Prospecto:Information for the Patient

Lacerol Retard120 mg Extended-Release Hard Capsules

diltiazem hydrochloride

Read this entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.See section 4

1.What is Lacerol Retard 120 mg capsules and for what it is used

2.What you need to knowbeforestarting totakeLacerol Retard 120 mg capsules

3.How to takeLacerol Retard 120 mg capsules

4.Possible adverse effects

1. Storage ofLacerol Retard 120 mg capsules

6.Contents of the package and additional information

Preventive treatment of angina attacks and treatment ofhigh blood pressure (hypertension).

Do not take this medication:

-if you are allergic to diltiazem hydrochloride or any of the other ingredients in this medication (listed in section 6).

-in case of shock

-in case of decompensated heart failure

-if you have severe hypotension

-if you are experiencing an acute myocardial infarction

-if you have pulmonary congestion (radiographically confirmed) or certain cardiac rhythm disorders (bradycardia –less than 40 beats per minute-, blockage, second or third degree, sinus node disease)

-if you are being treated with dantrolene in infusion (a medication to relax muscles).

-if you are already taking a medication containing ivabradina for the treatment of certain heart diseases

-if you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section: “Other medications and Lacerol Retard 120 mg”).

-if you have atrial fibrillation or flutter and simultaneous presence of the Wolff-Parkinson-White syndrome (a type of conduction disorder of the cardiac electrical stimulus)

-if you have left ventricular insufficiency with pulmonary congestion

-if you are pregnant or think you may be pregnant

-if you are breastfeeding,

- if you are a woman of childbearing age and not using an effective contraceptive method

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• if you have heart conditions such as left ventricular insufficiency, bradycardia (slow heart rate) or first-degree atrioventricular blockage (a type of arrhythmia) detected electrocardiographically, your doctor will need to closely monitor you.
• in the case of general anesthesia, you must 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 diltiazem concentrations in the blood may be higher, so you will need to closely monitor your heart rate at the beginning of treatment.
• if you perceive mood changes or have a risk of depression.
• if you have a risk of developing intestinal obstruction, as this medication, like others in its group, reduces intestinal movement.
• if you have diabetes mellitus, as diltiazem may increase blood sugar levels.
• if you have acute porphyria.
• This may cause transient and reversible skin alterations, although they may persist even if treatment continues. In rare cases, more severe skin reactions have occurred, requiring the withdrawal of the medication. If the skin reaction does not disappear, consult your doctor.
• This may cause an increase in liver enzymes, which is usually reversible if treatment is discontinued. Your doctor will perform regular checks.
• This may cause hypotension
• If you have a history of heart failure, difficulty breathing, slow heart rate, or low blood pressure. Cases of renal damage have been reported in patients with these conditions, and your doctor may need to monitor your renal function.

Do not forget that for this medication to be effective, you must take it regularly and for as long as your doctor has instructed, even if the treatment period is long.

You must strictly follow the dosage, without reducing or increasing it except on the instructions of your doctor.

Since the therapeutic effect of the different specialties with diltiazem in retard form has not been compared, it is not recommended to substitute one for another unless your doctor specifically recommends it.

Children

This medication should not be used in children, as it has not been sufficiently studied in these patients.

Other medications andLacerol Retard 120 mg

Informyour doctor orpharmacistifyouare taking,have takenrecentlyor may need to take any other medication.

Certain medications may interact with Lacerol Retard 120 mg. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

Contraindicated use:

Diltiazem should not be used with dantrolene or ivabradina.

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

Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, leading to an increased risk and severity of liver-related side effects.

