DILTIAZEM ALTER 60 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diltiazem Alter60 mg tablets EFG

Diltiazem hydrochloride

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, 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 Diltiazem Alter 60 mg tablets EFG and what is it used for
2. What you need to know before taking Diltiazem Alter
3. How to take Diltiazem Alter
4. Possible side effects
5. Storage of Diltiazem Alter
6. Package contents and additional information

1. What is Diltiazem Alter and what is it used for

Diltiazem Alter belongs to a group of medications called selective calcium channel blockers, which produce dilation of blood vessels, leading to a decrease in blood pressure, as well as an increase in blood flow and a decrease in the heart's oxygen needs.

Diltiazem Alter is indicated for:

• Prevention and treatment of angina pectoris, including Prinzmetal's angina (vasospastic angina).
• Treatment of high blood pressure.

2. What you need to know before taking Diltiazem Alter

Do not take Diltiazem Alter:

• if you are allergic to diltiazem hydrochloride or any other component of this medication (listed in section 6).
• if you are already taking a medication containing lomitapide used to treat high cholesterol levels (see section "Taking Diltiazem Alter with other medications").
• if you have any heart rhythm or conduction disorders, such as:

• sick sinus syndrome in patients without a pacemaker
• second- and third-degree atrioventricular block in patients without a pacemaker
• severe bradycardia (heart rate less than 40 beats per minute)

• if you have a cardiac condition such as left ventricular heart failure with pulmonary congestion.
• if you are being treated with dantrolene (in perfusion).
• if you are taking a medication containing ivabradine for the treatment of certain heart conditions.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Alter:

• if you have heart conditions such as ventricular failure, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram, your doctor will need to closely monitor you,
• if you have severe liver or kidney disease, or are over 65 years old. In these cases, diltiazem blood levels may be higher. Your doctor may need to monitor you more closely and perform periodic check-ups,
• if you are undergoing general anesthesia, you should inform the anesthesiologist that you are being treated with this medication,
• if you are an elderly patient or have kidney or liver disease (renal or hepatic insufficiency), diltiazem blood levels may be higher, so your doctor will need to closely monitor your heart rate at the start of treatment,
• if you experience mood changes, including depression, inform your doctor,
• if you are at risk of developing intestinal obstruction, as diltiazem, like other medications in the same group, can cause a decrease in intestinal movement,
• if you have latent or overt diabetes mellitus. Strict control is necessary in these patients due to the possible increase in blood glucose levels,
• the use of diltiazem may induce bronchospasm, including worsening of asthma, especially in patients with pre-existing bronchial hyperreactivity. Cases have also been reported after dose increases. You should inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medication,
• 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, and your doctor may need to monitor your kidney function.

It is not recommended to expose yourself to the sun during treatment, as photosensitivity reactions (skin spots) may occur.

Taking Diltiazem Alter with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

Certain medications may interact with Diltiazem Alter. In these cases, it may be necessary to change the dose or interrupt treatment with one of the medications.

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

Contraindicated combinations:

-Dantrolene: the simultaneous use of diltiazem with dantrolene (in perfusion) is contraindicated.

-Ivabradine (see section “Do not take Diltiazem Alter”).

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

It is especially important to inform your doctor if you are taking any of the following medications:

Combinations that require caution:

Medications for cardiovascular problems, such as:

• Alpha blockers, as they increase the hypotensive effect (decrease in blood pressure).
• Beta blockers, as they may cause heart disorders. This combination should only be used if clinically monitored and by electrocardiogram, especially at the start of treatment.
• It has been observed that the risk of depression increases when diltiazem is administered with beta blockers (see section 4 Possible side effects).
• Amiodarone, digoxin, as they increase the risk of bradycardia. Caution is necessary, especially in elderly patients and when using high doses.
• Other antiarrhythmic medications, as diltiazem has antiarrhythmic properties, and there is a risk of increased cardiac side effects. This combination should only be used if clinically monitored and by electrocardiogram.
• Nitrate derivatives, as they may increase the hypotensive effect and cause dizziness.

