Diltiazem Mylan Generics Italia: detailed information

Package leaflet: Information for the patient

Diltiazem Mylan Generics Italia 60 mg modified-release tablets

diltiazem hydrochloride
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diltiazem Mylan Generics Italia is and what it is used for
What you need to know before taking Diltiazem Mylan Generics Italia
How to take Diltiazem Mylan Generics Italia
Possible side effects
How to store Diltiazem Mylan Generics Italia
Contents of the pack and other information

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

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

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 below 90 mmHg);
if you have acute myocardial infarction with lung complications;
if you have an irregular heartbeat (sinoatrial node disease) or cardiac conduction disorders (sinoatrial block, second- or third-degree atrioventricular block) and do not have a functioning pacemaker;
if you have a very slow heart rate (severe bradycardia, less than 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 receiving dantrolene or amiodarone by infusion (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are taking a medicine containing lomitapide, used to treat high cholesterol levels (see section “Other medicines and Diltiazem Mylan Generics Italia”);
if you are pregnant, think you may be pregnant, are breastfeeding, or are a woman of childbearing age not using contraception;
if the person who is to take the medicine is a child.

If you are a woman of childbearing age and not using contraception, you must ensure that you prevent a possible pregnancy before starting treatment and during therapy with this medicine (also see section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Diltiazem Mylan Generics Italia.
Speak with your doctor if you have a history of heart failure, unusual shortness of breath, slow heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor your kidney function.
Use this medicine with 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, as dose adjustments may be necessary (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are at risk of intestinal obstruction, since diltiazem affects intestinal function;
if you are scheduled for surgery; in this case, inform your doctor or anaesthetist that you are taking this medicine;
if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
if you notice changes in mood.

Undergo regular monitoring of liver and kidney function during treatment, and also monitor heart function, especially at the beginning of treatment.
If you have diabetes mellitus, you should also monitor your blood sugar levels, as there is a risk of increased blood glucose.
Calcium antagonists, such as diltiazem, may be associated with mood changes, including depression.
The use of Diltiazem Mylan Generics Italia may cause bronchoconstriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after dose escalation. During treatment with Diltiazem Mylan Generics Italia, your doctor will monitor your respiratory function.
Abrupt discontinuation of treatment may lead to worsening of angina.
If you have cardiomegaly (enlarged heart) or very low blood pressure, treatment should only be initiated in a hospital setting.
During treatment with this medicine, you may notice parts of the tablets in your stools. This is normal and does not indicate lack of effectiveness of the medicine.
In some of the cases listed above, you may be prescribed different doses than normally used.
Children
Diltiazem Mylan Generics Italia is not recommended for use in children.
Other medicines and Diltiazem Mylan Generics Italia
Inform 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 treatment of a type of fever called malignant hyperthermia;
amiodarone, a medicine used to treat heart rhythm problems;
medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could increase the likelihood and severity of liver-related adverse effects;
ivabradine, a medicine used to treat certain heart conditions.

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

nitrates, medicines that dilate blood vessels. If you are taking this medicine, you should start treatment with nitrates only at gradually increasing doses;
theophylline, a medicine used to treat asthma;
antihypertensives (especially alpha-blockers), medicines used to treat high blood pressure. In this case, they may be used together with this medicine only if blood pressure is closely monitored;
beta-blockers, medicines used for high blood pressure and heart problems. In this case, they may be used together with this medicine only if heart function is closely monitored, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers;
cardioactive glycosides, heart medicines (e.g., digoxin). Exercise particular caution, especially if you are elderly or taking high doses of diltiazem;
medicines used for heart rhythm disorders (antiarrhythmics). In this case, diltiazem may be used only if your heart function is closely monitored;
carbamazepine and phenytoin, medicines used for epilepsy; in this case, your doctor will monitor blood levels of carbamazepine and phenytoin;
rifampicin, a medicine used for bacterial infections;
medicines used for ulcers (H2 antagonists) such as cimetidine and ranitidine. If you start or stop treatment with these medicines during treatment with Diltiazem Mylan Generics Italia, you should be monitored by your doctor;
cyclosporine, a medicine used to prevent organ transplant rejection;
medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
medicines used for psychiatric disorders (antipsychotics), including lithium;
medicines used for anaesthesia (see section “Warnings and precautions”);
contrast media for X-ray examinations, as they may enhance the cardiac effects of diltiazem, such as lowering of blood pressure;
medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could increase the likelihood and severity of liver-related adverse effects;
antiplatelet agents, medicines that prevent aggregation of blood cells called platelets, thereby increasing blood fluidity;
benzodiazepines, medicines for anxiety or sleep disorders such as midazolam, triazolam, as diltiazem increases blood levels of these drugs;
corticosteroids, medicines used to treat inflammation;
statins, medicines used to lower blood cholesterol; because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
cilostazol, a medicine used to relieve leg pain during walking. Diltiazem increases the activity of cilostazol;
Diltiazem Mylan Generics Italia may increase blood levels of colchicine (a medicine used to treat gout) when administered concomitantly;
Diltiazem Mylan Generics Italia may increase the risk of bleeding when taken together with blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
Diltiazem Mylan Generics Italia may lead to QT prolongation (ECG changes such as alterations in heart rate and rhythm, along with symptoms of dizziness) when administered together with medicines known or potentially able to prolong the QT interval.

