LACEROL HTA RETARD 240 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Patient Information Leaflet

Lacerol HTA Retard 240 mg prolonged-release hard capsules

Diltiazem hydrochloride

Read the entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

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

Contents of the leaflet

1. What is Lacerol HTA Retard and what is it used for

2. What you need to know before taking Lacerol HTA Retard

3. How to take Lacerol HTA Retard

4. Possible side effects

5. Storage of Lacerol HTA Retard

6. Package contents and additional information.

1. What is Lacerol HTA Retard and what is it used for

Lacerol HTA Retard belongs to a group of medications called calcium channel blockers. They work by dilating blood vessels and reducing the heart's oxygen needs.

This medication is used to treat high blood pressure (hypertension).

2. What you need to know before taking Lacerol HTA Retard

Do not takeLacerol HTA Retard

• if you are allergic to diltiazem or any of the other ingredients of this medication (listed in section 6),
• if you have certain heart conditions, such as various types of arrhythmia (irregular heartbeats due to sinus node disease, atrioventricular block, atrial fibrillation with Wolff-Parkinson-White syndrome, bradycardia), heart attack, or heart failure (difficulty breathing due to fluid buildup in the lungs, generalized swelling due to fluid retention, very slow pulse, and very low blood pressure),

• if you are receiving an intravenous infusion of dantrolene (a medication to relax muscles),
• if you are taking a medication containing ivabradine for the treatment of certain heart conditions
• if you are already taking a medication containing lomitapida used to treat high cholesterol levels (see section: "Other medications and Lacerol HTA Retard").
• if you are pregnant or planning to become pregnant,
• if you are breastfeeding,
• if you are a woman of childbearing age and not using an appropriate contraceptive method.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lacerol HTA Retard

• if you need to undergo surgery under general anesthesia while being treated with this medication. You should inform your doctor or anesthesiologist beforehand,
• if you have any cardiac arrhythmia (sinus node disease, atrioventricular block) or if you are being treated with other medications used to treat heart conditions (beta blockers, digitalis), as the use of diltiazem in these situations may lead to an excessively slow heart rate (bradycardia),
• if you have low blood pressure (hypotension): treatment with diltiazem may cause a significant drop in blood pressure. Your doctor will inform you about how to avoid symptoms resulting from hypotension and what measures to take if these symptoms occur,
• if you have any liver or kidney disease or are an elderly person, Lacerol HTA Retard should be used with caution, as there is no available data in these patients,
• the use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and indicate the measures to be taken.
• if you have a history of heart failure, new difficulty breathing, slow heart rate, or low blood pressure. There have been reports of kidney damage in patients with these conditions; your doctor may need to monitor your kidney function.

Children and adolescents

The efficacy and safety of use in children have not been established. Therefore, the use of Lacerol HTA Retard is not recommended in children and adolescents (under 18 years of age).

Other medications and Lacerol HTA Retard

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

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

• Ivabradine (see section "Do not take Lacerol").
• Medications containing lomitapida used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which can lead to an increased risk and severity of side effects related to the liver.

• Effects of other medications on Lacerol HTA Retard

The following medications may increase the effects of Lacerol HTA Retard 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),
• phenytoin (used to treat epilepsy),
• St. John's Wort (used in cases of fatigue, tiredness, or sleep disorders),

• cimetidine, ranitidine (used to reduce stomach acid production).

• Effects of Lacerol HTA Retard on other medications

Lacerol HTA Retard may increase the effects of the following medications by increasing their concentrations in the blood:

• phenytoin, carbamazepine (used to treat epilepsy),
• midazolam, triazolam, buspirone (used to treat anxiety),
• digoxin, organic nitrates (used to treat heart conditions),
• cyclosporine, sirolimus (used to suppress the immune system),
• methylprednisolone (corticosteroid used to treat inflammatory conditions),

• simvastatin and lovastatin (medications to reduce cholesterol and other fatty substances in the blood),
• theophylline, for the treatment of bronchial asthma,

• medications that reduce blood clot formation (oral anticoagulants, such as acenocoumarol or warfarin),
• rifampicin (antibiotic),
• diltiazem may potentiate the effects of other medications used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to slow down the heart rate (amiodarone),
• diltiazem may potentiate the effect of anesthetics,
• diltiazem may also potentiate the effects of dantrolene (muscle relaxant) and increase the risk of intense agitation (psychotic episodes) in patients being treated with lithium salts (used to treat certain mental illnesses).

The combined use of Lacerol HTA Retard with other medications should be done under medical supervision and with gradual dose adjustment.

Taking Lacerol HTA Retard with food, drinks, and alcohol

The capsules of Lacerol HTA Retard are administered orally, swallowed whole, without chewing, with a sufficient amount of liquid, and can be taken both on an empty stomach and with food.

During treatment with this medication, you should not consume alcohol, as it may cause a drop in blood pressure with dizziness and/or fainting.

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 medication.

Do not take Lacerol HTA Retard if you are pregnant or trying to become pregnant. Women of childbearing age should use an effective contraceptive method. If you become pregnant while taking Lacerol HTA Retard, stop taking the medication immediately and consult your doctor. Lacerol HTA Retard may cause fetal malformations.

Lacerol HTA Retard is excreted in breast milk; therefore, you should not breastfeed if you are being treated with this medication.

