Dilzene

Package leaflet: Information for the patient

Dilzene 60 mg modified-release tablets

diltiazem hydrochloride
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dilzene is and what it is used for

Dilzene contains the active substance diltiazem hydrochloride. Diltiazem belongs to a class of medicines called calcium antagonists, which have a direct effect on the heart.
Dilzene works by relaxing the muscle in the arterial wall, increasing blood flow in the coronary arteries (the vessels supplying blood to the heart), reducing blood pressure, and preventing coronary spasms.
Diltiazem also improves energy production in the heart.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems), including exertional angina, post-infarction angina, and angina due to coronary spasm (vasospastic angina or Prinzmetal's angina);
• mild to moderate high blood pressure (arterial hypertension).

2. What you should know before taking Dilzene

Do not take Dilzene

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if your maximum blood pressure value (systolic blood pressure) is below 90 mmHg;
• if your pulse rate is less than 40 beats per minute (severe bradycardia);
• if you have a rare type of arrhythmia called sick sinus syndrome;
• if you have an electrical conduction disorder of the heart (particularly sinoatrial block, second- or third-degree atrioventricular block in patients without a functioning ventricular pacemaker);
• if you have acute myocardial infarction with pulmonary congestion;
• if you have severe heart failure with fluid accumulation (congestive heart failure);
• if you have left ventricular heart dysfunction (left ventricular failure) with pulmonary congestion;
• if you are taking ivabradine (see "Other medicines and Dilzene");
• if you are receiving amiodarone (a medicine for heart rhythm disorders) or dantrolene (a muscle relaxant) by infusion (see section "Other medicines and Dilzene");
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding or if you are a woman of childbearing age (see section "Pregnancy and breastfeeding").

Dilzene must not be used in pediatric patients, unless otherwise prescribed by a physician.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Exercise particular caution:

• If you are elderly, have impaired kidney or liver function, or are taking other medicines for high blood pressure, your doctor will prescribe the lowest effective dose of Dilzene.
• If you are at risk of intestinal obstruction, your doctor will exercise special caution when prescribing Dilzene, as this medicine may reduce normal intestinal motility.
• If you are due to undergo general anesthesia, inform the anaesthetist that you are taking Dilzene, as this medicine may enhance the cardiac effects of anaesthetics.
• Dilzene may cause mood changes, including depression.
• Do not replace Dilzene with another similar medicine containing the same active substance (diltiazem).

Your doctor will closely monitor you, especially at the beginning of treatment:

• if you have impaired heart function, particularly of the left ventricle;
• if you have a low pulse rate (bradycardia), which may be further reduced by treatment;
• if you have a heart conduction disorder called first-degree atrioventricular block (detected by electrocardiogram), which could worsen during treatment;
• if you have impaired kidney or liver function.

Children and adolescents
Dilzene must not be used in pediatric patients, unless otherwise prescribed by a physician.
Other medicines and Dilzene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Do not take Dilzene if you are using:

• Ivabradine
• Diltiazem is contraindicated in patients receiving ivabradine (risk of bradycardia)
• Dantrolene (muscle relaxant) by infusion, as this may cause a severe and potentially fatal heart rhythm disorder;
• Amiodarone (medicine for heart rhythm disorders), as it increases the risk of heart problems.

Your doctor will exercise particular caution when prescribing Dilzene if you are taking:

• Antihypertensives (medicines for high blood pressure), particularly alpha-blockers;
• Nitrate derivatives (blood vessel dilators);
• Beta-blockers (medicines for high blood pressure, chest pain due to heart problems, and heart rhythm disorders);
• Antiarrhythmics (medicines for heart rhythm disorders);
• Cardiac glycosides (medicines that improve heart function), e.g. digoxin, especially if you are elderly or taking high doses;
• Cyclosporine (a medicine that suppresses the immune system);
• Carbamazepine (a medicine for epilepsy and mood disorders);
• Phenytoin (a medicine for epilepsy);
• Antidepressants (medicines for depression), e.g. imipramine and other tricyclic antidepressants;
• Antipsychotics (medicines for severe psychiatric disorders);
• Theophylline (a bronchodilator);
• Antacids (H\₂ receptor antagonists) such as cimetidine and ranitidine;
• Rifampicin (an antibiotic);
• Lithium (a medicine for mood disorders);
• Anaesthetics;
• Benzodiazepines (tranquilizers) such as midazolam and triazolam;
• Corticosteroids (hormone-like medicines) such as methylprednisolone;
• Statins (medicines that lower cholesterol).