Effects of other drugs on Lacerol

The following medications may increase the effects of Lacerol by increasing its concentration in the blood:

• fluconazole (used to treat fungal infections)
• erythromycin and other macrolides (antibiotics)
• ritonavir (used to treat viral infections)
• amiodarone (used to slow the heart rate)
• cimetidine and ranitidine (used to reduce stomach acid production)

The following medications may decrease the effects of Lacerol by reducing its concentration in the blood:

• phenytoin (used to treat epilepsy)
• St. John's Wort (used in cases of fatigue, weakness, or sleep disturbances)
• rifampicin (antibiotic)

Effects of Lacerol on other drugss

Lacerol may increase the effects of the following medications by increasing their concentrations in the blood or potentiating their effect:

• phenytoin, carbamazepine (used to treat epilepsy)
• triazolam, midazolam, buspirone (used to treat anxiety)
• digoxin (used to treat heart diseases)
• ciclosporin, sirolimus (used to suppress the immune system)
• midazolam, triazolam (used to induce sleep)
• prednisolone (corticosteroid used to treat inflammatory problems)
• simvastatin and lovastatin (medications to reduce cholesterol levels in the blood)
• theophylline (used to treat asthma)
• anticoagulant oral medications, such as acenocoumarol or warfarin
• rifampicin (antibiotic)

• medications used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to slow the heart rate (amiodarone)

• anesthetics
• lithium salts (used to treat certain mental health conditions): may increase the risk of intense agitation (psychotic episodes)

The concomitant use of Lacerol with other medications should be carried out under medical supervision and with progressive dose adjustments.

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.

Lacerol Retard 120 mgshould 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 lactation, 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

At the beginning of treatment, it is advisable not to perform tasks that require special attention until the response to the medication is satisfactory.

Lacerol Retard 120 mgcontains saccharose.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, 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 again.

TheLacerol Retard 120 mgcapsules should be swallowed whole with a little water or with food.

Adults:

Angina pectoris:The usual initial dose is 90 mg twice a day. If necessary, the dose can be gradually increased to 120 mg twice a day, or to 180 mg twice a day. Your doctor will gradually increase the dose until the optimal response is obtained.

Hypertension:The initial dose is 120-180 mg per day. Although each patient may respond to a different dose, the usual maintenance dose range is between 180 mg and 360 mg per day. Your doctor will gradually increase the dose until the optimal response is obtained.

Elderly patients, renal or hepatic insufficiency:

The initial dose adjustment should be done with caution.

All dose modifications and monitoring will be performed under medical supervision.

If you take moreLacerol Retard 120 mgthan 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

If you forgot to takeLacerol Retard 120 mg

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

If you interrupt treatment with Lacerol Retard 120mg

If you interrupt treatment with Lacerol Retard, you may experience a worsening of your disease, presenting symptoms such as chest pain or a sudden increase in blood pressure. Do not interrupt treatment with this medication without consulting your doctor first. If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications,Lacerol Retard 120 mgmay 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

• Swelling of hands, feet, or ankles (peripheral edema).

Common:may affect up to 1 in 10 patients

• Swelling (edema).
• Weakness (asthenia).
• General discomfort.
• Redness (rubefaction).
• Mild, moderate, or severe disruption or alteration of the heart's electrical signal (first, second, or third-degree AV block, palpitations, bradycardia).
• Nausea, constipation, indigestion, stomach pain.
• Skin eruptions, skin redness (erythema).
• Headache, dizziness.
• Joint swelling.

Uncommon:may affect up to 1 in 100 patients

• Sedation.
• Orthostatic hypotension, low blood pressure (hypotension).
• Chest pain, irregular heartbeats (arrhythmias), rapid heartbeats (tachycardia), slow heartbeats (bradycardia), abnormal heart contractions (ventricular extrasystoles), congestive heart failure with generalized swelling (congestive heart failure), hypotonia of the heart muscle, sinoatrial block.
• Abnormal loss of appetite (anorexia), burning sensation, diarrhea, taste alterations (dysgeusia), vomiting, dry mouth.
• Liver function test alterations, elevated lactate dehydrogenase (LDH) enzyme, elevated creatine phosphokinase (CPK) enzyme, and elevated bilirubin in blood tests.
• Small red spots on the skin (petechiae), itching (pruritus), skin eruptions (exanthema), light sensitivity (photosensitivity), urticaria, lesions on the skin typically circular, with a red center, pale ring, and outer ring of reddish color (erythema multiforme).
• Difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesias), tendency to fall asleep (somnolence), tremors, vertigo.
• Tinnitus (ringing in the ears).
• Depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that are not there while awake) and personality alterations.
• Elevated blood glucose levels (hyperglycemia).
• Decreased vision (amblyopia), eye irritation.
• Joint pain.
• Nocturia (needing to urinate at night) and increased frequency of urination (polyuria).
• Enlarged lymph nodes (lymphadenopathy) and increased eosinophils (a type of white blood cell).
• Dyspnea (difficulty breathing), nasal bleeding (epistaxis), nasal congestion.
• Sexual function alterations.
• Elevated liver enzymes (transaminases).

