DILTIAZEM PENSA 60 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diltiazem Pensa 60 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.Because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Diltiazem Pensa and what is it used for
2. What you need to know before taking Diltiazem Pensa
3. How to take Diltiazem Pensa
4. Possible side effects
5. Storage of Diltiazem Pensa
6. Contents of the pack and further information

1. What is Diltiazem Pensa and what is it used for

Diltiazem Pensa belongs to a group of medications called selective calcium channel blockers, which produce a 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.

Diltiazem is indicated for:

• Treatment and prevention of angina pectoris, including Prinzmetal's angina (vasospastic angina).
• Treatment of high blood pressure.

2. What you need to know before taking Diltiazem Pensa

Do not take Diltiazem Pensa

• If you are allergic to the active substance or any of the other ingredients of this medication (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 taking a medication that contains ivabradina for the treatment of certain heart diseases.
• If you are already taking a medication that contains lomitapida, used to treat high cholesterol levels (see section: "Other medications and Diltiazem Pensa; contraindicated combinations").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Pensa.

• If you have a history of heart failure, 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.
• If you have heart conditions such as left ventricular failure, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram, your doctor will need to closely monitor you.
• In the event of general anesthesia, you should inform the anesthesiologist that you are being treated with this medication.
• If you are an elderly patient or have kidney or liver disease (renal or hepatic insufficiency), diltiazem blood levels may be higher, so your doctor will need to closely monitor your 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 medications 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 increases. You should inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medication.
• If you have a history of bradycardia (slow heart rate), low blood pressure, heart failure, or difficulty breathing, as cases of kidney damage have been reported in patients with these conditions.

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

Other medications and Diltiazem Pensa

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

Certain medications may interact with Diltiazem Pensa. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications:

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

Contraindicated combinations:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (in perfusion) is contraindicated.
• Ivabradina (see section "Do not take Diltiazem Pensa").
• Medications that contain lomitapida, used to treat high cholesterol levels. Diltiazem may increase lomitapida concentrations, which may lead to an increased risk and severity of side effects related to the liver.

Combinations that require caution:

Medications 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 start of treatment.
• Amiodarone and digoxin, as they increase the risk of bradycardia. Caution is necessary, especially in elderly patients and when using high doses.
• Other antiarrhythmic medications, as diltiazem has antiarrhythmic properties, and 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 medications increases the amount of these medications in the blood, so your doctor will need to adjust the dose during treatment with diltiazem:

• Cyclosporine (immunosuppressive medication used in transplants),
• Phenytoin (medication for treating epilepsy). It is recommended to monitor phenytoin plasma concentrations when administered concomitantly with diltiazem.
• Carbamazepine (medication for treating epilepsy),
• Theophylline (medication for asthma).
• H2 antagonists (cimetidine and ranitidine, medications for treating stomach ulcers), as they increase the amount of diltiazem in the blood, so either treatment with these medications will be discontinued or the daily dose of diltiazem will be adjusted.
• Rifampicin (antibiotic used to treat tuberculosis and some infections), which may decrease the amount of diltiazem in the blood, so your doctor will need to 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 concomitant diltiazem and X-ray contrast medium.
• Lithium (medication for treating mental health problems), as it may increase lithium toxicity. Your doctor will closely monitor your lithium blood levels.

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

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

• Patient monitoring is recommended for those 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), which are medications with sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant effects, as diltiazem increases the amounts of these medications in the blood, prolonging their duration of action in the body. Your doctor will be particularly cautious when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.

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

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

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

Children and adolescents

Diltiazem Pensa 60 mg is not a suitable medication for children.

Taking Diltiazem Pensa with food, drinks, and alcohol

It is recommended to take this medication preferably before meals.

Avoid consuming grapefruit juice (see the section "Other medications and Diltiazem Pensa").

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 medication.

This medication should not be administered to pregnant women or 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 with an alternative method.

Driving and using machines

Based on the side effects reported with the use of Diltiazem Pensa, such as dizziness (frequent) and discomfort (frequent), the ability to drive and operate machinery may be impaired, although no studies have been conducted on this.

Diltiazem Pensa contains lactose and hydrogenated castor oil

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

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

3. How to take Diltiazem Pensa

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor again.

Diltiazem is administered orally. Your doctor will indicate the duration of your treatment.

Prevention and treatment of angina pectoris:

The recommended dose is 1 tablet every 8 hours (three times a day), preferably taken before meals.

• Hypertension:

Treatment of hypertension should be started with half (1/2) 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 patients with kidney or liver disease

Since diltiazem blood levels may be higher in these cases, 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 explicit advice from your doctor.

If you take more Diltiazem Pensa than you should

If you have taken more diltiazem than you should, consult your doctor or pharmacist immediately, or call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and package leaflet of the medication to the healthcare professional.

Taking too much diltiazem may cause a significant decrease in blood pressure (leading to collapse), slowing of the heart rate, sinus arrest, changes in cardiac conduction, cardiac arrest, decreased renal function, and renal failure.

In the event of a significant overdose, the patient should be taken 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 Diltiazem Pensa

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 dose at the usual time. However, if it is almost time for the next dose or it is close to it, do not take the missed tablet.

If you stop taking Diltiazem Pensa

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

If you stop taking diltiazem, you may experience a worsening of your condition.

If you have any other questions about the use of this medication, 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 frequent: may affect more than 1 in 10 patients

Frequent: may affect up to 1 in 10 patients

Infrequent: 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:

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

Disorders of the nervous system:

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

Cardiac disorders:

• Frequent: atrioventricular block (a type of arrhythmia), palpitations.
• Infrequent: 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:

• Frequent: hot flashes.
• Infrequent: drop 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 worsening of asthma).

Gastrointestinal disorders:

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

Hepatobiliary disorders:

• Infrequent: 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:

• Frequent: skin redness (erythema)
• Rare: skin irritation and itching (urticaria)
• Frequency not known: sensitivity to light (photosensitivity), inflammation of the throat, lips, and respiratory tract (angioneurotic edema), 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 (exfoliative disease of the skin), 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 exfoliative 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").

Disorders of the reproductive system and breast:

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

General disorders and administration site conditions:

• Very frequent: edema in the lower limbs.
• Frequent: 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 Diltiazem Pensa

It does not require special storage conditions.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging (after Exp. 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 that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Diltiazem Pensa

The active ingredient is diltiazem hydrochloride. Each tablet contains 60 mg of diltiazem hydrochloride.

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

Appearance of the product and package contents

Diltiazem Pensa tablets are white, circular, flat, beveled, and scored on one side.

The tablets are presented in blisters containing 30 and 60 tablets.

Marketing authorization holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (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: March 2023

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