TRUMSAL 180 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Trumsal 180 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 pack

1. What Trumsal 180 mg capsules are and what they are used for.
2. What you need to know before you take Trumsal 180 mg capsules
3. How to take Trumsal 180 mg capsules
4. Possible side effects
5. Storing Trumsal 180 mg capsules
6. Contents of the pack and other information

1. What Trumsal 180 mg capsules are and what they are used for

Trumsal 180 mg capsules, whose active ingredient is diltiazem, belong to a group of medicines called calcium antagonists.

Trumsal 180 mg capsules are used for the treatment of mild or moderate hypertension as they act by decreasing the pressure in the blood vessels and reducing the heart's workload.

2. What you need to know before you take Trumsal 180 mg capsules

Do not take Trumsal 180 mg

-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 "Using Trumsal with other medicines").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Trumsal 180mg.

• If you suffer from any heart rhythm disorder (sick sinus syndrome, 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 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 Trumsal.

-If you suffer from liver or kidney disease or are elderly: since there is no data available for these patients, Trumsal 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 take.

-As 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 Trumsal in children.

Using Trumsal 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 Trumsal 180 mg capsules

The following medicines can increase the effects of Trumsal 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 Trumsal 180 mg on other medicines

Trumsal can 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 enhance 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 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).
• Medicines 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 side effects related to the liver.

The combined use of Trumsal 180 mg capsules with other medicines should be done under medical supervision and with gradual dose adjustment.

Taking Trumsal 180 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 Trumsal 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 Trumsal, stop taking the medicine immediately and consult your doctor. Trumsal may cause fetal malformations.

Trumsal is excreted in breast milk; therefore, you should not breast-feed if you are being treated with Trumsal.

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

Trumsal 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 Trumsal 180 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.

Trumsal 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 individuals 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 will 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 Trumsal every day, 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 Trumsal. Do not stop treatment before consulting your doctor, as it may be harmful to your health.

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

If you take more Trumsal 180 mg capsules than you should

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

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

Treatment: in case of ingestion of a significant overdose, observation in ICUs or coronary units is advised. 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 Trumsal 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 Trumsal 180 mg capsules

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

It is important that you take Trumsal regularly at the same time every 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 taking Trumsal 180 mg capsules

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

If you have any further questions about 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 are frequent (affect less than 1 person in 10):

• Fatigue (asthenia), swelling (edema)
• Redness (flush)
• 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), moderate or severe interruption or alteration of the heart's electrical signal (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, 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 and 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.
• 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).
• Enlargement of lymph nodes (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.

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

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").

Reporting side effects

If you experience any side effects, consult 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 Healthcare Products Agency (AEMPS) website, www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Trumsal 180 mg capsules

Keep in the original packaging.

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use Trumsal 180 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 pharmacy's SIGRE collection point. 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 other information

Composition of Trumsal 180 mg capsules

-The active ingredient is diltiazem. Each prolonged-release capsule contains 180 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

Trumsal 180 mg prolonged-release capsules are presented in the form of transparent-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 Healthcare Products (AEMPS) http://www.aemps.es/