DILTIAZEM 60 mg Tabletka

Treść ulotki

1. Diltiazem Mylan Generics Italia 60 mg modified-release tablets
   1. What is Diltiazem Mylan Generics Italia and what it is used for
   2. What you need to know before taking Diltiazem Mylan Generics Italia
   3. How to take Diltiazem Mylan Generics Italia
   4. Possible side effects
   5. How to store Diltiazem Mylan Generics Italia
   6. Contents of the pack and other information
2. Diltiazem Mylan Generics Italia 120 mg prolonged-release tablets
   1. What is Diltiazem Mylan Generics Italia and what is it used for
   2. What you need to know before taking Diltiazem Mylan Generics Italia
   3. How to take Diltiazem Mylan Generics Italia
   4. Possible side effects
   5. How to store Diltiazem Mylan Generics Italia
   6. Contents of the pack and other information
3. Diltiazem Mylan Generics Italia 300 mg prolonged-release tablets
   1. What is Diltiazem Mylan Generics Italia and what is it used for
   2. What you need to know before taking Diltiazem Mylan Generics Italia
   3. How to take Diltiazem Mylan Generics Italia
   4. Possible side effects
   5. How to store Diltiazem Mylan Generics Italia
   6. Contents of the pack and other information

Diltiazem Mylan Generics Italia 60 mg modified-release tablets

diltiazem hydrochloride

Equivalent Medicinal Product
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 they have the same symptoms as you, 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 Diltiazem Mylan Generics Italia is and what it is used for
• 2. What you need to know before you take Diltiazem Mylan Generics Italia
• 3. How to take Diltiazem Mylan Generics Italia
• 4. Possible side effects
• 5. How to store Diltiazem Mylan Generics Italia
• 6. Contents of the pack and other information

1. What is Diltiazem Mylan Generics Italia and what it is used for

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

• chest pain (angina pectoris) due to exertion, a heart attack, or problems with the vessels that carry blood to the heart (Prinzmetal's angina);
• high blood pressure in cases of mild or moderate severity.

2. What you need to know before taking Diltiazem Mylan Generics Italia

Do not take Diltiazem Mylan Generics Italia

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you have an acute heart attack with lung problems;
• if you have an irregular heartbeat (sick sinus syndrome) or disturbances in cardiac conduction (sinoatrial block, second or third degree atrioventricular block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems such as left ventricular failure with pulmonary congestion and congestive heart failure;
• if you are using medicines such as dantrolene and amiodarone for infusion (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are already taking a medicine containing ivabradine for the treatment of certain heart diseases (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are pregnant, if you think you may be pregnant, or if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives);
• if the person who needs to take the medicine is a child.

If you are a woman of childbearing potential and are not using contraceptives, you should make sure to prevent a possible
pregnancy before starting treatment and during therapy with this medicine (see also
section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Mylan Generics Italia.
Talk to 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, the
doctor may need to monitor 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, bradycardia or first-degree atrioventricular block;
• if you are elderly or if you have kidney or liver problems, especially if you are also taking other medicines that lower blood pressure, because a modification of the dosage may be necessary (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are at risk of intestinal obstruction, as diltiazem has effects on bowel function;
• if you are going to have surgery, in this case inform your doctor or anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct-acting oral anticoagulants (e.g. dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
• if you notice changes in your mood.

Undergo periodic checks of liver and kidney function during treatment and also check heart function, especially at the beginning of treatment.
If you suffer from diabetes mellitus, you should also check your blood sugar levels, as there is a risk
of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including
depression.
The use of Diltiazem Mylan Generics Italia may cause constriction of the bronchi (bronchospasm),
including a worsening of asthma, particularly in those patients who already have some difficulty
breathing or after increasing the dosage. During therapy with Diltiazem Mylan Generics Italia your
doctor will subject you to checks of respiratory function.
Abrupt discontinuation of treatment may be associated with a worsening of angina.
In case of heart enlargement (cardiomegaly) or very low blood pressure, treatment
must be initiated only in a hospital setting.
During treatment with this medicine you may notice the presence of parts of the tablets in
your stools. This is normal and does not indicate a lack of efficacy of the medicine.
In some of the cases cited, different doses than those normally used may be prescribed for you.

Children
Diltiazem Mylan Generics Italia is not recommended in children.

