Patient Information Leaflet: Information for the Patient

Lacerol 60 mg Tablets

diltiazem hydrochloride

Read this 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, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

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

1. What Lacerol is and what it is used for

2. What you need to know before taking Lacerol

3. How to take Lacerol

4. Possible side effects

5. Storage of Lacerol

6. Contents of the pack and additional information

Lacerol belongs to a group of medications called calcium channel blockers. They act by dilating blood vessels and at the same time reducing the heart's oxygen needs.

This medication is used for:

?The treatment and prevention of chest angina, including Prinzmetal's angina (vasospastic).

?The treatment of high blood pressure (hypertension).

Do not take Lacerol

• if you are allergic to diltiazem or any of the other ingredients in this medication (listed in section 6),
• in case of shock
• if you have any heart disease such as left ventricular heart failure with pulmonary congestion
• if you have severe low blood pressure (hypotension)
• if you are experiencing an acute myocardial infarction
• if you have certain heart rhythm disorders, such as: bradycardia (less than 40 beats per minute), blockage, second or third degree in patients without a pacemaker, sinus node disease in patients without a pacemaker
• if you are being treated with dantrolene in infusion (a medication to relax muscles).
• if you are already taking a medication that contains ivabradina for the treatment of some heart diseases

heart diseases

• if you are already taking a medication that contains lomitapida used for the treatment of high cholesterol levels (see section “Other medications and Lacerol”).
• if you are pregnant or think you may be pregnant

• if you are breastfeeding,
• if you are a fertile woman and do not use an appropriate contraceptive method.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Lacerol.

• if you have heart conditions such as left ventricular heart failure, bradycardia (slow heart rate) or first-degree atrioventricular blockage (a type of heart rhythm disorder) detected by electrocardiogram, your doctor will need to closely monitor you.
• in the case of general anesthesia, you must inform the anesthesiologist that you are being treated with this medication.
• if you are an elderly patient or if you have kidney or liver disease (renal or hepatic insufficiency), the diltiazem concentration in the blood may be higher, so you will need to closely monitor your heart rate at the beginning of treatment.
• if you perceive mood changes or are at risk of depression.
• if you are at risk of developing intestinal obstruction, as diltiazem, like other medications in the same group, can decrease intestinal movement.
• if you have diabetes mellitus, as diltiazem can increase blood sugar levels.
• if you have acute porphyria (a disease characterized by the accumulation in the liver of toxic compounds including porphyrins and their precursors).
• if you experience hypotension: treatment with diltiazem can 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.
• diltiazem has been associated with skin reactions. Your doctor will evaluate these symptoms and indicate the measures to take.
• diltiazem has significant hepatic metabolism, excreted by the kidneys as well as by the bile. Like other medications administered over prolonged periods of time, laboratory parameters must be regularly monitored.
• it may cause an increase in liver enzymes, which is usually reversible if treatment is discontinued, your doctor will perform regular checks.
• if you have a history of heart failure, new difficulty breathing, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, your doctor may need to monitor your renal function.

Children and adolescents

There is no established efficacy and safety of use in children. Therefore, Lacerol is not recommended for use in children and adolescents (under 18 years old).

Other medications and Lacerol

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

Contraindicated use:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (in infusion) is contraindicated.
• Ivabradina (see section “Do not take Lacerol”).
• • Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida and may increase the likelihood and severity of side effects related to the liver

•Effects of other medications on Lacerol

The following medications may increase the effects of Lacerol by increasing its concentration in the blood:

• fluconazole and other antifungals (used to treat fungal infections),
• erythromycin and other macrolides (antibiotics),
• ritonavir (used to treat viral infections),

• amiodarone and other antiarrhythmics (used to decrease heart rate),

• cimetidine and ranitidine (used to decrease stomach acid production).

