Diltiazem Stada 60 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diltiazem Stada 60 mg tablets EFG

Diltiazem hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as 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 and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Diltiazem Stada is and what it is used for
2. What you need to know before taking Diltiazem Stada
3. How to take Diltiazem Stada
4. Possible side effects
5. How to store Diltiazem Stada
6. Contents of the pack and other information

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

Diltiazem Stada belongs to a group of medicines called selective calcium channel blockers, which cause dilation of blood vessels, resulting in a reduction of blood pressure, as well as an increase in blood flow and a decrease in the heart's oxygen requirements.

Diltiazem Stada is indicated for:

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

2. What you need to know before starting Diltiazem Stada

Do not take Diltiazem Stada:

• if you are allergic to diltiazem hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• if you have a heart rhythm or conduction disorder, 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 below 40 beats per minute).
• if you have a heart condition such as left ventricular failure with pulmonary congestion.
• if you are being treated with dantrolene (by infusion).
• if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions.
• if you are already taking a medicine containing lomitapide used to treat high cholesterol levels (see section “Taking Diltiazem Stada with other medicines”).

Warnings and precautions

Talk to your doctor or pharmacist before starting 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 monitor you closely.
• if you are undergoing general anesthesia, you must inform the anesthesiologist that you are being treated with this medicine.
• if you are elderly or have kidney or liver disease (renal or hepatic impairment), blood levels of diltiazem may be higher, so heart rate should be closely monitored at the beginning 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 class, reduces intestinal motility.
• if you have latent or overt diabetes mellitus. Strict 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 increases. Inform your doctor if you develop 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 new-onset breathing difficulty, as cases of kidney injury have been reported in patients with these conditions.
• if you have a history of heart failure, new breathing difficulty, slow heartbeat, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

Sun exposure during treatment is not recommended, as photosensitivity reactions (skin rashes) may occur.

Taking Diltiazem Stada with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Certain medicines may interact with Diltiazem Stada. In such cases, it may be necessary to adjust the dose or discontinue one of the medicines.

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

Combinations that are contraindicated:

• Dantrolene: concomitant use of diltiazem with dantrolene (by infusion) is contraindicated.
• Ivabradine (see section “Do not take Diltiazem Stada”).
• Medicines containing lomitapide used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could increase the likelihood and severity of liver-related side effects.

Combinations that require caution:

Medicines used to treat heart conditions, such as:

• Alpha-blockers, as they may enhance the hypotensive effect (decrease in blood pressure).
• Beta-blockers, as cardiac disorders may occur. This combination should only be used under clinical and electrocardiographic monitoring, especially at the start of treatment.
• An increased risk of depression has been observed when diltiazem is administered together with beta-blockers (see section 4 Possible side effects).
• Amiodarone, digoxin, as they increase the risk of bradycardia. Caution is especially needed in elderly patients and when high doses are used.
• Other antiarrhythmic medicines, as diltiazem has antiarrhythmic properties, increasing the risk of cardiac adverse effects. This combination should only be used under clinical and electrocardiographic monitoring.
• Nitrate derivatives, as they may enhance the hypotensive effect and cause fainting.

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

• Cyclosporine (an immunosuppressant used in transplant patients).
• Phenytoin (a medicine used to treat epilepsy). Monitoring of plasma phenytoin levels is recommended when administered together with diltiazem.
• Carbamazepine (a medicine used to treat epilepsy).
• Theophylline (a medicine used for asthma).
• H2 antagonists (cimetidine and ranitidine, medicines used to treat stomach ulcers), as they increase diltiazem blood levels; therefore, treatment with these medicines may need to be discontinued or the daily dose of diltiazem adjusted.
• Rifampicin (an antibiotic used to treat tuberculosis and certain infections), which may reduce diltiazem blood levels; your doctor will monitor you closely.
• X-ray contrast media: patients treated with diltiazem may experience increased cardiovascular effects, such as hypotension, when given an intravenous bolus of ionic X-ray contrast media. Special caution is required in patients receiving diltiazem concomitantly with X-ray contrast media.
• Lithium (a medicine used to treat mental health conditions), as it may increase lithium toxicity. Your doctor will closely monitor your blood lithium levels.

General information to consider:

• Due to possible additive effects, caution and careful evaluation are required when diltiazem is administered together with other agents known to affect cardiac conduction and/or contractility.

• Antiplatelet agents (medicines that prevent blood cells called “platelets” from clumping and forming clots): the possibility of additive effects on platelet aggregation from diltiazem and antiplatelet agents (such as acetylsalicylic acid, ticagrelor, cilostazol) should be considered.