Other medicines and Diltiazem Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not use this medicine in association with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat heart problems;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• ivabradine, a medicine used to treat certain heart diseases.

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

• nitrates, medicines that dilate blood vessels. If you are taking this medicine, you can start treatment with nitrates only at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• antihypertensives (especially alpha-blockers), medicines used to treat high blood pressure. In this case, you can use them together with this medicine only if you keep your blood pressure under strict control;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, you can use them together with this medicine only if you keep heart function under strict control, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers;
• cardiac glycosides (e.g. digoxin). Take particular care especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, you can use diltiazem only if your heart function is kept under strict control;
• carbamazepine and phenytoin, medicines used for epilepsy, in this case the doctor will keep carbamazepine and phenytoin levels in the blood under control;
• rifampicin, a medicine for bacterial infections;
• medicines used for ulcers (H2-blockers) such as cimetidine and ranitidine. If you start treatment with these medicines or stop them during treatment with Diltiazem Mylan Generics Italia, you should be checked by your doctor;
• cyclosporine, a medicine used against organ rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for psychiatric disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examinations, as they may increase the heart effects of diltiazem such as lowering blood pressure;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• antiplatelet agents, medicines that prevent the aggregation of some blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, because diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation;
• statins, medicines used to lower cholesterol in the blood; because there may be a risk of severe muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. Diltiazem increases the activity of cilostazol;
• Diltiazem Mylan Generics Italia may lead to an increase in the level of colchicine (drug used to treat gout) when administered concomitantly;
• Diltiazem Mylan Generics Italia may lead to an increased risk of bleeding if taken together with blood thinners such as direct-acting oral anticoagulants (e.g. dabigatran, rivaroxaban, apixaban);
• Diltiazem Mylan Generics Italia may lead to a prolongation of the QT interval (alterations in the ECG such as changes in heartbeat and rhythm, together with symptoms of dizziness) when administered together with drugs that have the potential/are known to prolong the QT interval.

Diltiazem Mylan Generics Italia with drinks
Avoid taking this medicine together with grapefruit juice as this may increase
its effect. If you are taking grapefruit juice, your doctor should check for possible manifestation
of side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diltiazem Mylan Generics Italia if you are pregnant or planning a
pregnancy.
If you are a woman of childbearing potential, you should prevent a possible pregnancy before starting treatment
and during therapy with diltiazem, using appropriate contraceptive methods.
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take diltiazem, stop breastfeeding.

Driving and operating machinery
This medicine may affect your ability to drive and operate machinery as it may
cause side effects such as dizziness and malaise. If this happens, avoid driving or
operating machinery.

Diltiazem Mylan Generics Italia contains castor oil and lactose
This medicine contains castor oil which may cause stomach upset and diarrhea.
This medicine contains lactose. If you have been diagnosed with lactose intolerance,
contact your doctor before taking this medicine.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take the tablets with a little water and without chewing.
The tablet can be divided into equal parts.
The time of taking it during the day is irrelevant, but it must remain constant; ideally it is
taken before or during a meal.
Use particular caution, especially at the beginning of treatment.

Treatment of angina pectoris:the recommended dose is 1 tablet (60 mg), 3 times a day at
regular intervals. If necessary, the doctor may decide to increase the dose to 2 tablets (120 mg), 3
times a day depending on your condition.
The maintenance dose may be half a tablet, 3 times a day.

Treatment of high blood pressure (hypertension):the recommended dose ranges from half to 1 tablet, 3
times a day.

Use in children
There is no data regarding the safety of use and efficacy in children. The use of Diltiazem Mylan
Generics Italia is therefore not recommended in children.

Use in elderly people and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood pressure, take this
medicine with caution, especially at the beginning of treatment, using the minimum effective dose.

If you take more Diltiazem Mylan Generics Italia than you should
If you have taken more tablets than you should, inform your doctor or go to the nearest hospital emergency room.
Bring the package of the medicine with you. This way the doctor will know what you have taken. The following effects may occur: feeling of dizziness or weakness, lowering of blood pressure
up to collapse, blurred vision, chest pain, shortness of breath, fainting, unusually fast or slow heartbeat and other heart problems (conduction disturbances
atrioventricular, sinus arrest and cardiac arrest), confused speech, confusion, reduced
renal function, coma and sudden death.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath
which can develop up to 24-48 hours after taking it.