If you need to take Dilzene together with any of the medicines listed above, your doctor will monitor you closely and may order tests. Your doctor will also assess whether it is necessary to adjust the dose of Dilzene or of the concomitant medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Dilzene must not be used during pregnancy.
If you are a woman of childbearing age, your doctor must rule out pregnancy before you start taking Dilzene. Furthermore, during treatment with Dilzene, you must use an effective method of contraception.
Breastfeeding
You must not take Dilzene if you are breastfeeding, as the medicine passes into breast milk.
If use of Dilzene is considered essential for your health, you must use an alternative method to feed your baby.
Driving and operating machinery
Dilzene may cause drowsiness, dizziness and malaise. If you experience one or more of these effects, do not drive or operate machinery.
Dilzene contains lactose and hydrogenated castor oil
Dilzene contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Dilzene contains hydrogenated castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take Dilzene

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The tablet may be divided into equal parts.

Treatment of angina pectoris
The recommended dose is 1 tablet three times a day. Take the tablet at regular intervals.
If necessary, your doctor may instruct you to increase the dose up to a maximum of 2 tablets three times a
day.

Treatment of high blood pressure
The recommended dose is from half a tablet to 1 tablet three times a day. Your doctor will tell you exactly
when to take the medicine.
If you are elderly, have kidney or liver impairment, or need to take another medicine for high blood pressure at the same time, your doctor will prescribe the lowest effective dose of Dilzene, exercising particular caution at the start of treatment. At the beginning of treatment, your doctor will prescribe half a tablet of Dilzene.

If you take more Dilzene than you should
In case of accidental overdose of Dilzene, inform your doctor immediately or go to the nearest hospital.
After taking an excessive dose of Dilzene, you may experience:

• severe drop in blood pressure, up to collapse
• slowing of the heartbeat, with or without heart rhythm disturbances
• disturbances in the heart's electrical conduction.

If you forget to take Dilzene
Do not take a double dose to make up for the missed dose.

If you stop taking Dilzene
Do not stop treatment with Dilzene abruptly, as this may cause worsening of chest pain episodes (angina).
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

• swelling due to fluid accumulation in the limbs (peripheral edema)

Common side effects (may affect up to 1 in 10 people)

• headache
• dizziness
• disturbances in the heart's electrical conduction (first-, second- or third-degree atrioventricular block; bundle branch block)
• palpitations
• hot flushes
• constipation
• indigestion
• stomach ache
• nausea
• skin redness (erythema)
• malaise

Uncommon side effects (may affect up to 1 in 100 people)

• nervousness
• insomnia
• slow heart rate
• sudden drop in blood pressure upon standing (orthostatic hypotension)
• vomiting
• diarrhea
• increase in certain liver enzymes (AST, ALT, ALP)
• increased levels of certain substances in the blood (LDH and CPK)

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

• memory loss (amnesia)
• depression
• personality changes
• hallucinations
• drowsiness
• tingling sensations
• ringing or buzzing in the ears (tinnitus)
• tremor
• heart rhythm disorders
• cessation of heartbeat (asystole)
• fainting (syncope)
• chest pain due to heart problems (angina)
• dry mouth
• altered taste
• abdominal pain
• loss of appetite (anorexia)
• weight gain
• frequent need to urinate at night (nocturia)
• increased urine production (polyuria)
• hives
• small skin hemorrhages (petechiae)
• itching
• widespread skin redness (generalized erythema)
• bone and joint pain
• reduced vision (amblyopia)
• eye irritation
• difficulty breathing (dyspnea)
• impotence
• weakness

