Uni-MasDil 200 mg prolonged-release capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

U ni-Masdil 200 mg prolonged-release capsules

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; do not give it to other people, even if they have the same symptoms, as 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 Uni-Masdil 200 mg is and what it is used for.

2. What you need to know before taking Uni-Masdil 200 mg.

3. How to take Uni-Masdil 200 mg.

4. Possible adverse effects.

5. How to store Uni-Masdil 200 mg.

6. Contents of the pack and other information.

1. What Uni-Masdil 200 mg is and what it is used for

Uni-Masdil 200 mg belongs to a group of medicines known as selective calcium channel blockers with direct cardiac effects, derived from benzothiazepine.

Uni-Masdil 200 mg is indicated for the preventive treatment of stable angina attacks. The prolonged-release formulation of Uni-Masdil 200 mg allows diltiazem to be absorbed over an extended period, enabling once-daily administration.

2. What you need to know before taking Uni-Masdil 200 mg

Do not take Uni-Masdil 200 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 Uni-Masdil 200 mg with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Uni-Masdil 200 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, close monitoring by your doctor will be necessary.

• If you are taking anticoagulants such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Uni-Masdil 200 mg.

• If you are elderly or have kidney or liver disease (renal or hepatic impairment), blood levels of diltiazem may be higher, so careful monitoring of heart rate is needed at the start of treatment.

• If you are undergoing general anesthesia, you must inform the anesthesiologist that you are being treated with this medicine.

• 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. Strict 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.

Taking Uni-Masdil 200 mg with other medicines

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

Certain medicines may interact with Uni-Masdil 200 mg. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

Combinations that are contraindicated:

• Dantrolene: the concomitant use of diltiazem with dantrolene (by infusion) is contraindicated.
• Ivabradine (see section “Do not take Uni-Masdil 200 mg”).
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could 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 used to treat cardiovascular conditions, such as:

• Alpha-blockers, as they may enhance the hypotensive effect (lowering of blood pressure).
• Beta-blockers, as cardiac disorders 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 together with beta-blockers (see section 4 Possible side effects).
• Amiodarone, digoxin, as they 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 adverse cardiac effects. This combination should only be used under clinical and electrocardiographic monitoring.
• Nitrate derivatives, as the hypotensive effect may be enhanced, leading to fainting.

The combination of diltiazem with the following medicines increases the blood levels of these medicines, so your doctor will need to adjust the dose 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 administered together 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, so either treatment with these medicines will be discontinued or your daily dose of diltiazem will be adjusted.

• Rifampicin (an antibiotic used to treat tuberculosis and certain infections), as it may reduce blood levels of diltiazem, so 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 concomitantly with X-ray contrast media.

• 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. Uni-Masdil 200 mg may lead to increased colchicine levels (a medicine used to treat gout) when administered concomitantly.

• Uni-Masdil 200 mg may increase the risk of bleeding if taken together with anticoagulants such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban).

• Uni-Masdil 200 mg may cause QT interval prolongation (ECG changes such as changes in heart rate or rhythm, with symptoms of dizziness) when administered together with medicines known or suspected to prolong the QT interval.

General information to consider:

• Due to possible additive effects, caution and careful evaluation are required when diltiazem is administered together 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, and 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 for increased 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 for severe allergies due to their immunosuppressive capacity, as diltiazem reduces the metabolism of methylprednisolone, so your doctor will monitor you closely and may need to adjust your methylprednisolone dose.

• 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

Uni-Masdil 200 mg is not suitable for children.

Taking Uni-Masdil 200 mg with food, drinks and alcohol

The pharmacological effect of Uni-Masdil 200 mg is not affected by food or drink. It can be taken before or during main meals, at any time of day, but it is recommended to take it at the same time each day.

Grapefruit juice should be avoided (see section “Taking Uni-Masdil 200 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 should not be given to pregnant women or women of childbearing age 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, your baby should be fed by an alternative method.

Driving and using machines

Based on the adverse effects reported with Uni-Masdil 200 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.

Uni-Masdil 200 mg contains sodium

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

3. How to take Uni-Masdil 200 mg

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

Remember to take your medication.

The route of administration of Uni-Masdil 200 mg is oral. The capsule must be swallowed whole, without being opened or chewed.

The dose you need will be determined by your doctor and will be individually adjusted for you. In general, the recommended doses are as follows:

• Adults: the daily dose will be one capsule of UNI-MASDIL 200 mg per day, i.e., 200 mg of diltiazem hydrochloride per day.

• Elderly patients: see the section “Warnings and precautions”.

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

Substitution between diltiazem products is not recommended unless you receive explicit advice from your doctor.

If you take more Uni-Masdil 200 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 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 breathing, which may develop up to 24–48 hours after ingestion.

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

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

If you forget to take Uni-Masdil 200 mg

Do not take a double dose to make up for missed 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 already time for the next dose or close to it, wait and take it at that time.

If you stop taking Uni-Masdil 200 mg

Your doctor will advise you on the duration of your treatment with Uni-Masdil 200 mg. Do not stop treatment prematurely.

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 gets 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: hyperglycaemia.

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 rapid standing, 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: increase in liver enzyme levels in the blood during the initial treatment period. These increases are usually transient.

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 (angioneuritic edema), erythema multiforme (a serious skin disease associated with red spots, blisters), including rare cases of Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes), toxic epidermal necrolysis (a skin disease characterized by skin peeling), sweating, exfoliative dermatitis (skin redness, itching, hair loss), and acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface that are small, inflamed, pus-filled, and blister-like), occasionally erythematous desquamation with or without fever. 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: edema in the lower limbs.

Common: malaise.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Uni-Masdil 200 mg

Store below 30ºC.

Do not use Uni-Masdil 200 mg after the expiry date stated on the packaging following EXP. The expiry date refers to the last day of the month indicated.

Keep out of sight and reach of children.

Medicines should 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 properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Uni-Masdil 200 mg prolonged-release capsules

• The active substance is diltiazem hydrochloride. Each prolonged-release capsule contains 200 mg of diltiazem hydrochloride.
• The other components are: microcrystalline cellulose, acrylic and methacrylic acid copolymers, ethylcellulose, sodium carmellose, diacetylated monoglycerides, magnesium stearate.

The gelatin capsule shell consists of: gelatin, titanium dioxide (E-171), iron oxide red (E-172), iron oxide black (E-172).

Appearance of the product and contents of the pack

Uni-Masdil 200 mg capsules have a white body and a pink cap. They are supplied in packs containing 28 prolonged-release capsules.

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.

Carrer de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the most recent revision of the 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 Health Products (AEMPS) http://www.aemps.gob.es /