If you forget to take Diltiazem Mylan Generics Italia
If you forget to take a tablet, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Diltiazem Mylan Generics Italia
Do not abruptly stop treatment with this medicine as it may worsen heart problems such as
angina. Consult your doctor before stopping treatment.
If you have any doubts 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 will experience them.
The following side effects may occur:

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

• swelling due to fluid retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• localized pain in the head or neck (headache), dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flashes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritation with redness (erythema);
• general malaise.

Uncommon(may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heart rate (bradycardia);
• feeling of dizziness when standing up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• alteration of blood tests related to the liver, such as increased aspartate transferase (AST), alanine-aminotransferase (ALT), alkaline phosphatase (ALP) and lactic dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• heart problems (irregular heartbeat (arrhythmia), transient loss of consciousness (syncope), chest pain (angina);
• dry mouth, altered taste, abdominal pain;
• alteration of blood tests such as increased creatine phosphokinase (CPK);
• loss or reduction of appetite (anorexia), weight gain;
• increased need to urinate (nocturia, polyuria);
• skin irritation such as hives, irregular red spots on the skin (petechiae), itching;
• general redness (erythema) due to alterations of blood vessels (leucocytoclastic vasculitis);
• pain in bones and joints;
• visual disturbances (amblyopia) and eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

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

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

Not known(frequency cannot be estimated based on available data)

• blood problems (thrombocytopenia, prolonged bleeding time);
• mood changes (including depression);
• movement problems (extrapyramidal syndrome), dizziness;
• heart problems such as sinoatrial block, congestive heart failure, alteration of electrocardiogram results; temporary arrest of the formation of the cardiac impulse at the level of the sinus node (sinus arrest) and arrest of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node level) if the medicine is administered intravenously;
• inflammation of blood vessels (vasculitis), fluid retention (edema) especially in the lower limbs;
• sweating, headache;
• enlargement of the gums (gingival hyperplasia);
• inflammation of the liver (hepatitis);
• increased blood sugar levels (hyperglycemia);
• increased skin sensitivity to sunlight (including lichenoid keratosis in areas of skin exposed to the sun);
• drug-induced lichenoid eruption;
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema);
• skin rash, severe skin condition that can affect the areas around the mouth and other parts of the body (erythema multiforme), rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin disease (toxic epidermal necrolysis or Lyell's syndrome), skin peeling (exfoliative dermatitis), severe skin reaction with pustule formation (acute generalized exanthematous pustulosis), redness, blisters and skin peeling with or without fever and sweating;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as joint swelling, fatigue and skin rashes (called "lupus-like syndrome");
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Diltiazem Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Diltiazem Mylan Generics Italia contains

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

Description of the appearance of Diltiazem Mylan Generics Italia and contents of the pack
Pack containing 50 modified-release tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124, Milan, Italy.

Manufacturer
FINE FOODS &Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, Brembate (BG)

Diltiazem Mylan Generics Italia 120 mg prolonged-release tablets

diltiazem hydrochloride

Generic Medicine
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 they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Diltiazem Mylan Generics Italia and what is it used for

Diltiazem Mylan Generics Italia contains the active ingredient diltiazem hydrochloride which belongs to a
group of medicines called calcium channel blockers (calcium antagonists), used for the treatment
of high blood pressure.
Diltiazem Mylan Generics Italia is indicated for the treatment of chest pain (angina pectoris) due to
effort, heart attack or problems with the vessels that carry blood to the heart (Prinzmetal's angina).

2. What you need to know before taking Diltiazem Mylan Generics Italia

Do not take Diltiazem Mylan Generics Italia

• if you are allergic to diltiazem or to any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure less than 90 mmHg);
• if you have an acute heart attack with lung problems;
• if you have an irregular heartbeat (sick sinus syndrome) or disturbances in cardiac conduction ((sinoatrial block, second or third degree atrioventricular block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems such as left ventricular failure with pulmonary congestion and congestive heart failure;
• if you are using medicines such as dantrolene and amiodarone for infusion (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are already taking a medicine containing ivabradine for the treatment of certain heart diseases (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are pregnant, if you think you may be pregnant, or if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives);
• if the person who needs to take the medicine is a child.