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

• a type of acute kidney inflammation (interstitial nephritis)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• low platelet count in the blood (thrombocytopenia)
• low white blood cell count (leucopenia)
• prolonged bleeding time (a blood coagulation test)
• mood changes including depression
• movement disorders (extrapyramidal syndrome)
• vertigo
• a heart rhythm disorder (sinoatrial block)
• severe impairment of heart function (congestive heart failure)
• electrocardiogram (ECG) abnormalities
• inflammation of blood vessels (vasculitis, including leukocytoclastic vasculitis)
• swelling due to fluid accumulation (edema), particularly of the lower limbs and face (angioedema)
• sweating
• gum enlargement
• liver inflammation (hepatitis), reversible after discontinuation of treatment
• elevated blood sugar levels
• sensitivity to sunlight (photosensitivity), including thickening of the skin in sun-exposed areas
• various skin reactions ranging from mild to potentially fatal (redness, blistering, peeling, etc.)
• nosebleeds
• breast enlargement in males (gynecomastia)

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 Dilzene

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Dilzene contains

• The active substance is diltiazem hydrochloride. Each tablet contains 60 mg of diltiazem hydrochloride.
• The other components are lactose, hydrogenated castor oil, macrogol 6000, magnesium stearate.

Description of the appearance of Dilzene and package contents
Each package contains 1 blister with 50 modified-release divisible tablets.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. Via Pontina km 30,400 00071 Pomezia (Rome)
Package leaflet: information for the patient
Dilzene 120 mg prolonged-release tablets
diltiazem hydrochloride
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 Dilzene is and what it is used for
2. What you need to know before taking Dilzene
3. How to take Dilzene
4. Possible side effects
5. How to store Dilzene
6. Package contents and other information

1. What Dilzene is and what it is used for

Dilzene contains the active substance diltiazem hydrochloride. Diltiazem belongs to a class of medicines called calcium antagonists, which have a direct effect on the heart.
Dilzene works by relaxing the muscle in the walls of arteries, increasing blood flow in the coronary arteries (the vessels that carry blood to the heart), reducing blood pressure, and preventing coronary artery spasms.
Diltiazem also improves energy production in the heart.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems) in its exertional form, post-infarction (following a heart attack), or due to coronary artery spasm (vasospastic angina or Prinzmetal's angina);
• mild to moderate high blood pressure (arterial hypertension).

2. What you should know before taking Dilzene

Do not take Dilzene

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if your maximum blood pressure value (systolic blood pressure) is below 90 mmHg;
• if your heart rate is below 40 beats per minute (severe bradycardia);
• if you have a rare type of arrhythmia called sick sinus syndrome;
• if you have an electrical conduction disorder of the heart (particularly sinoatrial block, second- or third-degree atrioventricular block in patients without a functioning ventricular pacemaker);
• if you have acute myocardial infarction with pulmonary congestion;
• if you have severe heart failure with fluid accumulation (congestive heart failure);
• if you have left ventricular heart dysfunction (left ventricular failure) with pulmonary congestion;
• if you are taking ivabradine (see section "Other medicines and Dilzene");
• if you are taking amiodarone (a medicine for heart rhythm disorders) or dantrolene (a muscle relaxant) by infusion (see section "Other medicines and Dilzene");
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding or if you are a woman of childbearing age (see section "Pregnancy and breastfeeding").

Dilzene must not be used in pediatric patients, unless otherwise prescribed by the doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Take special care:

• If you are elderly, have impaired kidney or liver function, or are taking other medicines for high blood pressure, your doctor will prescribe the lowest effective dose of Dilzene.
• If you are at risk of intestinal obstruction, your doctor will exercise particular caution when prescribing Dilzene, as this medicine may reduce normal intestinal motility.
• If you are undergoing general anesthesia, inform the anesthesiologist that you are taking Dilzene, as this medicine may enhance the cardiac effects of anesthetics.
• Dilzene may cause mood changes, including depression.
• Do not replace Dilzene with another similar medicine containing the same active substance (diltiazem).

Your doctor will closely monitor you, especially at the beginning of treatment:

• if you have impaired heart function, particularly of the left ventricle;
• if you have a low heart rate (bradycardia), which may be further reduced by the treatment;
• if you have a heart conduction disorder called first-degree atrioventricular block (detected by electrocardiogram), which may worsen during therapy;
• if you have impaired kidney or liver function.

