DINISOR RETARD 120 mg MODIFIED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

DINISOR RETARD 120 mg modified-release tablets

diltiazem hydrochloride

Read the entire package leaflet carefully before starting to take the medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is DINISOR and what is it used for
2. What you need to know before taking DINISOR
3. How to take DINISOR
4. Possible side effects
5. Storage of DINISOR
6. Package contents and additional information

1. What is DINISOR and what is it used for

DINISOR, whose active ingredient is diltiazem, belongs to a group of medicines called calcium antagonists. DINISOR is used for the treatment and prevention of angina pectoris, as it widens (dilates) the heart arteries, increasing blood flow. DINISOR also acts by widening other blood vessels in the body, so it is also used in the treatment of high blood pressure (hypertension).

2. What you need to know before taking DINISOR

Do not take DINISOR

• If you are allergic (hypersensitive) to the active ingredient or any of the other components of DINISOR.
• If you have any heart rhythm or conduction disorders, such as sinus node dysfunction syndrome in patients without a pacemaker, second- or third-degree atrioventricular block in patients without a pacemaker, or severe bradycardia (heart rate less than 40 beats per minute).
• If you have any heart disease, such as left ventricular insufficiency.

• If you are being treated with dantrolene.
• If you are taking medications containing ivabradine for the treatment of certain heart diseases.
• If you are already taking a medication containing lomitapida used for the treatment of high cholesterol levels (see section: "Taking DINISOR with other medications").

Warnings and precautions

• If you have any cardiac arrhythmia(sick sinus node syndrome, atrioventricular block) or if you are receiving treatment with other medications used to treat heart diseases (beta blockers, digitalis) since the use of diltiazem in these situations may lead to an excessively slow heart rate and rhythm (bradycardia).
• If you are going to have surgery,as diltiazem may enhance the effects of anesthetics.
• If you have a ventricular function disorder.
• If you have hypotension:treatment with diltiazem may 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 have liver or kidney disease or are elderly:since there is no data available for these patients, DINISOR should be used with caution.
• The use of diltiazem has been associated with skin reactions and mood changes (including depression). Your doctor will assess these symptoms and indicate the measures to be taken.
• If you are at risk of developing intestinal obstruction, as diltiazem, like other medications in the same group, causes a decrease in intestinal movement.
• 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.

Using DINISOR with other medications

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including those obtained without a prescription.

Contraindicated use:

Diltiazem should not be used with dantrolene (muscle relaxant).

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

Medications containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increased risk and severity of liver-related side effects.

Effects of other medications on DINISOR

The following medications may increase the effects of DINISOR 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)
• cimetidine and ranitidine (used to reduce stomach acid production)

The following medications may decrease the effects of DINISOR by reducing its concentration in the blood:

• phenytoin (used to treat epilepsy)
• St. John's Wort (used for depression, fatigue, or sleep disorders)
• rifampicin (antibiotic)

Effects of DINISOR on other medications

DINISOR may increase the effects of the following medications by increasing their concentrations in the blood or enhancing their effect:

• phenytoin, carbamazepine (used to treat epilepsy)
• triazolam, midazolam, 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 disorders)
• simvastatin and lovastatin (medications to lower cholesterol levels in the blood)
• theophylline (used to treat asthma)
• medications that reduce blood clot formation (oral anticoagulants, such as acenocoumarol or warfarin)
• rifampicin (antibiotic)

• medications used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to slow down the heart rate (amiodarone)

• anesthetics
• lithium salts (used to treat certain mental illnesses): may increase the risk of intense agitation (psychotic episodes)
• sirolimus, temsirolimus, everolimus (medications that reduce immune system activity)

The combined use of DINISOR with other medications should be done under medical supervision and with gradual dose adjustment.

Use in children

There is no experience with the use of DINISOR in children.

Pregnancy and breastfeeding

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.

Consult your doctor or pharmacist before using any medication.

This medication should not be administered to pregnant women or women of childbearing age who are not using an effective contraceptive method.

This medication should not be taken during breastfeeding, as it passes into breast milk. If the doctor considers it essential to take this medication, the baby should be fed with an alternative method.

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 DINISOR.

DINISOR RETARD 120 mg contains lactose, hydrogenated castor oil, and sodium

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains hydrogenated castor oil. It may cause stomach upset and diarrhea.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take DINISOR

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

DINISOR is administered orally. Your doctor will indicate how many tablets you should take each day.

