LACEROL 60 mg TABLETS

Introduction

Prospectus: Patient Information

Lacerol 60 mg tablets

diltiazem hydrochloride

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Prospectus Content

1. What is Lacerol and what is it used for
2. What you need to know before starting to take Lacerol
3. How to take Lacerol
4. Possible adverse effects
5. Storage of Lacerol
6. Package contents and additional information

1. What is Lacerol and what is it used for

Lacerol 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 for:

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

? Treatment of high blood pressure (hypertension).

2. What you need to know before starting to take Lacerol

Do not take Lacerol

• if you are allergic to diltiazem or any other component of this medication (listed in section 6),
• in case of shock
• if you have any heart disease, such as left ventricular insufficiency with pulmonary congestion
• if you have severe low blood pressure (severe hypotension)
• if you have had a heart attack
• if you have certain heart rhythm disorders, such as: bradycardia - less than 40 beats/minute -, second- or third-degree block in patients without a pacemaker, sick sinus node disease in patients without a pacemaker
• if you are being treated with dantrolene in perfusion (a medication to relax muscles).
• if you are already taking a medication that contains ivabradina for the treatment of certain heart diseases

if you are taking a medication that contains lomitapida, used to treat 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 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.

• if you have heart conditions, such as left ventricular insufficiency, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of heart rhythm disorder) detected by electrocardiogram, your doctor will need to closely monitor you.
• in case of general anesthesia, you should inform the anesthesiologist that you are being treated with this medication.
• if you are an elderly patient or have kidney or liver disease (renal or hepatic insufficiency), diltiazem blood levels may be higher, so your heart rate will need to be closely monitored at the start of treatment.
• if you experience 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 of toxic compounds in the liver, including porphyrins and their precursors).
• if you have low blood pressure: treatment with diltiazem may cause excessive blood pressure drop. Your doctor will inform you about how to avoid symptoms resulting from hypotension and what measures to take if these symptoms occur.
• the use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and indicate the measures to take.
• diltiazem has significant hepatic metabolism, being excreted by the kidneys as well as by bile. Like other medications administered for prolonged periods, laboratory parameters should be regularly monitored.
• It can cause an increase in liver enzymes, which is usually reversible if treatment is discontinued. Your doctor will perform periodic checks.
• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage 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 is not recommended in children and adolescents (under 18 years of age).

Other medications and Lacerol

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

Contraindicated use:

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

• Effects of other medications on Lacerol

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

• 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 can decrease the effects of Lacerol by reducing its blood concentration:

• phenytoin (used to treat epilepsy)
• St. John's Wort (used for fatigue, tiredness, or sleep disorders)
• rifampicin (antibiotic)

• Effects of Lacerol on other medications

Lacerol can increase the effects of the following medications by increasing their blood concentrations or enhancing their effect:

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

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

• medications that reduce blood clot formation (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 illnesses): may increase the risk of intense agitation (psychotic episodes)
• X-ray contrast medium: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when administered an intravenous bolus of an ionic X-ray contrast medium. Special caution is required in patients who receive concomitant diltiazem and X-ray contrast medium.

General information to keep in mind:

• Antiplatelet medications (medications that prevent platelet aggregation): the possibility of an additive effect on platelet aggregation of diltiazem and antiplatelet medications (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered.

• Medications metabolized by the CYP3A4 enzyme, as this may result in a decrease in diltiazem blood levels or an increase in the levels of any medications administered with it.
• Patient monitoring is recommended for those consuming grapefruit juice, as it may increase the adverse effects of diltiazem. Grapefruit juice should be avoided if an interaction is suspected.
• Cilostazol: by inhibiting cilostazol metabolism, diltiazem increases its pharmacological activity.

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

Taking Lacerol with food and beverages

It is recommended to take this medication preferably before meals.

Grapefruit juice should be avoided (see section "Other medications and Lacerol").

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.

This medication should not be administered to pregnant women or women of childbearing age 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 with an alternative method.

Driving and using machines

The ability to drive and use machines may be impaired, especially at the start of treatment with diltiazem.

3. How to take Lacerol

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

The recommended dose is:

Adults

Chest angina: the initial dose is 1 tablet every 12 hours. Your doctor will gradually increase the dose to achieve 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 to achieve the optimal response.

Elderly patients, patients with kidney or liver insufficiency

Initial dose adjustment should be done with caution.

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

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (e.g., 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 time. Taking the tablets at the same time every day will have a better effect on your blood pressure. It will also help you remember to take the tablets.

