LACEROL RETARD 120 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet:Information for the Patient

Lacerol Retard120 mg prolonged-release hard capsules

diltiazem hydrochloride

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lacerol Retard 120 mg capsules are and what they are used for
2. What you need to know before you take Lacerol Retard 120 mg capsules
3. How to take Lacerol Retard 120 mg capsules
4. Possible side effects
   1. Storage of Lacerol Retard 120 mg capsules

1. Contents of the pack and further information

1. What Lacerol Retard 120 mg capsules are and what they are used for

Preventive treatment of chest pain attacks and treatment of high blood pressure (arterial hypertension).

2. What you need to know before you take Lacerol Retard 120 mg capsules

Do not take this medicine:

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• in case of shock
• in case of unstable heart failure
• if you have severe hypotension
• if you have had a heart attack
• if you have pulmonary congestion (confirmed by X-ray) or certain heart rhythm disorders (bradycardia - less than 40 beats/minute -, block, of second or third degree, sick sinus syndrome)
• if you are being treated with dantrolene by infusion (a medicine to relax muscles).
• if you are taking a medicine containing ivabradine for the treatment of certain heart diseases
• if you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: "Other medicines and Lacerol Retard 120 mg").
• if you have atrial fibrillation or atrial flutter and simultaneous presence of the Wolff-Parkinson-White syndrome (a type of disorder in the conduction of the heart's electrical stimulus)
• if you have left ventricular failure with pulmonary congestion
• if you are pregnant or think you may be pregnant
• if you are breast-feeding,
• if you are a woman of childbearing age and are not using an adequate contraceptive method

Warnings and precautions

Talk to your doctor or pharmacist before starting this medicine:

• 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 case of general anesthesia, you should inform the anesthesiologist that you are being treated with this medicine.
• if you are an elderly patient or have kidney or liver disease (renal or hepatic insufficiency), diltiazem blood levels may be higher, so you will need to be closely monitored for heart rate at the start of treatment.
• if you notice mood changes or are at risk of depression.
• if you are at risk of developing an intestinal obstruction, as diltiazem, like other medicines 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.
• It can cause skin disorders that can be transient and disappear even if treatment is continued. In rare cases, more serious skin rashes have occurred, in which case the medicine should be withdrawn. If the skin reaction does not disappear, consult your doctor.
• It can cause an increase in liver enzymes, which is usually reversible if treatment is discontinued, your doctor will perform periodic checks.
• It can cause hypotension
• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, it is possible that your doctor will need to monitor your kidney function.

Do not forget that for this medication to be effective, it should be taken regularly and for as long as your doctor has indicated, even if the duration of treatment is long.

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

Since the therapeutic effect has not been compared between the different diltiazem specialties in retard form, it is not recommended to substitute one for another except on the express recommendation of the doctor.

Children

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

Other medicines and Lacerol Retard 120 mg

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

Certain medicines may interact with Lacerol Retard 120 mg. In these cases, it may be convenient to change the dose or interrupt treatment with one of the medicines.

Contraindicated use:

Diltiazem should not be used with dantrolene or ivabradina.

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

Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem can increase the concentration of lomitapide, which can lead to an increased probability and severity of liver-related side effects.

Effects of other medicines on Lacerol

The following medicines can 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 down the heart rate)
• cimetidine and ranitidine (used to decrease stomach acid production)

The following medicines can 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 exhaustion, fatigue, or sleep disorders)
• rifampicin (antibiotic)

Effects of Lacerol on other medicines

Lacerol can increase the effects of the following medicines by increasing their concentrations in the blood or by enhancing their effect:

• phenytoin, carbamazepine (used to treat epilepsy)
• triazolam, midazolam, buspirone (used to treat anxiety)
• digoxin (used to treat heart diseases)
• cyclosporine, sirolimus (used to suppress the immune system)
• midazolam, triazolam (used to induce sleep)
• methylprednisolone (corticosteroid used to treat inflammatory problems)
• simvastatin and lovastatin (medicines to lower cholesterol levels in the blood)
• theophylline (used to treat asthma)
• medicines that reduce blood clot formation (oral anticoagulants, such as acenocoumarol or warfarin)
• rifampicin (antibiotic)

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

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

The combined use of Lacerol with other medicines should be done under medical supervision and adjusting the doses progressively.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Lacerol Retard 120 mg should not be administered to pregnant women

or to women of childbearing age who are not using an effective contraceptive method.

This medicine should not be taken during breast-feeding, as it passes into breast milk. If the doctor considers it essential to take this medicine, the baby should be fed by an alternative method.

Driving and using machines

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

Lacerol Retard 120 mg contains sucrose.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Lacerol Retard 120 mg capsules

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The capsules of Lacerol Retard 120 mg should be swallowed whole with a little water or with food.

Adults:

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

Arterial 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 their monitoring will be done under medical supervision.