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

• Electrocardiogram changes.
• Prolonged bleeding time.
• Toxic epidermal necrolysis, acute skin reaction with increased sensitivity in mucous membranes (Stevens-Johnson syndrome), generalized acute pustular exanthematous dermatitis.
• Male breast enlargement (gynecomastia), painful menstruation (dysmenorrhea), vaginal inflammation (vaginitis), prostatitis.

Frequency not known(cannot be estimated from available data)

• Fever, movement and walking disorders (extrapyramidal symptoms), vasculitis, pallor, arrhythmias such as sinus pause (sinus arrest), cardiac asystole, atrial flutter, ventricular tachycardia, and ventricular fibrillation, gingival hyperplasia, dental anomalies, intestinal paralysis (ileus paralytic), angioneurotic edema, sweating, acute generalized pustular exanthema (sudden eruption accompanied by fever, with formation of pus-filled lesions on the skin surface), dermatitis exfoliativa (inflammation of the skin with peeling, with or without fever), erythema desquamativum (redness of the skin with peeling), purpura, cutaneous hypertrophy, amnesia, syncope (temporary loss of consciousness), myoclonus (sudden, involuntary muscle contractions), muscle hypertonia, mood changes (including depression), confusion, decreased appetite, gout, blurred vision, non-inflammatory retinopathy (retinopathy), muscle pain (myalgia), musculoskeletal pain, bursitis (inflammation of the joints), cystitis (inflammation of the urinary bladder), kidney stones (nephrolithiasis), thrombocytopenia (abnormal decrease in platelet count), hemolytic anemia (abnormal decrease in red blood cell count), increased cough, rhinitis (inflammation of the nasal mucosa and sinuses), pharyngitis (inflammation of the pharynx), bronchitis (inflammation of the bronchi), hepatitis (inflammation of the liver), granulomatous hepatitis (a specific type of liver inflammation), and lupus-like syndrome (a condition in which the body's defense system attacks normal tissue, causing symptoms such as joint inflammation, fatigue, and skin eruptions).

After marketing, and infrequently (without a demonstrated cause-and-effect relationship), the following adverse events have been reported in patients treated with diltiazem: alopecia (hair loss) and leukopenia (decreased white blood cell count).

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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No requires special conditions for conservation.

Keepthis medicationout of sightand out of reachof children.

Do not usethis medicationafter 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 down the drains or in the trash. Dispose of the packaging and medications you no longer need at theSIGREcollection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacerol Retard 120 mg

• The active ingredient is diltiazem hydrochloride. Each capsule contains 120 mg of diltiazem (as diltiazem hydrochloride).
• The other components are sucrose, cornstarch, polyvinylpyrrolidone (E 1201), sodium lauryl sulfate, cetyl alcohol, ethylcellulose (E462), dibutyl sebacate, talc (E553b). Composition of the capsule : gelatin, yellow iron oxide, and titanium dioxide (E171).

Appearance of the product and contents of the packaging

Lacerol Retard 120 mg prolonged-release hard capsules are hard gelatin capsules with a yellow cap and transparent body

Lacerol Retard 120 mg prolonged-release hard capsules are presented in PVC/Aluminum blisters containing 60 capsules

Marketing Authorization Holder

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Last review date of this leaflet: April 2023

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