Diltiazem Mylan Generics Italia and beverages
Avoid taking this medicine with grapefruit juice, as it may increase its effect. If you are consuming grapefruit juice, your doctor should monitor you for possible adverse effects.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult 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 age, you must 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 using machines
This medicine may affect your ability to drive vehicles or operate machinery, as it may cause adverse effects such as dizziness and malaise. If this occurs, avoid driving or operating machinery.
Diltiazem Mylan Generics Italia contains castor oil and lactose
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhoea.
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets with a little water and without chewing them.
The tablet may be divided into equal parts.
The time of day for administration is not critical, but it should remain consistent; ideally, take the tablet before or during a meal.
Exercise particular caution, especially at the beginning of treatment.

Treatment of angina pectoris: the recommended dose is 1 tablet (60 mg), taken 3 times a day at regular intervals. If necessary, your 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 a tablet to 1 tablet, 3 times a day.

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

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

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

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

If you stop taking Diltiazem Mylan Generics Italia
Do not stop treatment abruptly, as this may worsen heart problems such as angina. Consult your doctor before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

The following side effects may occur:

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

swelling due to fluid accumulation (peripheral edema).

Common (may affect up to 1 in 10 people)

headache or neck pain (cephalalgia), 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);
dizziness upon standing due to low blood pressure (orthostatic hypotension);
vomiting, diarrhoea;
changes in blood tests related to the liver, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH).

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

nosebleeds (epistaxis);
memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
heart problems (abnormal heart rhythm (arrhythmia), transient loss of consciousness (syncope), chest pain (angina));
dry mouth, altered taste, abdominal pain;
changes in blood tests such as increased creatine phosphokinase (CPK);
loss or reduced appetite (anorexia), weight gain;
increased need to urinate (nocturia, polyuria);
skin irritation such as urticaria, small red spots on the skin (petechiae), itching;
generalized skin redness due to blood vessel changes (leukocytoclastic vasculitis);
bone and joint pain;
vision disturbances (amblyopia) and eye irritation;
breathing difficulties (dyspnoea);
reduced sexual performance (impotence).

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

decrease in white blood cell count (leucopenia);
kidney problems (interstitial nephritis).

Not known (frequency cannot be estimated from available data)

blood disorders (thrombocytopenia, prolonged bleeding time);
mood changes (including depression);
movement disorders (extrapyramidal syndrome), dizziness;
heart problems such as sinoatrial block, congestive heart failure, changes in electrocardiogram (ECG) results; temporary cessation of cardiac impulse formation at the sinoatrial node (sinus arrest), and cardiac arrest due to absence of contraction phase (asystole);
low blood pressure (hypotension), slow heart rate (bradycardia), and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
inflammation of blood vessels (vasculitis), fluid retention (edema), especially in the lower limbs;
sweating, headache;
increased gum size (gingival hyperplasia);
liver inflammation (hepatitis);
increased blood sugar levels (hyperglycaemia);
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 which may cause difficulty in swallowing or breathing (angioneurotic edema);
skin rash, severe skin condition that may affect areas around the mouth and other body parts (erythema multiforme), rare skin condition with blisters and bleeding of 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, blistering, and peeling of the skin with or without fever and sweating;
a condition in which the body's immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue, and skin rashes (called "lupus-like syndrome");
breast enlargement in men (gynaecomastia);
reduced muscle strength (asthenia);
bronchial constriction (bronchospasm), including worsening of asthma.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects helps 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 stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Diltiazem Mylan Generics Italia contains

