Carreldon Retard 240 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Carreldon Retard 240 mg prolonged-release tablets

diltiazem hydrochloride

Read the entire leaflet carefully before you start taking this medicine because 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, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Carreldon Retard is and what it is used for
2. What you need to know before taking Carreldon Retard
3. How to take Carreldon Retard
4. Possible side effects
5. How to store Carreldon Retard
6. Contents of the pack and other information

1. What Carreldon Retard is and what it is used for

Carreldon Retard belongs to a group of medicines called calcium channel blockers. These work by dilating blood vessels and at the same time reducing the heart's oxygen requirements.

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

2. What you need to know before taking Carreldon Retard

Do not take Carreldon Retard

• If you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If you have certain heart conditions such as various types of arrhythmia (irregular heartbeat due to sinoatrial node disease, atrioventricular block, atrial fibrillation together with Wolff-Parkinson-White syndrome, symptomatic bradycardia), myocardial infarction or heart failure (difficulty breathing due to pulmonary congestion, generalized swelling due to fluid retention, very slow pulse and very low blood pressure).
• If you are concurrently receiving an intravenous infusion of dantrolene (a muscle relaxant).
• If you are pregnant, or planning to become pregnant.
• If you are breastfeeding.
  • If you are a woman of childbearing potential and are not using an appropriate contraceptive method.
• If you are already taking a medicine containing ivabradine for the treatment of certain heart conditions.
• If you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: “Taking Carreldon Retard with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Carreldon Retard:

If you have a history of heart failure, new onset breathing difficulties, slow heartbeats or low blood pressure. Cases of kidney injury have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

• If you have any cardiac arrhythmia (sinoatrial node disease, atrioventricular block) or if you are receiving treatment with other medicines used to treat heart conditions (beta-blockers, digitalis), as the use of diltiazem in these situations may lead to excessively slow pulse and heart rhythm (bradycardia).
• If you have hypotension: treatment with diltiazem may cause an excessive drop in blood pressure. Your doctor will advise you on how to avoid symptoms resulting from hypotension and what steps to take if such symptoms occur.
• If you have liver or kidney disease or are elderly: since data are not available in these patients, Carreldon Retard should be used with caution.
• In children: there is no experience with the use of Carreldon Retard in children.
• Use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and advise you on the necessary measures.

Other medicines and Carreldon Retard

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

Do not take Carreldon Retard and inform your doctor or pharmacist immediately:

• If you are receiving dantrolene (a muscle relaxant), as it may increase the risk of severe agitation (psychotic episodes) in patients treated with lithium salts (used to treat certain mental disorders).
• If you are receiving ivabradine (a medicine indicated for angina pectoris).
• If you are taking medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase lomitapide concentration, which could lead to an increased frequency and severity of liver-related side effects.

Effects of other medicines on Carreldon Retard

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

• Fluconazole (used to treat fungal infections).
• Erythromycin and other macrolides (antibiotics).
• Ritonavir (used to treat viral infections).
• Amiodarone (used to reduce heart rate).
• Phenytoin (used to treat epilepsy).
• St. John's wort (used for fatigue, tiredness or sleep disturbances).
• Cimetidine and ranitidine (used to reduce stomach acid production).

Effects of Carreldon Retard on other medicines

Carreldon Retard may increase the effects of the following medicines by increasing their blood concentrations:

• Phenytoin, carbamazepine (used to treat epilepsy).
• Triazolam, buspirone (used to treat anxiety).
• Digoxin, organic nitrates (used to treat heart conditions).
• Cyclosporine, sirolimus (used to suppress the immune system).
• Methylprednisolone (a corticosteroid used to treat inflammatory conditions).
• Simvastatin and lovastatin (medicines to reduce cholesterol and other fatty substances in the blood).
• Theophylline, for the treatment of bronchial asthma.
• Medicines that reduce blood clotting (oral anticoagulants such as acenocoumarol or warfarin).
• Rifampicin (an antibiotic).
• Diltiazem may enhance the effects of other medicines used to lower blood pressure (nitrates, alpha- and beta-blockers, diuretics, angiotensin-converting enzyme inhibitors) and to reduce heart rate (amiodarone).
• Diltiazem may enhance the effects of anaesthetics.

The combined use of Carreldon Retard with other medicines should be under medical supervision, with gradual dose adjustments.

Taking Carreldon Retard with food, drinks and alcohol

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

During treatment with this medicine, you should not consume alcohol, as it may cause a drop in blood pressure leading to dizziness and/or fainting.

