Package Leaflet: Information for the User

Diltiwas Retard 120 mg prolonged-release hard capsules

diltiazem hydrochloride

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you get any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you start taking Diltiwas Retard

3. How to take Diltiwas Retard

4. Possible side effects

5. Storage of Diltiwas Retard

6. Contents of the pack and additional information

Diltiwas Retard is a medication that belongs to a group of drugs called calcium antagonists that acts by reducing the heart's oxygen needs and increasing the amount of blood that reaches the cardiac muscle.

Diltiwas Retard is indicated for the treatment and prevention of ischemic cardiopathy.

Do not take Diltiwas Retard

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medication (listed in section 6).
• if you have certain heart conditions such as various types of arrhythmia (irregular heartbeats due to sinoatrial node syndrome or second- or third-degree atrioventricular block, except if you have a pacemaker).
• if you have a very slow pulse below 40 beats per minute.
• if you have left ventricular insufficiency (when the left ventricle does not pump enough oxygenated blood to the rest of the body) with fluid accumulation in the lungs.
• if you have congestive heart failure with pulmonary edema (inability of the heart to pump enough blood to the rest of the body and fluid accumulation).
• if you are receiving an infusion of dantrolene (a muscle relaxant) intravenously at the same time.
• if you have hypotension (low blood pressure).
• if you have a complicated acute myocardial infarction with a very slow pulse, severe hypotension, and left ventricular insufficiency. If you are pregnant or planning to become pregnant.
• if you are a fertile woman and not using an appropriate contraceptive method.
• if you are breastfeeding.
• if you are taking a medication that contains ivabradine for the treatment of certain heart diseases.
• if you are already taking a medication that contains lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiwas with other medications").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiwas Retard.

• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, your doctor may need to monitor your kidney function.

• If you are a geriatric patient.
• If you have any heart arrhythmia (sinus node disease, atrioventricular block), if your heart rate is slow, or if you are receiving treatment with other medications used to treat heart diseases (beta blockers, digitalis) as the use of diltiazem in these situations may lead to an excessively slow pulse and heart rate (bradycardia).
• If you experience hypotension: 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 have any liver or kidney disease or are elderly: since there are 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 evaluate these symptoms and indicate the measures to take.
• If you require general anesthesia, you must inform the anesthesist of the treatment with diltiazem.
• Since the therapeutic effect has not been compared between the different specialties with diltiazem of immediate or modified (retard) release, it is not recommended to substitute one for the other unless there is an express recommendation from the prescribing doctor.

Taking Diltiwas Retard with other medications

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

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

Medications that contain 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.

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

Nitrate derivatives (used to treat hypertension):increase in hypotensive effects and dizziness (additional vasodilating effects). Inallpatients treated with Diltiwas Retard, the prescription of nitrate derivatives should only bemadein gradually increasing doses.

Theophylline (used for asthma): increase in theophylline levels in the blood.

Alpha-antagonists (used to treat hypertension):increase inanti-hypertensive effects:

The concomitant treatment withalpha-antagonists may produce or worsen hypotension.Thecombination of diltiazem with an alpha-antagonist should be considered only with strict control of blood pressure.

Amiodarone (used to decrease heart rate), digoxin (used to treat heart diseases):increase inthe risk of bradycardia (decrease in heart rate). You should be cautious when these are combined with diltiazem, particularly in elderly subjects and whenhigh doses are used.

Beta-blockers (used to treat hypertension): possibility of heart alterations.

Other antiarrhythmic agents (used to prevent or suppress heart rhythm alterations): since diltiazem has antiarrhythmic properties,it is not recommended to prescribe it concomitantly with otherantiarrhythmicagents.

Carbamazepine (used to treat epilepsy): increase in carbamazepine levels in the blood.

Rifampicin (antibiotic):risk of decrease in diltiazem levels in the blood after starting rifampicin treatment.

Agentsused to decrease stomach acid (cimetidine, ranitidine): increase in diltiazem levels in the blood.

Ciclosporin (used to suppress the immune system): increase in ciclosporin levels in the blood.

The concomitant use of Diltiwas Retard with other drugs should be carried out under medical control and adjusting the doses progressively.

Due to the possibility of additive effects,it is necessary to be cautious andcarefully evaluate patients who receive Diltiwas Retard simultaneously with other agentsthat are known to affect the heart.

