DILZENE 60 mg Modified-Release Tablet

Зміст інструкції

1. Dilzene 60 mg extended-release tablets
   1. What is Dilzene 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
2. Dilzene 120 mg prolonged-release tablets
   1. What is Dilzene 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
3. Dilzene 300 mg prolonged-release hard capsules
   1. What is Dilzene and what is it 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

Dilzene 60 mg extended-release tablets

diltiazem hydrochloride

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Dilzene and what it is used for

Dilzene contains the active ingredient diltiazem hydrochloride. Diltiazem belongs to the class of medicines
called calcium antagonists which have a direct effect on the heart.
Dilzene works by relaxing the musculature in the wall of the arteries, with an increase in blood flow in the
coronary arteries (vessels that carry blood to the heart) and a reduction in blood pressure, and prevents spasms
of the coronary arteries.
Diltiazem also improves energy production at the heart level.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems) in its variant forms from exertion, following myocardial infarction (post-infarction) or due to spasm of the coronary arteries (vasospastic angina or Prinzmetal's angina);
• elevated blood pressure (arterial hypertension) of mild and moderate degree.

2. What you need to know before taking Dilzene

Do not take Dilzene

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

Dilzene should not be used in children, unless otherwise prescribed by the doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Pay particular attention:

• If you are elderly, if you have impaired kidney or liver function, or if you are taking other medicines for high blood pressure, your doctor will prescribe the minimum effective dose of Dilzene.
• If you are a subject at risk of intestinal obstruction, your doctor will use particular caution when prescribing Dilzene, as it may limit normal bowel movements.
• If you are to undergo general anesthesia, inform the anesthesiologist that you are taking Dilzene, as this medicine may enhance the effects of anesthetics on the heart.
• Dilzene can cause mood changes, including depression.
• Do not substitute Dilzene with another similar medicine containing the same active ingredient (diltiazem).

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

• if you have reduced heart function, particularly of the left ventricle
• if you have a low pulse rate (bradycardia), which may be further reduced by therapy
• if you have a disturbance of the electrical conduction of the heart 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 should not be used in children, 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) for infusion, as a severe and potentially life-threatening heart rhythm disturbance may occur;
• Amiodarone (medicine for heart rhythm disorders), as it increases the risk of heart problems.

Your doctor will use particular caution when prescribing Dilzene if you are using:

• Antihypertensives (medicines for high blood pressure), in particular the group of alpha-blockers
• Nitrates (vasodilators)
• Beta-blockers (medicines for high blood pressure, chest pain caused by 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 and taking high doses.
• Cyclosporine (medicine that suppresses the immune system)
• 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 mental 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 reduce cholesterol).

If you have to take Dilzene with any of the medicines listed above, your doctor will monitor you
closely and have you undergo tests. In addition, the doctor will assess the need to adjust the dose of
Dilzene or the medicine taken concurrently.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dilzene should not be used during pregnancy.
If you are a woman of childbearing potential, your doctor will exclude pregnancy before you start
taking Dilzene. In addition, during treatment with Dilzene, you should use an effective method of
contraception.
Breastfeeding
If you are breastfeeding, you should not take Dilzene, as the medicine passes into breast milk.
If the use of Dilzene is considered essential for your health, you should use an alternative method to
feed your baby.

Driving and using machines
Dilzene can cause drowsiness, dizziness and malaise, if you notice one or more of these effects, do not drive
vehicles or use machines.

Dilzene contains lactose and hydrogenated castor oil
Dilzene contains lactose, if your doctor has diagnosed you with intolerance to certain sugars, contact
him/her before taking this medicine.
Dilzene contains hydrogenated castor oil, which can cause stomach upset and diarrhea.

3. How to take Dilzene

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The tablet can be divided into equal parts.
Treatment of angina pectoris
The recommended dose is 1 tablet 3 times a day. Take the tablet at regular intervals.
If necessary, your doctor may tell you to increase the dose up to a maximum of 2 tablets 3 times a
day.
Treatment of high blood pressure
The recommended dose is from half a tablet to 1 tablet 3 times a day. Your doctor will tell you exactly
when to take the medicine.
If you are elderly, have kidney or liver insufficiency, or are taking another
medicine for high blood pressure at the same time, your doctor will prescribe the minimum effective dose of Dilzene, using
particular caution at the beginning 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 ingestion of an excessive dose of Dilzene, inform your doctor immediately or
go to the nearest hospital.
After ingestion of 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 of the heart's electrical conduction.

