Leaflet: information for the user

Masdil 60 mg tablets

Diltiazem hydrochloride

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Masdil 60 mg

4. Possible side effects

5. Storage of Masdil 60 mg

6. Contents of the pack and additional information

Masdil 60 mg,belongs to a group of medications called calcium channel blockers which produce a dilation of the blood vessels, resulting in a decrease in blood pressure, as well as an increase in blood flow and a decrease in the heart's oxygen needs.

Masdil 60 mg is indicated for:

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

Treatment of high blood pressure.

Do not take Masdil 60 mg:

• if you are allergic to hydrochloride diltiazem or to any of the other ingredients of this medication (listed in section 6).
• if you have any heart rhythm or conduction disorders, such as sinus dysfunction syndrome in patients without a pacemaker, second- or third-degree atrioventricular block in patients without a pacemaker, or severe bradycardia (heart rate less than 40 beats per minute).
• if you have any heart disease, such as left ventricular insufficiency with pulmonary congestion.
• if you are being treated with dantrolene (in infusion).
• if you are already taking a medication containing ivabradina used for the treatment of some heart diseases.
• if you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section “Taking Masdil 60 mg with other medications”).

Warnings and precautions

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

• If you have heart conditions such as left ventricular insufficiency, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram, your doctor will need to closely monitor you.
• if you are taking anticoagulants such as direct oral anticoagulants (for example: dabigatrán, rivaroxaban, apixaban) together with Masdil 60 mg.
• In the case of general anesthesia, you should inform the anesthesiologist that you are being treated with this medication.
• If you are an elderly patient or if you have kidney or liver disease (renal or hepatic insufficiency), the concentrations of diltiazem in the blood may be higher, so your doctor will need to closely monitor your heart rate at the beginning of treatment.
• If you experience mood changes, including depression, inform your doctor.
• If you have a risk of developing intestinal obstruction, as diltiazem, like other medications in the same group, can decrease intestinal movement.
• If you have diabetes mellitus, latent or manifest. A strict control is necessary in these patients due to the possible increase in blood glucose levels.
• If you have a history of asthma, diltiazem can induce bronchospasm, including the worsening of asthma, especially in patients with pre-existing bronchial hyperreactivity. Also, cases have been reported after increasing the dose. Inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medication.
• If you have a history of heart failure, new difficulty breathing, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, so your doctor may need to monitor your renal function.

Do not recommend exposure to the sun during treatment as it may cause photosensitivity reactions (skin spots).

Taking Masdil 60 mg with other medications

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

Certain medications may interact with Masdil 60 mg. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

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

Combinations that are contraindicated:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (in infusion) is contraindicated.
• Ivabradina (see section “Do not take Masdil 60 mg”).
• Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increase in the probability and severity of side effects related to the liver.

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

Combinations that require caution:

Medications for treating cardiovascular problems, such as:

• Alpha-blockers, as they increase the hypotensive effect (decrease in blood pressure)
• Beta-blockers, as they may cause cardiac arrhythmias. This combination should only be used if you are clinically monitored and by electrocardiogram, especially at the beginning of treatment.
• Amiodarone, digoxin, as they increase the risk of bradycardia. You should be cautious, especially in elderly patients and when using high doses.
• Other antiarrhythmic medications, as diltiazem has antiarrhythmic properties, so there is a risk of increased cardiac adverse effects. This combination should only be used if you are clinically monitored and by electrocardiogram.
• Nitrate derivatives, as they may increase the hypotensive effect and dizziness.

The combination of diltiazem with the following medications increases the amount of these medications in the blood, so your doctor will need to adjust the dose during treatment with diltiazem:

• Ciclosporina (immunosuppressive medication used in transplants).
• Fenitoína (medication for treating epilepsy). It is recommended to monitor the concentrations of fenitoína in plasma when administered together with diltiazem.
• Carbamazepina (medication for treating epilepsy).
• Teofilina (medication for asthma).
• Antagonists H2 (cimetidina and ranitidina medications for treating stomach ulcers), as they produce an increase in the amount of diltiazem in the blood, so either the treatment with these will be interrupted or the daily dose of diltiazem will be adjusted.
• Rifampicina (antibiotic used for treating tuberculosis and some infections) that may produce a decrease in the amount of diltiazem in the blood, so your doctor will closely monitor you.
• Contrast medium for X-rays: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when administered an intravenous bolus of an ionic contrast medium for X-rays. Special caution is required in patients who receive diltiazem and a contrast medium for X-rays concomitantly.
• Litio (medication for treating mental health problems) as it may increase the toxicity of this medication. Your doctor will closely monitor your lithium levels in the blood.
• Colchicina. Masdil 60 mg may lead to an increase in the level of colchicina (medication used for treating gout) when administered concomitantly.
• Masdil 60 mg may increase the risk of bleeding if taken together with anticoagulants such as direct oral anticoagulants (for example: dabigatrán, rivaroxaban, apixaban).
• Masdil 60 mg may cause prolongation of the QT interval (changes in the ECG, such as changes in heart rate or rhythm, with symptoms of dizziness) when administered together with medications that have the potential or known to prolong the QT interval.