Diltiwas Retard is metabolized in the liver bytheisoenzymeCYP3A4 but also inhibits it. Other drugs have a similar or opposite metabolism and there may be cases of increased levels in the blood of one or the other drug depending on whether they inhibit or not that liver enzyme.

Benzodiazepines (midazolam, triazolam used to treat anxiety): diltiazem significantly increases midazolam and triazolam levels in the blood.

Corticosteroids (methylprednisolone, used to treat inflammatory problems):diltiazem may increase the concentration of methylprednisolone in the blood and may require an adjustment of the methylprednisolone dose.

Statins:(medications to decrease cholesterol levels in the blood): diltiazem increases the concentration of some statins in the blood. There is a risk of myopathy (muscle disorder) and rhabdomyolysis (muscle necrosis with complications such as renal insufficiency) with the concomitant use of diltiazem and some statins.

Taking Diltiwas Retard with food, drinks, and alcohol

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

During treatment with this medication, do not take alcohol, as it may cause a

decrease in blood pressure with dizziness and/or fainting.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Fertile women should use an effective contraceptive method.If you become pregnant while taking Diltiwas Retard, stop taking the medication immediately and consult your doctor. Diltiwas Retard may induce fetal malformations.

Diltiwas Retard is excreted in breast milk, therefore, do not breastfeed while taking this medication.If the use ofthis medicationis considered necessary, an alternative method for infant feeding should be used.

Driving and operating machines

Based on the reported adverse reactions, that is, dizziness (frequent), general discomfort (frequent), your ability to drive and operate machines may be impaired.Therefore, it is advisable not to perform tasks that require special attention (driving vehicles, operating hazardous machinery, etc.), until the response to the medication is satisfactory.

Diltiwas Retard 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 as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Adults:

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

Patients over 65 years, renal or hepatic insufficiency:

The initial dose adjustment should be done with caution.

All dose modifications and control should be done under medical supervision.

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

Take Diltiwas Retard 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.

Your doctor will tell you the duration of your treatment with Diltiwas Retard. Do not stop treatment prematurely as it 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 emergency service of a hospital. Bring the packaging of the medication with you. This is so that the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, irregular heartbeats, difficulty speaking, confusion, decreased renal function, coma, and sudden death.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeDiltiwas Retard

Do not take a double dose tocompensate for the missed doses.It is essential 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 interrupt the treatment withDiltiwas Retard

If you interrupt the treatment with Diltiwas Retard, 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 Diltiwas Retard without consulting your doctor first.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

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

The following are common side effects (may affect more than 1 in 100 people):

• Face redness
• Swelling of the legs
• Abnormal slowing of the heart rate
• Nausea
• Headache
• Discomfort
• Dizziness
• Intense physical fatigue

The following are infrequent side effects(may affectup to1in 1000 people):

• Decreased blood pressure when standing up
• Palpitations
• Face redness
• Urticaria with or without fever
• Abnormal skin response to light

The following are rare side effects (may affectup to 1 in 10,000 people):

• Reduced heart capacity to pump blood
• Digestive disorder
• Stomach pain
• Constipation
• Dry mouth
• Moderate elevations of liver transaminases, usually transient
• Transient hepatitis
• Generalized skin peeling
• Acute pustular eruption
• Face redness with peeling
• Generalized blistering
• Swelling of the gums
• Swelling of the breasts in men, reversible after stopping diltiazem treatment.

The following are very rare side effects not known (may affectup to 1 in more than 10,000 people):

• Separation and exfoliation of the skin due to cell death

The following are 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https.//www.notificaRAM.es

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

This medication does not require special conditions for conservation.

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Diltiwas Retard

• The active ingredient is diltiazem hydrochloride.
• The other components (excipients) are: povidone, cornstarch, ammonio methacrylate copolymer, sucrose, paraffin, and talc. Composition of the capsule: 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 packaging

Diltiwas Retard 120 mg prolonged-release hard capsules are presented in the form of hard, opaque orange and red capsules. Each package contains 40 capsules.

Holder of the marketing authorization and responsible for manufacturing

Alfasigma España, S.L.

Avenida Diagonal, 490

08006 Barcelona

Date of the last review of this leaflet: April 2023

Other sources of information

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