Package Leaflet: Information for the User

Angiodrox 300 mgProlonged-Release Hard Capsules

diltiazem

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

• Keep this leaflet, as 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This includes very rare side effects. Check with your doctor or pharmacist if any of the following happen to you:

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

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

3.How to take Angiodrox 300 mg capsules

4.Possible side effects

5Storage of Angiodrox 300 mg capsules

6.Contents of the pack and additional information

Angiodrox 300 mg capsules, whose active ingredient is diltiazem, belongs to a group of medications 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).

Do not take 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, difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, your doctor may need to monitor your kidney function.

Since the therapeutic effect of the different specialties with immediate or modified release diltiazem has not been compared, it is not recommended to substitute one for another unless there is an explicit recommendation from the prescribing doctor.

Careful observation is necessary in patients with heart problems.

If you are diabetic, you may need to adjust your existing treatment.

If you have liver or kidney disease or are an elderly patient, your doctor will closely 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 capsules 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 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 medications used to treat heart diseases (beta-blockers, digitalis), since the use of diltiazem in these situations may lead to an excessively slow heart rate and rhythm (bradycardia).

If you experience hypotension(low blood pressure): treatment with diltiazem may lead to an excessive decrease 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 upon discontinuing treatment.

If you are to undergo any surgical intervention that requires general anesthesia, you should inform your doctor and the anesthesiologist about your 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 evaluate these symptoms and indicate the measures to take.

Other medications and Angiodrox 300 mg capsules

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Contraindicated use with other medications:

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

Use with other medications that require caution:

Lithium(used to treat certain mental disorders): risk of increased lithium neurotoxicity.

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

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

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

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

Beta-blockers (to treat hypertension): possibility of cardiac alterations.

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

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

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

Agentsused to reduce 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 medication and inform your doctor if you are taking:

Medications containing lomitapida, used for the treatment of high cholesterol levels.

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

The concomitant use of Angiodrox with other medications should be carried out under medical supervision and by adjusting the doses progressively.

General information to be taken into account

Due to the possibility of additive effects, caution should be exercised and patients who receive Angiodrox simultaneously with other agents known to affect the heart should be carefully evaluated.

Angiodrox is metabolized in the liver by the CYP3A4 enzyme but also inhibits it. Other medications have a similar or opposite metabolism and cases of increased levels of one or the other medication may occur, depending on whether they inhibit or not that liver enzyme.

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

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

Statins(medications to reduce 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 renal failure) with the simultaneous use of diltiazem and some statins.

Taking Angiodrox 300 mg capsules with food and drinks

Take this medication preferably before meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Do not take Angiodrox if you are pregnant or trying to become pregnant. Women of childbearing age should use an effective contraceptive method. If you become pregnant while taking Angiodrox, discontinue the medication immediately and consult your doctor.

Angiodrox is excreted in breast milk, therefore, do not breastfeed while taking Angiodrox.If the use of Angiodrox is considered necessary, an alternative method of infant feeding should be used.

Driving and operating machinery

Based on the reported adverse reactions, that is, dizziness (frequent), general discomfort (frequent), your ability to drive and operate machinery may be impaired. Therefore, it is advisable not to perform tasks that require special attention (driving vehicles, operating hazardous machinery, etc.), until the response to the medication is satisfactory.

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

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

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

Angiodrox is administered orally. For initial treatment, capsules of Angiodrox with lower doses 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:

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

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 should 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 medication.

Your doctor will tell you the duration of your treatment with Angiodrox. Do not stop treatment as it may be harmful to your health.

If you think 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 tablets than you should, inform your doctor or go immediately to the emergency service of a hospital. Bring the packaging of the medication with you. This is so the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, irregular heartbeats, difficulty speaking, confusion, decreased renal function, coma, and sudden death.

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

If you forgot to take Angiodrox 300 mg capsules

Do not take a double dose to compensate for the missed doses.It is essential 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 the next dose, do not take the missed capsule.

If you interrupt treatment withAngiodrox 300 mg capsules

If you interrupt treatment with Angiodrox, you may experience 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 consulting your doctor first.

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

Like all medications, Angiodrox may cause side effects, although not everyone will experience them.The side effects of diltiazem vary in intensity from one patient to another and should be taken into account especially at the beginning of treatment or when changing medication.

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

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

The following are common side effects (may affect up to 1 in 10 people):

- Headache, dizziness.

• Cardiac rhythm disturbances: atrioventricular block (intermittent or alteration of the electrical signal in the heart of moderate or severe degreemay be of first degree (milder), second or third degree; may occur branch block of the bundle), palpitations, bradycardia.
• Redness (flushing).
• Constipation, indigestion, stomach pain, nausea.
• Erythema (redness of the skin), skin rash.
• General malaise, swelling (edema), fatigue (asthenia).

