ANGIODROX 300 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Angiodrox 300 mgprolonged-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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What Angiodrox 300 mg capsules are and what they are used for
2. What you need to know before you take Angiodrox 300 mg capsules
3. How to take Angiodrox 300 mg capsules
4. Possible side effects

5 Storage of Angiodrox 300 mg capsules

1. Contents of the pack and other information

1. What Angiodrox 300 mg capsules are and what they are used for

Angiodrox 300 mg capsules, whose active ingredient is diltiazem, belong to a group of medicines called calcium antagonists. Angiodrox is used for the treatment and prevention of angina pectoris, as it widens (dilates) the heart's arteries, increasing blood flow. Angiodrox also acts by widening other blood vessels in the body, so it is also used in the treatment of high blood pressure (hypertension).

2. What you need to know before you take Angiodrox 300 mg capsules

Do not take Angiodrox 300 mg capsules:

• if you have certain heart diseases such as various types of arrhythmia (irregular heartbeats due to sinus node syndrome or second- or third-degree atrioventricular block, except if you have a pacemaker)
• if you have a very slow pulse, below 40 beats per minute
• if you have left ventricular insufficiency (when the left ventricle does not fully pump oxygenated blood to the rest of the body), with fluid accumulation in the lungs
• if you have congestive heart failure with pulmonary edema (inability of the heart to pump enough blood to the rest of the body and fluid accumulation)
• if you are allergic (hypersensitive) to diltiazem or any of the other components of Angiodrox, included in section 6
• if you are receiving an intravenous infusion of dantrolene (a muscle relaxant) at the same time
• if you have hypotension (low blood pressure)
• if you have acute myocardial infarction complicated by very slow pulse, severe hypotension, and left ventricular insufficiency
• if you are pregnant, plan to become pregnant, or want to breastfeed your child
• if you are taking a medicine that contains ivabradine, for the treatment of certain heart diseases.
• If you are already taking a medicine that contains lomitapida, used for the treatment of high cholesterol levels (see section "Other medicines and Angiodrox 300 mg capsules").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Angiodrox 300 mg capsules.

If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. There have been reports of kidney damage in patients with these conditions, it is possible that your doctor may need to monitor your kidney function.

Since the therapeutic effect has not been compared between different diltiazem specialties with immediate or modified release (retard), according to whether they are rapidly absorbed or not in the digestive tract, it is not recommended to substitute one for another unless expressly recommended by the prescribing doctor.

Detailed observation is necessary in patients with heart problems.

If you are diabetic, you may need an adjustment in the treatment you are already receiving.

If you have liver or kidney disease or are an elderly patient, 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 movements. Therefore, it should be used with caution in patients at risk of developing intestinal obstruction. The residues of the tablets of the slow-release formulations may pass into the patient's feces; however, this fact has no clinical relevance.

If you have acute porphyria, it is not safe for you 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 any cardiac arrhythmia (sinus node disease, atrioventricular block) or if you are receiving treatment with other medicines used to treat heart diseases (beta blockers, digitalis), since the use of diltiazem in these situations may lead to an excessively slow pulse and heart rhythm (bradycardia).

If you have hypotension (low blood pressure): treatment with diltiazem may lead to an excessive drop in blood pressure. Your doctor will inform you about how to avoid the symptoms resulting from hypotension and what measures to take if these symptoms occur.

In rare cases, Angiodrox may cause liver damage, which is reversible when treatment is discontinued.

If you are going to undergo surgery that requires general anesthesia, you should inform your doctor and anesthesiologist about the treatment with Angiodrox.

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

The use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and indicate the measures to be taken.

Other medicines and Angiodrox 300 mg capsules

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

Contraindicated use with other medicines:

The combination of diltiazem and dantrolene in infusion (muscle relaxant) is potentially hazardous.

Use with other medicines that requires caution:

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

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

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

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

Amiodarone (used to decrease heart rate), digoxin (used to treat heart diseases): increased risk of bradycardia (decreased heartbeats). Caution should be exercised when these are combined with diltiazem, particularly in elderly subjects and when high doses are used.

Beta-blockers (to treat hypertension): possibility of alterations in the heart.

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

Carbamazepine (to treat epilepsy): increased carbamazepine levels in the blood:

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

Agents used to decrease stomach acid production (cimetidine, ranitidine): increased diltiazem levels in the blood.

