DILTIAZEM SANDOZ 60 mg TABLETS

Introduction

Package Leaflet: Information for the User

Diltiazem Sandoz 60 mg Tablets EFG

Diltiazem Hydrochloride

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

Diltiazem Sandoz is used for the treatment and prevention of chest pain (angina pectoris), as it widens (dilates) the heart's arteries, increasing blood flow.

Diltiazem Sandoz also acts by widening other blood vessels in the body, so it is also used in the treatment of high blood pressure (hypertension).

2. What you need to know before you take Diltiazem Sandoz

Do not take Diltiazem Sandoz:

• if you are allergic to diltiazem or 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 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,
• if you are taking medicines containing ivabradine for the treatment of certain heart diseases,
• if you are already taking a medicine that contains 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 being treated with other medicines used to treat heart diseases (beta blockers, digitalis) since the use of diltiazem in these situations may lead to an excessively slow heart rate and rhythm (bradycardia).
• If you are going to have surgery,as diltiazem may enhance the effects of anesthetics
• If you have a ventricular function disorder.
• If you have hypotension: treatment with diltiazem may lead to an excessive drop in blood pressure. Your doctor will inform you about how to avoid the symptoms resulting from hypotension and what measures to take if these symptoms occur.
• If you have liver or kidney disease or are elderly: since there is no data available in these patients, Diltiazem Sandoz should be used with caution.
• The use of diltiazem has been associated with skin reactions and mood changes (including depression). Your doctor will assess these symptoms and indicate the measures to be taken.
• If you are at risk of developing an intestinal obstruction, as diltiazem, like other medicines in the same group, produces a decrease in intestinal movement.
• If you have a history of heart failure, new difficulty breathing, slow heartbeats, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

Taking Diltiazem Sandoz with other medicines

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

Contraindicated use:

Diltiazem should not be used with dantrolene (muscle relaxant).

Medicines containing lomitapide used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability 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 concentration in the blood:

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

The following medicines may decrease the effects of diltiazem by reducing its concentration in the blood:

• phenytoin (used to treat epilepsy)
• St. John's Wort (used in cases of exhaustion, fatigue, or sleep disorders)
• rifampicin (antibiotic)

Effects of diltiazem on other medicines:

Diltiazem may increase the effects of the following medicines by increasing their concentrations in the blood or by enhancing their effect:

• phenytoin, carbamazepine (used to treat epilepsy)
• triazolam, midazolam, buspirone (used to treat anxiety)
• digoxin (used to treat heart diseases)
• cyclosporin, sirolimus (used to suppress the immune system)
• methylprednisolone (corticosteroid used to treat inflammatory problems)
• simvastatin and lovastatin (medicines to lower blood cholesterol levels)
• theophylline (used to treat asthma)
• medicines that reduce blood clot formation (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 down the heart rate (amiodarone)
• anesthetics
• lithium salts (used to treat certain mental illnesses): may increase the risk of intense agitation (psychotic episodes)
• sirolimus, temsirolimus, everolimus (medicines that reduce the activity of the immune system)

The combined use of diltiazem with other medicines should be done under medical supervision and with gradual dose adjustment.

Children and adolescents

There is no experience with 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 the section "Taking Diltiazem Sandoz with other medicines").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 the doctor considers it essential to take this medicine, the baby should be fed with an alternative method.

Driving and using machines

The ability to drive and use machines may be impaired, especially at the start of treatment with diltiazem.

3. How to take Diltiazem Sandoz

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

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

The recommended dose is:

Adults

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

Elderly patients, patients with renal or hepatic impairment

The initial dose adjustment should be done with caution.

All dose modifications and monitoring should be done under medical supervision.

Instructions for correct administration

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

Diltiazem Sandoz should be taken preferably before meals.

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

Your doctor will indicate the duration of your treatment with Diltiazem Sandoz. Do not stop treatment before consulting your doctor, as it may 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 a drop in blood pressure, slowing of the heart rate, conduction disorders, and decreased kidney function.

In case of a drop in blood pressure, sit with your head down.

In case of a significant overdose, you should be taken to a specialized center to apply the necessary measures.

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 forget to take Diltiazem Sandoz

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

If you stop taking Diltiazem Sandoz

If you stop treatment with Diltiazem Sandoz, you may experience worsening of your disease, with symptoms such as chest pain or a sudden increase in blood pressure.

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of diltiazem vary in intensity from one patient to another and should be taken into account especially at the start of treatment or when changing medication.

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

• edema in the lower limbs.

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

• headache, dizziness,
• atrioventricular block (a type of arrhythmia), palpitations, slow heart rate (bradycardia),
• flushing,
• constipation, difficult digestion (dyspepsia), stomach pain, nausea,
• skin rash,
• swelling of the joints,
• fatigue (asthenia), tiredness, malaise.

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

• nervousness, difficulty falling asleep (insomnia),
• drop in blood pressure when standing up quickly, associated or not with dizziness (orthostatic hypotension),
• vomiting, diarrhea,
• increase in liver enzyme levels in the blood.

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

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

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

• reduction in platelet count (thrombocytopenia),
• decreased appetite, high blood sugar levels (hyperglycemia),
• mood changes, including depression, confusion, hallucinations, personality changes, and sleep disturbances,
• movement disorders (extrapyramidal syndrome), memory loss (amnesia), abnormal sensation of tingling, numbness, or burning (paresthesia), tendency to fall asleep (somnolence), temporary loss of consciousness (syncope), tremor, sudden involuntary muscle contractions.
• lazy eye (partial loss of vision in one or both eyes), eye irritation,
• ringing in the ears (tinnitus),
• interruption or alteration of the heart's electrical signal (sinoatrial block, sinus arrest), difficulty of the heart to pump blood (congestive heart failure), rapid heartbeats (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeats (arrhythmia), chest pain or tightness (angina pectoris),
• inflammation of blood vessels (vasculitis),
• difficulty breathing (dyspnea), nosebleeds (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 respiratory tract (angioedema), erythema multiforme (severe skin disease associated with red spots, blisters), including rare cases of Stevens-Johnson syndrome (severe skin and mucous membrane reactions), toxic epidermal necrolysis (skin shedding disease), sweating, exfoliative dermatitis (redness, itching, hair loss), and generalized acute pustular exanthema (sudden rash with fever and formation of pustules or skin lesions), 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 (gynecomastia), sexual function disorders,
• walking difficulties,
• elevation of the enzyme creatine phosphokinase (CPK) in blood tests, weight gain,
• a condition in which the body's defense system attacks normal tissue, causing symptoms such as joint inflammation, fatigue, and skin rash (called "lupus-like syndrome").

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es. By reporting side 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 which is 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 should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Diltiazem Sandoz

• The active ingredient is diltiazem. Each tablet contains 60 mg of diltiazem as diltiazem hydrochloride.
• The other ingredients are: hypromellose, glycerol behenate, colloidal silica, magnesium stearate.

Appearance of the product and pack contents

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte Edificio Roble C/ Serrano Galvache, 56 28033 Madrid Spain

Manufacturer:

LACER, S.A. C/ Boters nº 5 Parc Tecnológic del Vallés 08290 Cerdanyola del Vallés (Barcelona) Spain

Date of last revision of this leaflet:May 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.