Children and adolescents
Dilzene must not be used in pediatric patients, unless otherwise prescribed by the doctor.
Other medicines and Dilzene
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
Do not take Dilzene if you are using:

• Ivabradine: Diltiazem is contraindicated in patients receiving ivabradine (risk of bradycardia).
• Dantrolene (muscle relaxant) by infusion, as this may cause a severe and potentially fatal heart rhythm disorder.
• Amiodarone (medicine for heart rhythm disorders), as it increases the risk of heart problems.

Your doctor will exercise particular caution when prescribing Dilzene if you are taking:

• Antihypertensives (medicines for high blood pressure), particularly alpha-blockers;
• Nitrates (vasodilators);
• Beta-blockers (medicines for high blood pressure, chest pain due to heart problems, and heart rhythm disorders);
• Antiarrhythmics (medicines for heart rhythm disorders);
• Cardiac glycosides (medicines that improve heart function), e.g. digoxin, especially if you are elderly or taking high doses;
• Cyclosporine (an immunosuppressant medicine);
• Carbamazepine (medicine for epilepsy and mood disorders);
• Phenytoin (medicine for epilepsy);
• Antidepressants (medicines for depression), e.g. imipramine and other tricyclic antidepressants;
• Antipsychotics (medicines for severe psychiatric disorders);
• Theophylline (bronchodilator);
• Antacids (H2-receptor antagonists) such as cimetidine and ranitidine;
• Rifampicin (antibiotic);
• Lithium (medicine for mood disorders);
• Anesthetics;
• Benzodiazepines (tranquilizers) such as midazolam and triazolam;
• Corticosteroids (hormone-like medicines) such as methylprednisolone;
• Statins (medicines that lower cholesterol).

If you need to take Dilzene together with any of the medicines listed above, your doctor will monitor you closely and may perform tests. Your doctor will also assess whether it is necessary to adjust the dose of Dilzene or of the concomitant medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Dilzene must not be used during pregnancy.
If you are a woman of childbearing age, your doctor must rule out pregnancy before you start taking Dilzene. Furthermore, you must use an effective method of contraception during treatment with Dilzene.
Breastfeeding
You must not take Dilzene while breastfeeding, as the medicine passes into breast milk.
If the use of Dilzene is considered essential for your health, you must use an alternative method to feed your baby.
Driving and use of machines
Dilzene may cause drowsiness, dizziness, and malaise. If you experience one or more of these effects, do not drive or operate machinery.
Dilzene contains sucrose and polymeric castor oil
Dilzene contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
Dilzene contains polymeric castor oil, which may cause gastrointestinal disturbances and diarrhea.
Dilzene contains less than 1 mmol (23 mg) of sodium per tablet, i.e., it is practically 'sodium-free'.

3. How to take Dilzene

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet every 12 hours.
The tablets must not be chewed, but swallowed whole with some liquid.
If you are elderly, have kidney or liver impairment, or need to take another
medicine for high blood pressure at the same time, your doctor will prescribe the lowest effective dose of Dilzene,
exercising particular caution at the beginning of treatment.
If you take more Dilzene than you should
In case of accidental overdose of Dilzene, contact your doctor immediately or go
to the nearest hospital.
After taking an excessive dose of Dilzene, you may experience:

• severe drop in blood pressure, up to collapse
• slowing of the heartbeat, with or without heart rhythm disturbances
• disturbances in the heart's electrical conduction.

