Diltiazem Sandoz 60 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diltiazem Sandoz 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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Diltiazem Sandoz, whose active substance is diltiazem, belongs to a group of medicines called calcium antagonists.

Diltiazem Sandoz is used to treat and prevent angina pectoris, as it widens (dilates) the coronary arteries, thereby increasing blood flow to the heart.

Diltiazem Sandoz also works by dilating other blood vessels throughout the body, and is therefore also used in the treatment of high blood pressure (hypertension).

2. What you need to know before taking Diltiazem Sandoz

Do not take Diltiazem Sandoz:

• if you are allergic to diltiazem or to any of the other ingredients 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 below 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,
• if you are taking medications containing ivabradine for the treatment of certain heart conditions,
• if you are already taking a medicine containing lomitapide used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Sandoz with other medicines").

Warnings and precautions

• If you have any cardiac arrhythmia (sick sinus syndrome, atrioventricular block) or if you are receiving treatment with other medicines used to treat heart conditions (beta-blockers, digitalis), as the use of diltiazem in these situations may lead to excessively slow heart rate and rhythm (bradycardia).
• If you are due to undergo surgery, since diltiazem may enhance the effects of anaesthetics.
• If you have impaired ventricular function.
• If you have hypotension: treatment with diltiazem may lead to an excessive drop in blood pressure. Your doctor will advise you on how to avoid symptoms resulting from low blood pressure and what measures to take if such symptoms occur.
• If you have liver or kidney disease or are elderly: since there is limited data available in these patient groups, Diltiazem Sandoz should be used with caution.
• The use of diltiazem has been associated with skin reactions and changes in mood (including depression). Your doctor will assess these symptoms and advise you on the necessary measures.
• If you are at risk of developing intestinal obstruction, as diltiazem, like other medicines in the same class, reduces intestinal motility.
• If you have a history of heart failure, new onset of breathing difficulty, slow heartbeats, 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.

Taking Diltiazem Sandoz with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Contraindicated use:

Diltiazem must not be used together with dantrolene (a muscle relaxant).

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

Effects of other medicines on diltiazem:

The following medicines may increase the effects of diltiazem by increasing its blood concentration:

• fluconazole (used to treat fungal infections),
• erythromycin and other macrolides (antibiotics),
• ritonavir (used to treat viral infections),
• amiodarone (used to reduce heart rate),
• cimetidine and ranitidine (used to reduce stomach acid production).

The following medicines may reduce the effects of diltiazem by decreasing its blood concentration:

• phenytoin (used to treat epilepsy),
• St. John’s wort (used for fatigue, tiredness, or sleep disturbances),
• rifampicin (an antibiotic).

Effects of diltiazem on other medicines:

Diltiazem may increase the effects of the following drugs by increasing their blood concentrations or enhancing their action:

• phenytoin, carbamazepine (used to treat epilepsy),
• triazolam, midazolam, buspirone (used to treat anxiety),
• digoxin (used to treat heart conditions),
• ciclosporin, sirolimus (used to suppress the immune system),
• methylprednisolone (a corticosteroid used to treat inflammatory conditions),
• simvastatin and lovastatin (medicines to lower blood cholesterol levels),
• theophylline (used to treat asthma),
• medicines that reduce blood clotting (oral anticoagulants such as acenocoumarol or warfarin),
• rifampicin (antibiotic),
• medicines used to lower blood pressure (nitrates, alpha- and beta-blockers, diuretics, angiotensin-converting enzyme inhibitors) and to slow heart rate (amiodarone),
• anaesthetics,
• lithium salts (used to treat certain mental illnesses): may increase the risk of severe agitation (psychotic episodes),
• sirolimus, temsirolimus, everolimus (medicines that reduce immune system activity).

The combined use of diltiazem with other medicines should be carried out under medical supervision, with gradual dose adjustments.

Children and adolescents

There is no experience regarding the use of diltiazem in children.

Taking Diltiazem Sandoz with food, drinks, and alcohol

It is recommended to take this medicine preferably before meals.

Grapefruit juice should be avoided (see section "Taking Diltiazem Sandoz 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 must not be given to pregnant women or women of childbearing age 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 alternative means.

Driving and using machines

Your ability to drive and operate machinery may be impaired, especially at the beginning of treatment with diltiazem.

3. How to take Diltiazem Sandoz

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

Diltiazem Sandoz is administered orally. Your doctor will tell you how many tablets to take each day.

Recommended dose:

Adults

Angina pectoris: The initial dose is 1 tablet every 12 hours. Your doctor will gradually increase the dose until the optimal response is achieved. The maximum dose is 4 tablets every 12 hours (480 mg/day).

Hypertension: The initial dose is 1 tablet every 12 or 8 hours. Your doctor will gradually increase the dose until the optimal response is achieved. The maximum dose is 4 tablets every 12 hours (480 mg/day).

