CRONODINE 240 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Cronodine 240 mg prolonged-release capsules

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 Cronodine 240 mg capsules and what is it used for.
2. What you need to know before you take Cronodine 240 mg capsules
3. How to take Cronodine 240 mg capsules
4. Possible side effects
5. Storage of Cronodine 240 mg capsules
6. Contents of the pack and further information

1. What is Cronodine 240 mg capsules and what is it used for

Cronodine 240 mg capsules, whose active substance is diltiazem, belongs to a group of medicines called calcium antagonists.

Cronodine 240 mg capsules is used for the treatment of mild or moderate hypertension as it acts by decreasing the pressure in the blood vessels and reducing the heart's workload.

2. What you need to know before you take Cronodine 240 mg capsules

Do not take Cronodine 240 mg capsules

• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from certain heart diseases such as: low heart rate (pulse less than 55 beats/minute) heart block (interference with the normal heartbeat that can lead to palpitations, dizziness, fatigue, or fainting) or have breathing difficulties, fatigue, and swelling of the ankles.
• if you are pregnant or think you may be pregnant, or are 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 that contains lomitapide used to treat high cholesterol levels (see section "Use of Cronodine with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cronodine 240mg.

• If you have any cardiac arrhythmia (sick sinus syndrome, atrioventricular block) or if you are receiving treatment with other medicines used to treat heart diseases (beta blockers, digitalis) as the use of diltiazem in these situations can lead to an excessively slow pulse and heart rhythm (bradycardia).

• If you have low blood pressure (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 are going to undergo any surgical procedure that requires general anesthesia, you should inform your doctor and anesthesiologist about the treatment with Cronodine.
• If you have liver or kidney disease or are elderly: since there is no data available in these patients, Cronodine should be used with caution.
• If you have a history of heart failure, new breathing difficulties, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, it is possible that your doctor may need to monitor your kidney function.

• The use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and indicate the measures to be taken.

• Since the therapeutic effect has not been compared between the different diltiazem specialties in the form of prolonged-release capsules, it is not recommended to substitute one for another, unless explicitly recommended by the prescribing doctor.

Children

There is no experience with the use of Cronodine in children.

Use of Cronodine with other medicines

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

Effects of other medicines on Cronodine 240 mg capsules

The following medicines may increase the effects of Cronodine 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 decrease heart rate)
• phenytoin (used to treat epilepsy)
• St. John's Wort (used in cases of exhaustion, fatigue, or sleep disorders)
• cimetidine and ranitidine (used to decrease stomach acid production)

Effects of Cronodine 240 mg on other medicines

Cronodine 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 (used to treat heart diseases)
• cyclosporine, sirolimus (used to suppress the immune system)
• methylprednisolone (corticosteroid used to treat inflammatory problems)
• simvastatin and lovastatin (medicines to lower cholesterol levels in the blood)
• theophylline (used to treat 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 decrease heart rate (amiodarone).
• Diltiazem may potentiate the effects of anesthetics.
• Diltiazem may also potentiate the effects of dantrolene (muscle relaxant) and increase the risk of severe agitation (psychotic episodes) in patients treated with lithium salts (used to treat certain mental illnesses).
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of side effects related to the liver.

The combined use of Cronodine 240 mg capsules with other medicines should be done under medical supervision and adjusting the doses progressively.

Taking Cronodine 240 mg capsules with food and drinks

It can be taken with an empty stomach or with meals, with a sufficient amount of liquid (e.g., a glass of water).

Pregnancy, breast-feeding, and fertility

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

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

Cronodine is excreted in breast milk, therefore, do not breast-feed if you are being treated with Cronodine.

Driving and using machines

The ability to perform activities such as operating machinery or driving vehicles may be impaired, especially at the beginning of treatment with Cronodine, as it may cause a reduction in blood pressure with possible dizziness. Therefore, it is not recommended to drive vehicles or operate hazardous machinery until the response to the medicine is satisfactory.

Cronodine contains Saccharose

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

3. How to take Cronodine 240 mg capsules

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

Cronodine is administered orally. The normal dose is 1 or 2 capsules per day taken in a single dose.

Adults:

Diltiazem hydrochloride doses of 240 mg per day can be used in adults. This dose may be decreased or increased up to a maximum of 360 mg per day at the doctor's discretion according to the needs of each patient.

