CARRELDON RETARD 240 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Carreldon 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 package leaflet

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

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

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

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

2. What you need to know before you take 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 diseases such as various types of arrhythmia (irregular heartbeats due to sinus node disease, atrioventricular block, atrial fibrillation with Wolff-Parkinson-White syndrome, symptomatic bradycardia), infarction or heart failure (difficulty breathing due to lung congestion, generalized swelling due to fluid retention, very slow pulse and very low blood pressure).
• If you are receiving dantrolene (a muscle relaxant) by intravenous infusion at the same time.
• If you are pregnant, or planning to become pregnant.
• If you are breast-feeding.
• • If you are a woman of childbearing age and are not using an appropriate contraceptive method.
• If you are already taking a medicine containing ivabradine for the treatment of certain heart diseases.
• If you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: "Taking Carreldon 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 difficulty breathing, slow heartbeats or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, and your doctor may need to monitor your kidney function.

• If you have any cardiac arrhythmia (sinus node disease, atrioventricular block) or if you are being treated with other medicines used to treat heart diseases (beta blockers, digitalis) since the use of diltiazem in these situations can lead to an excessively slow pulse and heart rhythm (bradycardia).
• If you have hypotension: treatment with diltiazem can lead to an excessive drop in blood pressure. Your doctor will inform you about how to avoid the 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 is no data 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.
• The use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and indicate the measures to be taken.

Other medicines and Carreldon Retard

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not takeCarreldon Retardand 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 being treated with lithium salts (used to treat certain mental illnesses).
• 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 the concentration of lomitapide, which can lead to an increased probability 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 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 down the heart rate).
• Phenytoin (used to treat epilepsy).
• St. John's Wort (used in cases of exhaustion, fatigue 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 concentrations in the blood:

• Phenytoin, carbamazepine (used to treat epilepsy).
• Triazolam, buspirone (used to treat anxiety).
• Digoxin, organic nitrates (used to treat heart diseases).
• Cyclosporin, sirolimus (used to suppress the immune system).
• Methylprednisolone (corticosteroid used to treat inflammatory problems).
• Simvastatin and lovastatin (medicines to reduce the amount of cholesterol and other fatty substances in the blood).
• Theophylline, for the treatment of bronchial asthma.
• Medicines that reduce blood clot formation (oral anticoagulants, such as acenocoumarol or warfarin).
• Rifampicin, (antibiotic).
• Diltiazem may potentiate the effects of other medicines used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to slow down the heart rate (amiodarone).
• Diltiazem may potentiate the effects of anesthetics.

The combined use of Carreldon Retard with other medicines should be carried out under medical supervision and with gradual dose adjustment.

Taking Carreldon Retard with food, drinks and alcohol

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

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant or if you are trying to become pregnant. Women of childbearing age 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 should not breast-feed if you are being treated with this medicine.

Driving and using machines

Your ability to perform activities such as operating machinery or driving a vehicle may be impaired, especially at the start of treatment with Carreldon Retard.

Carreldon Retard contains lactose and castor oil

This medicine contains lactose. If your doctor has told you that you have an intolerance to some 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 Carreldon Retard

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

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

Elderly patients, renal or hepatic impairment

All dose modifications and their monitoring will be carried out under medical supervision.

Instructions for correct administration

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 Carreldon 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 effect of Carreldon Retard is too strong or too weak, tell your doctor or pharmacist.

It is not recommended to substitute diltiazem retard medicines between them unless you have received express 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 department of a hospital. Take the medicine package with you. This is 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 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Carreldon 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 stop taking Carreldon Retard

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

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

If you have any further questions on 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 diltiazem. In such cases, you should inform your doctor as soon as possible:

Common side effects (may affect up to 1 in 10 people):

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

Uncommon side effects (may affect up to 1 in 100 people):

• swelling of hands, feet or ankles (peripheral edema), thirst.
• chest pain or tightness (angina pectoris), irregular heartbeats (arrhythmias), interruption or alteration of the heart's electrical signal of moderate or severe degree (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 accelerated heartbeats (palpitations), fainting (syncope).
• loss of appetite (anorexia), burning sensation, constipation, diarrhea, taste disturbances (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, abdominal pain and gum inflammation (gingival hyperplasia).
• abnormal liver function tests (mild elevations of transaminases), elevated lactate dehydrogenase (LDH), elevated creatine phosphokinase (CPK) and elevated bilirubin in blood tests.
• small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), skin redness (erythema), skin reaction to light (photosensitivity), hives, skin lesions usually circular and composed of a red center, pale ring and reddish outer ring (erythema multiforme) and hair loss (alopecia), skin inflammation with peeling (exfoliative dermatitis), skin redness with peeling (erythematous desquamation).
• 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 being awake) and personality changes.
• elevated 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) and increase in a specific type of white blood cells (eosinophils) and decrease in the total number of white blood cells (leukopenia).
• difficulty breathing (dyspnea), nosebleeds (epistaxis) and nasal congestion.
• sexual function disorders.

Rare side effects (may affect up to 1 in 1,000 people):

• 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 the mucous membranes (Stevens-Johnson syndrome),
• inflammation of the skin (generalized acute pustular exanthematous dermatitis).
• enlargement of breast tissue in men (gynecomastia).
• inflammation of the liver (hepatitis).

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

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

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Carreldon 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 stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Angileptol mint flavor

Each tablet contains:

• The active ingredients:

Chlorhexidine dihydrochloride, 5 mg

Benzocaine, 4 mg

Enoxolone, 3 mg

• The other ingredients (excipients) are: sorbitol (E420), acesulfame potassium (E950), magnesium stearate and mint flavor

Appearance of the product and pack contents

Angileptol are sucking tablets, white, round and with the Greek letter σ on one face.

They come in packs containing 15 and 30 sucking tablets.

Other presentations

Angileptol Mint-eucalyptus flavor

Angileptol Honey-lemon flavor

Marketing authorization holder

Alfasigma Spain S.L.

C/ Aribau 195, 4th floor

08021 Barcelona, Spain

Manufacturer

Pharmaloop, S.L.

Polígono Industrial Azque C/Bolivia, 15

28806 Alcalá de Henares (Madrid), Spain

or

Alfasigma, S.p.A.

Via Pontina, Km 30,400

00071 Pomezia (Rome), Italy

Date of last revision of this leaflet:September 2021

Other sources of information

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