If you are a woman of childbearing potential and are not using contraceptives, you should make sure to prevent possible
pregnancy before starting treatment and during therapy with this medicine (see also
section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Mylan Generics Italia.
Talk to 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, the
doctor may need to monitor kidney function.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have heart problems such as reduced function of the left ventricle, bradycardia or first-degree atrioventricular block;
• if you are elderly or if you have kidney or liver problems, especially if you are also taking other medicines that lower blood pressure, because a dose adjustment may be necessary (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are at risk of intestinal obstruction, as diltiazem has effects on bowel function;
• if you are going to have surgery, in this case inform your doctor or anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
• if you notice changes in mood.

Undergo periodic checks of liver and kidney function during treatment and also check heart function, especially at the beginning of treatment.
If you suffer from diabetes mellitus, you should also check your blood sugar levels, as there is a risk
of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including
depression.
The use of Diltiazem Mylan Generics Italia may cause constriction of the bronchi (bronchospasm),
including a worsening of asthma, particularly in patients who already have some difficulty
breathing or after increasing the dosage. During therapy with Diltiazem Mylan Generics Italia your
doctor will perform checks of respiratory function.
Abrupt discontinuation of treatment may be associated with a worsening of angina.
In case of enlargement of the heart (cardiomegaly) or very low blood pressure, treatment
must be initiated only in a hospital setting.
During treatment with this medicine you may notice the presence of parts of the tablets in your
stools. This is normal and does not indicate a lack of efficacy of the medicine.
In some of the cases mentioned, different doses than those normally used may be prescribed to you.

Children
Diltiazem Mylan Generics Italia is not recommended in children .
Other medicines and Diltiazem Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not use this medicine in combination with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat heart problems;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects.
• ivabradine, a medicine used to treat certain heart diseases.

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

• nitrates, medicines that dilate blood vessels. If you are taking this medicine, you can start treatment with nitrates only at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• antihypertensives (especially alpha-blockers), medicines used to treat high blood pressure. In this case, you can use them together with this medicine only if you keep blood pressure under strict control;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, you can use them together with this medicine only if you keep heart function under strict control, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers;
• cardiac glycosides (e.g. digoxin). Pay particular attention especially if you are elderly or if you take high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, you can use diltiazem only if your heart function is kept under strict control;
• carbamazepine and phenytoin, medicines used for epilepsy, in this case the doctor will keep carbamazepine and phenytoin levels in the blood under control;
• rifampicin, a medicine for bacterial infections;
• medicines used for ulcers (H2-blockers) such as cimetidine and ranitidine. If you start treatment with these medicines or stop them during treatment with Diltiazem Mylan Generics Italia, you should be checked by your doctor;
• cyclosporine, a medicine used against organ rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for psychiatric disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examination, as they may increase the heart effects of diltiazem such as lowering blood pressure;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• antiplatelet agents, medicines that prevent the aggregation of some blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, because diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation;
• statins, medicines used to lower blood cholesterol levels; because there may be a risk of severe muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. Diltiazem increases the activity of cilostazol;
• Diltiazem Mylan Generics Italia may lead to an increase in the level of colchicine (drug used to treat gout) when administered concomitantly;
• Diltiazem Mylan Generics Italia may lead to an increased risk of bleeding if taken together with blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• Diltiazem Mylan Generics Italia may lead to a prolongation of the QT (alterations in the ECG such as alterations in the heartbeat and rhythm, together with symptoms of dizziness) when administered together with drugs that have the potential/are known to prolong the QT interval.
• .

Diltiazem Mylan Generics Italia with drinks
Avoid taking this medicine together with grapefruit juice as this may increase
its effect. If you are taking grapefruit juice, your doctor should check for possible
side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Diltiazem Mylan Generics Italia if you are pregnant or planning a
pregnancy.
If you are a woman of childbearing potential, you should prevent possible pregnancy before starting treatment
and during therapy with diltiazem, using appropriate methods of contraception.
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take diltiazem, stop breastfeeding.

Driving and using machines
This medicine may affect your ability to drive and operate machinery because it may
cause side effects such as dizziness and malaise. If this happens to you, avoid driving or
using machines.

Diltiazem Mylan Generics Italia contains castor oil
This medicine contains castor oil, which may cause stomach upset and diarrhea.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the tablets with a little water and without chewing.
The time of taking it during the day is irrelevant, but it must remain constant; ideally it is
taken before or during a meal.
Use particular caution, especially at the beginning of treatment.
The recommended dose is 1 tablet every 12 hours. The doctor may vary the dose depending on your
condition.