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

If you stop taking Dilzene
Do not abruptly stop treatment with Dilzene as it may cause a worsening of episodes
of chest pain (angina).
If you have any doubts about 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.
manifest.

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

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

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

• headache
• dizziness
• disturbances of the heart's electrical conduction (first, second or third degree atrioventricular block; bundle branch block)
• palpitations
• hot flushes
• constipation
• difficult digestion
• stomach pain
• 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 getting up
• vomiting
• diarrhea
• increase in certain liver enzymes (AST, ALT, ALP)
• increase in levels of certain substances in the blood (LDH and CPK)

Rare side effects (may affect up to 1 in 1000 people)

• memory loss (amnesia)
• depression
• personality change
• hallucinations
• drowsiness
• tingling
• ringing and buzzing in the ears
• tremor
• heart rhythm disturbances
• cardiac arrest (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 during the night (nocturia)
• increased amount of urine produced (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 estimated from available data)

• low number of platelets in the blood (thrombocytopenia)
• low number of white blood cells in the blood (leukopenia)
• prolongation of bleeding time (a blood coagulation test)
• mood changes including depression
• movement disorders (extrapyramidal syndrome)
• vertigo
• a heart rhythm disorder (sinoatrial block)
• severe heart failure (congestive heart failure)
• electrocardiogram changes
• inflammation of blood vessels (vasculitis, including leucocytoclastic vasculitis)
• swelling due to fluid retention (edema), especially in the lower limbs and face (angioedema)
• sweating
• gum enlargement
• liver inflammation (hepatitis), reversible after discontinuation of treatment
• high blood sugar levels
• sensitivity to sunlight (photosensitivity), including thickening of the skin in areas of skin exposed to the sun
• skin reactions of various types (redness, blistering, scaling, etc.) from mild to potentially life-threatening
• nosebleeds
• breast enlargement in males (gynecomastia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 at a temperature 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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dilzene contains

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

Description of the appearance of Dilzene and contents of the pack
Each pack contains 1 blister of 50 divisible modified-release tablets.

Marketing Authorisation 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 (Roma)

Dilzene 120 mg prolonged-release tablets

diltiazem hydrochloride

Read 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Dilzene and what it is used for

Dilzene contains the active substance diltiazem hydrochloride. Diltiazem belongs to the class of medicines
called calcium antagonists which have a direct effect on the heart.
Dilzene works by relaxing the musculature in the wall of the arteries, with an increase in blood flow in the
coronary arteries (vessels that carry blood to the heart) and a reduction in blood pressure, and prevents spasms
of the coronary arteries.
Diltiazem also improves energy production at the heart level.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems) in its variant forms from exertion, following myocardial infarction (post-infarction) or due to spasm of the coronary arteries (vasospastic angina or Prinzmetal's angina);
• elevated blood pressure (arterial hypertension) of mild and moderate degree.

2. What you need to know before taking Dilzene

Do not take Dilzene

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

Dilzene should not be used in children, unless otherwise prescribed by the doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Pay particular attention:

• If you are elderly, if you have impaired kidney or liver function, or if you are taking other medicines for high blood pressure, your doctor will prescribe the minimum effective dose of Dilzene.
• If you are at risk of intestinal obstruction, your doctor will use particular caution when prescribing Dilzene, as it may limit normal bowel movements.
• If you are to undergo general anesthesia, inform the anesthesiologist that you are taking Dilzene, as this medicine may enhance the effects of anesthetics on the heart.
• Dilzene can cause changes in mood, including depression.
• Do not substitute Dilzene with another similar medicine containing the same active ingredient (diltiazem).

Your doctor will keep you under close control, especially at the beginning of treatment:

• if you have reduced heart function, particularly of the left ventricle
• if you have a low pulse rate (bradycardia), which may be further reduced by therapy
• if you have a disturbance of electrical conduction in the heart 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 should not be used in children, 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 taking:

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

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

• Antihypertensives (medicines for high blood pressure), in particular the group of alpha-blockers
• Nitrates (vasodilators)
• Beta-blockers (medicines for high blood pressure, chest pain caused by 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 and taking high doses.
• Cyclosporine (medicine that suppresses the immune system)
• 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 mental 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 (hormonal medicines) such as methylprednisolone
• Statins (medicines that reduce cholesterol).