The combination of diltiazem with the following medications increases the amount of these medications in the blood, so your doctor will need to adjust the dose during treatment with diltiazem:

• Cyclosporin (immunosuppressive medication used in transplants).
• Phenytoin (medication for treating epilepsy). It is recommended to monitor phenytoin plasma concentrations when administered with diltiazem.
• Carbamazepine (for treating epilepsy).
• Theophylline (medication for asthma).
• H2 antagonists (cimetidine and ranitidine, medications for treating stomach ulcers), as they increase the amount of diltiazem in the blood, so either treatment with these medications will be interrupted or the daily dose of diltiazem will be adjusted.
• Rifampicin (antibiotic used to treat tuberculosis and some infections), which may decrease the amount of diltiazem in the blood, so your doctor will need to closely monitor you.
• X-ray contrast medium: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when administered an intravenous bolus of an ionic X-ray contrast medium. Special caution is required in patients who receive diltiazem and an X-ray contrast medium concomitantly.
• Lithium (medication for treating mental health problems), as it may increase lithium toxicity. Your doctor will closely monitor your lithium blood levels.

General information to consider:

? Due to the possible additive effects, caution and evaluation are necessary in cases where diltiazem is administered simultaneously with other agents known for their effects on cardiac conduction and/or contractility.

? Antiplatelet medications (medications that prevent blood cells called "platelets" from aggregating and forming a clot): the possibility of an additive effect on platelet aggregation of diltiazem and antiplatelet medications (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered.

? Medications metabolized by the CYP3A4 enzyme, as this may result in a decrease in diltiazem blood levels or an increase in the amount of any medications administered with it.

? Patients who consume grapefruit juice should be monitored, as they may increase the adverse effects of diltiazem. Grapefruit juice should be avoided if an interaction is suspected.

? Benzodiazepines (midazolam, triazolam), which are medications with sedative, anxiolytic, anticonvulsant, amnestic, and muscle relaxant effects, as diltiazem increases the amounts of these medications in the blood, prolonging their duration of action in the body. Your doctor will be especially careful when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.

? Corticosteroids (methylprednisolone) used as anti-inflammatory medications and in severe allergies due to their immunosuppressive capacity, as diltiazem reduces the metabolism of methylprednisolone, so your doctor will closely monitor you and adjust the dose of methylprednisolone.

? Statins (medications used to lower cholesterol), as diltiazem greatly increases the amount of some statins in the blood, which may cause statin toxicity problems.

? Cilostazol: by inhibiting the metabolism of cilostazol, diltiazem increases its pharmacological activity.

Children and adolescents

Diltiazem Alter is not a suitable medication for children.

Taking Diltiazem Alter with food, drinks, and alcohol

It is recommended to take this medication preferably before meals.

Grapefruit juice should be avoided (see the section "Taking Diltiazem Alter with other medications").

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.

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 your doctor considers it essential to take this medication, the baby should be fed with an alternative method.

Driving and using machines

Based on the side effects reported with the use of diltiazem, such as dizziness (frequent) and malaise (frequent), the ability to drive and operate machinery may be impaired, although no studies have been conducted on this.

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.

3. How to take Diltiazem Alter

Follow your doctor's instructions for taking this medication exactly. If you have any doubts, consult your doctor or pharmacist.

Diltiazem Alter is administered orally.

Prevention and treatment of angina pectoris:The usual dose is 1 tablet every 8 hours (three times a day), preferably taken before meals.

Hypertension:Treatment of hypertension should be started with half a 60 mg tablet every 8 hours (three times a day), i.e., 90 mg of diltiazem per day.

Your doctor may increase or decrease these doses if necessary.

Use in elderly patients and patients with kidney or liver disease

Since diltiazem blood levels may be higher in these cases, your doctor will need to consider adjusting the dose at the start of treatment.

Patient with renal or hepatic insufficiency: use with caution. See the section "Warnings and precautions".

It is not recommended to substitute diltiazem specialties with each other unless your doctor explicitly recommends it.

If you take more Diltiazem Alter than you should

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

If you take more tablets than you should, inform your doctor or go to the emergency department of a hospital immediately. Bring the medication package with you. This is so the doctor knows what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeats, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

In case of significant overdose, the patient should be taken to a hospital, where gastric lavage and/or osmotic diuresis may be performed.