Elderly patients and people with liver or kidney diseases:

The initial dose adjustment should be done with caution. Generally, lower doses (120 mg/day) are required at least at the beginning of treatment.

All dose modifications and monitoring will be done under medical supervision.

Instructions for correct administration

Swallow the capsules whole, without chewing, with or without food, with a sufficient amount of liquid (e.g., water).

Take Cronodine every day and approximately at the same time. Taking the capsules at the same time every day will have a better effect on your blood pressure. It will also help you remember when to take the capsules.

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Cronodine. Do not stop the treatment before without consulting your doctor.

If you feel that the effect of Cronodine is too strong or too weak, consult your doctor or pharmacist.

If you take more Cronodine 240 mg capsules than you should

If you have accidentally taken more Cronodine than your doctor prescribed, consult your doctor or pharmacist immediately or go to the nearest hospital, as an overdose of Cronodine capsules can cause serious symptoms that usually take several hours to appear. Bring your box of capsules.

Call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

Treatment: in case of ingestion of a significant overdose, it is recommended to observe in ICUs or coronary units. Gastric lavage followed by 50 or 100 mg of activated charcoal, shortly after ingestion, may reduce absorption. Cases of severe hypotension require plasma expanders, calcium gluconate iv, and inotropic agents (e.g., dopamine, dobutamine, or isoprenaline). Symptomatic bradycardia and heart block may respond to the application of atropine, isoprenaline, or, if necessary, cardiac pacing with a pacemaker.

An overdose of Cronodine can cause a drop in blood pressure. In this case, sit with your head down. It can also cause a decrease in kidney function.

If you forget to take Cronodine 240 mg capsules

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

It is important that you take Cronodine regularly at the same time every day.

If you forget to take your capsule, but remember within the next 12 hours, take the capsule when you remember. If you remember after more than 12 hours of your usual time, do not take it. Continue with the next dose at the usual time. If you forget several doses, consult your doctor.

If you stop taking Cronodine 240 mg capsules

If you stop taking Cronodine, you may experience a worsening of your disease, presenting symptoms such as chest pain or a sudden increase in blood pressure. Do not stop taking Cronodine without consulting your doctor first.

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

4. Possible side effects

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

The following side effects are frequent (affect less than 1 person in 10):

• Fatigue (asthenia), swelling (edema)
• Flushing (rubor)
• Mild heart rhythm disorders, usually without symptoms (first-degree AV block, bradycardia)
• Headache, dizziness
• Nausea
• Skin rash

The following side effects are uncommon (affect less than 1 person in 100):

• Swelling of hands, feet, or ankles (peripheral edema), thirst.

• Chest pain (angina pectoris), irregular heartbeats (arrhythmias), interruption or alteration of the electrical signal in the heart 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), temporary loss of consciousness (syncope).
• Abnormal loss of appetite (anorexia), heartburn, constipation, diarrhea, taste disorders (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia).
• Alteration of liver function tests (mild elevations of transaminases), elevation of lactate dehydrogenase (LDH) and creatine phosphokinase (CPK) 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 composed of a red center, pale ring, and reddish outer ring (erythema multiforme), and hair loss (alopecia).
• Difficulty walking, 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.
• Elevation of blood glucose levels (hyperglycemia).
• Vague eye (partial loss of vision in one or both eyes), eye irritation.
• Pain in the joints.
• Need to urinate at night (nocturia) and increased number of times you need to urinate (polyuria).
• Increase in lymph node size (lymphadenopathy), 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.

The following side effects have a frequency that cannot be estimated from the available data:

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

If you experience any side effect that you think is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

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 Health Products Agency (AEMPS) website, www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cronodine 240 mg capsules

Keep in the original packaging.

Store at room temperature.

Keep out of sight and reach of children.

Do not use Cronodine 240 mg capsules after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cronodine 240 mg capsules

• -The active substance is diltiazem. Each prolonged-release capsule contains 240 mg of diltiazem (as hydrochloride).
• -The other ingredients are saccharose, polyvinylpyrrolidone (E-1201), shellac, ethylcellulose (E-462), talc.

Capsule: gelatin, erythrosine (E-127), indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the product and packaging contents

Cronodine 240 mg prolonged-release capsules are presented in the form of transparent-red opaque capsules, in packages containing 30 capsules.

Marketing authorization holder and manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/Sagitario 14

03006 Alicante

Phone: 965286700

Fax: 965286434

Asacpharma Group

Date of the last revision of this leaflet:May 2023

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