Leaflet: information for the user

Carreldon Retard 240 mg prolonged-release tablets

diltiazem hydrochloride

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leafletas you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

Carreldon Retard belongs to a group of medications known as calcium channel blockers. They act by dilating blood vessels and at the same time decreasing the heart's oxygen requirements.

This medication is used for the treatment and prevention of angina pectoris.

Do not take Carreldon Retard

• If you are allergic to diltiazem hydrochloride or any of the other components 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 (a muscle relaxant).
• 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.
• Ifyou are already taking a medication containing ivabradine for the treatment of certain heart conditions.
• If you are already taking a medication containing lomitapide used for the treatment of high cholesterol (see section: “Taking Carreldon with other medications”).

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCarreldon Retard:

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.

• 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 pulse and heart rate (bradycardia).
• If you experience hypotension: 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 elderly: since there are no available data in these patients, Carreldon Retard should be used with caution.
• In children: there is no experience with the use of Carreldon Retard in children.
• The use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and advise on the necessary measures.

Other medications and Carreldon Retard

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

Do not takeCarreldon Retardand inform your doctor or pharmacist immediately:

Effects of other drugs on Carreldon Retard

The following drugs may increase the effects of Carreldon Retard by increasing its concentration in the blood:

• Fluconazole (used to treat fungal infections).
• Erythromycin and other macrolides (antibiotics).
• Ritonavir (used to treat viral infections).
• Amiodarone (used to slow the heart rate).
• Phenytoin (used to treat epilepsy).
• St. John's Wort (used in cases of debilitation, fatigue, or sleep disturbances).
• Cimetidine and ranitidine (used to reduce stomach acid production).

Effects of Carreldon Retard on other drugs

Carreldon Retard may increase the effects of the following drugs, by increasing their concentrations in the blood:

• Phenytoin, carbamazepine (used to treat epilepsy).
• Triazolam, buspirone (used to treat anxiety).
• Digoxin, organic nitrates (used to treat heart conditions).
• Ciclosporin, sirolimus (used to suppress 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 (used to prevent blood clotting).
• 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 slow the heart rate (amiodarone).
• Diltiazem may potentiate the effects of anesthetics.

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

Taking Carreldon Retard with food, drinks, and alcohol

Carreldon Retard tablets should be taken orally, should be swallowed whole, without chewing, and with a sufficient amount of liquid, preferably before meals.

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

Pregnancy and lactation

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 this medication 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 Carreldon Retard, discontinue the medication immediately and consult your doctor. This medication may induce fetal malformations.

This medication is excreted in breast milk, therefore, do not breastfeed while taking this medication.

Driving and operating machinery

The ability to perform activities such as operating machinery or driving vehicles may be impaired, especially at the beginning of treatment with Carreldon Retard.

Carreldon Retard contains lactose and ricin oil

This medication contains lactose. If your doctor has indicated 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 of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual dose is 1 tablet per day. It is recommended to take the medication at the same time every day.

Patients with advanced age, renal or hepatic insufficiency

All dose modifications and their control will be performed under medical supervision.

Instructions for correct administration

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 Carreldon 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 Carreldon Retard is too strong or too weak, inform your doctor or pharmacist.

It is not recommended to substitute 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 Carreldon 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.

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 Carreldon 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 interrupt treatment with Carreldon Retard

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

Do not interrupt treatment with this medication without consulting your doctor first.

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

Like all medications, this medication may cause side effects, although not everyone will experience them. The following side effects have been reported for diltiazem. In such cases, you should inform your doctor as soon as possible:

Frequent side effects (may affect between 1 and 10 of 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
• general discomfort

Rare side effects (may affect between 1 and 10 of every 1,000 patients):

• swelling of hands, feet, or ankles (peripheral edema), thirst.
• chest pain (angina), 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, abdominal pain, 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 eruptions (exanthema), itching (pruritus), skin redness (erythema), light sensitivity (photosensitivity), hives, skin lesions usually circular, composed of a red center, pale ring, and outer ring of reddish color (erythema multiforme), and hair loss (alopecia), skin inflammation with peeling (dermatitis exfoliativa), skin redness with peeling (erythema desquamativum).
• problems with walking and movement (extrapyramidal disorders), vertigo, difficulty initiating or maintaining sleep (insomnia), nervousness, abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), and tremor.
• ringing in the ears (tinnitus).
• memory loss (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).
• lazy eye (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 total number of white blood cells (leukopenia).
• difficulty breathing (dyspnea), nosebleed (epistaxis), and nasal congestion.
• alterations in sexual function.

Rare side effects (may affect between 1 and 10 of 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).

Side effects of unknown frequency: cannot be estimated from available data

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 not listed in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de uso humano https://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.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the box and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Carreldon Retard

• The active ingredient is diltiazem hydrochloride. Each tablet contains 240 mg of diltiazem hydrochloride.
• The other components (excipients) are: lactose monohydrate, hydroxypropyl cellulose (E463), hydroxypropyl methylcellulose (E464), ethyl cellulose, ammonio methacrylate copolymer type A, shellac, triacetin, carbomer 934P, talc (E553b), magnesium stearate, and hydrogenated ricin oil.

Appearance of the product and content of the packaging

Carreldon Retard 240 mg are prolonged-release tablets of white color, oblong, and scored on one face. The score is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

There are packaging with 20 and 30 tablets.

Holder of the marketing authorization

Alfasigma España, S.L.

Avda. Diagonal, 490

08006 Barcelona. SPAIN

Responsible for manufacturing

LACER, S.A.

C/ Boters, 5

08290 Cerdanyola del Vallés. SPAIN

or

Alfasigma, S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALY

Last review date of this prospectus: March 2024

Other sources of information

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