CRONODINE 120 mg PROLONGED-RELEASE CAPSULES

Introduction

Leaflet: information for the user

Cronodine 120 mg prolonged-release capsules

Diltiazem Hydrochloride

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Cronodine 120 mg capsules are and what they are used for.
2. What you need to know before taking Cronodine 120 mg capsules
3. How to take Cronodine 120 mg capsules
4. Possible side effects
5. Storage of Cronodine 120 mg capsules
6. Package contents and additional information

1. What Cronodine 120 mg capsules are and what they are used for

Cronodine 120 mg capsules, whose active ingredient is diltiazem, belong to a group of medications called calcium antagonists.

Cronodine 120 mg capsules are used to treat mild or moderate hypertension, as they act by decreasing pressure in blood vessels and reducing cardiac workload.

2. What you need to know before taking Cronodine 120 mg capsules

Do not take Cronodine 120 mg:

• if you are allergic to diltiazem or any of the other components of this medication (listed in section 6).
• if you have certain heart diseases, such as low heart rate (pulse less than 55 beats/minute), heart block (interference with normal heart rhythm 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 breastfeeding.
• if you are a woman of childbearing age and are not using an appropriate contraceptive method.
• if you are already taking a medication that contains lomitapide, used to treat high cholesterol levels (see section "Use of Cronodine with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cronodine 120mg.

• If you have any cardiac arrhythmia (sick sinus syndrome, atrioventricular block) or are receiving treatment with other medications used to treat heart diseases (beta blockers, digitalis), as the use of diltiazem in these situations may lead to an excessively slow heart rate (bradycardia).
• If you have low blood pressure (hypotension): treatment with diltiazem may lead to an excessive drop in 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 are going to undergo surgery that requires general anesthesia, you should inform your doctor and anesthesiologist about your treatment with Cronodine.
• If you have liver or kidney disease or are elderly: since there is no data available for these patients, Cronodine should be used with caution.
• If you have a history of heart failure, new breathing difficulties, slow heart rate, or low blood pressure. Cases of kidney damage 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 indicate the measures to take.
• Since the therapeutic effect has not been compared between 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 medications

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

Effects of other medications on Cronodine 120 mg capsules

The following medications 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 slow down the 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 reduce stomach acid production)

Effects of Cronodine 120 mg on other medications:

Cronodine may increase the effects of the following medications 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 (medications to lower cholesterol levels in the blood)
• theophylline (used to treat asthma)
• medications that reduce blood clot formation (oral anticoagulants, such as acenocoumarol or warfarin)
• rifampicin (antibiotic)
• Diltiazem may enhance the effects of other medications 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 enhance the effects of anesthetics.
• Diltiazem may also enhance the effects of dantrolene (muscle relaxant) and increase the risk of severe agitation (psychotic episodes) in patients being treated with lithium salts (used to treat certain mental illnesses).
• Medications containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which can lead to an increased probability and severity of liver-related side effects.

The combined use of Cronodine 120 mg capsules with other medications should be done under medical supervision and with gradual dose adjustment.

Taking Cronodine 120 mg capsules with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

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 medication immediately and consult your doctor. Cronodine may cause fetal malformations.

Cronodine is excreted in breast milk; therefore, you should not breastfeed if you are 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 it may cause a drop in blood pressure with possible dizziness. Therefore, it is not recommended to drive vehicles or operate hazardous machinery until your response to the medication is satisfactory.

Cronodine contains sucrose

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

3. How to take Cronodine 120 mg capsules

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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, depending on the medical criteria and the needs of each patient.

Elderly patients and those with liver or kidney disease:

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 should be done under medical supervision.

Instructions for correct administration

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

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

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

Your doctor will indicate the duration of your treatment with Cronodine. Do not stop treatment without consulting your doctor first, as it 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 120 mg capsules than you should

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

Call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Treatment: in case of a significant overdose, it is recommended to observe the patient in an ICU or coronary unit. 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 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 120 mg capsules

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

It is important to 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 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 treatment with Cronodine 120 mg capsules

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following are common side effects (affecting less than 1 in 10 people):

• 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 are uncommon side effects (affecting less than 1 in 100 people):

• Swelling of hands, feet, or ankles (peripheral edema), thirst.
• Chest pain (angina pectoris), irregular heartbeats (arrhythmias), moderate or severe heart block (second- or third-degree AV block), rapid heart rate (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), heartburn, constipation, diarrhea, taste disorders (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia).
• Abnormal liver function tests (mild elevations of transaminases), elevated 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 outer red 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 tremors.
• 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).
• Vague 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).
• Increased lymph node size (lymphadenopathy), increased eosinophils (a type of white blood cell), and decreased total white blood cell count (leukopenia).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), and nasal congestion.
• Sexual function disorders.

The following are side effects with unknown frequency (cannot be estimated from available data):

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cronodine 120 mg capsules

Keep in the original packaging.

Store at room temperature.

Keep out of sight and reach of children.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Cronodine 120 mg capsules

• The active ingredient is diltiazem. Each prolonged-release capsule contains 120 mg of diltiazem (as hydrochloride).
• The other components are sucrose, polyvinylpyrrolidone (E-1201), shellac, ethylcellulose (E-462), talc.

Capsule: gelatin, erythrosine (E-127), indigotine (E-132).

Appearance of the product and package contents

Cronodine 120 mg prolonged-release capsules are presented in the form of transparent, transparent-red capsules, in packages containing 30 or 60 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 medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/