Diltiwas Retard 120 mg hard capsules prolonged release

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diltiwas Retard 120 mg prolonged-release hard capsules

diltiazem hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Diltiwas Retard is and what it is used for
2. What you need to know before taking Diltiwas Retard
3. How to take Diltiwas Retard
4. Possible adverse effects
5. How to store Diltiwas Retard
6. Contents of the pack and other information

1. What Diltiwas Retard is and what it is used for

Diltiwas Retard is a medicine that belongs to a group of drugs known as calcium antagonists, which work by reducing the heart's oxygen requirements and increasing the amount of blood reaching the heart muscle.

Diltiwas Retard is indicated for the treatment and prophylaxis of ischemic heart disease.

2. What you need to know before taking Diltiwas Retard

Do not take Diltiwas Retard

• if you are allergic to diltiazem hydrochloride or to any of the other components of this medicine (listed in section 6).
• if you have certain heart conditions such as various types of arrhythmia (irregular heartbeats due to sick sinus syndrome or second- or third-degree atrioventricular block), unless you have a pacemaker.
• if you have a very slow pulse below 40 beats per minute.
• if you have left ventricular failure (when the left ventricle does not fully pump oxygenated blood to the rest of the body), with fluid accumulation in the lungs.
• if you have congestive heart failure with pulmonary edema (the heart's inability to pump sufficient blood to the rest of the body and fluid accumulation).
• if you are simultaneously receiving an intravenous infusion of dantrolene (a medication to relax muscles).
• if you have hypotension (low blood pressure).
• if you have acute myocardial infarction complicated by very slow pulse, severe hypotension, and left ventricular failure.
• if you are pregnant or planning to become pregnant.
• if you are a woman of childbearing age and are not using an appropriate contraceptive method.
• if you are breastfeeding.
• if you are taking a medication containing ivabradine for the treatment of certain heart conditions.
• if you are already taking a medication containing lomitapide used for treating high cholesterol levels (see section: “Taking Diltiwas with other medicines”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiwas Retard

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

• If you are an elderly patient.

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

• If you have hypotension: 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 such symptoms occur.

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

• In children: there is no experience with the use of Diltiwas Retard in children.

• If you develop a skin rash caused by diltiazem, your doctor will assess these symptoms and advise you on the necessary measures.

• If you require general anesthesia, you must inform the anesthesiologist that you are being treated with diltiazem.

• As the therapeutic effect has not been compared between different diltiazem formulations with immediate or modified (retard) release, substitution of one for another is not recommended unless specifically advised by the prescribing physician.

Taking Diltiwas Retard with other medicines

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

In particular, do not take this medicine and inform your doctor if you are taking:

Medications containing lomitapide used for treating high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could lead to an increased likelihood and severity of liver-related side effects.

Lithium (used to treat certain mental illnesses): risk of increased lithium-induced neurotoxicity.

Nitrate derivatives (to treat hypertension): increased hypotensive effects and fainting (additive vasodilatory effects). In all patients treated with Diltiwas Retard, nitrate derivatives should only be prescribed in gradually increasing doses.

Theophylline (used for asthma): increased blood levels of theophylline.

Alpha-antagonists (to treat hypertension): increased antihypertensive effects.

Concomitant treatment with alpha-antagonists may cause or worsen hypotension. The combination of diltiazem with an alpha-antagonist should only be considered under strict blood pressure monitoring.

Amiodarone (used to reduce heart rate), digoxin (used to treat heart conditions): increased risk of bradycardia (reduced heart rate). Caution should be exercised when combining these with diltiazem, particularly in elderly patients and when high doses are used.

Beta-blockers (to treat hypertension): possible cardiac disturbances.

Other antiarrhythmic agents (used to prevent or suppress cardiac rhythm disturbances): since diltiazem has antiarrhythmic properties, concomitant prescription with other antiarrhythmic agents is not recommended.

Carbamazepine (to treat epilepsy): increased blood levels of carbamazepine.

Rifampicin (an antibiotic): risk of decreased blood levels of diltiazem after starting treatment with rifampicin.

Agents used to reduce stomach acid (cimetidine, ranitidine): increased blood concentrations of diltiazem.

Cyclosporine (used to suppress the immune system): increased blood levels of cyclosporine.

The combined use of Diltiwas Retard with other drugs should be carried out under medical supervision, with gradual dose adjustments.

Due to the possibility of additive effects, caution is necessary and careful evaluation of patients receiving Diltiwas Retard simultaneously with other agents known to affect the heart is required.

Diltiwas Retard is metabolized in the liver by the CYP3A4 isoenzyme but also inhibits it. Other drugs have a similar or opposing metabolism, and cases of increased blood concentrations of one or the other drug may occur depending on whether they inhibit or not this liver enzyme.

Benzodiazepines (midazolam, triazolam used to treat anxiety): diltiazem significantly increases blood concentrations of midazolam and triazolam.

Corticosteroids (methylprednisolone, used to treat inflammatory conditions): diltiazem may increase blood concentrations of methylprednisolone, and a dose adjustment of methylprednisolone may be necessary.