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

Description of the appearance of Diltiazem Mylan Generics Italia and contents of the pack
Carton containing 50 modified-release tablets.
Marketing Authorization 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)

Patient information leaflet: information for the patient

Diltiazem Mylan Generics Italia 120 mg prolonged-release tablets

diltiazem hydrochloride
Generic Medicine
Please read this entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diltiazem Mylan Generics Italia is and what it is used for
What you need to know before taking Diltiazem Mylan Generics Italia
How to take Diltiazem Mylan Generics Italia
Possible side effects
How to store Diltiazem Mylan Generics Italia
Contents of the pack and other information

1. What Diltiazem Mylan Generics Italia is 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) caused by physical exertion, heart attack, or problems with the blood vessels supplying 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 below 90 mmHg);
if you have acute myocardial infarction with lung complications;
if you have an irregular heartbeat (sinoatrial disease) or cardiac conduction disorders (sinoatrial block, second- or third-degree atrioventricular block) and do not have a functioning pacemaker;
if you have a very slow heart rate (severe bradycardia, less than 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 or amiodarone by infusion (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are using a medicine containing lomitapide, used to treat high cholesterol levels (see section “Other medicines and Diltiazem Mylan Generics Italia”);
if you are pregnant, think you may be pregnant, are breastfeeding, or if you are a woman of childbearing age and are not using contraception;
if the person who is to take the medicine is a child.

If you are a woman of childbearing age and are not using contraception, you must ensure that you 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.
Speak with your doctor if you have a history of heart failure, unusual shortness of breath, slow heartbeat, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor kidney function.

Use this medicine with 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, as dose adjustment may be necessary (see “Other medicines and Diltiazem Mylan Generics Italia”);
if you are at risk of intestinal obstruction, since diltiazem affects intestinal function;
if you are undergoing surgery; in this case, inform your doctor or anaesthetist that you are taking this medicine;
if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
if you notice changes in mood.

You should undergo regular monitoring of liver and kidney function during treatment, and also heart function, especially at the beginning of treatment.
If you have diabetes mellitus, you should also monitor your blood sugar levels, as there is a risk of increased blood glucose.
Calcium antagonists, such as diltiazem, may be associated with mood changes, including depression.
The use of Diltiazem Mylan Generics Italia may cause bronchoconstriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after dose escalation. During therapy with Diltiazem Mylan Generics Italia, your doctor will monitor your respiratory function.
Abrupt discontinuation of treatment may lead to worsening angina.
If you have heart enlargement (cardiomegaly) or very low blood pressure, treatment should only be initiated in a hospital setting.
During treatment with this medicine, you may notice parts of the tablets in your stools. This is normal and does not indicate lack of effectiveness of the medicine.
In some of the cases listed above, you may be prescribed different doses than those normally used.

Children
Diltiazem Mylan Generics Italia is not recommended for use 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 treatment of a type of fever called malignant hyperthermia;
amiodarone, a medicine used to treat heart problems;
medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentration, which could increase the likelihood and severity of liver-related adverse effects;
ivabradine, a medicine used to treat certain heart conditions.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Diltiazem Mylan Generics Italia if you are pregnant or planning a pregnancy.
If you are a woman of childbearing age, you must 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 it passes into breast milk.
If you need to take diltiazem, you must stop breastfeeding.

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

Diltiazem Mylan Generics Italia contains castor oil
This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets with water and do not chew them.
The time of day when you take the medicine is not important, but it should remain consistent; ideally take it before or during a meal.
Use particular caution, especially at the beginning of treatment.
The recommended dose is 1 tablet every 12 hours. Your doctor may adjust the dose depending on your condition.

Use in children
There are no data available regarding the safety and efficacy of use in children. Therefore, the use of Diltiazem Mylan Generics Italia is not recommended in children.

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

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

If you stop taking Diltiazem Mylan Generics Italia
Do not stop treatment abruptly, as this may worsen heart problems such as angina. Consult your doctor before stopping treatment.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
The following side effects may occur:
Very common (may affect more than 1 in 10 people)

swelling due to fluid accumulation (peripheral oedema).

