Package Leaflet: Information for the User

Diltiazem Alter60 mg film-coated tablets

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 their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Diltiazem Alter belongs to a group of medications called calcium channel blockers, which produce a dilation of blood vessels, resulting in 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, includingPrinzmetal's angina (vasospastic).
• Treatment of high blood pressure.

Do not take Diltiazem Alter:

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you are already taking a medicine that contains lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Alter with other medicines”).
• if you have any heart rhythm or conduction disorders, such as:

• sinus dysfunction 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 heart condition such as left ventricular insufficiency with pulmonary congestion.
• if you are being treated with dantrolene (intravenous).
• if you are already taking a medicine that contains ivabradina for the treatment of some heart diseases.

Warnings and precautions

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

• if you have heart problems such as heart 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 a severe liver or kidney disease, or if you are over 65 years old. In these cases, the diltiazem levels in the blood may be higher. Your doctor may need to monitor you more closely and even perform regular control tests,
• if you are undergoing general anesthesia, you must inform the anesthesiologist that you are being treated with this medicine,
• if you are an elderly patient or if you have kidney or liver disease (renal or hepatic insufficiency), the diltiazem levels in the blood may be higher, so your doctor will need to closely monitor your heart rate at the beginning of treatment,
• if you experience mood changes, including depression, inform your doctor,
• if you have a risk of developing intestinal obstruction, as diltiazem, like other medicines in the same group, can cause a decrease in intestinal movement,
• if you have latent or manifest diabetes. You will need to be closely monitored in these patients due to the possible increase in blood glucose levels,
• the use of diltiazem can induce bronchospasm, including the worsening of asthma, especially in patients with pre-existing bronchial hyperreactivity. Cases have also been reported after increasing the dose. You must inform your doctor if you experience any signs or symptoms of respiratory problems during treatment with this medicine,
• if you have a history of heart failure, new difficulty breathing, slow heart rate, or low blood pressure. Cases of renal damage have been reported in patients with these conditions, your doctor may need to monitor your renal function.

Do not expose yourself to the sun during treatment as photosensitivity reactions (skin spots) may occur.

Taking Diltiazem Alter with other medicines

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

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

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

Combinations that are contraindicated:

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

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

-Medicines 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.

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

Combinations that require caution:

Medicines for treating cardiovascular problems, such as:

• Alpha blockers, as they increase the hypotensive effect (decrease in blood pressure).
• Beta blockers, as they may cause heart problems. This combination should only be used if you are being clinically monitored and by electrocardiogram, especially at the beginning of treatment.
• A study has shown an increased risk of depression when diltiazem is administered with beta blockers (see section 4 Possible side effects).
• Amiodarone, digoxin, as they increase the risk of bradycardia. You should be cautious, especially in elderly patients and when using high doses.
• Other antiarrhythmic medicines, as diltiazem has antiarrhythmic properties, so there is a risk of increased cardiac side effects. This combination should only be used if you are being clinically monitored and by electrocardiogram.
• Nitrate derivatives, as they may increase the hypotensive effect and dizziness.

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

• Ciclosporin (an immunosuppressive medicine used in transplants).
• Fenitoína (a medicine for treating epilepsy). It is recommended to monitor the plasma concentrations of fenitoína when it is administered with diltiazem.
• Carbamazepina (for treating epilepsy).
• Theophylline (a medicine for asthma).
• Antagonists H2 (cimetidina and ranitidina, medicines for treating stomach ulcers), as they increase the amount of diltiazem in the blood, so either the treatment with these will be interrupted or the daily dose of diltiazem will be adjusted.
• Rifampicina (an antibiotic used for treating tuberculosis and some infections) that may decrease the amount of diltiazem in the blood, so your doctor will closely monitor you.
• Contrast medium for X-rays: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when they are administered an intravenous bolus of an ionic contrast medium for X-rays. Special caution is required in patients who receive diltiazem and a contrast medium for X-rays concomitantly.
• Litio (a medicine for treating mental health problems) as it may increase the toxicity of this medicine. Your doctor will closely monitor your lithium levels in the blood.

General information to be taken into account:

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 agents (medicines that prevent platelets from aggregating and forming a blood clot): you should consider the possibility of an additive effect on platelet aggregation of diltiazem and antiplatelet agents (such as acetylsalicylic acid, ticagrelor, cilostazol).