• Medicines metabolized by the CYP3A4 enzyme, as this may result in decreased blood levels of diltiazem or increased levels of any co-administered medicine.

• Patients consuming grapefruit juice should be monitored for increased adverse effects of diltiazem. 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 blood levels of these medicines, prolonging their duration of action. Your doctor will exercise special caution when prescribing benzodiazepines (especially short-acting ones) if you are taking diltiazem.

• Corticosteroids (methylprednisolone), used as anti-inflammatory agents and in severe allergies due to their immunosuppressive properties, as diltiazem reduces the metabolism of methylprednisolone; your doctor will monitor you closely and may need to adjust the dose of methylprednisolone.

• Statins (medicines used to lower cholesterol), as diltiazem greatly increases blood levels of certain statins, potentially causing statin-related toxicity.

• Cilostazol: by inhibiting cilostazol metabolism, diltiazem enhances its pharmacological activity.

Children and adolescents

Diltiazem Stada is not suitable 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 section “Taking Diltiazem Stada with other medicines”).

Pregnancy, breastfeeding, and fertility

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

This medicine must not be given to pregnant women or women of childbearing potential who are not using an effective method of contraception.

This medicine must 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 using machines

Based on adverse effects reported with diltiazem use, such as dizziness (common) and malaise (common), your ability to drive or operate machinery may be impaired, although no specific studies have been conducted on this.

3. How to take Diltiazem Stada

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

The route of administration of Diltiazem Stada is oral.

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

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

Your doctor may increase or decrease these doses if considered necessary.

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

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

Patients with renal insufficiency or hepatic insufficiency: should be used with caution. See section “Warnings and precautions”.

Substitution between different diltiazem medicinal products is not recommended unless you receive explicit advice from your doctor.

If you take more Diltiazem Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

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

An excessively high dose of this medicine may cause a significant drop in blood pressure (possibly leading to collapse and reduced kidney function), slowing of heart rate, sinus arrest, disturbances in cardiac conduction, cardiac arrest, and renal failure.

In case of significant overdose, you should be transferred 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 possible and then take the next dose at the usual time. However, if it is already time for the next dose or nearly so, do not take the missed tablet.

If you stop taking Diltiazem Stada

Your doctor will advise you on the duration of your treatment with this medicine. Do not stop treatment prematurely. If you interrupt treatment with diltiazem, your condition may worsen.

If you have any further questions 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 everyone experiences 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 available data)

Blood and lymphatic system disorders:

• Frequency not known: thrombocytopenia.

Metabolism and nutrition disorders:

• Frequency not known: hyperglycaemia.

Psychiatric disorders:

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

Vascular disorders:

• Common: hot flushes.
• Uncommon: drop in blood pressure upon standing 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 worsening of asthma).

Gastrointestinal disorders:

• Common: constipation, indigestion (dyspepsia), stomach pain, nausea.
• Uncommon: vomiting, diarrhoea.
• Rare: dry mouth.
• Frequency not known: inflammation of the hard palate (gingival hyperplasia).

Hepatobiliary disorders:

• Uncommon: increased liver enzyme levels in blood during the initial treatment period. These increases are usually temporary.
• Frequency not known: hepatitis (inflammatory disease affecting the liver).

Skin and subcutaneous tissue disorders:

• Common: skin redness (erythema).
• Rare: skin irritation and itching (urticaria).
• Frequency not known: light sensitivity (photosensitivity), swelling of the throat, lips and airways (angioneurotic oedema), rash, erythema multiforme (a serious skin disease associated with red spots, blisters), including cases of Stevens-Johnson syndrome (severe blistering reactions of the skin and mucous membranes), toxic epidermal necrolysis (a severe skin peeling disease), sweating, exfoliative dermatitis (skin redness, itching, hair loss), acute generalized exanthematous pustulosis (sudden rash accompanied by fever, with formation of pustules or lesions on the skin surface characterized as small, inflamed, pus-filled, and blister-like), occasionally erythematous desquamation with or without fever; a condition in which the body's immune system attacks normal tissue, causing symptoms such as swollen joints, fatigue, and skin rashes (called "lupus-like syndrome").

Reproductive system and breast disorders:

• Frequency not known: excessive breast development in men (gynaecomastia).

General disorders and administration site conditions:

• Very common: swelling of the lower limbs (peripheral oedema).
• Common: malaise.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiazem Stada

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diltiazem Stada

• The active substance is diltiazem hydrochloride.

Each tablet contains 60 mg of diltiazem hydrochloride.

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

Appearance of the medicine and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio 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 most recent revision of this leaflet: April 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/