General information to be taken into account:

• Due to the possible additive effects, caution and evaluation are necessary in cases where diltiazem is administered simultaneously with other agents known to affect cardiac conduction and/or contractility.

• Antiplatelet medications (medications that prevent platelets from aggregating and forming a blood clot): consider the possibility of additive effect on platelet aggregation of diltiazem and antiplatelet medications (such as acetylsalicylic acid, ticagrelor, cilostazol).

• Medications metabolized by the CYP3A4 enzyme, as this may result in a decrease in the amount of diltiazem in the blood or an increase in the amount of any medication administered with it.

• Monitor patients who consume grapefruit juice, as it may increase the adverse effects of diltiazem. Avoid grapefruit juice if an interaction is suspected.

• Benzodiacepinas (midazolam, triazolam), which are medications with sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant effects (muscle relaxants), as diltiazem increases the amounts of these medications in the blood, prolonging their time in the body. Your doctor will have special care when prescribing benzodiacepinas (especially those with short action) if you are taking diltiazem.

• Corticosteroids (metilprednisolona) used as anti-inflammatory and in severe allergies due to their immunosuppressive capacity, as diltiazem reduces the metabolism of metilprednisolona, so your doctor will closely monitor you and adjust the dose of metilprednisolona.

• Estatinas (medications used to lower cholesterol levels), as diltiazem increases the amount of some statins in the blood, which could produce problems of statin toxicity.

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

Children and adolescents

Masdil 60 mg is not an appropriate medication for children.

Taking Masdil 60 mg with food, drinks, and alcohol

It is recommended to take this medication preferably before meals.

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be administered to pregnant women or to women of childbearing age who are not using an effective contraceptive method.

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

Driving and operating machinery

Based on the adverse effects reported with the use of Masdil 60mg, such as dizziness (frequent) and discomfort (frequent), the ability to drive and operate machinery may be impaired, although no study has been conducted on this.

Masdil 60 mg contains hydrogenated ricin oil and lactose

This medication may cause stomach discomfort and diarrhea because it contains hydrogenated ricin oil.

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The administration route 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: Hypertension treatment should start with half a tablet of 60 mg every 8 hours (three times a day), that is, 90 mg of diltiazem per day.

Your doctor may increase or decrease these doses if necessary.

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

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

Patients with renal insufficiency or hepatic insufficiency: use with caution. See the "Warnings and precautions" section.

Do not recommend substituting diltiazem specialties among them unless you receive explicit recommendation from your doctor.

If you take more Masdil 60 mg than you should

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 take more tablets than you should, inform your doctor or go immediately to the emergency service of a hospital. Bring the medication packaging with you. This is so that 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.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing that may develop up to 24-48 hours after ingestion.

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

Atropine, 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 compensate for the missed doses.If you forget to take a dose, take it as soon as you can and the next one at the usual time. However, if it is already time for the next dose or is close to it, do not take the missed dose.

If you interrupt treatment with Masdil 60 mg

Your doctor will indicate the duration of your treatment with Masdil 60 mg. Do not stop treatment before.

If you interrupt treatment with Masdil 60 mg, you may experience a worsening of your disease.

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

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

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

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: may affect up to 1 in 100 patients

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

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

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.

Mental and behavioural disorders:

• Uncommon:anxiety, difficulty falling asleep (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:sinus node block, heart failure (congestive heart failure), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

• Common:flushes.
• Uncommon:postural hypotension (dizziness or fainting when standing up) associated or not with dizziness.
• Frequency not known:vasculitis (diseases that involve inflammation of the blood vessels) including leucocytoclastic vasculitis.

Respiratory, thoracic and mediastinal disorders:

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

Gastrointestinal disorders:

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

Hepatobiliary disorders:

• Uncommon:initially elevated liver enzyme levels in the blood during treatment. These elevations are generally transient.
• Frequency not known:hepatitis (inflammatory disease of the liver)

Skin and subcutaneous tissue disorders:

• Common:erythema (redness of the skin)
• Rare:urticaria (hives)

• Frequency not known:photosensitivity, pharyngitis, lips and respiratory tract edema (angioneurotic edema), rash, erythema multiforme (severe skin disease associated with red patches and blisters), including cases of Stevens-Johnson syndrome (severe skin and mucous membrane vesiculation), toxic epidermal necrolysis (peeling skin disease), sweating, exfoliative dermatitis (redness of the skin, itching, hair loss), acute generalized pustular exanthema (sudden rash accompanied by fever, with formation of small, inflamed, pus-filled lesions on the skin surface), occasionallyerythema desquamativum with or without fever.A condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin eruptions (called"lupus-like syndrome").

Drug-induced skin eruption that may appear on the skin or mouth (drug-induced lichenoid eruption).

Reproductive and breast disorders:

• Frequency not known:excessive breast volume in men (gynaecomastia).

General disorders and administration site conditions:

• Very common:lower limb oedema.
• Common:unwell feeling.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of 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 Masdil 60 mg

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

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

Appearance of the product and contents of the packaging

Masdil 60 mg tablets are presented in the form of white, circular, flat, bisected, scored tablets on one side and with the anagram "Masdil 60" on the other, in packaging containing 30, 60 tablets and 500 tablets (clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet: February 2025

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