Diltiazem Alter 60 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diltiazem Alter 60 mg tablets EFG

Diltiazem hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Diltiazem Alter 60 mg tablets EFG is and what it is used for
2. What you need to know before taking Diltiazem Alter
3. How to take Diltiazem Alter
4. Possible adverse effects
5. How to store Diltiazem Alter
6. Contents of the pack and other information

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

Diltiazem Alter belongs to a group of medicines called selective calcium channel blockers, which produce 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 Alter 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 to take Diltiazem Alter

Do not take Diltiazem Alter:

• if you are allergic to diltiazem hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

• if you are already taking a medicine containing lomitapide used to treat high cholesterol levels (see section: "Taking Diltiazem Alter with other medicines").

• 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

• 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.

Warnings and precautions

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

• if you have heart conditions such as ventricular insufficiency, bradycardia (slow heart rate), or first-degree atrioventricular block (a type of arrhythmia) detected by electrocardiogram; close monitoring by your doctor will be necessary,
• if you have severe liver or kidney disease, or if you are over 65 years of age. In these cases, blood concentrations of diltiazem may be higher. Increased medical supervision may be required, including periodic check-ups,
• 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 concentrations of diltiazem may be higher, so close monitoring of heart rate is necessary 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 following 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 heart failure, new onset of breathing difficulty, slow heart rate, or low blood pressure. Cases of kidney injury have been reported in patients with these conditions, and your doctor may need to monitor your kidney function.

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

Taking Diltiazem Alter with other medicines

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

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

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

Combinations that are contraindicated:

• Dantrolene: concomitant use of diltiazem with dantrolene (by infusion) is contraindicated.

• Ivabradine (see section "Do not take Diltiazem Alter").

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

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

Combinations that require caution:

Medicines used to treat cardiovascular conditions, such as:

• Alpha-blockers, as they may enhance the hypotensive effect (lowering of blood pressure).
• Beta-blockers, as cardiac disturbances may occur. This combination should only be used under clinical and electrocardiographic monitoring, especially at the beginning 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 may 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 the blood levels of these medicines, so your doctor will need to adjust their dosage during treatment with diltiazem:

• Cyclosporine (an immunosuppressant used in transplant patients).
• Phenytoin (a medicine used to treat epilepsy). Monitoring of plasma phenytoin concentrations is recommended when administered concomitantly with diltiazem.
• Carbamazepine (used to treat epilepsy).
• Theophylline (a medicine 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 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 therefore 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 necessary when diltiazem is administered simultaneously with other agents known for their effects on 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 medicines (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 concomitantly administered medicines.

? Patients who consume grapefruit juice should be monitored, as it may increase the 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 in the body. 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 for severe allergies due to their immunosuppressive properties, as diltiazem reduces the metabolism of methylprednisolone; therefore, your doctor will monitor you closely and may need to adjust your methylprednisolone dose.

? 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 increases its pharmacological activity.

Children and adolescents

Diltiazem Alter is not an appropriate medicine for children.

Taking Diltiazem Alter with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

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

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 medicine.

This medicine must not be administered to pregnant women or to 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 treatment with this medicine essential, the baby must be fed by an alternative method.

Driving and using machines

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

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Diltiazem Alter

Follow exactly the instructions for use of this medicine as given by your doctor. If in 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 daily), preferably taken before meals.

Hypertension: Treatment of hypertension should be initiated 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 there may be an increase in blood levels of diltiazem, your doctor should consider the need to adjust your dose at the beginning of treatment.

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

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

If you take more Diltiazem Alter than you should

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

If you take more tablets than you should, inform your doctor or go immediately to the emergency department of a hospital. Take the medicine packaging with you. This will allow the doctor to know what you have taken. The following effects may occur: dizziness or weakness, blurred vision, chest pain, difficulty breathing, fainting, unusually fast or slow heartbeat, difficulty speaking, confusion, decreased kidney function, coma, and sudden death.

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 Alter

Do not take a double dose to make up for missed 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 Alter

Your doctor will advise you on the duration of your treatment with Diltiazem Alter. Do not stop treatment prematurely. If you interrupt treatment with Diltiazem Alter, 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 will experience 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: hyperglycemia.

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 disorder (sinus arrest), cardiac arrest (asystole).

Vascular disorders:

• Common: hot flushes.
• 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 worsening of asthma).

Gastrointestinal disorders:

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

Hepatobiliary disorders:

• Uncommon: increase in liver enzyme levels in the 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: redness of the skin (erythema).
• Rare: skin irritation and itching (urticaria).
• Frequency not known: sensitivity to light (photosensitivity), swelling of the throat, lips and airways (angioneurotic edema), 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 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, blister-like), occasionally exfoliative erythema 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 (gynecomastia).

General disorders and administration site conditions:

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

Reporting of adverse effects

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

5. Storage of Diltiazem Alter

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

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 empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diltiazem Alter

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

Nature of the product and contents of the container

The tablets are white, cylindrical, and scored on one side.

Diltiazem Alter is available in packs of 60 tablets in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/