The following are uncommon side effects (may affect up to 1 in 100 people):

• Enlargement of lymph nodes (lymphadenopathy), increase of a specific type of white blood cell (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, somnolence, fainting, tremors.
• Chest pain or pressure (angina pectoris), irregular heartbeats (arrhythmias), abnormal heart contractions (ventricular extrasystoles), decreased heart muscle tone,alteration of the electrical signal in the heart (sinoatrial block), heart failure with generalized swelling (congestive heart failure).
• Orthostatic hypotension (fall in blood pressure when standing up or standing for a long time), low blood pressure (hypotension).
• Vomiting, diarrhea, abnormal loss of appetite (anorexia), stomach burning, alterations in taste(dysgeusia), weight gain, dry mouth.
• Alteration of liver function tests (increase in transaminase values), increase in lactate dehydrogenase (LDH) enzyme, and increase in alkaline phosphatase (ALP) enzyme 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 on exposed areas, skin lesions, usually circular, composed of a red center, pale ring, and outer ring of reddish color (erythema multiforme), including Stevens-Johnson syndrome (the most severe form of erythema multiforme that can even involve other organs of the body) and toxic epidermal necrolysis (with blisters and skin detachment).
• Sexual function alterations.
• Thirst.
• Tinnitus (ringing in the ears).
• Increased blood glucose levels (hyperglycemia) in patients who also suffer from diabetes mellitus.
• Blurred vision (partial loss of vision in one or both eyes), eye irritation.
• Muscle and bone pain.
• Nocturia (need to urinate at night) and increased frequency of urination (polyuria).
• Difficulty breathing (dyspnea), nosebleed (epistaxis), and nasal congestion.
• Increased creatine phosphokinase (CPK) enzyme in blood tests.

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

- Decrease in platelets in the blood (thrombocytopenia), decrease in total white blood cell count (leucopenia), hemolytic anemia (red blood cells in the blood are destroyed before normal, so the blood does not have enough red blood cells).

- Changes in mood (including depression).

- Extrapyramidal syndrome (syndrome associated with rigidity, involuntary movements, absence of movement, and tremors), hypertonia (muscle tone too high), amnesia.

- Asystole without symptoms (complete absence of electrical activity in the myocardium that occurs without symptoms), atrial fibrillation (a type of cardiac 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 (cardiac rhythm disorder with a ventricular frequency greater than 250 beats per minute), changes in the electrocardiogram.

- Vasculitis (disease in which there is inflammation of blood vessels) including leukocytoclastic vasculitis (vasculitis where there is also necrosis of blood vessels), pallor.

- Increase in gum volume, changes in teeth, intestinal obstruction.

- Inflammation of the liver (hepatitis).

- Angioneurotic edema (swelling of skin and mucous membranes, usually of the face, mouth, tongue, throat, and hands), sweating, generalized skin peeling, acute pustular eruption, occasionally skin redness with detachment, with or without fever, hair loss (alopecia), skin hypertrophy (calluses), purpura (purple spots produced by bleeding in the skin), medicamentous lichenoid eruption.

- Enlargement of one or both breast glands in men, painful menstruation,

inflammation of the vaginal mucosa, prostate disease.

- Fever.

- Dizziness.

- Blurred vision, retinopathy (any non-inflammatory disease affecting the retina).

- Neck pain, arthritis (disease produced by cartilage wear), bursitis (inflammation of the bursa, a structure in the form of a bag, located between bones, tendons, and muscles, which is produced by excessive use of a joint or due to a direct injury), gout.

- Abnormally high urine production, cystitis (inflammation of the bladder), kidney stones.

- Increased cough, respiratory alterations, rhinitis (inflammation of the nasal mucosa that causes sneezing, itching, etc.), sinusitis (infection of the nasal sinuses), pharyngitis (inflammation of the pharynx), bronchitis (inflammation of the bronchi).

- Increase in 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 eruptions (called "lupus-like syndrome").

Reporting of side effects

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

Store below 30 °C.

Keep this medication 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 disposed of through drains or in the trash.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Angiodrox 300 mg capsules

-The active ingredient isdiltiazem. Each prolonged-release hard capsule contains 300 mg of diltiazem (as hydrochloride).

-The other components arestarch, cornstarch, povidone, ethylcellulose, talc, polyoxyethylcellulose, sodium lauryl sulfate, cetyl alcohol, dibutyl sebacate, gelatin, and titanium dioxide (E-171).

Appearance of the product and content of the container

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

Other presentations

Angiodrox90 mgprolonged-release hard capsules: containers holding 30 or 60 capsules.

Angiodrox120 mgprolonged-release hard capsules: containers holding 30 or 60 capsules.

Angiodrox180 mgprolonged-release hard capsules: containers holding 30 or 60 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

Recipharm Parets, S.L.

Ramón y Cajal, 2

08150 Parets del Vallés (Barcelona)

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the last review of this leaflet:November 2024.

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/