Use in children
There is no data regarding the safety of use and efficacy in children. The use of Diltiazem Mylan
Generics Italia is therefore not recommended in children.

Use in the elderly and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood
pressure, take this medicine with caution, especially at the beginning of treatment using the minimum
effective dose.

If you take more Diltiazem Mylan Generics Italia than you should
If you have taken more tablets than you should, inform your doctor or go to the emergency room of the
nearest hospital. Bring the package of the medicine with you. This way the doctor will know what you
have taken.
The following effects may occur: feeling of dizziness or weakness, lowering of blood
pressure up to collapse, blurred vision, chest pain, shortness of breath, fainting, unusually fast or
slow heartbeat and other heart problems (atrioventricular conduction disturbances, sinus arrest and
cardiac arrest), confused speech, confusion, reduced
renal function, coma and sudden death.
An excess of fluid can accumulate in the lungs (pulmonary edema) causing shortness of breath
which can develop up to 24-48 hours after taking it.

If you forget to take Diltiazem Mylan Generics Italia
If you forget to take a tablet, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for the missed dose.

If you stop taking Diltiazem Mylan Generics Italia
Do not abruptly stop treatment with this medicine because it may worsen heart problems such
as angina. Consult your doctor before stopping treatment.
If you have any doubts 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 will experience them.
The following side effects may occur:

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

• swelling due to fluid retention (peripheral edema).

Common(may affect up to 1 in 10 people)

• localized pain in the head or neck (headache), dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flashes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritation with redness (erythema);
• general malaise.

Uncommon(may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heart rate (bradycardia);
• feeling of dizziness when standing up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• alteration of blood tests related to the liver, such as increased aspartate transferase (AST), alanine-aminotransferase (ALT), alkaline phosphatase (ALP) and lactic dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• heart problems (irregular heartbeat (arrhythmia), transient loss of consciousness (syncope), chest pain (angina);
• dry mouth, altered taste, abdominal pain;
• alteration of blood tests such as increased creatine phosphokinase (CPK);
• loss or reduction of appetite (anorexia), weight gain;
• increased need to urinate (nocturia, polyuria);
• skin irritation such as urticaria, irregular red spots on the skin (petechiae), itching;
• generalized redness (erythema) due to alterations in blood vessels (leucocytoclastic vasculitis);
• pain in bones and joints;
• visual disturbances (amblyopia) and eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

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

• decreased number of white blood cells (leukopenia);
• kidney problems (interstitial nephritis).

Not known(frequency cannot be estimated from available data)

• blood problems (thrombocytopenia, prolonged bleeding time);
• mood changes (including depression);
• movement problems (extrapyramidal syndrome), dizziness;
• heart problems such as sinoatrial block, congestive heart failure, alteration of electrocardiogram results; temporary cessation of cardiac impulse formation at the level of the sinus node (sinus arrest) and cessation of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node level) if the medicine is administered intravenously;
• inflammation of blood vessels (vasculitis), fluid retention (edema) especially in the lower limbs;
• sweating, headache;
• enlargement of the gums (gingival hyperplasia);
• inflammation of the liver (hepatitis);
• increased blood sugar levels (hyperglycemia);
• increased skin sensitivity to sunlight (including lichenoid keratosis in areas of skin exposed to the sun);
• drug-induced lichenoid eruption;
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema);
• skin rash, severe skin condition that can affect the areas around the mouth and other parts of the body (erythema multiforme), rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin disease (toxic epidermal necrolysis or Lyell's syndrome), skin peeling (exfoliative dermatitis), severe skin reaction with pustule formation (acute generalized pustulosis exanthematous), redness, blisters and skin peeling with or without fever and sweating;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as joint swelling, fatigue and skin rashes (called "lupus-like syndrome");
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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 Diltiazem Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Diltiazem Mylan Generics Italia contains

• The active ingredient is diltiazem hydrochloride. One tablet contains 120 mg of diltiazem hydrochloride.
• The other ingredients are: mannitol, hypromellose, ethylcellulose, hydrogenated castor oil, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Diltiazem Mylan Generics Italia and contents of the pack
Pack containing 24 extended-release tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124, Milan