Adults:

Angina pectoris:the initial dose is 1 tablet per day. Your doctor will gradually increase the dose to achieve the optimal response. The maximum dose is 4 tablets per day (480 mg/day).

Hypertension:the initial dose is 1 tablet per day. Your doctor will gradually increase the dose to achieve the optimal response. The maximum dose is 4 tablets per day (480 mg/day).

Elderly patients, renal or hepatic insufficiency:

The initial dose adjustment should be done with caution.

All dose modifications and monitoring will be done under medical supervision.

Instructions for correct administration

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (e.g., a glass of water). The tablets should not be divided or crushed. DINISOR should be taken preferably before meals. If your doctor indicates that you need to take 2-4 tablets per day, take them at regular intervals (every 6-12 hours).

Take DINISOR every day and approximately at the same time. Taking the tablets at the same time each day will have a better effect on your blood pressure. It will also help you remember to take the tablets.

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 DINISOR. Do not stop treatment before consulting your doctor, as it may be harmful to your health.

If you think the effect of DINISOR is too strong or too weak, consult your doctor or pharmacist.

If you take more DINISOR than you should:

An overdose of DINISOR may cause a drop in blood pressure, slowing of the heart rate, changes in cardiac conduction, and decreased kidney function. In case of a drop in blood pressure, sit with your head down.

In case of a significant overdose, you should be taken to a specialized center to apply the necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take DINISOR:

Do not take a double dose to make up for forgotten doses. It is important to take DINISOR 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 tablet.

If you stop taking DINISOR:

If you stop taking DINISOR, you may experience a worsening of your disease, with symptoms such as chest pain or a sudden increase in blood pressure. Do not stop taking DINISOR without consulting your doctor first. If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Diltiazem reactions vary in intensity from one patient to another and should be taken into account especially at the start of treatment or when changing medication.

Interrupt treatment with DINISOR and contact your doctor immediately if you experience any of the following symptoms:

• Swelling of the face, tongue, or throat, difficulty swallowing, urticaria, and difficulty breathing (angioedema), unknown frequency.

• A extremely severe allergic reaction with skin rash, usually in the form of blisters or ulcers in the mouth and eyes, as well as in other mucous membranes, such as the genitals (Stevens-Johnson syndrome), unknown frequency.
• Severe and extensive skin damage (exfoliation of the epidermis and mucous membranes) (toxic epidermal necrolysis), unknown frequency.

Other side effects:

Very common (may affect more than 1 in 10 patients)

• Edema in the lower limbs.

Common (may affect up to 1 in 10 patients)

• Headache, dizziness.
• Atrioventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia).
• Flushing.
• Constipation, difficult digestion (dyspepsia), stomach pain, nausea.
• Skin rashes.
• Swelling of the joints.
• Fatigue (asthenia), tiredness, discomfort.

Uncommon (may affect up to 1 in 100 patients)

• Nervousness, difficulty falling asleep (insomnia).
• Drop in blood pressure when standing up quickly, with or without dizziness (hypotension).
• Vomiting, diarrhea.
• Increased levels of liver enzymes in the blood.

Rare (may affect up to 1 in 1,000 patients)

• Dry mouth.
• Skin irritation and itching (urticaria).

Unknown frequency (cannot be estimated from the available data)

• Decrease in the number of platelets (thrombocytopenia).
• Decreased appetite, high blood sugar levels (hyperglycemia).
• Mood changes including depression, confusion, hallucinations, personality and sleep disorders.
• Movement disorders (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremors, sudden involuntary muscle contractions.
• Lazy eye (partial loss of vision in one or both eyes), eye irritation.
• Ear ringing (tinnitus).
• Disruption or alteration of the heart's electrical signal (sinoatrial block, sinus arrest), difficulty pumping blood (congestive heart failure), rapid heartbeat (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeat (arrhythmia), chest pain or tightness (angina pectoris).
• Inflammation of blood vessels (vasculitis).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), nasal congestion.
• Gingival inflammation (gingival hyperplasia).
• Hepatitis (inflammatory disease affecting the liver), liver disorder (granulomatous liver disease).
• Light sensitivity (photosensitivity), erythema multiforme (severe skin disease associated with red spots, blisters), sweating, exfoliative dermatitis (skin redness, itching, hair loss), and generalized acute pustular exanthematous dermatitis (sudden eruption accompanied by fever, with formation of pustules or lesions on the skin surface characterized by being small, inflamed, full of pus, and similar to a blister), small red spots on the skin (petechiae), itching (pruritus).
• Joint pain, muscle pain.
• Need to urinate at night (nocturia), increased frequency of urination (polyuria).
• Excessive breast volume in men (gynecomastia), sexual function disorders.
• Walking problems
• Elevation of the creatine phosphokinase (CPK) enzyme in blood tests, weight gain.
• 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 of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Diltiazem reactions vary in intensity from one patient to another and should be taken into account especially at the start of treatment or when changing medication.

