Diltiazem Sandoz

Patient Information Leaflet

Diltiazem Sandoz 120 mg prolonged-release hard capsules, 300 mg prolonged-release hard capsules

Generic medicine
Please read this leaflet carefully before 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 contains the active substance diltiazem, which belongs to a group of medicines called calcium channel blockers (calcium antagonists), used for the treatment of high blood pressure.
Diltiazem Sandoz is indicated for the treatment of:

• chest pain (angina pectoris) due to physical exertion, heart attack, or problems with the blood vessels supplying the heart (Prinzmetal's angina);
• mild to moderate high blood pressure

2. What you need to know before taking Diltiazem Sandoz

Do not take Diltiazem Sandoz

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (hypotension) (systolic pressure below 90 mmHg);
• if you are experiencing an acute heart attack with lung complications;
• if you have an irregular heartbeat due to certain heart diseases (sinoatrial node disease) or cardiac conduction disorders (atrioventricular block, sinoatrial block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, less than 40 beats per minute);
• if you have severe heart problems possibly associated with lung issues (left ventricular failure with pulmonary congestion and congestive heart failure);
• if you are taking a medicine called dantrolene or intravenous amiodarone (see section “Other medicines and Diltiazem Sandoz”);
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding, or if you are a woman of childbearing age not using medication to prevent pregnancy (contraceptives);
• if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions;
• if you are taking a medicine containing lomitapide, used to treat high cholesterol levels (see section “Other medicines and Diltiazem Sandoz”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Sandoz.
Speak with your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat, 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.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced left ventricular function, slow heartbeat (bradycardia), or other heart disorders (first-degree atrioventricular block);
• if you are elderly, or have kidney or liver problems;
• if you are also taking other medicines that lower blood pressure, as your blood pressure might drop excessively (see “Other medicines and Diltiazem Sandoz”);
• if you are at risk of intestinal obstruction, since diltiazem may affect intestinal function;
• if you are scheduled for surgery; in this case, inform your doctor or anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Sandoz.

In some of the above cases, you may be prescribed different doses than normally used.
Your doctor will periodically monitor your heart, liver, and kidney function (during and especially at the beginning of treatment), as well as your blood sugar levels if you have diabetes mellitus, since there is a risk of increased blood glucose.
Calcium antagonists, such as diltiazem, may be associated with mood changes, including depression.
The use of Diltiazem Sandoz may cause bronchoconstriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after a dose increase. During treatment with Diltiazem Sandoz, your doctor will monitor your respiratory function.
Children
This medicine is not recommended for children.
Other medicines and Diltiazem Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, do not use this medicine and inform your doctor if you are taking:

• dantrolene (infusion), a medicine used for muscle spasms and for treating a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat certain heart conditions;
• medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could lead to an increased likelihood and severity of liver-related adverse effects.

Use particular caution and inform your doctor if you are taking any of the following medicines (in some cases, your doctor may adjust the dose of diltiazem or the other medicines):

• antihypertensives, medicines that reduce blood pressure. If you are taking this medicine together with an antihypertensive, your doctor will closely monitor your blood pressure;
• nitrates, medicines that dilate blood vessels. If you are taking this medicine, nitrates will be prescribed at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, your doctor will closely monitor heart function, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers (see section 4.8);
• heart medicines in general, and particularly cardiac glycosides (e.g., digoxin). Exercise particular caution, especially if you are elderly or taking high doses of diltiazem;
• medicines used for heart rhythm disorders (antiarrhythmics). In this case, your doctor will closely monitor your heart function;
• carbamazepine and phenytoin, medicines used for epilepsy; in this case, your doctor will monitor blood levels of carbamazepine and phenytoin;
• rifampicin, a medicine for bacterial infections (antibiotic);
• medicines used for stomach ulcers known as anti-H(_2) agents, such as cimetidine and ranitidine. If treatment with these medicines is started or stopped during treatment with Diltiazem Sandoz, your doctor may adjust the dose of Diltiazem Sandoz;
• cyclosporine, a medicine used to prevent organ transplant rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for mental disorders (antipsychotics), including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast media for X-ray examinations, as they may enhance the cardiac effects of diltiazem, such as lowering of blood pressure;
• antiplatelet agents, medicines that prevent aggregation of blood cells called platelets, thereby increasing blood fluidity;
• benzodiazepines, medicines for anxiety such as midazolam and triazolam, since diltiazem increases blood concentrations of these medicines;
• corticosteroids, medicines used to treat inflammation. Your doctor will monitor you and adjust the corticosteroid dose if necessary;
• statins, medicines used to lower blood cholesterol, because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain during walking. Diltiazem Sandoz increases the activity of cilostazol;
• Diltiazem Sandoz may increase colchicine levels (a drug used to treat gout) when administered concomitantly;
• Diltiazem Sandoz may increase the risk of bleeding when taken together with blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• Diltiazem Sandoz may lead to QT prolongation (ECG changes such as alterations in heartbeat and rhythm, along with symptoms of dizziness) when administered together with medicines known or potentially able to prolong the QT interval.

