Cronodine 240 mg prolonged-release capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cronodine 240 mg prolonged-release capsules

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, and you should not give it to other people, 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 Cronodine 240 mg capsules are and what they are used for
2. What you need to know before taking Cronodine 240 mg capsules
3. How to take Cronodine 240 mg capsules
4. Possible side effects
5. How to store Cronodine 240 mg capsules
6. Contents of the pack and other information

1. What Cronodine 240 mg capsules is and what it is 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 to moderate hypertension, as it acts by lowering the pressure in the blood vessels and reducing the heart's workload.

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

Do not take Cronodine 240 mg capsules

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6).
• if you have certain heart conditions such as: low heart rate (pulse less than 55 beats/minute), heart block (interference with normal heartbeat that may cause palpitations, dizziness, fatigue, or fainting), or if you have difficulty breathing, fatigue, or ankle swelling.
• if you are pregnant or think you may be pregnant, or if you are planning to become pregnant.
• if you are breastfeeding.
• if you are a woman of childbearing age and are not using an appropriate contraceptive method.
• if you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section “Use of Cronodine with other medicines”).

Warnings and precautions

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

• If you have any cardiac arrhythmia (sinoatrial disease, atrioventricular block) or are receiving treatment with other medicines used to treat heart conditions (beta-blockers, digitalis), because the use of diltiazem in these situations may lead to excessively slow pulse and heart rhythm (bradycardia).

• If you have hypotension (low blood pressure): 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 are undergoing any surgical procedure requiring general anesthesia, you must inform your doctor and anesthesiologist that you are being treated with Cronodine.

• If you have liver or kidney disease or are elderly: since there is no available data in these patients, Cronodine should be used with caution.

• 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.

• The use of diltiazem has been associated with skin reactions. Your doctor will assess these symptoms and advise you on the necessary measures.

• As the therapeutic effect has not been compared between different diltiazem-containing products in the form of modified-release capsules, substitution of one for another is not recommended unless specifically directed by the prescribing physician.

Children

There is no experience regarding 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 need to use any other medicines.

Effects of other drugs on Cronodine 240 mg capsules

The following medicines may increase the effects of Cronodine 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 slow heart rate)
• phenytoin (used to treat epilepsy)
• St. John’s wort (used for low mood, fatigue, or sleep disturbances)
• cimetidine and ranitidine (used to reduce stomach acid production)

Effects of Cronodine 240 mg on other medicines

Cronodine 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 (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 lower blood cholesterol levels)
• theophylline (used to treat asthma)
• medicines that reduce blood clotting (oral anticoagulants such as acenocoumarol or warfarin)
• rifampicin (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 slow heart rate (amiodarone).
• Diltiazem may enhance the effects of anesthetics.
• Diltiazem may also enhance the effects of dantrolene (a muscle relaxant) and increase the risk of severe agitation (psychotic episodes) in patients receiving lithium salts (used to treat certain mental illnesses).
• 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.

The concomitant use of Cronodine 240 mg capsules with other medicines should be done under medical supervision with gradual dose adjustments.

Taking Cronodine 240 mg capsules with food and drink

This medicine may be taken on an empty stomach or with meals, with sufficient liquid (e.g., a glass of water).

Pregnancy, breastfeeding, and fertility

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 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, you must not breastfeed while being treated with Cronodine.

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 Cronodine, as a reduction in blood pressure with possible dizziness may occur. Therefore, driving vehicles and operating dangerous machinery are not recommended until your response to the medicine is satisfactory.

Cronodine contains sucrose

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

3. How to take Cronodine 240 mg capsules

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

Cronodine is administered orally. The usual dose is 1 or 2 capsules daily, taken as a single dose.

Adults:

Daily doses of diltiazem hydrochloride 240 mg may be used in adults. This dose may be decreased or increased up to a maximum of 360 mg daily at the physician's discretion, depending on individual patient needs.

Elderly patients and patients with hepatic or renal disease:

Initial dose adjustment should be performed cautiously. Generally, lower doses (120 mg/day) are required, at least at the beginning of treatment.

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

Instructions for proper administration

Swallow the capsules whole, without chewing, either with meals or on an empty stomach, together with a sufficient amount of liquid (e.g., water).

Take Cronodine every day and approximately at the same time each day. Taking the capsules at the same time daily will provide better control of your blood pressure and will help you remember when to take them.

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

Your doctor will inform you of the duration of your treatment with Cronodine. Do not stop treatment prematurely, as this may be harmful to your health.

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 prescribed by your doctor, contact your doctor or pharmacist immediately or go to the nearest hospital, as an overdose of Cronodine capsules may cause serious symptoms, which usually appear after several hours. Bring your capsule pack with you.

Call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

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

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

If you forget to take Cronodine 240 mg capsules

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

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

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

If you stop taking Cronodine 240 mg capsules

If you stop treatment with Cronodine, you may experience worsening of your condition, with symptoms such as chest pain or tightness, or a sudden rise in blood pressure. Do not stop treatment with Cronodine 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, Cronodine may cause adverse effects, although not everyone experiences them.

The following are frequent adverse effects (affect fewer than 1 in 10 people):

• Tiredness (asthenia), swelling (edema)
• Flushing (rubor)
• Mild disturbances in heart rhythm, usually without symptoms (first-degree AV block, bradycardia)
• Headache, dizziness
• Nausea
• Skin rashes

The following are uncommon adverse effects (affect fewer than 1 in 100 people):

• 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, sinoatrial 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), heartburn, constipation, diarrhea, altered taste (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia)
• Abnormalities in liver function tests (mild elevations of transaminases), increased lactate dehydrogenase (LDH) enzyme, and increased creatine phosphokinase (CPK) enzyme in blood tests
• Small red spots on the skin (petechiae), skin rash (exanthema), itching (pruritus), redness of the skin (erythema), skin reaction to light (photosensitivity), urticaria, skin lesions usually circular with a red center, pale ring, and outer reddish ring (erythema multiforme), and hair loss (alopecia)
• Difficulty walking, trouble 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 are not there while awake), and personality changes
• Increased blood glucose levels (hyperglycemia)
• Lazy eye (partial vision loss 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

The following adverse effects have unknown frequency (cannot be estimated from available data):

• Condition in which the body's immune system attacks normal tissues, causing symptoms such as inflamed 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, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaram.es.

By reporting adverse 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 the sight and reach of children.

Do not use Cronodine 240 mg capsules after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cronodine 240 mg capsules

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

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

Appearance of the product and contents of the container

Cronodine 240 mg prolonged-release capsules are presented as opaque scarlet-colored transparent capsules, in containers containing 30 capsules.

Marketing Authorization Holder and Manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.
C/Sagitario 14
03006 Alicante
Telephone: 965286700
Fax: 965286434
Grupo Asacpharma

Date of the most recent review of this leaflet: May 2023

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