Package Leaflet: Information for the User

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

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

2. What you need to know before you start taking Diltiazem Sandoz

3. How to take Diltiazem Sandoz

4. Possible side effects

5. Storage of Diltiazem Sandoz

6. Contents of the pack and additional information

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

Diltiazem Sandoz is used for the treatment and prevention of 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).

Do not take Diltiazem Sandoz:

• if you are allergic to diltiazem or any of the other ingredients in this medicine (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 heart failure with pulmonary congestion,
• if you are being treated with dantrolene,
• if you are taking medications that contain ivabradina for the treatment of certain heart diseases,
• if you are already taking a medicine that contains lomitapida used for the treatment of high cholesterol levels (see section: "Taking Diltiazem Sandoz with other medicines").

Warnings and precautions

• If you have any heart arrhythmia(sick sinus syndrome, atrioventricular block) or if you are receiving treatment with other medications 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 to be operated on,since diltiazem may potentiate the effects of anesthetics
• If you have a ventricular function disorder.
• If you have hypotension: diltiazem treatment 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 are no available data 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 have a risk of developing intestinal obstruction, since, like other medications in this group, diltiazem reduces intestinal movement.
• If you have a history of heart failure, new difficulty breathing, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions, and your doctor may need to monitor your renal function.

Taking Diltiazem Sandoz with other medicines

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

Contraindicated use:

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

Medicines containing lomitapida used for the treatment of high cholesterol levels. Diltiazem may increase the concentration of lomitapida, which may lead to an increase in the 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 for the treatment of fungal infections),
• erythromycin and other macrolides (antibiotics),
• ritonavir (used for the treatment of viral infections),
• amiodarone (used to reduce 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 for the treatment of epilepsy)
• St. John's Wort (used in cases of weakness, fatigue, or sleep disturbances)
• rifampicin (antibiotic)

Effects of diltiazem on other medicines:

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

• phenytoin, carbamazepine (used for the treatment of epilepsy)
• triazolam, midazolam, buspirone (used for the treatment of anxiety)
• digoxin (used for the treatment of heart diseases)
• ciclosporin, sirolimus (used to suppress the immune system)
• prednisolone (corticosteroid used for the treatment of inflammatory problems)
• simvastatin and lovastatin (medicines to reduce cholesterol levels in the blood)
• theophylline (used for the treatment of asthma)
• oral anticoagulants, such as acenocoumarol or warfarin (used to prevent blood clots)
• rifampicin (antibiotic)
• medicines used to reduce blood pressure (nitrates, alpha and beta blockers, diuretics, angiotensin-converting enzyme inhibitors) and to reduce heart rate (amiodarone)
• anesthetics
• lithium salts (used for the treatment of certain mental disorders): may increase the risk of intense agitation (psychotic episodes)
• sirolimus, temsirolimus, everolimus (medicines that reduce immune system activity)

The concomitant use of diltiazem with other medicines should be carried out under medical supervision and with progressive dose adjustments.

Children and adolescents

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

Taking Diltiazem Sandoz with food, drinks, and alcohol

This medicine should be taken preferably before meals.

It is recommended to avoid taking grapefruit juice (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 plan to become pregnant, consult your doctor or pharmacist before using 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 by an alternative method.

Driving and operating machinery

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

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

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

The recommended dose is:

Adults

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

Older patients, patients with renal or hepatic insufficiency

The initial dose adjustment should be done with caution.

All dose modifications and control 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 hour. Taking the tablets at the same hour 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 tell you the duration of your treatment with Diltiazem Sandoz. Do not stop treatment without consulting your doctor, as it may be harmful to your health.

If you think 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

A diltiazem overdose can cause a drop in blood pressure, slowing of heart rate, cardiac conduction disturbances, and decreased renal function.

In case of low 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 medication and the amount ingested.

If you forget to take Diltiazem Sandoz

Do not take a double dose to compensate for the missed doses. It is essential to take Diltiazem Sandoz regularly at the same hour each day. If you forget to take a dose, take it as soon as you can. However, if it is almost time for the next dose, do not take the missed dose.

If you interrupt treatment with Diltiazem Sandoz

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

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

If you have any other doubts 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 side effects of diltiazem vary in intensity from one patient to another and should be taken into account especially at the beginning of treatment or when changing medication.

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

• swelling in the lower limbs.

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

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

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

• anxiety, difficulty falling asleep (insomnia),
• rapid blood pressure drop upon standing 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 patients):

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

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

• reduction in platelet count (thrombocytopenia),
• decreased appetite, elevated blood sugar levels (hyperglycemia),
• changes in mood including depression, confusion, hallucinations, alterations in personality and sleep,
• 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 and 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 electrical signal in the heart (sinoatrial block, sinus arrest), difficulty pumping blood (congestive heart failure), rapid heart rate (tachycardia), abnormal heart contractions (ventricular extrasystoles), irregular heartbeats (arrhythmia), chest pain or pressure (angina pectoris),
• inflammation of blood vessels (vasculitis),
• difficulty breathing (dyspnea), nosebleed (epistaxis), nasal congestion,
• inflammation of the gums (gingival hyperplasia),
• hepatitis (inflammatory disease affecting the liver), liver disease (granulomatous hepatitis),
• light sensitivity (photophobia), inflammation of the throat, lips, and respiratory tract (angioneuritic edema), erythema multiforme (severe skin disease associated with red patches, blisters), including rare cases of Stevens-Johnson syndrome (severe vesicular skin and mucous membrane reactions), toxic epidermal necrolysis (peeling skin disease), sweating, exfoliative dermatitis (skin redness, itching, hair loss), and acute generalized pustular exanthematous dermatitis (sudden eruption accompanied by fever with the formation of pustules or lesions on the skin surface that are small, inflamed, filled with pus, and similar to a blister), small red spots on the skin (petechiae), itching (pruritus).
• joint pain, muscle pain,
• nocturia (need to urinate at night), increased frequency of urination (polyuria),
• breast enlargement in men (gynecomastia), sexual function alterations,
• difficulty walking,
• increased creatine phosphokinase (CPK) levels in blood tests, weight gain,
• 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").

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Diltiazem Sandoz

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

Appearance of the product and content of the packaging

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing:

LACER, S.A.

C/ Boters nº 5

Parc Tecnológic del Vallés

08290 Cerdanyola del Vallés (Barcelona)

Spain

Last review date of this leaflet:May 2023

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