Package Insert: Information for the User

Cronodine 120 mg Extended-Release Capsules

Diltiazem Hydrochloride

Read this package insert carefully before taking this medication, as it contains important information for you.

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

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

Cronodine 120 mg capsules is used for the treatment of mild or moderate hypertension as it acts by reducing blood pressure in the blood vessels and decreasing cardiac workload.

Do not take Cronodine 120 mg:

• if you are allergic to diltiazem or any of the other ingredients of this medication (listed in section 6).
• if you have certain heart conditions such as: low heart rate (less than 55 beats per minute) heart block (interference with normal heart rhythm that may cause palpitations, dizziness, fatigue, or fainting) or difficulty breathing, fatigue, and swelling of the ankles.
• 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 fertile woman and are not using an appropriate contraceptive method.
• - if you are already taking a medication that contains lomitapida 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 heart arrhythmia (sinus node disease, atrioventricular block) or if you are receiving treatment with other medications used to treat heart diseases (beta blockers, digitalis) since the use of diltiazem in these situations may lead to an excessively slow heart rate and rhythm (bradycardia).
• If you have hypotension (low blood pressure): the treatment with diltiazem may lead to an excessive decrease 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 to undergo any surgical intervention that requires general anesthesia, you must inform your doctor and the anesthesiologist about the treatment with Cronodine.
• If you have liver or kidney disease or are elderly: since there are no available data in these patients, Cronodine should be used with caution.
• If you have a history of heart failure, new difficulty breathing, 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 renal function.
• The use of diltiazem has been associated with skin reactions. Your doctor will evaluate these symptoms and indicate the measures to take.
• Since the therapeutic effect has not been compared between the different specialties with diltiazem in the form of delayed-release capsules, it is not recommended to substitute one for another, except for express recommendation from the prescribing doctor.

Children

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

Use of Cronodine with other medications

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

Effects of other drugs on Cronodine 120 mg capsules

The following drugs 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 debilitation, fatigue, or sleep disturbances)
• cimetidine and ranitidine (used to decrease stomach acid production)

Effects of Cronodine 120 mg on other drugs:

Cronodine may increase the effects of the following drugs, 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)
• ciclosporin, sirolimus (used to suppress the immune system)
• prednisolone (corticosteroid used to treat inflammatory conditions)
• simvastatin and lovastatin (medications to decrease cholesterol levels in the blood)
• theophylline (used to treat asthma)
• oral anticoagulants, such as acenocoumarol or warfarin (used to prevent blood clots)
• rifampicin (antibiotic)
• Diltiazem may potentiate the effects of other medications 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 also may potentiate the effects of dantrolene (muscle relaxant), and increase the risk of intense agitation (psychotic episodes) in patients treated with lithium salts (used to treat certain mental disorders).
• Medications containing lomitapida used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increase in the probability and severity of liver-related side effects.

The concomitant use of Cronodine 120 mg capsules with other medications should be carried out under medical supervision and adjusting the doses progressively.

Taking Cronodine 120 mg capsules with food and drinks

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

Pregnancy, lactation, 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 if you are trying to become pregnant. Fertile women should 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, do not breastfeed while taking Cronodine.

Driving and operating machinery

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 decrease in blood pressure with possible dizziness. Therefore, do not drive vehicles and operate hazardous machinery until the response to the medication is satisfactory.

Cronodine contains Saccharose

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions of this medication 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:

It can be used in adults doses of diltiazem hydrochloride of 240 mg per day. This dose can be reduced or increased up to a maximum of 360 mg per day at the discretion of the doctor according to the needs of each patient.

Patients over 65 years old and those suffering from liver or kidney diseases:

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

All dose modifications and their control will be performed under medical supervision.

Instructions for correct administration

Swallow the capsules whole, without chewing, both with meals and on an empty stomach, along with a sufficient amount of liquid (for example, water).

Take Cronodine every day and 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 when 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 discontinue treatment prematurely 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 your doctor prescribed, consult your doctor or pharmacist immediately or go to the nearest hospital as a Cronodine overdose can cause severe symptoms that usually take several hours to appear. Bring your capsule box.

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

Treatment: in case of significant overdose, it is recommended to observe in ICUs or coronary units. A gastric lavage followed by 50 or 100 mg of activated charcoal, shortly after ingestion, may reduce absorption. Cases of deep hypotension require plasma expanders (gluconate calcium IV) 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.

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

If you forget to take Cronodine 120 mg capsules

Do not take a double dose to compensate for the missed doses.

It is essential 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. Follow the next dose when it is time. If you miss several doses, consult your doctor.

If you interrupt treatment with Cronodine 120 mg capsules

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

• Fatigue (asthenia), swelling (edema).
• Redness (rubor).
• Mild alterations in heart rhythm, usually without symptoms (first-degree AV block, bradycardia).
• Headache, dizziness.
• Nausea.
• Skin eruptions.

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

• Swelling of hands, feet, or ankles (peripheral edema), thirst.
• Chest pain or pressure (angina pectoris), irregular heartbeats (arrhythmias), moderate or severe interruption or alteration of the electrical signal in the heart (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 rapid heartbeats (palpitations), temporary loss of consciousness (syncope).
• Abnormal loss of appetite (anorexia), heartburn, constipation, diarrhea, alterations in taste (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and inflammation of the gums (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 eruption (exanthema), itching (pruritus), skin redness (erythema), light sensitivity (photosensitivity), urticaria, skin lesions generally circular, composed of a red center, pale ring, and outer ring of reddish color (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.
• Tinnitus (ringing in the ears).
• Memory loss (amnesia), depression, sleep disorders, hallucinations (seeing, hearing, or feeling things that do not exist while awake), and personality changes.
• Elevation of blood glucose levels (hyperglycemia).
• Blurred vision (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 cell (eosinophils), and decrease in the total number of white blood cells (leukopenia).
• Dyspnea (difficulty breathing), nasal bleeding (epistaxis), and nasal congestion.
• Alterations in sexual function.

The following are the side effects of 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 eruptions (called "lupus-like syndrome").

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use,www.notificaram.es.

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

Store 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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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), indigotin (E-132).

Appearance of the product and contents of the packaging

Cronodine 120 mg prolonged-release capsules are presented in the form of transparent pink capsules, in containers containing 30 or 60 capsules.

Holder of the marketing authorization and responsible manufacturer

ESPECIALIDADES FARMACÉUTICAS CENTRUM, S.A.

C/Sagitario 14

03006 Alicante

Telephone: 965286700

Fax: 965286434

Asacpharma Group

Last review date of this leaflet:May 2023

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