Manufacturer
FINE FOODS &Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, Brembate (BG)

Diltiazem Mylan Generics Italia 300 mg prolonged-release tablets

diltiazem hydrochloride

Equivalent Medicinal Product
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 Diltiazem Mylan Generics Italia is and what it is used for
• 2. What you need to know before you take Diltiazem Mylan Generics Italia
• 3. How to take Diltiazem Mylan Generics Italia
• 4. Possible side effects
• 5. How to store Diltiazem Mylan Generics Italia
• 6. Contents of the pack and other information

1. What is Diltiazem Mylan Generics Italia and what is it used for

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

• chest pain (angina pectoris) due to exertion, heart attack, or problems with the blood vessels leading to the heart (Prinzmetal's angina);
• high blood pressure in cases of mild or moderate severity.

2. What you need to know before taking Diltiazem Mylan Generics Italia

Do not take Diltiazem Mylan Generics Italia

• if you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6);
• if you have low blood pressure (systolic pressure below 90 mmHg);
• if you have an acute heart attack with lung problems;
• if you have an irregular heartbeat (sick sinus node disease) or conduction disorders (sinoatrial block, second or third degree atrioventricular block) and do not have a functioning pacemaker;
• if you have a very slow heartbeat (severe bradycardia, below 40 beats per minute);
• if you have severe heart problems such as left ventricular failure with pulmonary congestion and congestive heart failure;
• if you are using medicines such as dantrolene and amiodarone for infusion (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are already taking a medicine containing ivabradine for the treatment of certain heart diseases (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are using a medicine containing lomitapide, used for the treatment of high cholesterol levels (see section “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are pregnant, if you think you may be pregnant, or if you are breastfeeding or if you are a woman of childbearing potential and are not using medicines to prevent pregnancy (contraceptives);
• if the person who needs to take the medicine is a child.

If you are a woman of childbearing potential and are not using contraceptives, you should make sure to prevent possible
pregnancy before starting treatment and during therapy with this medicine (see also
section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Mylan Generics Italia.
Talk to 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, the
doctor may need to monitor 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, bradycardia or first-degree atrioventricular block;
• if you are elderly or have kidney or liver problems, especially if you are also taking other medicines that lower blood pressure, because a dose adjustment may be necessary (see “Other medicines and Diltiazem Mylan Generics Italia”);
• if you are at risk of intestinal obstruction, as diltiazem has effects on bowel function;
• if you are going to have surgery, in which case inform your doctor or anesthesiologist that you are taking this medicine;
• if you are taking blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
• if you notice changes in your mood.

Undergo periodic checks of liver and kidney function during treatment and also check heart function, especially at the beginning of treatment.
If you suffer from diabetes mellitus, you should also check your blood sugar levels, as there is a risk
of increased blood sugar.
Calcium antagonists, such as diltiazem, may be associated with changes in mood, including
depression.
The use of Diltiazem Mylan Generics Italia may cause constriction of the bronchi (bronchospasm),
including worsening of asthma, particularly in patients who already have some difficulty
breathing or after increasing the dosage. During therapy with Diltiazem Mylan Generics Italia your
doctor will perform checks of your respiratory function.
Sudden discontinuation of treatment may be associated with a worsening of angina.
In case of heart enlargement (cardiomegaly) or very low blood pressure, treatment
must be initiated only in a hospital environment.
During treatment with this medicine you may notice the presence of parts of the tablets in your
stools. This is normal and does not indicate a lack of effectiveness of the medicine.
In some of the cases mentioned, different doses than those normally used may be prescribed.

Children
Diltiazem Mylan Generics Italia is not recommended for children.
Other medicines andDiltiazem Mylan Generics Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not use this medicine in combination with:

• dantrolene (infusion), a medicine used for muscle spasms and for the treatment of a type of fever called malignant hyperthermia;
• amiodarone, a medicine used to treat heart problems;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• ivabradine, a medicine used to treat certain heart diseases.

