Masdil Retard 120 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Masdil Retard 120 mg prolonged-release tablets

Diltiazem hydrochloride

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Masdil Retard 120 mg is and what it is used for

2. What you need to know before taking Masdil Retard 120 mg

3. How to take Masdil Retard 120 mg

4. Possible side effects

5. Storage of Masdil Retard 120 mg

6. Contents of the pack and other information

1. What Masdil Retard 120 mg is and what it is used for

Masdil Retard 120 mg belongs to a group of medicines called selective calcium channel blockers, which produce dilation of blood vessels, resulting in a reduction of blood pressure, as well as an increase in blood flow and a decrease in the heart's oxygen requirements.

Masdil Retard 120 mg is indicated for:

• prevention and treatment of angina pectoris, including Prinzmetal's (vasospastic) angina

treatment of moderate arterial hypertension

2. What you need to know before taking Masdil Retard 120 mg

Do not take Masdil Retard 120 mg:

• if you are allergic to diltiazem hydrochloride or any of the other components of this medicine (listed in section 6).
• if you have a heart rhythm or conduction disorder, such as Sick Sinus Syndrome in patients without a pacemaker, second- or third-degree atrioventricular block in patients without a pacemaker, or severe bradycardia (heart rate below 40 beats per minute).
• if you have a heart condition such as left ventricular failure with pulmonary congestion.
• if you are being treated with dantrolene (by infusion).
• if you are already taking a medicine containing ivabradine used to treat certain heart conditions.
• if you are already taking a medicine containing lomitapide used to treat high cholesterol levels (see section: “Taking Masdil Retard 120 mg with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Masdil Retard 120 mg:

• If you have heart conditions such as ventricular failure, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram, your doctor will need to monitor you closely.
• If you are taking anticoagulants such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Masdil Retard 120 mg.
• If you are undergoing general anesthesia, you must inform the anesthesiologist that you are being treated with this medicine.
• If you are elderly or have kidney or liver disease (renal or hepatic impairment), blood levels of diltiazem may be higher, so close monitoring of heart rate is necessary at the start of treatment.
• If you experience mood changes, including depression, inform your doctor.
• If you are at risk of intestinal obstruction, as diltiazem, like other medicines in the same class, may reduce intestinal motility.
• If you have latent or overt diabetes mellitus. Close monitoring is required in these patients due to the possible increase in blood glucose levels.
• The use of diltiazem may induce bronchospasm, including worsening of asthma, especially in patients with pre-existing bronchial hyperreactivity. Cases have also been reported after dose increases. Inform your doctor if you develop signs or symptoms of respiratory problems during treatment with this medicine.
• If you have a history of heart failure, new onset of breathing difficulty, slow heart rate, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions, and your doctor may need to monitor your kidney function.

Sun exposure is not recommended during treatment, as photosensitivity reactions (skin spots) may occur.

Unless specifically instructed by your doctor, substitution of Masdil Retard 120 mg with another sustained-release diltiazem-containing medicine is not recommended.

The active ingredient in Masdil Retard 120 mg is contained within a tablet shell that is excreted intact in the feces.

Taking Masdil Retard 120 mg with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Masdil Retard 120 mg. In such cases, it may be necessary to adjust the dose or discontinue one of the medicines.

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

Combinations that are contraindicated:

• Dantrolene: concomitant use of diltiazem with dantrolene (by infusion) is contraindicated.
• Ivabradine (see section “Do not take Masdil Retard 120 mg”).
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could increase the likelihood and severity of liver-related side effects.

It is especially important that you inform your doctor if you are taking any of the following medicines:

Combinations that require caution:

Medicines used to treat heart conditions, such as:

• Alpha-blockers, as the blood pressure-lowering effect (hypotensive effect) may be increased.

• Beta-blockers, as cardiac disturbances may occur. This combination should only be used under clinical and electrocardiographic monitoring, especially at the beginning of treatment.

• An increased risk of depression has been observed when diltiazem is administered with beta-blockers (see section 4 Possible side effects).

• Amiodarone, digoxin, as the risk of bradycardia increases. Caution is especially needed in elderly patients and when high doses are used.

• Other antiarrhythmic medicines, as diltiazem has antiarrhythmic properties, increasing the risk of cardiac adverse effects. This combination should only be used under clinical and electrocardiographic monitoring.

• Nitrate derivatives, as they may increase the hypotensive effect and cause fainting.