Ciclosporin (used to suppress the immune system): increased ciclosporin levels in the blood.

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

Medicines that contain lomitapida, used for the treatment of high cholesterol levels.

Diltiazem may increase the concentration of lomitapida, which may lead to an increased probability and severity of selected side effects on the liver.

The combined use of Angiodrox with other drugs should be done under medical control and adjusting the doses progressively.

General information to be taken into account

Due to the possibility of additive effects, it is necessary to exercise caution and carefully assess patients who receive Angiodrox simultaneously with other agents known to affect the heart.

Angiodrox is metabolized in the liver by the CYP3A4 isoenzyme, but it also inhibits it. Other drugs have similar or opposite metabolism, and cases of increased blood levels of one or another drug may occur, depending on whether they inhibit or not this liver enzyme.

Benzodiazepines (midazolam, triazolam used to treat anxiety): diltiazem increases midazolam and triazolam levels in the blood.

Corticosteroids (methylprednisolone, used to treat inflammatory problems): diltiazem may increase methylprednisolone levels in the blood and may require a dose adjustment of methylprednisolone.

Statins (medicines to decrease cholesterol levels in the blood): diltiazem increases the levels of some statins in the blood. There is a risk of myopathy (muscle disorder) and rhabdomyolysis (muscle necrosis with complications such as kidney failure) with the simultaneous use of diltiazem and some statins.

Taking Angiodrox 300 mg capsules with food and drinks

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 if you are trying to become pregnant. Women of childbearing age 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 if you are being treated with Angiodrox. If the use of Angiodrox is considered essential, an alternative method for infant feeding should be used.

Driving and using machines

Based on the reported adverse reactions, i.e., dizziness (frequent), general malaise (frequent), the ability to drive and use machines may be altered. Therefore, it is advisable not to perform tasks that require special attention (driving vehicles, handling hazardous machinery, etc.) until the response to the medicine is satisfactory.

Important information about some of the components of Angiodrox 300 mg capsules

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

3. How to take Angiodrox 300 mg capsules

Follow exactly the administration instructions of Angiodrox indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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

Adults:

Angina pectoris:the dose is 1 capsule per day. The maximum dose is 480 mg/day.

Arterial hypertension:the dose is 1 capsule per day.

Elderly patients, renal or hepatic insufficiency: The initial dose adjustment should be done with caution.

All dose modifications and monitoring will be done under medical supervision.

Instructions for correct administration

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

Take Angiodrox every day and approximately at the same time. Taking the capsules at the same time each day will have a better effect on your blood pressure. It will also help you remember when to take the capsules.

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

Your doctor will indicate the duration of your treatment with Angiodrox. Do not stop treatment before, as it 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 300 mg capsules than you should

If you take more capsules than you should, inform your doctor or go immediately to the emergency department of a hospital. Bring the medicine package with you. This is so that the doctor knows what you have taken. The following effects may occur: feeling of dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

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

If you forget to take Angiodrox 300 mg capsules

Do not take a double dose to make up for forgotten doses. It is important that you 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 the next dose, do not take the forgotten capsule.

If you stop taking Angiodrox 300 mg capsules

If you stop taking Angiodrox, you may have a worsening of your disease, presenting symptoms such as chest pain or a sudden increase in blood pressure. Do not stop treatment with Angiodrox without first consulting your doctor.

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

4. Possible Adverse Effects

Like all medicines, Angiodrox can produce adverse effects, although not all people suffer from them. The adverse effects of diltiazem vary in intensity from one patient to another and should be taken into account especially at the start of treatment or when changing medication.

The following are very frequent adverse effects (may affect more than 1 in 10 people):

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

The following are frequent adverse effects (may affect up to 1 in 10 people):

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

The following are infrequent adverse effects (may affect up to 1 in 100 people):