Common (may affect up to 1 in 10 people)

localized headache or neck pain (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);
dizziness upon standing due to a drop in blood pressure (orthostatic hypotension);
vomiting, diarrhoea;
changes in liver blood tests, such as increased aspartate transaminase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH).

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

nosebleeds (epistaxis);
memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
heart problems (abnormal heart rhythm (arrhythmia), transient loss of consciousness (syncope), chest pain (angina));
dry mouth, altered taste, abdominal pain;
changes in 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 skin redness due to blood vessel abnormalities (leukocytoclastic vasculitis);
bone and joint pain;
vision disturbances (amblyopia) and eye irritation;
breathing difficulties (dyspnoea);
reduced sexual performance (impotence).

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

decrease in white blood cell count (leucopenia);
kidney problems (interstitial nephritis).

Not known (frequency cannot be estimated from available data)

blood disorders (thrombocytopenia, prolonged bleeding time);
mood changes (including depression);
movement disorders (extrapyramidal syndrome), dizziness;
heart problems such as sinoatrial block, congestive heart failure, changes in electrocardiogram results; temporary cessation of cardiac impulse formation at the sinus node (sinus arrest), and cardiac arrest due to absence of the contraction phase (asystole);
low blood pressure (hypotension), slow heart rate (bradycardia), and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
inflammation of blood vessels (vasculitis), fluid retention (oedema), particularly in the lower limbs;
sweating, headache;
increased gum size (gingival hyperplasia);
liver inflammation (hepatitis);
increased blood sugar levels (hyperglycaemia);
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, which may cause difficulty in swallowing or breathing (angioneurotic oedema);
skin rash, severe skin condition that may affect areas around the mouth and other body parts (erythema multiforme), rare skin condition with blisters and bleeding of 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 (generalized exanthematous pustulosis), redness, blistering, and peeling of the skin with or without fever and sweating;
a condition in which the body's immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue, and skin rashes (called "lupus-like syndrome");
breast enlargement in men (gynaecomastia);
reduced muscle strength (asthenia);
bronchial constriction (bronchospasm), including worsening of asthma.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you 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 stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines 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 substance is diltiazem hydrochloride. One tablet contains 120 mg of diltiazem hydrochloride.
The other components 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
Carton pack containing 24 prolonged-release tablets.
Marketing Authorization 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)

Patient Information Leaflet

Diltiazem Mylan Generics Italia 300 mg prolonged-release tablets

diltiazem hydrochloride
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Diltiazem Mylan Generics Italia is and what it is used for
What you need to know before taking Diltiazem Mylan Generics Italia
How to take Diltiazem Mylan Generics Italia
Possible side effects
How to store Diltiazem Mylan Generics Italia
Contents of the pack and other information

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

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

2. What you should 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 below 90 mmHg);
if you have acute heart attack with lung complications;
if you have an irregular heartbeat (sinoatrial disease) 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 heart rate (severe bradycardia, less than 40 beats per minute);
if you have serious heart problems such as left ventricular failure with pulmonary congestion and congestive heart failure;
if you are taking medicines such as dantrolene or amiodarone by infusion (see "Other medicines and Diltiazem Mylan Generics Italia");
if you are already taking a medicine containing ivabradine for the treatment of certain heart conditions (see "Other medicines and Diltiazem Mylan Generics Italia");
if you are taking a medicine containing lomitapide, used to treat high cholesterol levels (see section "Other medicines and Diltiazem Mylan Generics Italia");
if you are pregnant, think you may be pregnant, are breastfeeding, or if you are a woman of childbearing potential and are not using contraception;
if the person who is to take the medicine is a child.

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 heart rate, or low blood pressure. Cases of kidney damage have been reported in patients with these conditions; your doctor may need to monitor your kidney function.

Use this medicine with great caution and inform your doctor in the following cases:

if you have heart problems such as reduced left ventricular function, 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, as dosage adjustment may be necessary (see "Other medicines and Diltiazem Mylan Generics Italia");
if you are at risk of intestinal obstruction, since diltiazem affects intestinal function;
if you are scheduled for surgery; in this case, inform your doctor or anaesthetist that you are taking this medicine;
if you are taking blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban) together with Diltiazem Mylan Generics Italia;
if you notice changes in mood.

