Package Insert: Information for the User

Trumsal 180 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.

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

Trumsal 180 mg capsules are used for the treatment of mild or moderate hypertension as it acts by reducing blood pressure in blood vessels and decreasing cardiac workload.

Do not take Trumsal 180 mg

-if you are allergic to diltiazem or any of the other ingredients in 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 for the treatment of high cholesterol levels (see section “Use of Trumsal with other medications”).

Warnings and precautions

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

-If you have any arrhythmia (heart disease of the sinoatrial node, atrioventricular block) or if you are receiving treatment with other medications used to treat heart disease (beta blockers, digitalis) since the use of diltiazem in these situations may lead to an excessively slow heart rate and rhythm (bradycardia).

-If you experience hypotension (low blood pressure): treatment with diltiazem may lead to an excessive decrease in blood pressure. Your doctor will inform you about how to avoid the resulting symptoms of 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 Trumsal.

-If you have liver or kidney disease or are elderly: since there are no available data in these patients, Trumsal 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 Trumsal in children.

Use of Trumsal 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 Trumsal 180 mg capsules

The following drugs may 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 reduce heart rate)

- phenytoin (used to treat epilepsy)

- St. John's Wort (used in cases of weakness, fatigue or sleep disturbances)

- cimetidine and ranitidine (used to reduce stomach acid production)

Effects of Trumsal 180 mg on other drugs

Trumsal 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 disease)

- ciclosporin, sirolimus (used to suppress the immune system)

- methylprednisolone (corticosteroid used to treat inflammatory conditions)

- simvastatin and lovastatin (medications to reduce cholesterol levels in the blood)

- theophylline (used to treat asthma)

- medications that reduce blood clotting (oral anticoagulants, such as acenocoumarol or warfarin)

- 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 reduce 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 for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increase in the probability and severity of side effects related to the liver.

The concomitant use of Trumsal 180 mg capsules with other medications should be carried out under medical control and adjusting the doses progressively.

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 (for example, 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 Trumsal 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 Trumsal, stop taking the medication immediately and consult your doctor. Trumsal may cause fetal malformations.

Trumsal is excreted in breast milk, therefore, do not breastfeed while taking Trumsal.

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 Trumsal, 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.

Trumsal 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.

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

Adults:

The dose of chlorhidrate of diltiazem that can be used in adults is 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 patients with liver or kidney disease:

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 Trumsal every day and approximately at the same hour. Taking the capsules at the same hour 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 Trumsal. Do not discontinue treatment prematurely 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 a Trumsal 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 Trumsal 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 Trumsal 180 mg capsules

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

It is essential to take Trumsal regularly at the same hour each day.

If you forget to take your capsule, but remember within 12 hours of your usual hour, take the capsule when you remember. If you remember after more than 12 hours of your usual hour, 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 Trumsal 180 mg capsules

If you interrupt treatment with Trumsal, you may experience a worsening of your disease, presenting symptoms such as chest pain or a sudden increase in blood pressure. Do not discontinue treatment with Trumsal 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 (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 alterations.

- Elevated blood glucose levels (hyperglycemia).

- Blurred vision (partial loss of vision in one or both eyes), eye irritation.

- Joint pain.

- Nocturia (need to urinate at night) 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).

- Difficulty breathing (dyspnea), nasal bleeding (epistaxis), and nasal congestion.

- Alterations in sexual function.

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

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").

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 that does not appear in this leaflet. 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.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use Trumsal 180 mg capsules after the expiration date shown 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 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 Trumsal 180 mg capsules

-The active ingredient is diltiazem. Each prolonged-release hard capsule contains 180 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) and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Trumsal 180 mg prolonged-release capsules are presented in the form of transparent pinkish opaque capsules, in containers holding 30 capsules.

Holder of the marketing authorization and responsible for manufacturing

Especialidades Farmacéuticas Centrum S.A

C/Sagitario 14

03006 Alicante

Telephone: 965286700

Fax: 965286434

Grupo Asacpharma

Last review date of this leaflet:May 2023

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.es/