Leaflet: information for the user

Diltiazem pensa 60 mg tablets EFG

Read this 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 yourdoctor or pharmacist.
• This medicine has been prescribed for youonlyand should not be given to others even if they havethe same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor or pharmacist, evenif they are not listed in this leaflet. See section 4.

1. What isDiltiazem Pensaand what it is used for

2. What you need to know before you start takingDiltiazem Pensa

3. How to takeDiltiazem Pensa

4. Possible side effects

5. Storage ofDiltiazem Pensa

6. Contents of the pack and additional information

Diltiazem Pensabelongs to a group of medications called calcium channel blockers, which produce a dilation of 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

Diltiazem is indicated for:

- Treatment and prevention of chest pain (angina), including Prinzmetal's angina (vasospastic).

- Treatment of high blood pressure.

No take Diltiazem Pensa

• If you are allergic to the active ingredient or any of the other components 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 (intravenous).
• If you are already taking a medication that contains ivabradina for the treatment of certain heart diseases.
• If you are already taking a medication that contains lomitapida used for the treatment of 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, new difficulty breathing, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, and your doctor may need to monitor your kidney function.

- 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 undergoing general anesthesia, 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), the concentration of diltiazem in the blood may be higher, and you 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 this group, can cause a decrease in intestinal motility.

- If you have diabetes mellitus, latent or manifest. You will need to have a strict control in these patients due to the possible increase in blood glucose levels.

- The use of diltiazem can induce bronchospasm, including the worsening of asthma, especially in patients with pre-existing bronchial hyperreactivity. Cases have also 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 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.

No recommend exposure to the sun during treatment as it may cause photosensitivity reactions (skin rashes).

Other medications and Diltiazem Pensa

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

Contraindicated combinations:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (intravenous) is contraindicated.
• Ivabradina (see section “Do not take Diltiazem Pensa”).
• Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which can lead to an increased risk and severity of liver-related side effects.

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 cardiac arrhythmias. This combination should only be used if you are closely monitored clinically and by electrocardiogram, especially at the beginning of treatment

- Amiodarone and 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, which may increase the risk of cardiac side effects. This combination should only be used if you are closely monitored clinically 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, and your doctor will need to adjust the dose during treatment with diltiazem:

- Cyclosporine (immunosuppressive medication used in transplants),

- Phenobarbital (medication for epilepsy). It is recommended to monitor phenobarbital plasma concentrations when administered concomitantly with diltiazem

- Carbamazepine (medication for epilepsy),

- Theophylline (medication for asthma)

- H2 antagonists (cimetidine and ranitidine medications for stomach ulcers), as they increase the amount of diltiazem in the blood, and either the treatment with these medications will be discontinued, or the daily dose of diltiazem will be adjusted

- Rifampicin (antibiotic used for the treatment of tuberculosis and some infections), which may decrease the amount of diltiazem in the blood, and 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

- Lithium (medication for mental health problems), as it may increase the toxicity of lithium. Your doctor will closely monitor your lithium levels in the blood

General information to consider:

- 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 effects on platelet aggregation of diltiazem and antiplatelet medications (such as aspirin, 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 medications administered with it.

- 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 medications with sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant effects, as diltiazem increases the amounts of these medications in the blood, prolonging their time in the body. Your doctor will take special care when prescribing benzodiazepines (especially those with short action) if you are taking diltiazem.

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

- Statins (medications used to lower cholesterol levels), as diltiazem increases the amount of some statins in the blood, which may cause problems with statin toxicity.

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

Children and adolescents

Diltiazem Pensa 60 mg is not an appropriate medication for children.

Taking Diltiazem Pensa with food, drinks, and alcohol

It is recommended to take this medication preferably before meals.

Avoid taking grapefruit juice (see the section “Other medications and Diltiazem Pensa”).

Pregnancy, breastfeeding, 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 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 Diltiazem Pensa, such as dizziness (frequent) and discomfort (frequent), your ability to drive and operate machinery may be impaired, although no studies have been conducted on this.

Diltiazem Pensa contains lactose and 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.

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

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

Hypertension treatment should be initiated with half (1/2) tablet of 60 mg every 8 hours (3 times a day), that is, 90 mg of diltiazem per day. Your doctor may increase or decrease these doses if necessary.

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

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

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

It is not recommended to substitute diltiazem specialties among them unless you receive explicit recommendation 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 the medication leaflet to the healthcare professional.

A high dose of diltiazem may cause a significant decrease in blood pressure (which may lead to collapse), slowing of heart rate, sinus arrest, cardiac conduction disturbances, cardiac arrest, decreased renal function, and renal insufficiency.

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

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

If you forgot to take Diltiazem Pensa

Do not take a double dose to compensate for the missed doses.

If you forgot 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 the treatment with Diltiazem Pensa

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

If you interrupt the treatment with diltiazem, 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 may 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:flushing.

-Uncommon:postural hypotension (dizziness or fainting when standing up) associated or not with dizziness.

-Frequency not known:vasculitis (inflammation of 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, diarrhea.

-Rare:dry mouth.

-Frequency not known:gingival hyperplasia (inflammation of the hard palate).

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 liver disease)

Skin and subcutaneous tissue disorders:

-Common:skin redness (erythema)

-Rare:skin irritation and itching (urticaria)

-Frequency not known:photosensitivity, inflammation of the throat, lips, and respiratory tract (angioneuritic 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 (skin redness, itching, hair loss), acute generalized pustular exanthema (sudden rash accompanied by fever, with the formation of small, inflamed, pus-filled lesions on the skin surface), occasionally erythema 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").

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:uncomfortable 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 through the Spanish 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 requires special conservation conditions.

Keep this medication out of the sight and reach of children.

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

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

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 content of the packaging

Diltiazem Pensa tablets are white, circular, flat, bisected, and scored on one face.

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

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (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: March 2023

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