• Increased size of lymph nodes (lymphadenopathy), increase in a specific type of white blood cells (eosinophils).
• Nervousness, difficulty initiating or maintaining sleep (insomnia), memory loss (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake), personality changes, gait disorders, drowsiness, tingling, somnolence, fainting, tremor.
• Chest pain or oppression (angina pectoris), irregular heartbeats (arrhythmias), abnormal heart contractions (ventricular extrasystoles), decreased heart muscle tone, alteration of the heart's electrical signal (sinoatrial block), heart failure with generalized swelling (congestive heart failure).
• Orthostatic hypotension (drop in blood pressure when standing up or standing for a long time), low blood pressure (hypotension).
• Vomiting, diarrhea, abnormal loss of appetite (anorexia), heartburn, taste alterations (dysgeusia), weight gain, dry mouth.
• Alteration of liver function tests (increase in transaminase values), increase in lactate dehydrogenase (LDH) and alkaline phosphatase (ALP) enzymes in blood tests.
• Small red spots on the skin (petechiae), itching (pruritus), skin rash (exanthema), urticaria, increased sensitivity of the skin to sunlight (photosensitivity), including flat warts in exposed areas, skin lesions, usually circular with a red center, pale ring, and reddish outer ring (erythema multiforme), including Stevens-Johnson syndrome (the most severe form of erythema multiforme that can affect organs) and toxic epidermal necrolysis (with blisters and skin peeling).
• Sexual function disorders.
• Thirst.
• Ringing in the ears (tinnitus).
• Elevation of blood glucose levels (hyperglycemia) in patients who also suffer from diabetes mellitus.
• Lazy eye (partial loss of vision in one or both eyes), eye irritation.
• Pain in muscles and bones.
• Need to urinate at night (nocturia) and increased number of times urination is needed (polyuria).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), and nasal congestion.
• Elevation of creatine phosphokinase (CPK) enzyme in blood tests.

The following are adverse effects of unknown frequency (cannot be estimated from available data):

• Decrease in platelets in the blood (thrombocytopenia), decrease in total number of white blood cells (leukopenia), hemolytic anemia (red blood cells in the blood are destroyed before their time, so the blood does not have enough red blood cells).
• Mood changes (including depression).
• Extrapyramidal syndrome (syndrome associated with rigidity, involuntary movements, absence of movement, and tremor), hypertonia (muscle tone too high), amnesia.
• Asymptomatic asystole (complete absence of electrical activity in the myocardium that occurs without symptoms), atrial flutter (a type of heart rhythm disorder), premature ventricular complexes (a type of ventricular arrhythmia), ventricular tachycardia (sequence of three or more heartbeats with a frequency greater than 100 beats per minute), ventricular fibrillation (heart rhythm disorder with a rapid ventricular rate >250 beats per minute), changes in the electrocardiogram.

Vasculitis (disease in which there is inflammation of blood vessels) including leucocytoclastic vasculitis (vasculitis where necrosis of blood vessels also occurs), paleness.

The following are other adverse effects:

• Fever.
• Dizziness.
• Blurred vision, retinopathy (any non-inflammatory disease that affects the retina).
• Neck pain, arthritis (disease caused by wear and tear on cartilage), bursitis (inflammation of the bursa, a bag-like structure that sits between bones, tendons, and muscles, caused by excessive use of a joint or due to a direct injury), gout.

The following are other adverse effects:

• Abnormally high production of urine, cystitis (inflammation of the bladder), kidney stones.
• Increased cough, respiratory disorders, rhinitis (inflammation of the mucous membrane of the nose that causes sneezing, itching, etc.), sinusitis (infection of the nasal sinuses), pharyngitis (inflammation of the pharynx), bronchitis (inflammation of the bronchi).

The following are other adverse effects:

• Increased bleeding time (the time it takes for the first platelet plug to form that occludes the wound, preventing bleeding).

State in which the body's defense 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Angiodrox 300 mg Capsules

Store below 30 ºC.

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

Do not use Angiodrox 300 mg capsules after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Angiodrox 300 mg Capsules

• The active ingredient is diltiazem. Each prolonged-release capsule contains 300 mg of diltiazem (as hydrochloride).
• The other components are sucrose, cornstarch, povidone, ethylcellulose, talc, polyoxyethylcellulose, sodium lauryl sulfate, cetyl alcohol, dibutyl sebacate, gelatin, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Angiodrox 300 mg prolonged-release hard capsules are presented in the form of white opaque capsules, in packages containing 30 capsules.

Other Presentations

Angiodrox 90 mg prolonged-release hard capsules: packages containing 30 or 60 capsules.

Angiodrox 120 mg prolonged-release hard capsules: packages containing 30 or 60 capsules.

Angiodrox 180 mg prolonged-release hard capsules: packages containing 30 or 60 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)

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last revision of this prospectus:November 2024.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/