Lacerol Retard 180 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacerol Retard 180 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, ask 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 may harm them.

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

Contents of this leaflet

1. What Lacerol Retard 180 mg capsules are and what they are used for

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

3. How to take Lacerol Retard 180 mg capsules

4. Possible side effects

5. How to store Lacerol Retard 180 mg capsules

6. Contents of the pack and other information

1. What Lacerol Retard 180 mg capsules are and what they are 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 180 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 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/minute–, second- or third-degree atrioventricular block, sinus node disease)
• if you are receiving intravenous dantrolene (a muscle relaxant medicine)
• 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 180 mg”)
• if you have atrial fibrillation or atrial flutter with concurrent Wolff-Parkinson-White syndrome (a type of cardiac electrical conduction disorder)
• 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

Consult 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 on electrocardiogram, close monitoring by your doctor will be necessary.
• 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 close monitoring of heart rate is required 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 diltiazem, like other drugs in the same class, 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 severe skin rashes have occurred, in which case the medicine should be discontinued. If the skin reaction does not resolve, consult your doctor.
• It may cause an increase in liver enzymes, which is usually reversible upon discontinuation; your doctor will perform periodic checks.
• It may cause hypotension.
• If you have a history of heart failure, new onset of breathing difficulty, slow heart rate, 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 prescribed, 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 products, substitution between them is not recommended unless explicitly advised by your doctor.

Children

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

Other medicines and Lacerol Retard 180 mg

Inform 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 180 mg. In such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

Contraindicated use:

Diltiazem must not be used concomitantly 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 lead to an increased risk 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 reduce the effects of Lacerol by decreasing 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 concentration or enhancing their action:

• phenytoin, carbamazepine (used to treat epilepsy)

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

• digoxin (used to treat heart conditions)

• ciclosporin, 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 illnesses): may increase the risk of severe agitation (psychotic episodes)

The combined 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 180 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 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 him before taking this medicine.

3. How to take Lacerol Retard 180 mg capsules

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

Lacerol Retard 180 mg capsules should be swallowed whole with some water or food.

Adults:

Angina pectoris: The usual initial dose is 90 mg twice daily. If necessary, the dose may be gradually increased to 120 mg twice daily or to 180 mg twice daily. Your doctor will gradually increase your 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 your 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 180 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 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 heartbeat, difficulty speaking, confusion, reduced 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 treatment with Lacerol Retard, your condition may worsen, causing symptoms such as chest pain or tightness, or a sudden increase in blood pressure. Do not stop treatment with this medicine without consulting your doctor first. 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 180 mg may produce 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.
• Flushing (erythema).
• Interruption or disturbance of the heart's electrical signal, mild, moderate or severe (first-, second- and third-degree A-V block, palpitations, bradycardia).
• Nausea, constipation, dyspepsia, gastric pain.
• Skin rashes, redness of the skin (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, taste disturbances (dysgeusia), vomitings, dry mouth.
• Abnormal liver function tests, increased lactate dehydrogenase (LDH) enzyme, increased creatine phosphokinase (CPK) enzyme, and increased bilirubin in blood tests.
• Small red spots on the skin (petechiae), itching (pruritus), skin rash (exanthema), skin reaction to light (photosensitivity), urticaria, skin lesions usually circular in shape consisting of a red center, pale ring, and outer reddish ring (erythema multiforme).
• Difficulty falling or staying asleep (insomnia), restlessness, 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 impairment (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 dysfunction.
• Increased liver enzymes (transaminases).

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

• Changes in 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), inflammation of the skin (generalized acute exanthematous pustulosis).
• Enlargement of breast glands in men (gynecomastia), painful menstruation (dysmenorrhea), inflammation of the vagina (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 disturbances such as: pause in 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, generalized acute exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or skin lesions characterized as small, inflamed, pus-filled, and blister-like), skin inflammation with peeling with or without fever (exfoliative dermatitis), red, peeling skin (desquamative erythema), purpura, cutaneous hypertrophy, memory loss (amnesia), temporary loss of consciousness (syncope), sudden involuntary muscle jerks (myoclonus), increased muscle tone (hypertonia), mood changes (including depression), confusion, 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").

In addition, after marketing and infrequently (without a causal relationship having been established), the following adverse events have 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 type of 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 Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide 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 expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

• Composition of Lacerol Retard 180 mg The active substance is diltiazem hydrochloride. Each capsule contains 180 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, erythrosine, iron oxide red, iron oxide yellow, indigo carmine, and titanium dioxide (E 171).

Nature of the product and pack contents

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

Lacerol Retard 180 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 leaflet: April 2023

"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"