DILTIAZEM STADA 60 mg TABLETS

Introduction

Leaflet: Information for the user

Diltiazem Stada 60 mg tablets EFG

Diltiazem hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine 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 leaflet. See section 4.

Contents of the leaflet

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

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

Diltiazem Stada belongs to a group of medicines called selective calcium channel blockers, which cause 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 Stada is indicated in:

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

2. What you need to know before taking Diltiazem Stada

Do not take Diltiazem Stada:

• if you are allergic to diltiazem hydrochloride or any of the other components of this medicine (listed in section 6)
• if you have any heart rhythm or conduction disorders, such as sick sinus 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 failure with pulmonary congestion
• if you are being treated with dantrolene (in perfusion)
• if you are taking a medicine that contains ivabradine for the treatment of certain heart diseases
• if you are taking a medicine that contains lomitapida, used to treat high cholesterol levels (see section "Taking Diltiazem Stada with other medicines")

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Stada

• if you have heart conditions, such as left 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 are to undergo general anesthesia, you should inform the anesthesiologist that you are being treated with this medicine
• 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 medicines in the same group, can cause a decrease in intestinal movement
• if you have latent or overt diabetes mellitus, as close monitoring 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 increase. You should inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medicine
• if you have a history of bradycardia (slow heart rate), low blood pressure, heart failure, or difficulty breathing, as cases of kidney damage have been reported in patients with these conditions
• 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 kidney function

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

Taking Diltiazem Stada with other medicines

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

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

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

Contraindicated combinations:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (in perfusion) is contraindicated
• Ivabradine (see section "Do not take Diltiazem Stada")
• Medicines that contain lomitapida, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increased risk and severity of liver-related side effects

Combinations that require caution:

Medicines for heart 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 medicines, 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 fainting

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 (immunosuppressive medicine used in transplants)
• Phenytoin (medicine for treating epilepsy). It is recommended to monitor phenytoin plasma concentrations when administered with diltiazem
• Carbamazepine (medicine for treating epilepsy)
• Theophylline (medicine for asthma)
• H2 antagonists (cimetidine and ranitidine, medicines for treating stomach ulcers), as they increase the amount of diltiazem in the blood, so either treatment with these medicines 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 (medicine for treating mental health problems), as it may increase the toxicity of lithium. Your doctor will closely monitor your lithium blood levels

General information to be considered:

• 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 medicines (medicines 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 medicines (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered

• 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

• Patients who consume grapefruit juice should be monitored for increased diltiazem side effects. Grapefruit juice should be avoided if an interaction is suspected

• 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 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 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 (medicines used to lower cholesterol), as diltiazem greatly increases the amount of some statins in the blood, which could lead to statin toxicity problems

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

Children and adolescents

Diltiazem Stada is not a suitable medicine for children.

Taking Diltiazem Stada with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

Grapefruit juice should be avoided (see the section "Taking Diltiazem Stada with other medicines")

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine

This medicine should not be administered to pregnant women or 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 with an alternative method

Driving and using machines

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

3. How to take Diltiazem Stada

Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist

The route of administration of Diltiazem Stada is oral

Prevention and treatment of chest pain: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: caution is necessary. See the section "Warnings and precautions"

It is not recommended to substitute diltiazem specialties with each other unless you receive explicit advice from your doctor

If you take more Diltiazem Stada 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 medicine and the amount taken

If you have taken more diltiazem than you should, consult your doctor or pharmacist immediately

Taking too much of this medicine can cause a significant decrease in blood pressure (leading to collapse and decreased kidney function), slowing of the heart rate, sinus arrest, changes in cardiac conduction, cardiac arrest, and kidney failure

In case of severe 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 Stada

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 already time for the next dose or it is close, do not take the missed tablet

If you stop taking Diltiazem Stada

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before. If you stop taking diltiazem, you may experience worsening of your disease

If you have any other doubts about the use of this medicine, 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 common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

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

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

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:

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

Disorders of the Nervous System:

• 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:sinoatrial block, difficulty of the heart to pump blood (congestive heart failure), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular Disorders:

• Common:hot flashes.
• Uncommon:drop in blood pressure when standing up quickly, with or without dizziness (orthostatic hypotension).
• Frequency not known:vasculitis (diseases characterized by inflammation of blood vessels) including leukocytoclastic 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:inflammation of the hard palate (gingival hyperplasia).

Hepatobiliary Disorders:

• Uncommon:increased levels of liver enzymes in the blood during the initial treatment period. These elevations are generally transient.
• Frequency not known:hepatitis (inflammatory disease affecting the liver)

Disorders of the Skin and Subcutaneous Tissue:

• Common: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 (exfoliative 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; a 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 common:edema in the lower limbs.
• Common: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 does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Diltiazem Stada

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

No special storage conditions are required.

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 wastewater or household waste. Deposit 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. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Diltiazem Stada

• The active ingredient is diltiazem hydrochloride.

Each tablet contains 60 mg of diltiazem hydrochloride.

• The other components are hypromellose, glycerol behenate, colloidal silica, and magnesium stearate.

Appearance of the Product and Package Contents

Diltiazem Stada 60 mg are white, round, and biconvex tablets.

They are presented in blister packs containing 30, 60, or 500 (clinical package) tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Manufacturer:

Lácer, S.A.

Boters, 5. Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès

Spain

Date of the Last Revision of this Prospectus:April 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/