Pregnancy and breastfeeding

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

Do not take this medicine if you are pregnant or trying to become pregnant. Women of childbearing potential must use an effective contraceptive method. If you become pregnant while taking Carreldon Retard, stop taking the medicine immediately and consult your doctor. This medicine may cause fetal malformations.

This medicine is excreted in breast milk; therefore, you must not breastfeed while being treated with this medicine.

Driving and using machines

Your 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 hydrogenated castor oil

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

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

3. How to take Carreldon Retard

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Elderly patients, renal or hepatic impairment

Any dose adjustments and their monitoring must be carried out 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 medicine.

Your doctor will determine the duration of your treatment with Carreldon Retard and may adjust your dose if necessary. Do not change the dose prescribed by your doctor, and do not stop treatment without consulting your doctor first, as this could be harmful to your health.

If you feel that the effect of Carreldon Retard is too strong or too weak, inform your doctor or pharmacist.

Substitution between diltiazem retard formulations is not recommended unless you have received explicit advice from your doctor to do so.

If you take more Carreldon Retard than you should

If you take more tablets than prescribed, inform your doctor or go immediately to the nearest hospital emergency department. Take the medicine packaging with you so that the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, abnormally fast or slow heartbeat, difficulty speaking, confusion, reduced kidney function, coma, and sudden death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the name of the medicine and the amount ingested.

If you forget to take Carreldon Retard

If you forget to take a dose, do not worry; wait until your next scheduled dose, take your next tablet at that time, and then continue with your normal dosing schedule.

Do not take a double dose to make up for missed doses.

If you stop taking Carreldon Retard

If you stop treatment with this medicine, your condition may worsen, with symptoms such as chest pain or tightness, or a sudden increase in blood pressure.

Do not stop treatment with this medicine without first consulting your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects have been reported with diltiazem. In such cases, you should inform your doctor as soon as possible:

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

• swelling (edema)
• fatigue (asthenia)
• flushing
• mild disturbances in heart rhythm, usually without symptoms (first-degree AV block, bradycardia)
• headache, dizziness
• nausea
• skin rashes
• general malaise

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 patients):

• swelling of hands, feet or ankles (peripheral edema), thirst
• chest pain or tightness (angina pectoris), irregular heartbeat (arrhythmias), interruption or disturbance of the heart's electrical signal of moderate or severe degree (second- or third-degree AV block, sino-atrial block), rapid heartbeat (tachycardia), abnormal heartbeats (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, altered taste (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, abdominal pain and gum inflammation (gingival hyperplasia)
• abnormal liver function tests (mild elevations of transaminases), increased lactate dehydrogenase (LDH) enzyme, increased creatine phosphokinase (CPK) enzyme, and increased bilirubin levels in blood tests
• small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), skin redness (erythema), skin reaction to light (photosensitivity), urticaria, skin lesions usually circular with a red center, pale ring, and outer reddish ring (erythema multiforme), hair loss (alopecia), skin inflammation with peeling (exfoliative dermatitis), red, peeling skin (erythematous desquamative)
• difficulty walking and movement problems (extrapyramidal disorders), vertigo, difficulty falling or staying asleep (insomnia), nervousness, abnormal sensations 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 are not real while awake), and personality changes
• increased 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 cells (eosinophils), and decrease in total white blood cell count (leukopenia)
• difficulty breathing (dyspnea), nosebleeds (epistaxis), and nasal congestion
• sexual function disorders

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

• inflammation of blood vessels (vasculitis)
• changes in the electrocardiogram (ECG)
• skin disorder with blistering and peeling of the skin (toxic epidermal necrolysis)
• acute skin reaction with increased sensitivity in mucous membranes (Stevens-Johnson syndrome)
• skin inflammation (generalized acute exanthematous pustular dermatitis)
• enlargement of breast glands in men (gynecomastia)
• inflammation of the liver (hepatitis)

Adverse effects with unknown frequency: cannot be estimated from the available data

• Condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (called "lupus-like syndrome").

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Carreldon Retard

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Carreldon Retard

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

Appearance of the product and contents of the pack

Carreldon Retard 240 mg are prolonged-release tablets, white in color, slightly mottled, oblong-shaped, and scored on one side. The score mark is intended only to facilitate breaking the tablet and swallowing, but not to divide it into equal doses.

Pack sizes containing 20 and 30 tablets are available.

Marketing Authorization Holder

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Manufacturer

LACER, S.A.

C/ Boters, 5

08290 Cerdanyola del Vallés. SPAIN

or

Alfasigma, S.p.A.

Via Enrico Fermi, 1

65020 Alanno, Pescara. ITALY

Date of the most recent review of this leaflet: March 2024

Other sources of information

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