If you take more Lacerol Retard 120 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 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 package 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, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death

If you forget to take Lacerol Retard 120 mg

Do not take a double dose to make up for forgotten doses.

If you stop taking Lacerol Retard 120 mg

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

4. Possible side effects

Like all medicines, Lacerol Retard 120 mg can cause side effects, although not everybody gets them.

The following side effects have been reported according to the frequencies detailed below:

Very common: may affect more than 1 in 10 people

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

Common: may affect up to 1 in 10 people

• Swelling (edema).
• Weakness (asthenia).
• General malaise.
• Redness (flushing).
• Interruption or alteration of the heart's electrical signal of mild, moderate, or severe degree (first-, second-, or third-degree AV block, palpitations, bradycardia)
• Nausea, constipation, dyspepsia, gastric pain.
• Skin rashes, skin redness (erythema).
• Headache, dizziness.
• Joint swelling.

Uncommon: may affect up to 1 in 100 people

• Thirst.
• Low blood pressure caused by sudden changes in body position (orthostatic hypotension), low blood pressure (hypotension).
• Chest pain or tightness (angina), irregular heartbeats (arrhythmias), fast heartbeats (tachycardia), slow heartbeats (bradycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), cardiac muscle weakness, sinoatrial block.
• Loss of appetite (anorexia), burning sensation, diarrhea, taste alterations (dysgeusia), vomiting, dry mouth.
• Alterations in liver function tests, elevation of lactate dehydrogenase (LDH), elevation of creatine phosphokinase (CPK), and elevation of bilirubin in blood tests.
• Small red spots on the skin (petechiae), itching (pruritus), skin rash (exanthema), skin reaction to light (photosensitivity), hives, skin lesions usually circular and composed of a red center, pale ring, and outer red ring (erythema multiforme).
• Difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesias), tendency to fall asleep (somnolence), tremors, vertigo.
• Ringing in the ears (tinnitus).
• Depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while being awake), and personality changes.
• Elevation of blood glucose levels (hyperglycemia).
• Decreased vision (amblyopia), eye irritation.
• Joint pain.
• Need to urinate at night (nocturia) and increased frequency of urination (polyuria).
• Enlargement of lymph nodes (lymphadenopathy) and increase in a specific type of white blood cells (eosinophilia).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), nasal congestion.
• Sexual function disorders.
• Elevation of liver enzymes (transaminases).

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

• Changes in the electrocardiogram.
• Increased bleeding time.
• Skin disorder with blistering and peeling of the skin (toxic epidermal necrolysis), acute skin reaction with increased sensitivity in the mucous membranes (Stevens-Johnson syndrome), inflammation of the skin (generalized pustular exanthematous dermatitis).
• Enlargement of breast tissue in men (gynecomastia), painful menstruation (dysmenorrhea), vaginal inflammation (vaginitis), prostate disease.

Frequency not known (cannot be estimated from the available data)

• Fever, movement and walking disorders (extrapyramidal disorders), inflammation of blood vessels (vasculitis), paleness, alterations in heart rhythm such as: pause in sinus rhythm (sinus arrest), cardiac arrest (asystole), atrial flutter, ventricular tachycardia, and ventricular fibrillation, gum inflammation (gingival hyperplasia), tooth anomaly, paralysis of intestinal muscles (paralytic ileus), swelling of the skin, mucous membranes, and submucosal tissues (angioneurotic edema), sweating, acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to a blister), skin inflammation with peeling with or without fever (exfoliative dermatitis), skin redness with peeling (exfoliative erythroderma), purpura, skin thickening, memory loss (amnesia), temporary loss of consciousness (syncope), sudden involuntary muscle contractions (myoclonus), increased muscle tone (hypertonia), mood changes (including depression), confused state, decreased appetite, gout, blurred vision, non-inflammatory disease of the retina (retinopathy), muscle pain (myalgia), musculoskeletal pain, joint inflammation (bursitis), bladder inflammation (cystitis), kidney stones (nephrolithiasis), abnormal decrease in the number of circulating platelets in the blood (thrombocytopenia), abnormal decrease in the number of red blood cells (hemolytic anemia), increased cough, inflammation of the nasal mucosa and paranasal sinuses (rhinitis, sinusitis), inflammation of the pharynx (pharyngitis), inflammation of the bronchial mucosa (bronchitis), liver inflammation (hepatitis), granulomatous liver disease (a specific type of inflammatory liver disorder), a 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").

After marketing and rarely (without a proven cause-and-effect relationship), the following adverse events have been reported in patients treated with diltiazem: alopecia (hair loss) and leukopenia (decrease in the number of white blood cells).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacerol Retard 120 mg capsules

No special storage conditions are required.

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition ofLacerol Retard 120 mg

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

Appearance of the product and package contents

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

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

Marketing authorization holder

LACER, S.A. – Boters, 5

08290 Cerdanyola del Vallès

Barcelona - Spain

Date of the last revision of thisleaflet: April 2023

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