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

• nitrates, medicines that dilate blood vessels. If you are taking this medicine, you can only start treatment with nitrates at gradually increasing doses;
• theophylline, a medicine used for asthma therapy;
• antihypertensives (especially alpha-blockers), medicines used to treat high blood pressure. In this case, you can use them together with this medicine only if you keep your blood pressure under strict control;
• beta-blockers, medicines used for high blood pressure and heart problems. In this case, you can use them together with this medicine only if you keep heart function under strict control, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers;
• cardiac glycosides, medicines for the heart (e.g., digoxin). Take particular care especially if you are elderly or are taking high doses of diltiazem;
• medicines used for heart rhythm problems (antiarrhythmics). In this case, you can use diltiazem only if your heart function is kept under strict control;
• carbamazepine and phenytoin, medicines used for epilepsy, in this case the doctor will keep carbamazepine and phenytoin levels in the blood under control;
• rifampicin, a medicine for bacterial infections;
• medicines used for ulcers (anti-H2) such as cimetidine and ranitidine. If you start or stop treatment with these medicines during treatment with Diltiazem Mylan Generics Italia, you should be checked by your doctor;
• cyclosporine, a medicine used against organ rejection;
• medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
• medicines used for psychiatric disorders (antipsychotics) including lithium;
• medicines used for anesthesia (see section “Warnings and precautions”);
• contrast agents for X-ray examination, as they may increase the effects on the heart of diltiazem such as lowering blood pressure;
• medicines that contain lomitapide, used to treat high cholesterol levels. Diltiazem may increase the concentration of lomitapide, which may lead to an increased probability and severity of liver-related side effects;
• antiplatelet agents, medicines that prevent the aggregation of certain blood cells called platelets, increasing blood fluidity;
• benzodiazepines, medicines for depression, such as midazolam, triazolam, because diltiazem increases the concentration of these drugs in the blood;
• corticosteroids, medicines used to treat inflammation;
• statins, medicines used to lower cholesterol in the blood, because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
• cilostazol, a medicine used to relieve leg pain when walking. Diltiazem increases the activity of cilostazol;
• Diltiazem Mylan Generics Italia may lead to an increase in the level of colchicine (drug used to treat gout) when administered concomitantly;
• Diltiazem Mylan Generics Italia may lead to an increased risk of bleeding if taken together with blood thinners such as direct-acting oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
• Diltiazem Mylan Generics Italia may lead to a prolongation of the QT (alterations of the ECG such as alterations of the heartbeat and rhythm, together with symptoms of dizziness) when administered together with drugs that have the potential/are known to prolong the QT interval.

Diltiazem Mylan Generics Italia with drinks
Avoid taking this medicine together with grapefruit juice as this may increase
its effect. If you are taking grapefruit juice, your doctor should check for possible manifestation
of side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist before taking this medicine.
Do not take Diltiazem Mylan Generics Italia if you are pregnant or planning a
pregnancy.
If you are a woman of childbearing potential, you should prevent possible pregnancy before starting treatment
and during therapy with diltiazem, using appropriate methods of contraception.
Do not take this medicine if you are breastfeeding, as this medicine passes into breast milk.
If you need to take diltiazem, stop breastfeeding.

Driving and using machines
This medicine may affect your ability to drive and operate machinery as it may
cause side effects such as dizziness and discomfort. If this happens, avoid driving or
using machines.

Diltiazem Mylan Generics Italia contains castor oil
This medicine contains castor oil, which may cause stomach upset and diarrhea.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Use particular caution especially at the beginning of the treatment.
The recommended dose is 1 tablet per day. Take the tablet whole, with a little water and
without chewing. The time of taking it during the day is irrelevant, but it must remain constant;
ideally, it should be taken before or during a meal.

Use in children
There is no data regarding the safety of use and efficacy in children. The use of Diltiazem Mylan
Generics Italia is therefore not recommended in children.

Use in elderly people and with kidney or liver problems
If you are elderly or have liver or kidney problems or are taking other medicines for high blood pressure, take this
medicine with caution, especially at the beginning of the treatment, using the minimum effective dose.

If you take more Diltiazem Mylan Generics Italia than you should
If you have taken more tablets than you should, inform your doctor or go to the emergency room of the nearest
hospital. Bring the package of the medicine with you. This way the doctor will know what you have taken. The following effects may occur: feeling of dizziness or weakness, lowering of blood pressure
to the point of collapse, blurred vision, chest pain, shortness of breath, fainting, unusually fast or slow heartbeat and other heart problems (conduction disturbances
atrioventricular, sinus arrest and cardiac arrest), confused speech, confusion, reduced
kidney function, coma and sudden death.
An excess of fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath
which may develop up to 24-48 hours after taking it.