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

• phenytoin (used to treat epilepsy)
• St. John's Wort (used in cases of weakness, fatigue, or sleep disturbances)
• rifampicin (antibiotic)

•Effects of Lacerol on other medications

Lacerol may increase the effects of the following medications by increasing their concentrations in the blood or potentiating their effect:

• phenytoin, carbamazepine (used to treat epilepsy),
• midazolam, triazolam, buspirone (used to treat anxiety),
• digoxin (used to treat heart diseases),
• ciclosporin, sirolimus (used to suppress the immune system),
• prednisolone (corticosteroid used to treat inflammatory problems),

• simvastatin and lovastatin (medications to reduce cholesterol and other fatty substances in the blood),
• theophylline (used to treat asthma)

• blood thinners (oral anticoagulants, such as acenocoumarol or warfarin),
• rifampicin (antibiotic),
• medications used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to decrease heart rate (amiodarone)
• anesthetics
• lithium salts (used to treat certain mental disorders): may increase the risk of intense agitation (psychotic episodes)
• contrast medium for X-rays: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when administered an intravenous bolus of an ionic contrast medium for X-rays. Special caution is required in patients who receive diltiazem and an ionic contrast medium for X-rays concomitantly.

General information to be taken into account:

• Antiplatelet medications (medications that prevent platelets from aggregating and forming a blood clot): the possibility of additive effect on platelet aggregation of diltiazem and antiplatelet medications (such as aspirin, ticagrelor, cilostazol) should be considered.

• Medications metabolized by the CYP3A4 enzyme, as this may result in a decrease in the amount of diltiazem in the blood or an increase in the amount of any medication administered with it.
• Patients who consume grapefruit juice should be monitored, as it may increase the adverse effects of diltiazem. Grapefruit juice should be avoided if an interaction is suspected.
• Cilostazol: by inhibiting the metabolism of cilostazol, diltiazem increases its pharmacological activity.

The concomitant use of Lacerol with other medications should be carried out under medical control and adjusting the doses progressively.

Taking Lacerol with food and drinks

It is recommended to take this medication preferably before meals.

Consuming grapefruit juice should be avoided (see section “Other medications and Lacerol”)

Pregnancy, lactation, and fertility

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

This medication should not be administered to pregnant women or fertile women who are not using an effective contraceptive method.

This medication should not be taken during breastfeeding, as it passes into breast milk. If the doctor considers it essential to take this medication, the baby should be fed by an alternative method.

Driving and operating machinery

Your ability to drive and operate machinery may be impaired, especially at the beginning of treatment with diltiazem

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:

Adults

Angina pectoris: the initial dose is 1 tablet every 12 hours. Your doctor will gradually increase the dose until you obtain the optimal response. The maximum dose is 4 tablets every 12 hours (480 mg/day).

Hypertension:

The initial dose is 1 tablet every 12 or 8 hours. Your doctor will gradually increase the dose until you obtain the optimal response.

Older patients, patients with kidney or liver insufficiency

The initial dose adjustment should be done with caution.

All dose modifications and control should be performed under medical supervision.

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). The tablets should not be divided or crushed.

Lacerol should be taken preferably before meals. Take Lacerol every day and approximately at the same hour. Taking the tablets at the same hour each day will have a better effect on your blood pressure. It will also help you remember when to take the tablets.

Your doctor will indicate the duration of your treatment with Lacerol 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 is too strong or too weak, inform your doctor or pharmacist.

If you take more Lacerol 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: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, irregular heartbeats, difficulty speaking, confusion, decreased renal function, coma, and sudden death.Sudden death.In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Lacerol

In case of forgotten dose, take the medication as soon as possible, continuing the treatment as prescribed. However, when the next dose is near, it is better not to take the forgotten dose and wait for the next one.

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

If you interrupt the treatment with Lacerol

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

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

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

Like all medicines, Lacerol can cause side effects, although not everyone will experience them.

The following side 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 between 1 and 10 in 100 patients):

• Swelling (edema).
• Fatigue (asthenia).
• General discomfort.
• Redness (rubefaction).
• Mild, moderate, or severe blockage or alteration of the heart's electrical signal (first, second, and third-degree A-V block, palpitations, bradycardia).

• Nausea, constipation, indigestion, stomach pain.
• Skin rashes, skin redness (erythema).

• Headache, dizziness.
• Joint swelling.