If you have to take Dilzene with one of the medicines listed above, your doctor will keep you under
close control and will perform some tests. In addition, the doctor will assess the need to adjust the dose of
Dilzene or the medicine taken at the same time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dilzene should not be used during pregnancy.
If you are a woman of childbearing potential, your doctor will need to rule out pregnancy before you start
taking Dilzene. In addition, during treatment with Dilzene, you should use an effective method of
contraception.
Breastfeeding
If you are breastfeeding, you should not take Dilzene, as the medicine passes into breast milk.
If the use of Dilzene is considered essential for your health, you should use an alternative method to
feed your baby.

Driving and using machines
Dilzene can cause drowsiness, dizziness and malaise, if you notice one or more of these effects, do not drive
vehicles or use machines.

Dilzene contains sucrose and polymerized 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 polymerized castor oil, which can cause stomach upset 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 following exactly the instructions of 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 should not be chewed, but swallowed whole with a little liquid.
If you are elderly, have kidney or liver insufficiency, or are taking another
medicine for high blood pressure at the same time, your doctor will prescribe the minimum effective dose of Dilzene, using
particular caution at the beginning of treatment.

If you take more Dilzene than you should
In case of accidental ingestion of an excessive dose of Dilzene, immediately inform your doctor or
go to the nearest hospital.
After ingestion of 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 of the electrical conduction of the heart.

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

If you stop taking Dilzene
Do not abruptly stop treatment with Dilzene as it may cause a worsening of episodes
of chest pain (angina).
If you have any doubts about 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.

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

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

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

• headache
• dizziness
• electrical conduction disturbances of the heart (first, second or third degree atrioventricular block; bundle branch block)
• palpitations
• hot flushes
• constipation
• difficult digestion
• stomach pain
• 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 getting up
• vomiting
• diarrhea
• increased levels of 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 1000 people)

• memory loss (amnesia)
• depression
• personality changes
• hallucinations
• drowsiness
• tingling
• ringing and buzzing in the ears
• tremor
• heart rhythm disturbances
• cardiac arrest (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 amount of urine produced (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 estimated from available data)

• low number of platelets in the blood (thrombocytopenia)
• low number of white blood cells in the blood (leukopenia)
• prolongation of bleeding time (a blood coagulation test)
• mood changes including depression
• movement disorders (extrapyramidal syndrome)
• vertigo
• a heart rhythm disorder (sinoatrial block)
• severe heart failure (congestive heart failure)
• changes in the electrocardiogram
• inflammation of blood vessels (vasculitis, including leucocytoclastic vasculitis)
• swelling due to fluid retention (edema), especially in the lower limbs and face (angioedema)
• sweating
• gum enlargement
• liver inflammation (hepatitis), reversible after discontinuation of treatment
• high blood sugar levels
• sensitivity to sunlight (photosensitivity), including thickening of the skin in areas of skin exposed to the sun
• skin reactions of various types (redness, blistering, peeling, etc.) from mild to potentially life-threatening
• nosebleeds
• breast enlargement in males (gynecomastia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 that is stated on the packaging after Scad. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dilzene contains

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

Description of the appearance of Dilzene and contents of the pack
Each pack contains 1 blister of 24 extended-release tablets.

Marketing Authorisation 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 (Roma)

Dilzene 300 mg prolonged-release hard capsules

diltiazem hydrochloride

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even 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 you take 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 is Dilzene and what is it used for

Dilzene contains the active substance diltiazem hydrochloride. Diltiazem belongs to the class of medicines
called calcium antagonists which have a direct effect on the heart.
Dilzene works by relaxing the musculature in the wall of the arteries, with increased blood flow in the
coronary arteries (vessels that carry blood to the heart) and reduction of blood pressure, and prevents spasms
of the coronary arteries.
Diltiazem also improves energy production at the heart level.
Dilzene is indicated for the treatment of:

• angina pectoris (chest pain caused by heart problems) in its variants from exertion, following myocardial infarction (post-infarction) or due to spasm of the coronary arteries (vasospastic angina or Prinzmetal's angina);
• elevated blood pressure (arterial hypertension) of mild and moderate degree.

2. What you need to know before taking Dilzene

Do not take Dilzene

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

Dilzene should not be used in children, unless otherwise prescribed by the doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dilzene.
Pay particular attention:

• If you are elderly, if you have impaired kidney or liver function, or if you are taking other medicines for high blood pressure, your doctor will prescribe the minimum effective dose of Dilzene.
• If you are a subject at risk of intestinal obstruction, your doctor will use particular caution when prescribing Dilzene, because it can limit the normal movements of the intestine.
• If you are to undergo general anesthesia, inform the anesthesiologist that you are taking Dilzene, because this medicine can enhance the effects of anesthetics on the heart.
• Dilzene can cause changes in mood, including depression.
• Do not replace Dilzene with another similar medicine containing the same active ingredient (diltiazem).