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

You should monitor patients who consume grapefruit juice, as it may increase the adverse effects of diltiazem. You should avoid grapefruit juice if you suspect an interaction.

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

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

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

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

Children and adolescents

Diltiazem Alter is not a suitable medicine for children.

Taking Diltiazem Alter with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

You should avoid taking grapefruit juice (see the section “Taking Diltiazem Alter with other medicines”).

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

Based on the adverse effects reported with the use of diltiazem, such as dizziness (frequent) and discomfort (frequent), your ability to drive and operate machinery may be impaired, although no study has been conducted on this.

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, 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 begin with half a tablet of 60 mg every 8 hours (three times a day), that is, 90 mg of diltiazem per day.

Your doctor may increase or decrease these doses if necessary.

Use in the elderly and in patients with kidney or liver disease

Since in these cases there may be an increase in diltiazem blood levels, your doctor should consider the need to adjust your dose at the start of treatment.

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

Do not recommend substituting diltiazem specialties among them unless you receive explicit recommendation from your doctor.

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 Toxicological 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 immediately to the emergency service of a hospital. Bring the medication packaging 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 significant overdose, you should be taken to a hospital, where they may perform gastric lavage and/or osmotic diuresis.

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

If you forgot to take Diltiazem Alter

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

If you interrupt treatment with Diltiazem Alter

Your doctor will indicate the duration of your treatment with Diltiazem Alter. Do not suspend treatment before. If you interrupt treatment with Diltiazem Alter, you may experience a worsening of your disease.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Very common: may affect more than 1 in 10 patients

Common: may affect up to 1 in 10 patients

Uncommon: 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 available data)

Blood and lymphatic system disorders:

-Frequency not known:thrombocytopenia.

Metabolism and nutrition disorders:

-Frequency not known:hyperglycemia.

Mental and behavioural disorders:

-Uncommon:anxiety, difficulty falling asleep (insomnia).

-Frequency not known:mood changes including depression.

Nervous system disorders:

-Common:headache, dizziness.

-Frequency not known:movement disorders (extrapyramidal syndrome).

Cardiac disorders:

-Common:atrioventricular block (a type of arrhythmia), palpitations.

-Uncommon:slow heart rate (bradycardia).

-Frequency not known:sinus node block, heart failure (congestive heart failure), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

-Common:flushes.

-Uncommon:rapid lowering of blood pressure upon standing associated or not with dizziness (orthostatic hypotension).

-Frequency not known:vasculitis (diseases that involve inflammation of the blood vessels) including leucocytoclastic vasculitis.

Respiratory, thoracic and mediastinal disorders:

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

Gastrointestinal disorders:

-Common:constipation, difficult digestion (dyspepsia), stomach pain, nausea.

-Uncommon:vomiting, diarrhea.

-Rare:dry mouth.

-Frequency not known:gingival hyperplasia (inflammation of the hard palate).

Hepatobiliary disorders:

-Uncommon:increase in liver enzyme levels in the blood during the initial treatment period. These elevations are generally transient.

-Frequency not known:hepatitis (inflammatory disease of the liver)

Skin and subcutaneous tissue disorders:

-Common:skin redness (erythema)

-Rare:skin irritation and itching (urticaria)

-Frequency not known:photosensitivity, throat, lip and respiratory tract inflammation (angioneuritic edema), rash, erythema multiforme (severe skin disease associated with red patches and blisters), including cases of Stevens-Johnson syndrome (severe vesicular skin and mucous membrane reactions), toxic epidermal necrolysis (peeling skin disease), sweating, exfoliative dermatitis (skin redness, itching, hair loss), acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of small, inflamed, pus-filled lesions on the skin surface), occasionally erythema desquamativum with or without fever. 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").

Reproductive and breast disorders:

-Frequency not known:excessive breast volume in men (gynaecomastia).

General disorders and administration site conditions:

-Very common:lower limb oedema.

-Common:unwellness

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly to the Spanish System for the Vigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

This medication does not require special conditions for conservation.

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

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

Diltiazem Alter Composition

• 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.

Product appearance and packaging contents

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

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

Marketing authorization holder and responsible manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Last review date of this leaflet:June 2023

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