Elderly patients, patients with renal or hepatic impairment

Initial dose adjustment should be done cautiously.

All dose modifications and monitoring must be carried out under medical supervision.

Instructions for correct administration

Swallow the tablets whole, without chewing, with a sufficient amount of liquid (for example, a glass of water). The tablets must not be divided or crushed.

Diltiazem Sandoz should preferably be taken before meals.

Take Diltiazem Sandoz every day and approximately at the same time each day. Taking the tablets at the same time daily will have a better effect on your blood pressure and will also help you remember when to take them.

Your doctor will determine the duration of your treatment with Diltiazem Sandoz. Do not stop treatment prematurely, as this could be harmful to your health.

If you feel that the effect of Diltiazem Sandoz is too strong or too weak, consult your doctor or pharmacist.

If you take more Diltiazem Sandoz than you should

An overdose of diltiazem may cause low blood pressure, slowed heart rate, disturbances in cardiac conduction, and reduced kidney function.

In case of low blood pressure, sit down with your head lowered.

In case of a significant overdose, you must be transferred to a specialized center to receive appropriate treatment.

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

If you forget to take Diltiazem Sandoz

Do not take a double dose to make up for missed doses. It is important to take Diltiazem Sandoz regularly at the same time each day. If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed tablet.

If you stop taking Diltiazem Sandoz

If you stop treatment with Diltiazem Sandoz, your condition may worsen, with symptoms such as chest pain or tightness, or a sudden rise in blood pressure.

Do not interrupt treatment with Diltiazem Sandoz without first consulting your doctor.

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 adverse effects of diltiazem vary in intensity from patient to patient and should be especially considered at the beginning of treatment or when changing medication.

Very common (may affect more than 1 in 10 patients):

• swelling of the lower limbs (edema).

Common (may affect up to 1 in 10 patients):

• headache, dizziness,
• atrioventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia),
• flushing,
• constipation, indigestion (dyspepsia), stomach pain, nausea,
• skin rashes,
• joint swelling,
• tiredness (asthenia), fatigue, malaise.

Uncommon (may affect up to 1 in 100 patients):

• nervousness, difficulty falling asleep (insomnia),
• drop in blood pressure upon standing quickly, with or without dizziness (orthostatic hypotension),
• vomiting, diarrhoea,
• increased liver enzyme levels in the blood.

Rare (may affect up to 1 in 1,000 patients):

• dry mouth,
• skin irritation and itching (urticaria).

Frequency not known (cannot be estimated from available data):

• reduction in the number of platelets (thrombocytopenia),
• decreased appetite, elevated blood sugar levels (hyperglycaemia),
• mood changes including depression, confusion, hallucinations, personality and sleep disturbances,
• movement disorders (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness or burning (paraesthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremor, sudden involuntary jerking of a muscle or group of muscles,
• lazy eye (partial loss of vision in one or both eyes), eye irritation,
• ringing in the ears (tinnitus),
• interruption or disturbance of the electrical signal in the heart (sinoatrial block, sinus arrest), difficulty of the heart to pump blood (congestive heart failure), rapid heartbeat (tachycardia), abnormal heartbeats (ventricular extrasystoles), irregular heartbeat (arrhythmia), chest pain or tightness (angina pectoris),
• inflammation of blood vessels (vasculitis),
• difficulty breathing (dyspnoea), nosebleed (epistaxis), nasal congestion,
• gum inflammation (gingival hyperplasia),
• hepatitis (inflammatory disease affecting the liver), liver disorder (granulomatous liver disease),
• sensitivity to light (photosensitivity), inflammation of the throat, lips and airways (angioneurotic oedema), erythema multiforme (serious skin disease associated with red spots, blisters), including rare 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), and 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), small red spots on the skin (petechiae), itching (pruritus),
• joint pain, muscle pain,
• need to urinate at night (nocturia), increased frequency of urination (polyuria),
• breast enlargement in men (gynaecomastia), disturbances in sexual function,
• difficulty walking,
• elevated creatine phosphokinase (CPK) enzyme levels in blood tests, weight gain,
• 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").

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 not listed in this leaflet. You may also report them directly through the national reporting system: Spanish System for Pharmacovigilance of Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Diltiazem Sandoz

Keep out of the sight and reach of children.

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Diltiazem Sandoz

• The active substance is diltiazem. Each tablet contains 60 mg of diltiazem as diltiazem hydrochloride.
• The other components are: hypromellose, glyceryl behenate, colloidal silicon dioxide, magnesium stearate.

Appearance of the medicinal product and contents of the pack

Diltiazem Sandoz is available in packs containing 30, 60 and 500 tablets (Hospital Pack). The tablets are white and biconvex.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A. Parque Norte Business Center Roble Building C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer:

LACER, S.A. C/ Boters, 5 Parc Tecnològic del Vallès 08290 Cerdanyola del Vallès (Barcelona) Spain

Date of the most recent review of this leaflet: May 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