Prospecto:Information for the Patient

Lacerol Retard 90 mg Hard Capsules with Prolonged Release

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 read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people,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 Lacerol Retard 90 mg Capsules are and for what they are used

2.What you need to knowbeforestarting totake Lacerol Retard 90 mg Capsules

3.How to take Lacerol Retard 90 mg Capsules

4.Possible adverse effects

1. Storage of Lacerol Retard 90 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 of 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 90 mg”).

-if you have atrial fibrillation or atrial 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 are 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 by electrocardiogram, 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 the same group, can cause a decrease in intestinal movement.
• if you have diabetes mellitus, as diltiazem can increase blood sugar levels.
• if you have acute porphyria.
• This may lead to dermatological alterations that may be transient and disappear even if treatment continues. In rare cases, more severe skin eruptions have been reported, in which case the medication should be discontinued. If the dermatological 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 periodic 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, 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 duration 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 explicitly recommends it.

Children

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

Other medications andLacerol Retard 90 mg

Inform your doctor orpharmacistifyouare taking,havetakenrecentlyormayhavetotakeanyothermedication.

Certain medications may interact with Lacerol Retard 90 mg. In these cases, it may be necessary to change the dose or discontinue treatment with one of the medications.

Contraindicated use:

This medication 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, which may lead to an increase in the likelihood 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 weakness, fatigue, 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, consultyour doctor or pharmacist before using this medication.

Lacerol Retard 90 mgshould not be administered to pregnant womenor 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 90 mgcontains saccharose.

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him 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 90 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 achieved.

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 achieved.

Elderly patients, renal or hepatic insufficiency:

The initial dose adjustment should be done with caution.

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

If you take moreLacerol Retard 90 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 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 90 mg

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

If you interrupt treatment with Lacerol Retard 90mg

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 stop 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 90 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, and third-degree A-V block, palpitations, bradycardia).
• Nausea, constipation, indigestion, stomach pain.
• Skin rashes, skin redness (erythema).
• Headache, dizziness.
• Joint swelling.

Uncommon:may affect up to 1 in 100 patients

• Weight loss.
• Low blood pressure caused by sudden changes in body position (orthostatic hypotension), low blood pressure (hypotension).
• Chest pain (angina), irregular heartbeats (arrhythmias), rapid heartbeats (tachycardia), slow heartbeats (bradycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), heart muscle hypotonia, 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 rash (exanthema), increased sensitivity to light (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

• Changes in the electrocardiogram.
• 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 disorders (extrapyramidal symptoms), vasculitis, pallor, arrhythmias such as sinus pause (sinus arrest), asystole, atrial flutter, ventricular tachycardia, and ventricular fibrillation, gingival hyperplasia (inflammation of the gums), dental anomalies, intestinal paralysis (ileus), angioneuritic edema (swelling of the skin, mucous membranes, and submucosal tissues), sweating, acute generalized pustular exanthema (sudden rash accompanied by fever, with formation of pus-filled lesions on the skin), 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 rashes).

After marketing and infrequently (without demonstrating a 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.

Medications should not be thrown into the drains or 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. In this way, you will help protect the environment.

Composition of Lacerol Retard 90 mg

• The active ingredient is diltiazem hydrochloride. Each capsule contains 90 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, iron oxide red, iron oxide yellow, iron oxide black, and titanium dioxide (E171).

Appearance of the product and content of the packaging

Lacerol Retard 90 mg prolonged-release hard capsules are hard gelatin capsules with a light brown opaque cap and a transparent body

Lacerol Retard 90 mg prolonged-release hard capsules are presented in PVC/Aluminum blisters containing 60 capsules

Holder of the marketing authorization

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Date of the last review of this leaflet: April 2023

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