Atropine, adrenaline, glucagon, or calcium gluconate may be administered as antidotes.

If you forget to take Diltiazem Alter

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take it as soon as you can and the next one at the usual time. However, if it is almost time for the next dose or it is close to it, do not take the missed tablet.

If you stop taking Diltiazem Alter

Your doctor will indicate the duration of your treatment with Diltiazem Alter. Do not stop treatment before then. If you stop taking Diltiazem Alter, you may experience a worsening of your condition.

If you have any other questions about the use of this medication, 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.

The following adverse effects have been reported according to the frequencies detailed below:

Very frequent: may affect more than 1 in 10 patients

Frequent: may affect up to 1 in 10 patients

Infrequent: may affect up to 1 in 100 patients

Rare: may affect up to 1 in 1,000 patients

Very rare: may affect up to 1 in 10,000 patients

Frequency not known (cannot be estimated from the available data)

Disorders of the blood and lymphatic system:

• Frequency not known: thrombocytopenia.

Disorders of metabolism and nutrition:

• Frequency not known: hyperglycemia.

Psychiatric disorders:

• Infrequent: nervousness, difficulty falling asleep (insomnia).
• Frequency not known: mood changes including depression.

Disorders of the nervous system:

• Frequent: headache, dizziness.
• Frequency not known: movement disorders (extrapyramidal syndrome).

Cardiac disorders:

• Frequent: atrioventricular block (a type of arrhythmia), palpitations.
• Infrequent: slow heart rate (bradycardia).
• Frequency not known: sinoatrial block, difficulty of the heart to pump blood (congestive heart failure), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

• Frequent: hot flashes.
• Infrequent: drop in blood pressure when standing up quickly, with or without dizziness (orthostatic hypotension).
• Frequency not known: vasculitis (diseases that cause inflammation of blood vessels) including leukocytoclastic vasculitis.

Respiratory, thoracic, and mediastinal disorders:

-Frequency not known:bronchospasm (including worsening of asthma).

Gastrointestinal disorders:

• Frequent: constipation, difficult digestion (dyspepsia), stomach pain, nausea.
• Infrequent: vomiting, diarrhea.
• Rare: dry mouth.
• Frequency not known: inflammation of the hard palate (gingival hyperplasia).

Hepatobiliary disorders:

• Infrequent: increase in liver enzyme levels in the blood during the initial treatment period. These elevations are generally transient.
• Frequency not known: hepatitis (inflammatory disease that affects the liver)

Disorders of the skin and subcutaneous tissue:

• Frequent: skin redness (erythema)
• Rare: skin irritation and itching (urticaria)
• Frequency not known: sensitivity to light (photosensitivity), inflammation of the throat, lips, and respiratory tract (angioneurotic edema), rash, erythema multiforme (severe skin disease associated with red spots, blisters), including cases of Stevens-Johnson syndrome (severe vesicular reactions of the skin and mucous membranes), toxic epidermal necrolysis (peeling skin disease), sweating, exfoliative dermatitis (redness, itching, hair loss), acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface characterized by being small, inflamed, filled with pus, and similar to a blister), occasionally exfoliative erythema with or without fever. 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").

Disorders of the reproductive system and breast:

• Frequency not known: excessive breast volume in men (gynecomastia).

General disorders and administration site conditions:

• Very frequent: edema in the lower limbs.
• Frequent: discomfort

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 is not listed in this prospectus. You can also report them 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. Conservation of Diltiazem Alter

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

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

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

6. Content of the Packaging and Additional Information

Composition of Diltiazem Alter

• The active ingredient is Diltiazem hydrochloride. Each tablet contains 60 mg of diltiazem hydrochloride.
• The other components are: lactose monohydrate, hydroxypropylmethylcellulose, calcium phosphate dibasic, hydroxypropylcellulose, talc, magnesium stearate, carbomer 934 P4.

Appearance of the Product and Packaging Content

The tablets are white, cylindrical, and have a notch on one of their faces.

Diltiazem Alter is presented in packages of 60 tablets in PVC/aluminum blister packs.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Date of the Last Revision of this Prospectus:June 2023

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/