If you forget to take Dilzene
Do not take a double dose to make up for the forgotten dose.
If you stop taking Dilzene
Do not stop treatment with Dilzene abruptly, as this may cause worsening of
chest pain episodes (angina).
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

• swelling due to fluid accumulation in the limbs (peripheral edema)

Common side effects (may affect up to 1 in 10 people)

• headache
• dizziness
• disturbances in the heart's electrical conduction (first-, second- or third-degree atrioventricular block; bundle branch block)
• palpitations
• hot flushes
• constipation
• indigestion
• stomach ache
• nausea
• skin redness (erythema)
• malaise

Uncommon side effects (may affect up to 1 in 100 people)

• nervousness
• insomnia
• slowed heartbeat
• sudden drop in blood pressure when standing up
• vomiting
• diarrhoea
• increase in certain liver enzymes (AST, ALT, ALP)
• increased levels of certain substances in the blood (LDH and CPK)

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

• memory loss (amnesia)
• depression
• personality changes
• hallucinations
• somnolence
• tingling sensations
• ringing or buzzing in the ears
• tremor
• heart rhythm disorders
• cessation of heartbeat (asystole)
• fainting (syncope)
• chest pain caused by heart problems (angina)
• dry mouth
• altered taste
• abdominal pain
• loss of appetite (anorexia)
• weight gain
• frequent need to urinate at night (nocturia)
• increased urine production (polyuria)
• urticaria
• small skin hemorrhages (petechiae)
• itching
• widespread skin redness (generalized erythema)
• bone and joint pain
• reduced vision (amblyopia)
• eye irritation
• difficulty breathing (dyspnea)
• impotence
• weakness

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

• a type of acute kidney inflammation (interstitial nephritis)

Side effects with unknown frequency (frequency cannot be determined from available data)

• low platelet count in the blood (thrombocytopenia)
• low white blood cell count (leucopenia)
• prolonged bleeding time (a blood coagulation test)
• mood changes including depression
• gait disorders (extrapyramidal syndrome)
• vertigo
• a heart rhythm disorder (sinoatrial block)
• severe impairment of heart function (congestive heart failure)
• electrocardiogram abnormalities
• inflammation of blood vessels (vasculitis, including leukocytoclastic vasculitis)
• swelling due to fluid accumulation (edema), particularly of the lower limbs and face (angioneurotic edema)
• sweating
• gum enlargement
• liver inflammation (hepatitis), reversible after discontinuation of treatment
• elevated blood sugar levels
• sensitivity to sunlight (photosensitivity), including thickening of the skin in sun-exposed areas
• various skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
• nosebleeds
• breast enlargement in males (gynecomastia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may 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 Dilzene

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Dilzene contains

• The active substance is diltiazem hydrochloride. Each tablet contains 120 mg of diltiazem hydrochloride.
• The other components are:
  o Tablet core: monosodium citrate, sucrose, povidone, magnesium stearate, macrogol 6000.
  o Tablet coating: sucrose, coating polymer, acetyltributyl citrate, polymerized castor oil, sodium bicarbonate, ethylvanillin, titanium dioxide (E171).

Description of the appearance of Dilzene and contents of the pack
Each pack contains 1 blister with 24 prolonged-release tablets.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. Via Pontina km 30,400 00071 Pomezia (Rome)
Package leaflet: information for the patient

Dilzene 300 mg prolonged-release hard capsules

diltiazem hydrochloride
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 other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including any not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Dilzene is and what it is used for

Dilzene contains the active substance diltiazem hydrochloride. Diltiazem belongs to a class of medicines called calcium antagonists, which have a direct effect on the heart.
Dilzene works by relaxing the muscle in the walls of arteries, increasing blood flow in the coronary arteries (the vessels supplying blood to the heart), reducing blood pressure, and preventing coronary artery spasms.
Diltiazem also improves energy production in the heart.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems), including exertional angina, post-infarction angina, and angina due to coronary spasm (vasospastic angina or Prinzmetal's angina);
• mild to moderate high blood pressure (arterial hypertension).

2. What you need to know before taking Dilzene

Do not take Dilzene

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if your maximum blood pressure value (systolic blood pressure) is below 90 mmHg;
• if your heart rate is less than 40 beats per minute (severe bradycardia);
• if you have a rare type of arrhythmia called sick sinus syndrome;
• if you have an electrical conduction disorder of the heart (in particular, sinoatrial block, second- or third-degree atrioventricular block in patients without a functioning ventricular pacemaker);
• if you have acute myocardial infarction with pulmonary congestion;
• if you have severe heart failure with fluid accumulation (congestive heart failure);
• if you have left ventricular heart dysfunction (left ventricular failure) with pulmonary congestion;
• if you are taking ivabradine (see section “Other medicines and Dilzene”);
• if you are receiving amiodarone (a medicine for heart rhythm disorders) or dantrolene (a muscle relaxant) by infusion (see section “Other medicines and Dilzene”);
• if you are pregnant or suspect you may be pregnant, if you are breastfeeding, or if you are a woman of childbearing potential (see section “Pregnancy and breastfeeding”).

