Package Insert: Information for the User

DINISOR RETARD 120 mg Modified Release Tablets

diltiazem hydrochloride

Read this package insert carefully before starting to take the 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 for you and should not be given to others, even if they have the same symptoms, 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.

DINISOR, whose active ingredient is diltiazem, belongs to a group of medications called calcium antagonists. DINISOR is used for the treatment and prevention of angina pectoris, as it widens (dilates) the heart's 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).

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 in patients without a pacemaker, 2nd or 3rd 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 that contain ivabradina 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 DINISOR with other medications").

Warnings and precautions

• If you have any arrhythmia (sinus node dysfunction, 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 pulse (bradycardia).
• If you are to be operated on,since diltiazem may potentiate the effects of anesthetics
• If you have a ventricular function disorder.
• If you have 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 liver or kidney disease or are elderly: since there are no available data in these patients, DINISOR should be used with caution.
• The use of diltiazem has been associated with skin reactions and changes in mood (including depression). Your doctor will assess these symptoms and indicate the measures to be taken.
• If you have a risk of developing intestinal obstruction, since, like other medications in the same group, diltiazem reduces intestinal movement.
• 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, and your doctor may need to monitor your renal function.

Use of DINISOR with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

Contraindicated use:

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

Particularly, 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 liver-related side effects.

Effects of other drugs on DINISOR

The following drugs 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 reduce heart rate)
• cimetidine and ranitidine (used to reduce stomach acid production)

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

• phenytoin (used to treat epilepsy)
• St. John's Wort (used in cases of weakness, fatigue, or sleep disturbances)
• rifampicin (antibiotic)

Effects of DINISOR on other drugs

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

• phenytoin, carbamazepine (used to treat epilepsy)
• triazolam, midazolam, buspirone (used to treat anxiety)
• digoxin (used to treat heart diseases)
• ciclosporin, sirolimus (used to suppress the immune system)
• prednisolone (corticosteroid used to treat inflammatory problems)
• simvastatin and lovastatin (medications to reduce cholesterol levels in the blood)
• theophylline (used to treat asthma)
• oral anticoagulants, such as acenocoumarol or warfarin (used to prevent blood clots)
• rifampicin (antibiotic)

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

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

The concomitant use of DINISOR with other medications should be carried out under medical supervision and with progressive dose adjustments.

Use in children

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consultyour 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 to women of childbearing age who are not using an effective contraceptive method.

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

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 withDINISOR.

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

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

This medication contains hydrogenated castor oil (ricin oil). It may cause stomach discomfort and diarrhea.

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist.

DINISOR is administered orally. Your doctor will tell you 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 until you obtain 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 until you obtain 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 control should be done under medical supervision.

Instructions for correct administration

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

Take DINISOR every day and approximately at the same hour. Taking the tablets 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 tablets.

Follow these instructions unless your doctor has given you other different instructions. Remember to take your medication.

Your doctor will tell you the duration of your treatment with DINISOR. Do not stop treatment prematurely as it may be harmful to your health.

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

If you take more DINISOR than you should:

A DINISOR overdose may cause a drop in blood pressure, slowing of heart rate, alterations in cardiac conductivity, and decreased renal function. In case of low blood pressure, sit down 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take DINISOR:

Do not take a double dose to compensate for the missed doses.It is important that you takeDINISORregularly at the same hour 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 interrupt treatment with DINISOR:

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

Like all medications, this medication may cause side effects, although not everyone will experience them. Diltiazem reactions vary in intensity from one patient to another and should be taken into account especially at the beginning of treatment or when changing medication.

Stop 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, hives, and difficulty breathing (angioedema), unknown frequency.

• A 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, for example, the genitals (Stevens-Johnson syndrome), unknown frequency.
• Severe and extensive skin damage (toxic epidermal necrolysis), unknown frequency.

Other side effects:

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

• Swelling in the lower limbs.

Common (may affect up to 1 in 10 patients)

• Headache, dizziness.
• Auriculoventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia).
• Redness.
• Constipation, difficult digestion (dyspepsia), stomach pain, nausea.
• Skin eruptions.
• Swelling of the joints.
• Weakness (asthenia), fatigue, discomfort.

Uncommon (may affect up to 1 in 100 patients)

• Nervousness, difficulty falling asleep (insomnia).
• Low blood pressure upon rapid standing, associated or not with dizziness (hypotension).
• Vomiting, diarrhea.
• Increased levels of liver enzymes in the blood.

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

• Dry mouth.
• Irritation and itching of the skin (urticaria).

