Lacerol Retard 120 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacerol Retard 120 mg prolonged-release hard capsules

diltiazem hydrochloride

Read the entire 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.

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

Contents of the leaflet

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

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

3. How to take Lacerol Retard 120 mg capsules

4. Possible side effects

5. How to store Lacerol Retard 120 mg capsules

6. Contents of the pack and other information

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

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

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

Do not take this medicine:

• if you are allergic to diltiazem hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you are in shock
• if you have decompensated heart failure
• if you have severe hypotension
• if you have acute myocardial infarction
• if you have pulmonary congestion (confirmed radiographically) or certain cardiac rhythm disorders (bradycardia – less than 40 beats/min, second- or third-degree atrioventricular block, sinoatrial node disease)
• if you are receiving dantrolene by intravenous infusion (a medicine used to relax muscles)
• if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions
• if you are already taking a medicine containing lomitapide used to treat high cholesterol levels (see section: “Other medicines and Lacerol Retard 120 mg”)
• if you have atrial fibrillation or atrial flutter together with Wolff-Parkinson-White syndrome (a type of disorder in cardiac electrical conduction)
• if you have left ventricular failure with pulmonary congestion
• if you are pregnant or think you might 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

Talk to your doctor or pharmacist before taking this medicine:

• if you have heart conditions such as left ventricular dysfunction, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram; your doctor will need to monitor you closely.
• if you are undergoing general anesthesia, you must inform the anesthesiologist that you are being treated with this medicine.
• if you are elderly or have kidney or liver disease (renal or hepatic impairment), blood levels of diltiazem may be higher, so heart rate should be closely monitored at the start of treatment.
• if you experience mood changes or are at risk of depression.
• if you are at risk of intestinal obstruction, as, like other medicines in the same group, diltiazem may reduce intestinal motility.
• if you have diabetes mellitus, as diltiazem may increase blood sugar levels.
• if you have acute porphyria.
• It may cause skin reactions, which may be transient and disappear even if treatment continues. Rarely, more serious skin rashes may occur, in which case the medicine should be discontinued. If the skin reaction does not resolve, consult your doctor.
• It may cause increased liver enzymes, which usually resolves if treatment is stopped; your doctor will perform periodic checks.
• It may cause hypotension.
• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

Remember that for this medication to be effective, it must be taken regularly and for as long as your doctor has instructed, even if the treatment duration is long.

You must strictly follow the prescribed dosage, without reducing or increasing it unless instructed by your doctor.

Since the therapeutic effect has not been compared between different diltiazem modified-release formulations, switching from one to another is not recommended unless specifically advised by your doctor.

Children

This medicine should not be used in children, as it has not been sufficiently studied in this patient group.

Other medicines and Lacerol Retard 120 mg

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

Certain medicines may interact with Lacerol Retard 120 mg. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

Contraindicated use:

Diltiazem must not be used together with dantrolene or ivabradine.

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

Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could increase the likelihood and severity of liver-related side effects.

Effects of other drugs on Lacerol

The following drugs may 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 reduce heart rate)
• cimetidine and ranitidine (used to reduce stomach acid production)

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

• phenytoin (used to treat epilepsy)
• St. John’s wort (used for fatigue, tiredness, or sleep disturbances)
• rifampicin (antibiotic)

Effects of Lacerol on other drugs

Lacerol may increase the effects of the following drugs by increasing their blood concentrations or enhancing their effects:

• phenytoin, carbamazepine (used to treat epilepsy)

• triazolam, midazolam, buspirone (used to treat anxiety)

• digoxin (used to treat heart conditions)

• cyclosporine, sirolimus (used to suppress the immune system)

• midazolam, triazolam (used to induce sleep)

• methylprednisolone (a corticosteroid used to treat inflammatory conditions)

• simvastatin and lovastatin (medicines to lower blood cholesterol levels)

• theophylline (used to treat asthma)

• medicines that reduce blood clotting (oral anticoagulants such as acenocoumarol or warfarin)

• rifampicin (antibiotic)

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

• anesthetics

• lithium salts (used to treat certain mental disorders): may increase the risk of severe agitation (psychotic episodes)

Concomitant use of Lacerol with other medicines should be under medical supervision, with gradual dose adjustments.

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 120 mg must not be given 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 your doctor considers it essential to take this medicine, the baby should be fed by an alternative method.

Driving and using machines

At the beginning of treatment, it is advisable to avoid tasks requiring special attention until your response to the medicine is well established.