Dilzene must not be used in pediatric patients, unless otherwise prescribed by a physician.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Exercise particular caution:

• If you are elderly, if you have impaired kidney or liver function, or if you are taking other antihypertensive medicines, your doctor will prescribe the lowest effective dose of Dilzene.
• If you are at risk of intestinal obstruction, your doctor will exercise particular caution when prescribing Dilzene, as this medicine may reduce normal intestinal motility.
• If you are scheduled to undergo general anesthesia, inform the anaesthesiologist that you are taking Dilzene, as this medicine may enhance the cardiac effects of anaesthetics.
• Dilzene may cause mood changes, including depression.
• Do not replace Dilzene with another medicine containing the same active substance (diltiazem).

Your doctor will closely monitor you, especially at the beginning of treatment:

• if you have impaired heart function, particularly of the left ventricle;
• if you have a low heart rate (bradycardia), which could be further reduced by treatment;
• if you have a heart conduction disorder called first-degree atrioventricular block (detected by electrocardiogram), which could worsen during therapy;
• if you have impaired kidney or liver function.

Children and adolescents
Dilzene must not be used in pediatric patients, unless otherwise prescribed by a physician.
Other medicines and Dilzene
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take Dilzene if you are using:

• Ivabradine: Diltiazem is contraindicated in patients receiving ivabradine (risk of bradycardia).
• Dantrolene (a muscle relaxant) by infusion, as this may lead to a severe and potentially fatal heart rhythm disorder.
• Amiodarone (a medicine for heart rhythm disorders), as it increases the risk of heart problems.

Your doctor will exercise particular caution when prescribing Dilzene if you are taking:

• Antihypertensives (medicines for high blood pressure), particularly alpha-blockers;
• Nitrate derivatives (blood vessel dilators);
• Beta-blockers (medicines for high blood pressure, chest pain due to heart problems, and heart rhythm disorders);
• Antiarrhythmics (medicines for heart rhythm disorders);
• Cardiac glycosides (medicines that improve heart function), e.g. digoxin, especially if you are elderly or taking high doses;
• Cyclosporine (an immunosuppressive medicine);
• Carbamazepine (a medicine for epilepsy and mood disorders);
• Phenytoin (a medicine for epilepsy);
• Antidepressants (medicines for depression), e.g. imipramine and other tricyclic antidepressants;
• Antipsychotics (medicines for severe psychiatric disorders);
• Theophylline (a bronchodilator);
• Antacids (H₂-receptor antagonists) such as cimetidine and ranitidine;
• Rifampicin (an antibiotic);
• Lithium (a medicine for mood disorders);
• Anaesthetics;
• Benzodiazepines (tranquillisers) such as midazolam and triazolam;
• Corticosteroids (hormone-like medicines) such as methylprednisolone;
• Statins (medicines that lower cholesterol).

If you need to take Dilzene together with any of the medicines listed above, your doctor will monitor you closely and may perform tests. Your doctor will also assess whether it is necessary to adjust the dose of Dilzene or of the concomitant medicine.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Dilzene must not be used during pregnancy.
If you are a woman of childbearing potential, your doctor must rule out pregnancy before you start taking Dilzene. Furthermore, during treatment with Dilzene, you must use an effective method of contraception.
Breastfeeding
You must not take Dilzene if you are breastfeeding, as the medicine passes into breast milk.
If the use of Dilzene is considered essential for your health, you must use an alternative method to feed your baby.
Driving and using machines
Dilzene may cause drowsiness, dizziness, and malaise. If you experience one or more of these effects, do not drive or operate machinery.
Dilzene contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is practically ‘sodium-free’.