Your doctor will indicate the duration of your treatment with Lacerol 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 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 hospital emergency department. 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, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Lacerol

In case of forgetting a 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 make up for forgotten doses.

If you interrupt treatment with Lacerol

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

Do not interrupt 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.

4. Possible Adverse Effects

Like all medications, Lacerol can produce adverse effects, although not all people suffer from them.

The following adverse effects have been reported according to the detailed frequencies below:

Very frequent (may affect more than 1 in 10 patients):

? Swelling of hands, feet, or ankles (peripheral edema).

Frequent (may affect between 1 and 10 out of 100 patients):

• Swelling (edema).
• Fatigue (asthenia).
• General malaise.
• Redness (rubefaction).
• Interruption or alteration of the electrical signal in the heart of mild, moderate, or severe degree (first-, second-, and third-degree AV block, palpitations, bradycardia).

• Nausea, constipation, dyspepsia, gastric pain.
• Skin rashes, skin redness (erythema).

• Headache, dizziness.
• Joint swelling.

Infrequent (may affect between 1 and 10 out of 1,000 patients):

• Thirst.
• Drop in blood pressure caused by sudden changes in body position (orthostatic hypotension), low blood pressure (hypotension).
• Chest pain or pressure (angina pectoris), irregular heartbeats (arrhythmias), rapid heartbeats (tachycardia), abnormal heart contractions (ventricular extrasystoles), heart failure with generalized swelling (congestive heart failure), hypotonia of the heart muscle, sinoatrial block (delay in the conduction of the stimulus to the heart's atria).
• Abnormal loss of appetite (anorexia), burning sensation, diarrhea, taste alterations (dysgeusia), vomiting, dry mouth.
• Alteration of liver function tests, elevation of lactate dehydrogenase enzyme (LDH), elevation of creatine phosphokinase enzyme (CPK), and elevation of 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 typically circular, composed of a red center, pale ring, and outer red ring (erythema multiforme).
• Difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling or numbness (paresthesia), tendency to fall asleep (somnolence), tremor, vertigo.
• Ringing in the ears (tinnitus).
• Depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake), and personality changes.
• Elevation of 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 in a specific type of white blood cells (eosinophils).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), and nasal congestion.
• Alteration of sexual function.
• Elevation of liver enzymes (transaminases).

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

• Changes in the electrocardiogram.
• Increased bleeding time.
• Skin disorder with blister formation and skin peeling (toxic epidermal necrolysis), acute skin reaction with increased sensitivity in mucous membranes (Stevens-Johnson syndrome), inflammation of the skin (generalized acute pustular exanthematous dermatitis),
• Enlargement of breast tissue in men (gynecomastia), painful menstruation (dysmenorrhea), vaginal inflammation (vaginitis), prostate disease.

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

• Fever, walking and movement problems (extrapyramidal disorders), inflammation of blood vessels (vasculitis), paleness, alterations in heart rhythm such as sinus pause (sinus arrest), cardiac insufficiency (asystole), atrial flutter, ventricular tachycardia, and ventricular fibrillation, gum inflammation (gingival hyperplasia), tooth anomaly, paralysis of intestinal muscles (paralytic ileus), swelling of the skin, mucous membranes, and submucosal tissues (angioneurotic edema), sweating, generalized acute pustular exanthematous eruption (sudden eruption accompanied by fever, with formation of pustules or lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to a blister), skin inflammation with peeling with or without fever (exfoliative dermatitis), skin redness with peeling (erythematous desquamation), purpura, skin hypertrophy, memory loss (amnesia), temporary loss of consciousness (syncope), sudden involuntary muscle twitch (myoclonus), increased muscle tone (hypertonia), mood changes (including depression), confused state, decreased appetite, gout, blurred vision, non-inflammatory disease of the retina (retinopathy), muscle pain (myalgia), musculoskeletal pain, joint inflammation (bursitis), bladder inflammation (cystitis), kidney stones (nephrolithiasis), abnormal decrease in the number of circulating platelets in the blood (thrombocytopenia), abnormal decrease in the number of red blood cells (hemolytic anemia), increased cough, inflammation of the mucous membranes of the nasal cavities 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 alteration), 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").

After marketing 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 (decrease in the number of white blood cells).

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 reporting system: Spanish Pharmacovigilance System for Human Use Medications: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Lacerol

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after "Cad". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Packaging Content and Additional Information

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 Packaging Content

Lacerol is a biconvex, white tablet without irregularities. There are packages with 30, 60, and 500 tablets.

Marketing Authorization Holder and Manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the Last Revision of this Prospectus: April 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/