Masdil 60 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Masdil 60 mg tablets

Diltiazem hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 could 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.

Leaflet contents:

1. What Masdil 60 mg is and what it is used for
2. What you need to know before taking Masdil 60 mg
3. How to take Masdil 60 mg
4. Possible side effects
5. How to store Masdil 60 mg
6. Contents of the pack and other information

1. What Masdil 60 mg is and what it is used for

Masdil 60 mg belongs to a group of medicines called selective calcium channel blockers, which cause 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 60 mg is indicated for:

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

Treatment of high blood pressure.

2. What you need to know before taking Masdil 60 mg

Do not take Masdil 60 mg:

• if you are allergic to diltiazem hydrochloride or any of the other ingredients 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 60 mg with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Masdil 60 mg

• If you have heart conditions such as left ventricular failure, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected on 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 60 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 beginning 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, reduces 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; your doctor may need to monitor your kidney function.

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

Taking Masdil 60 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 60 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:

Contraindicated combinations:

• Dantrolene: concomitant use of diltiazem with dantrolene (by infusion) is contraindicated.
• Ivabradine (see section “Do not take Masdil 60 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 to inform your doctor if you are taking any of the following medicines:

Combinations requiring caution:

Medicines used to treat cardiovascular conditions, such as:

• Alpha-blockers, as they may enhance the hypotensive effect (lowering of blood pressure).
• Beta-blockers, as cardiac disturbances may occur. This combination should only be used under clinical and electrocardiographic monitoring, especially at the start 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 they may increase the risk of bradycardia. 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 enhance the hypotensive effect and cause fainting.

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

• Cyclosporine (an immunosuppressant used in transplant patients).
• Phenytoin (a medicine used to treat epilepsy). Monitoring of plasma phenytoin concentrations is recommended 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), as they increase blood levels of diltiazem; therefore, either treatment with these medicines 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; your doctor will monitor you closely.
• 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 and X-ray contrast media concomitantly.
• 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 60 mg may lead to increased colchicine levels (a medicine used to treat gout) when administered concomitantly.
• Masdil 60 mg may increase the risk of bleeding if taken with anticoagulants such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban).
• Masdil 60 mg may cause QT interval prolongation (ECG changes such as changes in heart rate or rhythm, with symptoms such as dizziness) when administered with medicines 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): the possibility of additive effects on platelet aggregation from 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 blood levels of any co-administered medicines.

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

• Benzodiazepines (midazolam, triazolam), which are 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 in severe allergies due to their immunosuppressive properties, as diltiazem reduces the metabolism of methylprednisolone; therefore, your doctor will monitor you closely and may need to adjust the dose of methylprednisolone.

• 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 60 mg is not suitable for children.

Taking Masdil 60 mg with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

Avoid consuming grapefruit juice (see section “Taking Masdil 60 mg with other medicines”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or 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 administered to pregnant women or to women of childbearing potential who are not using an effective contraceptive method.

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 the use of Masdil 60 mg, such as dizziness (common) and malaise (common), the ability to drive or operate machinery may be impaired, although no specific studies have been conducted.

Masdil 60 mg contains hydrogenated castor oil and lactose

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

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

3. How to take Masdil 60 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 60 mg is oral.

Prevention and treatment of angina pectoris: The usual dose is 1 tablet every 8 hours (three times a day), preferably taken before meals.

Hypertension: Treatment of hypertension should be initiated with half a 60 mg tablet every 8 hours (three times a day), i.e., 90 mg of diltiazem per day.

Your doctor may increase or decrease these doses if considered necessary.

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 insufficiency: should use this medicine 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 60 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 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 emergency department of a hospital. 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 in breathing, which may develop within 24–48 hours after ingestion.

In case of significant overdose, you should be transferred to a hospital, where gastric lavage and/or osmotic diuresis may be performed.

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

If you forget to take Masdil 60 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 your next dose, do not take the missed tablet.

If you stop taking Masdil 60 mg

Your doctor will advise you on the duration of your treatment with Masdil 60 mg. Do not stop treatment earlier.

If you stop treatment with Masdil 60 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 the 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 upon standing 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 liver enzyme levels 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 disease associated with red spots, blisters), including cases of Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes), toxic epidermal necrolysis (a severe skin condition involving peeling of the skin), 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 (called "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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Masdil 60 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 containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Masdil 60 mg

• The active substance is diltiazem hydrochloride. Each tablet contains 60 mg of diltiazem (as hydrochloride).

• The other components are lactose, stearic acid, hydrogenated castor oil, carboxymethylcellulose, magnesium stearate, silicon dioxide.

Appearance of the product and contents of the pack

Masdil 60 mg tablets are presented as white, circular, flat, bevel-edged tablets, scored on one side and marked with the anagram "Masdil 60" on the other, in packs containing 30, 60 tablets and 500 tablets (clinical 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

Date of the most recent review of this summary: 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/