Diltiazem stada 60 mg comprimidos efg

Leaflet: information for the user

Diltiazem Stada 60 mg tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Diltiazem Stada belongs to a group of medications known as 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 Stada is indicated for:

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

Do not take Diltiazem Stada:

• if you are allergic to hydrochloride diltiazem or any of the other ingredients of this medication (listed in section 6).
• if you have any heart rhythm or conduction disorders, such as sinus 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 with pulmonary congestion.
• if you are being treated with dantrolene (intravenous).
• if you are already taking a medication that contains 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 Diltiazem Stada with other medications”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Diltiazem Stada

• if you have heart conditions such as left ventricular insufficiency, 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 undergoing general anesthesia, 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), the diltiazem concentration 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 medications in this group, can cause a decrease in intestinal motility.
• if you have latent or manifest diabetes mellitus. Strict control is necessary 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 dose increase. Inform your doctor if you experience signs or symptoms of respiratory problems during treatment with this medication.
• if you have a history of bradycardia (slow heart rate), low blood pressure, heart failure, or difficulty breathing, as cases of renal 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 renal damage have been reported in patients with these conditions, so your doctor may need to monitor your renal function.

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

Taking Diltiazem Stada with other medications

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

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

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

Contraindicated combinations:

• Dantrolene: the simultaneous use of diltiazem with dantrolene (intravenous) is contraindicated.
• Ivabradina (see section “Do not take Diltiazem Stada”).
• 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.

Combinations requiring caution:

Medications for heart problems, such as:

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:

• Ciclosporin (immunosuppressive medication used in transplants).
• Fenitoína (medication for epilepsy). It is recommended to monitor the concentrations of fenitoína in plasma when administered concurrently with diltiazem.
• Carbamazepina (medication for epilepsy).
• Teofilina (medication for asthma).
• Antagonists H2 (cimetidina and ranitidina medications for stomach ulcers), as they increase the amount of diltiazem in the blood, so either the treatment with these medications will be discontinued or the daily dose of diltiazem will be adjusted.
• Rifampicina (antibiotic used for the treatment of 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 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 concurrently.
• Litio (medication for mental health problems) as it may increase the toxicity of this medication. Your doctor will closely monitor your lithium levels in the blood.

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 platelets from aggregating and forming a blood clot): consider the possibility of additive effects on platelet aggregation of diltiazem and antiplatelet medications (such as acetylsalicylic acid, ticagrelor, cilostazol).

• Medications 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 medication administered with it.

• Monitor patients who consume grapefruit juice for increased adverse effects of diltiazem. Avoid grapefruit juice 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 time in the body. Your doctor will take special care 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 (medications used to lower cholesterol levels), as diltiazem increases the amount of some statins in the blood, which may cause problems with statin toxicity.

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

Children and adolescents

Diltiazem Stada is not a suitable medication for children.

Taking Diltiazem Stada with food, drinks, and alcohol

It is recommended to take this medication preferably before meals.

Avoid taking grapefruit juice (see section “Taking Diltiazem Stada with other medications”).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be 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 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 studies have been conducted on this.

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

The administration route of Diltiazem Stada is oral.

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

Hypertension: Hypertension treatment 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 elderly patients and patients with kidney or liver disease

Since in these cases, an increase in diltiazem levels in the blood may occur, 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 Stada 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 have taken more diltiazem than you should, consult your doctor or pharmacist immediately.

A high dose of this medication can cause a significant decrease in blood pressure (which may lead to collapse and decreased renal function), bradycardia, sinus arrest, cardiac conduction abnormalities, cardiac arrest, and renal insufficiency.

In case of significant overdose, you should be taken to a hospital, where a 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 compensate for the missed 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 is close to it, do not take the missed dose.

If you interrupt treatment with Diltiazem Stada

Your doctor will indicate the duration of your treatment with this medication. Do not suspend treatment before. If you interrupt treatment with diltiazem, 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 may 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 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 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 block, heart failure (congestive heart failure), cardiac rhythm disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

• Common:flushing.
• Uncommon:postural hypotension (dizziness or fainting when standing up) associated or not with dizziness.
• Frequency not known:vasculitis (inflammation of blood vessels) including leucocytoclastic vasculitis.

Respiratory, thoracic and mediastinal disorders:

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

Gastrointestinal disorders:

• Common:constipation, indigestion, stomach pain, nausea.
• Uncommon:vomiting, diarrhoea.
• 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, inflammation of the throat, lips and respiratory tract (angioneuritic oedema), rash, erythema multiforme (severe skin disease associated with red patches and blisters), including cases of Stevens-Johnson syndrome (severe skin and mucous membrane vesiculation), toxic epidermal necrolysis (peeling skin disease), sweating, exfoliative dermatitis (skin redness, itching, hair loss), acute generalised pustular psoriasis (sudden rash accompanied by fever, with the formation of pus-filled lesions on the skin surface that are small, inflamed, filled with pus and similar to a blister), 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:swelling in the lower limbs.
• Common:uncomfortable feeling.

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:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

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 in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

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 content of the packaging

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

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

info@stada.es

Responsible manufacturer:

Lácer, S.A.

Boters, 5. Parc Tecnològic del Vallès

08290 Cerdanyola del Vallès

Spain

Last review date of this leaflet:April2023

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/