Lacerol HTA Retard 240 mg prolonged-release hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacerol HTA Retard 240 mg capsules

extended-release tablets

Diltiazem hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, as 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 the package leaflet

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

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

3.- How to take Lacerol HTA Retard

4.- Possible adverse effects

5.- Storage of Lacerol HTA Retard

6.- Contents of the pack and other information.

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

Lacerol HTA Retard belongs to a group of medicines called calcium channel blockers. These work by dilating blood vessels and at the same time reducing the heart's oxygen requirements.

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

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

Do not take Lacerol HTA Retard

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6),
• if you have certain heart diseases such as various types of arrhythmia (irregular heartbeats due to sinus node disease, atrioventricular block, atrial fibrillation together with Wolff-Parkinson-White syndrome, symptomatic bradycardia), myocardial infarction or heart failure (difficulty breathing due to pulmonary congestion, generalized swelling due to fluid retention, very slow pulse and very low blood pressure),
• if you are concurrently receiving an intravenous infusion of dantrolene (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 for the treatment of high cholesterol levels (see section: "Other medicines 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 are not using an appropriate contraceptive method.

Warnings and precautions

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

• if you are scheduled for surgery under general anesthesia while taking this medicine. You must inform your doctor or anesthetist beforehand,
• if you have any cardiac arrhythmia (sinoatrial disease, atrioventricular block) or are receiving treatment with other medicines used to treat heart conditions (beta-blockers, digitalis), since the use of diltiazem in these situations may lead to an excessively slow pulse and heart rhythm (bradycardia),
• if you have hypotension (low blood pressure): treatment with diltiazem may cause an excessive drop in blood pressure. Your doctor will advise you on how to avoid symptoms resulting from hypotension and what measures to take if these symptoms occur,
• if you have liver or kidney disease or are elderly, Lacerol HTA Retard should be used with caution due to lack of available data in these patient groups,
• the use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and advise you on the appropriate measures to take,
• if you have a history of heart failure, new onset breathing difficulty, 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.

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 medicines and Lacerol HTA Retard

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

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

• Ivabradine (see section “Do not take Lacerol”).

• Medications containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could lead to an increased likelihood and severity of liver-related side effects.

• Effects of other medicines on Lacerol HTA Retard

The following medicines may increase the effects of Lacerol HTA Retard 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),

• phenytoin (used to treat epilepsy),

• St. John’s wort (used in cases of fatigue, tiredness, or sleep disturbances),

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

• Effects of Lacerol HTA Retard on other medicines

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

• phenytoin, carbamazepine (used to treat epilepsy),

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

• digoxin, organic nitrates (used to treat heart diseases),

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

• methylprednisolone (a corticosteroid used to treat inflammatory conditions),

• simvastatin and lovastatin (medicines to reduce cholesterol and other fatty substances in the blood),

• theophylline, for the treatment of bronchial asthma,

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

• rifampicin (antibiotic),

• diltiazem may enhance the effects of other medicines used to lower blood pressure (nitrates, alpha- and beta-blockers, diuretics, angiotensin-converting enzyme inhibitors) and to reduce heart rate (amiodarone),

• diltiazem may enhance the effects of anesthetics,

• diltiazem may also enhance the effects of dantrolene (a muscle relaxant) and increase the risk of severe agitation (psychotic episodes) in patients receiving lithium salts (used to treat certain mental illnesses).

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

Taking Lacerol HTA Retard with food, drinks, and alcohol

Lacerol HTA Retard capsules are administered orally, swallowed whole without chewing, with an adequate amount of liquid, and may be taken either on an empty stomach or with food.

During treatment with this medicine, you must not consume alcohol, as it could cause a drop in blood pressure leading to dizziness and/or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Lacerol HTA Retard is excreted in breast milk; therefore, you must not breastfeed while taking this medicine.

Driving and operating machinery

The 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 advised you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Lacerol HTA Retard

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

The recommended dose is 1 capsule once daily. It is advisable to take the medicine at the same time every day.

