spain

Further information about this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 Madrid
Spain

Date of the most recent review of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) https://www.aemps.gob.es/