You should undergo regular liver and kidney function tests during treatment, and also have your heart function monitored, especially at the beginning of treatment.

If you have diabetes mellitus, you should also monitor your blood sugar levels, as there is a risk of increased blood glucose.

Calcium channel blockers such as diltiazem may be associated with mood changes, including depression.

The use of Diltiazem Mylan Generics Italia may cause bronchial constriction (bronchospasm), including worsening of asthma, particularly in patients who already have breathing difficulties or after dose increases. During treatment with Diltiazem Mylan Generics Italia, your doctor will monitor your respiratory function.

Abrupt discontinuation of treatment may lead to worsening of angina.

If you have an enlarged heart (cardiomegaly) or very low blood pressure, treatment should only be initiated in a hospital setting.

During treatment with this medicine, you may notice parts of the tablets in your stools. This is normal and does not indicate lack of effectiveness of the medicine.

In some of the cases listed above, you may be prescribed different doses than those normally used.

Children

Diltiazem Mylan Generics Italia is not recommended for use in children.

Other medicines and Diltiazem Mylan Generics Italia

Inform 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 treating a type of fever called malignant hyperthermia;
amiodarone, a medicine used to treat heart problems;
medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could increase the likelihood and severity of liver-related adverse effects;
ivabradine, a medicine used to treat certain heart conditions.

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

nitrates, medicines that dilate blood vessels. If you are taking this medicine, treatment with nitrates should be started only at gradually increasing doses;
theophylline, a medicine used to treat asthma;
antihypertensives (especially alpha-blockers), medicines used to treat high blood pressure. In this case, they may be used together with this medicine only if blood pressure is closely monitored;
beta-blockers, medicines used for high blood pressure and heart problems. In this case, they may be used together with this medicine only if heart function is closely monitored, especially at the beginning of treatment. An increased risk of depression has been reported when diltiazem is administered together with beta-blockers;
cardiac glycosides, heart medicines (e.g., digoxin). Exercise particular caution, especially if you are elderly or taking high doses of diltiazem;
medicines used for heart rhythm disorders (antiarrhythmics). In this case, diltiazem may be used only if your heart function is closely monitored;
carbamazepine and phenytoin, medicines used for epilepsy; in this case, your doctor will monitor blood levels of carbamazepine and phenytoin;
rifampicin, a medicine used for bacterial infections;
medicines used for ulcers (H2 antagonists) such as cimetidine and ranitidine. If you start or stop treatment with these medicines during treatment with Diltiazem Mylan Generics Italia, you should be monitored by your doctor;
cyclosporine, a medicine used to prevent rejection of organ transplants;
medicines for depression (antidepressants) such as imipramine and tricyclic antidepressants;
medicines used for psychiatric disorders (antipsychotics), including lithium;
medicines used for anaesthesia (see section "Warnings and precautions");
contrast media used in X-ray examinations, as they may enhance the effects of diltiazem on the heart, such as lowering of blood pressure;
medicines containing lomitapide, used to treat high cholesterol levels. Diltiazem may increase lomitapide concentrations, which could increase the likelihood and severity of liver-related adverse effects;
antiplatelet agents, medicines that prevent aggregation of blood cells called platelets, thereby increasing blood fluidity;
benzodiazepines, medicines for depression, such as midazolam, triazolam, because diltiazem increases blood concentrations of these drugs;
corticosteroids, medicines used to treat inflammation;
statins, medicines used to lower blood cholesterol, because there may be a risk of serious muscle damage (myopathy and rhabdomyolysis);
cilostazol, a medicine used to relieve leg pain during walking. Diltiazem increases the activity of cilostazol;
Diltiazem Mylan Generics Italia may increase colchicine levels (a medicine used to treat gout) when administered concomitantly;
Diltiazem Mylan Generics Italia may increase the risk of bleeding when taken together with blood thinners such as direct oral anticoagulants (e.g., dabigatran, rivaroxaban, apixaban);
Diltiazem Mylan Generics Italia may lead to QT prolongation (ECG changes such as changes in heart rate and rhythm, together with symptoms of dizziness) when administered together with medicines that have the potential or are known to prolong the QT interval.

Diltiazem Mylan Generics Italia and beverages

Avoid taking this medicine with grapefruit juice, as it may increase its effect. If you are consuming grapefruit juice, your doctor should monitor you for possible adverse effects.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult 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 must 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 it passes into breast milk.