Interrupt treatment with DINISOR and contact your doctor immediately if you experience any of the following symptoms:

• Swelling of the face, tongue, or throat, difficulty swallowing, urticaria, and difficulty breathing (angioedema), unknown frequency.

• A extremely severe allergic reaction with skin rash, usually in the form of blisters or ulcers in the mouth and eyes, as well as in other mucous membranes, such as the genitals (Stevens-Johnson syndrome), unknown frequency.
• Severe and extensive skin damage (exfoliation of the epidermis and mucous membranes) (toxic epidermal necrolysis), unknown frequency.

Other side effects:

Very common (may affect more than 1 in 10 patients)

• Edema in the lower limbs.

Common (may affect up to 1 in 10 patients)

• Headache, dizziness.
• Atrioventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia).
• Flushing.
• Constipation, difficult digestion (dyspepsia), stomach pain, nausea.
• Skin rashes.
• Swelling of the joints.
• Fatigue (asthenia), tiredness, discomfort.

Uncommon (may affect up to 1 in 100 patients)

• Nervousness, difficulty falling asleep (insomnia).
• Drop in blood pressure when standing up quickly, with or without dizziness (hypotension).
• Vomiting, diarrhea.
• Increased levels of liver enzymes in the blood.

Rare (may affect up to 1 in 1,000 patients)

• Dry mouth.
• Skin irritation and itching (urticaria).

Unknown frequency (cannot be estimated from the available data)

• Decrease in the number of platelets (thrombocytopenia).
• Decreased appetite, high blood sugar levels (hyperglycemia).
• Mood changes including depression, confusion, hallucinations, personality and sleep disorders.
• Movement disorders (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremors, sudden involuntary muscle contractions.
• Lazy eye (partial loss of vision in one or both eyes), eye irritation.
• Ear ringing (tinnitus).
• Disruption or alteration of the heart's electrical signal (sinoatrial block, sinus arrest), difficulty pumping blood (congestive heart failure), rapid heartbeat (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeat (arrhythmia), chest pain or tightness (angina pectoris).
• Inflammation of blood vessels (vasculitis).
• Difficulty breathing (dyspnea), nosebleeds (epistaxis), nasal congestion.
• Gingival inflammation (gingival hyperplasia).
• Hepatitis (inflammatory disease affecting the liver), liver disorder (granulomatous liver disease).
• Light sensitivity (photosensitivity), erythema multiforme (severe skin disease associated with red spots, blisters), sweating, exfoliative dermatitis (skin redness, itching, hair loss), and generalized acute pustular exanthematous dermatitis (sudden eruption accompanied by fever, with formation of pustules or lesions on the skin surface characterized by being small, inflamed, full of pus, and similar to a blister), small red spots on the skin (petechiae), itching (pruritus).
• Joint pain, muscle pain.
• Need to urinate at night (nocturia), increased frequency of urination (polyuria).
• Excessive breast volume in men (gynecomastia), sexual function disorders.
• Walking problems
• Elevation of the creatine phosphokinase (CPK) enzyme in blood tests, weight gain.
• 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 of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of DINISOR

Keep out of sight and reach of children.

Do not use DINISOR after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated. Store in the original packaging.

This medicine does not require any special storage conditions.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofDINISOR RETARD 120 mg

• The active ingredient is diltiazem hydrochloride. Each tablet contains 120 mg of diltiazem (as hydrochloride).

The other components are:

Core:lactose monohydrate, hydrogenated castor oil, carboxymethylcellulose, stearic acid, magnesium stearate.

Coating:hypromellose, titanium dioxide (E-171), talc, macrogol 6000, silicone antifoaming agent S184

Appearance of DINISOR RETARD 120 mgand package contents

DINISOR RETARD 120 mg tablets are white, round, and marked with "D120" on one side.

DINISOR RETARD 120 mg tablets are presented in cardboard boxes with aluminum/PVC blisters containing 40 tablets.

Other presentations

DINISOR® RETARD 180 mg modified-release tablets

Marketing Authorization Holder

Pfizer, S.L.

Avda. de Europa, 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid).

Manufacturer

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

Date of the last revision of this prospectus: November 2024

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