MASDIL 60mg TABLETS

Introduction

Package Leaflet: Information for the User

Masdil 60 mg Tablets

Diltiazem Hydrochloride

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 Masdil 60 mg is and what it is used for
2. What you need to know before you take 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 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 produce dilation of blood vessels, leading to 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 angina)

Treatment of high blood pressure.

2. What you need to know before you take 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 any heart rhythm or conduction disorders, 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 less than 40 beats per minute).
• if you have any heart disease, such as left ventricular failure with pulmonary congestion.
• if you are being treated with dantrolene (in perfusion).
• if you are already taking a medicine that contains ivabradine used to treat certain heart conditions.
• if you are already taking a medicine that contains 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 detected by electrocardiogram, your doctor will need to monitor you closely.
• If you are taking anticoagulants such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) with Masdil 60 mg.
• In the event of general anesthesia, you should inform the anesthesiologist that you are being treated with this medicine.
• If you are an elderly patient or have kidney or liver disease (renal or hepatic insufficiency), diltiazem blood levels may be higher, so you will need to be closely monitored for heart rate at the start of treatment.
• If you experience mood changes, including depression, inform your doctor.
• If you are at risk of developing intestinal obstruction, as diltiazem, like other medicines in the same group, can cause a decrease in intestinal movement.
• If you have latent or overt diabetes mellitus. Close monitoring is necessary 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 increase. You should inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medicine.
• If you have a history of heart failure, new 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.

Avoid sun exposure during treatment, as photosensitivity reactions (skin spots) may occur.

Taking Masdil 60 mg with other medicines

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

Certain medicines may interact with Masdil 60 mg. In these cases, it may be convenient to change the dose or interrupt treatment with one of the medicines.

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

Contraindicated combinations:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (in perfusion) is contraindicated.
• Ivabradine (see section "Do not take Masdil 60 mg").
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide levels, which may lead to an increased risk 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 for cardiovascular problems, such as:

• Alpha blockers, as they increase the hypotensive effect (decrease in blood pressure)
• Beta blockers, as they may cause heart disorders. This combination should only be used if clinically monitored and by electrocardiogram, especially at the beginning of treatment.
• A increase in the risk of depression has been observed when diltiazem is administered with beta blockers (see section 4 Possible side effects).
• Amiodarone, digoxin, as they increase the risk of bradycardia. Caution is necessary, especially in elderly patients and when using high doses.
• Other antiarrhythmic medicines, as diltiazem has antiarrhythmic properties, so there is a risk of increased cardiac side effects. This combination should only be used if clinically monitored and by electrocardiogram.
• Nitrate derivatives, as they may increase the hypotensive effect and cause dizziness.

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

• Cyclosporin (immunosuppressive medicine used in transplants).
• Phenytoin (medicine for treating epilepsy). It is recommended to monitor phenytoin plasma concentrations when administered with diltiazem.
• Carbamazepine (medicine for treating epilepsy).
• Theophylline (medicine for asthma).
• H2 antagonists (cimetidine and ranitidine, medicines for treating stomach ulcers), as they produce an increase in diltiazem blood levels, so either treatment with these medicines will be interrupted or the daily dose of diltiazem will be adjusted.
• Rifampicin (antibiotic used to treat tuberculosis and some infections), which may decrease diltiazem blood levels, so your doctor will closely monitor you.
• X-ray contrast medium: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when administered an intravenous bolus of an ionic X-ray contrast medium. Special caution is required in patients who receive diltiazem and an X-ray contrast medium concomitantly.
• Lithium (medicine for treating mental health problems), as it may increase lithium toxicity. Your doctor will closely monitor your lithium blood levels.
• Colchicine. Masdil 60 mg may cause an increase in colchicine levels (medicine used to treat gout) when administered concomitantly.
• Masdil 60 mg may increase the risk of bleeding if taken with anticoagulants such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban).
• Masdil 60 mg may cause prolongation of the QT interval (ECG changes, such as changes in heart rate or rhythm, with symptoms of dizziness) when administered with medicines that have the potential to prolong the QT interval.

General information to be considered:

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

• Antiplatelet medicines (medicines that prevent blood cells called "platelets" from aggregating and forming a clot): the possibility of an additive effect on platelet aggregation of diltiazem and antiplatelet medicines (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered.

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

• Patients who consume grapefruit juice should be monitored, as they 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 the amounts of these medicines in the blood, prolonging their stay in the body. Your doctor will be especially careful when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.

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

• Statins (medicines used to lower cholesterol), as diltiazem greatly increases the amount of some statins in the blood, which could lead to statin toxicity problems.

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

Children and adolescents

Masdil 60 mg is not a suitable medicine for children.

Taking Masdil 60 mg with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

Grapefruit juice should be avoided (see the section "Taking Masdil 60 mg with other medicines").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and using machines

Based on the side effects reported with the use of Masdil 60 mg, such as dizziness (frequent) and malaise (frequent), the ability to drive and use machines may be impaired, although no studies have been conducted on this.

Masdil 60 mg contains hydrogenated castor oil and lactose

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

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

3. How to take Masdil 60 mg

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of 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), administered preferably before meals.

Hypertension: The treatment of hypertension should be started 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 necessary.

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

Since in these cases, diltiazem blood levels may be higher, your doctor will need to consider adjusting the dose at the start of treatment.

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

It is not recommended to substitute diltiazem specialties with each other unless you receive express 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 Toxicology Information Service, phone: 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. Bring the medicine package 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, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

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

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

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 make up for forgotten 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 close to it, do not take the missed tablet.

If you stop taking Masdil 60 mg

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

If you stop taking Masdil 60 mg, you may experience worsening of your disease.

If you have any other 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 all people suffer from them.

The following adverse 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 the available data)

Disorders of the Blood and Lymphatic System:

• Frequency not known:thrombocytopenia.

Disorders of Metabolism and Nutrition:

• Frequency not known:hyperglycemia.

Psychiatric Disorders:

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

Disorders of the Nervous System:

• 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), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular Disorders:

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

Respiratory, Thoracic, and Mediastinal Disorders:

-Frequency not known: bronchospasm (including exacerbation of asthma).

Gastrointestinal Disorders:

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

Hepatobiliary Disorders:

• Uncommon:increase in liver enzyme levels in the blood during the initial treatment period. These elevations are generally transient.
• Frequency not known:hepatitis (inflammatory disease that affects the liver)

Disorders of the Skin and Subcutaneous Tissue:

• Common:skin redness (erythema)
• Rare:skin irritation and itching (urticaria)

• Frequency not known:sensitivity to light (photosensitivity), inflammation of the throat, lips, and respiratory tract (angioedema), rash, erythema multiforme (severe skin disease associated with red spots, blisters), including cases of Stevens-Johnson syndrome (severe vesicular reactions of the skin and mucous membranes), toxic epidermal necrolysis (skin disease that causes peeling), sweating, exfoliative dermatitis (redness, itching, hair loss), acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface that are characterized by being small, inflamed, filled with pus, and similar to a blister), occasionally erythema with or without fever. Condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed 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).

Disorders of the Reproductive System and Breast:

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

General Disorders and Administration Site Conditions:

• Very common:edema in the lower limbs.
• Common:discomfort.

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Masdil 60 mg

It does not require special storage conditions.

Keep out of sight and reach of children.

Do not use this medicine 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 thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need at 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 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 castor oil, carboxymethylcellulose, magnesium stearate, silicon dioxide.

Appearance of the Product and Package Contents

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

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 Last Revision of this Prospectus: February 2025

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