Uncommon(may affect between 1 and 10 in 1,000 patients):

• Thirst.
• Low blood pressure caused by sudden changes in body position (orthostatic hypotension), low blood pressure (hypotension).
• Chest pain, irregular heartbeats (arrhythmias), rapid heartbeats (tachycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), heart muscle hypotonia, sinoatrial block (delay in conduction of the stimulus to the heart's auricles).
• Abnormal loss of appetite (anorexia), burning sensation, diarrhea, taste alterations (dysgeusia), vomiting, dry mouth.
• Liver function test alterations, elevated lactate dehydrogenase (LDH) enzyme, elevated creatine phosphokinase (CPK) enzyme, and elevated bilirubin in blood tests, weight gain.

• Small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), skin reaction to light (photosensitivity), urticaria, skin lesions generally circular, composed of a red center, pale ring, and outer ring of reddish color (erythema multiforme).
• Difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesia), tendency to fall asleep (somnolence), tremors, vertigo.
• Ringling in the ears (tinnitus).
• Depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake) and personality alterations.
• Elevated blood glucose levels (hyperglycemia).
• Decreased vision (amblyopia), eye irritation.
• Joint pain.
• Need to urinate at night (nocturia) and increased frequency of urination (polyuria).
• Enlargement of lymph nodes (lymphadenopathy) and increase of a specific type of white blood cell (eosinophils).
• Difficulty breathing (dyspnea), nasal bleeding (epistaxis), and nasal congestion.
• Alteration of sexual function.
• Elevated liver enzymes (transaminases).

Rare(may affect between 1 and 10 in 10,000 patients):

• Changes in the electrocardiogram.
• Increased bleeding time.
• Toxic epidermal necrolysis, acute skin reaction with increased sensitivity in mucous membranes (Stevens-Johnson syndrome), generalized acute pustular exanthematous dermatitis, gynecomastia in men, painful menstruation (dysmenorrhea), vaginal inflammation (vaginitis), prostatitis.

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

• Fever, movement and walking disorders (extrapyramidal disorders), vasculitis, pallor, heart rhythm alterations such as: sinus pause (sinus arrest), cardiac asystole, auricular flutter, ventricular tachycardia, and ventricular fibrillation, gingival hyperplasia, dental anomaly, intestinal muscle paralysis (ileus paralyticus), skin, mucous membrane, and submucosal tissue swelling (angioneurotic edema), sweating, acute generalized pustular exanthema, (sudden eruption accompanied by fever, with formation of pustules or skin lesions that are small, inflamed, filled with pus, and similar to a blister), exfoliative dermatitis, erythematous desquamation, purpura, cutaneous hypertrophy, memory loss (amnesia), temporary loss of consciousness (syncope), involuntary and sudden muscle contractions (myoclonus), increased muscle tone (hypertonia), mood changes (including depression), confusion, decreased appetite, gout, blurred vision, non-inflammatory retinopathy (retinopathy), muscle pain (myalgia), musculoskeletal pain, joint inflammation (bursitis), urinary bladder inflammation (cystitis), kidney stones (nephrolithiasis), decreased platelet count (thrombocytopenia), decreased red blood cell count (hemolytic anemia), increased cough, nasal and sinus mucosa inflammation (rhinitis, sinusitis), pharyngeal inflammation (pharyngitis), bronchial mucosa inflammation (bronchitis), hepatitis, granulomatous liver disease (a specific type of liver inflammation), and "lupus-like" syndrome (a condition in which the body's defense system attacks normal tissue, causing symptoms such as inflamed joints, fatigue, and skin rashes).

After its commercialization, and infrequently (without a demonstrated cause-and-effect relationship), the following adverse events have been reported in patients treated with diltiazem: alopecia (hair loss) and leukopenia (decreased 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 prospectus. You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es. By reporting adverse 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.

No special storage conditions are required.

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

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at theSIGREcollection pointofyour pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lacerol

The active ingredient is diltiazem. Each tablet contains 60 mg of diltiazem hydrochloride

The other components (excipients) are: hypromellose, glycerol behenate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and content of the packaging

Lacerol are biconvex tablets, white in color, and without irregularities. There are packaging with 30, 60, and 500 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last review of this leaflet: April 2023

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