Unknown frequency (cannot be estimated from available data)

• Reduction in the number of platelets (thrombocytopenia).
• Decreased appetite, elevated blood sugar levels (hyperglycemia).
• Changes in mood, including depression, confusion, hallucinations, personality and sleep alterations.
• Movement alterations (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremor, sudden and involuntary muscle contractions.
• Wandering eye (partial loss of vision in one or both eyes), eye irritation.
• Tinnitus (ringing in the ears).
• Interruption or alteration of the electrical signal in the heart (sinoatrial block, sinus arrest), difficulty pumping blood (congestive heart failure), rapid heart rate (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeats (arrhythmia), chest pain or pressure (angina pectoris).
• Inflammation of blood vessels (vasculitis).
• Difficulty breathing (dyspnea), nasal bleeding (epistaxis), nasal congestion.
• Gingival hyperplasia (inflammation of the gums).
• Hepatitis (inflammatory disease affecting the liver), liver alteration (granulomatous liver disease).
• Sensitivity to light (photosensitivity), erythema multiforme (severe skin disease associated with red patches and blisters), sweating, exfoliative dermatitis (redness, itching, hair loss), and generalized acute pustular exanthematous dermatitis (sudden eruption accompanied by fever, with the formation of small, inflamed, pus-filled lesions on the skin surface), small red patches on the skin (petechiae), itching (pruritus).
• Joint pain, muscle pain.
• Increased need to urinate at night (nocturia), increased frequency of urination (polyuria).
• Excessive breast tissue in men (gynecomastia), alterations in sexual function.
• Difficulty walking.
• Elevated creatine phosphokinase (CPK) levels in blood tests, weight gain.
• State 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Like all medications, this medication may cause side effects, although not everyone will experience them. Diltiazem reactions vary in intensity from one patient to another and should be taken into account especially at the beginning of treatment or when changing medication.

Stop 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, hives, and difficulty breathing (angioedema), unknown frequency.

• A 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, for example, the genitals (Stevens-Johnson syndrome), unknown frequency.
• Severe and extensive skin damage (toxic epidermal necrolysis), unknown frequency.

Other side effects:

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

• Swelling in the lower limbs.

Common (may affect up to 1 in 10 patients)

• Headache, dizziness.
• Auriculoventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia).
• Redness.
• Constipation, difficult digestion (dyspepsia), stomach pain, nausea.
• Skin eruptions.
• Swelling of the joints.
• Weakness (asthenia), fatigue, discomfort.

Uncommon (may affect up to 1 in 100 patients)

• Nervousness, difficulty falling asleep (insomnia).
• Low blood pressure upon rapid standing, associated or not with dizziness (hypotension).
• Vomiting, diarrhea.
• Increased levels of liver enzymes in the blood.

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

• Dry mouth.
• Irritation and itching of the skin (urticaria).

Unknown frequency (cannot be estimated from available data)

• Reduction in the number of platelets (thrombocytopenia).
• Decreased appetite, elevated blood sugar levels (hyperglycemia).
• Changes in mood, including depression, confusion, hallucinations, personality and sleep alterations.
• Movement alterations (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremor, sudden and involuntary muscle contractions.
• Wandering eye (partial loss of vision in one or both eyes), eye irritation.
• Tinnitus (ringing in the ears).
• Interruption or alteration of the electrical signal in the heart (sinoatrial block, sinus arrest), difficulty pumping blood (congestive heart failure), rapid heart rate (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeats (arrhythmia), chest pain or pressure (angina pectoris).
• Inflammation of blood vessels (vasculitis).
• Difficulty breathing (dyspnea), nasal bleeding (epistaxis), nasal congestion.
• Gingival hyperplasia (inflammation of the gums).
• Hepatitis (inflammatory disease affecting the liver), liver alteration (granulomatous liver disease).
• Sensitivity to light (photosensitivity), erythema multiforme (severe skin disease associated with red patches and blisters), sweating, exfoliative dermatitis (redness, itching, hair loss), and generalized acute pustular exanthematous dermatitis (sudden eruption accompanied by fever, with the formation of small, inflamed, pus-filled lesions on the skin surface), small red patches on the skin (petechiae), itching (pruritus).
• Joint pain, muscle pain.
• Increased need to urinate at night (nocturia), increased frequency of urination (polyuria).
• Excessive breast tissue in men (gynecomastia), alterations in sexual function.
• Difficulty walking.
• Elevated creatine phosphokinase (CPK) levels in blood tests, weight gain.
• State 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 the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

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

This medication does not require any special storage conditions.

Medicines should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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 (ricin oil), carboxymethylcellulose, stearic acid, magnesium stearate.

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

Appearance of DINISOR RETARD 120 mgand content of the packaging

DINISOR RETARD 120 mg tablets are white, round tablets with “D120” marked on one face.

DINISOR RETARD 120 mg tablets are presented in aluminum/PVC blister packs 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).

Responsible for manufacturing

Pfizer Manufacturing Deutschland GmbH

Mooswaldallee 1

79108 Freiburg Im Breisgau

Germany

Last review date of this leaflet: November 2024

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