LACEROL COR RETARD 240 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Lacerol Cor Retard 240 mg prolonged-release tablets

Diltiazem hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

? If you have any further questions, ask your doctor or pharmacist.

? This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

? If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

3.- How to take Lacerol Cor Retard

4.- Possible side effects

5.- Storage of Lacerol Cor Retard

6.- Contents of the pack and further information

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

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

This medicine is used to treat ischemic heart disease and to prevent angina pectoris.

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

Do not take Lacerol Cor Retard

? if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

? if you have cardiac rhythm or conduction disorders, such as:

• sinoatrial node dysfunction,
• second and third degree atrioventricular block if you do not have a pacemaker,
• significant bradycardia (pulse equal to or less than 40 beats/minute).

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

? if you are to receive an intravenous infusion of dantrolene (a drug used in muscle contraction disorders).

• if you are already taking a medicine that contains ivabradine for the treatment of certain heart diseases
• if you are already taking a medicine that contains lomitapide used for the treatment of high cholesterol levels (see section: “Other medicines 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 take Lacerol Cor Retard.

? if you are to undergo surgery under general anesthesia while being treated with this medicine. You should inform your doctor or anesthesiologist beforehand.

? if you have liver or kidney disease, or if you are over 65 years old, diltiazem blood levels may be higher. Your doctor may need to monitor you more closely and even have you undergo periodic check-ups.

? if you have heart disease or tend to have low blood pressure, inform your doctor before taking this medicine.

? if you suffer from any other disease or have swelling of the lower limbs 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 medicine and contact your doctor.? 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

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

Use in elderly people

Experience in elderly people (over 65 years of age) is limited. Since biological functions may be diminished in this group of patients, your doctor will indicate the dose you should take and closer monitoring will be necessary (see “Warnings and precautions”).

Other medicines and Lacerol Cor Retard

Tell your doctor or pharmacist if you are using, have recently used, or might use 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”).
• Medicines that contain lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase lomitapide levels, which may lead to an increased risk and severity of liver-related side effects.

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

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

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

? Amiodarone and other drugs for the treatment of arrhythmias.

? Cyclosporine, tacrolimus (used in organ transplants).

? Carbamazepine, for the treatment of epilepsy.

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

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

? Rifampicin, for the treatment of tuberculosis.

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

? Theophylline, for the treatment of bronchial asthma.

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

Taking Lacerol Cor Retard with food, drinks, and alcohol

Lacerol Cor Retard tablets are administered orally, swallowed whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water), and can be taken with or without food. It is recommended to take the tablet at the same time every day.

During treatment with this medicine, do not drink alcohol, as it may cause a drop in blood pressure with dizziness and/or fainting.

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 medicine.

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

Driving and using machines

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

Lacerol Cor Retard contains lactose and hydrogenated castor oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Lacerol Cor Retard

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

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

Instructions for the correct administration of the preparation

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). Remember to take your medicine.

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

It is not recommended to substitute diltiazem medicines in retard form with each other unless you have received explicit advice from your doctor to do so.

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 department of a hospital. Take the medicine package with you. This is so the doctor knows what you have taken. The following effects may occur: feeling of 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.

If you took more tablets than the dose prescribed by your doctor, contact your doctor immediately or go to the nearest hospital, taking the package and leaflet of the medicine with you. You can also call the Toxicology Information Service. Telephone 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Lacerol Cor Retard

If you forget to take a dose, do not worry; wait until the next dose to take your next tablet and then continue your normal dosing regimen. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• feeling of facial heat
• flushing
• swelling of the lower limbs and/or ankles
• slow pulse
• nausea
• headache
• dizziness
• general malaise
• fatigue.

Uncommon 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
• sleepiness
• redness of the skin
• itching and/or hives
• 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 that affects the skin and sometimes the mucous membranes and may rarely be accompanied by increased sensitivity of the mucous membranes (Stevens-Johnson syndrome)
• skin inflammation (exfoliative dermatitis, pustular exanthematous dermatitis)
• moderate elevations of liver enzymes (transaminases, alkaline phosphatase, LDH, bilirubin).

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

• toxic epidermal necrolysis: A skin disorder characterized by the formation of blisters and peeling of the skin.

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

• A condition in which the body's defense system attacks normal tissue and causes symptoms such as joint inflammation, fatigue, and skin rashes (called “lupus-like syndrome”).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lacerol Cor Retard

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP.”. The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lacerol Cor Retard:

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

The other ingredients (excipients) are: lactose monohydrate, hydroxypropyl cellulose, hydroxypropylmethyl cellulose, ethyl cellulose, ammonio methacrylate copolymer type A, shellac, triacetin, carbomer, talc, magnesium stearate, and hydrogenated castor oil.

Appearance of the product and contents of the pack:

Lacerol Cor Retard are white, oblong, and scored on one side prolonged-release tablets. The score line is only to facilitate breaking and swallowing, but not to divide into equal doses. There are packs of 20 and 30 tablets.

Only certain pack sizes may be marketed.

Marketing authorization holder and manufacturer:

LACER, S.A.

C/. Boters, 5

08290 Cerdanyola del Vallés

Barcelona - Spain

This leaflet was approved inApril2023

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