If you forget to take Diltiazem Mylan Generics Italia
If you forget to take a tablet, take it as soon as you remember, unless it is almost time to
take the next dose. Do not take a double dose to make up for the forgotten dose.

If you stop taking Diltiazem Mylan Generics Italia
Do not abruptly stop the treatment with this medicine because it may worsen heart problems such as
angina. Consult your doctor before stopping the treatment.
If you have any doubts 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 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 edema).

Common(may affect up to 1 in 10 people)

• localized pain in the head or neck (headache), dizziness;
• serious heart problems such as atrioventricular block, palpitations;
• hot flushes;
• constipation, digestive disorders, stomach pain, nausea;
• skin irritation with redness (erythema);
• general malaise.

Uncommon(may affect up to 1 in 100 people)

• nervousness, insomnia;
• slowing of the heart rate (bradycardia);
• feeling of dizziness when getting up due to a drop in blood pressure (orthostatic hypotension);
• vomiting, diarrhea;
• alteration of blood tests related to the liver, such as increased aspartate transferase (AST), alanine-aminotransferase (ALT), alkaline phosphatase (ALP) and lactic dehydrogenase (LDH).

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

• nosebleeds (epistaxis);
• memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
• altered sensitivity of the limbs (paresthesia), ringing in the ears (tinnitus), tremor;
• heart problems (irregular heart rhythm (arrhythmia), transient loss of consciousness (syncope), chest pain (angina);
• dry mouth, altered taste, abdominal pain;
• alteration of blood tests such as increased creatine phosphokinase (CPK);
• loss or reduction of appetite (anorexia), weight gain;
• increased need to urinate (nocturia, polyuria);
• skin irritation such as hives, irregular red spots on the skin (petechiae), itching;
• general redness (erythema) due to alterations of blood vessels (leucocytoclastic vasculitis);
• pain in bones and joints;
• visual disturbances (amblyopia) and eye irritation;
• difficulty breathing (dyspnea);
• decreased sexual potency (impotence).

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

• decreased number of white blood cells (leukopenia);
• kidney problems (interstitial nephritis).

Not known(frequency cannot be estimated from available data)

• blood problems (thrombocytopenia, prolonged bleeding time);
• mood changes (including depression);
• movement problems (extrapyramidal syndrome), dizziness;
• heart problems such as sinoatrial block, congestive heart failure, alteration of electrocardiogram results; temporary arrest of the formation of the cardiac impulse at the level of the sinus node (sinus arrest) and arrest of the heart due to the absence of the contraction phase (asystole);
• lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia) and other heart problems (atrioventricular block at the node level) if the medicine is administered intravenously;
• inflammation of blood vessels (vasculitis), fluid retention (edema) especially in the lower limbs;
• sweating, headache;
• enlargement of the gums (gingival hyperplasia);
• inflammation of the liver (hepatitis);
• increased blood sugar levels (hyperglycemia);
• increased skin sensitivity to sunlight (including lichenoid keratosis in sun-exposed skin areas);
• drug-induced lichenoid eruption;
• swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing or breathing (angioedema);
• skin rash, severe skin condition that can affect the areas around the mouth and other parts of the body (erythema multiforme), rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin disease (toxic epidermal necrolysis or Lyell's syndrome), skin peeling (exfoliative dermatitis), severe skin reaction with pustule formation (acute generalized exanthematous pustulosis), redness, blisters and skin peeling with or without fever and sweating;
• a condition in which the body's defense system attacks normal tissues causing symptoms such as joint swelling, fatigue and skin rashes (called "lupus-like syndrome");
• growth of breast tissue in men (gynecomastia);
• decreased muscle strength (asthenia);
• constriction of the bronchi (bronchospasm), including worsening of asthma.

Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system 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 Mylan Generics Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Diltiazem Mylan Generics Italia contains

• The active ingredient is diltiazem hydrochloride. One tablet contains 300 mg of diltiazem hydrochloride.
• The other ingredients are: mannitol, hypromellose, ethylcellulose, hydrogenated castor oil, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Diltiazem Mylan Generics Italia and contents of the pack
Pack containing 14 extended-release tablets.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano

Manufacturer
FINE FOODS &Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, Brembate (BG)