3. How to take Dilzene

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one 300 mg capsule once daily.
Treatment with Dilzene should be initiated at the lowest possible doses.
Take Dilzene at the same time every day, ideally before or during a meal.
The capsules must not be chewed, but swallowed whole with some liquid.
If you are elderly, have renal or hepatic impairment, or need to take another antihypertensive medicine concomitantly, your doctor will prescribe the lowest effective dose of Dilzene, exercising particular caution at the beginning of treatment.
If you take more Dilzene than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
After an overdose of Dilzene, you may experience:

• severe drop in blood pressure, up to collapse
• slowing of the heart rate, with or without heart rhythm disturbances
• disturbances in the heart's electrical conduction.

If you forget to take Dilzene
Do not take a double dose to make up for the forgotten dose.
If you stop taking Dilzene
Do not stop treatment with Dilzene abruptly, as this may worsen episodes of chest pain (angina).
If you have any doubts 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.

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

• Swelling due to fluid accumulation in limbs (peripheral edema)

Common side effects (may affect up to 1 in 10 people)

• Headache
• Dizziness
• Disorders of the heart's electrical conduction (first-, second- or third-degree atrioventricular block; bundle branch block)
• Palpitations
• Hot flushes
• Constipation
• Indigestion
• Stomach discomfort
• Nausea
• Skin redness (erythema)
• Malaise

Uncommon side effects (may affect up to 1 in 100 people)

• Nervousness
• Insomnia
• Slow heartbeat
• Sudden drop in blood pressure when standing up
• Vomiting
• Diarrhea
• Increase in certain liver enzymes (AST, ALT, ALP)
• Increased levels of certain substances in the blood (LDH and CPK)

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

• Memory loss (amnesia)
• Depression
• Personality changes
• Hallucinations
• Drowsiness
• Tingling sensations
• Ringing or buzzing in the ears (tinnitus)
• Tremor
• Heart rhythm disorders
• Cessation of heartbeat (asystole)
• Fainting (syncope)
• Chest pain due to heart problems (angina)
• Dry mouth
• Altered taste
• Abdominal pain
• Loss of appetite (anorexia)
• Weight gain
• Frequent need to urinate at night (nocturia)
• Increased urine production (polyuria)
• Hives (urticaria)
• Small skin hemorrhages (petechiae)
• Itching (pruritus)
• Widespread skin redness (generalized erythema)
• Bone and joint pain
• Decreased vision (amblyopia)
• Eye irritation
• Breathing difficulty (dyspnea)
• Impotence
• Weakness

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

• A type of acute kidney inflammation (interstitial nephritis)

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Low platelet count in the blood (thrombocytopenia)
• Low white blood cell count in the blood (leukopenia)
• Prolonged bleeding time (a blood coagulation test)
• Mood changes including depression
• Gait disturbances (extrapyramidal syndrome)
• Vertigo
• A heart rhythm disorder (sinoatrial block)
• Severe heart dysfunction (congestive heart failure)
• Electrocardiogram abnormalities
• Inflammation of blood vessels (vasculitis, including leukocytoclastic vasculitis)
• Swelling due to fluid accumulation (edema), particularly in the lower limbs and face (angioneurotic edema)
• Sweating
• Gum enlargement
• Liver inflammation (hepatitis), reversible after discontinuation of treatment
• Elevated blood sugar levels
• Sensitivity to sunlight (photosensitivity), including skin thickening in sun-exposed areas
• Various skin reactions (redness, blistering, peeling, etc.), ranging from mild to potentially fatal
• Nosebleeds
• Breast enlargement in males (gynecomastia)

Reporting of side effects
If you experience any side effects, 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.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Dilzene

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Dilzene contains

• The active substance is diltiazem hydrochloride. Each capsule contains 300 mg of diltiazem hydrochloride.
• The other components are microcrystalline cellulose, sodium carmellose, acrylic and methacrylic acid copolymer ester, ethylcellulose, diacetylated monoglycerides, magnesium stearate.
• Capsule components are gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of Dilzene and contents of the pack
Each pack contains 1 blister with 14 prolonged-release hard capsules.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. Via Pontina km 30,400 00071 Pomezia (Rome)