The combination of diltiazem with the following medicines increases the blood levels of these medicines, so your doctor may need to adjust their dose during treatment with diltiazem:

• Cyclosporine (an immunosuppressant used in transplant patients).

• Phenytoin (a medicine used to treat epilepsy). Plasma phenytoin levels should be monitored when co-administered with diltiazem.

• Carbamazepine (a medicine used to treat epilepsy).

• Theophylline (a medicine used for asthma).

• H2 antagonists (cimetidine and ranitidine), medicines used to treat stomach ulcers, which may increase blood levels of diltiazem, so either treatment with these should be discontinued or the daily dose of diltiazem adjusted.

• Rifampicin (an antibiotic used to treat tuberculosis and certain infections), which may reduce blood levels of diltiazem, requiring close monitoring by your doctor.

• X-ray contrast media: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when given an intravenous bolus of ionic X-ray contrast media. Special caution is required in patients receiving diltiazem concomitantly with X-ray contrast agents.

• Lithium (a medicine used to treat mental health conditions), as it may increase lithium toxicity. Your doctor will closely monitor your blood lithium levels.

• Colchicine. Masdil Retard 120 mg may increase colchicine levels (a medicine used to treat gout) when administered concomitantly.

• Masdil Retard 120 mg may increase the risk of bleeding if taken together with anticoagulants such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban).

• Masdil Retard 120 mg may cause QT interval prolongation (ECG changes such as changes in heart rate or rhythm, with symptoms of dizziness) when administered with drugs known or suspected to prolong the QT interval.

General information to consider:

• Due to possible additive effects, caution and medical evaluation are required when diltiazem is administered concomitantly with other agents known to affect cardiac conduction and/or contractility.

• Antiplatelet medicines (medicines that prevent blood cells called “platelets” from clumping and forming clots): additive effects on platelet aggregation between diltiazem and antiplatelet medicines (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered.

• Medicines metabolized by the CYP3A4 enzyme, as this may result in decreased blood levels of diltiazem or increased levels of any co-administered medicines.

Patients should be monitored if consuming grapefruit juice, as it may increase the adverse effects of diltiazem. Grapefruit juice should be avoided if an interaction is suspected.

• Benzodiazepines (midazolam, triazolam), medicines with sedative, anxiolytic, anticonvulsant, amnestic, and muscle-relaxant effects, as diltiazem increases blood levels of these medicines, prolonging their duration of action. Your doctor will exercise special caution when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.

• Corticosteroids (methylprednisolone), used as anti-inflammatory agents and for severe allergies due to their immunosuppressive properties, as diltiazem reduces the metabolism of methylprednisolone, requiring close monitoring and possible dose adjustment by your doctor.

• Statins (medicines used to lower cholesterol), as diltiazem greatly increases blood levels of certain statins, potentially causing statin-related toxicity.

• Cilostazol: by inhibiting cilostazol metabolism, diltiazem increases its pharmacological activity.

Children and adolescents

Masdil Retard 120 mg is not an appropriate medicine for children.

Taking Masdil Retard 120 mg with food, drinks, and alcohol

Masdil Retard 120 mg can be taken at any time of day, regardless of meals.

Grapefruit juice should be avoided (see section “Taking Masdil Retard 120 mg with other medicines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

This medicine must not be given to pregnant women or women of childbearing potential who are not using an effective method of contraception.

This medicine should not be taken during breastfeeding, as it passes into breast milk. If your doctor considers it essential to take this medicine, the baby should be fed by alternative means.

Driving and using machines

Based on the adverse effects reported with Masdil Retard 120 mg, such as dizziness (common) and malaise (common), your ability to drive or operate machinery may be impaired, although no specific studies have been conducted.

Masdil Retard 120 mg contains polyethylene glycol castor oil, sucrose, and sodium.

This medicine may cause stomach discomfort and diarrhea because it contains polyethylene glycol castor oil.

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

This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to take Masdil Retard 120 mg

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The route of administration of Masdil Retard 120 mg is oral.

Use in adults

The usual dose is 1 tablet every 12 hours (one in the morning and one at night).

The Masdil Retard 120 mg tablet must not be chewed, but swallowed whole with a glass of water.

The dose may be taken at any time of day, before or during meals, but it is advisable to take your dose at the same time every day.

