LACEROL RETARD 180 mg PROLONGED-RELEASE HARD CAPSULES

2. What you need to know before taking Lacerol Retard 180 mg capsules

Do not take this medicine:

• if you are allergic to diltiazem hydrochloride or any of the other components of this medicine (listed in section 6).
• in case of shock
• in case of decompensated heart failure
• if you have severe hypotension
• if you are having an acute myocardial infarction
• if you have pulmonary congestion (confirmed radiographically) or certain cardiac rhythm disorders (bradycardia - less than 40 beats/minute -, block, second or third degree, sick sinus node disease)
• if you are being treated with dantrolene in perfusion (a muscle relaxant medication).
• if you are already taking a medicine that contains ivabradina for the treatment of certain heart diseases
• if you are already taking a medicine that contains lomitapida used for the treatment of high cholesterol levels (see section: "Other medicines and Lacerol Retard 180 mg").
• if you have atrial fibrillation or atrial flutter and simultaneous presence of Wolff-Parkinson-White syndrome (a type of cardiac conduction disorder)
• if you have left ventricular failure 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 adequate contraceptive method

Warnings and precautions

Consult your doctor or pharmacist before starting to take 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 electrocardiographically, 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 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 perceive mood changes or are at risk of depression.
• 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 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, and 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 prescribed dosage, without decreasing or increasing it except on the instructions of your doctor.

As 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 180 mg

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

Certain medicines may interact with Lacerol Retard 180 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 that contain lomitapida used for the treatment of high cholesterol levels. Diltiazem can increase the concentration of lomitapida, which can lead to an increased probability and severity of liver-related side effects.

Effects of other drugs on Lacerol

The following drugs can increase the effects of Lacerol by increasing its blood concentration:

• 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 drugs can decrease the effects of Lacerol by reducing its blood concentration:

• 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 drugs

Lacerol can increase the effects of the following drugs by increasing their blood concentrations or 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 drugs should be done under medical supervision and with gradual dose adjustment.

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 medicine.

Lacerol Retard 180 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 breastfeeding, 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 180 mg contains sucrose.

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

3. How to take Lacerol Retard 180 mg capsules

Follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again.

The Lacerol Retard 180 mg capsules 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 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.

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 monitoring will be done under medical supervision.

If you take more Lacerol Retard 180 mg than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you take more tablets than you should, inform your doctor or go immediately to the hospital emergency department. 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, abnormally fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

If you forget to take Lacerol Retard 180 mg

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

If you stop taking Lacerol Retard 180 mg

If you stop taking Lacerol Retard, you may experience a worsening of your disease, with 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 doubts about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lacerol Retard 180 mg can cause side effects, although not everyone gets 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).
• Fatigue (asthenia).
• General malaise.
• Redness (rubefaction).
• Interruption or alteration of the electrical signal in the heart of mild, moderate, or severe degree (first, second, and 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 patients

• 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 hypotonia, sinoatrial block.
• Loss of appetite (anorexia), burning sensation, diarrhea, taste alterations (dysgeusia), vomiting
• Abnormal 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), light-induced skin reaction (photosensitivity), hives, skin lesions typically 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 patients

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

Frequency not known (cannot be estimated from available data)

• Fever, movement and walking disorders (extrapyramidal disorders), blood vessel inflammation (vasculitis), paleness, heart rhythm disorders such as sinus pause, cardiac arrest (asystole), atrial flutter, ventricular tachycardia, and ventricular fibrillation, gum inflammation (gingival hyperplasia), tooth anomaly, intestinal muscle paralysis (paralytic ileus), swelling of the skin, mucous membranes, and submucosal tissues (angioneurotic edema), sweating, acute generalized exanthematous pustulosis, skin inflammation with peeling with or without fever (exfoliative dermatitis), skin redness with peeling (erythema multiforme), purpura, skin thickening, memory loss (amnesia), temporary loss of consciousness (syncope), sudden involuntary muscle jerks (myoclonus), increased muscle tone (hypertonia), mood changes (including depression), confusional state, decreased appetite, gout, blurred vision, non-inflammatory retina disease (retinopathy), muscle pain (myalgia), musculoskeletal pain, joint inflammation (bursitis), bladder inflammation (cystitis), kidney stones (nephrolithiasis), abnormally low platelet count (thrombocytopenia), abnormally low red blood cell count (hemolytic anemia), increased coughing, inflammation of the nasal mucosa and paranasal sinuses (rhinitis, sinusitis), pharynx inflammation (pharyngitis), bronchial mucosa inflammation (bronchitis), liver inflammation (hepatitis), granulomatous liver disease, a condition in which the body's defense system attacks normal tissue, causing symptoms such as joint inflammation, fatigue, and skin rashes (lupus-like syndrome).

After marketing and rarely (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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect 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 contribute to providing more information on the safety of this medicine.

5. Storage of Lacerol Retard 180 mg capsules

No special storage conditions are required.

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

Do not use this medicine after the expiration date stated 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 medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging contents and additional information

• Composition ofLacerol Retard 180 mgThe active ingredient is diltiazem hydrochloride. Each capsule contains 180 mg of diltiazem (as diltiazem hydrochloride).
• The other components are sucrose, cornstarch, povidone (E 1201), sodium lauryl sulfate, cetyl alcohol, ethylcellulose (E462), dibutyl sebacate, talc (E553b). Capsule composition: gelatin, erythrosine, red iron oxide, yellow iron oxide, carmine, and titanium dioxide (E171).

Appearance of the product and packaging contents

Lacerol Retard 180 mg prolonged-release hard capsules are hard gelatin capsules with an orange cap and a transparent body.

Lacerol Retard 180 mg prolonged-release hard capsules are presented in cardboard boxes containing 60 capsules in PVC/Aluminum blisters.

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