Prospecto: information for the patient

Lacerol HTA Retard 240 mg capsules

hard capsules with prolonged release

Diltiazem hydrochloride

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

?Keep this prospect, as you may need to read it again.

?If you have any doubts, consult your doctor or pharmacist.

?This medicine has been prescribed only for you and should not be given to others, 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 not listed in this prospect. See section 4.

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

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

3.- How to take Lacerol HTA Retard

4.- Possible adverse effects

5.- Storage of Lacerol HTA Retard

6.- Contents of the package and additional information.

Lacerol HTA Retard belongs to a group of medications known as calcium channel blockers. They work by dilating blood vessels and at the same time reducing the heart's need for oxygen.

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

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 sinoatrial node disease, atrioventricular block, atrial fibrillation with Wolff-Parkinson-White syndrome, symptomatic bradycardia), myocardial infarction or heart failure (difficulty breathing due to pulmonary congestion, generalized edema due to fluid retention, very slow pulse and very low blood pressure),

• if you are receiving concomitant intravenous infusion of dantrolene (muscle relaxant medication),
• if you are already taking a medication containing ivabradina for the treatment of certain heart conditions
• if you are already taking a medication containing lomitapida used for the treatment of 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 fertile woman and not using an appropriate contraceptive method.

Warnings and precautions

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

• if you are to undergo surgery under general anesthesia while on treatment with this medication. You must inform your doctor or anesthesist beforehand,
• if you have any heart arrhythmia (sinoatrial node disease, atrioventricular block) or if you are receiving treatment with other medications used to treat heart conditions (beta blockers, digitalis), as the use of diltiazem in these situations may lead to excessively slow heart rate and rhythm (bradycardia),
• if you experience hypotension (low blood pressure): treatment with diltiazem may lead to excessive lowering of 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 are 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 necessary measures,
• if you have a history of heart failure, new difficulty breathing, slow heart rate or low blood pressure. Cases of renal injury have been reported in patients with these conditions, your doctor may need to monitor your renal 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).

Other medications and Lacerol HTA Retard

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

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

• Ivabradina (see section “Do not take Lacerol HTA Retard”).
• Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increase in the likelihood and severity of liver-related side effects.

•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 (antibiotic),
• ritonavir (used to treat viral infections),

• amiodarone (used to decrease heart rate),
• phenytoin (used to treat epilepsy),
• St. John's Wort (used in cases of weakness, fatigue or sleep disturbances),

• cimetidine, ranitidine (used to decrease 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),
• ciclosporin, sirolimus (used to decrease the immune system),
• prednisolone (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,

• 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 decrease 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 treated with lithium salts (used to treat certain mental disorders).

The concomitant use of Lacerol HTA Retard with other medications should be carried out under medical supervision and by gradually adjusting the doses.

Taking Lacerol HTA Retard with food, drinks and alcohol

Lacerol HTA Retard capsules 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, do not consume alcohol, as it may cause a decrease in blood pressure with dizziness and/or fainting.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take Lacerol HTA Retard if you are pregnant or if you are trying to become pregnant. Fertile women 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 do not breastfeed while on treatment with this medication.

Driving and operating machinery

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 saccharose

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

Follow exactly the administration instructions of this medication 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 always at the same time every day.

Patients of advanced age and patients with renal and/or hepatic insufficiency

The initial dose adjustment should be made with caution.

All dose modifications and their control will 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 medication.

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

If you estimate that the action of Lacerol HTA Retard is too strong or too weak, inform your doctor or pharmacist.

It is not recommended to substitute medications with diltiazem in retard form among them unless you have received explicit recommendation from your doctor in this regard.

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 service of a hospital. Bring the packaging of the medication with you. This is so that the doctor knows what you have taken. The following effects may occur: feeling of dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, irregular heartbeats, difficulty speaking, confusion, decreased renal function, coma, and sudden death.

Death.

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

If you forgot to take Lacerol HTA Retard

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Lacerol HTA Retard

If you interrupt treatment with Lacerol HTA Retard you may experience a worsening of your disease, presenting symptoms such as chest pain or a sudden increase in blood pressure.

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

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

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

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

•Frequent side effects(may affect between 1 and 10 in every 100 patients):

• swelling (edema),
• fatigue (asthenia),
• redness,
• mild alterations in heart rhythm, usually without symptoms (first-degree AV block, bradycardia),

• headache, dizziness,
• nausea,

• skin eruptions.

•Infrequent side effects(may affect between 1 and 10 in every 1,000 patients):

• swelling of hands, feet, or ankles (peripheral edema), thirst,
• chest pain (angina pectoris), irregular heartbeats (arrhythmias), moderate or severe interruption or alteration of the electrical signal in the heart (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 rapid heartbeats (palpitations), temporary loss of consciousness (syncope),
• abnormal loss of appetite (anorexia), burning sensation, constipation, diarrhea, alterations in taste (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and inflammation of the gums (gingival hyperplasia),
• alterations in liver function tests (mild elevations of transaminases), elevation of the lactate dehydrogenase enzyme (LDH), elevation of the creatine phosphokinase enzyme (CPK), and elevation of bilirubin in blood tests,
• small red spots on the skin (petechiae), skin eruption (exanthema), itching (pruritus), redness of the skin (erythema), skin reaction to light (photosensitivity), urticaria, lesions on the skin, usually circular, composed of a red center, pale ring, and outer ring of reddish color (erythema multiforme), and hair loss (alopecia), inflammation of the skin with peeling (dermatitis exfoliativa), redness of the skin with peeling (erythema desquamativum),

• 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 tremor,
• ringing in the ears (tinnitus),
• loss of memory (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake) and personality alterations,
• elevation of blood glucose levels (hyperglycemia),
• drooping eyelid (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 cell (eosinophils), and decrease in the number of white blood cells (leukopenia),
• difficulty breathing (dyspnea), nasal bleeding (epistaxis), and nasal congestion,
• sexual function alterations.

•Rare side effects(may affect between 1 and 10 in 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), generalized acute pustular exanthematous dermatitis,
• enlargement of breast tissue in men (gynecomastia),
• inflammation of the liver (hepatitis).

•Unknown frequency(cannot be estimated from available data)

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

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

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

Do not store at a temperature above 25°C.

Do not use this medication after the expiration date that appears on the packaging after “Cad.” The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at theSIGREcollection pointofthe pharmacy. If in doubt, please consult your pharmacist on how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lacerol HTA Retard

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

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

Appearance of the product and contents of the packaging

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

Holder of the marketing authorizationand responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: April 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/