Use in elderly patients and in patients with kidney or liver disease

Since in these cases there may be an increase in blood levels of diltiazem, your doctor should consider the need to adjust your dose at the beginning of treatment.

Patients with renal or hepatic impairment: must be used with caution. See section “Warnings and precautions”.

Interchangeability between different diltiazem medicinal products is not recommended unless you receive explicit advice from your doctor.

If you take more Masdil Retard 120 mg than you should

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

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

Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop within 24–48 hours after ingestion.

In case of significant overdose, the patient should be transferred to a specialized center for gastric lavage and/or osmotic diuresis.

Atropine, adrenaline, glucagon, or calcium gluconate may be administered as antidotes.

If you forget to take Masdil Retard 120 mg

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as possible, and then take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed tablet.

If you stop taking Masdil Retard 120 mg

Your doctor will determine the duration of your treatment with Masdil Retard 120 mg. Do not stop treatment prematurely. If you interrupt treatment with Masdil Retard 120 mg, your condition may worsen.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported according to the frequencies detailed below:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known (cannot be estimated from available data)

Blood and lymphatic system disorders:

• Frequency not known: thrombocytopenia.

Metabolism and nutrition disorders:

• Frequency not known: hyperglycemia.

Psychiatric disorders:

• Uncommon: nervousness, difficulty sleeping (insomnia).
• Frequency not known: mood changes including depression.

Nervous system disorders:

• Common: headache, dizziness.
• Frequency not known: movement disorders (extrapyramidal syndrome).

Cardiac disorders:

• Common: atrioventricular block (a type of arrhythmia), palpitations.
• Uncommon: slow heart rate (bradycardia).
• Frequency not known: sinoatrial block, difficulty of the heart to pump blood (congestive heart failure), heart rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

• Common: hot flushes.
• Uncommon: drop in blood pressure when standing up quickly, with or without dizziness (orthostatic hypotension).
• Frequency not known: vasculitis (diseases characterized by inflammation of blood vessels), including leukocytoclastic vasculitis.

Respiratory, thoracic and mediastinal disorders:

• Frequency not known: bronchospasm (including worsening of asthma).

Gastrointestinal disorders:

• Common: constipation, indigestion (dyspepsia), stomach pain, nausea.
• Uncommon: vomiting, diarrhea.
• Rare: dry mouth.
• Frequency not known: inflammation of the hard palate (gingival hyperplasia).

Hepatobiliary disorders:

• Uncommon: increased levels of liver enzymes in the blood during the initial treatment period. These increases are usually temporary.
• Frequency not known: hepatitis (inflammatory disease affecting the liver).

Skin and subcutaneous tissue disorders:

• Common: redness of the skin (erythema).
• Rare: skin irritation and itching (urticaria).
• Frequency not known: sensitivity to light (photosensitivity), swelling of the throat, lips, and airways (angioneurotic edema), rash, erythema multiforme (a serious skin condition associated with red spots, blisters), including rare cases of Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes) and toxic epidermal necrolysis (a severe skin peeling disease), sweating, exfoliative dermatitis (skin redness, itching, hair loss), acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface characterized as small, inflamed, pus-filled, and blister-like), occasionally erythematous desquamation with or without fever. A condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (known as "lupus-like syndrome").

Skin rash that may appear on the skin or sores in the mouth (drug-induced lichenoid eruption).

Reproductive system and breast disorders:

• Frequency not known: excessive breast development in men (gynecomastia).

General disorders and administration site conditions:

• Very common: swelling of the lower limbs (peripheral edema).
• Common: malaise.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Masdil Retard 120 mg

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to 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 pack and other information

Composition of Masdil Retard 120 mg

• The active substance is diltiazem hydrochloride. Each prolonged-release tablet contains 120 mg of diltiazem (as hydrochloride).
• The other components are sodium dihydrogen citrate, sucrose, povidone, magnesium stearate and macrogol 6000 for the core; sucrose, PVC/PVAc/PVOH copolymer, acetyltributyl citrate, polymerized castor oil, sodium bicarbonate, ethyl vanillin and titanium dioxide (E-171) for the coating.

Nature of the product and pack sizes

Masdil Retard 120 mg prolonged-release tablets are presented as coated, round, biconvex, white tablets in packs containing 60 tablets and 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

or

Meribel Pharma Parets, S.L.U

Ramón y Cajal, 2

08150 Parets del Vallès

Barcelona – Spain

Date of the most recent revision of this leaflet: February 2025

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