Driving and using machines

Your ability to perform activities such as operating machinery or driving vehicles may be impaired, especially at the beginning of treatment with Lacerol HTA Retard.

Lacerol HTA Retard contains sucrose

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

3. How to take Lacerol HTA Retard

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

The recommended dose is 1 capsule once a day. It is recommended to take the medication at the same time every day.

Elderly patients and patients with renal and/or hepatic impairment

The initial dose adjustment should be done with caution.

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

Swallow the capsules whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). Remember to take your medication.

Your doctor will indicate the duration of your treatment with Lacerol HTA Retard and may also adjust the dose if necessary. Do not change the dose indicated by your doctor, and do not stop treatment without consulting your doctor first, as it may be harmful to your health.

If you think the effect of Lacerol HTA Retard is too strong or too weak, inform your doctor or pharmacist.

It is not recommended to substitute medications containing diltiazem in retard form with each other unless you have received explicit advice from your doctor to do so.

If you take more Lacerol HTA Retard than you should

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

In case of overdose or accidental ingestion, contact your doctor immediately or go to the nearest hospital, bringing the medication package and leaflet with you. You can also call the Toxicology Information Service. Telephone 915 62 04 20, indicating the medication and the amount taken.

If you forget to take Lacerol HTA Retard

If you forget to take a dose, do not worry; wait until the next dose to take your next capsule and then continue your normal dosing regimen.

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

If you stop taking Lacerol HTA Retard

If you stop taking Lacerol HTA Retard, you may experience worsening of your condition, with symptoms such as chest pain or a sudden increase in blood pressure.

Do not stop taking Lacerol HTA Retard without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Lacerol HTA Retard can cause side effects, although not everyone will experience them.

The following side effects have been reported with diltiazem. In such cases, you should inform your doctor as soon as possible:

• Common side effects (may affect 1 to 10 in every 100 patients):
  • swelling (edema),
  • fatigue (asthenia),
  • flushing,
  • mild heart rhythm disturbances, usually without symptoms (first-degree AV block, bradycardia),

• headache, dizziness,
• nausea,

• skin rash.

• Uncommon side effects (may affect 1 to 10 in every 1,000 patients):
  • swelling of hands, feet, or ankles (peripheral edema), thirst,
  • chest pain (angina pectoris), irregular heartbeats (arrhythmias), interruption or alteration of the heart's electrical signal of moderate or severe degree (second- or third-degree AV block, sinoatrial block), rapid heartbeats (tachycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), low blood pressure (hypotension), sensation of strong or accelerated heartbeats (palpitations), fainting (syncope),
  • loss of appetite (anorexia), burning sensation, constipation, diarrhea, taste disturbances (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia),
  • abnormal liver function tests (mild elevations of transaminases), elevated lactate dehydrogenase (LDH), elevated creatine phosphokinase (CPK), and elevated bilirubin in blood tests,
  • small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), skin redness (erythema), skin reaction to light (photosensitivity), hives (urticaria), skin lesions usually circular and composed of a red center, pale ring, and outer red ring (erythema multiforme), and hair loss (alopecia), skin inflammation with peeling (exfoliative dermatitis), skin redness with peeling (erythematous desquamation),

• problems with walking and movement (extrapyramidal disorders), vertigo, difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesia), tendency to fall asleep (somnolence), and tremors,
• ringing in the ears (tinnitus),
• memory loss (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while being awake), and personality changes,
• elevated blood glucose levels (hyperglycemia),
• lazy eye (partial loss of vision in one or both eyes), eye irritation,
• joint pain,
• need to urinate at night (nocturia) and increased frequency of urination (polyuria),
• enlargement of lymph nodes (lymphadenopathy), increase in a specific type of white blood cells (eosinophils), and decrease in the number of white blood cells (leukopenia),
• difficulty breathing (dyspnea), nosebleeds (epistaxis), and nasal congestion,
• sexual function disorders.

• Rare side effects (may affect 1 to 10 in every 10,000 patients):
  • inflammation of blood vessels (vasculitis),
  • changes in the electrocardiogram,
  • skin disorder with blistering and skin peeling (toxic epidermal necrolysis), acute skin reaction with increased sensitivity in mucous membranes (Stevens-Johnson syndrome), inflammation of the skin (pustular exanthematous generalized dermatitis),
  • enlargement of breast tissue in men (gynecomastia),
  • inflammation of the liver (hepatitis).

• Frequency not known (cannot be estimated from available data)
  • a condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin rashes (referred to as "lupus-like syndrome").

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Lacerol HTA Retard

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

Do not store above 25°C.

Do not use this medication after the expiration date stated on the package after "EXP.". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lacerol HTA Retard

The active ingredient is diltiazem. Each capsule contains 240 mg of diltiazem hydrochloride.

The other ingredients (excipients) are: sucrose, cornstarch, paraffin, povidone, ammonio methacrylate copolymers, talc, indigo carmine (E132), titanium dioxide (E171), gelatin.

Appearance of the product and package contents

Lacerol HTA Retard are prolonged-release hard capsules. The capsules are hard gelatin with a blue opaque cap and body. There are packages with 20 and 30 capsules.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of last revision of this leaflet: 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/