If you need to take diltiazem, stop breastfeeding.

Driving and using machines

This medicine may affect your ability to drive or operate machinery, as it may cause adverse effects such as dizziness and malaise. If this occurs, avoid driving or using machinery.

Diltiazem Mylan Generics Italia contains castor oil

This medicine contains castor oil, which may cause gastrointestinal disturbances and diarrhoea.

3. How to take Diltiazem Mylan Generics Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use particular caution, especially at the beginning of treatment.
The recommended dose is 1 tablet daily. Swallow the tablet whole, with a little water and
without chewing it. The time of day when you take it is unimportant, but it should remain consistent;
ideally, take it before or during a meal.

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

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

If you take more Diltiazem Mylan Generics Italia than you should
If you have taken more tablets than prescribed, inform your doctor or go to the nearest hospital emergency department.
Bring the medicine pack with you so that the doctor knows what you have taken. The following effects may occur:
dizziness or weakness, low blood pressure up to collapse, blurred vision, chest pain, shortness of breath, fainting,
abnormally fast or slow heartbeat, and other heart problems (atrioventricular conduction disturbances, sinus arrest, and cardiac arrest),
confused speech, confusion, reduced kidney function, coma, and sudden death.
Excess fluid may accumulate in the lungs (pulmonary edema), causing breathlessness, which may develop up to 24–48 hours after ingestion.

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 for your 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 stop treatment with this medicine abruptly, as this may worsen heart problems such as angina.
Consult your doctor before stopping treatment.

If you have any questions about 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 accumulation (peripheral edema).

Common (may affect up to 1 in 10 people)

localized headache or neck pain (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);
sensation of dizziness when standing up, due to a drop in blood pressure (orthostatic hypotension);
vomiting, diarrhoea;
changes in liver blood tests, such as increased aspartate transferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and lactate dehydrogenase (LDH).

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

nosebleeds (epistaxis);
memory problems (amnesia), depression, personality changes, hallucinations, drowsiness;
altered sensation in limbs (paraesthesiae), ringing in the ears (tinnitus), tremor;
heart problems (abnormal heart rhythm (arrhythmia), transient loss of consciousness (syncope), chest pain (angina));
dry mouth, altered taste, abdominal pain;
changes in 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 blood vessel abnormalities (leucocytoclastic vasculitis);
bone and joint pain;
vision disturbances (amblyopia) and eye irritation;
breathing difficulties (dyspnoea);
reduced sexual function (impotence).

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

decrease in white blood cell count (leucopenia);
kidney problems (interstitial nephritis).

Not known (frequency cannot be estimated from available data)

blood disorders (thrombocytopenia, prolonged bleeding time);
mood changes (including depression);
movement disorders (extrapyramidal syndrome), dizziness;
heart problems such as sinoatrial block, congestive heart failure, changes in electrocardiogram results; temporary cessation of impulse formation at the sinus node (sinus arrest), and cardiac arrest due to absence of contraction phase (asystole);
low blood pressure (hypotension), slow heart rate (bradycardia), and other heart problems (atrioventricular block at the nodal level) if the medicine is administered intravenously;
inflammation of blood vessels (vasculitis), fluid retention (edema), particularly in the lower limbs;
sweating, headache;
increased size of the gums (gingival hyperplasia);
liver inflammation (hepatitis);
increased blood sugar levels (hyperglycaemia);
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, which may cause difficulty in swallowing or breathing (angioneurotic edema);
skin rash, severe skin condition that may affect areas around the mouth and other body parts (erythema multiforme), rare skin condition with blisters and bleeding of 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 (generalized exanthematous pustulosis), redness, blisters, and skin peeling with or without fever and sweating;
a condition in which the body's immune system attacks normal tissues, causing symptoms such as joint swelling, fatigue, and skin rashes (called "lupus-like syndrome");
breast enlargement in men (gynaecomastia);
reduced muscle strength (asthenia);
bronchial constriction (bronchospasm), including worsening of asthma.

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

5. How to store Diltiazem Mylan Generics Italia

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

6. Package contents and other information

What Diltiazem Mylan Generics Italia contains

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

Description of the appearance of Diltiazem Mylan Generics Italia and package contents
Carton pack containing 14 prolonged-release tablets.
Marketing Authorization 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)