Statins: (medications to lower blood cholesterol levels): diltiazem increases blood concentrations of certain statins. There is a risk of myopathy (muscle disorder) and rhabdomyolysis (muscle necrosis with complications such as kidney failure) with concomitant use of diltiazem and certain statins.

Taking Diltiwas Retard with food, drinks, and alcohol

The Diltiwas Retard capsules should be swallowed whole, without chewing, and with sufficient liquid, preferably before meals.

During treatment with this medicine, you should not consume alcohol, as this could lead to a drop in blood pressure with dizziness and/or fainting.

Pregnancy, breastfeeding, and fertility

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

Do not take Diltiwas Retard if you are pregnant or think you might be, if you plan to become pregnant, or if you are breastfeeding.

Women of childbearing age must use an effective contraceptive method. If you become pregnant while taking Diltiwas Retard, stop taking the medicine immediately and consult your doctor. Diltiwas Retard may cause fetal malformations.

Diltiwas Retard is excreted in breast milk; therefore, you must not breastfeed while being treated with this medicine. If the use of this medicine is considered essential, an alternative method of infant feeding should be used.

Driving and use of machines

Based on the reported adverse reactions, i.e., dizziness (common), general malaise (common), the ability to drive and operate machinery may be impaired. Therefore, it is advisable not to perform tasks requiring special attention (driving vehicles, operating dangerous machinery, etc.) until your response to the medicine is satisfactory.

Diltiwas Retard contains sucrose

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

3. How to take Diltiwas Retard

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

Diltiwas Retard is administered orally. Your doctor will indicate how many capsules you should take each day.

Adults:

The dose is 1 capsule every 12 hours. Your doctor will gradually increase your dose until the optimal response is achieved.

Elderly patients, renal or hepatic impairment:

Initial dose adjustment should be performed with caution.

All dose modifications and monitoring must be carried out under medical supervision.

Swallow the capsules whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). Diltiwas Retard should preferably be taken before meals.

Take Diltiwas Retard every day and approximately at the same time each day. Taking the capsules at the same time daily will provide a better effect on your blood pressure. It will also help you remember when to take them.

Your doctor will determine the duration of your treatment with Diltiwas Retard. Do not stop treatment prematurely, as this may be harmful to your health.

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

If you take more Diltiwas Retard than you should

If you take more capsules than you should, inform your doctor or go immediately to the hospital emergency department. Take the medicine pack with you. This will allow the doctor to see what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, abnormally fast or slow heartbeat, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Diltiwas Retard

Do not take a double dose to make up for forgotten doses. It is important to take Diltiwas Retard regularly at the same time each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed capsule.

If you stop taking Diltiwas Retard

If you stop treatment with Diltiwas Retard, you may experience worsening of your condition, with symptoms such as chest pain or tightness, or a sudden rise in blood pressure. Do not stop treatment with Diltiwas Retard 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 produce adverse effects, although not everyone experiences them.

The adverse effects of diltiazem vary in intensity from one patient to another and should be especially considered at the beginning of treatment or when changing medication.

The following are frequent adverse effects (may affect more than 1 in 100 people):

• Facial flushing
• Swelling of legs
• Abnormal slowing of heart rate
• Nausea
• Headache
• Malaise
• Dizziness
• Severe physical fatigue

The following are uncommon adverse effects (may affect up to 1 in 1,000 people):

• Reduction in blood pressure upon standing
• Palpitations
• Skin redness
• Urticaria with or without fever
• Abnormal skin reaction to light

The following are rare adverse effects (may affect up to 1 in 10,000 people):

• Reduced ability of the heart to pump blood
• Digestive disorder
• Stomach pain
• Constipation
• Dry mouth
• Moderate increases in liver transaminases, usually transient
• Inflammation of the liver (hepatitis), usually transient
• Generalized skin peeling
• Acute pustular eruption
• Redness of the skin with shedding
• Generalized blistering rash
• Swelling of the gums
• Breast enlargement in men, reversible after discontinuation of diltiazem treatment

The following are very rare adverse effects of unknown frequency (may affect up to 1 in more than 10,000 people):

• Separation and exfoliation of the skin due to cell death

The following are adverse effects with unknown frequency: cannot be estimated from the 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 via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiwas Retard

This medicine does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diltiwas Retard

• The active substance is diltiazem hydrochloride.
• The other components (excipients) are: povidone, corn starch, ammonium methacrylate copolymer, sucrose, paraffin, and talc. Capsule composition: gelatin, yellow iron oxide (E-172), red iron oxide (E-172), indigo carmine (E-132), erythrosine (E-127), and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Diltiwas Retard 120 mg prolonged-release hard capsules are presented as orange and red opaque hard capsules. Each pack contains 40 capsules.

Marketing Authorization Holder and Manufacturer

Alfasigma España, S.L.

C/ Aribau 195, 4º

08021 Barcelona. Spain

Date of the most recent review of this leaflet: April 2023

Other sources of information

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