Lacerol Retard 120 mg contains sucrose.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lacerol Retard 120 mg capsules

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Adults:

Angina pectoris: The usual initial dose is 90 mg twice daily. If necessary, the dose may be gradually increased up to 120 mg twice daily or 180 mg twice daily. 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 differently, 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 impairment:

Initial dose adjustment should be performed with caution.

All dose modifications and monitoring must be carried out under medical supervision.

If you take more Lacerol Retard 120 mg than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you take more capsules than you should, inform your doctor or go immediately to the emergency department of a hospital. Take the medicine packaging with you so 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 heartbeat, difficulty speaking, confusion, reduced 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 treatment with Lacerol Retard, your condition may worsen, causing symptoms such as chest pain or pressure, or a sudden rise in blood pressure. Do not stop treatment with this medicine without first consulting your doctor. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Lacerol Retard 120 mg may cause adverse effects, although not everyone experiences them.

The following adverse 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).
• Tiredness (asthenia).
• General malaise.
• Redness (rubefaction).
• Mild, moderate, or severe interruption or disturbance of the heart's electrical signal (first-, second-, and third-degree A-V block, palpitations, bradycardia).
• Nausea, constipation, dyspepsia, stomach pain.
• Skin rashes, skin redness (erythema).
• Headache, dizziness.
• Joint swelling.

Uncommon: may affect up to 1 in 100 patients

• Thirst.
• Drop in blood pressure due to sudden changes in body position (orthostatic hypotension), low blood pressure (hypotension).
• Chest pain or tightness (angina), irregular heartbeats (arrhythmias), rapid heartbeat (tachycardia), slow heartbeat (bradycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), cardiac muscle hypotonia, sinoatrial block.
• Abnormal loss of appetite (anorexia), burning sensation, diarrhea, altered taste (dysgeusia), vomiting, dry mouth.
• Abnormal liver function tests, increased blood levels of the enzyme lactate dehydrogenase (LDH), increased blood levels of the enzyme creatine phosphokinase (CPK), and increased blood bilirubin levels.
• Small red spots on the skin (petechiae), itching (pruritus), skin rash (exanthema), skin reaction to light (photosensitivity), urticaria, skin lesions typically circular with a red center, pale ring, and outer reddish ring (erythema multiforme).
• Difficulty falling or staying asleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesia), tendency to fall asleep (somnolence), tremor, dizziness.
• Ringing in the ears (tinnitus).
• Depression, dream disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake), and personality changes.
• Increased blood glucose levels (hyperglycemia).
• Vision loss (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.
• Increased liver enzymes (transaminases).

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

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

Frequency not known (cannot be estimated from available data)

• Fever, difficulty walking and movement problems (extrapyramidal disorders), inflammation of blood vessels (vasculitis), pallor, heart rhythm disorders such as: pause in the sinus rhythm (sinus arrest), cardiac arrest (asystole), atrial flutter, ventricular tachycardia, and ventricular fibrillation, gum inflammation (gingival hyperplasia), dental abnormalities, 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 pustule formation or skin lesions characterized as small, inflamed, pus-filled, and blister-like), exfoliative dermatitis (skin inflammation with peeling, with or without fever), desquamative erythema (red, peeling skin), purpura, cutaneous hypertrophy, 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 retinal disease (retinopathy), muscle pain (myalgia), musculoskeletal pain, joint inflammation (bursitis), inflammation of the urinary bladder (cystitis), kidney stones (nephrolithiasis), abnormally low platelet count (thrombocytopenia), abnormally low 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 immune system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin rashes (called "lupus-like syndrome").

After marketing and infrequently (without a proven causal relationship), the following adverse events have also been reported in patients treated with diltiazem: alopecia (hair loss) and leucopenia (decrease in white blood cell count).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es.

By reporting adverse 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 medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Lacerol Retard 120 mg

• The active substance is diltiazem hydrochloride. Each capsule contains 120 mg of diltiazem (as diltiazem hydrochloride).
• The other components are sucrose, corn starch, polyvinylpyrrolidone (E 1201), sodium lauryl sulfate, cetyl alcohol, ethylcellulose (E 462), dibutyl sebacate, talc (E 553b). Capsule composition: gelatin, yellow iron oxide, and titanium dioxide (E 171).

Appearance of the product and contents of the container

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 available in cardboard 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 most recent review of this summary: April 2023

"Detailed and up-to-date information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/"