Elderly patients and patients with renal and/or hepatic impairment

Initial dose adjustment should be carried out with caution.

All dose modifications and monitoring must be performed under medical supervision.

Swallow the capsules whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). Remember to take your medicine.

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

If you consider the effect of Lacerol HTA Retard to be too strong or too weak, inform your doctor or pharmacist.

Substitution between modified-release diltiazem-containing medicines is not recommended 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. Take the medicine pack with you. This will allow the doctor to know what you have taken. The following effects may occur: feeling dizzy or weak, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeat, difficulty speaking, confusion, reduced kidney function, coma, and sudden death.

In case of overdose or accidental ingestion, contact your doctor immediately or go to the nearest hospital, taking the medicine pack and leaflet with you. You may also call the Toxicology Information Service at telephone number 915 62 04 20, indicating the medicine 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 scheduled dose to take your next capsule, and then continue with your normal dosing regimen.

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

If you stop taking Lacerol HTA Retard

If you discontinue treatment with Lacerol HTA Retard, your condition may worsen, resulting in symptoms such as chest pain or tightness, or a sudden increase in blood pressure.

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

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

4. Possible adverse effects

Like all medicines, Lacerol HTA Retard can cause adverse effects, although not everyone experiences them.

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

• Common adverse effects (may affect between 1 and 10 out of every 100 patients):

  • swelling (edema),
  • fatigue (asthenia),
  • flushing,
  • mild disturbances in heart rhythm, usually without symptoms (first-degree AV block, bradycardia),
  • headache, dizziness,
  • nausea,
  • skin rash.

• Uncommon adverse effects (may affect between 1 and 10 out of every 1,000 patients):

  • swelling of hands, feet or ankles (peripheral edema), thirst,
  • chest pain or tightness (angina pectoris), irregular heartbeat (arrhythmias), interruption or disturbance of the heart's electrical signal of moderate or severe degree (second- or third-degree AV block, sinoatrial block), rapid heartbeat (tachycardia), abnormal heartbeats (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), low blood pressure (hypotension), sensation of strong or rapid heartbeats (palpitations), temporary loss of consciousness (syncope),
  • abnormal loss of appetite (anorexia), burning sensation, constipation, diarrhea, taste disturbances (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia),
  • abnormalities in liver function tests (mild elevations of transaminases), increased lactate dehydrogenase (LDH) enzyme, increased creatine phosphokinase (CPK) enzyme, and increased bilirubin in blood tests,
  • small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), skin redness (erythema), skin reaction to light (photosensitivity), urticaria, skin lesions usually circular with a red center, pale ring, and outer reddish ring (erythema multiforme), and hair loss (alopecia), skin inflammation with peeling (exfoliative dermatitis), redness of the skin with peeling (desquamative erythema),
  • difficulty 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 tremor,
  • ringing in the ears (tinnitus),
  • memory loss (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake), and personality changes,
  • increased blood glucose levels (hyperglycemia),
  • lazy eye (partial vision loss 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 adverse effects (may affect between 1 and 10 out of every 10,000 patients):

  • inflammation of blood vessels (vasculitis),
  • changes in the electrocardiogram,
  • 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),
  • inflammation of the liver (hepatitis).

• Frequency not known (cannot be estimated from available data):

  • condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (called "lupus-like syndrome").

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 HTA Retard

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

Do not store above 25°C.

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. Return unused containers and medicines to the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lacerol HTA Retard

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

The other components (excipients) are: sucrose, corn starch, paraffin, povidone, ammonium methacrylate copolymers, talc, indigotine (E132), titanium dioxide (E171), gelatin.

Appearance of the product and contents of the container

Lacerol HTA Retard is prolonged-release hard capsules. The capsules are hard gelatin capsules with opaque blue cap and body. Pack sizes are available containing 20 and 30 capsules.

Marketing Authorization Holder and Manufacturing Responsible Party

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/