Diltiazem Sandoz and beverages
Avoid taking this medicine with grapefruit juice, as it may increase its effect. If you are consuming grapefruit juice, your doctor should monitor for possible adverse effects.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Diltiazem Sandoz if you are pregnant, planning a pregnancy, or if you are a woman of childbearing age not using medication to prevent pregnancy (contraceptives).
Breastfeeding
Do not take this medicine if you are breastfeeding, as diltiazem is excreted in breast milk.
If you need to take Diltiazem Sandoz, discontinue breastfeeding.
Driving and using machines
This medicine may affect your ability to drive or use machinery because it may cause adverse effects such as dizziness and malaise. If this occurs, avoid driving or operating machinery.
Diltiazem Sandoz contains sucrose
This medicine contains sucrose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Diltiazem Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended starting dose is 90 mg twice daily. Your doctor may decide to increase this
dose to 1 capsule of 120 mg twice daily or 1 capsule of 300 mg once daily, depending on
your response to treatment.
Do not chew the capsules; swallow them whole with a glass of water.
The 120 mg and 300 mg capsules are intended for maintenance therapy.
Use particular caution, especially at the beginning of treatment.
Use in children
The use of Diltiazem Sandoz is not recommended in children.
Use in elderly patients and patients with kidney or liver problems
If you are elderly or have liver or kidney problems, or are taking other medicines for high blood pressure, the recommended starting dose is the lowest effective dose.
If you take more Diltiazem Sandoz than you should
In case of accidental ingestion or overdose of Diltiazem Sandoz, contact your doctor immediately or go to the nearest hospital emergency department. Take the medicine pack with you. This way, the doctor will know what you have taken.
Symptoms of overdose include: low blood pressure up to collapse, slowed heart rate (bradycardia), and other heart problems (atrioventricular conduction disturbances, sinus arrest, and cardiac arrest), reduced kidney function.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.
If you forget to take Diltiazem Sandoz
If you forget to take a capsule, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Diltiazem Sandoz
Do not stop treatment with this medicine abruptly, as this may worsen heart problems such as angina. Consult your doctor before stopping treatment.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur:

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

• swelling due to fluid retention (peripheral oedema).

Common (may affect up to 1 in 10 people)

• headache (cephalaea), dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive problems (dyspepsia), stomach pain, nausea;
• skin irritations such as redness (erythema);
• general malaise.

Uncommon (may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heartbeat (bradycardia);
• dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhoea;
• liver disorders with abnormal liver blood tests, such as increased aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
• chest pain (angina), irregular heartbeat (arrhythmia), which may lead to loss of consciousness (syncope);
• dry mouth, altered taste, abdominal pain;
• changes in blood tests such as increased creatine phosphokinase (CPK);
• loss of appetite (anorexia), weight gain;
• increased need to urinate (polyuria), including during night-time rest (nocturia);
• skin irritations such as hives, generalized redness (erythema) due to blood vessel disorders (leucocytoclastic vasculitis), small skin hemorrhages (petechiae), itching;
• bone and joint pain;
• vision disturbances (amblyopia), eye irritation;
• breathing difficulties (dyspnoea);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• reduced sexual function (impotence).

Very rare (may affect up to 1 in 10,000 people)

• kidney problems such as interstitial nephritis;
• decrease in the number of white blood cells (leucopenia).

Not known (frequency cannot be estimated from the available data)

• decrease in certain blood cells (platelets) and blood clotting disorders (prolonged bleeding time);
• mood changes (including depression);
• development of abnormal movements affecting gait (extrapyramidal syndrome), dizziness;
• heart problems (sinoatrial block), severe reduction in heart function (congestive heart failure), changes in electrocardiogram results; temporary interruption of cardiac impulse formation at the sinus node (sinus arrest), and cardiac arrest due to absence of contraction phase (asystole);
• fluid retention (oedema), particularly in the lower limbs;
• low blood pressure (hypotension), slowed heart rate (bradycardia), and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
• sweating;
• reduced muscle strength (asthenia);
• increased size of the gums (gingival hyperplasia);
• inflammation of the liver (hepatitis);
• increased blood sugar levels (hyperglycaemia);
• skin disorders due to light sensitivity (photosensitivity) (including lichenoid keratosis in sun-exposed skin areas);
• swelling of the skin and mucous membranes due to fluid accumulation (angioneurotic oedema);
• various skin diseases with redness, blisters, peeling, pustules, sweating, sometimes accompanied by fever (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis or Lyell's syndrome, exfoliative dermatitis, generalized acute exanthematous pustulosis, desquamative erythema with or without fever);
• breast enlargement in men (gynaecomastia);
• bronchial constriction (bronchospasm), including worsening of asthma;
• a condition in which the body's immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue, and skin rashes (called "lupus-like syndrome");
• skin eruption or mouth ulcers (drug-induced lichenoid eruption).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diltiazem Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diltiazem Sandoz contains
Diltiazem Sandoz 120 mg prolonged-release capsules

• The active substance is diltiazem. Each capsule contains 120 mg of diltiazem hydrochloride.
• The other components are: sucrose and maize starch microgranules, povidone, talc, Aquacoat ECD 30, dibutyl sebacate, ethylcellulose, sucrose. Capsule shell composition: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132).

Diltiazem Sandoz 300 mg prolonged-release capsules

• The active substance is diltiazem. Each capsule contains 300 mg of diltiazem hydrochloride.
• The other components are: sucrose and maize starch microgranules, povidone, talc, Aquacoat ECD 30, dibutyl sebacate, ethylcellulose, sucrose. Capsule shell composition: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132).

Description of the appearance of Diltiazem Sandoz and contents of the pack
Diltiazem Sandoz 120 mg prolonged-release capsules
Carton pack containing 24 capsules in PVC/AL blisters.
Diltiazem Sandoz 300 mg prolonged-release capsules
Carton pack containing 14 capsules in PVC/AL blisters.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer
Ethypharm SA, Chemin de la Poudriere, 76120 Grand-Quevilly (Seine-Maritime), France;
Famar A.V.E., Anthoussa Avenue 7, 15344 Anthoussa Attiki, Greece.