Trumsal 180 mg prolonged-release capsules

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do 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 the effects are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Trumsal 180 mg capsules is and what it is used for

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

Trumsal 180 mg capsules are used for the treatment of mild to moderate hypertension, as it works by lowering the pressure in the blood vessels and reducing the workload of the heart.

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

Do not take Trumsal 180 mg

• 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 have difficulty breathing, fatigue, or swollen 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 woman of childbearing age and are not using an appropriate contraceptive method.

• if you are already taking a medicine containing lomitapide used to treat high cholesterol levels (see section "Use of Trumsal with other medicines").

Warnings and precautions

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

• If you have any cardiac arrhythmia (sinoatrial disease, atrioventricular block) or if you 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 an 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 these symptoms occur.

• If you are scheduled for any surgical procedure requiring general anesthesia, you must inform your doctor and anesthesiologist that you are being treated with Trumsal.

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

• If you have a history of heart failure, new onset breathing difficulty, 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.

• Since the therapeutic effect has not been compared between different diltiazem-containing products in the form of sustained-release capsules, substitution between them is not recommended unless specifically advised by your prescribing doctor.

Children

There is no experience regarding the use of Trumsal in children.

Use of Trumsal with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Effects of other drugs on Trumsal 180 mg capsules

The following drugs may increase the effects of Trumsal 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 reduce heart rate)
• phenytoin (used to treat epilepsy)
• St. John's wort (used for fatigue, tiredness, 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 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 (an 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 reduce 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 treated with lithium salts (used to treat certain mental illnesses).
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could lead to an increased likelihood and severity of liver-related side effects.

The combined use of Trumsal 180 mg capsules with other medicines should be carried out under medical supervision with gradual dose adjustments.

Taking Trumsal 180 mg capsules with food and drink

Can 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 plan 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 must not breastfeed while being treated with Trumsal.

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 Trumsal, 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.

Trumsal contains sucrose

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

3. How to take Trumsal 180 mg capsules

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

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

Adults:

Doses of diltiazem hydrochloride of 240 mg daily 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 the individual needs of the patient.

Elderly patients and patients with hepatic or renal disease:

Initial dose adjustment should be performed with caution. 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 correct 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 Trumsal every day and approximately at the same time each day. Taking the capsules at the same time daily 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 advice. Remember to take your medicine.

Your doctor will tell you how long to take Trumsal. Do not stop treatment prematurely, as this could 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 prescribed by your doctor, contact your doctor or pharmacist immediately or go to the nearest hospital, as an overdose of Trumsal capsules may cause serious symptoms, which usually take several hours to appear. Take your capsule pack with you.

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

Treatment: in case of significant overdose, monitoring 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 Trumsal 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 Trumsal 180 mg capsules

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

It is important that you take Trumsal 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 it. Continue with your next dose at the usual time. If you miss several doses, consult your doctor.

If you stop taking Trumsal 180 mg capsules

If you stop treatment with Trumsal, your condition may worsen, with symptoms such as chest pain or pressure, or a sudden rise in blood pressure. Do not stop treatment with Trumsal 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, this medicine can cause adverse effects, although not everyone will experience them.

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

• Tiredness (asthenia), swelling (edema)
• Redness (flushing)
• 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 heartbeats (arrhythmias), interruption or disturbance of the heart's electrical signal of moderate or severe degree (second- or third-degree AV block, sino-atrial block), rapid heartbeat (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), stomach burning, constipation, diarrhea, altered taste (dysgeusia), indigestion (dyspepsia), vomiting, weight gain, dry mouth, and gum inflammation (gingival hyperplasia)
• Abnormal 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), skin redness (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), nosebleed (epistaxis), and nasal congestion
• Sexual function disturbances

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.

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

• Condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (called "lupus-like syndrome").

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 through the Spanish Pharmacovigilance System for Human Medicinal Products, www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 expiry date indicated on the packaging after EXP. The expiry date refers to the last day of the month shown.

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

6. Contents of the pack and other information

Composition of Trumsal 180 mg capsules

• The active substance 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 shell: gelatin, erythrosine (E-127), indigo carmine (E-132), and titanium dioxide (E-171).

Appearance of the medicine and contents of the pack

Trumsal 180 mg prolonged-release capsules are presented as opaque whitish capsules, in packaging 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 revision of this leaflet: May 2023

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