The doctor will keep you under close control, especially at the beginning of treatment:

• if you have reduced heart function, especially of the left ventricle
• if you have a low pulse rate (bradycardia), which may be further reduced by therapy
• if you have a disturbance of the electrical conduction of the heart called first-degree atrio-ventricular block (detected by electrocardiogram), which may worsen during therapy
• if you have impaired kidney or liver function.

Children and adolescents
Dilzene should not be used in children, 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 taking:

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

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

• Antihypertensives (medicines for high blood pressure), in particular the group of alpha-blockers
• Nitrates (vasodilators)
• Beta-blockers (medicines for high blood pressure, chest pain caused by 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 and taking high doses.
• Cyclosporine (medicine that suppresses the immune system)
• 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 mental 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 reduce cholesterol).

If you have to take Dilzene with one of the medicines listed above, your doctor will keep you under
close control and have you undergo tests. In addition, the doctor will assess the need to adjust the dose of
Dilzene or the medicine taken at the same time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Dilzene should not be used during pregnancy.
If you are a woman of childbearing potential, your doctor will have to exclude a possible pregnancy before you begin to
take Dilzene. In addition, during treatment with Dilzene you should use an effective method of contraception.
Breastfeeding
If you are breastfeeding, you should not take Dilzene, because the medicine passes into breast milk.
If the use of Dilzene is considered essential for your health, you should use an alternative method to
feed your baby.

Driving and operating machinery
Dilzene can cause drowsiness, dizziness and malaise, if you notice one or more of these effects, do not drive vehicles or
use 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule of 300 mg once a day.
Treatment with Dilzene should be started at the lowest possible doses.
Take Dilzene every day at the same time, ideally before or during a meal.
The capsules should not be chewed, but swallowed whole with some liquid.
If you are elderly, have kidney or liver insufficiency or need to take another
medicine for high blood pressure at the same time, your doctor will prescribe the minimum effective dose of Dilzene, using
particular caution at the beginning of treatment.

If you take more Dilzene than you should
In case of accidental ingestion of an excessive dose of Dilzene, immediately inform your doctor or
go to the nearest hospital.
After ingestion of 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 of the electrical conduction of the heart.

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

If you stop taking Dilzene
Do not abruptly stop treatment with Dilzene as it may cause a worsening of episodes
of chest pain (angina).
If you have any doubts about 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.

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

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

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

• headache
• dizziness
• disturbances of the heart's electrical conduction (first, second or third degree atrioventricular block; bundle of His block)
• palpitations
• hot flushes
• constipation
• difficult digestion
• stomach pain
• 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 getting up
• vomiting
• diarrhea
• increase in certain liver enzymes (AST, ALT, ALP)
• increase in 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 change
• hallucinations
• drowsiness
• tingling
• ringing and buzzing in the ears
• tremor
• heart rhythm disturbances
• cardiac arrest (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 during the night (nocturia)
• increased amount of urine produced (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 estimated based on available data)

• low number of platelets in the blood (thrombocytopenia)
• low number of white blood cells in the blood (leucopenia)
• prolongation of 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 changes
• inflammation of blood vessels (vasculitis, including leucocytoclastic vasculitis)
• swelling due to fluid retention (edema), especially in the lower limbs and face (angioedema)
• sweating
• gum enlargement
• liver inflammation (hepatitis), reversible after discontinuation of treatment
• high blood sugar levels
• sensitivity to sunlight (photosensitivity), including thickening of the skin in areas of skin exposed to the sun
• skin reactions of various types (redness, blistering, scaling etc.) from mild to potentially life-threatening
• nosebleeds
• breast enlargement in males (gynecomastia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 at a temperature above 30°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 in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dilzene contains

• The active ingredient is diltiazem hydrochloride. Each capsule contains 300 mg of diltiazem hydrochloride.
• The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose, acrylic and methacrylic ester copolymer, ethylcellulose, acetylated monoglycerides, magnesium stearate.
• The capsule components are gelatin, titanium dioxide (E171), yellow iron oxide (E 172).

Description of the appearance of Dilzene and contents of the pack
Each pack contains 1 blister of 14 prolonged-release hard capsules.

Marketing Authorisation 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 (Roma)