Package Insert: Information for the User

Lacerol Cor Retard 240 mg prolonged-release tablets

Diltiazem hydrochloride

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

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

?If you have any questions, 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 do not appear in this package insert. See section 4.

1.- What is Lacerol Cor Retard and how is it used

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

3.- How to take Lacerol Cor Retard

4.- Possible adverse effects

5.- Storage of Lacerol Cor Retard

6.- Contents of the package and additional information

Lacerol Cor Retard belongs to a group of medications called calcium channel blockers, with a predominantly cardiac action. They act by dilating blood vessels and at the same time reducing the heart's need for oxygen.

This medication is used to treat ischemic cardiopathy and to prevent angina pectoris.

Do not take Lacerol Cor Retard

?If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).

?If you have heart rhythm or conduction disorders, such as:

- sinus node dysfunction,

- second- or third-degree atrioventricular block if you do not have a pacemaker,

- significant bradycardia (pulse of 40 beats per minute or less).

?If you have decompensated heart failure or a myocardial infarction with complications.

?If you need to receive an intravenous infusion of dantrolene (a medication used for muscle contraction alterations).

•If you are already taking a medication containing ivabradine for the treatment of some heart diseases

•If you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section: “Other medications and Lacerol COR Retard”).

?If you have very low blood pressure (systolic blood pressure less than 90 mmHg).

?If you have a type of arrhythmia known as atrial fibrillation in the presence of the so-called Wolff-Parkinson-White syndrome.

?If you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeLacerol Cor Retard.

?If you are to be surgically treated under general anesthesia while taking this medication. You must inform your doctor or anesthesiologist beforehand.

?If you have liver or kidney disease, or if you are over 65 years old, the diltiazem concentration in the blood may be higher. Your doctor may need to monitor you more closely and even perform periodic control tests.

?If you have any heart disease or a tendency to have low blood pressure, inform your doctor before taking this medication.

?If you experience any other disease or swelling of the lower extremities and/or ankles. Inform your doctor or pharmacist promptly in these cases.

?If you develop skin rashes or other allergic reactions (such as itching or swelling of the face or lips), stop taking this medication and contact your doctor.?If you have a history of heart failure, difficulty breathing, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, and your doctor may need to monitor your renal function.

Children

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

Use in the elderly

The experience in the elderly (over 65 years) is limited. Since biological functions may be decreased in this patient group, your doctor will indicate the dose you should take and close monitoring will be necessary (see “Warnings and precautions”).

Other medications and Lacerol Cor Retard

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

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

It is especially important to inform your doctor if you are taking any of the following medications:

?Beta-blockers (used to treat high blood pressure).

?Digoxin, organic nitrates (used in heart diseases).

?Amiodarone and other medications for the treatment of arrhythmias.

?Ciclosporin, tacrolimus (used in organ transplants).

?Carbamazepine, used for the treatment of epilepsy.

?Cimetidine and ranitidine (used in the treatment of stomach ulcers).

?Lithium, used for the treatment of manic-depressive disorder.

?Rifampicin, used to treat tuberculosis.

?Simvastatin, pravastatin (used to reduce the amount of cholesterol and other fatty substances in the blood).

?Theophylline, used for the treatment of bronchial asthma.

?Midazolam, triazolam (used to produce relaxation or sleep and alleviate anxiety).

Lacerol Cor Retard with food, drinks, and alcohol

Lacerol Cor Retard tablets are administered orally, swallowed whole, without chewing, with the help of a glass of water, and can be taken either on an empty stomach or with food. It is recommended to take the tablet at the same time every day. (see also “3.- How to take Lacerol Cor Retard”)

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

Pregnancy, lactation, and fertility

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

Lacerol Cor Retard should not be taken during pregnancy and lactation. Therefore, if you are pregnant, think you may be pregnant, or are breastfeeding, stop taking this medication and inform your doctor as soon as possible.

Driving and operating machinery

At the beginning of treatment with this medication, your ability to drive vehicles and use machines may be reduced due to a decrease in your reflexes, which may be exacerbated if you consume alcohol at the same time. Therefore, do not drive or use potentially hazardous machinery until you have checked how you tolerate the medication.

Lacerol Cor Retard contains lactose and hydrogenated ricin oil

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

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

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

Instructions for Correct Administration of the Preparation

Swallow the tablets 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 Cor 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 Cor Retard is too strong or weak, inform your doctor or pharmacist.

Do not recommend substituting medications with diltiazem in the form of retard between them unless you have received explicit recommendation from your doctor in this regard.

If You Take More Lacerol Cor 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.

If you took more tablets than the dose prescribed by your doctor, contact your doctor immediately or go to the nearest hospital with the packaging and the medication leaflet. 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 Cor Retard

If you forgot to take a dose, do not worry; wait until the next dose to take your next tablet and continue with your normal dosing regimen. Do not take a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The following side effects have been reported for Lacerol Cor Retard. In such cases, inform your doctor as soon as possible:

Frequent side effects(between 1 and 10 in every 100 patients/people):

- sensation of facial heat

- shortness of breath

- swelling of the lower extremities and/or ankles

- slowing of the pulse

- nausea

- headache

- dizziness

- general discomfort

- fatigue.

Infrequent side effects(between 1 and 10 in every 1,000 patients/people):

- decrease in blood pressure when standing up

- tachycardia

- palpitations

- fainting

- difficult digestion

- abdominal pain

- constipation

- dry mouth

- drowsiness

- skin redness

- itching and/or urticaria

- abnormal increased sensitivity to sunlight.

Rare side effects(between 1 and 10 in every 10,000 patients/people):

- sinoatrial and/or atrioventricular block

- inflammation of blood vessels

- congestive heart failure

- changes in the electrocardiogram

- inflammation of the gums

- erythema multiforme: Acute reaction affecting the skin and sometimes the mucous membranes, which may rarely be accompanied by increased sensitivity of the mucous membranes (Stevens-Johnson syndrome)

- inflammation of the skin (exfoliative dermatitis, pustular exanthematous dermatitis)

- moderate elevations of liver enzymes (transaminases, alkaline phosphatase, LDH, bilirubin).

Very rare side effects(in fewer than 1 in every 10,000 patients/people):

- toxic epidermal necrolysis: Skin disorder characterized by the formation of blisters and peeling of the skin.

Unknown frequency(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 box and blister after “CAD.” The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash.Deposit containers and medications you no longer need at the Sigre Point of your pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This will help protect the environment.

Composition of Lacerol Cor Retard:

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

The other components (excipients) are: Lactose monohydrate, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, ammonio methacrylate copolymer type A, shellac, triacetin, carbomer, talc, magnesium stearate, and hydrogenated ricin oil.

Appearance of the product and contents of the packaging:

Lacerol Cor Retard are prolonged-release white, oval-shaped, and scored tablets on one side.The score is only for fracturing and facilitating swallowing, but not for dividing into equal doses.There are packaging with 20 and 30 tablets.

Only some packaging sizes may be commercially available

Holder of the marketing authorization and responsible for manufacturing:

LACER, S.A.

C/. Boters, 5

08290 Cerdanyola del Vallés

Barcelona - Spain

This leaflet was approved inApril2023

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